(160 days)
Not Found
No
The description focuses on a closed-loop control system based on direct temperature measurements, not AI/ML algorithms. There are no mentions of AI, DNN, or ML, nor descriptions of training or test sets typically associated with such technologies.
Yes.
The device's intended use is "Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients," which indicates a therapeutic purpose.
No
The ThermoSuit System is a thermal regulating system designed for temperature reduction and monitoring, not for diagnosing an illness or condition.
No
The device description explicitly lists multiple hardware components (ThermoSuit Body Enclosure, Multi-lumen Umbilicus Hose, Reservoir/Pump Assembly, Pump Controller Console, Other Components) that are integral to the device's function. While software validation is mentioned, it is part of the overall system testing, not the sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for temperature regulation (reduction and monitoring) in patients. This is a therapeutic and monitoring function performed directly on the patient's body.
- Device Description: The device works by circulating cold water in direct contact with the patient's skin. This is an external, physical intervention.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide information about a patient's health. IVDs are specifically designed for testing samples in vitro.
The ThermoSuit System is a medical device used for patient temperature management, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NZE
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
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).
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
Not Found
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
MTA 6900 Medi-Therm III Hyper/Hypothermia System with HP7010 Hyper/Hypothermia Blanket.
K912051
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the text "K061023 Page 1 of 5" at the top. Below the text is a logo that says "LRS" with a line going through the letters. To the right of the letters is a graphic that looks like a heart rate monitor.
7 510(k) SUMMARY
Company and Product Information 7.1
SEP 2 0 2006
| Company | Life Recovery Systems HD, LLC
The Sid Wolvek Research Center
170 Kinnelon Road, Suite 9
Kinnelon, NJ 07405
Phone 973.283.2800
Fax 973.283.2910
Email 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 System
with HP7010 Hyper/Hypothermia Blanket.
The predicate device is a modification of a previous |
version, MTA5900 Medi-Therm II Hyper/Hypothermia System, K912051.
1
K061CA3
Page 2 of 5
7.2 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
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).
2
K061023
Page 3 of 5
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
3
- 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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K061023
Page 5 of 5
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.
5
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
6
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
7
8 Indications for Use
| 510(k) Number | K061023 |
|---|---|
| Device Name: | ThermoSuit System™ |
| Indications | |
| for Use | 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. | |
| Patient Population | The ThermoSuit System™ (Size M) is indicated for patients |
| greater than 58" (147 cm) and less than 75" (190 cm) in height | |
| and less than 26" (66 cm) in width. | |
| Prescription Use | |
| (Part 21 CFR 801 Subpart D) | Over-The-Counter Use |
| AND/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