The Metaphor uses the direct measurement of Oxygen uptake (VO2) and Carbon Dioxide production (VCO2) to objectively and noninvasively assess breath by breath metabolic function during rest or exercise. The Metaphor can assess energy expenditure to support nutritional assessment. Optional measurement of Nitrous Oxide (N2O) is available for enhanced accuracy of the CO2 measurement in the presence of N2O.

The Metaphor is a comprehensive pulmonary mechanics monitor which can display graphic and numeric data in patients who are mechanically ventilated or breathing spontaneously.

The Metaphor pulse oximetry function provides continuous SpO2 and pulse rate measurements in neonatal through adult populations with appropriate probes.

The Metaphor provides adjustable visible and audible alarms. The device is not intended for use as a transport monitor.

Device Description

The Metaphor Metabolic Monitor integrates the functions of a sidestream respiratory gas monitor (CO2, O2, N2O), and pulmonary mechanics monitor (pressure, flow, and volume). These features allow the Metaphor to measure Oxygen uptake (VO2) and Carbon Dioxide production (VCO2) to objectively and noninvasively assess breath by breath metabolic function during rest or exercise.

The system is comprised of two main elements:

Metaphor PC software host application running on a dedicated touch screen computer terminal, which presents computed physiological monitoring parameters, including metabolic measurements, as graphic and numeric data. This application manages the user interface, including alarms, and it interfaces to the BXB_DAS.
The BXB DAS embedded measurement platform this subsystem contains the sensor technology to perform the gas, pressure, and flow measurements, and integrates a 510(k) cleared third party pulse oximeter module. The BXB DAS subsystem interfaces with single patient use EZ-Flow sensors and SpO2 sensors.

AI/ML Overview

This summary describes the acceptance criteria and the study that proves the Metaphor Metabolic Monitor meets those criteria, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria (Implied)	Reported Device Performance
Electrical Safety	Conformance with applicable standards.	"The device passed the tests."
Electromagnetic Compatibility (EMC)	Conformance with applicable standards.	"The device passed the tests."
Shock and Vibration	Conformance with applicable standards.	"The device passed the tests."
Environment (Temperature & Humidity)	Conformance with applicable standards.	"The device passed the tests."
Biocompatibility	Conformance with biocompatibility requirements.	"The materials met the requirements."
Respiratory Gas Monitors	Satisfy performance criteria.	"The device satisfied performance criteria."
Pressure/Flow Measurement	Satisfy performance criteria.	"The device satisfied performance criteria."
Metabolic Measurements (Extended Range Bench Testing)	Satisfy performance criteria, comparison testing where possible.	"The device satisfied performance criteria."
Pulse Oximeter Integration	Demonstrate successful integration.	"Pulse oximeter simulation tests were performed to demonstrate successful integration."
Alarms Testing	Perform testing and satisfy criteria.	"Alarms testing was performed. The device satisfied performance_criteria."
PC Software and BXB_DAS Subsystem Embedded Software	Verified to requirements, validated to meet intended use.	"PC software and BXB_DAS subsystem embedded software were verified to requirements and validated to meet intended use."
Risk, Hazard, and Failure Mode Analysis	Residual risks determined to be acceptable.	"Risk, hazard and failure mode analysis was performed and residual risks were determined to be acceptable."

2. Sample Sizes and Data Provenance

Test Set Sample Size: Not explicitly stated for any specific test. The document refers to various "tests" and "testing" without providing breakdowns of the number of samples or cases used.
Data Provenance: The study was a non-clinical evaluation. No human patient data (retrospective or prospective) was used for performance validation. The testing involved bench tests, simulations, and conformance to electrical and material standards. This suggests the data was generated in a lab setting by the manufacturer, TreyMed, Inc., located in Sussex, Wisconsin, USA.

3. Number of Experts and Qualifications for Ground Truth

Not Applicable. Since this was a non-clinical study involving bench testing and conformance to standards, there was no ground truth established by medical experts for diagnostic or clinical performance claims. The performance was assessed against engineering and safety standards.

4. Adjudication Method for the Test Set

Not Applicable. No clinical test set or expert-driven adjudication was performed as part of this submission. The tests were objective engineering and safety evaluations against predefined criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states "Clinical Tests Submitted: (none)". Therefore, no MRMC study or AI-assisted human reader improvement was assessed or reported. This device does not involve image interpretation or diagnostic decisions that would typically necessitate such a study.

