WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00 by WELLS JOHNSON CO.

This document is a 510(k) clearance letter from the FDA for a medical device called the "Wells Johnson Infusion System, Model 20-6000-00." This type of letter addresses substantial equivalence to a predicate device and allows the device to be marketed. It does not typically contain detailed information about specific performance acceptance criteria or detailed study results like those found in a clinical study report or a premarket approval (PMA) application.

Therefore, for the information requested in your prompt:

A table of acceptance criteria and the reported device performance: This information is not present in the provided document. The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on meeting specific performance acceptance criteria in the same way a clinical trial for a novel device would.
Sample sized used for the test set and the data provenance: Not available in this document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available in this document.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an "Infusion System," which is a physical medical device, not an AI or imaging diagnostic tool that would typically involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available in this document, as it pertains to performance studies not detailed here. The primary "ground truth" for a 510(k) is the performance of the predicate device to which it is compared for substantial equivalence.
The sample size for the training set: Not applicable/available.
How the ground truth for the training set was established: Not applicable/available.

In summary, the provided document is an FDA clearance letter based on substantial equivalence for a physical medical device (an infusion system). It does not contain the detailed performance study information, acceptance criteria, or ground truth establishment methods that would be typically found in a clinical study report for a diagnostic device or AI algorithm.

Summary

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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

: :

Regulation Number and Section

§ 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).