(379 days)
Not Found
No
The summary describes a system for measuring physiological parameters and storing data for later analysis. There is no mention of AI, ML, or any algorithms that would process the data in a way characteristic of these technologies. The analysis is performed on a personal computer with supplied software, but the description doesn't indicate this software uses AI/ML.
No
The device measures cardiorespiratory function and metabolic parameters for monitoring and analysis, primarily in sports medicine and rehabilitation, rather than directly treating a condition.
Yes
The device measures O2 consumption, CO2 production, and heart rate to monitor cardiorespiratory function, which are physiological markers used to assess the health and function of a system, placing it within the realm of diagnosis even if for athletic performance or rehabilitation.
No
The device description clearly outlines hardware components worn by the user (harness, face mask, anatomic cap) and a Receiver Unit that collects and transmits data. The software is described as running on a personal computer for later analysis, indicating it is a component of a larger system that includes hardware for data acquisition.
Based on the provided information, the Cosmed K4 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a "metabolic measurement system that allows telemetry monitoring of cardiorespiratory function during physical activities as well as in sports medicine and rehabilitation." It measures physiological parameters directly from the subject (O2 consumption, CO2 production, heart rate).
- Device Description: The description details how the device interacts with the subject (harness, face mask, cap) to collect respiratory flow, gas concentrations, and heart rate. This is in vivo measurement, not in vitro (testing samples outside the body).
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples. The measurements are taken directly from the living subject.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Cosmed K4 measures physiological responses of the body itself, not properties of a sample taken from the body.
N/A
Intended Use / 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.
Product codes
73 BZC
Device Description
Not Found
Mentions image processing
No
Mentions AI, DNN, or ML
No
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
A summary of the performance of accuracy testing is contained in Attachment #8.
Performance has been verified via Quality Control testing as explained in Attachment #8.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
xy
1
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.
2
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 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. | ||
| 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.
He
3
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.
4
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
j
5
:
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