(160 days)
The Medical Products, Inc. Temporte and Tempo II™ warming cabinets are design to store and warm I.V. fluid bags/bottles, irrigation solution bags/bottles, blankets, towels, etc. prior to their use.
Warning: The facility should contact the manufacturer of the products to be place inside the warming cabinet and obtain guidelines for exposing their product to temperatures other than those stated on the bags or bottles.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Tempo and Temp H20 warming cabinets) and does not contain the information requested in your prompt.
Specifically, the document states:
- It's a "substantially equivalent letter" correcting a previous one.
- It discusses regulatory details, classifications, and general controls provisions of the Act.
- It mentions the "Indications for Use" for the warming cabinets.
- It provides contact information for the FDA.
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about any specific study (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for test or training sets).
Therefore, I cannot extract the requested information from this document.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Durward Faries, Jr. President Smith Associates P.O. Box 4343 Crofton, Maryland 21114-4341
JAN 1 0 2017
Re: K973748
Trade/Device Name: Tempo and Temp H20 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ Dated: January 14, 1998 Received: January 20, 1998
Dear Mr. Faries:
This letter corrects our substantially equivalent letter of March 3, 1998.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809 ); medical device reporting (reporting of
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Page 2 - Mr. Durward Faries, Jr.
medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin Keith
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: TempO and TempH2O Warming Cabinets
Classification Panel: 80LGZ, General Hospital
Indications for Use:
desiment - -
The Medical Products, Inc. Temporte and Tempo II™ warming cabinets are design to store and warm I.V. fluid bags/bottles, irrigation solution bags/bottles, blankets, towels, etc. prior to their use.
Warning: The facility should contact the manufacturer of the products to be place inside the warming cabinet and obtain guidelines for exposing their product to temperatures other than those stated on the bags or bottles.
please sign form
HT
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) ...
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
or
Over-the-Counter Use
Latoya Currente
Division Sign Off
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K973748
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).