(30 days)
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Not Found
No
The summary describes a standard infusion pump and does not mention any AI or ML capabilities, image processing, or performance studies related to AI/ML algorithms.
Yes
Explanation: The device is used to administer intravenous fluid, blood products, epidural solutions, and enteral feeding solutions, which are all therapeutic interventions for patients.
No
The device description states its intended use is for administering fluids and solutions, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states "Abbott LifeCare Standard Tubing Infusion Pump," which is a hardware device. The intended use also describes the delivery of fluids, which is a function of a physical pump.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as delivering fluids, blood products, and feeding solutions directly to the patient's body (intravenous, epidural, enteral). This is a therapeutic or supportive function, not a diagnostic one.
- IVD Definition: In vitro diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such examinations.
- Device Description: The description "Abbott LifeCare Standard Tubing Infusion Pump" aligns with a device used for administering substances to a patient, not for analyzing samples.
The information provided strongly indicates that this is a medical device used for patient care and treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The subject device is intended for intravenous fluid, blood products, short-term epidural administration not exceeding 96 hours, and for delivery of enteral feeding solutions to patients in hospital and home care environments.
Product codes
FRN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital and home care environments.
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
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Key Metrics
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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/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its head, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
NOV 20 1900
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jerry Jennings Director, Regulatory Operations Abbott Laboratories Hospital Products Division D-389 Building, AP30 200 Abbott Park Road Abbott Park, Illinois 60064-3537
K983838 Re : Abbott LifeCare Standard Tubing Infusion Trade Name: Pump Regulatory Class: II Product Code: FRN October 20, 1998 Dated: October 21, 1998 Received:
Dear Mr. Jennings:
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 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 The general controls provisions of the Act 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 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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 - Mr. Jennings
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (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/dsmamain.html".
sincerely yours,
Timothý /A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page I 1 of
510(k) NUMBER (IF KNOWN): ____________________________________________________________________________________________________________________________________________________ K983838
DEVICE NAME: _Abbott_LifeCare Standard Tubing Infusion Pump
INDICATIONS FOR USE:
The subject device is intended for intravenous fluid, blood products, short-term epidural administration not exceeding 96 hours, and for delivery of enteral feeding solutions to patients in hospital and home care environments.
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
Patrici Caserite
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 3838 510(k) Number _