Request for Pre-Submission

FDA, United States

Radiological Health and Device Center

DCC – W066-G609

Hampshire New Avenue-10903

MD 20993-0002, Silver Spring

Attention: xxxxx

Department of Cardiovascular Devices-Director

Device Evaluation Office

Re:  Pre-Submission Meeting Request for a Premarket Approval (PMA)

Dear xxxxx

Please find enclosed single copies for both electronic and a paper, on CD, for this Pre-Submission Meeting Request. As an exact duplicate, the e-copy is from the single paper copy.

As a request, we ask for a Pre-Submission Meeting to discuss the development and regulatory path of the Azure™ device, a pacemaker DR MRI Sure scan. The device is a Medtronic Azure™ system.  The details of the requested meeting are below:

Proposed Agenda

We request a one-hour meeting to discuss the following topics:

• Introductions (5 minutes)
• Predicate devices (20 minutes)
• Proposed clinical studies (20 minutes)
• Labeling (15 minutes)

As the Azure^TM technologies, we request the FDA with due respect to offer maximum protection for this information as indicated by the law. Azure^TM technologies would want to consider the information in the pre-submission to be confidential and highly prioritized.

For any question that might emerge concerning this pre-submission, please reach me at xxxx@gmail.com

Sincerely,

Name xxxxx

Regulatory Affairs, Vice Chairman

Azure™ Technologies, Inc.

Airport Parkway, Suite 250

California 05110

Fax: xxxxxxx

Phone no: xxxxxxx

Email: xxxx@gmail.com

Table of Contents

Re:  Pre-Submission Meeting Request for a Premarket Approval (PMA) 1

Proposed Agenda. 1

Device Description. 4

Previous Discussions or Submissions. 6

Intended Use Proposition/ Use Indication. 6

Proposed Predicate Devices. 7

AliveCor Heart Monitor. 7

Omron 7 Series Ultra Silent BP652N Wrist Blood Pressure Monitor. 10

Overview of Product Development 13

Specific Questions. 17

Feedback Method. 17

Device Description

Previous Discussions or Submissions

Azure™ Technologies, Inc has not had any discussions on the proposed medical device with the FDA.  This Pre-Submission Request is the first submission put forward for discussion with the FDA. Therefore, the proposal submitted is an original idea that has not been presented before for any medical experiment.

Intended Use Proposition/ Use Indication

Proposed Predicate Devices

The proposed device is the most current model of Azure^TM technologies (Model W3SR01). The device model is compared with other predicative devices as aligned from the FDA guidelines. These include AliveCor Heart Monitor as well as the Omron 7 Series Ultra Silent BP652N Wrist Blood Pressure Monitor. Analysis from the results indicates no much differences from the predicative devices.

AliveCor Heart Monitor

Omron 7 Series Ultra Silent BP652N Wrist Blood Pressure Monitor

Overview of Product Development

• Azure™ Technologies, Inc. has designed the proposed device (Model W3SR01) as per the recognized standards applicable to product code DR IPG and MRI SR. The device is featured by specific standards and guidelines. Such features maintain the device’s effectiveness and efficiency when applied by the patients. The standards include the following:
  • ISO 14117:2019: Equipment for medical practices (Featured through its compatibility regarding electromagnetic). Section 2 Guarantees therapy mechanisms through its assistance in treating the problems that lead to heart diseases. Particularly, the device indicates its physical capability. The ability to store energy for a long time indicates its battery effectiveness.

The proposed device has specific battery charging conditions for recharging the lithium-ion battery. That is, despite a smartphone display being enabled in the device, its Lithium-ion battery recharged through special features of battery for the device proposed. An addition of two electrodes for noise cancellation in the device does not allow an impact on the proposed device’s safety and effectiveness.

• ISO 14708-2:2005: Informatics for device proposed based on health. The proposed device indicates its capability in health tests regarding the patient’s responses. Section 3 indicates various features that are analyzed regarding the functions and effectiveness of the device proposed. Therefore, the safety of patients is guaranteed and no possibility for risks as the FDA guidelines would expect for any proposed device. The following functions for the proposed device help to assure its safety and effectiveness when being used.
  • Device specialization – Specializes in monitoring the patient’s pressure in blood as well as pulse rate.
  • Ensure medical communication- The device is capable of wireless transfer of responses detected to the clinic.
  • Advanced communication protocol – Computer-assisted electrocardiography. Hence the device uses mobile phone apps to transfer responses detected from the patient.
  • Specialization – The proposed device focus on a basic electrocardiograph that enables information transfer.
  • Advanced specialization – Use of Bluetooth mechanism to transfer wireless data from the patient’s responses to be displayed apps for evaluation

As a result, the proposed device follows particular guidelines as indicated in two documents. The most primary aspects of the guidelines are to ensure no contradictions when using the device. Most importantly, the guidelines might act as warning measures to the user/ patient. The following are the guideline documents.

