HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS) by HTTP HYPOTHERMIA THERAPY

The HTTP system is intended to prevent and treat Hypothermia and provide warmth to cold or shivering patients. In addition, the HTTP system should be used whenever conditions exist that could cause patients to become cold/hypothermic.

The HTTP system is indicated primarily for use in hospital, intensive care units, in operating, recovery and emergency rooms, in burns units and on medical/surgical floors. This system can be used with adults patients.

Device Description

The HTTP 2001 Controller and HTTP "Warm me" Blankets ("HTTP System") are designed to compensate for body heat loss before, during and after surgery, especially cavity surgery, and to compensate for the decrease in intensity of all internal processes due to narcosis.

The system conducts direct heat to up to 4 blankets. HTTP Blankets are available in different shapes and sizes, including a modular kit of 4 blankets, e.g., one for each leg, the Full Chest, Half Chest, Back or Abdomen "Warm me" Blanket. The blankets are modular, pliable, disposable, insulated and isolated.

HTTP System is suitable for all patient sizes. Each blanket is connected to a separate heater. A single blanket uses a single heater. The complete set of blankets applies heat to all sections of the patient's body that are not involved in the surgery.

A computerized feedback loop controls patient core temperature in response to each patient's needs, as prescribed by the physician.

The electrical output from Controller to blankets is only 6V. The system is powered by mains or by batteries.

AI/ML Overview

The provided text describes a 510(k) summary for the HTTP System, a thermal regulation device. However, it does not include information about acceptance criteria, a specific study proving the device meets those criteria, or the detailed study parameters requested in your prompt.

The document focuses on:

Device identification: Name, submitter, classification, predicate devices.
Intended use and indications for use.
Device description: How it works (direct heat, modular blankets, computerized feedback for temperature control).
Safety and Effectiveness: Mentions compliance with various electrical and electromagnetic standards (EN60601-1, EN60601-2-35, EN60601-1-2), software verification/validation, and biocompatibility testing for blankets. It vaguely states "The effective performance of the HTTP System has been established through in vitro and clinical studies" but provides no details on these studies or their results related to specific performance metrics.
Substantial Equivalence: Compares its characteristics to predicate devices.

Therefore, I cannot populate the table or answer most of your specific questions based on the provided text, as the necessary details are simply not present.

Here's a breakdown of what cannot be answered and why:

1. Table of acceptance criteria and reported device performance: No specific acceptance criteria (e.g., target temperature range, heating rate, temperature uniformity) are mentioned, nor are any quantitative performance results provided from studies.
2. Sample size and data provenance for the test set: No details on any "test set" are given for performance evaluation.
3. Number and qualifications of experts for ground truth: Not applicable, as no ground truth establishment for a diagnostic or AI performance is mentioned.
4. Adjudication method for the test set: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No mention of such a study. This device is a therapeutic hypothermia/warming system, not an AI-assisted diagnostic tool for human readers.
6. Standalone (algorithm only) performance: The device has a "computerized feedback loop" but no specific "algorithm-only" performance metrics are provided. The "effective performance" is stated to be established through in vitro and clinical studies generally, not specifically for an algorithm's standalone operation.
7. Type of ground truth used: Not applicable in the context of diagnostic performance evaluation. The "effective performance" likely refers to its ability to maintain or change patient temperature, but the ground truth definition for this is not specified.
8. Sample size for the training set: No information is provided about a training set. While the device has a "computerized feedback loop," and presumably some internal control algorithm, the document does not describe it as an AI/ML system that undergoes a separate training phase with a distinct dataset for external validation.
9. How the ground truth for the training set was established: Not applicable, as no training set is described.

In summary, the provided 510(k) summary is for a medical device (a thermal regulation system) and focuses on its safety, general effectiveness, and substantial equivalence to predicate devices, rather than the detailed performance evaluation of an AI/ML algorithm or diagnostic tool.

Summary

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510(k) Summary HTTP Hypothermia Therapy Ltd. HTTP System 510(k) Number K D40440

HTTP Hypothermia Therapy Ltd. Submitter's Name: Technological Center P.O.Box 23664, Ramot, 91236, Jerusalem Beit Rampe, Har Hotzvim, Jerusalem, Israel Tel: +972-2-5879148 Fax: +972-2-5879149

Contact Person: Arava Hacohen Push-Med Ltd. 117, Ahuza St., Ra'ananna 43373, Israel Tel: 972-9-7718130 Fax: 972-9-7718131
HTTP System (HTTP 2001 Controller and HTTP "Warm Trade Name: me" Blankets)

Classification Name: System, Thermal Regulation

The FDA has classified these devices under Class II (product Classification: code DWJ) which are reviewed by the Division of Cardiovascular, Respiratory, and Neurological Devices.

