BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)

K102525 · Breathe Technologies, Inc. · ONZ · Dec 2, 2010 · Anesthesiology

Device Facts

• Record ID: K102525
• Device Name: BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)
• Applicant: Breathe Technologies, Inc.
• Product Code: ONZ · Anesthesiology
• Decision Date: Dec 2, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

BT-V2S is a volume assist ventilator for adult patients with respiratory insufficiency. Device supports patients capable of spontaneous breathing (min 3.5cc/kg tidal volume). Modification adds BT-NT nasal interface to existing BT-V2S ventilator platform. System connects to patient via nasal mask or tracheostomy circuit. Used in institutional environments for continuous applications including ambulation, physical therapy, and rehabilitation. Operated by trained personnel under physician direction. Provides respiratory support to facilitate patient mobility and therapy efforts.

Clinical Evidence

Bench testing only. Compliance with ISO 10993 for biocompatibility. Performance verified using lung model testing against FDA Draft Reviewer Guide for Ventilators (1995), ASTM F1100-90, IEC 60601-1, and IEC 60601-2-12.

Technological Characteristics

Volume assist ventilator. Materials: various plastics (biocompatible per ISO 10993). Interface: nasal mask (BT-NT) or tracheostomy circuit. Connectivity: dual tubing. Standards: ASTM F1100-90, IEC 60601-1, IEC 60601-2-12.

Indications for Use

Indicated for adult patients with respiratory insufficiency capable of spontaneous breathing (min tidal volume 3.5cc/kg predicted body weight), with or without tracheostomy. Used for continuous support during ambulation and rehabilitation in institutional 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-V2 (K100528)

Submission Summary (Full Text)

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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: [phone] |
| Correspondent Contact<br>Information: | Craig Coombs<br>President |
| | Coombs Medical Device Consulting, Inc |
| | 1193 Sherman St. |
| | Alameda, CA 94501 |
| | Office: 510.337.0140 |
| | Fax: [phone] |
| Device Common Name: | Continuous Ventilator, Facility Use |
| Device Classification & Name: | 21 CFR 868.5895 |
| Device Classification &<br>Product Code: | Class II<br>ONZ |
| 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

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.

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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

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.

#### 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 [phone] or [phone] 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:

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.

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