The device is intended for thermal regulating a patient's temperature to prevent hypothermia by a warm air heated blanket to reduce cold discomfort during and after surgical procedures.

Device Description

The Snuggle Warm® 4000 Convective Warming System consists of a Convective Warming Unit, a hose that connects to the Convective Warming Unit on one end and connects to a blanket on the other end. The forced warm air travels from the Warming unit through the hose to the blanket that is placed on the patient.

AI/ML Overview

The provided document describes the regulatory submission for a Sterile Cardiac Blanket. It includes information about the device's characteristics, intended use, and performance testing designed to demonstrate substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Maximum Temperature delivered to the patient: Maximum contact surface temperature not exceeding 48.0°C and average contact surface temperature not exceeding 46.0°C in normal condition, as per ASTM F 2196-02.	Maximum Temperature delivered to the patient: "The Sterile Cardiac Blanket was tested in accordance to the ASTM F 2196-02 Standard Specification for Circulating Liquid and Forced Air Patient Temperature Management Devices. This testing verified that the Sterile Cardiac Blanket maintained a maximum contact surface temperature of not exceeding 48.0℃ and an average contact surface temperature of not exceeding 46.0°C in normal condition." (This directly states the device met the criteria.)
Burst Pressure-Pre/post sterilization: Meet the same robustness requirements as the predicate non-sterile Convective Warming Blankets.	Burst Pressure-Pre/post sterilization: "The Burst Pressure of the Sterile Cardiac Blanket was tested in the same manner as the currently marketed non-sterile Convective Warming Blankets were inflated until bursting, and the burst pressure was measured. The Sterile Cardiac Blanket met the same robustness requirements, as do the predicate blankets." (This indicates the device aligned with the predicate's performance.)
Tape Strength-Pre and Post Sterilization: Sterilization to have minimal negative effects on the tape adhesive, even after a worst-case scenario of 3 levels of ethylene oxide exposure.	Tape Strength-Pre and Post Sterilization: "The tensile strength of the tape bond was measured pre and post sterilization, and after 3 levels of ethylene oxide exposure. While 3 levels of ethylene oxide dosage would represent a worst-case scenario. Test results indicate that sterilization have minimal negative effects on the tape adhesive." (This confirms the device met this criterion.)

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes (i.e., number of blankets tested) used for the performance tests (maximum temperature, burst pressure, tape strength). It refers to "testing" and "test results" without numerical quantities.

Regarding data provenance, the tests were conducted in-house by Smiths Medical ASD, Inc. and are described as "Proprietary and Confidential Information." There's no mention of external laboratory testing or specific geographic origin of the test data beyond the company's location in Rockland, MA, USA. The testing appears to be prospective in the sense that it was conducted specifically to evaluate the new sterile device against established standards and the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This device is a physical medical device (a sterile cardiac blanket); therefore, the concept of "ground truth" established by experts in the context of diagnostic imaging or clinical interpretation does not apply. The acceptance criteria are based on quantifiable physical properties and performance standards (e.g., ASTM F 2196-02), and the evaluation is through objective measurements rather than expert consensus on a subjective interpretation.

4. Adjudication method for the test set

Not applicable. As described above, the evaluation involves objective physical measurements against predefined standards and comparison to a predicate device, not subjective interpretations requiring adjudication among experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical sterile cardiac blanket, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical sterile cardiac blanket, not an algorithm, so the concept of standalone performance does not apply.

7. The type of ground truth used

The "ground truth" (or more appropriately, the standard of comparison) used for this device's acceptance was primarily:

Established Performance Standards: Specifically, ASTM F 2196-02 for temperature delivery.
Performance of a Predicate Device: The existing non-sterile Convective Warming Blankets (Model SW4000) served as the benchmark for burst pressure and robustness, as well as general performance expectations. The goal was to demonstrate "substantial equivalence."

8. The sample size for the training set

Not applicable. This is a physical device being evaluated for safety and performance against established standards, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device submission.