Predicate Device: The HTTP System is substantially equivalent to the Allon 2001 system (MTRE Advanced Technology Ltd.) cleared under K00+546 and K003349, and the Bair Hugger Model 750 (Augustine Medical, Inc.) Cleared under K001149 in terms of intended use, indication for use, technological characteristics, performance data and user interface.
Performance Standards: No performance standards have been established for such devices under sections 514 of the Federal Food, Drug, and Cosmetic Act. However, the HTTP System complies with the following voluntary standards IEC 60601-1(1988), including amendments #1(1991), #2(1995), IEC 60601-2-35(1997), IEC 60601-1-2(1993), EN 55011(1998), EN 61000-4-2(1995), EN 61000-4-3(1996) EN 61000-4-4(1995), EN 61000-4-5(1995),

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CISPR 16-1(1993), CISPR 16-2(1996), MIL-STD, Method 810e and IEC Standards: 68-2.

The HTTP System is intended to prevent and treat Indication for use: hypothermia and provide warmth to cold or shivering patients. In addition, the HTTP System should be used whenever conditions exist that could cause patients to become cold/hypothermic.
The HTTP System is indicated primarily for use in hospital invasive care units, in operating, recovery and emergency rooms, in burn units, and on medical/surgical floors. This system can be used with adult patients

The HTTP 2001 Controller and HTTP "Warm me" Blankets Device Description: ("HTTP System") are designed to compensate for body heat loss before, during and after surgery, especially cavity surgery, and to compensate for the decrease in intensity of all internal processes due to narcosis.

The system conducts direct heat to up to 4 blankets. HTTP Blankets are available in different shapes and sizes, including a modular kit of 4 blankets, e.g., one for each leg, the Full Chest, Half Chest, Back or Abdomen "Warm me" Blanket. The blankets are modular, pliable, disposable, insulated and isolated.

HTTP System is suitable for all patient sizes. Each blanket is connected to a separate heater. A single blanket uses a single heater. The complete set of blankets applies heat to all sections of the patient's body that are not involved in the surgery.

computerized feedback loop controls patient core A temperature in response to each patient's needs, as prescribed by the physician.

The electrical output from Controller to blankets is only 6V. The system is powered by mains or by batteries.

Safety and Effectiveness: The electrical safety of the HTTP system was proven through compliance with the EN60601-1 and EN60601-2-35 recognized standards. The electromagnetic immunity of the system was proven through compliance with the EN60601-1-2. The HTTP software and software applications have been verified and validated. The biological safety of the HTTP blanket has been assured through Biocompatibility testing. The

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effective performance of the HTTP System has been established through in vitro and clinical studies.

Substantial Equivalence: Evidence of substantial equivalence has been demonstrated through:

The HTTP intended use and indications for use were . previously cleared by FDA for the predicate devices.
· The technical characteristics of the HTTP are similar to those of its predicate devices. Differences between the devices include electrical heat as heating medium, modular blanket design and some other minor technological differences.
· Heating output values of the HTTP System are well within previous cleared values of the predicate devices.
Safety and performance testing demonstrated significant . similarity to the predicate devices.

Therefore, the Company believes that the HTTP System is substantially equivalent to its predicate devices cited above without raising new safety and/or effectiveness issues.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2004

HTTP Hypothermia Therapy Ltd. c/o Ms. Dorith Bar-Adon Belt Rampe Har Hotzvim Jerusalem 91236 ISRAEL

Re: K040440

HTTP System (2001 Controller and Warm Me Blankets) Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulatory System Regulatory Class: Class II (two) Product Code: DWJ Dated: February 16, 2004 Received: February 20, 2004

Dear Ms. Bar-Adon:

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.

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Page 2 - Ms. Dorith Bar-Adon

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); 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. This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Donna R. Vochner

A 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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Indications for Use

510(k) Number : K040440

Device Name: HTTP system [HTTP 2001 Controller with HTTP "Warm me" Blankets]

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use (21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Donna P. Lachner

(Division Sign-Off) Division on Cardiovascular Devices

510(K) Number_K040440

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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).