SPIROPALM

K093174 · Cosmed Srl · BZG · Feb 26, 2010 · Anesthesiology

Device Facts

• Record ID: K093174
• Device Name: SPIROPALM
• Applicant: Cosmed Srl
• Product Code: BZG · Anesthesiology
• Decision Date: Feb 26, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2

Intended 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 Voluntary Ventilation) and Pulse Oximetry tests in the physician's office or a hospital setting.

Device Story

Spiropalm and Spiropalm Plus are pulmonary function testing systems; perform basic spirometry (FVC, SVC, MVV) and pulse oximetry. Used in physician offices or hospitals by healthcare professionals. Device captures respiratory flow/volume and blood oxygen saturation signals; processes data to provide diagnostic lung function metrics. Output displayed for clinician review to assist in respiratory assessment and clinical decision-making. Benefits include portable, integrated monitoring of lung function and oxygenation status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Portable pulmonary function testing system; integrates spirometry and pulse oximetry sensors. Operates as a diagnostic spirometer (21 CFR 868.1840).

Indications for Use

Indicated for patients requiring pulmonary function testing (basic spirometry) and pulse oximetry monitoring in clinical settings such as physician offices or hospitals.

Regulatory Classification

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.

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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

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## 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.

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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) |