DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE

K133957 · Galemed Corp. · BYE · Apr 14, 2014 · Anesthesiology

Device Facts

• Record ID: K133957
• Device Name: DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE
• Applicant: Galemed Corp.
• Product Code: BYE · Anesthesiology
• Decision Date: Apr 14, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5965
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

Single patient use adjustable positive end expiratory pressure (PEEP) valves for use in hospital, transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions. For use with neonates to adults. Environment of Use: Hospital, extended care facilities, emergency medical services, and patient transport. May be used in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

Device Story

Disposable adjustable PEEP valve; spring-actuated mechanism; elevates lung pressure above atmospheric at end of exhalation. Used in hospital, transport, emergency, and post-hospital care; operated by clinicians. Device connects to breathing circuits or manual resuscitators. Modified from predicate to include non-magnetic materials (push rod, springs) for MR conditional use up to 3.0 Tesla. Provides mechanical pressure regulation; no electronic or software components. Benefits patient by maintaining positive end-expiratory pressure during constant or intermittent gas flow.

Clinical Evidence

Bench testing only. Performance data included leakage testing, pressure/resistance accuracy, drop testing, environmental stress testing, and age testing. MR conditional status verified per ASTM F2052-02 in a 3 Tesla suite, confirming deflection < 45 degrees.

Technological Characteristics

Spring-actuated mechanical valve; 22/30 mm connections. Materials: non-magnetic components (rod and springs) for MR compatibility. MR conditional up to 3.0 Tesla static magnetic field. No software, electronics, or energy source. Disposable, single-patient use.

Indications for Use

Indicated for neonates to adults requiring elevated end expiratory pressure therapy in hospital, transport, emergency, or post-hospital settings. Contraindicated in individuals not requiring elevated end expiratory pressure therapy.

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.

Predicate Devices

• Galemed PEEP valve (K082092)
• Mercury Medical - PEEP Valve MR (K081266)

Submission Summary (Full Text)

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## K133957

# APR 1 4 2014

## 510(k) Summary Page 1 of 4 12-Feb-14

Galemed Corp. Amoy Export Processing Zone, 39 Section 3, Haijing East Road Xiamen, Fujian Province, China

| Official Contact: | Enhe Liu, QA Director |
|----------------------------|-------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | Disposable Adjustable PEEP Valve |
| Common/Usual Name: | PEEP Valve |
| Classification Name: | BYE - Attachment, breathing, positive end expiratory<br>pressure<br>21 CFR 868.5965 |
| Predicate Devices: | K082092 - Galemed PEEP valve<br>K081266 - Mercury Medical - PEEP Valve MR |

## Device Description

The proposed Galemed Disposable Adjustable PEEP valves are identical to their predicate PEEP Valves, K.082092, except we have replaced some components that were magnetic with nonmagnetic material in order to meet the requirements for MR conditional environments of use. Otherwise the PEEP valves are identical.

Galemed disposable adjustable PEEP valves elevate the pressure in a patient's lungs above atmospheric pressure at the end of exhalation.

The Galemed disposable adjustable PEEP valve for use in MR environments is identical to our predicate, K082092, disposable PEEP valve, except we have replaced the materials in 2 components, a push rod and the springs to materials which are less magnetic. Other than these 2 changes, the device is identical to the predicate. These changes / modifications have been evaluated and demonstrated that they do not alter nor change the performance or safety profile of the new device as compared to the predicates.

### Modifications to Proposed Device compared to Predicate

The proposed Galemed Disposable Adjustable PEEP valves are identical to their predicate PEEP Valves, K.082092, except we have replaced some components that were magnetic with nonmagnetic material in order to meet the requirements for MR conditional environment of use. Otherwise the PEEP valves are identical.

## Indications for Use

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

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510(k) Summary Page 2 of 4 12-Feb-14

## Environment of Use

Hospital, extended care facilities, emergency medical services, and patient transport

May be used in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

### Contraindications

Contraindicated in individuals not requiring elevated end expiratory pressure therapy

## Predicate Device Comparison:

The proposed disposable adjustable PEEP valves are identical to our predicate Galemed PEEP valves, K082092, except for a change in materials for the rod and the springs to less magnetic materials.

