PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234

K980658 · Baxter Healthcare Corp · FJI · May 19, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980658
• Device Name: PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234
• Applicant: Baxter Healthcare Corp
• Product Code: FJI · Gastroenterology, Urology
• Decision Date: May 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended specifically for use in patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It may also be indicated in the treatment of patients intoxicated with poisons or drugs.

Device Story

Polysynthane (PSNTM) Hemodialyzer (Models PSN-130, PSN-150) is a hollow fiber dialyzer used for extracorporeal blood treatment. Device facilitates solute clearance (urea, creatinine, Vitamin B12) and ultrafiltration in patients with renal failure or intoxication. Operates via hemodialysis principles; blood flows through hollow fibers while dialysate flows externally, allowing diffusion and convection across the semi-permeable membrane. Used in clinical settings by trained healthcare professionals. Output is the processed blood returned to the patient, aiding in toxin removal and fluid balance. Benefits include restoration of metabolic homeostasis in renal patients.

Clinical Evidence

No clinical data. Bench testing only. Device validated for biocompatibility per ISO 10993-1, sterility per AAMI ST-27 (SAL 1x10^-6), pyrogenicity per USP, and particulate matter per USP XXIII <788>.

Technological Characteristics

Hollow fiber dialyzer; materials consistent with predicate. Sterilization via Ethylene Oxide (EO) per AAMI ST-27. Biocompatibility per ISO 10993-1. Functional testing includes blood side integrity and manufacturing specification conformance.

Indications for Use

Indicated for patients with acute or chronic renal failure requiring hemodialysis when conservative therapy is inadequate, and for patients intoxicated with poisons or drugs.

Regulatory Classification

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.

Predicate Devices

• CA® Hollow Fiber Dialyzers
• PSNTM Polysynthane Dialyzers

Submission Summary (Full Text)

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## 1 0 1998 MAY

4980658

## 510(K) SUMMARY

| Submitter's name:<br>Address: | Ann Marie Pahlman MPR A-2E<br>1620 Waukegan Rd.<br>McGaw Park, IL 60080 |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone:<br>Fax: | 847 473-6078<br>847 473-6952 |
| Contact:<br>Date Prepared: | Ann Marie Pahlman or Robert Wilkinson<br>February 16, 1998 |
| Trade name:<br>Common name:<br>Classification name: | Polysynthane (PSNTM) Hemodialyzer<br>Hemodialyzer<br>Hemodialysis System and Accessories per 21 CFR 876.5820 |
| Equivalent predicate: | CA® Hollow Fiber Dialyzers,<br>PSNTM Polysynthane Dialyzers |
| Device Description: | Model PSN-130 Hemodialyzer<br>Model PSN-150 Hemodialyzer |
| Intended Use: | Intended specifically for use in patients with acute or chronic renal failure when<br>conservative therapy is judged to be inadequate. It may also be indicated in the<br>treatment of patients intoxicated with poisons or drugs. |
| Summary of the<br>technological<br>Dialyzers. | The general function and materials of the subject PSNTM Hemodialyzers are the same<br>as the Baxter predicate Dialyzers with a slight change in clearance values for urea,<br>creatinine, Vitamin B 12, and ultrafiltration similar to that of the CA® Hollow Fiber |

Clinical data: N/A

Components of the subject PSNTM Hemodialyzers have met the biological Conclusions drawn requirements of ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Guidance on slection of tests. The validation of the sterilization cycle for the PSNTM Hemodialyzer is based upon the Association for the Advancement of Medical Instrumentation (AAMI) Guideline (ST-27-Industrial Ethylene Oxide (EO) Sterilization of Medical Devices) to ensure a sterility assurance level (SAL) of 1x10 -. Prior to release, sterilant residues of EO, ECH and EG are consistent with the proposed limits for the "blood ex vivo" device category as published in the June 23, 1978 Federal Register.

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510(K) SUMMARY February 16, 1998 Polysynthane (PSNTM) Hemodialyzer Page 2 of 2

> Pyrogen testing of the subject dialyzers meets the requirements of Chapter 161, Transfusion and Infusion Assemblies and Similar Medical Devices of Supplement 2 of the USP.

Particles are counted per USP XXIII <788>.

Functional testing for blood side integrity and conformance to manufacturing specifications are performed as in-process and/or final inspections prior to product release ensuring a quality product.

Additional information requested by FDA: none to date

Official Correspondent:

Robert L. Wilkinson

Robert L. Wilkinson Director Regulatory Affairs

Prepared by:

Ann Marie Dahlman

Ann Marie Pahlman Manager Regulatory Affairs

2/16/98
Date

2/16/98
Date

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 1 9 1998

Ms. Ann-Marie Pahlman Manager, Regulatory Affairs Baxter Healthcare Corporation 1620 Waukegan Road McGaw Park, IL 60085-6730 Re: K980658 PSN® Polysynthane Hemodialyzers Models 130 and 150 Dated: February 16, 1998 Received: February 19, 1998 Regulatory Class: II 21 CFR 876.5820/Procode: 78 FJI

Dear Ms. Pahlman:

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 (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 OS 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 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 predication 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 80) and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrb/dsmaldsmam.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):

Device Name: PSN Hollow Fiber Dialyzer

Indications for Use:

Hemodialysis with these dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It may also be indicated in the treatment of patients intoxicated with poisons or drugs.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Satting
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K970658

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)