(48 days)
Snuggle Warm® 4000 Convective Warming System that includes non-sterile Convective Warming Blankets (Model SW4000)
Not Found
No
The summary describes a simple convective warming system with no mention of AI or ML capabilities. The performance studies focus on temperature regulation and material strength, not algorithmic performance.
Yes
The device is intended to prevent hypothermia and reduce cold discomfort during and after surgical procedures, which are therapeutic actions to manage a patient's condition.
No
Explanation: The device is described as a thermal regulating system for patient temperature, delivering warm air via a blanket to prevent hypothermia. Its purpose is therapeutic (warming) rather than diagnostic (identifying or characterizing a medical condition).
No
The device description clearly outlines hardware components: a Convective Warming Unit, a hose, and a blanket. The performance studies also focus on the physical properties and performance of these hardware components (temperature, burst pressure, tape strength).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "thermal regulating a patient's temperature to prevent hypothermia by a warm air heated blanket to reduce cold discomfort during and after surgical procedures." This describes a therapeutic or supportive function performed directly on the patient, not a diagnostic test performed on a sample taken from the patient.
- Device Description: The device description details a system that delivers warm air to a blanket placed on the patient. This aligns with a physical therapy or temperature management device, not a device used for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The performance studies described (temperature, burst pressure, tape strength) are related to the physical performance and safety of the warming system and blanket, not the accuracy or reliability of a diagnostic test.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DWJ
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.
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
Not Found
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)
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.
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.
Snuggle Warm® 4000 Convective Warming System that includes non-sterile Convective Warming Blankets (Model SW4000)
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
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 Weymouth |
Rockland MA 02370 | |
CONTACT PERSON: | Vernon Trimble |
Director of Regulatory Affairs/Quality Assurance | |
PHONE NUMBER: | |
FAX NUMBER: | |
SUMMARY DATE: | 781-878-8011 |
781-878-7540 | |
March 9, 2004 | |
DEVICE TRADE NAME: | Sterile Cardiac Blanket (a component of Snuggle Warm® 4000 |
Convective Warming System) | |
COMMON NAME: | Convective Warming Blanket (a component of Convective |
Warming System). | |
DEVICE CLASSIFICATION NAME: | The FDA has classified Thermal Regulation Systems as Class II |
devices under CFR Title 21, Section 870.5900. The product code | |
is DWJ. | |
PREDICATE DEVICE: | Snuggle Warm® 4000 Convective Warming System that includes |
non-sterile Convective Warming Blankets (Model SW4000) | |
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. | |
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. | |
TECHNOLOGICAL | |
CHARACTERISTICS: | 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
1
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.
2
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
4
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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