(183 days)
Not Found
No
The description focuses on a simple convective warming system with a temperature control mechanism, and explicitly states that AI, DNN, or ML are "Not Found".
Yes
The device is described as a "Convective Warming System" intended for "thermal regulating a patient's temperature to prevent hypothermia" during and after surgical procedures, which are therapeutic functions.
No
Explanation: The device is a convective warming system intended for thermal regulation to prevent hypothermia, not for diagnosing medical conditions.
No
The device description clearly states it consists of a warming unit and a disposable blanket, indicating it is a hardware-based system, not software-only.
Based on the provided information, the Snuggle Warm 4000 Convective Warming System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "thermal regulating a patient's temperature to prevent hypothermia by a warm air heated blanket system." This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The description details a system that generates and distributes warm air to a patient. This is a physical intervention, not a test performed on samples taken from the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The Snuggle Warm 4000 is a medical device used for patient warming, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DWJ
Device Description
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.
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
appropriately trained healthcare professionals in clinical environments.
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)
Not Found
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.
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.
Not Found
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
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):
-
Sponsor name and address: 1.
SIMS® LEVEL 1®, Inc. 160 Weymouth Street, Rockland, MA. 02370 -
Sponsor telephone number: 781-878-8011, Ext. 730 2.
-
Contact Person: Gabriel J. Muraca, Jr. Manager Regulatory Affairs 3.
-
Date summary was prepared: June 6, 2001 4.
-
Device Name: Snuggle Warm® 4000 Convective Warming System న్.
-
Common Name: an external convective warming system used to warm the patient (). during and after surgical procedures.
-
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.
1
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
2
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.
3
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
4
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
✓
Prescription Use (Per 21 (FR 801 109)
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Over-the-Counter Use