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 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.

AI/ML Overview

The provided text is a 510(k) summary for the Althin Medical AB A-15 Hemodialyzer, which is a medical device. This document does not describe a study involving performance metrics like accuracy, sensitivity, or specificity, which are typically associated with AI/ML model evaluations. Instead, it describes a
The acceptance criteria are that the device perform equivalently to the predicate device. The study performed that demonstrates that the A-15 Hemodialyzer meets this criteria is functional testing. The functional testing was based on the specifications of the predicate device, the Altra Nova 140 Hemodialyzer (K945625). The results of the functional testing showed "significant equivalence." Additionally, biocompatibility testing was performed in accordance with ISO 10993, and the device passed all indicated tests.

Here's a breakdown of the requested information based on the provided text. Please note that many of the categories you requested are typically relevant for AI/ML device evaluations and are not applicable to the traditional medical device submission described here.

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Functional performance equivalent to predicate device (Altra Nova 140 Hemodialyzer, K945625)	Functional testing showed "significant equivalence" to the predicate device's specifications. The device conforms to its specifications and is suitable for its intended use.
Biocompatibility	Passed the panel of tests indicated for a hemodialyzer device in accordance with ISO 10993.

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

Sample size for test set: Not specified in the document. The testing involved "functional testing" and "biocompatibility testing," but the number of units tested is not provided.
Data provenance: Not explicitly stated. The company, Althin Medical AB, is based in Sweden. The testing would have been conducted to support the 510(k) submission to the FDA in the USA.

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)

Number of experts: Not applicable. The "ground truth" for this type of device is based on established engineering specifications and industry standards for functional and biocompatibility performance, not expert medical opinion on individual cases.

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

Adjudication method: Not applicable. This does not involve interpretation of data by multiple experts.

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

MRMC study: No. This is a traditional hemodialyzer, not an AI/ML device, so such a study is not relevant or described.

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

Standalone performance: Not applicable. This is a physical medical device, not an algorithm.

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

Type of ground truth: The ground truth for this device's performance is based on established engineering specifications for hemodialyzers (e.g., ultrafiltration coefficient, clearance) and the requirements of biocompatibility standards (ISO 10993). Performance is compared against the specifications of a legally marketed predicate device.

8. The sample size for the training set

Sample size for training set: Not applicable. This is not a machine learning device and therefore does not have a "training set" in the context of AI/ML.

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

Ground truth for training set: Not applicable, as there is no training set for this type of device.

Summary

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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 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:	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.

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 (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):

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(Per CFR 801.109)	✓	OR	Over-The-Counter Use(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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Regulation Number and Section

§ 876.5820 Hemodialysis system and accessories.

(a)
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.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.