• FDA-2020-D-0957: Medical electrical equipment. The document is laid out as a platform to make the best selection of a pacemaker through which a patient can rely upon. Most importantly, would want to achieve the most efficient implantation of the device. As a result, the device must be differentiated from similar devices through a different established measure. AzureTM technologies understand that according to FDA guidelines, the medical device must comply with clinical standards; thus, leaving no room for risk or danger to a patient’s health. Key elements in the document regarding the device are as follows;
  • Section 2-25: Specific measures for primary performance, safety, and effectiveness of electrocardiographs. The performance of the device has aligned with its ability to maintain better health condition to the user.
  • Section 1-2: Internal verification and validation testing.
• FDA-2013-S-0610: Cardiac rhythm report and test, based on performance as well as divisions created through initiated algorithms of the proposed device. As indicated in the document, the patient is not allowed to use the device after its capability has lowered. This is to ensure maximum reliability for the device as far as the health of the patient is concerned. Therefore, the device is limited to a single user until the recovery process is achieved. Another patient should not allow the implantation of an already used device as the reliability of the device cannot be depended upon. Risks that might emerge unnecessarily by implanting the device the second time should be avoided by the use of a new device.

• Non-clinical testing performed to date:
  • “proposed and predicative devices performance comparison tests recorded”
  • “Test concerning the performance records detected”
  • “Test for verification and cleaning concerning device users”
• Additional tests consisted of:
  • “Software verification and validation”
  • “Biocompatibility of patient contacting materials”
  • “Examining related safeties detected based on electrical capability, compatibility in electromagnets as well as requirements for discharge in electrostatic measures”
• Anticipated clinical testing
  • Azure™ Technologies, Inc. intends to perform clinical testing under ISO-81060-2:21013: Section 2 focuses on the key measures that clinicians follow when developing investigative measures of equipment. Most of the requirements focus on the pressure of blood in the artery through an automated non-invasive estimation.
    • Comparability assessment of proposed device with proposed predicate device for blood pressure measurement
    • Comparability assessment of proposed device with proposed predicate device and conventional 12 lead ECG system for the measurement of ECG rhythms and detection of atrial fibrillation, tachycardia, bradycardia, and normal sinus rhythms.
    • The ability for device sustainability when in use, the level to which it can be relied upon.

Specific Questions

• Based on the submissions we have given, does the FDA advise for further developments on the device, or is there a need to maintain the current features until performance evaluation?
• Are there concerns with proposing two predicate devices that each perform a separate function when compared to the proposed device that combines both functions in one?
• Provided that the proposed device detects bradycardia and tachycardia, are there concerns from the FDA to make consider the proposed device to implement with immediate effect?
• Are there any comments from the FDA on our proposal not to conduct any human factors testing on the cuff closure mechanism of the proposed device (metal bucket)?
• The proposed device includes a guide that leads a person into the correct position for blood pressure monitoring. Does the FDA recommend conducting clinical studies that would provide evidence of cuff placement accuracy?
• Other than the clinical studies listed above, what additional clinical studies would FDA recommend performing that would provide significant evidence that measuring blood pressure using a wrist cuff is equivalent to measuring blood pressure with an arm cuff?
• What kind of testing would FDA consider sufficient to demonstrate that the addition of two noise-canceling electrodes does not interfere with accurate detection of atrial fibrillation and normal sinus rhythm and does not falsify the presence or lack of bradycardia and tachycardia?
• Would FDA recommend using a different predicate device to make comparisons between fibrillation of arteries as well as hypertension identification, tachycardia as well as bradycardia since the proposed predicate device cannot make a diagnosis; thus, requiring healthcare provider to receive a record of ECG to review first?
• Does the FDA agree that it is sufficient to inform the user in the instructions manual that the detection of atrial fibrillation, bradycardia, and tachycardia must be confirmed by a physician or another healthcare professional? Would FDA require additional labeling anywhere on the device?

Feedback Method

1. Meeting format

We request an in-person meeting and would require a conference phone and an LCD projector for the meeting.

1. Preferred Meeting Dates:

• September 2^nd, 2020, from 8 am and 4 pm EST
• November 8^th, 2020 from 8 am and 4 pm EST
• December 5^th, 2020 from 8 am and 4 pm EST
  1. Planned Attendees:

1. EDF JFT, Vice President of Engineering, Azure™ Technologies, Inc.
2. YTR POT, Vice President of Non-clinical Operations, Azure™ Technologies, Inc.
3. FGT FRT, Vice President of Clinical Operations, Azure™ Technologies, Inc.
4. WAGER YTR, Vice President of Regulatory Affairs, Azure™ Technologies, Inc.