AF-220 HEMODIALYZER

K992573 · Althin Medical AB · KDI · Jan 18, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K992573
• Device Name: AF-220 HEMODIALYZER
• Applicant: Althin Medical AB
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Jan 18, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Hemodialysis with Althin capillary dialyzers are indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.

Device Story

AF-220 Hemodialyzer functions as an artificial kidney for hemodialysis. Device utilizes semipermeable hollow fibers to divide blood and dialysate compartments. During treatment, patient blood flows through hollow fibers; water and toxic waste products diffuse across the semipermeable membrane into the dialysate compartment. Requires use with a controlled dialysate delivery system equipped with an ultrafiltration controller to manage fluid removal. Intended for clinical use in patients with acute or chronic renal failure. Sterilized by gamma radiation; single-use only.

Clinical Evidence

Bench testing only. Functional performance testing demonstrated equivalence to the predicate device specifications. Biocompatibility testing was performed on the finished sterile device in accordance with ISO 10993, with all tests passed.

Technological Characteristics

High permeability hemodialyzer using hollow fiber technology. Single-use, gamma-sterilized. Biocompatibility compliant with ISO 10993. Requires external dialysate delivery system with ultrafiltration control.

Indications for Use

Indicated for patients with acute or chronic renal failure requiring hemodialysis when conservative therapy is inadequate.

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

• Altra Flux 200 Hemodialyzer (K926373)

Submission Summary (Full Text)

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# 510(k) Summary

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## JAN 1 8 2000

:

# of Safety and Effectiveness

## [As Required by 21 CFR 807.92(c)]

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92(a).

#### Submitter information.

| Company Name: | Althin Medical AB |
|-------------------------|-----------------------------------------------------------|
| Company Address: | Fridhemsvägen 15<br>Box 39<br>S- 372 21 Ronneby<br>Sweden |
| Tel: | [phone] |
| Fax: | [phone] |
| Contact person: | Lars-Olof Sandberg<br>Regulatory Affairs Manager |
| Date Summary Prepared: | 990730 |
| Trade/Proprietary name: | AF-220 Hemodialyzer |
| Common name: | Hemodialyzer |
| Classification name: | High permeability dialyzer per 21 CFR §867.5860 |

## Substantially Equivalent legally marketed device:

| Company | Device | 510(k) number | Date cleared |
|--------------------|----------------|---------------|--------------|
| Althin Medical Inc | Altra Flux 200 | K926373 | 02/13/95 |
| | Hemodialyzer | | |

The AF-220 Hemodialyzer is substantially equivalent to other predicate devices currently in commercial distribution in terms of their intended use. The fundamental technical characteristics are similar to those of the predicate device and are listed on the predicate device comparison table provided in this notification

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K992573
p. 2/3

#### Device description.

The AF-220 Hemodialyzer is a high permeability hemodialyzer that is used as an artificial kidney in a hemodialysis system to treat patients with acute or chronic renal failure. The blood from a patient flows through the arterial tubing of the extracorporeal blood circuit to the blood compartment of the hemodialyzer, then returns through the venous tubing of the extracorporeal blood system to the patient. The hemodialyzer has semipermeable hollow fibers which divide the device into two compartments. When the blood passes through the hollow fibers, water and toxic waste products from the blood pass through the semipermeable membrane into the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the hemodialyzer.

A high permeability hemodialyzer has a semipermeable membrane that is more permeable to water than that of the conventional dialyzer. This device must be used in conjunction with a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood. This highly permeable, semipermeable membrane may also permit greater loss of high molecular weight substances from the blood, compared with the conventional hemodialyzer.

Each AF-220 Hemodialyzer is packaged in a plastic bag and 20 hemodialyzers are packed in a cardboard box.

It is sterilized by gamma radiation and intended, and labeled, for single use only.

### Intended use of the device.

Hemodialysis with Althin capillary dialyzers are indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.

### Comparison of technical characteristics

The AF-220 Hemodialyzer operates using the same hollow fiber technology as the legally marketed predicate device. Apart from differences in ultrafiltration coefficient and clearance, both the subject and predicate devices are used as comparable artificial kidneys in a hemodialysis system to treat patients with acute or chronic renal failure.

### Functional testing.

Functional testing has been conducted to evaluate the functional performance of the AF-220 Hemodialyzer. Testing was based on the specification cleared for the predicate device and test results showed significant equivalence. Moreover, the results of the functional testing attest that the AF-220 Hemodialyzer conforms to its specifications and has demonstrated that it is suitable for its intended use.

Additionally, biocompatibility testing was performed on the finished sterile device in accordance with ISO10993. Test results showed that the AF-220 Hemodialyzer passed the panel of tests indicated for a hemodialyzer device.

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#### Conclusions.

The information included in this submission demonstrate that the AF-220 Hemodialyzer is similar in design, materials, intended uses, indications and contraindications to the previously concurred Altra Flux 200 Hemodialyzer. Therefore, based on the information provided in this 510(k) Notification, the AF-220 Hemodialyzer is considered substantially equivalent to the Altra Flux 200 Hemodialyzer.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized human profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 8 2000

Mr. Lars-Olof Sandberg Regulatory Affairs Manager Althin Medical AB Box 39 Fridhemsvägen 15 S-372 21 Ronneby SWEDEN

Re: K992573 AF-220 Hemodialyzer Dated: July 30, 1999 Received: August 2, 1999 Requiatory Class: III 21 CFR §876.5860/Procode: 78 KDI

Dear Mr. Sandberg:

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 legally marketed predicate 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). 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 requirements, 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 requlations.

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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting 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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# Indications for use.

x992573 510(k) number (if known): Althin Medical AB AF-220 Hemodialyzer Device name: Hemodialysis with Althin capillary dialyzers are indicated for Indications for use: patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.

> (Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use
(Per CFR 801.109)
OR

Over-The-Counter Use

(Optional format 1-2-96)

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