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.

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.

AI/ML Overview

This 510(k) summary describes a Disposable Adjustable PEEP Valve for use in MR environments. The submission claims substantial equivalence to two predicate devices: the Galemed PEEP valve (K.082092) and the Mercury Medical PEEP Valve (K081266) for its MR conditional characteristics.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria (Predicate / Recognized Standard)	Reported Device Performance
MR Conditional (ASTM F2052-02)	Deflection not more than 45 degrees in a 3 Tesla MR suite.	The proposed device did not deflect this far and thus met the requirements.
Leakage	After setting to 5 cm H₂O and pressurizing, the pressure drop shall not be in excess of 2 cmH₂O within 5 seconds after reaching 5 cmH₂O.	Met the pass/fail criteria (before and after age testing).
Pressure / Resistance Accuracy	At flow rates of 2, 3, 5, 10, and 15 lpm, when set to 5 cmH₂O, resistance should be 5 +2.5/-2 cmH₂O; when set to 20 cmH₂O, resistance should be 20 +2.5/-2 cmH₂O.	Met its performance specifications criteria (after being subjected to a number of conditions).
Drop Test	No specific criteria mentioned, but implied to be sufficient to prevent leakage and maintain pressure/resistance performance.	Met the pass/fail criteria for leakage and pressure/resistance.
Environmental Conditions (High/Low Temperature)	No specific criteria mentioned, but implied to be sufficient to maintain performance specifications.	Met its performance specifications criteria.
Transportation	No specific criteria mentioned, but implied to be sufficient to maintain performance specifications.	Met its performance specifications criteria.
Age Testing	No specific criteria mentioned, but implied to be sufficient to maintain performance specifications.	Met its performance specifications criteria.
MR Conditional (Predicate Mercury)	May be used in a Magnetic Resonance (MR) environment, not to exceed a 1.5 Tesla or less. Spatial gradient of 450 gauss/cm or less.	May be used in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla. Spatial gradient of 720 gauss/cm or less. (Claimed improvement over predicate)

Notes on Acceptance Criteria:

For Leakage, Pressure/Resistance Accuracy, Drop Test, Environmental Conditions, Transportation, and Age Testing, the document states "met the pass/fail criteria" or "met its performance specifications criteria" without explicitly detailing the numerical boundaries of these criteria in the provided text. The criteria are only fully detailed for the MR Conditional test.
The MR Conditional acceptance criteria for the proposed device (3.0 Tesla, 720 gauss/cm) represent an improvement in capability over the Mercury Medical predicate (1.5 Tesla, 450 gauss/cm).

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size for the test sets used in the non-clinical testing (e.g., how many PEEP valves were tested for leakage, MR compatibility, etc.). It refers to "the device" or "the sample," implying at least one, but without specific counts.

Sample Size: Not explicitly stated (implied to be one or more for each test).
Data Provenance: The tests were performed by the manufacturer, Galemed Corp., in China, as indicated by the company address. These appear to be prospective tests performed specifically for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This device is a medical device, not an AI or diagnostic imaging device. Therefore, the concept of "ground truth established by experts" as typically applied to AI models for classification or detection tasks does not directly apply here. The "ground truth" for this device's performance is objective measurements against engineering specifications and recognized standards (e.g., ASTM F2052-02).

4. Adjudication Method for the Test Set

Not applicable. As described in point 3, this is not a diagnostic device requiring expert adjudication of results. Performance is measured against predefined objective physical and engineering criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

Not applicable. This is a physical medical device (PEEP valve), not an AI or imaging system, so an MRMC study is irrelevant.

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

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is objective engineering measurements against:

Recognized Standards: Specifically, ASTM F2052-02 for MR conditional properties.
Performance Specifications: Internal specifications for leakage, pressure/resistance accuracy, and durability (drop test, environmental, transportation, age testing). These specifications are based on the predicate device's performance and industry requirements for PEEP valves.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model requiring a training set. The device itself is manufactured, and its performance is verified through testing, not trained.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a physical medical device.

Summary

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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 expiratorypressure21 CFR 868.5965
Predicate Devices:	K082092 - Galemed PEEP valveK081266 - Mercury Medical - PEEP Valve MR

Device Description

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

Modifications to Proposed Device compared to Predicate

Indications for Use

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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 TableFeatures	Predicate	Proposed
Indications for use	Single patient use adjustable positive end expiratorypressure (PEEP) valves for use in hospital, transport,emergency, and post hospital care to evaluate end lungpressure above atmospheric at the end of exhalation inconstant and intermittent gas flow conditions.	Single patient use adjustable positive end expiratory pressure(PEEP) valves for use in hospital, transport, emergency, and posthospital care to evaluate end lung pressure above atmospheric atthe end of exhalation in constant and intermittent gas flowconditions. For use with neonates to adults.
MR Conditional	Mercury Medical PEEP Valve, K081266May be used in a Magnetic Resonance (MR)environment, not to exceed a 1.5 Tesla or less.Spatial gradient of 450 gauss/cm or less.	Environment of Use: Hospital, extended care facilities,emergency medical services, and patient transport. May be usedin a Magnetic Resonance (MR) environment, not to exceed a 3.0Tesla static magnetic field.May be used in a Magnetic Resonance (MR) environment, not toexceed a 3.0 Tesla.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 medicalservices, and patient transport	Hospital, extended care facilities, emergency medical services,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 endexpiratory pressure therapy	Contraindicated in individuals not requiring elevated endexpiratory 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,the pressure drop shall not be in excess of 2 cmH2Owithin 5 seconds after reaching 5 cmH2O	After setting the sample to 5 cm H₂O and pressurizing, thepressure drop shall not be in excess of 2 cmH2O within 5 secondsafter reaching 5 cmH2O
Pressure / Accuracy	At flow rates of 2, 3, 5, 10, and 15 lpm the resistancevalue should when set to 5 cmH2O be 5 +2.5/-2 and whenset to 20 cmH.0 he 20 +2 5/2	At flow rates of 2, 3, 5, 10, and 15 lpm the resistance valueshould when set to 5 cmH2O be 5 +2.5/-2 and when set to 20cmH.O he 20+25/-2

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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).