(155 days)
No
The summary does not mention AI, ML, or any related concepts, and the device description is purely mechanical.
Yes
The device is intended to treat spontaneously breathing patients by providing CPAP to elevate pressure in the patient's lungs. Providing therapy to patients is the definition of a therapeutic device.
No
Explanation: The device description states its intended use is to "provide CPAP" and "elevate pressure in the patient's lungs" or "generate and maintain constant positive airway pressure." This describes a therapeutic function (providing respiratory support), not a diagnostic one (identifying a disease or condition).
No
The device description clearly indicates it is a hardware device ("respiratory aid device intended for use with a facemask and gas supplying device") and mentions performance studies related to physical characteristics ("Comparative Flow vs. CPAP Pressure", "Performance of the pressure relief valve").
Based on the provided information, the Mercury CPAP is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide CPAP to spontaneously breathing patients to elevate pressure in their lungs. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a respiratory aid used with a facemask or endotracheal tube to generate and maintain positive airway pressure. This aligns with a respiratory support device, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Mercury CPAP's function is to directly support respiration in a patient.
N/A
Intended Use / Indications for Use
The Mercury CPAP is intended to provide CPAP to spontaneously breathing patients in the hospital and pre-hospital environment.
Product codes
BYE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital and pre-hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(k) Summary Page 1 of 3 16-Mar-09
| Mercury Medical, Inc.
11300 - 49th St. North
Clearwater, FL 33762-4800 | Tel - (727) 573-0088
Fax - (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:
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.
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
1
510(k) Summary Page 2 of 3
16-Mar-09
Summary of substantial equivalence
.
| Predicate | Proposed Device | |
|---|---|---|
| Vygon Boussignac CPAP | ||
| K013884 | Mercury CPAP | |
| Indications for Use | Intended to provide CPAP to | |
| spontaneously breathing patients in the | ||
| hospital and pre-hospital environment | The Mercury CPAP is intended to | |
| provide CPAP to spontaneously | ||
| breathing patients in the hospital and | ||
| pre-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 be | |
| connected | 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 and | ||
| Warnings | None | None |
·
2
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.
3
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.
4
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
5
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)
or
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: