Shape-HF Cardiopulmonary Testing System

• K Number: K150888
• Device Name: Shape-HF Cardiopulmonary Testing System
• Manufacturer: SHAPE MEDICAL SYSTEMS, INC
• Date Cleared: 2016-01-21 ( 294 days)
• Product Code: BTY
• Regulation Number: 868.1890

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 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: 1. Cardiopulmonary health assessment; 2. Assessing heart and lung disease and defining probable sources of heart and/or lung limitations; 3. Assessing patient risk in heart and/or lung disease; 4. Assessing and monitoring physiological response to therapy, including pharmaceutical and/or medical device intervention; and 5. Assessing fitness levels and exercise tolerance.

Predicate Devices

K090722, K980094

Reference Devices

K082077

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary mentions "predictive pulmonary function values that are calculated based on the data obtained during testing," but there is no explicit mention of AI, ML, or related terms, nor is there any description of training or test sets which are typical for ML-based devices. The performance studies focus on equivalence to a predicate device, not on the performance of an AI/ML algorithm.

Therapeutic

No
The device is used for monitoring, assessing, and evaluating cardiopulmonary function, not for treating or providing therapy.

Diagnostic

Yes
The device is described as a "Cardiopulmonary Testing System" that aides in "Assessing heart and lung disease and defining probable sources of heart and/or lung limitations" and "Assessing patient risk in heart and/or lung disease." These functions clearly indicate its use for diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "stationary device" and a "stationary testing system," implying hardware components are involved in monitoring cardiopulmonary functions and evaluating variables. The summary also mentions "System Verification and Validation test" and "Software Validation," suggesting both hardware and software aspects were validated.

IVD (In Vitro Diagnostic)

Based on the provided information, the Shape-HF™ Cardiopulmonary Testing System is not an In Vitro Diagnostic (IVD) device.

Here's why:

• IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions.
• Shape-HF™ Function: The Shape-HF™ system directly monitors cardiopulmonary functions during stress testing and other procedures. It measures gas exchange and other physiological parameters in vivo (within the living body), not by analyzing samples in vitro (outside the body).
• Intended Use: The intended use describes monitoring cardiopulmonary functions during procedures and providing predictive values based on data obtained during testing, which implies direct measurement from the patient.
• Device Description: The description reinforces that it monitors parameters during laboratory or clinical conditions, again suggesting direct patient interaction rather than sample analysis.

Therefore, the Shape-HF™ Cardiopulmonary Testing System falls under the category of a medical device used for physiological monitoring and assessment, not an IVD device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

BTY

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:

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

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

adults and children older than 14 years old

Intended User / Care Setting

Not Found

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

The modified Shape-HFTM 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K090722, K980094

Reference Device(s)

K082077

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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 [phone] or [phone] 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 [phone] or [phone] 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:

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.

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, Inc
5000 Township Parkway
St. Paul, MN 55110
Telephone: [phone]
Contact:	Mr. Bernard Horwath
Regulatory Affairs Consultant
4486 Timberline Ct
St. Paul, MN 55127
Telephone: [phone]
Marketed Device:	Shape-HFT™ Cardiopulmonary Testing System
510(k) Clearance:	K090722
Proprietary Name
Modified 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:

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:

• 1. Cardiopulmonary health assessment;
• 2. Assessing heart and lung disease and defining probable sources of heart and/or lung limitations;
• 3. Assessing patient risk in heart and/or lung disease;
• 4. Assessing and monitoring physiological response to therapy, including pharmaceutical and/or medical device intervention; and
• 5. 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)	Modified
Shape-HFT™ Cardiopulmonary Testing System	Shape-HFT™ Cardiopulmonary Testing System	Oxycon Alpha
Manufacturer	Shape Medical	Shape Medical	Jaeger
510(k) Number
Decision Date		K090722
March 31, 2009	K980094
July 28, 1998
Classification Name	Predictive Pulmonary Function Value Calculator; 21
CFR 868.1890, Class II, Product Code BTY	Predictive Pulmonary Function Value Calculator; 21
CFR 868.1890, Class II, Product Code BTY	Predictive Pulmonary Function Value Calculator; 21
CFR 868.1890, Class II, Product Code BTY
Indications for Use	The Shape-HFT™ 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.	The Shape-HFT™ 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.	The Jaeger Oxycon Alpha is a predictive pulmonary
function value calculator. It is a software driven,
active medical device for investigational exercise
measurements. It measures the human response to
increasing workloads with emphasis on the gas
exchange parameters. Measurements include
ventilation, oxygen uptake, carbon dioxide
production, and derived parameters.
Principle of Operation	The Shape-HFT™ System is a mobile instrument to be
used for breath-by-breath measurement during
cardiopulmonary metabolic gas exchange exercise
testing (CPX).	The Shape-HFT™ System is a mobile instrument to be
used for breath-by-breath measurement during
cardiopulmonary metabolic gas exchange exercise
testing (CPX).	The OxyconAlpha System is a mobile instrument to
be used for breath-by-breath measurement during
cardiopulmonary metabolic gas exchange exercise
testing (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 Flow
Measurement	Fixed orifice, differential pressure pneumotach	Fixed orifice, differential pressure pneumotach	Digital rotameter
Carbon Dioxide analyzer	Non-dispersive infrared	Non-dispersive infrared	Non-dispersive infrared
Paramagnetic 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, Dead
Space, Peak Expiratory Flow, Volume Inspired, Resting
Energy, Expiratory Time, Inspiratory Time, and
measurements derived from these.	Breath count, PetCO2, VCO2, VO2, VT, Heart Rate,
Respiratory Rate, Barometric Pressure, SPO2, Dead
Space, 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 Hz
Output: 5/12 VDC: 3 A	Input: 90/240 VAC; 50 – 60 Hz
Output: 5/12 VDC; 3 A	Input: 90/240 VAC; 50 – 60 Hz
Output: 5/12 VDC: 3 A

Table 1 Substantial Equivalence Comparison