The ThermoSuit System™ is a thermal requlating system.
Indications for Use are
a. Temperature reduction in patients where clinically
indicated, e.g. in hyperthermic patients;
b. Monitoring of patient temperature.

Device Description

The ThermoSuit System (TSS) is a device that allows rapid patient cooling by the circulation of cold water in direct contact with the skin of the patient. Patient temperature measurements control the extent and duration of cooling, by controlling pump output and drainage of cooling fluid. Temperature measurements and associated alarm signals are designed to prevent overcooling.

The ThermoSuit System™ consists of the following main components:

. ThermoSuit Body Enclosure
Multi-lumen Umbilicus Hose .
. Reservoir/Pump Assembly
. Pump Controller Console
. Other Components

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the ThermoSuit System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define numerical acceptance criteria (e.g., cooling rate target, temperature accuracy range) or quantifiable performance metrics for the ThermoSuit System. Instead, the performance testing focuses on functional verification and comparison with a predicate device.

Acceptance Criteria (Inferred from context)	Reported Device Performance
Optimal suit dimensions and operating parameters	Results from human volunteer testing used to optimize suit dimensions and operating parameters.
Mechanical integrity of the ThermoSuit Body Enclosure (pressure resistance)	ThermoSuit Body Enclosure passed testing with a 50% excess pressure in air compartments and fluid channels.
Product meets all performance specifications (functional testing with new and aged components)	ThermoSuit System was functionally tested with new and aged ThermoSuit Body Enclosures by measuring relevant design parameters; the product met all performance specifications.
Pump/Controller functions and software validation conform to device specifications	Performance testing included a full evaluation of Pump/Controller functions and software validation; results conformed to device specifications.
Ability to cool test systems (comparable to predicate device)	Comparative Cooling Bench Study (Heated Mannequin): New device and predicate device both cooled test systems. Cooling occurred at a higher rate in the new device. Animal Study (Large Pigs): New device and predicate device both cooled test systems. Cooling occurred at a higher rate in the new device.
System works in the hands of users (monitoring water volumes)	Monitoring of water volumes during system operation showed the system worked in the hands of users.
Users understand the Operator's Manual, device, and its operation	Users' responses to a detailed questionnaire established that they understood the Operator's Manual, the device, and its operation.
Biocompatibility for short-term skin contact	ISO 10993 (Biocompatibility for short-term skin contact) standard was met.
Electrical safety and electromagnetic compatibility	Met UL 60601-1, CSA C22.2 NO 601.1-M90, CENELEC EN 60601-1, CENELEC EN 60601-1-2, IEC 60601-1-2, and JIS T0601-1 standards.
Patient temperature monitoring functions as designed (prevents overcooling, alerts user)	Designed to prevent overcooling (temperature measurements and alarm signals) and alerts user when patient temperature approaches target.
Substantial equivalence to predicate device in cooling function and other key aspects (see Section 7.6)	Determined to be substantially equivalent to the predicate device in its cooling function and other listed attributes.

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

Human Volunteers (for suit optimization): Sample size not specified.
ThermoSuit Body Enclosures (mechanical integrity): "All suits" implies the entire production batch or a representative sample from it. Sample size not specified quantitatively.
Functional Testing (new and aged components): Sample size not specified quantitatively for components, but refers to "ThermoSuit System" and "ThermoSuit Body Enclosures."
Comparative Cooling Bench Study:
- Test Set: One "Heated Mannequin."
- Data Provenance: Benchtop study (laboratory setting).
Animal Study:
- Test Set: "Large pigs." Sample size not specified quantitatively.
- Data Provenance: Animal study (presumably in a controlled laboratory or research facility).
Design Validation (User Testing):
- Test Set: Four (4) Users, completing a total of nine (9) test runs.
- Data Provenance: User testing, likely in a simulated clinical or laboratory environment.
Data Provenance (overall): Primarily internal testing (bench, animal, user validation). Country of origin is not specified, but the company is US-based (Kinnelon, NJ), suggesting US provenance. All studies appear to be prospective.

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

For the technical and functional performance tests (mechanical integrity, pump/controller, software), the "ground truth" would be established by the engineering and testing protocols themselves, not typically by experts in a clinical sense.
For the cooling studies (mannequin and animal), the ground truth is the actual measured temperature change and cooling rates. This is a direct measurement, not an expert consensus.
For the user validation test, the ground truth for understanding the manual and device operation was established through a "detailed questionnaire" answered by the four users. Their qualifications as "Users" are not further specified (e.g., nurses, technicians, physicians), but they are implied to be representative of target operators.

4. Adjudication Method for the Test Set:

Not applicable in the conventional sense. The studies described are primarily objective measurements (temperature, pressure, functional checks) or direct user feedback (questionnaire). There's no mention of subjective interpretation of results requiring adjudication by multiple readers or evaluators.

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

No, an MRMC study was not done. The comparative studies involved the device and a predicate device in bench and animal models, not human readers interpreting cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The ThermoSuit System is a medical device that involves direct interaction with a patient and a human operator. Its "performance" isn't a standalone algorithm in the way an AI diagnostic tool would be. The closest equivalent would be the automated functions of the pump controller and software. The document states:

"Performance testing of the ThermoSuit System included a full evaluation of the Pump/Controller functions and software validation; the results conformed to the device specifications."
This indicates that the automated control aspects were tested for their inherent functionality according to specifications, representing a form of standalone performance for the automated components.

7. The Type of Ground Truth Used:

Objective Measurements: For mechanical tests (pressure), functional tests (pump/controller, software), and cooling studies (temperature reduction, cooling rate).
Test Specifications: The device was tested against its own "performance specifications" and "design parameters."
User Feedback: For understanding of the Operator's Manual and device operation in the design validation.
Compliance with Standards: For biocompatibility, electrical safety, and electromagnetic compatibility.
Comparison to Predicate Device: For cooling effectiveness, where the predicate device's performance served as a benchmark for "comparable" results.

8. The Sample Size for the Training Set:

This device is not an AI/ML algorithm that requires a "training set" in the computational sense. The development and optimization processes of the ThermoSuit System likely involved iterative design, prototyping, and testing (including the human volunteer testing for suit dimensions/operating parameters), which could be considered analogous to "training" in an engineering context, but not a data-driven training set for an algorithm. No specific sample sizes for such iterative development are provided here.

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

As above, there is no "training set" in the AI/ML context for this device. The development process would have involved engineering design principles, physical testing, and potentially user feedback during various stages to refine the product, with "ground truth" being established by physical measurements, functional requirements, and design specifications.

Summary

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7 510(k) SUMMARY

Company and Product Information 7.1

SEP 2 0 2006

Company	Life Recovery Systems HD, LLCThe Sid Wolvek Research Center170 Kinnelon Road, Suite 9Kinnelon, NJ 07405Phone 973.283.2800Fax 973.283.2910Email research@life-recovery.com
Contact Person	Robert B. Schock, Ph.D.Vice President, Research and Development
Date of 510(k) Summary	September 19, 2006
Trade Name	ThermoSuit System™
Classification Name	Thermal Regulating System
Regulation	21 CFR 870.5900
Class	II
Product Code	NZE
Predicate Device	MTA 6900 Medi-Therm III Hyper/Hypothermia Systemwith HP7010 Hyper/Hypothermia Blanket.The predicate device is a modification of a previous

version, MTA5900 Medi-Therm II Hyper/Hypothermia System, K912051.

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7.2 Device Description

The ThermoSuit System™ consists of the following main components:

. ThermoSuit Body Enclosure
An inflatable mattress lies beneath the patient, and a top sheet covers most of the patient (excluding the face). Both the mattress and the top sheet have integral fluid channels that bring circulating water in direct contact with the skin. An integral Level Control Assembly maintains the fluid height in the suit.
Multi-lumen Umbilicus Hose .
A Multi-lumen Umbilicus Hose connects the ThermoSuit Body Enclosure to the pump assembly via single twist on connector housings.
. Reservoir/Pump Assembly
The Reservoir/Pump Assembly consists of the pump drive units and reservoir bag integrated into a single assembly for quick drop-in installation.
. Pump Controller Console
The Pump Controller Console contains all the electronics, pneumatics and motor drives for the system. User controls are operated from a touchscreen display that is swivel mounted to adjust to user preference. A reusable temperature probe cable is included with the unit.
. Other Components
Disposables kit also contains: Operator's Manual (PN 53001), a T-Type esophageal thermocouple probe and a ThermoSuit Patch Kit (PN 73006).

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7.3 Device Functions

A patient who requires cooling is placed into the mattress of the ThermoSuit Body Enclosure. In use, the mattress is inflated with air and conforms to the shape and size of the patient. A polyurethane top sheet is attached to the rim of the inflated ThermoSuit with Velcro strips and covers the patient up to the level of the neck. Both the mattress and the top sheet have built-in flow channels that allow water to be pumped against the patient's skin for heat exchange. The mattress has a porous lining (polyester batting) that aids fluid circulation, and a drain channel system that returns water to the Level Control Assembly.

Patient temperature is monitored by means of an esophageal temperature probe. Alternatively, patient temperature may be measured with a nasopharyngeal temperature probe.

The target temperature for the treatment is entered on the touch screen, and cooling therapy is initiated. Cold water is circulated through the top and the bottom of the ThermoSuit Body Enclosure, drips on the patient, and is returned to the polyurethane reservoir in the Reservoir/Pump Assembly.

When the patient temperature approaches the target temperature, the Pump Controller Console alerts the user and purges the water from the ThermoSuit Body Enclosure. Water may also be purged by manual control.

7.4 Standards Met by New Device

ISO 10993: - Biocompatibility for short-term skin contact

UL 60601-1 UL Standard for Safety Medical Electrical Equipment, Part 1: General Requirements for Safety First Edition CSA C22.2 NO 601.1-M90 - Issue 1990/01/11 (R2001) Medical Electrical Equipment - Part 1: General Requirements for Safety General Instruction No 1; Supplement 1; 1994; Amendment 2 -February 1998 (R1997)
CENELEC EN 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety Incorporates Corrigendum July 1994; Includes Amendments A1: 1993, A11: 1993, A12: 1993, A2: 1995 and A13: 1996; IEC 601-1: 1988 + A1: 1991 + A2: 1995 + Corrigendum 1995, Modified
CENELEC EN 60601-1-2 2001 Medical Electrical Equipment Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility - Requirements and Tests IEC 60601-1-2: 2001

Life Recovery Systems

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IEC 60601-1-2 (1993-04) Medical Electrical Equipment Part 1: General Requirements for Safety 2. Collateral Standard: Electromagnetic Compatibility - Requirements and Tests First Edition; (CENELEC EN 60601-1-2: 1993)
JIS T0601-1 Medical Electrical Equipment Part 1: General Requirements for Safety

7.5 Intended Use

The ThermoSuit System is intended for

a. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients:
b. Monitoring of patient temperature

The intended use for the ThermoSuit System is narrower than that for the predicate device which has both cooling and warming functions.

7.6 Substantial Equivalence Determination

The ThermoSuit System™ is substantially equivalent to the predicate device in its cooling function; unlike the predicate device, it has no warming function.

The ThermoSuit System™ is substantially equivalent to the predicate device with regard to:

. removal of thermal energy from the patient
. use of a pump-driven circulation system for the cooling fluid
use of chilled water as cooling fluid .
utilization of a large part of the patient's surface for cooling .
components: .
- a flexible polymer component filled with cooling fluid
- a flexible piping system
- a software-controlled pump
utilization of the device in the hospital .
human factors: .
- operators must place the patient on the heat-exchange device
. safetv svstems:
- a temperature probe in the patient controls the pumping system
- software in the pumping system alerts the user to potential excess cooling

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7.7 Performance Testing

The ThermoSuit Body Enclosure was tested with human volunteers; the results were used to optimize suit dimensions and operating parameters.

Performance testing of the ThermoSuit Body Enclosure included a 50% excess pressure of the air compartments and fluid channels; all suits passed testing.

The ThermoSuit System was functionally tested with new and aged ThermoSuit Body Enclosures by measuring the relevant design parameters; the product met all performance specifications.

Performance testing of the ThermoSuit System included a full evaluation of the Pump/Controller functions and software validation; the results conformed to the device specifications.

Cooling studies comparing the ThermoSuit System and the predicate device were run in two models:

(1) Heated mannequin comparative cooling bench study

(2) Animal study (large pigs) with ThermoSuit's adapted to the animal's shape.

The results were comparable insofar as the new device and the predicate device both cooled the test systems, but cooling occurred at a higher rate in the new device.

7.8 Design Validation

The design was validated during functional testing by four (4) Users; completing a total of nine (9) test runs. Monitoring of water volumes in the ThermoSuit Body Enclosure and reservoir were made during system operation and showed that the system worked in the hands of users. The users' responses to a detailed questionnaire established that they understood the Operator's Manual, the device and its' operation.

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Public Health Service

Image /page/5/Picture/2 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "HEALTH SERVICES - USA" are arranged in a circular pattern around the top of the symbol. The word "DEPARTMENT" is arranged in a vertical pattern along the left side of the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP & U 2006

Life Recovery Systems HD, LLC c/o Robert B. Schock, Ph.D. Vice President, Research and Development The Sid Wolvek Research Center 170 Kennelon Road, Suite 9 Kennelon, NJ 07405

Re: K061023 ThermoSuit Systems™ Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: NZE Dated: August 10, 2006 Received: August 11, 2006

Dear Dr. Schock:

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. Please be advised that FDA's issuance of a substantial equivalence determination does not mean

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Page 2 -- Robert B. Schock, Ph.D.

that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a determination administered by other Federal agencies. You must or any redelal statutes and regulations and including, but not limited to: registration and listing (21 Comply will an the Act 31equirements,010; good manufacturing practice requirements as set CFK Fart 607), adoling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (QD) regulations 531-542 of the Act); 21 CFR 1000-1050. product factation control provisions (Decloss or device as described in your Section 510(k) This letter witi anow you to orgin mailing of substantial equivalence of your device to a legally premarket notineation: "The PDF intailigs 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 If you desire specific advice 101-10-101-11-1120. Also, please note the regulation entitled, Colliact the Office of Compilation (21CFR Part 807.97). You may obtain Misolanding by reference to premail.org with the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Ocess http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

some R. Vochner

(M) Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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8 Indications for Use

510(k) Number	K061023
Device Name:	ThermoSuit System™
Indicationsfor Use	The ThermoSuit System™ is a thermal requlating system.Indications for Use area. Temperature reduction in patients where clinicallyindicated, e.g. in hyperthermic patients;b. Monitoring of patient temperature.
Patient Population	The ThermoSuit System™ (Size M) is indicated for patientsgreater than 58" (147 cm) and less than 75" (190 cm) in heightand less than 26" (66 cm) in width.
Prescription Use(Part 21 CFR 801 Subpart D)	Over-The-Counter UseAND/OR(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Jones

sion Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices

510(k) number K061023

510(k) for ThermoSuit System 8-1

Regulation Number and Section

§ 870.5900 Thermal regulating system.

(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).