COSMED K4

K963373 · Cosmed Srl · BZC · Sep 10, 1997 · Anesthesiology

Device Facts

• Record ID: K963373
• Device Name: COSMED K4
• Applicant: Cosmed Srl
• Product Code: BZC · Anesthesiology
• Decision Date: Sep 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1880
• Device Class: Class 2

Intended 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 ventilation, the O₂ consumption the CO₂ production and the heart rate of the person being monitored.

Device Story

Portable metabolic measurement system; monitors cardiorespiratory function during physical activity. Subject wears harness-mounted portable unit and face mask; system measures respiratory flow, expiratory gas concentrations (O2, CO2), and heart rate via chest belt. Data transmitted via FM radio to receiver unit; stored for analysis on Windows-based PC software. Used in sports medicine and rehabilitation settings; operated by clinicians or technicians. Provides real-time metabolic data (VO2, VCO2, VE, HR) to assist in physiological assessment and clinical decision-making during exercise.

Clinical Evidence

No clinical data. Performance verified via bench-top quality control testing and software validation to demonstrate accuracy of metabolic measurements.

Technological Characteristics

Portable unit (400g) and receiver unit. Bi-directional turbine flowmeter; galvanic fuel cell O2 analyzer; non-dispersive infrared CO2 analyzer. FM radio transmission (433.920 MHz). Windows-based PC software for data elaboration. Biocompatible face mask and heart rate belt.

Indications for Use

Indicated for individuals undergoing cardiorespiratory monitoring during physical activities, sports medicine, or rehabilitation to measure ventilation, O2 consumption, CO2 production, and heart rate.

Regulatory Classification

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.

Predicate Devices

• AeroSport KB1-C Ambulatory Metabolic Measurement Systems (K945213)

Submission Summary (Full Text)

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K963373
510(k) Premarket Notification
Cosmed K4 - Portable Metabolic Measurement System
Sept 10, 1997

# SUBSTANTIAL EQUIVALENCE SUMMARY

This summary follows the format of the FDA 510(k) Substantial Equivalence Decision Making Process document.

## EQUIVALENT (PREDICATE) DEVICE:
K945213 (Teen 100) KB1-C Ambulatory Metabolic Measurement Systems

## Manufactured by:
AeroSport, Inc.
3518 West Liberty
Ann Arbor, MI 48103
Telephone: [phone]
Fax: [phone]

### A. Does the KB1-C Ambulatory Metabolic Measurement Systems have the same 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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510(k) Premarket Notification
Cosmed K4 - Portable Metabolic Measurement System

C. Could the new characteristics affect safety and effectiveness?

No, metabolic measurements are still accurately measured with both products. The software validation included in Attachment #6. demonstrates accuracy..

D. Do the new characteristics raise new types of safety or effectiveness questions?

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.

Prepared by Schiff & Company, West Caldwell, NJ
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510(k) Premarket Notification
Cosmed K4 - Portable Metabolic Measurement System

# 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 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 subject wears the equipment by a harness and breathes into a facemask held by an anatomic cap. The respiratory flow, the expiratory gas concentrations (02 and C02) and the Heart Rage 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. |
| MAJOR SEPARATE SYSTEM COMPONENTS | Portable Unit
Receiver Unit
Flowmeter (fixed to the facemask)
Heart Rate Monitor Belt | Portable Unit
Receiver Unit
Flowmeter (fixed to the facemask)
Heart 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 Unit and Windows PC Software for data elaboration | Internal Software in the Portable Unit, Windows PC software for data elaboration. |
| PORTABLE UNIT: SIZE AND WEIGHT | 170 x 48 x 90 mm
400 grams (+400 gm Battery Pack) | 230 x 120 x 75 mm
1 Kg (weight of the battery pack unknown) |
| RECEIVER UNIT: SIZE AND WEIGHT | 237 x 127 x 46 mm
1.2 kg | Not known |
| BIOCOMPATABILITY | The only part in contact with the patient is the face mask and the POLAR Heart Rate Belt. The mask is the same as the AeroSport KB1-C, and the POLAR belt is already sold in the US Market. | The only part in contact with the patient is the face mask and the heart rate belt. The mask is the same 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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
Regulatory Class: II (two)
Product Code: 73 BZC
Dated: June 10, 1997
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 regulation (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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


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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09/10/1997 07:51 2012275330 SCHIFF & COMPANY PAGE 02

510(k) Premarket Notification
Cosmed K4 - Portable Metabolic Measurement System

510(k) Number (if known): K963373

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 ventilation, the O₂ consumption the CO₂ 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)



(Optional Format 1-2-96)

Prepared by Schiff & Company, West Caldwell, NJ
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