(141 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related technologies, and the device description is not available to provide further clues.
No
This device is described as a pulmonary function testing system, used for diagnostic purposes (performing lung function tests), not for treatment.
Yes
The device is a spirometer for performing basic lung function tests and pulse oximetry tests, which are used to assess the current state of a patient's health by measuring physiological parameters.
No
The description explicitly states the device is a "pulmonary function testing system" and "Spirometers," which are hardware devices used to measure lung function. While software is likely involved in data processing and display, the core functionality relies on physical hardware.
Based on the provided information, the COSMED Spiropalm and Spiropalm Plus pulmonary function testing system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as performing "basic lung function tests (basic spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximal Voluntary Ventilation) and Pulse Oximetry tests". These are tests performed on the patient's body (measuring airflow and oxygen saturation), not on samples taken from the patient's body (like blood, urine, or tissue).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body to provide information about a person's health.
Therefore, since the device directly measures physiological parameters from the patient rather than analyzing samples, it falls outside the definition of an IVD.
N/A
Intended Use / Indications for Use
The COSMED Spiropalm and Spiropalm Plus pulmonary function testing system are Spirometers for performing lung function tests (basic spirometry: Forced Vital Capacity; Slow Vital Capacity; Maximal Ventilatory Ventilation) and Pulse Oximetry tests in the physician’s office or a hospital setting.
Product codes
BZG
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
Not Found
Intended User / Care Setting
Physician’s office or a hospital setting.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem of an eagle with three stripes across its body. The eagle is facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
COSMED S.R.L. C/O Mr. Robert Schiff President Schiff & Company 1129 Bloomfield Avenue, Suite 202 West Caldwell, New Jersey 07006
FEB 2 6 2010
Re: K093174
Trade/Device Name: Spiropalm Series Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: February 18, 2010 Received: February 19, 2010
Dear Mr. Schiff:
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. Schiff
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 vours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Statement of indication for use
K093174 510(k) Number:
Device Name: Spiropalm series
Indication for use
The COSMED Spiropalm and Spiropalm Plus pulmonary function testing system are The OOOMED opiropains and Opic lung function tests (basic spirometry: Forced Vital Spirometers for portoming the Maximum Voluntary Ventilation) and Pulse Oximetry tests Openly, Slow Vitar Supacity, Maximal in the physician's office or a hospital setting.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription use | X |
|---|---|
| (Per 21 CFR 801.109) | |
| or | |
| Over-the-Counter Use | |
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | 4093174 |
| (Optional format 1-2-96) |