For thermal regulation of a patient's temperature to prevent hypothermia and/or reduce cold discomfort during and after surgical procedures. It is intended for use by appropriately trained healthcare professionals in clinical environments.

Device Description

Snuggle Warm® Convective Warming Systems (SW-4000 and EQ-5000) that will include the proposed blankets (Model SW-2013, SW-2014R, SW-2015, SW-2016, SW-2018, SW-2018 & SW-2019). The Convective Warming Systems (SW-4000 and EQ-5000), are identified as a Thermal Regulation System by the FDA, consists of a Convective Warming Unit (temperature controller), a hose, and a single-use Convective Warming Blanket. The Convective Warming Systems' (SW-4000 and EQ-5000) single-use disposable Convective Warming Blankets are placed in contact with the patient and attached to a warming unit via a hose with hose-end temperature controls. The warming unit generates warm air that is distributed throughout the warming blanket to warm the patient during and after surgical procedures. It is intended for thermally regulating a patient's temperature to prevent hypothermia by a warm air heated blanket system to reduce cold discomfort during and after surgical procedures. The seven proposed blankets are single-use Convective Warming Blankets that will be added to the existing Convective Warming Blanket family. They are components of the Convective Warming Systems (SW-4000 and EQ-5000) of which the indications for use remain the same.

AI/ML Overview

The provided text describes a 510(k) summary for several convective warming blankets. It does not contain information about acceptance criteria or a study proving performance against such criteria in the context of an AI/ML device.

However, based on the non-clinical data section, I can deduce the type of assessment performed. The device in question is a medical device (convective warming blankets), and its performance is evaluated against established standards and through comparison to predicate devices, rather than through an AI/ML model's statistical performance.

Therefore, many of the requested fields (sample size, experts, adjudication, MRMC, standalone, training set) are not applicable to this type of device submission.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Standards Compliance:
ASTM F2196:2002 (Standard Specification for Circulating Liquid and Forced Air Patient Temperature Management)	Blankets designed to meet these requirements.
ISO 10993-1:2003 (Biological Evaluation of Medical Devices - Evaluation and Testing)	Blankets designed to meet these requirements.
Material and Manufacturing Similarity:	Proposed and predicate blankets are made of similar materials and employ similar manufacturing processes.
Functional Equivalence:	Bench testing demonstrated that the proposed convective warming blankets are substantially equivalent to existing Snuggle Warm® convective warming blankets.
Design Features:	The proposed SW-2016, SW-2018, and SW-2019 blankets have movable panels similar to the predicate Bair Hugger® model 610.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable for this type of device. The assessment was based on bench testing and comparison of design and materials, not a "test set" of data in the context of an AI/ML device. The document explicitly states "Clinical Data: Not required."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. No ground truth establishment by external experts for a test set is mentioned. The evaluation was internal bench testing and compliance with standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No adjudication method for a test set is mentioned.

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 refers to AI/ML device studies, which this is not.

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

Not applicable. This refers to AI/ML device studies, which this is not.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable in the AI/ML sense. The "ground truth" here is compliance with engineering standards (ASTM F2196, ISO 10993-1) and demonstrated functional equivalence through bench testing to previously approved predicate devices.

8. The sample size for the training set:

Not applicable. No training set is mentioned as this is not an AI/ML device.

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

Not applicable. No training set is mentioned.

Summary

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smiths medical bringing technology to life

JUN - 3 2009

Smiths Medical ASD Inc. Critical Care Division 160 Weymouth Street Rockland, MA 02370, USA T: +1 781 878 8011 F: +1 781 878 8201 www.smiths-medical.com

K083336

Company Information:

SECTION 5. 510(k) Summary

Smiths Medical ASD, Inc. 160 Wevmouth Street Rockland, MA 02370 (781) 878-8011, ext 7904 Contact: Ms. Christine Lloyd, Regulatory Affairs Specialist

Summary Prepared: May 1, 2009

Product Name:

Trade Name:

Level 1 % Snuggle Warm " Adult Underbody Convective Warming Blanket (SW-2013)

Level 1 @ Snuggle Warm 9 Left Lateral Access Convective Warming Blanket (SW-2014L)