Comparative Table 1 discusses the major features of the proposed device and the legally marketed predicate device.

The Galemed Disposable Adjustable PEEP Valve is viewed as substantially equivalent to the predicate device based upon the following:

#### Indications -

- Indicated as a Single patient use adjustable positive end expiratory pressure (PEEP) . valve for use in hospital, transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions.
Discussion - The indications for use are identical for the proposed and predicate device, Galemed PEEP Valve, K082092.

- The addition of the indications for use in a Magnetic Resonance (MR) environment, not . to exceed a 3.0 Tesla static magnetic field is new but testing has demonstrated that the device meets the recognized standard as a MR conditional device.
Discussion - The indications for use as MR Conditional is identical for the proposed and predicate device, Mercury Medical, PEEP Valve, K081266.

#### Technology -

- The technology of the use as a, spring actuated valve, which when placed into a circuit or . manual resuscitator, provides positive end expiratory pressure for the patient is identical to the predicates.
Discussion - There are no differences in technology between the proposed device and the predicates - Galemed PEEP Valve, K082092 and Mercury Medical, PEEP Valve, K081266.

#### Materials -

- The materials are identical to predicate with the exception of a change in the spring . material.

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## 510(k) Summary Page 3 of 4 12-Feb-14

- According to ISO 10993-1 the proposed device would be considered External . communicating, Tissue / mucosal, limited duration (< 24 hr)
- . Stainless steel is well understood and no addition biocompatibility testing is required for this specific application of the material.

Discussion: We are utilizing identical materials to our predicate - Galemed PEEP Valve, K082092. The differences in the spring material or the rod do not affect performance nor raise any new safety concerns.

## Environment of Use -

- Hospital, extended care facilities, emergency medical services, and patient transport and . MR suites to 3 Tesla.
Discussion - The environment of use are identical between the proposed device and the predicates - Galemed PEEP Valve, K082092 and Mercury Medical, PEEP Valve, K081266.

## Non-clinical Testing -

We have performed the following performance data and testing:

- MR conditional in accordance with ASTM F2052-02 in a 3 Tesla MR suite .
- According to ASTM F2052-02 the proposed device should not deflect more than o 45 degree, the proposed device did not deflect this far and thus met the requirements.
- . Leakage
- The device was pressurized and leakage measured before and after age testing. o It met the pass /fail criteria
- Pressure / Resistance Accuracy .
- The device was tested for repeatability and accuracy after being subjected to a o number of conditions; it met its performance specifications criteria.
- . Drop test
- The device was dropped and tested for leakage and pressure / resistance. It met o the pass /fail criteria.
- Environmental Conditions .
- The device was subjected to high and low temperature conditions and then O tested, it met its performance specifications criteria.
- . Transportation
- The device was subjected to transportation testing and then tested it met its O performance specifications criteria.
- . Age testing
- The device was age testing and then evaluated it met its performance o specifications criteria.

Discussion - The performance testing when compared to the predicates - Galemed PEEP Valve, K082092 and Mercury Medical, PEEP Valve, K081266 (for MR conditional environments) support the conclusion of substantial equivalence.

## Substantial Equivalence Conclusion -

The sponsor believes that the testing and comparative data presented in the 510(k) supports our claim of substantially equivalence to the identified predicate devices, listed above.

