Single patient use positive end expiratory pressure (PEEP) valve for use in hospital, transport, emergency, and post hospital care settings to evaluate end lung pressure above atmospheric pressure at the end of exhalation in constant and intermittent gas flow conditions.

Device Description

Not Found

AI/ML Overview

This is a 510(k) clearance letter for the Besmed PEEP Valve, a medical device. These letters indicate that the FDA has found the device to be substantially equivalent to a predicate device already on the market. They typically do not contain detailed information about the acceptance criteria and the comprehensive study results in the way one might expect for a research paper or a PMA application.

However, based on the context of a 510(k) and the information provided, I can infer some aspects and highlight what is not present.

Acceptance Criteria and Device Performance for Besmed PEEP Valve (K160112)

Given that this is a 510(k) premarket notification, the "acceptance criteria" primarily refer to the FDA's determination of substantial equivalence to a predicate device, rather than specific performance metrics against a defined clinical endpoint. The submission would have included performance data to demonstrate this equivalence. The letter itself does not detail the specific acceptance criteria values or the reported device performance values but confirms that the device was found substantially equivalent based on the provided data.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from 510(k) Process)	Reported Device Performance (Inferred/Not Explicitly Stated in Letter)
Device performs as intended for positive end expiratory pressure in various settings.	Demonstrated performance equivalent to predicate device.
Meets applicable performance standards for PEEP valves.	Testing confirmed that the PEEP value achieved and maintained appropriate pressure levels under specified conditions.
Biocompatibility requirements met.	Materials used are biocompatible and safe for patient contact.
Sterilization validated (if applicable for single-patient use).	Sterilization process effectively renders the device sterile.
Shelf-life stability established.	Device maintains performance characteristics over its specified shelf-life.
Labeling is truthful and not misleading, and supports safe and effective use.	Labeling conforms to regulatory requirements and accurately describes the device's indications, warnings, and instructions for use.

Important Note: The provided document is the FDA's clearance letter. It does not include the detailed performance data or the specific acceptance criteria (e.g., "PEEP variability must be within +/- X cmH2O") that were part of the original 510(k) submission. For that level of detail, one would need to access the full 510(k) summary, if publicly available, or the internal submission documents.

Study Information (Based on general 510(k) requirements and inferences):

For a device like a PEEP valve, the "study" would typically involve non-clinical (bench) testing to demonstrate the valve's ability to maintain specified PEEP levels under various flow conditions and over time, as well as biocompatibility testing. Clinical studies are generally not required for Class II devices seeking 510(k) clearance unless there are new or significantly different indications for use or technology.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the clearance letter. For bench testing, this would refer to the number of devices tested. It is often a statistically relevant sample size to ensure reproducibility and reliability of the performance data.
Data Provenance: Not specified, but likely from the manufacturer's internal testing facilities or a contracted testing lab. Given the manufacturer's location, the testing could be international (e.g., Taiwan, where Besmed is located) or in the US. The letter itself does not mention retrospective or prospective data, but bench testing is generally performed prospectively to gather specific performance characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question typically applies to studies involving human interpretation (e.g., imaging studies). For a mechanical device like a PEEP valve, "ground truth" is established by physical measurements and engineering standards, not expert consensus in the same way. The "experts" would be engineers and technicians performing the tests, adhering to established test protocols and using calibrated equipment. Their qualifications would involve expertise in medical device testing, respiratory mechanics, and relevant regulatory standards. The number of such individuals involved in test design, execution, and data analysis would vary but is not individually enumerated.

4. Adjudication method for the test set:

Again, this generally applies to scenarios with subjective human interpretation. For bench testing of a PEEP valve, objective measurement against predefined specifications is the primary "adjudication." Any discrepancies in measurements (e.g., between multiple test runs or different equipment) would be resolved through review of calibration records, re-testing, or technical investigation, not through a consensus panel in the sense of clinical adjudication.

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. An MRMC study is completely irrelevant for a PEEP valve. This type of study is specific to diagnostic imaging devices or AI-driven decision support tools where human interpretation of medical images or data is involved. The Besmed PEEP Valve is a mechanical breathing attachment; it does not involve AI or human "readers" in its function or evaluation for substantial equivalence.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No. This is also irrelevant. This question pertains to AI/software as a medical device (SaMD) where algorithms perform tasks without direct human intervention. The Besmed PEEP Valve is a hardware device; it does not contain an algorithm in this context.

7. The type of ground truth used:

For a PEEP valve, the ground truth is based on objective physical measurements against established engineering specifications and recognized consensus standards (e.g., ISO standards for respiratory equipment). This would include measurements of:
- Pressure control/accuracy (e.g., maintaining a set PEEP +/- tolerance).
- Flow resistance.
- Leakage.
- Durability.
- Biocompatibility (through laboratory testing of materials).

8. The sample size for the training set:

Not applicable. The concept of a "training set" applies to machine learning/AI models. A PEEP valve is a mechanical device, not an AI model, and therefore does not have a training set.

9. How the ground truth for the training set was established:

Not applicable. As above, there is no training set for a mechanical PEEP valve.

In summary, the provided FDA clearance letter attests to the Besmed PEEP Valve's substantial equivalence to a predicate device, based on a comprehensive 510(k) submission that would have included detailed bench testing and engineering data. However, the letter itself does not provide these detailed technical specifications or study results, and many of the questions (especially those related to AI, human readers, and clinical studies) are not pertinent to this type of device and regulatory submission.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 29, 2016

Besmed Health Business Corp. c/o Paul Dryden Consultant No.5, Lane 116, Wu-kong 2nd Rd New Taipei City. TW

Re: K160112

Trade/Device Name: Besmed PEEP Valve Regulation Number: 21 CFR 868.5965 Regulation Name: Positive End Expiratory Pressure Breathing Attachment Regulatory Class: Class II Product Code: BYE Dated: March 29, 2016 Received: March 30, 2016

Dear Paul Dryden:

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.

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 of medical devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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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Indications for Use

510(k) Number (if known)

K160112

Device Name

Besmed PEEP Valve

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

XX Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Regulation Number and Section

§ 868.5965 Positive end expiratory pressure breathing attachment.

(a)
Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.(b)
Classification. Class II (performance standards).