(58 days)
The Breathe Technologies™ Ventilator BT-V2S, with accessories, is a volume assist ventilator intended to aid adult patients with respiratory in u vouln'is assist patients with 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, occurational 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 plysician
The Breathe Technologies™ Ventilator (BT-V2S) is a battery powered (which may be charged during use) wearable, volume ventilator that augments the patient's spontaneous breathing. The BT-V2S administers this physician-prescribed volume to the patient via the attached Breathe Technologies Patient Circuit (BT-PC). The end of the BT-PC is inserted into the patient's tracheostomy tube. The ventilator is small and light enough to be worn on a patient's belt, or slung over their shoulder.
The provided text describes a 510(k) premarket notification for the Breathe Technologies BT-V2S Ventilator. This submission focuses on demonstrating substantial equivalence to a predicate device (BT-VS) rather than presenting a de novo study with acceptance criteria and performance metrics for a new, unclassified device.
Therefore, the input document does not contain the acceptance criteria and study data typically associated with proving a device meets specific performance criteria through a clinical or rigorous standalone study. It primarily states that "Bench testing has demonstrated that the device is in compliance with the medical community's expectations, the product labeling and pertinent sections of the guidance's and standards."
Without a separate study report or detailed performance data, it's not possible to populate the requested table or answer most of the questions.
However, I can extract the information provided:
1. A table of acceptance criteria and the reported device performance:
The document explicitly states: "Bench testing has demonstrated that the device is in compliance with the medical community's expectations, the product labeling and pertinent sections of the guidance's and standards." This implies that the 'acceptance criteria' were likely defined by those standards and expectations, and the 'reported device performance' was that it met them. However, the specific quantitative criteria and results are not provided in this document.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. The document refers to "bench testing," not a test set with patient data or a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. No test set with ground truth established by experts is mentioned. The "medical community's expectations" are a general reference, not a specific expert panel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set with adjudication is mentioned.
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-assisted 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 algorithm-only device. The ventilatory function is directly interacting with the patient. The statement "Bench testing has demonstrated that the device is in compliance..." refers to the device's physical and functional performance, which is inherently "standalone" in the sense that it's the device's performance being assessed against engineering and medical standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the bench testing, the "ground truth" would be the engineering specifications, relevant industry standards (e.g., ISO 10993 for biocompatibility), and "medical community's expectations" related to ventilator performance. The document doesn't provide specifics on how these were quantified for each test.
8. The sample size for the training set:
Not applicable. This is a ventilator device, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable, for the same reason as point 8.
{0}------------------------------------------------
ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
APR 2 3 2011
Breathe Technologies Inc.
Breathe Technologies BT-V2S Special 510(k) Premarket Notification
| Device Information: | |
|---|---|
| Category | Comments |
| Sponsor: | Breathe Technologies4000 Executive Parkway, Ste. 190San Ramon, CA 94583Tel: 925-359-1500 |
| Correspondent ContactInformation: | Suzon LommelBreathe Technologies4000 Executive Parkway, Ste. 190San Ramon, CA 94583Tel: 925-359-1508Fax: 925-886-8622 |
| Device Common Name: | |
| Device Classification Number: | 21 CFR 868.5895 |
| Device Classification &Product Code: | Class II,ONZ |
| Device Proprietary Name: | Ventilator (BT-V2S) |
Section 5: 510(k) Summary
Predicate Device Information: [repeat table for each predicate]
| Predicate Device: | BT-VS |
|---|---|
| Predicate Device Manufacturer: | Breathe Technologies Inc. |
| Predicate Device Common Name: | Continuous Ventilator, Facility Use |
| Predicate Device Premarket Notification # | K082982 |
| Predicate Device Classification: | 21 CFR 868.5895 |
| Predicate Device Classification & | Class II, ONZ |
| Product Code: | ONZ |
b. Date Summary Prepared
22 February 2010
c. Description of Device
c.1. Intended Patient Populations with Medical Condition
Breathe Technologies™ has identified a group of ventilator dependent, or highly oxygen dependent patients, in institutional settings that are being poorly served by standard ventilators excluding the predicate Breathe Technologies BT-VS. This group needs ventilation support but only at low levels. They need to ambulate within the facility and participate in respiratory, physical and occupational therapy. The ease of carrying the 1 pound ventilator, while their inspiratory efforts are properly supplemented, may allow for ambulation for these patients. It is intended only for institutional use.
{1}------------------------------------------------
c.2. General Description of the Breathe Technologies Ventilator and Patient Circuit (BT-V2S)
The Breathe Technologies™ Ventilator (BT-V2S) is a battery powered (which may be charged during use) wearable, volume ventilator that augments the patient's spontaneous breathing.
The BT-V2S administers this physician-prescribed volume to the patient via the attached Breathe Technologies Patient Circuit (BT-PC). The end of the BT-PC is inserted into the patient's tracheostomy tube.
The ventilator is small and light enough to be worn on a patient's belt, or slung over their shoulder.
d. Intended Use
The Breathe Technologies™ Ventilator BT-V2S, with accessories, is a volume assist ventilator intended to aid patients with respiratory insufficiency. It is designed for patients with 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 BT-V2S is substantially equivalent in design, performance, software, materials, and intended use to the predicate device BT-VS, K#0802982 cleared July 20, 2009.
Both devices provide volume assist ventilation through a patient circuit inserted into a trans-tracheal tube to aid patients with respiratory insufficiency.
Both devices supply oxygen supplemented by entrained ambient air through the patient circuit.
Both devices are triggered by a patients' inspiration.
The devices use different mechanical components allowing for a lighter weight and smaller footprint. The predicate device weighs 3.1lbs while the subject device weighs 11b. The Company device may be more appropriate for patients as it is easier and lighter when worn.
The testing described below demonstrates that the differences in the devices do not raise any unresolved issues of safety or efficacy.
{2}------------------------------------------------
Breathe Technologies Inc.
Both ventilators may be cleaned using the same method and both patient circuits are single use only and ethylene oxide sterilized.
Company 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 has demonstrated that the device is in compliance with the medical community's expectations, the product labeling and pertinent sections of the guidance's and standards.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Suzon Lommel Vice President, Regulatory and Quality Affairs Breathe Technologies, Incorporated 4000 Executive Parkway, Suite 190 San Ramon, California 94583
APR 2 3 2010
Re: K100528
Trade/Device Name: Ventilator, BT-V2S with Accessories Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: ONZ Dated: April 20, 2010 Received: April 21, 2010
Dear Ms. Lommel:
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. Lommel
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
h for
Anthony 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
{5}------------------------------------------------
Section 4: Indications for Use Statement
510(k) Number (if known):
Device Name: Breathe Technologies Inc. Ventilator, BT-V2S with accessories
The Breathe Technologies™ Ventilator BT-V2S, with accessories, is a volume assist ventilator intended to aid adult patients with respiratory in u vouln'is assist patients with 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, occurational 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 plysician
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
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
L. Schulten
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection 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).