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 Description

The Shape-HF™ Cardiopulmonary Testing System is a stationary device that monitors parameters during laboratory or clinical conditions. The Shape-HF™ Cardiopulmonary Testing System evaluates multiple variables of cardiorespiratory function. The System is intended to be used as a tool to aid in:

Cardiopulmonary health assessment;
Assessing heart and lung disease and defining probable sources of heart and/or lung limitations;
Assessing patient risk in heart and/or lung disease;
Assessing and monitoring physiological response to therapy, including pharmaceutical and/or medical device intervention; and
Assessing fitness levels and exercise tolerance.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Shape-HFTM Cardiopulmonary Testing System:

Summary of Device Performance and Acceptance Criteria

The document provided is a 510(k) summary for a modified medical device. The primary goal of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to establish new safety and efficacy through extensive clinical trials with predefined acceptance criteria. Therefore, the "acceptance criteria" here are largely focused on demonstrating that the modified device performs comparably to the predicate and meets relevant safety standards.

The key change in the modified device is the oxygen sensor (from electrochemical fuel cell to paramagnetic cell) and associated software/housing updates.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence to Predicate System: The modified device should perform as well as the existing Shape-HF™ system (K090722). This implies that a change in the oxygen sensor and associated software should not negatively impact the accuracy or reliability of the cardiopulmonary measurements.	"The modified Shape-HF™ Cardiopulmonary Testing System was tested to verify its equivalence to the current predicate Shape-HFTM system. Testing included System Verification and Validation test, Software Validation, and a Comparison verification test utilizing the current and modified systems. All testing was successful and demonstrated that functional performance requirements were met."
Safety Standard Conformance: Adherence to relevant medical electrical equipment safety and EMC standards.	"The modified Shape-HFTM Cardiopulmonary Testing System has been tested and conforms to the following standards: IEC 60601-1 Medical Electrical Equipment Part 1 and IEC 60601-1-2 Medical Electrical Equipment - Part 1-2."
Biocompatibility: No changes to patient-contacting materials that would introduce new biocompatibility concerns.	"No change to the patient contacting materials."
Indications for Use Equivalence: Maintain the same indications for use as the predicate device.	"The Shape-HFTM Cardiopulmonary Testing System has the identical indications for use as the currently marketed device..."
Technological Characteristics Equivalence: Maintain similar technological characteristics and principle of operation, with justified changes.	"The modified Shape-HF™ Cardiopulmonary Testing System has the same principle of operation and technology characteristics as the predicate Shape-HF™ Cardiopulmonary Testing System. The primary change is the Oxygen Sensor... Both are considered standard oxygen sensing technologies."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a specific "test set" sample size in terms of patient data. The testing described is "System Verification and Validation test, Software Validation, and a Comparison verification test utilizing the current and modified systems." This suggests bench testing and comparative measurements between the two systems, likely using controlled gas mixtures and simulated physiological conditions, rather than a clinical study with a specific patient sample size.

Data Provenance: Not specified in terms of country of origin or retrospective/prospective. Given it's device verification, it would be laboratory/bench data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Experts are not mentioned in the context of establishing ground truth for the device's performance in this document. The "ground truth" for verification testing would likely be based on established reference standards for gas concentrations and flow rates, and potentially comparison to the performance of the previously cleared predicate device.

4. Adjudication Method for the Test Set

Not applicable. The "adjudication method" (e.g., 2+1) typically applies to clinical studies where human reviewers assess data for ground truth. Here, the testing is technical verification and validation.

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

Not applicable. This device is a predictive pulmonary function value calculator, not an AI-assisted diagnostic imaging device requiring human readers or interpretation improvement studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The testing described ("System Verification and Validation test, Software Validation, and a Comparison verification test utilizing the current and modified systems") aligns with standalone performance verification of the device's measurement capabilities. The device generates "predictive pulmonary function values," which is an algorithmic output based on physiological measurements. While a human interacts with the system, the core performance verification would focus on the accuracy of these measurements and calculations themselves.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for this type of device verification would be reference standards and established physiological principles. For example:

Gas Measurements: Calibrated gas mixtures with known concentrations of O2 and CO2 for testing the accuracy of the gas analyzers.
Flow/Volume Measurements: Calibrated flow generators or spirometers with known flow rates and volumes.
Software Validation: Ensuring calculations are performed correctly according to established algorithms, likely by comparing software outputs to manual calculations or a gold-standard reference.
Comparison to Predicate: The predicate device itself acts as a "ground truth" for demonstrating equivalence in performance.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning in a way that requires a "training set" for an AI algorithm in the typical sense (e.g., image classification). It's a physiological measurement system with embedded algorithms for calculating pulmonary function values. The software updates mentioned are to accommodate the new O2 sensor and adjust workload protocols, not to "train" a predictive model from data, beyond the initial development of the physiological models it uses.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a machine learning "training set" in the context of this 510(k) submission. If the device uses predictive models based on established physiological equations, their "ground truth" would be derived from decades of physiological research and clinical data that informed the development of those equations, rather than a specific training set for this particular 510(k) submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 21, 2016