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| 510(k) Summary |
|----------------|
| Page 4 of 4 |
| 12-Feb-14 |

Table 1 - Comparative Table

| Table 1 - Comparative Table<br>Features | Predicate | Proposed |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Single patient use adjustable positive end expiratory<br>pressure (PEEP) valves for use in hospital, transport,<br>emergency, and post hospital care to evaluate end lung<br>pressure above atmospheric at the end of exhalation in<br>constant and intermittent gas flow conditions. | Single patient use adjustable positive end expiratory pressure<br>(PEEP) valves for use in hospital, transport, emergency, and post<br>hospital care to evaluate end lung pressure above atmospheric at<br>the end of exhalation in constant and intermittent gas flow<br>conditions. For use with neonates to adults. |
| MR Conditional | Mercury Medical PEEP Valve, K081266<br>May be used in a Magnetic Resonance (MR)<br>environment, not to exceed a 1.5 Tesla or less.<br>Spatial gradient of 450 gauss/cm or less. | Environment of Use: Hospital, extended care facilities,<br>emergency medical services, and patient transport. May be used<br>in a Magnetic Resonance (MR) environment, not to exceed a 3.0<br>Tesla static magnetic field.<br><br>May be used in a Magnetic Resonance (MR) environment, not to<br>exceed a 3.0 Tesla.<br>Spatial gradient of 720 gauss/cm or less. |
| Patient Use / Duration if use | Single patient use, disposable, < 24 hours | Single patient use, disposable, < 24 hours |
| Environment of Use | Hospital, extended care facilities, emergency medical<br>services, and patient transport | Hospital, extended care facilities, emergency medical services,<br>and patient transport |
| Patient Population | Patient population from infant (neonate) to adults | Patient population from neonates to adults |
| Contraindications | Contraindicated in individuals not requiring elevated end<br>expiratory pressure therapy | Contraindicated in individuals not requiring elevated end<br>expiratory pressure therapy |
| Features, Specifications, and Performance | | |
| Standard 22 / 30 mm connections | Yes | Yes |
| Pressure Range (cmH2O) | Adjustable - 2.5 to 10, 0 to 1, 5 to 20, and 0 to 20 | Adjustable - 2.5 to 10, 0 to 1, 5 to 20, and 0 to 20 |
| Principle of Operation | Spring actuated valve | Spring actuated valve |
| Placement | Placed into a circuit or attached to a manual resuscitator | Placed into a circuit or attached to a manual resuscitator |
| Leakage | After setting the sample to 5 cm H2O and pressurizing,<br>the pressure drop shall not be in excess of 2 cmH2O<br>within 5 seconds after reaching 5 cmH2O | After setting the sample to 5 cm H₂O and pressurizing, the<br>pressure drop shall not be in excess of 2 cmH2O within 5 seconds<br>after reaching 5 cmH2O |
| Pressure / Accuracy | At flow rates of 2, 3, 5, 10, and 15 lpm the resistance<br>value should when set to 5 cmH2O be 5 +2.5/-2 and when<br>set to 20 cmH.0 he 20 +2 5/2 | At flow rates of 2, 3, 5, 10, and 15 lpm the resistance value<br>should when set to 5 cmH2O be 5 +2.5/-2 and when set to 20<br>cmH.O he 20+25/-2 |

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three curved lines representing wings or feathers.

#### Public Health Service

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

## April 14, 2014

GaleMed Corporation C/O Mr. Paul Dryden Amoy Export Processing Zone, 39 Section 3. Haijing East Road XIAMEN. FUJIAN. CHINA 361026

Re: K133957

Trade/Device Name: Disposable Adjustable PEEP Valve Regulation Number: 21 CFR 868.5965 Regulation Name: Breathing Attachment Positive End Expiratory Pressure Regulatorv Class: II Product Code: BYE Dated: February 12, 2014 Received: February 14, 2014

Dear Mr. 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 10 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. Smith

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Digitally sloned by Richard Date: 2014 04.15 13:17:29

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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## Indications for Use

510(k) Number (if known) K133957

Device Name

Disposable Adjustable PEEP Valve

#### Indications for Use (Describe)

Single patient use adjustable positive end expiratory pressure (PEEP) valves for use in hospital. transport, emergency, and post hospital care to evaluate end lung pressure at the end of exhalation in constant and internittent gas flow conditions.

For use with neonates to adults.

Environment of Use: Hospital, extended care facilities, emergency medical services, and patient transport

May be used in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

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

2 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: December 31, 2013

See PRA Statement on last page.

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (9/13)