(328 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on data acquisition and analysis without mentioning AI/ML techniques.
No
The device is indicated for the acquisition, analysis, display, printing, and storage of data in the diagnosis of cardiopulmonary disease conditions, rather than for treatment or therapy.
Yes
The text explicitly states: "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." and further lists tests like "Pulmonary Function testing" and "Cardiopulmonary Exercise testing," which are diagnostic procedures.
No
The device description explicitly states it is a "modular system with multiple configurations," implying the presence of hardware components for acquiring physiological data (e.g., for pulmonary function testing, cardiopulmonary exercise testing, and resting metabolism measurement). The summary does not indicate that the device is solely software.
Based on the provided information, the COSMED Quark Series system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the COSMED Quark Series system focuses on in vivo measurements of physiological functions (pulmonary function, cardiopulmonary exercise, resting metabolism) directly from the patient.
- The intended use describes the acquisition, analysis, display, and printing of data related to these physiological measurements, which are then used in the diagnosis of cardio-pulmonary disease conditions. This is consistent with a device that measures bodily functions directly, not one that analyzes samples taken from the body.
Therefore, the COSMED Quark Series system falls under the category of a medical device that performs physiological measurements, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Device model: Quark SPIRO
Indication for use: Pulmonary Function testing - Age 6 to adults
Major clinical conditions: Spontaneously breathing patients, healthy or affected by respiratory diseases such as asthma or COPD
Measured parameters: FVC, FEV1, FEF25-75%, PEF, MVV, SpO2
Device model: Quark PFT
Indication for use: Pulmonary Function testing - Age 6 to adults Cardiopulmonary Exercise testing - age 6 to adults
Major clinical conditions: Spontaneously breathing patients, healthy or affected by respiratory diseases such as asthma or COPD
Measured parameters: FVC, FEV1, FEF25-75%, PEF, MVV, FRC, DLCO, MIP/MEP, P0.1, SpO2, Ve, RF, HR, VO2, VCO2, TGV
Device model: Quark CPET
Indication for use: Pulmonary Function testing - Age 6 to adults Cardiopulmonary Exercise testing - age 6 to adults
Major clinical conditions: Spontaneously breathing patients, healthy or affected by diseases limiting exercise tolerance
Measured parameters: FVC, FEV1, FEF25-75%, PEF, MVV, VO2, VCO2, Ve, RF, HR, SpO2
Device model: Quark RMR
Indication for use: 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
Major clinical conditions: Spontaneously breathing patients; Ventilated patients with some limitations as in accordance with labeling
Measured parameters: 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.
Product codes
CBK, BTY
Device Description
Not Found
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
Age 6 to adults (for most indications), Age 3 to 6 years old (for Airways Resistance Test), 15Kg/30Lb to adults (for Measurement of Resting Metabolism (canopy dilution)), Age 10 to adults (for Measurement of Resting Metabolism (Ventilated patients)).
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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.
| Device
model | Indication for use | Major clinical conditions | Measured
parameters |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Quark SPIRO | Pulmonary Function testing - Age 6 to
adults | Spontaneously breathing
patients, healthy or
affected by respiratory
diseases such as asthma
or COPD | FVC, FEV1, FEF25-
75%, PEF, MVV,
SpO2 |
| Quark PFT | Pulmonary Function testing - Age 6 to
adults
Cardiopulmonary Exercise testing -
age 6 to adults | Spontaneously breathing
patients, healthy or
affected by respiratory
diseases such as asthma
or 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 to
adults
Cardiopulmonary Exercise testing -
age 6 to adults | Spontaneously breathing
patients, healthy or
affected by diseases
limiting 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 to
adults:
Measurement of Resting Metabolism
(Ventilated patients) - age 10 to
adults | Spontaneously breathing
patients;
Ventilated patients with
some limitations as in
accordance 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 Hospital | |
| Infection 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 |