FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX by FRESENIUS USA, INC.

The provided documents are a letter from the FDA regarding a 510(k) premarket notification and an "Indications for Use" statement for Fresenius Polysulfone Hemodialyzers. These documents are from 1998 and pertain to medical devices (dialyzers), not an AI-powered diagnostic device.

Therefore, the information required to describe the acceptance criteria and the study proving an AI device meets those criteria (such as detailed performance metrics, sample sizes, expert qualifications, ground truth methods, or MRMC studies) is not present in the provided text.

The documents confirm that the specified Fresenius Hemoflow Dialyzers were found "substantially equivalent" to predicate devices for use in acute or chronic hemodialysis. This substantial equivalence determination by the FDA is the "acceptance criteria" in this context, rather than specific performance metrics detailed in a study report for an AI device.

To answer your specific questions:

A table of acceptance criteria and the reported device performance: Not applicable/not provided. The acceptance was based on substantial equivalence to predicate devices, not on specific performance metrics of an AI model against predefined acceptance criteria.
Sample size used for the test set and the data provenance: Not applicable/not provided. This is a medical device approval based on substantial equivalence, not an AI model validation study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. Ground truth for an AI model is not relevant here.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not provided.
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/not provided. This is not an AI device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/not provided. This is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/not provided.
The sample size for the training set: Not applicable/not provided.
How the ground truth for the training set was established: Not applicable/not provided.

Summary

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Image /page/0/Picture/2 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized symbol resembling three abstract shapes stacked on top of each other, possibly representing human figures or waves. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is vertically oriented and positioned to the left of the symbol.

SEP 1 5 1998

Mr. Tom Folden Director, Product Development Fresenius Medical Care, N.A. 2637 Shadelands Drive Walnut Creek, CA 94598

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K970700

Multiple Use Labeling for Hemoflow Dialyzers Models F4, F5, F6, F7, F8, F60M, F70M, F80M, F60A, F70A, F80A, F60B, F70B, F80B Dated: June 18, 1998 Received: June 23, 1998 Regulatory class: II and III 21 CFR §876.5820/Product code: 78 MSE and 21 CFR $876.5860/Product code: 78 MSF

Dear Mr. Folden:

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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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.

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices); please contact the Office of Compliance at (301) 594-4613. 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/cdrb/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) Number (if Known): _ K970700

Device Name: _ Fresenius Polysulfone Hemodialyzers ___

Indications for Use:

Hemoflow dialyzers are designed for use in acute or chronic hemodialysis therapies as either single use or multiple use.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_	✓	or	Over the Counter Use_
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William Yu

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number	K970700
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Regulation Number and Section

§ 876.5820 Hemodialysis system and accessories.

(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.