CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)

K970654 · Baxter Healthcare Corp · MSE · Nov 12, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970654
• Device Name: CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
• Applicant: Baxter Healthcare Corp
• Product Code: MSE · Gastroenterology, Urology
• Decision Date: Nov 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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

CAHP™ High Performance Cellulose Diacetate Hollow Fiber Dialyzer (Model CAHP-90) is a hemodialyzer used for extracorporeal blood treatment. It facilitates solute removal and fluid management in patients with renal failure or intoxication. The device utilizes cellulose diacetate hollow fiber membranes to perform dialysis. It is intended for clinical use by healthcare professionals. The device supports both single-use and reuse protocols, provided specific disinfection procedures are followed. Clinical benefit is derived from the removal of metabolic waste products and toxins from the patient's blood.

Clinical Evidence

Clinical data collected per FDA Guidance for Hemodialyzer Reuse Labeling. Includes in vivo and in vitro performance data. Bench testing confirms compliance with USP XXI Class VI biological requirements, pyrogen testing per Japanese Pharmacopeia, and particle limits per USP 23 <788> and ASTM F25-68.

Technological Characteristics

Cellulose diacetate hollow fiber membrane. Sterilized via Ethylene Oxide (EtO) per AAMI ST-27 to SAL 10^-6. Materials meet USP XXI Class VI standards. Device is a hemodialyzer for extracorporeal blood processing.

Indications for Use

Indicated for patients with acute or chronic renal failure requiring hemodialysis when conservative therapy is inadequate, and for treatment of drug or poison intoxication. Indicated for single use or reuse on the same patient following specified procedures.

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

• CAHP™ High Performance Cellulose Diacetate Hollow Fiber Dialyzers (K970654)

Submission Summary (Full Text)

{0}

5976654
Page 1 of 2

# 510(K) SUMMARY

NOV 12 1997

| 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: | February 20, 1997 |
| Trade name: | CAHP™ High Performance Cellulose Diacetate Hollow Fiber Dialyzer |
| Common name: | Hemodialyzer |
| Classification name: | Hemodialysis System and Accessories per 21 CFR 876.5820 |
| Equivalent predicate: | CAHP™ High Performance Cellulose Diacetate Hollow Fiber Dialyzers |
| Device Description: | Model CAHP-90 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 CAHP™ Hemodialyzers are identical to the Baxter predicate Dialyzers. |
| Clinical data: | Clinical data was collected according to the FDA Guidance for Hemodialyzer Reuse Labeling. |
| Conclusions drawn | All patient contact components of the subject CAHP™ Hemodialyer have previously met the biological requirements of the guidelines for safety screening of materials for USP XXI Class VI materials. These Dialyzers are sterilized by the Nissho corporation using Ethylene Oxide Gas (EtO) to a sterility assurance level (SAL) of 1 x 10^{-6}. The validation of the sterilization cycle for the CAHP™ Hemodialyzer is based upon the Association for the Advancement of Medical Instrumentation (AAMI) Guideline (ST-27-Industrial Ethylene Oxide (EO) Sterilization of Medical Devices). Prior to release, sterilant residues of EtO, 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. |

G:\510(k)\reuse\cahpii\sum
66

{1}

Page 2 of 2

510(K) SUMMARY

February 20, 1997

CAHP™ High Performance Cellulose Diacetate Hollow Fiber Dialyzers

Page 2 of 2

Pyrogen testing meets the requirements of JMHW

Notification No. 494, “Approval Requirements for Dialyzers” and the

Japanese Pharmacopeia “Pyrogen test.”

Particles are compared to USP 23 &lt;788&gt; limits for Large Volume Injections (LVI) solutions and ASTM F25-68.

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.

In Vivo and In Vitro performance data, and directions for reuse have been included in the labeling.

Additional

information

requested by FDA: none to date

Official Correspondent:


Robert L. Wilkinson

Director Regulatory Affairs

2/20/97

Date

Prepared by:


Ann Marie Pahlman

Manager Regulatory Affairs

2/20/97

Date

G:\510(k)\reuse\cahpi\sum

{2}

DEPARTMENT OF HEALTH &amp; HUMAN SERVICES
Public Health Service

NOV 12 1997

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: K970654
Multiple Use Labeling for CAHP™ Cellulose Diacetate
Hollow Fiber Dialyzer - Model 90
Dated: August 11, 1997
Received: August 14, 1997
Regulatory class: II
21 CFR §876.5820/Product code: 78 MSE

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 (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

{3}

NOV 12 '97 16:08 FRUT RENH- REG H- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

510(k) Number (if known): K970654

Device Name: CAHP™ High Performance Cellulose Diacetate Hollow Fiber Dialyzers

## 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. These dialyzers are indicated for single use or reuse. If the dialyzer is reused on the same patient, the reuse procedure and disinfectant specified in the Direction Insert must be followed. No other reuse procedure or disinfectant has been evaluated for clinical acceptability.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K970654

Prescription Use ☑
Use
(Per 21 CFR 801.109)

OR

Over-The-Counter

G:510(k)reuse\cahpii\indicus