Shape Medical Systems, Inc. % Mr. Bernard Horwath Regulatory Consultant Horwath Resource Group 4486 Timberline Ct. St. Paul. Minnesota 55127

Re: K150888

Trade/Device Name: Shape-HFTM Cardiopulmonary Testing System Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: Class II Product Code: BTY Dated: December 18, 2015 Received: December 22, 2015

Dear Mr. Bernard Horwath:

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.

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

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K150888

Device Name: Shape-HFTM Cardiopulmonary Testing System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of Office of Device Evaluation (ODE)

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510(k) Summary

Shape-HFTM Cardiopulmonary Testing System

Date Prepared:	April 27, 2015 (Modified Jan 19, 2016)
Submitter:	Shape Medical Systems, Inc5000 Township ParkwaySt. Paul, MN 55110Telephone: 651-621-2990
Contact:	Mr. Bernard HorwathRegulatory Affairs Consultant4486 Timberline CtSt. Paul, MN 55127Telephone: 651-231-1761
Marketed Device:	Shape-HFT™ Cardiopulmonary Testing System
510(k) Clearance:	K090722
Proprietary NameModified Device:	Shape-HFT™ Cardiopulmonary Testing System
	Common/Usual Name: Cardiopulmonary Exercise Testing System
	Classification Name: Predictive Pulmonary Function Value Calculator

21 CFR 868.1890, Class II, Product Code BTY

Establishment Registration Number: 3008072932

Description:

1. Cardiopulmonary health assessment;
1. Assessing heart and lung disease and defining probable sources of heart and/or lung limitations;
1. Assessing patient risk in heart and/or lung disease;
1. Assessing and monitoring physiological response to therapy, including pharmaceutical and/or medical device intervention; and
1. Assessing fitness levels and exercise tolerance.

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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.

Substantial Equivalence:

The Shape-HFTM Cardiopulmonary Testing System has the identical indications for use as the currently marketed device and is substantially equivalent to the following predicate devices:

Shape-HFTM Cardiopulmonary Testing System, K090722 .
Jaeger OxyconAlpha, K980094 .

Reference Table 1 for a summary of Substantial Equivalence Comparison.

Technological Characteristics:

The modified Shape-HF™ Cardiopulmonary Testing System has the same principle of operation and technology characteristics as the predicate Shape-HF™ Cardiopulmonary Testing System. The primary change is the Oxygen Sensor which is now a non-depleting Paramagnetic Cell, supplied by Servomex, rather than the previous Electro-chemical Cell. Both are considered standard oxygen sensing technologies. The Jaeger predicate device also utilizes the Paramagnetic Cell Oxygen Sensor. To accommodate the Paramagnetic Cell Oxygen Sensor the Shape-HF™ system housing was customized with slightly larger dimensions. The Shape-HF Software was also modified to accommodate the new O2 Sensor and update the workload test protocols and user interface. In addition, the operating software in the lap top computer has been updated to Windows 7 from Windows XP. An on/off power switch has been added to the modified device for user convenience. The ECG device is optional intended to record the patient's electro-cardiogram. It is independent of the Shape-HF operation. Previously the ECG was user provided if desired; in the modified Shape-HF, a standard ECG device (Corscience K082077) is provided as a convenience to the user. All other technological aspects and performance specifications remain the same.

Biocompatibility:

No change to the patient contacting materials.

Safety Testing:

The modified Shape-HFTM Cardiopulmonary Testing System has been tested and conforms to the following standards:

IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safetv . (version IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012)
. IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility - Requirements and Tests (version IEC 60601-1-2:2007, Non-Life Supporting Equipment)

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Performance Bench Testing:

The modified Shape-HF™ Cardiopulmonary Testing System was tested to verify its equivalence to the current predicate Shape-HFTM system. Testing included System Verification and Validation test, Software Validation, and a Comparison verification test utilizing the current and modified systems. All testing was successful and demonstrated that functional performance requirements were met.

Conclusion:

Through the data and information presented, Shape Medical Systems, Inc. considers the modified Shape-HFTM Cardiopulmonary Testing System substantially equivalent to the predicate devices already on the market (cleared by the 510(k) process) in terms of indications for use, scientific technology, design and functional performance and present no new concerns about safety and effectiveness.

