(379 days)
The Cosmed K4 is a metabolic measurement system that allows telemetry monitoring of cardiorespiratory function during physical activities as well as in sports medicine and rehabilitation. The K4 measures, in real conditions, the O2 consumption the CO, production and the heart rate of the person being monitored.
The subject wears equipment by a harness and breathes into a face mask held on by an anatomic cap. The respiratory flow, expiratory flow, gas concentrations (02 and C02) and heart rate are measured and transmitted to the Receiver Unit. Data collected are stored for later analysis on a personal computer for which software is supplies and run in Windows Application.
The Cosmed K4 Portable Metabolic Measuring System is deemed substantially equivalent to the AeroSport Teen 100 / KB1-C Ambulatory Metabolic Measurement System. However, the provided text does not contain specific acceptance criteria for the Cosmed K4 device, nor does it detail a standalone study proving the device meets particular acceptance criteria.
The submission focuses on demonstrating substantial equivalence to a predicate device, the AeroSport KB1-C, rather than presenting a study against predefined acceptance metrics for the new device.
Here's a breakdown of the information that is available in the provided text, and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not available. The document does not explicitly state acceptance criteria (e.g., specific accuracy thresholds, precision targets, or ranges for V02, VC02, VE, HR measurements) for either the Cosmed K4 or the AeroSport KB1-C.
The document states:
- "No, metabolic measurements are still accurately measured with both products. The software validation included in Attachment #6, demonstrates accuracy."
- "Performance has been verified via Quality Control testing as explained in Attachment #8."
However, the contents of Attachment #6 and Attachment #8, which would presumably contain the actual performance data and what constitutes "accuracy" and "verified performance," are not provided in this extract.
The comparison chart lists the metabolic measurements provided by both devices (V02, VC02, VE, HR), but does not give performance metrics for these measurements for either device.
2. Sample Size Used for the Test Set and Data Provenance
Not available. The provided text does not describe a "test set" in the context of an accuracy or performance study with a specified sample size. It refers to "software validation" and "Quality Control testing," but no details on the participants, number of tests, or data provenance (country of origin, retrospective/prospective) are given for these activities.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not available. Since an external test set with ground truth is not described, there is no information about experts used for this purpose.
4. Adjudication Method for the Test Set
Not available. No test set or expert adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not available. The document describes a comparison between two devices, but not an MRMC study related to human reader performance with or without AI assistance. This device measures physiological parameters, not typically something that would involve human "readers" interpreting output in the same way, for example, a radiologist reads an image.
6. Standalone Performance Study
Partially indicated, but details missing. The text mentions "The software validation included in Attachment #6, demonstrates accuracy" and "Performance has been verified via Quality Control testing as explained in Attachment #8." These suggest that some form of standalone performance evaluation was done. However, specific results, methodologies, and quantitative data are not provided in the extracted document. The conclusion states, "The Cosmed K4 Portable Metabolic Measuring System and the AeroSport Teen 100 / KB1-C Ambulatory Metabolic Measurement System are substantially equivalent as demonstrated by information and literature contained in this pre-market notification document." This implies the "performance data" was primarily to support the claim of equivalence rather than meeting independent acceptance criteria for the new device.
7. Type of Ground Truth Used (for standalone performance)
Not available directly from the text. While it can be inferred that for metabolic measurements (V02, VC02, VE, HR), the ground truth would likely involve highly accurate reference measurement systems or established physiological standards, the document does not specify how the ground truth was established for the "software validation" or "Quality Control testing" mentioned.
8. Sample Size for the Training Set
Not applicable/Not available. Since the device appears to be hardware-based with associated software for data elaboration and does not explicitly refer to "AI" or machine learning models requiring training data for a test set described here, the concept of a "training set" in this context is not directly applicable. If "software validation" involved internal model calibration, those details are not provided.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not available. (See point 8.)
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SUBSTANTIAL EQUIVALENCE SUMMARY
This summary follows the format of the FDA 510(k) Substantial Equivalence Decision Making Process document.
EQUIVALENT (PREDICATE) DEVICE:
(Teen 100) KB1-C Ambulatory K945213 Metabolic Measurement Systems
Manufactured by:
AeroSport. Inc. 3518 West Liberty Ann Arbor, Mi 48103 Telephone: 313-668-3333 Fax: 313-741-0884
Does the KB1-C Ambulatory Metabolic Measurement Systems have the same A. indications statements?
Yes, both products are systems which telemetrically measure metabolic functions, as is the Cosmed K-4.
B. Does the KB1-C Ambulatory Metabolic Measurement Systems have the same technological characteristics, e.g., design, materials, etc. ?
The two systems have substantially the same characteristics as demonstrated in the comparison chart located in this attachment. There is a difference in the type of flowmeter used in both devices. The Cosmed K4 employs a Bi-directional Turbine and the AeroSport KB1-C employs a Orifice pneumotachometer. Both of which measure flowrate.
The only other difference being the radio transmission; the Cosmed K4 uses a FM 433,920 MHz which is approved in Europe. However, the product is manufactured for many countries in the world and the carrier frequency for the output power can be decided by the customer in order to meet country regulations.
