(73 days)
Not Found
Not Found
No
The summary describes a fluid warmer and explicitly states that AI, DNN, or ML are "Not Found".
No
The device is a warmer for I.V. fluids, not a device that directly treats a condition or disease. It aids in the preparation of fluids for other medical procedures.
No
Explanation: The device is described as a warmer for I.V. fluid bags/bottles, which is a therapeutic or assistive device, not one that identifies or analyzes medical conditions.
No
The device description clearly states it is a "warmer," which is a hardware device designed to store and warm I.V. fluids. There is no mention of software as the primary or sole component.
Based on the provided information, the MPI Tempo III warmer is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "store and warm I.V. fluid bags/bottles prior to their use." This describes a device used to prepare fluids for administration to a patient, not a device used to test samples taken from a patient (which is the definition of an IVD).
- Device Description: The description is simply "Tempo III warmer," which aligns with the warming function described in the intended use.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
Therefore, the MPI Tempo III warmer is a medical device, but it falls outside the category of In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes
LGZ, LDQ
Device Description
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
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
1
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
2
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