510(K) SUMMARY:

Level 1 9 Snuggle Warm® Right Lateral Access Convective Warming Blanket (SW-2014R)

Level 1 % Snuggle Warm " Upper Underbody Convective Warming Blanket (SW-2015)

Level 1 Snuggle Warm® Full Body Split Access Convective Warming Blanket (SW-2016)

Level 1 8 Snuggle Warm® Multi Access Convective Warming Blanket (SW-2018)

Level 10 Snuggle Warm® Poncho Convective Warming Blanket (SW-2019)

Common Name: Convective Warming Blankets

Classification Name: Thermal Regulating System (21 CFR 870.5900, Product Code DWJ)

Predicate Device(s):

K061513 Smiths Medical ASD, Inc., Level 1 % Snuggle Warm® Pediatric Underbody Blanket o and Level 1 " Snuggle Warm " Large Pediatric Underbody Blanket (SW-2009 and SW-2011)
K011907 Smiths Medical ASD, Inc. (formerly Level 1 Inc.), Snuggle Warm® 4000 o Convective Warming System. 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 a blanket; which connects onto the other end of the hose. The forced warm air travels from the Warming Unit through the hose to the blanket that is placed on the patient. (SW-4000, EO-5000, SW-2001, SW-2002, SW-2004, SW-2004, SW-2005, SW-2006, SW-2007, and SW-2010)

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K060865 Arizant Healthcare Inc., Bair Hugger® model 610 Full Body Surgical Blanket, o model 555 Pediatric Underbody Blanket, model 550 Large Pediatric Underbody Blanket and model 545 Adult Underbody Blanket.
There are currently 10 variations of Convective Warming Blankets in the non-sterile convective warming blanket family.

Disposables Single-Use Blankets

. SW-2001 Full Body Convective Warming Blanket
SW-2002 Pediatric Convective Warming Blanket .
SW-2003 Upper Body Convective Warming Blanket ●
SW-2004 Lower Convective Warming Blanket .
SW-2005 Neonate to Small Child Intraoperative Convective Warming Blanket .
SW-2006 Preemie to Neonate Intraoperative Convective Warming Blanket ●
SW-2007 Tube Body Convective Warming Blanket .
SW-2009 Pediatric Underbody Convective Warming Blanket ●
SW-2010 Large Upper Body Convective Warming Blanket .
SW-2011 Large Pediatric Convective Warming Underbody Blanket .

Device Description:

Snuggle Warm® Convective Warming Systems (SW-4000 and EQ-5000) that will include the proposed blankets (Model SW-2013, SW-2014R, SW-2015, SW-2016, SW-2018, SW-2018 & SW-2019)

The Convective Warming Systems (SW-4000 and EQ-5000), are identified as a Thermal . Regulation System by the FDA, consists of a Convective Warming Unit (temperature controller), a hose, and a single-use Convective Warming Blanket.
The Convective Warming Systems' (SW-4000 and EQ-5000) single-use disposable . Convective Warming Blankets are placed in contact with the patient and attached to a warming unit via a hose with hose-end temperature controls. The warming unit generates warm air that is distributed throughout the warming blanket to warm the patient during and after surgical procedures.
It is intended for thermally regulating a patient's temperature to prevent hypothermia by a . warm air heated blanket system to reduce cold discomfort during and after surgical procedures.

The seven proposed blankets are single-use Convective Warming Blankets that will be added to the existing Convective Warming Blanket family. They are components of the Convective Warming Systems (SW-4000 and EQ-5000) of which the indications for use remain the same.

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Indications for Use:

ﺬ

Technological Characteristics:

The proposed and predicate Snuggle Warm® convective warming blankets are made of similar materials and employ similar manufacturing processes. The warm air is distributed around the patient's body through the delivery channels and exits the blanket through a specially designed series of perforations in the patient side of the blanket.

The proposed SW-2016 Full Body Split Access blanket, the SW-2018 Multi Access blanket and the SW-2019 Poncho blanket have movable panels which can be secured away from the surgical area similiar to the Bair Hugger® model 610 Full Body Surgical Blanket.

