(328 days)
The COSMED Quark Series system is a modular system with multiple configurations, allowing the following the following the final The COSMED Quart Senes System is a modular of the max maxple only and only in the managements. The system and its accessories are indicated for the acquisition, analysis, to display, printing and The system and its accessories are molcated for the acquisition in the diagnosis of carry of cardio-purnonary disease conditions.
Quark SPIRO: Pulmonary Function testing - Age 6 to adults
Quark PFT: Pulmonary Function testing - Age 6 to adults; Cardiopulmonary Exercise testing - age 6 to adults
Quark CPET: Pulmonary Function testing - Age 6 to adults; Cardiopulmonary Exercise testing - age 6 to adults
Quark RMR: Measurement of Resting Metabolism (face mask) - age 6 to adults; Measurement of Resting Metabolism (canopy dilution) -15Kg/30Lb to adults: Measurement of Resting Metabolism (Ventilated patients) - age 10 to adults
Specific Indications for use: Quark SPIRO and Quark PFT also allows the Airways Resistance Test with the occlusion technique (Rocc test) for young patients from 3 to 6 years old.
The COSMED Quark Series system is a modular system with multiple configurations.
The provided text is related to a 510(k) premarket notification for a medical device (Cosmed S.R.L.'s Quark Series). It primarily focuses on the FDA's determination of substantial equivalence and the device's indications for use.
Crucially, the document does NOT contain information about acceptance criteria, detailed study designs, performance metrics, ground truth establishment, or sample sizes for testing or training sets.
Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided input.
The document discusses the regulatory classification and general requirements but does not delve into the technical validation or clinical study data that would demonstrate the device meets performance criteria.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
DEC 1 1 2012
Cosmed S.R.L. C/O Mr. Thomas Padula Vice President, Regulatory Compliance Schiff & Company, Incorporated 1129 Bloomfield Avenue WEST CALDWELL NJ 07006
Re: K120146
Trade/Device Name: Quark Series Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: II Product Code: CBK, BTY Dated: November 15, 2012 Received: November 16, 2012
Dear Mr. Padula:
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.
{1}------------------------------------------------
Page 2 - Mr. Padula
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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kwame O. Ulmer
Anthony D. Watson, B.S., M.S., M.B.A. · Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and
Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
{2}------------------------------------------------
Indications for use statement
| 510(k) Number: | K120146 |
|---|---|
| ---------------- | --------- |
Device Name:
Generic Indication for use (for all models)
Quark Series
The COSMED Quark Series system is a modular system with multiple configurations, allowing the following the following the final The COSMED Quart Senes System is a modular of the max maxple only and only in the managements.
The system and its accessories are indicated for the acquisition, analysis, to display, printing and The system and its accessories are molcated for the acquisition in the diagnosis of carry of cardio-purnonary disease conditions.
| Devicemodel | Indication for use | Major clinical conditions | Measuredparameters |
|---|---|---|---|
| Quark SPIRO | Pulmonary Function testing - Age 6 toadults | Spontaneously breathingpatients, healthy oraffected by respiratorydiseases such as asthmaor COPD | FVC, FEV1, FEF25-75%, PEF, MVV,SpO2 |
| Quark PFT | Pulmonary Function testing - Age 6 toadultsCardiopulmonary Exercise testing -age 6 to adults | Spontaneously breathingpatients, healthy oraffected by respiratorydiseases such as asthmaor COPD | FVC, FEV1, FEF25-75%, PEF, MVV,FRC, DLCO,MIP/MEP, P0.1,SpO2, Ve, RF, HR,VO2, VCO2, TGV |
| Quark CPET | Pulmonary Function testing - Age 6 toadultsCardiopulmonary Exercise testing -age 6 to adults | Spontaneously breathingpatients, healthy oraffected by diseaseslimiting exercise tolerance | FVC, FEV1, FEF25-75%, PEF, MVV,VO2, VCO2, Ve, RF,HR, SpO2 |
| Quark RMR | Measurement of Resting Metabolism(face mask) - age 6 to adults;Measurement of Resting Metabolism(canopy dilution) -15Kg/30Lb toadults:Measurement of Resting Metabolism(Ventilated patients) - age 10 toadults | Spontaneously breathingpatients;Ventilated patients withsome limitations as inaccordance with labeling | VO2, VCO2, Ve, RF,HR, SpO2 |
Specific Indications for use
Quark SPIRO and Quark PFT also allows the Airways Resistance Test with the occlusion technique (Rocc test) for young patients from 3 to 6 years old.
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Lester W. Schultheis Jr | ||
| 2012.12.07 15:35:02-05'00' | ||
| Prescription use | (Division Sign-Off) | |
| (Per 21 CFR 801.109) | Division of Anesthesiology, General HospitalInfection Control, Dental Devices | |
| Over-the-Counter Use | ||
| (Optional format 1-2-96) | ||
| 510(k) Number: | K120146 | |
| File: Indicationsforusestatement-1 | Rev. 15/11/2012 14:33:00 | Pag. 1/1 |
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).