(733 days)
For Patient Temperature Management
Wesco Blanket
I am sorry, but the provided text is a set of FDA correspondence letters regarding a 510(k) clearance for a "Wesco Blanket," and an "Indications for Use" statement.
This document does not contain information about:
- Acceptance criteria for device performance
- A study proving device meets acceptance criteria
- Reported device performance statistics
- Sample sizes for test or training sets
- Data provenance
- Number or qualifications of experts
- Adjudication methods
- MRMC comparative effectiveness studies or effect sizes
- Standalone algorithm performance
- Type of ground truth used
Therefore, I cannot fulfill your request for these specific details. The document primarily confirms the substantial equivalence of the Wesco Blanket to a predicate device for patient temperature management, allowing it to be legally marketed.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2000
Ms. Arlen C. West Wesco, Inc. 921 Sunset Drive East Peoria, IL 61611
Re: K981093 Wesco Blanket Requlatory Class: II (two) Product Code: DWJ Dated: March 2, 2000 Received: March 6, 2000
Dear Ms. West:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Arlen C. West
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
fox. Que L. Ampelee
James E. Dillard III
Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page of
510(k) Number (if known): K981093
Device Name: Wesco Blanket
Indications For Use: For Patient Temperature Management
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ola R. Ximenezli
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
K 981093 510(k) Number _
(Optional Format 3-10-98)
§ 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).