A-15 HEMODIALYZER

K992594 · Althin Medical AB · FJI · Sep 24, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K992594
• Device Name: A-15 HEMODIALYZER
• Applicant: Althin Medical AB
• Product Code: FJI · Gastroenterology, Urology
• Decision Date: Sep 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

A-15 Hemodialyzer functions as an artificial kidney within a hemodialysis system. Device utilizes semipermeable hollow fibers to divide blood and dialysate compartments. During operation, patient blood flows through arterial tubing into the blood compartment; water and toxic waste products diffuse across the semipermeable membrane into the dialysate compartment. A separate dialysate delivery system monitors and controls dialysate circulation. Device is intended for clinical use by healthcare professionals to treat renal failure. Benefits include removal of metabolic waste and excess fluid from patient blood. Device is single-use and sterilized via gamma radiation.

Clinical Evidence

Bench testing only. Functional performance testing demonstrated equivalence to predicate specifications. Biocompatibility testing performed on finished sterile device in accordance with ISO 10993; device passed all required panels.

Technological Characteristics

Conventional hemodialyzer; hollow fiber membrane technology. Single-use; gamma radiation sterilization. Packaged in plastic bags and cardboard boxes. No software or electronic components.

Indications for Use

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

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

• Altra Nova 140 Hemodialyzer (K945625)

Submission Summary (Full Text)

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# 510(k) Summary

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# 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 |
| Device identification. | |
| Trade/Proprietary name: | A-15 Hemodialyzer |
| Common name: | Hemodialyzer |
| Classification name: | Conventional hemodialyzer per 21 CFR §876.5820 |

### Substantially Equivalent legally marketed device:

| Company | Device | 510(k) number | Date cleared |
|--------------------|-----------------------------|---------------|--------------|
| Althin Medical Inc | Altra Nova 140 Hemodialyzer | K945625 | 5/30/95 |

The A-15 Hemodialyzer is substantially equivalent to other predicate devices currently in commercial distribution in terms of their intended use. The fundamental 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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### Device description.

The A-15 Hemodialyzer is a conventional 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.

Each A-15 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 Althin A-15 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 A-15 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 A-15 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 A-15 Hemodialyzer passed the panel of tests indicated for a hemodialyzer device.

### Conclusions.

The information included in this submission demonstrate that the A-15 Hemodialyzer is similar in design, materials, intended uses, indications and contraindications to the previously concurred Altra Nova 140 Hemodialyzer. Therefore, based on the information provided in this 510(k) Notification, the A-15 Hemodialyzer is considered substantially equivalent to the Altra Nova 140 Hemodialyzer.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 1999

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

Re: K992594 A-15 Hemodialyzer Dated: July 30, 1999 Received: August 3, 1999 Requiatory Class: II 21 CFR §876.5820/Procode: 78 FJI

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 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 labeling requlation (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.

510(k) number (if known):

Althin Medical AB A-15 Hemodialyzer Device name: 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.

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

| Prescription use<br>(Per CFR 801.109) | <div style="text-align:center;">✓</div> | OR | Over-The-Counter Use<br>(Optional format 1-2-96) |
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(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

| 510(k) Number | K992594 |
|---------------|---------|
|---------------|---------|

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