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

Device Description

The AF-150 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 membrane may also permit greater loss of high molecular weight substances from the blood, compared with the conventional hemodialyzer.

Each AF-150 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Althin Medical AB AF-150 Hemodialyzer, based on the provided 510(k) summary:

This device submission does not involve Artificial Intelligence (AI). The submission is for a medical device (hemodialyzer) and the "study" referred to is functional testing and biocompatibility testing to demonstrate substantial equivalence to a predicate device. Therefore, many of the requested AI-specific details (such as sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types for AI models) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary indicates that the AF-150 Hemodialyzer's performance was evaluated against the specifications cleared for its predicate device, the Altra Flux 140 Hemodialyzer (K945620). The key performance characteristics are related to its function as a high permeability hemodialyzer.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from predicate)	Reported Device Performance (AF-150 Hemodialyzer)
Functional Performance	Equivalent to predicate device specifications (e.g., clearance, ultrafiltration coefficient, as per predicate K945620)	"Functional testing... showed significant equivalence."
Biocompatibility	Compliance with ISO 10993 standards for hemodialyzers	"Test results showed that the AF-150 Hemodialyzer passed the panel of tests indicated for a hemodialyzer device."
Sterilization	Effective sterilization by gamma radiation	Sterilized by gamma radiation
Single Use Only	Designed for single use, no re-use	Labeled for single use only

Note: Specific quantitative acceptance criteria (e.g., exact clearance rates, ultrafiltration coefficients) are not provided in this summary but are implied to be met in comparison to the predicate device's cleared specifications.

Regarding AI-Specific Information:

Since this is a traditional medical device (hemodialyzer) and not an AI/ML-based device, the following points are not applicable and cannot be answered from the provided text. The "study" here refers to standard medical device functional and biocompatibility testing, not an AI model's performance evaluation.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable (N/A) for AI/ML. For functional testing of a physical medical device, the "sample size" would refer to the number of devices tested. This information is not provided in the summary. Data provenance is also not relevant in the context of device functional testing described here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A for AI/ML. Ground truth, in the context of AI, involves expert annotations or diagnoses. For a physical device, functional performance is measured objectively through testing (e.g., laboratory measurements for clearance, ultrafiltration) against defined specifications, not through expert consensus on a "test set."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A for AI/ML. Adjudication methods are used in AI performance studies to resolve discrepancies in expert annotations for ground truth. This is not relevant for functional device testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. MRMC studies are specific to evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a hemodialyzer.

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

N/A. This refers to AI algorithm performance. The device is a physical hemodialyzer.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

N/A for AI/ML. The "ground truth" for the device's functional evaluation comprises objective measurements based on established test methodologies for hemodialyzers (e.g., measuring ultrafiltration coefficients, clearance rates, and confirmed biocompatibility according to ISO 10993).

8. The sample size for the training set

N/A. This device does not use a training set as it is not an AI/ML algorithm.

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

N/A. This device does not use a training set or ground truth in the AI context.

Summary

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510(k) Summary

K992566

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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 15Box 39S- 372 21 RonnebySweden
Tel:	+46 457 759 00
Fax:	+46 457 17395
Contact person:	Lars-Olof SandbergRegulatory Affairs Manager
Date Summary Prepared:	990730
Device identification.
Trade/Proprietary name:	AF-150 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 140Hemodialyzer	K945620	05/18/95

The AF-150 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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Device description.

Each AF-150 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-150 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-150 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-150 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-150 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-150 Hemodialyzer is similar in design, materials, intended uses, indications and contraindications to the previously concurred Altra Flux 140 Hemodialyzer. Therefore, based on the information provided in this 510(k) Notification, the AF-150 Hemodialyzer is considered substantially equivalent to the Altra Flux 140 Hemodialyzer.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

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: K992566 AF-150 Hemodialyzer Dated: July 30, 1999 Received: August 2, 1999 Regulatory 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 (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 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro 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/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):

Device name:	Althin Medical AB AF-150 Hemodialyzer
Indications for use:	Hemodialysis with Althin capillary dialyzers are indicated forpatients with acute or chronic renal failure when conservativetherapy 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 Devices
510(k) Number K992566

(
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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.”