The Mercury CPAP is a respiratory aid device intended for use with a facemask and gas supplying device to elevate pressure in the patient's lungs. Alternatively the device may be used in conjunction with an endotracheal tube to generate and maintain constant positive airway pressure during standard intubation procedures.

AI/ML Overview

The Mercury CPAP device is considered substantially equivalent to its predicate device (Vygon Boussignac CPAP - K013884) based on comparative performance testing. The acceptance criteria are implicit in the comparison to the predicate device's performance characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

Feature	Acceptance Criteria (based on predicate Vygon Boussignac CPAP - K013884)	Reported Device Performance (Mercury CPAP)
Indications for Use	Identical to predicate: Provide CPAP to spontaneously breathing patients in hospital and pre-hospital environment.	Identical to predicate.
Technology	Similar technology used to generate CPAP pressure.	Similar technology used to generate CPAP pressure.
Materials	Materials in patient contact are identical to predicate devices.	Materials in patient contact are identical to predicate devices.
Environment of Use	Identical to predicate: Hospital and pre-hospital.	Identical to predicate.
Gas flow provided by	Wall gas or cylinder.	Wall gas or cylinder.
Requires a flow meter with ~30 Lpm range	Yes.	Yes.
Typical flow rate range	10-25 lpm.	10-25 lpm.
CPAP pressure range	Up to 10 cm H₂O.	Up to 10 cm H₂O.
In-line pressure manometer	Recommended: a manometer be connected.	Integral manometer (Mercury K954486).
Excessive pressure relief	No excessive pressure relief (for predicate).	Integrated pop-off at 25 cm H₂O.
Patient interface	Face mask with head harness, connects to ET tube with adapter.	Face mask with head harness, connects to ET tube without adapter.
Single patient use, disposable	Yes.	Yes.
Contraindications and Warnings	None.	None.
Comparative Flow vs. CPAP Pressure	Comparable to predicate results.	Demonstrated substantial equivalence.
Performance of pressure relief valve	Comparable to predicate (though predicate had none, Mercury CPAP tested its own integral valve).	Demonstrated substantial equivalence (for the Mercury CPAP's integral valve).

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

The document states "We have performed comparative performance testing, Comparative Flow vs. CPAP Pressure" and "Performance of the pressure relief valve." However, specific sample sizes for these tests are not provided in the summary. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It implies the testing was conducted by or for Mercury Medical, Inc.

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

This information is not applicable or not provided. The study is a comparative performance test of a medical device (CPAP machine) against a predicate device, focusing on physical and performance characteristics like gas flow, pressure, and mechanical features. It does not involve human interpretation or subjective assessment that would require expert ground truth establishment in the typical sense (e.g., image interpretation by radiologists).

4. Adjudication method for the test set

This information is not applicable or not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation where disagreements need to be resolved. This study focuses on device performance metrics.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study concerns the physical and performance characteristics of a CPAP device, not an AI or diagnostic imaging system that would involve human readers.

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

No, this is not an AI-driven device, and therefore the concept of "algorithm only" or "human-in-the-loop" performance is not relevant. The testing performed was on the physical device itself.

7. The type of ground truth used

The "ground truth" for this type of device comparison is the established performance characteristics and specifications of the predicate device (Vygon Boussignac CPAP - K013884), as well as engineering standards for CPAP functionality and safety. The Mercury CPAP's performance was compared against these established benchmarks.

8. The sample size for the training set

This information is not applicable. This is a hardware medical device and does not involve machine learning algorithms that require a "training set."

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

This information is not applicable as there is no training set for this type of device.

Summary

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K690710

510(k) Summary Page 1 of 3 16-Mar-09

Mercury Medical, Inc.11300 - 49th St. NorthClearwater, FL 33762-4800	Tel - (727) 573-0088Fax - (727) 571-3922	AUG 20 2009
Official Contact:	Jeff Ratner - VP Engineering and Quality Assurance
Proprietary or Trade Name:	Mercury CPAP
Common/Usual Name:	Flow generator / PEEP Valve
Classification Name/Code:	BYE - attachment, breathing, positive end expiratory pressure
Device:	Mercury CPAP
Predicate Devices:	Vygon SA - Boussignac CPAP - K013884

Device Description:

Indications for Use:

The Mercury CPAP is intended to provide CPAP to spontaneously breathing patients in the hospital and pre-hospital environment.

Environment of Use: Hospital and pre-hospital

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510(k) Summary Page 2 of 3

16-Mar-09

Summary of substantial equivalence

	Predicate	Proposed Device
	Vygon Boussignac CPAPK013884	Mercury CPAP
Indications for Use	Intended to provide CPAP tospontaneously breathing patients in thehospital and pre-hospital environment	The Mercury CPAP is intended toprovide CPAP to spontaneouslybreathing patients in the hospital andpre-hospital environment
Patient Population

Patient Population Environment of use

Hospital and pre-hospital

Same as predicate

Physical and Performance Characteristics
Gas flow provided by	Wall gas or cylinder	Wall gas or cylinder
Requires a flow meter with~30 Lpm range	Yes	Yes
Typical flow rate range	10-25 lpm	10-25 lpm
CPAP pressure range	Up to 10 cm H₂O	Up to 10 cm H₂O
In-line pressure manometer	Recommended that a manometer beconnected	Includes an integral manometer,Mercury K954486
Excessive pressure relief	No excessive pressure relief	Integrated pop-off at 25 cm H₂O
Patient interface	Face mask with head harness	Face mask with head harness
	Connects to ET tube with adapter	Connects to ET tube without adapter
	Permits a nebulizer to be connected
Single patient use, disposable	Yes	Yes
Environment of use	Hospital and pre-hospital	Hospital and pre-hospital
Contraindications and Warnings
Contraindications andWarnings	None	None

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510(k) Summary Page 3 of 3 16-Mar-09

The Mercury CPAP is viewed as substantially equivalent to the predicate device because:

Indications -

Identical to predicate Vygon Boussignac CPAP K013844 .

Technology -

Similar technology used to generate CPAP pressure -- Vygon Boussignac CPAP -. K013844

Materials -

The materials in patient contact are identical to predicate devices .

Environment of Use -

Identical to predicate Vygon Boussignac CPAP K013844 t

Differences -

The differences are:

Integral pressure manometer in the Mercury CPAP .
. Integral excessive pressure pop-off valve set to 25 cm H2O

Any other differences are not significant between the proposed device and the predicate device and do not introduce any new patient safety issues.

Comparative Performance

We have performed comparative performance testing, Comparative Flow vs. ● CPAP Pressure
. Performance of the pressure relief valve

The results demonstrated that the devices were substantially equivalent.

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Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border. Inside the circle is a symbol consisting of three stylized human figures connected by a flowing line. The figures are silhouetted and appear to be facing to the right.

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

Mercury Medical C/o Mr. Paul Dryden ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134

AUG 2 0 2009

Re: K090710

Trade/Device Name: Mercury CPAP Regulation Number: 21 CFR 868.5965 Regulation Name: Positive End Expiratory Pressure Breathing Attachment Regulatory Class: II Product Code: BYE Dated: July 16, 2009 Received: July 21, 2009

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 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.

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. Dryden

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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Ruaper

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use Statement

Page 1 of 1

510(k) Number:

(To be assigned)

Device Name: Mercury CPAP

Indications for Use:

The Mercury CPAP is intended to provide CPAP to spontaneously breathing patients in the hospital and pre-hospital environment.

Prescription Use XX (Part 21 CFR 801 Subpart D)

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)

L. Schult

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

4090710 510(k) Number:

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).