The Breathe Technologies Ventilator (BT-V2S), with Accessories, is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients, with or without a tracheostomy, that are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional environment. The device is intended for operation by trained personnel under the direction of a physician.

Device Description

This application is being filed to allow a new breathing circuit for the Breathe Technologies Ventilator (BT-V2). The Ventilator is fundamentally unchanged. The only difference between the predicate and application submissions is that the application requests clearance to market the BT-NT nasal interface with the BT-V2S ventilator.

The BT-NT is a nasal mask style patient circuit which attaches to the patients nose. It connects to the BT-V2S ventilator.

The BT-NT is approximately 12cm wide and 2cm thick at its thickest point under the patient's nose. These dimensions do not include the 231 cm dual tubing that connects to the Ventilator. It is composed of various plastics.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device modification (BT-V2S Ventilator and accessories). It states that the device is substantially equivalent to a predicate device, meaning it does not claim to offer superior performance or new functionalities that require extensive studies to prove acceptance criteria. Instead, the focus is on demonstrating that the modification (a new nasal interface breathing circuit, BT-NT) does not introduce new safety or efficacy concerns and that the device remains compliant with existing standards.

Therefore, the document does not contain the information requested in points 1-9 regarding the acceptance criteria, sample sizes, ground truth establishment, or expert involvement for a study proving device performance against specific acceptance criteria in the way one would expect for a novel AI/Diagnostic device.

Here's a breakdown of what is available and why most of the requested information is absent:

Explanation of Missing Information:

This document describes a "Special 510(k): Device Modification" for a ventilator. The core claim is "substantial equivalence" to a predicate device (BT-V2). This means the manufacturer is asserting that the modified device is as safe and effective as the previously cleared device, not that it is a new device with novel performance claims requiring rigorous clinical trials or AI performance evaluations. The modification here is specifically a "new breathing circuit for the Breathe Technologies Ventilator (BT-V2S)."

Therefore, the study performed is primarily bench testing and biocompatibility to prove that the modification does not negatively impact the existing performance and safety of the ventilator. This is fundamentally different from a study to establish novel performance metrics for AI or diagnostic accuracy where many of your questions would be highly relevant.

Information from the Document (and limitations):

Table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied): Compliance with
  - ISO 10993 (Biocompatibility)
  - FDA Draft Reviewer Guide for Ventilators (July 1995)
  - ASTM F1100 90 (1997), Standard Specification for Ventilators Intended for Use in Critical Care
  - IEC 60601 1 (1988), Amendment 1 (1991-11), Amendment 2 (1995): Medical electrical equipment - General Requirements for Safety
  - IEC 60601 2- 12 (2001-10): Medical electrical equipment - Particular requirements for the safety of lung ventilators - Critical care ventilators.
- Reported Device Performance:
  - Biocompatibility data demonstrates that the device is in compliance with ISO 10993.
  - Bench testing, including a lung model, has demonstrated that the BT-V2S remains in compliance with the expectations of the medical community, the product labeling, and the listed Standards and Guidances.
  - The document states: "The testing described below demonstrates that the differences in the devices do not raise any unresolved issues of safety or efficacy."
Sample size used for the test set and the data provenance: Not applicable. The "study" was bench testing (likely involving physical units of the ventilator and the new breathing circuit). There is no "test set" in the context of patient data, nor is there data provenance (e.g., country of origin, retrospective/prospective) for a bench test.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in this context, refers to the compliance with established engineering and medical device standards, which are evaluated by accredited labs and engineers, not typically by clinical experts establishing diagnostic "ground truth."
Adjudication method for the test set: Not applicable. There is no "adjudication" in the sense of resolving disagreements among experts on a test set. Compliance is determined by objective measurements against specified standard thresholds.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a ventilator, not an AI-powered diagnostic tool, and no MRMC study was performed or needed for this type of modification.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
The type of ground truth used: "Ground truth" was compliance with established engineering and medical device standards (ISO, ASTM, IEC) and the "expectations of the medical community" for ventilator performance, as verified through bench testing.
The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

Summary

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Breathe
TECHNOLOGIES.

