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-180 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-180 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 an analysis of the provided text regarding the acceptance criteria and study for the AF-180 Hemodialyzer:

Summary of Acceptance Criteria and Device Performance:

Based on the provided 510(k) summary, the device is being cleared based on substantial equivalence to a predicate device, the Altra Flux 170 Hemodialyzer. This means the acceptance criteria are implicitly that the AF-180 Hemodialyzer performs similarly enough to the predicate device in terms of its functional characteristics and safety profile.

Acceptance Criteria (Implicit)	Reported Device Performance
Functional Equivalence to Altra Flux 170 Hemodialyzer (except UF coefficient and clearance)	"Functional testing…showed significant equivalence."
Biocompatibility (e.g., non-toxic, non-irritating)	"Biocompatibility testing…passed the panel of tests indicated for a hemodialyzer device."
Intended Use (Hemodialysis for acute/chronic renal failure)	The device's intended use matches the predicate and is stated explicitly.
Design and Materials Similarity	"similar in design, materials, intended uses, indications and contraindications to the previously concurred Altra Flux 170 Hemodialyzer."

Detailed Study Information:

A table of acceptance criteria and the reported device performance: See table above.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document does not specify the sample size for the functional testing or biocompatibility testing. It only states that functional testing was "conducted."
- Data Provenance: Not specified. It's likely the testing was conducted by Althin Medical AB in Sweden, but this is not explicitly stated. The document does not indicate if the data was retrospective or prospective.
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):
- This information is not provided in the summary. For a medical device like a hemodialyzer, "ground truth" would typically refer to established standards or validated methods for measuring performance parameters (e.g., clearance rates, ultrafiltration coefficients) and safety (biocompatibility). These would be established by engineers, toxicologists, and other relevant experts within the company or external labs, but the specific number or qualifications are not mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None described. The summary describes "functional testing" and "biocompatibility testing" but does not detail any adjudication methods, as this is not typically applicable to this type of device testing where objective measurements are primary.
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:
- Not applicable. This device is a hemodialyzer, not an AI-assisted diagnostic or imaging device for human readers. Therefore, an MRMC study is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device (hemodialyzer), not a software algorithm. The "standalone" performance would be its functional performance and biocompatibility as tested.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance would be:
  - Industry Standards and Predicate Device Specifications: Functional testing was "based on the specification cleared for the predicate device."
  - Validated Test Methods: Biocompatibility testing was performed "in accordance with ISO10993," which is an international standard for biocompatibility evaluation of medical devices.
  - Objective Measurements: Performance parameters like ultrafiltration coefficient and clearance would be measured using validated laboratory methods.
The sample size for the training set:
- Not applicable. This device is a physical medical device, not an AI model that requires a training set.
How the ground truth for the training set was established:
- Not applicable. As explained above, there is no AI training set for this device.

Summary

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510(k) Summary

JAN 18 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 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-180 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 170	K945542	05/23/95
	Hemodialyzer

The AF-180 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.

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-180 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-180 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-180 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-180 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-180 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-180 Hemodialyzer is similar in design, materials, intended uses, indications and contraindications to the previously concurred Altra Flux 170 Hemodialyzer. Therefore, based on the information provided in this 510(k) Notification, the AF-180 Hemodialyzer is considered substantially equivalent to the Altra Flux 170 Hemodialyzer.

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Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 18 2000

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

Re: K992564 AF-180 Hemodialyzer Dated: July 30, 1999 Received: August 2, 1999

21 CFR §876.5860/Procode: 78 KDI

Requiatory Class: III

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 pror 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 Requlations, 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-180 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)

Over-The-Counter Use

(Optional format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K992564

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.”