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.

Device Description

The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions. The Shape-HF system is comparable to the Cortex Metalyzer 3BTM system (K993641). The device is software driven and electrically operated.

AI/ML Overview

The provided text is a 510(k) summary for the Shape-HF™ Cardiopulmonary Testing System. It describes the device, its intended use, and its comparison to a predicate device (Cortex Metalyzer 3B™). The summary emphasizes the substantial equivalence of the new device to the predicate.

However, the provided document does not contain details about specific acceptance criteria or a study that rigorously proves the device meets such criteria with defined metrics and statistical analysis. It focuses on establishing substantial equivalence based on similarities in intended use, applications, usage location, and technology with the predicate device.

Therefore, many of the requested items cannot be extracted directly from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document does not specify quantitative acceptance criteria (e.g., accuracy, precision) for device performance or present a table of reported performance against such criteria. It instead states that the device is "substantially equivalent" to a predicate, implying that its performance is expected to be similar or within acceptable limits as defined for the predicate.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Cannot be provided. The document does not describe any specific test set size, data provenance, or study design (retrospective/prospective) for evaluating the Shape-HF system's performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Cannot be provided. There is no mention of a test set, ground truth establishment, or experts involved in such a process.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Cannot be provided. As no test set or expert evaluation is described, there is no mention of an adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Cannot be provided. This document describes a "Predictive Pulmonary Function Value Calculator" and general cardiopulmonary testing. There is no indication of AI assistance, human reader involvement, or an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Cannot be fully determined, but it's implied. The device is described as "software driven" and provides "predictive pulmonary function values that are calculated based on the data obtained during testing." This suggests an algorithmic component. However, the document does not detail a standalone performance study where the algorithm's output was evaluated independently of any human interpretation or intervention, nor does it present specific performance metrics for such a standalone evaluation. The focus is on the overall system's equivalence to a predicate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be provided. There is no mention of ground truth in the context of the device's performance evaluation in this document.

8. The sample size for the training set

Cannot be provided. While the device calculates "predictive pulmonary function values," and such calculations often involve algorithms trained on data, the document does not provide any information about a training set, its size, or how it was used.

9. How the ground truth for the training set was established

Cannot be provided. As there is no mention of a training set, there is no information on how its ground truth was established.

Summary of what the document focuses on instead:

The provided document, a 510(k) summary, primarily aims to demonstrate "substantial equivalence" of the Shape-HF™ Cardiopulmonary Testing System to a legally marketed predicate device (Cortex Metalyzer 3B™). This is achieved by highlighting:

Equivalent Intended Use: Both devices monitor cardiopulmonary functions during stress testing, rehabilitation, sports medicine, etc., for adults and children over 14 years old in laboratory/clinical settings.
Similar Technology: Both use non-dispersive infrared for CO2 sensing and electrochemical fuel cells for O2 sensing. They also measure the same variables for pulmonary function calculations.
Minor Differences in Standard Technology: While there are differences (e.g., pulse oximeter vs. Polar Belt for heart rate, fixed orifice pneumotach vs. digital rotameter for volume transducer), these are considered "standard technology" and not significant enough to raise new questions of safety or effectiveness.

In summary, the document asserts that because the Shape-HF system is substantially equivalent to an already approved device, it meets the necessary regulatory requirements without needing to present novel performance data against specific, quantitative acceptance criteria in this submission.

Summary

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Koro722

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

Submitter:	Shape Medical Systems, Inc.5000 Township ParkwaySt. Paul, MN 55110Ph: 651.621.2990MAR 31 2009
Contact Information:	On behalf of Shape Medical Systems, Inc., the followingconsultant is assigned the responsibility of submissioncorrespondence:Darin BuschAEIOMed, Inc.1313 5th St. SE, Suite 205Minneapolis, MN 55414Phone: 612 455-0550Fax: 612 455-0551Email: darinb@aeiomed.com
Submission Date:	September 15, 2008
Trade Name:	Shape-HFTM Cardiopulmonary Testing System
Classification Name:	Predictive Pulmonary Function Value Calculator (21 CFRSection 868.1890)
Predicate Device:	Cortex Metalyzer 3BTM
Device Description andComparison:	The Shape-HF Cardiopulmonary Exercise Testing Systemis a stationary device that monitors parameters duringlaboratory or clinical conditions. The Shape-HF system iscomparable to the Cortex Metalyzer 3BTM system(K993641).The device is software driven and electrically operated.
Intended Use:	The Shape-HFTM Cardiopulmonary Testing System is apulmonary function stationary testing system intended to beused to monitor cardiopulmonary functions during stresstesting, rehabilitation, sports medicine, and other relatedprocedures for which cardiopulmonary gas exchange
Differences andSimilarities:	provides predictive pulmonary function values that arecalculated based on the data obtained during testing. TheSystem can be used on adults and children older than 14years old in a laboratory or clinical facility setting.The Shape-HFTM Cardiopulmonary Testing System issubstantially equivalent to the predicate device.
Intended Use:	The intended use of the Shape-HF System and the predicatedevice are equivalent.
Applications:	Both devices are used in applications such as stress testing,rehabilitation, occupational medicine, sports medicine,physiological research, and therapeutic assessment.
Usage location:	Both devices are designed for use in a laboratory or clinicalfacility setting.
Technology:	The Shape-HF system and the predicate device have verysimilar 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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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:

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)

Regulation Number and Section

§ 868.1890 Predictive pulmonary-function value calculator.

(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).