(88 days)
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.
The Breathe Technologies Ventilator with Accessories (BT-V2S) is a small, wearable, ventilator that interfaces with proprietary nasal and tracheostomy breathing circuits.
The provided text describes the Breathe Technologies Ventilator (BT-V2S) and its accessories, and a 510(k) submission for expanded indication to include use in the Home Care Environment. The information focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed acceptance criteria or a study design in the way you've outlined for a typical AI/software device.
Specifically, the document discusses general standards and guidelines the device complies with, and "Human Factors Studies" to demonstrate proper operation by intended users. It does not provide quantitative performance metrics, sample sizes, ground truth establishment, or expert-based evaluations in the context of an AI/algorithm-driven device.
Therefore, many of the requested fields cannot be directly extracted from the provided text. I will fill in the available information and indicate where data is not present.
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or performance metrics directly from a study in the format typically seen for AI/diagnostic devices. Instead, it states that the device is compliant with various industry standards and guidelines, and that "Human Factors Studies" demonstrated proper operation.
| Acceptance Criteria (Implied from compliance/study goals) | Reported Device Performance (Summary from text) |
|---|---|
| Compliance with FDA Draft Reviewer Guide for Ventilators (July 1995) | Demonstrated compliance |
| Compliance with ASTM F1100-90 (1997) | Demonstrated compliance |
| Compliance with IEC 60601-1 (1988), Amd 1 (1991-11), Amd 2 (1995) | Demonstrated compliance |
| Compliance with IEC 60601-2-12 (2001-10) | Demonstrated compliance |
| Compliance with ASTM F1246-91 (1991, Reapproved 2005) | Demonstrated compliance |
| Proper operation by intended users (Human Factors) for Home Use | "Demonstrated that the intended users... can properly operate the device." |
| Conformance with FDA Guideline: Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management. July 18, 2000 | Documented conformance |
| Conformance with IEC 62366: 2007 | Documented conformance |
| Conformance with ANSI/AMEE HE75:2009 | Documented conformance |
2. Sample size used for the test set and the data provenance
The document mentions "three Human Factors Studies" but does not provide sample sizes for these studies or their data provenance (e.g., country of origin, retrospective/prospective nature), beyond stating "The first study was with clinicians, and the second was with respiratory therapy patients."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a mechanical ventilator, and the studies mentioned are Human Factors studies focused on usability and proper operation, not diagnostic accuracy requiring expert ground truth in the traditional sense of medical image analysis. The "experts" would likely be the clinicians and patients participating in the Human Factors studies.
4. Adjudication method for the test set
Not applicable. Adjudication methods are typically relevant for establishing ground truth in diagnostic studies, which is not the type of study described here.
5. 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 is not an AI-driven device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-driven device.
7. The type of ground truth used
For the Human Factors studies, the "ground truth" was likely defined by observational data and user feedback demonstrating the ability of users (clinicians, patients, caregivers) to safely and effectively operate the device according to its instructions and design, and to identify and address any usability issues. This is not a pathology or outcomes data ground truth in the diagnostic sense.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The "training" here refers to the actual training of users on how to operate the device.
9. How the ground truth for the training set was established
Not applicable. See point 8.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for Breathe Technologies. The word "Breathe" is in large, bold letters on the top line. Below that, in smaller letters, is the word "TECHNOLOGIES". There is a curved line below the word "TECHNOLOGIES".
BT-V2S and Accessories Traditional 510(k): Expanded Indication
Section 5: 510(k) Summary
FEB 1 1 201
| Device Information: | |
|---|---|
| Category | Comments |
| Sponsor: | Breathe Technologies4000 Executive Parkway, Ste. 190San Ramon, CA 94583Tel: 925-359-1500 |
| Correspondent ContactInformation: | Craig CoombsPresidentCoombs Medical Device Consulting, Inc1193 Sherman St.Alameda, CA 94501Office: 510.337.0140Fax: 510.337.0416 |
| Device Common Name: | Mechanical Ventilator |
| Device Classification & Name: | 21 CFR 868.5895 Continuous Ventilator |
| Device Classification &Product Code: | Class IIONZ |
| 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
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image contains the words "Breathe" and "Technologies" stacked on top of each other. The word "Breathe" is in a larger font than the word "Technologies". There is a curved line underneath the word "Technologies".
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.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the word "Breathe" in a bold, sans-serif font. Below "Breathe" is the word "TECHNOLOGIES" in a smaller, sans-serif font. Underneath the words is a curved line that resembles a wave or a stylized breath.
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
{3}------------------------------------------------
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.
{4}------------------------------------------------
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 (800) 638-2041 or (301) 796-7100 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
{5}------------------------------------------------
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: _
§ 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).