ALTRA NOVA 200 HEMODIALYZER

K970681 · Althin Medical AB an Affiliate of Baxter Intl · MSF · Jul 23, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K970681
• Device Name: ALTRA NOVA 200 HEMODIALYZER
• Applicant: Althin Medical AB an Affiliate of Baxter Intl
• Product Code: MSF · Gastroenterology, Urology
• Decision Date: Jul 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Hemodialysis is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. The multiple use device can be reused on the same patient.

Device Story

Altra Nova 200 is a high-permeability hemodialyzer (artificial kidney) used in extracorporeal blood circuits. Device consists of two compartments separated by semipermeable hollow fibers. Blood flows through fibers while dialysate circulates in the surrounding compartment; water and toxic waste products transfer across the membrane via diffusion and ultrafiltration. Must be used with a controlled dialysate delivery system featuring an ultrafiltration controller to prevent excessive fluid loss. Operated by clinical staff in a dialysis setting. This submission adds multiple-use labeling to the previously cleared single-use device, validated for reprocessing on the same patient using the Renatron system. Benefits include removal of metabolic waste and excess water in patients with renal failure.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing of reprocessed devices to ensure safety and performance after multiple uses.

Technological Characteristics

High-permeability hemodialyzer with semipermeable hollow fiber membrane. Identical in construction and materials to the predicate device. Requires external dialysate delivery system with ultrafiltration control. Mechanical device; no software or electronic components.

Indications for Use

Indicated for patients with acute or chronic renal failure requiring hemodialysis when conservative therapy is inadequate. Intended for single or multiple use on the same patient.

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 Nova® 200 Hemodialyzer (K926379/B)

Submission Summary (Full Text)

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K910681

JUL 23 1998

# Altra Nova® 200 Hemodialyzer with Multiple Use Labeling

## 510(k) Summary of Safety and Effectiveness

(in accordance with the requirements of SMDA 1990 and 21 CFR 807.92)

The assigned 510(k) number for the Altra Flux 200 Hemodialyzer with multiple use labeling is: K970681.

## Applicant Information:

Date Prepared: March 10, 1997
Name: Althin Medical, Inc.
Address: 14620 N.W. 60th Ave.
Miami Lakes, FL 33014-9308
Contact Person: Mary Lane
Phone Number: [phone]
Fax Number: [phone]

## Device Information:

Trade Name: Altra Nova® 200 Hemodialyzer
Common Name: high permeability hemodialyzer or artificial kidney
Classification Name: Dialyzer, High Permeability with or without Sealed Dialysate System (21 CFR 876.5860) Product Code - 78 KDI

## Equivalent Device:

Altra Nova® 200 Hemodialyzer (single use device) cleared for marketing via Premarket Notification 510(k) number K926379/B.

## Device Description:

The Altra Nova® 200 multiple use hemodialyzer is the Altra Nova® 200 single use device with reuse labeling. Like the Altra Nova® 200 single use device, it 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

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K970681
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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.

## Intended Use:

Hemodialysis is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. The multiple use device can be reused on the same patient.

## Comparison to Predicate Device:

The Altra Nova® 200 Hemodialyzer with multiple use (reuse) labeling is identical to the currently marketed Altra Nova® 200 single use device. The product drawings, material list, chemical structure, production process flow for the membrane or dialyzer, and physical characteristics of the Altra Nova® 200 reusable hemodialyzer is identical to the currently marketed Altra Nova 200 single use hemodialyzer which received marketing clearance via the original 510(k) Premarket Notification K926379/B, dated February 13, 1995.

The only difference between the two products is that the multiple use device has been validated for multiple uses. Reprocessing between uses was performed according to the Renatron® operator’s manual. Testing performed on reprocessed devices demonstrate that the Altra Nova® 200 multiple use hemodialyzer is as safe and effective as the currently marketed Altra Nova® 200 single use hemodialyzer.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JUL 23 1998
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Gordon Robertson
Director, Regulatory Affairs
Althin Medical, Inc.
14620 N.W. 60th Avenue
Miami Lakes, FL 33014

Re: K970681
Multiple Use Labeling for the Altra Nova® 200 Hemodialyzer
Dated: April 22, 1998
Received: April 24, 1998
Regulatory Class: III
21 CFR 876.5860/Procode: 78 MSF

Dear Mr. Robertson:

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 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 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,


Enclosure

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INDICATIONS FOR USE

510(k) Number is if known:

Device Name:

Altra Nova® 200 Hemodialyzer

Indications for Use:

Altra Nova® 200 Hemodialyzers are intended for acute or chronic Hemodialysis.

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

The Altra Nova 200 Hemodialyzer is indicated for single use or multiple use with the same patient.

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

Concurrence of CDREL, Office of Device Evaluation (ODE)

Prescription Use (per 21 CRF 801.109)

OR

Over-The-Counter Use

Robert D. Rathbun
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K970681