(52 days)
Hemodialysis with Althin capillary dialyzers are indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
The A-18 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-18 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.
The Althin Medical AB A-18 Hemodialyzer is a conventional hemodialyzer used to treat patients with acute or chronic renal failure. The device was deemed substantially equivalent to the Althin Medical Inc Altra Nova 170 Hemodialyzer (K945621).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional equivalence to predicate device (Altra Nova 170 Hemodialyzer) | "Testing was based on the specification cleared for the predicate device and test results showed significant equivalence." |
| Conformance to specifications | "the results of the functional testing attest that the A-18 Hemodialyzer conforms to its specifications" |
| Suitability for intended use | "demonstrated that it is suitable for its intended use." |
| Biocompatibility (ISO10993) | "Test results showed that the A-18 Hemodialyzer passed the panel of tests indicated for a hemodialyzer device." |
| Similar design | "similar in design" to the predicate |
| Similar materials | "similar in materials" to the predicate |
| Similar intended uses, indications, and contraindications | "similar in intended uses, indications and contraindications" to the predicate |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the functional testing. It only mentions "functional testing has been conducted to evaluate the functional performance of the A-18 Hemodialyzer."
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The document refers to "specifications cleared for the predicate device" as the basis for testing, implying a comparison against established performance standards rather than expert-defined ground truth for specific cases.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. The submission focuses on demonstrating substantial equivalence to a predicate device through functional and biocompatibility testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a hemodialyzer, a physical medical device, not an algorithm or AI system. Therefore, standalone performance in the context of AI algorithms is not relevant. The "functional testing" described evaluates the device's physical performance.
7. The Type of Ground Truth Used
The ground truth for the functional testing appears to be based on the specifications and performance characteristics of the legally marketed predicate device (Altra Nova 170 Hemodialyzer), along with established industry standards for biocompatibility (ISO10993). This is a comparative "ground truth" rather than an expert consensus, pathology, or outcomes-based ground truth typical for diagnostic AI.
8. The Sample Size for the Training Set
This question is not applicable as the A-18 Hemodialyzer is a physical medical device and does not involve a training set in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
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510(k) Summary
Image /page/0/Picture/2 description: The image shows handwritten text on a white background. The text at the top reads 'K992565', with each character clearly written. Below this, the text 'P. 112' is present, indicating a page number. The handwriting appears to be simple and legible.
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-18 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 170 | K945621 | 05/30/95 |
| Hemodialyzer |
The A-18 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.
Image /page/1/Picture/1 description: The image shows handwritten text. The top line reads "K992565". The bottom line reads "Q212".
The A-18 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-18 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-18 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-18 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-18 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-18 Hemodialyzer passed the panel of tests indicated for a hemodialyzer device.
Conclusions.
The information included in this submission demonstrate that the A-18 Hemodialyzer is similar in design, materials, intended uses, indications and contraindications to the previously concurred Altra Nova 170 Hemodialyzer. Therefore, based on the information provided in this 510(k) Notification, the A-18 Hemodialyzer is considered substantially equivalent to the Altra Nova 170 Hemodialyzer.
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Public Health Service
Rockville MD 20850
Food and Drug Administration 9200 Corporate Boulevard
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wing shapes, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
SEP 2 3 1999
Mr. Lars-Olof Sandberg Regulatory Affairs Manager Althin Medical AB Box 39 Fridhemsvägen 15 S-372 21 Ronneby SWEDEN
Re: K992565 A-18 Hemodialyzer Dated: July 30, 1999 Received: August 2, 1999
21 CFR §876.5820/Procode: 78 FJI
Regulatory Class: II
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 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 regulation (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 A-18 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) and the prescription use is checked.
Radiological Devices
510(k) Number K992565
§ 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.