Summary

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Special 510(k) Premarket Notification Sterile Cardiac Blanket (SW2008) March 9, 2004

APR 2 7 2004

Smiths Medical ASD, Inc. Ko40632 160 Weymouth Street Rockland, MA 02370

Regulatory Submission Summary 510(k) Summary of Safety and Effectiveness Page 1 of 2

The 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

SUBMITTER NAME:	Smiths Medical ASD, Inc.
SUBMITTER ADDRESS:	160 WeymouthRockland MA 02370
CONTACT PERSON:	Vernon TrimbleDirector of Regulatory Affairs/Quality Assurance
PHONE NUMBER:FAX NUMBER:SUMMARY DATE:	781-878-8011781-878-7540March 9, 2004
DEVICE TRADE NAME:	Sterile Cardiac Blanket (a component of Snuggle Warm® 4000Convective Warming System)
COMMON NAME:	Convective Warming Blanket (a component of ConvectiveWarming System).
DEVICE CLASSIFICATION NAME:	The FDA has classified Thermal Regulation Systems as Class IIdevices under CFR Title 21, Section 870.5900. The product codeis DWJ.
PREDICATE DEVICE:	Snuggle Warm® 4000 Convective Warming System that includesnon-sterile Convective Warming Blankets (Model SW4000)
DEVICE DESCRIPTION:	The Snuggle Warm® 4000 Convective Warming System consistsof a Convective Warming Unit, a hose that connects to theConvective Warming Unit on one end and connects to a blanketon the other end. The forced warm air travels from the Warmingunit through the hose to the blanket that is placed on the patient.
INDICATIONS FOR USE:	The device is intended for thermal regulating a patient'stemperature to prevent hypothermia by a warm air heatedblanket to reduce cold discomfort during and after surgicalprocedures.
TECHNOLOGICALCHARACTERISTICS:	The proposed device has the same technological characteristics(i.e., design, material, chemical composition)as the predicate

Proprietary and Confidential Information of Smiths Medical ASD, Inc.

2040632

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Requlatory Submission Summary 510(k) Summary of Safety and Effectiveness Page 2 of 2

SUMMARY OF PERFORMANCE TESTING:

Maximum Temperature delivered to the patient: .

The Sterile Cardiac Blanket was tested in accordance to the ASTM F 2196-02 Standard Specification for Circulating Liquid and Forced Air Patient Temperature Management Devices. This testing verified that the Sterile Cardiac Blanket maintained a maximum contact surface temperature of not exceeding 48.0℃ and an average contact surface temperature of not exceeding 46.0°C in normal condition.

Burst Pressure-Pre/post sterilization: .

The Burst Pressure of the Sterile Cardiac Blanket was tested in the same manner as the currently marketed non-sterile Convective Warming Blankets were inflated until bursting, and the burst pressure was measured. The Sterile Cardiac Blanket met the same robustness requirements, as do the predicate blankets.

. Tape Strength-Pre and Post Sterilization:

The tensile strength of the tape bond was measured pre and post sterilization, and after 3 levels of ethylene oxide exposure. While 3 levels of ethylene oxide dosage would represent a worstcase scenario. Test results indicate that sterilization have minimal negative effects on the tape adhesive.

CONCLUSION:

The Sterile Cardiac Blanket performs as intended according to its performance specifications. The Sterile Cardiac Blanket is substantially equivalent to the predicate device (that includes non-sterile blankets). The Sterile Cardiac Blanket is substantially equivalent to the non-sterile blanket with respect to the intended use as a component of the Snuggle Warm® 4000 Convective Warming System

Proprietary and Confidential Information of Smiths Medical ASD, Inc.

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Image /page/2/Picture/11 description: The image is a black and white seal for the Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2004

Smiths Medical ASD, Inc. c/o Mr. Vernon Trimble Director of Regulatory/Affairs/Quality Assurance 160 Weymouth Street Rockland, MA 02370

Re: K040632

Snuggle Warm 4000 Convective Warming System, Model SW4000 Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulatory System Regulatory Class: Class II (two) Product Code: DWJ Dated: March 31, 2004 Received: April 2, 2004

Dear Mr. Trimble:

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 cither 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 – Mr. Vernon Trimble

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,

ua R. Varliner

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 (if known): ко40632

Device Name: Sterile Cardiac Blanket _

Indications For Use: The device is intended for thermal regulating a patient's temperature to prevent hypothermia by a warm air heated blanket to reduce cold discomfort during and after surgical procedures.

X 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)

Dana P. Vachmer

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

Biolors
510(k) Number Kodu Costo Costo Cost

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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).