(183 days)
The Snuggle Warm 4000 Convective Warming System is intended for thermal regulating a patient's temperature to prevent hypothermia by a warm air heated blanket system to reduce cold discomfort during and after surgical procedures. It is intended for use by appropriately trained healthcare professionals in clinical environments.
The Snuggle Warm consists of a disposable single use warming blanket that is placed in contact with the patient and a warming unit with a hose end temperature control connected to the blanket. 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 use by appropriately trained healthcare professionals in clinical environments.
The provided text is a 510(k) Premarket Notification for the Snuggle Warm® 4000 Convective Warming System. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel technology.
Therefore, the information required to populate the requested table regarding acceptance criteria and device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for the Snuggle Warm® 4000 Convective Warming System is not present within the provided text.
The document explicitly states: "There are no significant changes in technological characteristics or intended use that impact the safety or effectiveness of these warming devices." This indicates that the submission relies on the established safety and effectiveness of the predicate device (Temp Marq™/ Snuggle Warm Convective Warming System, K904690) rather than new performance studies for the modifications made to the Snuggle Warm® 4000.
Here's a breakdown of what can be extracted and what is missing based on your request:
1. Table of acceptance criteria and the reported device performance:
- Not provided. The document focuses on demonstrating "substantial equivalence" to a predicate device, implying that the performance is expected to be similar, but it does not specify new acceptance criteria or report specific performance metrics for the modified device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. No new test data is presented for the Snuggle Warm® 4000.
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 / Not provided. Since no new test set is described, there's no mention of experts or ground truth establishment for such a test.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided.
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 convective warming system, not an AI-powered diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is hardware, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided.
8. The sample size for the training set:
- Not applicable / Not provided. This document is for a hardware device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable / Not provided.
In summary, the provided 510(k) notification focuses on the regulatory process of demonstrating substantial equivalence to a predicate device rather than presenting new performance data or detailed studies as would be expected for a novel device or AI algorithm.
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DEC 1 82001
KD11907
Summary of Safety and Effectiveness
510(k) Premarket Notification for the Snuggle Warm® 4000 Convective Warming System
US FDA, Division of General, Restorative and Neurological Devices (DGRND) Branch: General Surgery Devices
The following information is provided in accordance with 21 CFR 807.92(a):
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Sponsor name and address: 1.
SIMS® LEVEL 1®, Inc. 160 Weymouth Street, Rockland, MA. 02370 -
Sponsor telephone number: 781-878-8011, Ext. 730 2.
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Contact Person: Gabriel J. Muraca, Jr. Manager Regulatory Affairs 3.
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Date summary was prepared: June 6, 2001 4.
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Device Name: Snuggle Warm® 4000 Convective Warming System న్.
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Common Name: an external convective warming system used to warm the patient (). during and after surgical procedures.
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The legally marketed predicate device currently in commercial distribution is the 7. Temp Marq™/ Snuggle Warm Convective Warming System, described in premarket notification K904690 and cleared for market on February 1, 1991.
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Description of device: 8.
The Snuggle Warm consists of a disposable single use warming blanket that is placed in contact with the patient and a warming unit with a hose end temperature control connected to the blanket. 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 use by appropriately trained healthcare professionals in clinical environments.
Indications for use: 9.
The Snuggle Warm Convective Warming System is intended for thermal regulating a patient 's temperature to prevent hypothermia by a warm air heated blanket system to reduce cold discomfort during and after surgical procedures. It is intended for use by appropriately trained healthcare professionals in clinical environments.
Technological characteristics: 10.
There are no significant changes in technological characteristics or intended use that impact the safety or effectiveness of these warming devices. As described in this submission, Level 1 has initiated modifications to improve the performance of the Snuggle Warm 4000 without affecting the safety or effectiveness of the Convective Warming System. The Snuggle Warm Convective Warming Systems are manufactured and certified in compliance with applicable International and US standards.
Gabriel J. Moreno, Jr.
Gabriel J. Muraca, Jr. Manager Regulatory Affairs SIMS® LEVEL 1®, Inc.
June 6, 2001
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DEPARTMENT OF HEALTH & HUMAN SERVICES • USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 2001
Mr. Gabriel J. Muraca, Jr. Manager, Regulatory Affairs SIMS Level 1, Inc. 160 Weymouth Street Rockland, MA 02370
Re: K011907
K011907
Trade Name: Snuggle Warm� 4000 Convective Warming System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulation System Regulatory Class: Class II (two) Product Code: DWJ Dated: September 28, 2001 Received: October 2, 2001
Dear Mr. Muraca:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your becaon 3 rQxy premised the device is substantially equivalent of in interests of 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 commerce prior to May 20, 1976, the ensordance with the provisions of the Federal Food, Drug, devices that have been receasinou in doce approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval incr You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dicierore, market also actives, colorements for annual registration, listing of general controls provisions of assice, 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 If your device is classified ($60 docro) ins. Existing major regulations affecting your device can thay be subject to such addresses connections, 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. Gabriel J. Muraca, Jr.
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 or my r vature 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,
Signature
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
KO11907 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Snuggle Warm® 4000 Convective Warming System Device Name:
Indications for Use:
The Snuggle Warm 4000 Convective Warming System is intended for thermal regulating a patient's temperature to prevent hypothermia by a warm air heated blanket system to reduce cold discomfort during and after surgical procedures. It is intended for use by appropriately trained healthcare professionals in clinical environments.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K011907
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Prescription Use (Per 21 (FR 801 109)
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Over-the-Counter Use
§ 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).