Altra Nova® 200 Hemodialyzers are intended for acute or chronic Hemodialysis. Hemodialysis is indicated for patients with acute or chronic result 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.

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 The hemodialyzer has semipermeable hollow fibers which divide the patient. 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.

AI/ML Overview

The provided text describes a 510(k) summary for the Altra Nova® 200 Hemodialyzer with multiple-use labeling. It focuses on demonstrating equivalence to an existing single-use device rather than performing a typical clinical study with acceptance criteria and reported device performance in the way a new diagnostic or AI-driven device would.

Therefore, many of the requested categories (e.g., AI integration, expert consensus, MRMC studies, training set details) are not applicable to this type of submission. The document is a regulatory submission for a medical device (hemodialyzer) seeking clearance for reuse, not a study evaluating software performance or diagnostic accuracy.

Here's a breakdown based on the information available, highlighting what is applicable and what isn't:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with performance metrics like sensitivity or specificity. Instead, the acceptance criteria for this device (a reusable hemodialyzer) revolve around demonstrating that the reprocessed device is as safe and effective as the single-use predicate device. The "performance" is implicitly tied to maintaining the original device's characteristics after reprocessing.

Acceptance Criteria (Implied)	Reported Device Performance
Reprocessed device is as safe as single-use.	"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." (No specific safety metrics provided in this summary)
Reprocessed device is as effective as single-use.	"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." (No specific efficacy metrics provided in this summary, but implies maintenance of the original device's filtration capabilities).
Reprocessing method maintains device integrity.	"Reprocessing between uses was performed according to the Renatron® operator's manual." (This indicates a validated reprocessing method was used, implying device integrity was maintained).
Device characteristics (materials, design) remain unchanged.	"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..."

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated in this 510(k) summary. The summary refers to "Testing performed on reprocessed devices," but the number of devices or cycles tested is not disclosed.
Data Provenance: Not specified, but likely proprietary internal testing conducted by Althin Medical, Inc. (the manufacturer) in the USA. It would be retrospective in the sense that the testing was performed on devices that were then reprocessed according to a defined protocol.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is Not Applicable (N/A). This submission is for a physical medical device (hemodialyzer), not an AI-driven or diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method for the test set:

This is Not Applicable (N/A). No adjudication method is described because the testing doesn't involve subjective interpretations or expert consensus. It likely involved objective measurements of device performance parameters (e.g., clearance rates, ultrafiltration rates, material integrity) after reprocessing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

This is Not Applicable (N/A). This is a physical medical device, not an AI or diagnostic tool that would involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is Not Applicable (N/A). This is a physical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth," in this context, is the original performance specifications and safety profile of the single-use Altra Nova® 200 Hemodialyzer. The study's goal was to demonstrate that the reprocessed device met these same predefined engineering and functional standards. This would involve objective measurements (e.g., chemical analysis, physical integrity tests, performance characteristics like solute clearance and ultrafiltration coefficient) against established benchmarks for the fresh device.

8. The sample size for the training set:

This is Not Applicable (N/A). There is no AI or machine learning model involved, therefore no training set.

9. How the ground truth for the training set was established:

This is Not Applicable (N/A). There is no AI or machine learning model involved, therefore no training set or ground truth establishment relevant to AI.

Summary

{0}------------------------------------------------

1 : - - - - - - - - - - - - - - - - - - - - - - -14116681

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:	(305) 825-5368
Fax Number:	(305) 825-5322

Device Information:

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

Equivalent Device:

をおい

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

Device Description:

A high permeability hemodialyzer has a semipermeable membrane that is more permeable to water than that of the conventional dialyzer. This device must be

{1}------------------------------------------------

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.

1 **** 2 2

K970681

Intended Use:

58680

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.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

JUL 23 1998

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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 ensetment 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 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 542 of the Act for derices 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 intro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdr/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

INDICATIONS FOR USE

510(k) Number is if known:

Device Name:

Altra Novato 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 result failure when conservative therapy is judged to be inadequate. joard to macquate.
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 CDRH. Office of Device Eveluxion (ODE)

Prescription Use (per 21 CRF 801.109)

Over-The-Counter Use

Robert Ratliff

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

Regulation Number and Section

§ 876.5860 High permeability hemodialysis system.

(a)
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).
(b)
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.”