SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM

K090722 · Shape Medical Systems, Inc. · BTY · Mar 31, 2009 · Anesthesiology

Device Facts

• Record ID: K090722
• Device Name: SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM
• Applicant: Shape Medical Systems, Inc.
• Product Code: BTY · Anesthesiology
• Decision Date: Mar 31, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1890
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The Shape-HFTM Cardiopulmonary Testing System is a pulmonary function stationary testing system intended to be used to monitor cardiopulmonary functions during stress testing, rehabilitation, sports medicine, and other related procedures for which cardiopulmonary gas exchange measurements are medically indicated. The System provides predictive pulmonary function values that are calculated based on the data obtained during testing. The System can be used on adults and children older than 14 years old in a laboratory or clinical facility setting.

Device Story

Stationary cardiopulmonary exercise testing system; monitors gas exchange and physiological parameters. Inputs: expired/inspired air flow via fixed orifice differential pressure pneumotach; heart rate via pulse oximeter; gas concentrations via non-dispersive infrared CO2 sensor and electrochemical fuel cell O2 sensor. Software processes sensor data to calculate predictive pulmonary function values. Used in laboratory or clinical settings by healthcare professionals for stress testing, rehabilitation, and sports medicine. Output: real-time cardiopulmonary data and calculated predictive values; assists clinicians in physiological assessment and therapeutic decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and bench testing of sensor components.

Technological Characteristics

Stationary cardiopulmonary testing system. Sensors: non-dispersive infrared (CO2), electrochemical fuel cell (O2), fixed orifice differential pressure pneumotach (flow), pulse oximeter (heart rate). Software-driven, electrically operated. Intended for adults and children >14 years.

Indications for Use

Indicated for monitoring cardiopulmonary functions during stress testing, rehabilitation, sports medicine, and related procedures requiring gas exchange measurements. Population: adults and children >14 years. Setting: laboratory or clinical facility.

Regulatory Classification

Identification

A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

Predicate Devices

• Cortex Metalyzer 3BTM (K993641)

Submission Summary (Full Text)

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Koro722

# 510(k) Summary of Safety and Effectiveness (As required by 807.92(c))

| Submitter: | Shape Medical Systems, Inc.<br>5000 Township Parkway<br>St. Paul, MN 55110<br>Ph: 651.621.2990<br>MAR 31 2009 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | On behalf of Shape Medical Systems, Inc., the following<br>consultant is assigned the responsibility of submission<br>correspondence:<br><br>Darin Busch<br>AEIOMed, Inc.<br>1313 5th St. SE, Suite 205<br>Minneapolis, MN 55414<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Submission Date: | September 15, 2008 |
| Trade Name: | Shape-HFTM Cardiopulmonary Testing System |
| Classification Name: | Predictive Pulmonary Function Value Calculator (21 CFR<br>Section 868.1890) |
| Predicate Device: | Cortex Metalyzer 3BTM |
| Device Description and<br>Comparison: | The Shape-HF Cardiopulmonary Exercise Testing System<br>is a stationary device that monitors parameters during<br>laboratory or clinical conditions. The Shape-HF system is<br>comparable to the Cortex Metalyzer 3BTM system<br>(K993641).<br><br>The device is software driven and electrically operated. |
| Intended Use: | The Shape-HFTM Cardiopulmonary Testing System is a<br>pulmonary function stationary testing system intended to be<br>used to monitor cardiopulmonary functions during stress<br>testing, rehabilitation, sports medicine, and other related<br>procedures for which cardiopulmonary gas exchange |
| Differences and<br>Similarities: | provides predictive pulmonary function values that are<br>calculated based on the data obtained during testing. The<br>System can be used on adults and children older than 14<br>years old in a laboratory or clinical facility setting.<br><br>The Shape-HFTM Cardiopulmonary Testing System is<br>substantially equivalent to the predicate device. |
| Intended Use: | The intended use of the Shape-HF System and the predicate<br>device are equivalent. |
| Applications: | Both devices are used in applications such as stress testing,<br>rehabilitation, occupational medicine, sports medicine,<br>physiological research, and therapeutic assessment. |
| Usage location: | Both devices are designed for use in a laboratory or clinical<br>facility setting. |
| Technology: | The Shape-HF system and the predicate device have very<br>similar technology in their components. |

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### Similarities:

Carbon dioxide sensor - Non-dispersive infrared in both systems. Oxygen sensor - Electrochemical fuel cell in both systems. Predictive value calculations - Both systems measure the same variables and then calculate values for pulmonary function. Intended population - Both systems are intended for use on adults or children over 14 years of age.

## Differences:

Heart rate sensor - The Shape-HF System uses a pulse oximeter for sensing heart rate and the predicate device uses a Polar Belt. Both types are considered standard technology for heart rate sensing. Volume transducer - The Shape-HF System uses a fixed orifice, differential pressure pneumotach while the predicate uses a digital rotameter. Both methods are considered standard technology for measuring expired/inspired air flow.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shape Medical Systems, Incorporated C/o Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

MAR 3 1 2009

Re: K090722

Trade/Device Name: Shape-HF™ Cardiopulmonary Exercise Testing System Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Valve Calculator Regulatory Class: II Product Code: BTY Dated: March 18, 2009 Received: March 19, 2009

Dear Mr. Lehtonen:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Lehtonen

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

Smithe Y. Michael Omd.

Ginette Y. Michaud, M.D. Acting 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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# Indications for Use

510(k) Number (if known): Kogo ZAZ_

Device Name:

Shape-HFTM Cardiopulmonary Exercise Testing System

Indications for Use:

The Shape-HF™ Cardiopulmonary Testing System is a pulmonary function stationary testing system intended to be used to monitor cardiopulmonary functions during stress testing, rehabilitation, sports medicine, and other related procedures for which cardiopulmonary gas exchange measurements are medically indicated. The System provides predictive pulmonary function values that are calculated based on the data obtained during testing. The System can be used on adults and children older than 14 years old in a laboratory or clinical facility setting.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Gunner

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k090722

Shape-HF System 510(k)