(280 days)
Not Found
No
The document does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies.
Yes.
The device's intended use is to aid adult patients with respiratory insufficiency, and it administers physician-prescribed volume to augment a patient's spontaneous breathing, which directly addresses a medical condition or provides therapy.
No
The device is described as a "volume assist ventilator intended to aid adult patients with respiratory insufficiency." Its function is to augment spontaneous breathing by administering physician-prescribed volume, not to diagnose a condition.
No
The device description explicitly states it is a "battery powered, wearable, volume ventilator" and mentions physical components like a "Patient Circuit" and "NIOV Pillows Interface," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The NIOV Ventilator is a device that provides mechanical ventilation to assist patients with breathing. It directly interacts with the patient's respiratory system, not with samples taken from the body.
- Intended Use: The intended use describes aiding adult patients with respiratory insufficiency by providing volume assist ventilation. This is a therapeutic intervention, not a diagnostic test.
- Device Description: The description details how the ventilator delivers air or oxygen to the patient via a circuit or nasal mask. This is consistent with a respiratory support device, not an IVD.
Therefore, the NIOV Ventilator falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
ONZ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
"operation by trained personnel, patients or their caregivers under the direction of a physician." "institutional or home care environment."
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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 Technologies |
| 175 Technology Drive, Suite 100 | |
| Irvine, CA 92618 | |
| Tel: 949-988-7700 | |
| Correspondent Contact | |
| Information: | Craig Coombs |
| President | |
| Coombs Medical Device Consulting, Inc | |
| 1193 Sherman St. | |
| Alameda, CA 94501 | |
| Office: 510.337.0140 | |
| Fax: 510.337.0416 | |
| Device Common Name: | Mechanical Ventilator |
| Device Classification & Name: | 21 CFR 868.5895 Continuous Ventilator |
| Device Classification & | |
| Product Code: | Class II |
| ONZ | |
| 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
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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.
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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 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.
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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
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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.
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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)
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Anva C. Harry -S 2014.03.05 13:04:58 -05'00'
FORM FDA 3881 (1/14)
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