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Could the new characteristics affect safety and effectiveness? C.
No, metabolic measurements are still accurately measured with both products. The software validation included in Attachment #6, demonstrates accuracy..
Do the new characteristics raise new types of safety or effectiveness questions? D.
No.
E. Do acceptable scientific methods exist for assessing effects of the new characteristics?
Not applicable.
F. Are performance data available to assess the effects of new characteristics?
A summary of the performance of accuracy testing is contained in Attachment #8.
G. Do performance data demonstrate equivalence?
Performance has been verified via Quality Control testing as explained in Attachment #8.
CONCLUSION:
The Cosmed K4 Portable Metabolic Measuring System and the AeroSport Teen 100 / KB1-C Ambulatory Metabolic Measurement System are substantially equivalent as demonstrated by information and literature contained in this pre-market notification document.
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COMPARISON CHART:
The following table displays the similarities and differences of the new device to the marketed device to which equivalency is claimed.
| COMPARISON FEATURE | COSMED K4 | AEROSPORT KBC-1 |
|---|---|---|
| INTENDED USE | Metabolic Measurements | Metabolic Measurements |
| MODE OF OPERATION | The subject wears equipment by aharness and breathes into a face maskheld on by an anatomic cap. Therespiratory flow, expiratory flow, gasconcentrations (02 and C02) and heartrate are measured and transmitted tothe Receiver Unit. Data collected arestored for later analysis on a personalcomputer for which software issupplies and run in WindowsApplication. | The subject wears the equipmentby a harness and breathes into afacemask held by an anatomiccap. The respiratory flow, theexpiratory gas concentrations (02and C02) and the Heart Rate aremeasured and transmitted to theReceiver Unit. Data collected arestored for later analysis on apersonal computer for whichsoftware is supplies and run inWindows Application. |
| MAJOR SEPARATE SYSTEMCOMPONENTS | Portable UnitReceiver UnitFlowmeter (fixed to the facemaskHeart Rate Monitor Belt | Portable UnitReceiver UnitFlowmeter (fixed to the facemaskHeart Rate Monitor Belt |
| METABOLIC MEASUREMENTS | V02 (Oxygen Uptake)VC02 (C02 Production)VE (Ventilation)HR (Heart Rate) | V02 (Oxygen Uptake)VC02 (C02 Production)VE (Ventilation)HR (Heart Rate) |
| FLOWMETER TYPE | bi-directional Turbine | Orifice pneumotachometer |
| 02 ANALYZER | Galvanic Fuel Cel | Galvanic Fuel Cel |
| C02 ANALYZER | Non-Dispersive Infrared | Non-Dispersive Infrared |
| HEART RATE MONITOR | POLAR (Finland) Belt | Unknown |
| RADIO TRANSMISSION | FM433.920 MHz, Approved in Europe* | FM 902-928MHz |
| SOFTWARE | Internal Software in the Receiver Unitand Windows PC Software for dataelaboration | Internal Software in the PortableUnit, Windows PC software fordata elaboration. |
| PORTABLE UNIT: SIZE ANDWEIGHT | 170 x 48 x 90 mm400 grams (+400 gm Battery Pack) | 230 x 120 x 75 mm1 Kg ( weight of the battery packunknown) |
| RECEIVER UNIT: SIZE ANDWEIGHT | 237 x 127 x 46 mm1.2 kg | Not known |
| BIOCOMPATABILITY | The only part in contact with thepatient is the face mask and thePOLAR Heart Rate Belt. The mask isthe same as the AeroSport KB1-C, andthe POLAR belt is already sold in theUS Market. | The only part in contact with thepatient is the face mask and theheart rate belt. The mask is thesame as used in the Cosmed K-4. |
- The Cosmed K4 is manufactured for sale in many different countries, the carrier frequency for the output power can be decided by the customer in order to meet Country regulations.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a symbol consisting of three curved lines that resemble a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
SEP 10 1997
Cosmed s.r.l. c/o Ms. Anne Marie Cesario Schiff & Company 1129 Bloomfield Avenue West Caldwell, New Jersey 07006
Re : K963373 K4 Portable Metabolic Measurement System Requlatory Class: II (two) Product Code: 73 BZC June 10, 1997 Dated: Received: June 12, 1997
Dear Ms. Cesario:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Anne Marie Cesario
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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:
510{k} Premarket Notification Cosmed K4 - Portable Metabolic Measurement System
510(k) Number (if known):
Device Name:
Cosmed K4 - Portable Metabolic Measurement System
Indications for Use:
The Cosmed K4 is a metabolic measurement system that allows telemetry monitoring of cardiorespiratory function during physical activities as well as in sports medicine and rehabilitation. The K4 measures, in real conditions, the O2 consumption the CO, production and the heart rate of the person being monitored.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
perfor
Prescription Use
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number.
or
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
11
§ 868.1880 Pulmonary-function data calculator.
(a)
Identification. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.(b)
Classification. Class II (performance standards).