PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER

K963933 · Baxter Healthcare Corp · FJI · Nov 24, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K963933
• Device Name: PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER
• Applicant: Baxter Healthcare Corp
• Product Code: FJI · Gastroenterology, Urology
• Decision Date: Nov 24, 1997
• 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 (PSN) Hemodialyzer (Models PSN-120, PSN-140) is a hollow fiber dialyzer used for extracorporeal blood treatment. It functions by facilitating solute exchange between blood and dialysate across a semipermeable fiber bundle membrane. Used in clinical settings for patients with renal failure or intoxication. The device removes metabolic waste products and toxins from the blood. Healthcare providers operate the hemodialysis system to manage patient fluid and electrolyte balance. The device is a disposable component of a larger hemodialysis system.

Clinical Evidence

No clinical data. Bench testing included biocompatibility evaluation of the fiber bundle per ISO 10993-1 and other components per USP XXI Class VI. Sterilization validation performed per AAMI ST-27 (Ethylene Oxide) to ensure SAL of 1x10^-6. Pyrogen testing conducted per USP Supplement 2, Chapter 161. Particulate matter compared to USP 23 limits for Large Volume Injections. Functional testing performed for blood side integrity and manufacturing specifications.

Technological Characteristics

Hollow fiber dialyzer; fiber bundle membrane; Ethylene Oxide (EO) sterilization; meets USP XXI Class VI and ISO 10993-1 biocompatibility standards; meets USP 23 limits for particulates; blood side integrity testing.

Indications for Use

Indicated for patients with acute or chronic renal failure requiring hemodialysis when conservative therapy is inadequate, and for treatment of 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

• CF Capillary Flow Dialyzers
• CA Cellulose Acetate Hollow Fiber Dialyzers
• HT Hollow Fiber Dialyzers

Submission Summary (Full Text)

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K963933
P1n2

# 510(K) SUMMARY

| Submitter’s name: | Ann Marie Pahlman MPR A-2E |
| --- | --- |
| Address: | 1620 Waukegan Rd.
McGaw Park, IL 60080 |
| Phone: | 847 473-6078 |
| Fax: | 847 473-6952 |
| Contact: | Ann Marie Pahlman or Robert Wilkinson |
| Date Prepared: | September 20, 1996 |
| Trade name: | Polysynthane (PSN) Hemodialyzer |
| Common name: | Hemodialyzer |
| Classification name: | Hemodialysis System and Accessories per 21 CFR 876.5820 |
| Equivalent predicate: | CF Capillary Flow Dialyzers, CA Cellulose Acetate Hollow Fiber Dialyzers, HT Hollow Fiber Dialyzers |
| Device Description: | Model PSN-120 PSN Hemodialyzer
Model PSN-140 PSN Hemodialyzer |
| 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. |
| Summary of the technological predicate device: | The general function and materials of the subject PSN Hemodialyzers are the same as the Baxter predicate Dialyzers. Differences in the subject PSN Hemodialyzers to the predicate Baxter Dialyzers consist of a change in the fiber bundle material and a slight change in clearance values for urea, creatinine and Vitamin B 12. |
| Clinical data: | N/A |
| Conclusions drawn from tests: | Components of the subject PSN Hemodialyzers, with the exception of the fiber bundle, have previously met the biological requirements of the guidelines for safety screening of materials for USP XXI Class VI materials. The fiber bundle was tested as suggested by to ISO 10993-1: Biological Evaluation of Medical Devices - Part 1. guidelines. The validation of the sterilization cycle for the PSN 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 $1 \times 10^{-6}$. 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. |

NOV 24 1997

54

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K963933
P292

510(K) SUMMARY

September 20, 1996

Polysynthane (PSN) Hemodialyzer

Page 2 of 2

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

Particles are compared to USP 23 limits for Large Volume Injections (LVI) solutions.

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

9/23/96

Date

Prepared by:

Ann Marie Pahlman

Manager Regulatory Affairs

9/23/96

Date

）

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Ms. Ann Marie Pahlman
Manager, Regulatory Affairs
Renal Division
Baxter Healthcare Corporation
1620 Waukegan Road
McGaw Park, Illinois 60085-6730

Re: K963933
PNS Hollow Fiber Dialyzer - Models 120 and 140
Dated: October 21, 1997
Received: October 23, 1997
Regulatory class: II
21 CFR §876.5820/Product code: 78 FJI

Dear Ms. Pahlman:

NOV 24 1997

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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) 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 [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/dsmamain.html".

Sincerely yours,


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 D. Setting
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K9

Prescription Use ☑ (Per 21 CFR 801.109)
OR
Over-The-Counter Use ☐

(Optional Format 1-2-96)