(280 days)
The NIOV Ventilator, with accessories; is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients that are capable of spontaneously breathing a minimum tidel volume of 3.5 ml/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical 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 their caregivers under the direction of a physician.
The Breathe Technologies NIOV Ventilator System is a battery powered, wearable, volume ventilator that augments the patient's spontaneous breathing. The NIOV Ventilator administers this physician-prescribed volume to the patient via the attached Breathe Technologies Patient Circuit (BT-PC) which inserts into the patient's tracheostomy tube, or via the Breath Technologies NIOV Pillows Interface, a type of nasal mask. The ventilator is small and light enough to be worn on a patient's belt, or slung over their shoulder. It is connected to a separate, third party, air or oxygen gas supply. The Ventilator is cleared for Institutional or Home Use.
The provided text describes the Breathe Technologies NIOV Ventilation System and its substantial equivalence to a predicate device, but it does not contain the specific information required to answer all parts of your request regarding acceptance criteria and a study proving those criteria.
Specifically, the text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed study results against specific, quantified acceptance criteria.
However, I can extract what is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantified, pass/fail manner. Instead, it refers to compliance with recognized standards and guidelines. The "reported device performance" is a general statement of compliance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with FDA Draft Reviewer Guide for Ventilators (July 1995) | Demonstrated continued compliance |
| Compliance with ASTM F1100-90 (1997) | Demonstrated continued compliance |
| Compliance with IEC 60601-1 (1988) | Demonstrated continued compliance |
| Compliance with IEC 60601-2-12 (2001-10) | Demonstrated continued compliance |
| Compliance with ASTM F1246-91 (1991, Reapproved 2005) | Demonstrated continued compliance |
| Operating as intended | Demonstrated by Software Design and Validation & bench testing |
The study that proves the device meets the (implied) acceptance criteria:
The study referenced is "bench testing of the device" and "Software Design and Validation process."
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" sample size in the context of clinical or performance data for the device itself. It mentions "bench testing," which implies laboratory-based tests on the device, but details on the number of units tested or specific scenarios are not provided. There is no mention of data provenance like country of origin or whether it was retrospective/prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The bench testing and software validation would likely rely on engineering and technical expertise to establish "ground truth" (i.e., correct device function or output), but no details on expert numbers or qualifications are given.
4. Adjudication method for the test set
This information is not provided.
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
No such study is mentioned. The device is a ventilator, not an AI-powered diagnostic imaging tool that would typically involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not relevant to a mechanical ventilator like the Breathe Technologies NIOV. The device itself operates "standalone" in the sense that it performs its function (ventilation) without direct human intervention in each breath cycle, but it is operated by trained personnel, patients, or caregivers. The document indicates that "bench testing of the device" demonstrated its operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench testing and software validation, the ground truth would likely be based on:
- Engineering specifications and design requirements.
- Measurements against calibrated standards for parameters like volume, pressure, flow, and timing.
- Expected behavior defined by the referenced industry standards (e.g., ASTM, IEC).
8. The sample size for the training set
This information is not provided. The device relies on embedded software and control algorithms, but the document does not discuss machine learning or "training sets" in the context of AI.
9. How the ground truth for the training set was established
Not applicable, as no training set for AI is mentioned.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for Breathe Technologies. The word "Breathe" is in a bold, sans-serif font, with the word "TECHNOLOGIES" in a smaller font underneath. A curved line is below the word "TECHNOLOGIES". The logo is in black and white.
| Device Information: | |
|---|---|
| Category | Comments |
| Sponsor: | Breathe Technologies175 Technology Drive, Suite 100Irvine, CA 92618Tel: 949-988-7700 |
| 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: | Breathe Technologies NIOV Ventilation System |
Section 5: 510(k) Summary
Predicate Device Information: Pending Clearance
| Predicate Device: | Ventilator, BT-V2S |
|---|---|
| Predicate Device Manufacturer: | Breathe Technologies |
| Predicate Device Premarket Notification # | K103345 |
| 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
5 March 2014
c. Description of Device
The Breathe Technologies NIOV Ventilator System is a battery powered, wearable, volume ventilator that augments the patient's spontaneous breathing.
