PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236

K980656 · Baxter Healthcare Corp · KDI · May 19, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980656
• Device Name: PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236
• Applicant: Baxter Healthcare Corp
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: May 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• 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-170, PSN-210) 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. Operated by clinical staff in a dialysis setting. Blood flows through the dialyzer, where semi-permeable membranes allow for the removal of toxins and excess fluid via diffusion and convection. Output is the treated blood returned to the patient. Benefits include restoration of fluid/electrolyte balance and removal of toxic substances.

Clinical Evidence

No clinical data. Bench testing only, including biological evaluation per ISO 10993-1, sterilization validation per AAMI ST-27, pyrogen testing per USP, and particulate counting per USP XXIII <788>.

Technological Characteristics

Hollow fiber hemodialyzer. Materials meet ISO 10993-1 biological requirements. Sterilization via Ethylene Oxide (EO) per AAMI ST-27 (SAL 1x10^6). Conforms to USP XXIII <788> for particulate matter and USP Chapter 161 for pyrogenicity. Mechanical device; no software or electronic components.

Indications for Use

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

Regulatory Classification

Identification

A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.). (3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).

Special Controls

*Classification.* Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ” (2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,” (3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,” (4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and (5) “Guidance for Hemodialyzer Reuse Labeling.”

Predicate Devices

• PSNT™ Polysynthane Dialyzers
• CAHPTM Hollow Fiber Dialyzers

Submission Summary (Full Text)

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## K980656

## MAY 1 9 1998

## 510(K) SUMMARY

| Submitter's name: | Ann Marie Pahlman MPR A-2E |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 1620 Waukegan Rd.<br>McGaw Park, IL 60080 |
| Phone: | 847 473-6078 |
| Fax: | 847 473-6952 |
| Contact: | Ann Marie Pahlman or Robert Wilkinson |
| Date Prepared: | February 16, 1998 |
| Trade name: | Polysynthane (PSNTM) Hemodialyzer |
| Common name: | Hemodialyzer |
| Classification name: | High Permeability Hemodialysis System per 21 CFR 876.5860 |
| Equivalent predicate: | PSNT™ Polysynthane Dialyzers,<br>CAHPTM Hollow Fiber Dialyzers |
| Device Description: | Model PSN-170 Hemodialyzer<br>Model PSN-210 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>predicate device | The general function and materials of the subject PSNT™ Hemodialyzers are the same<br>as the Baxter PSNT™ Dialyzers with a slight change in clearance values for urea,<br>creatinine, Vitamin B 12, and ultrafiltration similar to that of the CAHP Hollow Fiber<br>Dialyzers. |
| Clinical data: | N/A |

Components of the subject PSN™ Hemodialyzers have met the biological Conclusions drawn requirements of ISO 10993-1: Biological Evaluation of Medical Devices - Part : Guidance on selection 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 1x106. 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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Page 2/2

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 cocounted 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 Director Regulatory Affairs

2/16/98
Date

Prepared by:

Ann Marie Pace

Ann Marie Pahlman Manager Regulatory Affairs

2/16/98
Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Druq 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: K980656 PSNTM Polysynthane Hemodialyzers Models 170 and 210 Dated: February 16, 1998 Received: February 19, 1998 Regulatory Class: III 21 CFR 876.5860/Procode: 78 KDI

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 reslassified 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 probibitions 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 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 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 [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/cdrh/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):

Device Name:

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. Satling/

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number: K980656

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)