6. Standalone Performance Study

Yes, in the context of a non-clinical device. The described testing largely represents standalone performance of the algorithm and hardware components (e.g., flow measurement, gas monitoring, pulse oximetry integration, software verification) against engineering standards and specified performance criteria. The device's various functions (e.g., measuring VO2, VCO2, CO2, O2, N2O, SpO2, and pulmonary mechanics) were tested for their inherent accuracy and functionality in a non-clinical setting.

7. Type of Ground Truth Used

The "ground truth" for these non-clinical tests was based on engineering standards, predetermined specifications, and comparison to calibrated reference instruments or simulation data where applicable (e.g., pulse oximeter simulation). For example, electrical safety adherence is measured against established electrical safety standards, and gas concentration measurements would be validated against known gas mixtures.

8. Sample Size for the Training Set

Not applicable / Not specified. This device is a metabolic monitor, not a machine learning or AI-driven diagnostic system that typically requires a 'training set' in the conventional sense of supervised or unsupervised learning from clinical data. The software was "verified to requirements" and "validated to meet intended use," which refers to standard software development and testing practices, not machine learning model training.

9. How Ground Truth for the Training Set Was Established

Not applicable. As described above, there was no 'training set' in the context of machine learning. The device's functionality is based on established physical and chemical principles of measurement and data processing. The "ground truth" for the development of its software and hardware components would have been derived from physical laws, engineering specifications, and validated measurement techniques.

Summary

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JAN 22 2010

K093080

Page 1 of 4

510(k) Summary of Safety and Effectiveness in accordance with 21 CFR 807.92

(a) (1)	Submitted by:	TreyMed, Inc.
		N56 W24790 N Corporate CircleSussex, WI 53089262-820-1294 phone262-820-1295 faxwww.treymed.com
		E-mail: rhr@treymed.com
	Contact Person:	Robert H. Ricciardelli
	Position/Title:	President
	Date of Preparation:	September 25, 2009
	Trade Name:	Metaphor Metabolic Monitor
	Common/Classification Name:	Computer, Oxygen Uptake; PulseOximeter; Analyzer, Gas, Carbon-Dioxide, Gaseous-phase; Analyzer, Gas,Oxygen, Gaseous-phase; Analyzer, Gas,Nitrous-Oxide, Gaseous-phase;Spirometer, Monitoring;
	Product Code(s):	The following Class II classificationsappear to apply:BZL 21 CFR § 868.1730DQA 21 CFR § 870.2700CCK 21 CFR § 868.1400CCL 21 CFR § 868.1720CBR 21 CFR § 868.1700BZK 21 CFR § 868.1850
	Class:	Class II
(3)	Predicate Device(s):	K051092 Datex-Ohmeda S/5 Compact Airway Module (Model Family

E-CAiOVX), GE HealthCare MedGraphics CPX/D with Breeze EX software; Medical K955432 Graphics Corporation

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K982487 Meteor Hand Held Respiratory Mechanics Monitor, TreyMed, Inc. (formerly CardioPulmonary Technologies, Inc.) BCI WW1020 SPECTRO2 Pulse Oximeter, Smiths Medical PM, K083705 Inc. (formerly BCI) K090722 Shape-HF Cardiopulmonary Exercise Testing System, Shape Medical Systems, Inc.
Reason for Submission: New Device

(4) Description of Device:

The system is comprised of two main elements:

Metaphor PC software host application running on a dedicated touch . screen computer terminal, which presents computed physiological monitoring parameters, including metabolic measurements, as graphic and numeric data. This application manages the user interface, including alarms, and it interfaces to the BXB_DAS.
The BXB DAS embedded measurement platform this subsystem . contains the sensor technology to perform the gas, pressure, and flow measurements, and integrates a 510(k) cleared third party pulse oximeter module. The BXB DAS subsystem interfaces with single patient use EZ-Flow sensors and SpO2 sensors.

(2) Intended use:

Respiratory gas measurements are useful in critical care monitoring scenarios. Pulmonary mechanics measurements are useful in ventilated patients. Metabolic measurements are useful to determine the rate of energy expenditure in a variety of clinical scenarios, as described below.

Indications for Use:

The Metaphor uses the direct measurement of Oxygen uptake (VO)) and Carbon Dioxide production (VCO2) to objectively and noninvasively assess breath by breath metabolic function during rest or exercise. The Metaphor can assess energy expenditure to support nutritional assessment. Optional

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measurement of Nitrous Oxide (N>O) is available for enhanced accuracy of the CO2 measurement in the presence of N2O.

The Metaphor is a comprehensive pulmonary mechanics monitor which can display graphic and numeric data in patients who are mechanically ventilated or breathing spontaneously.