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Table 1 Substantial Equivalence Comparison
Device(s)	ModifiedShape-HFT™ Cardiopulmonary Testing System	Shape-HFT™ Cardiopulmonary Testing System	Oxycon Alpha
Manufacturer	Shape Medical	Shape Medical	Jaeger
510(k) NumberDecision Date		K090722March 31, 2009	K980094July 28, 1998
Classification Name	Predictive Pulmonary Function Value Calculator; 21CFR 868.1890, Class II, Product Code BTY	Predictive Pulmonary Function Value Calculator; 21CFR 868.1890, Class II, Product Code BTY	Predictive Pulmonary Function Value Calculator; 21CFR 868.1890, Class II, Product Code BTY
Indications for Use	The Shape-HFT™ Cardiopulmonary Testing System is apulmonary function stationary testing system intended tobe used to monitor cardiopulmonary functions duringstress testing, rehabilitation, sports medicine, and otherrelated procedures for which cardiopulmonary gasexchange measurements are medically indicated. TheSystem provides predictive pulmonary function valuesthat are calculated based on the data obtained duringtesting. The System can be used on adults and childrenolder than 14 years old in a laboratory or clinical facilitysetting.	The Shape-HFT™ Cardiopulmonary Testing System is apulmonary function stationary testing system intendedto be used to monitor cardiopulmonary functionsduring stress testing, rehabilitation, sports medicine,and other related procedures for whichcardiopulmonary gas exchange measurements aremedically indicated. The System provides predictivepulmonary function values that are calculated based onthe data obtained during testing. The System can beused on adults and children older than 14 years old in alaboratory or clinical facility setting.	The Jaeger Oxycon Alpha is a predictive pulmonaryfunction value calculator. It is a software driven,active medical device for investigational exercisemeasurements. It measures the human response toincreasing workloads with emphasis on the gasexchange parameters. Measurements includeventilation, oxygen uptake, carbon dioxideproduction, and derived parameters.
Principle of Operation	The Shape-HFT™ System is a mobile instrument to beused for breath-by-breath measurement duringcardiopulmonary metabolic gas exchange exercisetesting (CPX).	The Shape-HFT™ System is a mobile instrument to beused for breath-by-breath measurement duringcardiopulmonary metabolic gas exchange exercisetesting (CPX).	The OxyconAlpha System is a mobile instrument tobe used for breath-by-breath measurement duringcardiopulmonary metabolic gas exchange exercisetesting (CPX).
Intended Population of Use	Adult or children over 14 years of age.	Adults or children over 14 years of age.	Patient population is 4 years of age and older.
Environment of Use	Laboratory or healthcare facility location.	Laboratory or healthcare facility location.	Laboratory or healthcare facility location.
Expired/inspired air FlowMeasurement	Fixed orifice, differential pressure pneumotach	Fixed orifice, differential pressure pneumotach	Digital rotameter
Carbon Dioxide analyzer	Non-dispersive infrared	Non-dispersive infrared	Non-dispersive infraredParamagnetic cell
Oxygen Analyzer	Paramagnetic cell, non-depleting	Electrochemical fuel cell	Paramagnetic cell
ECG	Optional	Optional-User provided	Unknown
Heart Rate	Pulse Oximeter	Pulse Oximeter	Polar Heart Rate Monitor
Signal Processing	PC based DLL	PC based DLL	Unknown
Primary Measurements	Breath count, PetCO2, VCO2, VO2, VT, Heart Rate,Respiratory Rate, Barometric Pressure, SPO2, DeadSpace, Peak Expiratory Flow, Volume Inspired, RestingEnergy, Expiratory Time, Inspiratory Time, andmeasurements derived from these.	Breath count, PetCO2, VCO2, VO2, VT, Heart Rate,Respiratory Rate, Barometric Pressure, SPO2, DeadSpace, Peak Expiratory Flow, Volume Inspired,Resting Energy, Expiratory Time, Inspiratory Time,and measurements derived from these.	Measurements include ventilation, oxygen uptake,carbon dioxide production, and derived parameters.
Software Op System	Windows 7	Windows XP	Unknown
Safety Testing	IEC 60601-1; IEC 60601-1-2	IEC 60601-1; IEC 60601-1-2	Unknown
Operating Voltage	Input: 90/240 VAC; 50 – 60 HzOutput: 5/12 VDC: 3 A	Input: 90/240 VAC; 50 – 60 HzOutput: 5/12 VDC; 3 A	Input: 90/240 VAC; 50 – 60 HzOutput: 5/12 VDC: 3 A

Table 1 Substantial Equivalence Comparison

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).