Besmed PEEP Valve

K160112 · Besmed Health Business Corp · BYE · Apr 29, 2016 · Anesthesiology

Device Facts

• Record ID: K160112
• Device Name: Besmed PEEP Valve
• Applicant: Besmed Health Business Corp
• Product Code: BYE · Anesthesiology
• Decision Date: Apr 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Besmed PEEP Valve is a single-patient-use respiratory accessory; attaches to manual resuscitators or other breathing circuits. Device functions as a mechanical valve to maintain positive end-expiratory pressure (PEEP) above atmospheric levels during exhalation. Used in hospital, transport, emergency, and post-hospital settings; operated by clinicians or trained personnel. Provides adjustable PEEP levels to support lung recruitment and oxygenation. Mechanical design ensures consistent pressure regulation during both constant and intermittent gas flow conditions. Benefits patient by preventing alveolar collapse and improving gas exchange.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Mechanical PEEP valve; single-patient use; designed for integration with manual resuscitators and breathing circuits. Operates via spring-loaded or similar mechanical pressure regulation mechanism to maintain positive pressure during exhalation. No software, electronics, or energy source required.

Indications for Use

Indicated for patients requiring positive end expiratory pressure (PEEP) therapy in hospital, transport, emergency, and post-hospital care settings. Used to maintain end lung pressure above atmospheric pressure during exhalation under constant or intermittent gas flow conditions.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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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