CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210)

K970662 · Baxter Healthcare Corp · MSF · Mar 11, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K970662
• Device Name: CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210)
• Applicant: Baxter Healthcare Corp
• Product Code: MSF · Gastroenterology, Urology
• Decision Date: Mar 11, 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

CA® Cellulose Acetate Hollow Fiber Dialyzers (Models 170, 210) function as hemodialyzers for extracorporeal blood treatment. Device facilitates solute removal and fluid management in patients with renal failure or intoxication. Operated by clinical staff in dialysis settings. Blood flows through hollow fibers; dialysate flows counter-currently to facilitate mass transfer across semi-permeable cellulose acetate membrane. Output is treated blood returned to patient. Device supports single use or reuse protocols. Clinical benefit includes restoration of electrolyte balance, removal of metabolic waste, and detoxification.

Clinical Evidence

Clinical data collected per FDA Guidance for Hemodialyzer Reuse Labeling. Testing includes in vivo and in vitro performance data. Biocompatibility meets USP XXI Class VI requirements. Sterilization validated per AAMI ST-27. Pyrogen testing meets JMHW Notification No. 494 and Japanese Pharmacopeia standards. Particulate testing meets USP 23 <788> and ASTM F25-68.

Technological Characteristics

Hollow fiber dialyzer using cellulose acetate membrane. Sterilized via Ethylene Oxide (EtO) gas to SAL 10^-6. Materials meet USP XXI Class VI. Conforms to AAMI ST-27 for sterilization, USP 23 <788> and ASTM F25-68 for particulate limits, and JMHW/Japanese Pharmacopeia for pyrogenicity.

Indications for Use

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

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

• CA® Cellulose Acetate Hollow Fiber Dialyzers (K970662)

Submission Summary (Full Text)

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K970662
Page 1 of 2

# 510(K) SUMMARY

MAR 11 1998

| 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: | CA® Cellulose Acetate Hollow Fiber Dialyzer |
| Common name: | Hemodialyzer |
| Classification name: | High Permeability Hemodialysis System per 21 CFR 876.5860 |
| Equivalent predicate: | CA® Cellulose Acetate Hollow Fiber Dialyzers |
| Device Description: | Models CA-170, and CA-210 Hemodialyzers |
| 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 CA® 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 CA® 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 CA® Hemodialyzer is based upon the Association for the Advancement of Medical Instrumentation (AAMI) Guideline (ST-27-Industrial Ethylene Oxide (EtO) 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. |

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K970662
Page 2 of 2

510(K) SUMMARY

February 20, 1997

CA® Cellulose Acetate 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

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71

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DEPARTMENT OF HEALTH &amp; HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
MAR 11 1998

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

Re: K970662
Multiple Use Labeling for CA® Cellulose Acetate
Hollow Fiber Dialyzers - Models 170 and 210
Dated: August 11, 1997
Received: August 14, 1997
Regulatory class: III
21 CFR §876.5860/Product code: 78 MSF

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,

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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NOV 12 '97 16:08
FROM RENAL REG AFFAIRS
PAGE.005

510(k) Number (if known): K970662

Device Name: CA Cellulose Acetate 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. This dialyzer is 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 K970662

Prescription Use ☑
Use
(Per 21 CFR 801.109)

OR

Over-The-Counter

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