BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)

K103345 · Breathe Technologies, Inc. · ONZ · Feb 11, 2011 · Anesthesiology

Device Facts

• Record ID: K103345
• Device Name: BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)
• Applicant: Breathe Technologies, Inc.
• Product Code: ONZ · Anesthesiology
• Decision Date: Feb 11, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Breathe Technologies™ Ventilator, with accessories, is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who 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 or home care environment. The device is intended for operation by trained personnel, patients, or caregivers under the direction of a physician.

Device Story

BT-V2S is a small, wearable volume assist ventilator interfacing with proprietary nasal and tracheostomy breathing circuits. It provides respiratory support for adult patients with respiratory insufficiency capable of spontaneous breathing (min 3.5cc/kg tidal volume). Used in institutional or home care environments for continuous applications including ambulation, physical therapy, and rehabilitation. Operated by trained personnel, patients, or caregivers under physician direction. Device transforms user-defined settings into mechanical ventilation; output is delivered via breathing circuits. Healthcare providers use the interface to monitor and adjust therapy. Benefits include patient mobility and support during rehabilitation. This submission expands indications to include home care use, supported by human factors studies validating the user interface and instructions for use.

Clinical Evidence

No clinical trials; evidence consists of three human factors studies. Study 1 evaluated clinicians; Study 2 evaluated respiratory therapy patients; Study 3 validated that modifications to training, instructions for use, and user interface addressed issues identified in Study 2. Bench testing confirmed compliance with ASTM F1100-90, ASTM F1246-91, IEC 60601-1, and IEC 60601-2-12.

Technological Characteristics

Wearable volume assist ventilator. Complies with ASTM F1100-90 (1997), ASTM F1246-91 (2005), IEC 60601-1 (1988/1991/1995), and IEC 60601-2-12 (2001). Interfaces with proprietary nasal and tracheostomy circuits. Electrically powered.

Indications for Use

Indicated for adult patients with respiratory insufficiency capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. Intended for continuous use in institutional or home care settings.

Regulatory Classification

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.

Predicate Devices

• Ventilator, BT-V2S (K102525)

Submission Summary (Full Text)

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K103345

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BT-V2S and Accessories Traditional 510(k): Expanded Indication

# Section 5: 510(k) Summary

## FEB 1 1 201

| Device Information: | |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Category | Comments |
| Sponsor: | Breathe Technologies<br>4000 Executive Parkway, Ste. 190<br>San Ramon, CA 94583<br>Tel: [phone] |
| Correspondent Contact<br>Information: | Craig Coombs<br>President<br>Coombs Medical Device Consulting, Inc<br>1193 Sherman St.<br>Alameda, CA 94501<br>Office: 510.337.0140<br>Fax: [phone] |
| Device Common Name: | Mechanical Ventilator |
| Device Classification & Name: | 21 CFR 868.5895 Continuous Ventilator |
| Device Classification &<br>Product Code: | Class II<br>ONZ |
| Device Proprietary Name: | Ventilator (BT-V2S) |

#### Predicate Device Information:

| Predicate Device: | Ventilator, BT-V2S |
|-------------------------------------------|-----------------------|
| Predicate Device Manufacturer: | Breathe Technologies |
| Predicate Device Premarket Notification # | K102525 |
| Predicate Device Common Name: | Mechanical Ventilator |
| Predicate Device Classification & Name: | 21 CFR 868.5895 |
| Predicate Device Classification & | Class II |
| Product Code: | ONZ |

#### b. Date Summary Prepared

11 February 2011

#### c. Description of Device

The Breathe Technologies Ventilator with Accessories (BT-V2S) is a small, wearable, ventilator that interfaces with proprietary nasal and tracheostomy breathing circuits.

This application is being filed to clear the use of the BT-V2S in the Home Care Environment. The device is unchanged from the previous cited submissions, except for the layout and workflow of its User Interface, along with the various Instructions for Use necessary to ensure proper use by the patient or lay caregiver.

#### d. Intended Use

The Breathe Technologies™ Ventilator, with accessories, is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously

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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 or home care environment. The device is intended for operation by trained personnel, patients, or caregivers under the direction of a physician.

### e. Comparison to Predicate Device

The Breathe Technologies Ventilator (BT-V2S) is substantially equivalent in Intended Use, Indications for Use, technology, design, and performance to the BT-V2S that was cleared in a previous 510(k) (K102525). The predicate and application ventilators and patient circuits are mechanically identical.

The application BT-V2S's Indication for Home Use is supported by multiple Human Factors studies. These studies demonstrate that the application device works as described in its labeling, and is therefore substantially equivalent to its predicate.

### f. Summary of Supporting Data

The Software Design and Validation process (Section 16) along with the bench testing of the device (Section 18) demonstrated that the BT-V2S operates as intended.

In particular, testing demonstrated that the BT-V2S continues to be compliant with the following Guidelines and Standards:

- 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
- ASTM F1246-91 (1991, Reapproved 2005); Standard Specification for . Electrically Powered Home Care Ventilators, Part 1 - Positive Pressure Ventilators and Ventilator Circuits

Additionally, three Human Factors Studies (Section 20) demonstrated that the intended users of the Ventilator (trained personnel, patients, or caregivers under the direction of a physician) can properly operate the device. The first study was with clinicians, and the second was with respiratory therapy patients. The third study demonstrated that the changes required in the training, Instructions for Use and User Interface were adequate to address the issues observed in the second study.

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The Human Factors testing documented conformance with these external Guidelines/Standards:

FDA Guideline: Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management. July 18, 2000

IEC 62366: 2007: Medical devices - Application of usability engineering to medical devices. FDA Recognition Number 5-50.

ANSI/AMEE HE75:2009: Human Factors Engineering-Design of Medical Devices.

END

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is black. The background is white. The text is centered in the image.

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

Mr. Joseph Cipillone Vice President Breathe Technologies, Incorporated 4000 Executive Parkway, Suite 190 San Ramon, California 94583

FFB 1 1 201

Re: K103345

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: November 11, 2010 Received: November 15, 2010

Dear Mr. Capillone:

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. Capillone

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/CentersOffices/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

hh 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

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# Section 4: Indications for Use Statement

510(k) Number (if known):

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

Indications for Use:

The Breathe Technologies™ Ventilator, with accessories, is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who 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 or home care environment. The device is intended for operation by trained personnel, patients, or caregivers under the direction of a physician.

Prescription Use × (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)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

L. Achutha

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

510(k) Number: _