(73 days)
The Medical Products, Inc. (MPI) Tempo III warmer is designed to store and warm I.V. fluid bags/boctles prior to their use.
Tempo III warmer
This FDA 510(k) letter for the Tempo III Infusion Pump does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.
This document is a regulatory approval letter based on substantial equivalence to a predicate device, not a performance study report. Therefore, I cannot extract the requested information from the provided text.
Specifically, the letter states:
- "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..."
This means the device was found to be "substantially equivalent" to an already approved device, rather than undergoing a new, independent performance study with defined acceptance criteria.
The letter discusses regulatory requirements, contact information, and the device's intended use (an I.V. fluid warmer), but it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample size or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- MRMC study details or effect size.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Durward Faries, Jr. Medical Products Incorporated 14014 Sullyfield Circle, #A Chantilly, Virginia 20151
JAN 1 0 2017
Re: K981509
Trade/Device Name: Tempo III Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ, LDQ Dated: April 15, 1998 Received: April 28, 1998
Dear Mr. Faries Jr .:
This letter corrects our substantially equivalent letter of July 10, 1988.
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
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Page 2 - Mr. Durward Faries, Jr.
CFR Part 807); labeling (21 CFR Parts 801 and 809 ); medical device reporting (reporting of 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/ReportalProblem/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 I. Keith -S
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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1-75 WED LC-44
3
O
510(k) Number (if Known):
Tempo III Device Name
Indications for Use:
The Medical Products, Inc. (MPI) Tempo III warmer is designed to store and warm I.V. fluid bags/boctles prior to their use.
The facility should concact the manufacturer of the products the Warning: be placed inside the Tempo III warmer, and obtain guidelines for exposing their product to temperatures other than those stated on the bay or bottle.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109 Over-The Counter Use
(Optional Format 1-2-96)
Patricio Caventti.
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K981509
§ 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).