Non-Clinical Data:

Bench testing was performed to demonstrate that the proposed convective warming blankets are substantially equivalent to the existing Snuggle Warm " convective warming blankets currently marketed by Smiths Medical. The blankets are designed to meet the requirements of the following standards:

. ASTM F2196:2002, Standard Specification for Circulating Liquid and Forced Air Patient Temperature Management
. ISO 10993-1 2003, Biological Evaluation of Medical Devices - Evaluation and Testing

Clinical Data:

Not required

Conclusion:

The proposed Convective Warming Blankets are safe and effective as well being substantially equivalent to the predicate devices.

Very truly yours,

SMITHS MEDICAL ASD, INC.

Christine Lloyd

Ms. Christine Lloyd Regulatory Affairs Specialist

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration. 9200 Corporate Boulevard Rockville MD 20850

JUN - 3 2009

Smiths Medical ASD Inc. c/o Ms. Christine Lloyd Regulatory Affairs Specialist Critical Care Division 160 Weymouth Street Rockland, MA 02370

K083336 Re:

Level 18 Snuggle Warm® Adult Underbody Convective Warming Blanket (SW-2013)

Level 1® Snuggle Warm® Left Lateral Access Convective Warming Blanket (SW-2014L)

Level 1@ Smuggle Warm® Right Lateral Access Convective Warming Blanket (SW-2014R)

Level 1 @ Snuggle Warm® Upper Underbody Convective Warming Blanket (SW-2015)

· Level 1® Snuggle Warm® Full Body Split Access Convective Warming Blanket (SW-2016)

Level 1® Snuggle Warm® Multi Access Convective Warming Blanket (SW-2018)

Level 1® Snuggle Warm® Poncho Convective Warming Blanket (SW-2019)

Regulation Number: 21 CFR 870.5900

Regulation Name: Catheter, Cannula and Tubing Vascular, Cardiopulmonary Bypass Regulatory Class: Class II

Product Code: DWJ

Dated: May 1, 2009

Received: May 4, 2009

Dear Ms. Lloyd:

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

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Page 2 - Ms. Christine Lloyd

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 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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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

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Page 3 - Ms. Christine Lloyd

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

Carlos Concession

Sincerely yours, ్ర

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

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Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket

Indications for Use:

Prescription Use	X(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)

(Division Sign-Off)
Division of Cardiovascular Devices	Page 1 of

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Indications for Use

510(k) Number (if known):

Device Name: Level 1 ° Snuggle Warm Left Lateral Access Convective Warming Blanket

Indications for Use:

Prescription Use X (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)
--	--------------------------------------------------------	--

(Division/Sign-Off)
Division of Cardiovascular Devices
510(k) Number	14083336

Page 1 of 1
-------------

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Indications for Use

510(k) Number (if known):

Device Name: Level 1 ° Snuggle Warm® Right Lateral Access Convective Warming Blanket

Indications for Use:

Prescription Use X (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)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K083356

Page 1 of 1

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Indications for Use

510(k) Number (if known):

Device Name: Level 1 ° Snuggle Warm® Upper Underbody Convective Warming Blanket

Indications for Use:

Prescription Use	X
(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)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K083336

Page 1 ofOver-The-Counter Use

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Indications for Use

510(k) Number (if known):

Device Name: Level 1 % Snuggle Warm Full Body Split Access Convective Warming Blanket

Indications for Use:

Prescription Use X (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)

(Division/Sign-Off)
Division of Cardiovascular Devices
510(k) Number K083336

Page_1_of

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Indications for Use

510(k) Number (if known):

Device Name: Level 1º Snuggle Warm® Multi Access Convective Warming Blanket

Indications for Use:

Prescription Use

(Part 21 CFR 801 Subpart D)	AND/OR	(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)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	1083336

Page 1 of 1
-------------

AND/OR

Over-The-Counter Use

Page 17 of 57

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Level 1® Snuggle Warm® Poncho Convective Warming Blanket

Indications for Use:

Prescription Use X(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)
(Division/Sign-Off)Division of Cardlovascular Devices1488 954510(k) Number		Page 1 of 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).