The NIOV Ventilator administers this physician-prescribed volume to the patient via the attached Breathe Technologies Patient Circuit (BT-PC) which inserts into the patient's tracheostomy tube, or via the Breath Technologies NIOV Pillows Interface, a type of nasal mask.
The ventilator is small and light enough to be worn on a patient's belt, or slung over their shoulder. It is connected to a separate, third party, air or oxygen gas supply.
The Ventilator is cleared for Institutional or Home Use.
{1}------------------------------------------------
Breathe
TECHNOLOGIES
d. Intended Use
The NIOV Ventilator, with accessories, is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients that are capable of spontaneously breathing a minimum tidal volume of 3.5 ml/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 their caregivers under the direction of a physician.
e. Comparison to Predicate Device
The Breathe Technologies NIOV Ventilator is substantially equivalent in Intended Use. Indications for Use, technology, design, and performance to the BT-V2S that was cleared under K103345. The ventilators' patient circuits are mechanically identical. They differ only in a few dimensions.
The modifications for the application device are described in part 1h of section 11. All the changes, except for the additional supply gas, would be considered a "Not Significant" change when judged by themselves according to the FDA memorandum "Deciding when to Submit a 510(k) for a Change to an Existing Device, K97-1." Many have already been implemented per the justifications of the K97-1 memo.
None of the changes creates a change in the indications for use or a change in the fundamental scientific technology of the Breathe NIOV Ventilator.
Since only one of the modifications are significant per FDA guidelines, and the addition of air as a supply gas does not raise new questions of safety or effectiveness, the version of the Breathe NIOV Ventilator submitted in this application is substantially equivalent to the predicate version of the BT-V2S described in K103345.
Breathe Technologies concludes that based on intended use, performance and documentation the application NIOV Ventilator is substantially equivalent to the BT-V2S that was cleared under K103345.
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 Breathe NIOV Ventilator System operates as intended.
In particular, testing demonstrated that Breathe NIOV Ventilator System 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
{2}------------------------------------------------
- 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
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms. The symbol is composed of three curved lines that create a sense of movement and dynamism.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 6, 2014
Breathe Technologies c/o Mr. Craig Coombs, President Coombs Medical Device Consulting, Inc. 1193 Sherman St. Alameda CA 94501
Re: K131562
Trade/Device Name: Breathe Technologies NIOV Ventilation System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous ventilator Regulatory Class: II Product Code: ONZ Dated: January 31, 2014 Received: February 3, 2014
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.
{4}------------------------------------------------
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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.
Image /page/4/Picture/7 description: The image shows a logo or seal with text and graphic elements. The text includes "Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID". The logo features a stylized design with geometric shapes and decorative flourishes. The word "FOR" is also present in the image.
Sincerely yours.
Erin I. Keith, M.S. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
:
Enclosure
{5}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K131562
Device Name
Breathe Technologies NIOV Ventilation System
Indications for Use (Describe)
The NIOV Ventilator, with accessories; is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients that are capable of spontaneously breathing a minimum tidel volume of 3.5 ml/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical 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 their caregivers under the direction of a physician.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
PLEASE DO NOT WRITE BELOW THIS LINE. - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY 上海: 上海 :" ﻧ Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Image /page/5/Picture/13 description: The image shows the logo for the Food and Drug Administration (FDA). The logo is a stylized version of the letters "FDA", with each letter formed by multiple parallel lines. The letters are arranged horizontally, with "F" on the left, "D" in the middle, and "A" on the right. The logo is in black and white.
Anva C. Harry -S 2014.03.05 13:04:58 -05'00'
FORM FDA 3881 (1/14)
PSC Publishing Services (301) 413-6740 FF
at . - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
{6}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB 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).