(184 days)
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No
The provided 510(k) summary does not contain any mention of AI, ML, image processing, or any other indicators typically associated with AI/ML technology in medical devices. The description focuses on fluid delivery via intravenous and epidural routes.
Yes
The device is described as administering intravenous fluid, blood and blood products, and epidural medication, which are considered therapeutic interventions.
No
The device is described as being for the delivery of intravenous fluids, blood, blood products, and epidural administration. This indicates a therapeutic or supportive function, not a diagnostic one. There is no mention of the device being used to identify or analyze a condition.
No
The provided text describes an infusion pump with specific intended uses and anatomical sites, which are typically hardware-based medical devices. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the delivery of fluids, blood products, and epidural administration directly into the body (intravenous and epidural). This is a therapeutic or delivery 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 about a person's health. This device does not perform such examinations.
- Lack of IVD-related information: The description lacks any mention of analyzing biological samples, diagnostic tests, or providing diagnostic information.
Therefore, this device falls under the category of a medical device used for delivery or administration, not an IVD.
N/A
Intended Use / Indications for Use
The subject device is intended for intravenous fluid, blood and blood products, administration not exceeding 96 hours, and for delivery of short-term epidural administration not exceeding 96 hours, in the hospital and home care environment.
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
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Intended User / Care Setting
hospital and home care environment.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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Image /page/0/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged horizontally, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or informational context.
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, surrounded by a circle of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
. …
Mr. David T. Guzek Director, Regulatory Affairs Abbott Manufacturing, Incorporated -------Úne Abbott Park Abbott Park, Illinois 60064
JUL - 3 1997
Re : K965230 Abbott Lifecare Standard Tubing Infusion Trade Name: Pump Regulatory Class: II Product Code: FRN April 4, 1997 Dated: Received: April 7, 1997
Dear Mr. Guzek:
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 You may, therefore, market the Medical Device Amendments. device, subject to the general controls provisions of the Federal Food, Druq, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, and 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requiation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, the Food and Drug Administration (FDA) action. 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 section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
1
Page 2 - Mr. Guzek
On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the regulation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.
This letter immediately will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in anyway represent your device or its labeling as being approved by FDA. 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), promotion, or advertising, please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at (301) 594-4639. Other general information on your responsibilities under the Act, may be obtained from the Division of Smalp Manufacturers Assistance at its toll free number (800) 638/2041 or at (301) 443-6597.
Sincerely yours
Timothy A. Ulatowski
Timberly A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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| 510(k) Number (if known): | K965230 |
|---|---|
| Device Name: | Abbott LifeCare Standard Tubing Pump / ACCLAIM TM |
| Indications For Use: |
wmb Infusion PumpThe subject device is intended for intravenous fluid, blood and blood products, The subject device is intended for intrivation not exceeding 96 hours, and for delivery of
short-term epidural administration not exceed maits and home sere short-lefth epiddral administration not enterest of the spital and home care environment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Patricia Cuconte
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. K465230
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
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