K102525
BT-V2S and Accessories

Special 510(k): Device Modification

Section 5: 510(k) Summary

DEC - 2 2010

Device Information:
Category	Comments
Sponsor:	Breathe Technologies
	4000 Executive Parkway, Ste. 190
	San Ramon, CA 94583
	Tel: 925-359-1500
Correspondent ContactInformation:	Craig CoombsPresident
	Coombs Medical Device Consulting, Inc
	1193 Sherman St.
	Alameda, CA 94501
	Office: 510.337.0140
	Fax: 510.337.0416
Device Common Name:	Continuous Ventilator, Facility Use
Device Classification & Name:	21 CFR 868.5895
Device Classification &Product Code:	Class IIONZ
Device Proprietary Name:	Ventilator (BT-V2S)

Predicate Device Information:

Predicate Device:	Ventilator, BT-V2
Predicate Device Manufacturer:	Breathe Technologies
Predicate Device Premarket Notification #	K100528
Predicate Device Common Name:	Continuous Ventilator, Facility Use
Predicate Device Classification & Name:	21 CFR 868.5895
Predicate Device Classification &	Class II
Product Code:	ONZ

b. Date Summary Prepared

27 August 2010

c. Description of Device

The BT-NT is a nasal mask style patient circuit which attaches to the patients nose. It connects to the BT-V2S ventilator.

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Image /page/1/Picture/1 description: The image shows the logo for Breathe Technologies. The word "Breathe" is written in a bold, sans-serif font on the top line. Below that, the word "TECHNOLOGIES" is written in a smaller, sans-serif font. Underneath the words is a curved line that resembles a smile or a wave.

d. Intended Use

e. Comparison to Predicate Device

The Breathe Technologies BT-V2S and Accessories is substantially equivalent in Intended Use, Indications for Use, technology, design, materials, physician or patient use, and energy source to the predicate Breathe Technologies BT-V2S and Accessories (K100528).

This application presents the BT-V2S with a nasal interface breathing circuit (BT-NT) in addition to its predicate breathing circuit (BT-TT, aka BT-PC).

The testing described below demonstrates that the differences in the devices do not raise any unresolved issues of safety or efficacy.

Breathe Technologies concludes that the devices are substantially equivalent.

f. Summary of Supporting Data

Biocompatibility data demonstrates that the device is in compliance with ISO 10993.

Bench testing, including a lung model, has demonstrated that the BT-V2S remains in compliance with the expectations of the medical community, the product labeling, and the following Standards and Guidances:

FDA Draft Reviewer Guide for Ventilators (July 1995)
ASTM F1100 90 (1997), Standard Specification for Ventilators Intended for Use in Critical Care
· IEC 60601 1 (1988), Amendment 1 (1991-11), Amendment 2 (1995): Medical electrical equipment - General Requirements for Safety
IEC 60601 2- 12 (2001-10); Medical electrical equipment Particular requirements for the safety of lung ventilators - Critical care ventilators

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Image /page/2/Picture/0 description: The image shows a logo with the words "DEPARTMENT OF HEALTH & HU." arranged vertically along the left side. To the right of the text is a stylized graphic consisting of three curved lines stacked on top of each other. The lines appear to be a simplified representation of a human figure or symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Breathe Technologies, Incorporated C/O Mr. Craig Coombs Coombs Medical Device Consulting 1193 Sherman Street Alameda, California 94501

DEC - 2 2010

Re: K102525

Trade/Device Name: Breathe Technologies Ventilator (BT-V2S) with Accessories Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: ONZ Dated: August 27, 2010 Received: September 3, 2010

Dear Mr. Coombs:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Mr. Coombs

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersQffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

h for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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BT-V2S and Accessories Special 510(k): Device Modification

Section 4: Indications for Use Statement

DEC - 2 2010

510(k) Number (if known):

Device Name: Breathe Technologies Ventilator (BT-V2S) with Accessories

Indications For Use:

Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K102525

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).