(126 days)
Not Found
Not Found
No
The summary contains no mention of AI, ML, or related concepts, and the device description is not available to provide further clues.
No
The intended use is "fluid irrigation and infiltration," which describes a functional surgical assistant rather than a device designed to treat a medical condition or restore health.
No
Explanation: The "Intended Use / Indications for Use" states "General surgical fluid irrigation and infiltration," which describes a therapeutic or procedural function, not a diagnostic one. There is no mention of identifying, detecting, or measuring a disease or condition.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only. The intended use suggests a physical device for fluid handling.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The stated intended use is "General surgical fluid irrigation and infiltration." This describes a procedure performed on a patient during surgery, not a test performed on a sample taken from a patient to diagnose or monitor a condition.
- Lack of IVD Characteristics: The description doesn't 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
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The intended use of this device clearly falls outside of this definition.
N/A
Intended Use / Indications for Use
General surgical fluid irrigation and infiltration.
Product codes
FRN
Device Description
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Mentions image processing
Not Found
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
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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized emblem consisting of three abstract shapes that resemble birds in flight or flowing ribbons.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 30 1999
Mr. Ken Rodenburg Technical Manager Wells Johnson Company P.O. Box 18230 85731-8230 Tucson, Arizona
Re : K991437 Wells Johnson Infusion System, Trade Name: Model 20-6000-00 Regulatory Class: II Product Code: FRN June 9, 1999 Dated: Received: June 10, 1999
Dear Mr. Rodenburg:
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 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.
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. A 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
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Page 2 - Mr. Rodenburg
verify such assumptions. Failure to comply with the GMP vertif back abbampenin regulatory action. In addition, FDA regulation may rebarannouncements concerning your device in may pabilon Farenter. Please note: this response to your che read in the submission does not affect any premarker nocerright have under sections 531 through 542 of obligation you magis the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as first receir wir as 0 k) premarket notification. The FDA described in your sion, promalence of your device to a legally Finding of bubbeanstation a classification for your marketed predicate actes 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 regaradiagnostic 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
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
Indications for use are: General surgical fluid irrigation and infiltration.
Rahaux Cussente
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _
PRESCRIPTION DEVICE
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