The Metaphor pulse oximetry function provides continuous SpO2 and pulse rate measurements in neonatal through adult populations with appropriate probes.

The Metaphor provides adjustable visible and audible alarms. The device is not intended for use as a transport monitor.

Prescription Device.

(6) Technological Characteristics:

The Metaphor utilizes similar measurement methods as the referenced predicate devices:

Flow detection based on differential pressure measurement .
o Sidestream qas sampling
� CO2 and N₂O gas monitoring via infrared optical measurement
O> monitoring using electrochemical cell 0
Integration of a listed subsystem for pulse oximetry .
WIN PC-based control program .

As described above, the Metaphor implements a PC based monitor application with the TreyMed BXB DAS (breath by breath data acquisition subsystem) to perform and display the measurements.

Metaphor Metabolic Monitor has the same The technological characteristics as the referenced combination of 510(k) listed devices:

The Metaphor integrates the same flow measurement technology and o EZ-Flow sensor technology as two predicate devices (Meteor, Shape-HF), and the same measurement principle (differential pressure). The Metaphor uses the EZ-Flow sensor.
The Metaphor. Shape-HF and BCI WW1020 devices use identical . oximetry technology, the BCI technology.
Metaphor reports metabolic parameters similar to CPX/D and Shape-. HF, including VO2 and RQ, employing similar technical means.
Metaphor provides respiratory gas monitoring parameters (CO2, O2, . optional N2O) similar to the Datex CAiOVX using similar means.

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(b) (1) Non-Clinical Tests Submitted:

The Metaphor Metabolic Monitor was tested in accordance with applicable standards for medical device electrical safety, electromagnetic compatibility, shock and vibration, and environment (temperature and humidity). The device passed the tests.

Materials utilized in patient contact surfaces were reviewed for conformance with biocompatibility requirements. The materials met the requirements.

System level tests of the Metaphor Metabolic Monitor included testing in support of requirements for respiratory gas monitors, pressure/flow measurement testing, and extended range bench testing of metabolic measurements, including, where possible, comparison testing. Pulse oximeter simulation tests were performed to demonstrate successful integration. Alarms testing was performed. The device satisfied performance criteria.

The Metaphor Metabolic Monitor PC software and BXB_DAS subsystem embedded software were verified to requirements and validated to meet intended use. Risk, hazard and failure mode analysis was performed and residual risks were determined to be acceptable.

(2) Clinical Tests Submitted:

(none)

Conclusions from Tests: (3)

As described in (b)(1) and (b)(2) above, the testing demonstrates that the Metaphor Metabolic Monitor is as safe and effective as, and functions in a manner equivalent to the predicate devices.

ર-4

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Mr. Robert H. Ricciardelli President TreyMed, Incorporated N56 W24790 North Corporate Circle Sussex, Wisconsin 53089

JAN 22 2010

Re: K093080

Trade/Device Name: Metaphor Metabolic Monitor Regulation Number: 21 CFR 868.1730 Regulation Name: Oxygen Uptake Computer Regulatory Class: II Product Code: BZL, DQA, CCK, CBR, CCL, BZC Dated: January 18, 2010 Received: January 19, 2010

Dear Mr. Ricciardelli:

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 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. Ricciardelli

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.goy/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/cdrh/mdr/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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

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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Indications for Use

510(k) Number (if known):

Device Name: TreyMed, Inc. Metaphor Metabolic monitor

Indications for use:

The Metaphor uses the direct measurement of Oxygen uptake (VO2) and Carbon Dioxide production (VCO2) to objectively and noninvasively assess breath by breath metabolic function during rest or exercise. The Metaphor can assess energy expenditure to support nutritional assessment. Optional measurement of Nitrous Oxide (N₂O) is available for enhanced accuracy of the CO2 measurement in the presence of N2O.

The Metaphor is a comprehensive pulmonary mechanics monitor which can display graphic and numeric data in patients who are mechanically ventilated or breathing spontaneously.

The Metaphor pulse oximetry function provides continuous SpO2 and pulse rate measurements in neonatal through adult populations with appropriate probes.

The Metaphor provides adjustable visible and audible alarms. The device is not intended for use as a transport monitor.

Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician or other licensed practitioner.

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)

Schulthe

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

Page 1 of 1

510(k) Number: K093080

Regulation Number and Section

§ 868.1730 Oxygen uptake computer.

(a)
Identification. An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a patient and may include components for determining expired gas volume and composition.(b)
Classification. Class II (performance standards).