(89 days)
Hemodialysis with these dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It may also be indicated in the treatment of patients intoxicated with poisons or drugs.
Model PSN-130 Hemodialyzer
Model PSN-150 Hemodialyzer
The provided text describes a 510(k) summary for the Polysynthane (PSN™) Hemodialyzer, which is a medical device for use in patients with acute or chronic renal failure, or those intoxicated with poisons or drugs. The document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving performance against pre-defined acceptance criteria in the way one would for a novel device or a clinical trial.
Therefore, the requested information elements related to clinical study design, sample sizes, expert ground truth, MRMC studies, or standalone performance studies are addressed as "Not Applicable" or "Not Provided" based on the content. The acceptance criteria in this context are primarily related to safety and manufacturing quality rather than specific performance metrics demonstrated through a clinical study.
Here's a breakdown based on the provided text:
Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission focused on substantial equivalence, the "acceptance criteria" are implied by compliance with established standards and comparison to predicate devices, particularly regarding safety and manufacturing quality. The reported device performance relates to these compliance activities.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Components met biological requirements of ISO 10993-1. |
| Sterilization Assurance | Validation of sterilization cycle based on AAMI Guideline (ST-27) to ensure a sterility assurance level (SAL) of 1x10⁻⁶. Sterilant residues (EO, ECH, EG) consistent with proposed limits published in Federal Register (June 23, 1978). |
| Pyrogenicity | Pyrogen testing meets USP Chapter 161 requirements for Transfusion and Infusion Assemblies and Similar Medical Devices. |
| Particulate Matter | Particles counted per USP XXIII <788>. |
| Manufacturing Integrity | Functional testing for blood side integrity and conformance to manufacturing specifications performed as in-process and/or final inspections. |
| Functional Equivalence | General function and materials are the same as Baxter predicate Dialyzers. Slight change in clearance values for urea, creatinine, Vitamin B12, and ultrafiltration, similar to CA® Hollow Fiber Dialyzers. (This is a comparison point, not a strict "acceptance criterion" in itself without specific thresholds provided, but it's central to the 510(k) argument). |
Study Details
-
Sample size used for the test set and the data provenance:
- Sample Size: Not applicable/Not provided. The submission does not describe a "test set" in the context of clinical performance evaluation. The data presented is related to materials testing, sterilization validation, and manufacturing controls.
- Data Provenance: Not applicable/Not provided in terms of geographic origin or prospective/retrospective for a specific test set. The data arises from internal testing and compliance activities.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth establishment by experts for a test set is not relevant to this type of submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/None. No adjudication method is described as there is no clinical test set requiring such expert consensus.
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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 tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a hemodialyzer; it does not involve algorithms or human-in-the-loop performance in the context of AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided in the clinical sense. The "ground truth" here is compliance with established biological, sterility, pyrogenicity, and particulate standards, as well as manufacturing specifications, rather than clinical outcomes or diagnostic accuracy.
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The sample size for the training set: Not applicable/Not provided. This submission does not involve a "training set" as it is not an AI/ML device.
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How the ground truth for the training set was established: Not applicable/Not provided. Not relevant to this device type.
Summary of Device and 510(k) Approach:
The provided document is a 510(k) premarket notification for a hemodialyzer. The primary method for demonstrating its acceptability is by proving "substantial equivalence" to legally marketed predicate devices (CA® Hollow Fiber Dialyzers, PSN™ Polysynthane Dialyzers). This means the device functions similarly and uses similar materials to previously cleared devices, and it meets established safety and manufacturing standards.
The "studies" mentioned are not clinical trials evaluating efficacy or diagnostic performance, but rather:
- Biological safety testing: Compliance with ISO 10993-1.
- Sterilization validation: Compliance with AAMI Guideline (ST-27) and residue limits.
- Quality control testing: Pyrogen testing (USP), particulate counting (USP), and functional testing (in-process/final inspections).
- Performance comparison: Clearance values for urea, creatinine, Vitamin B12, and ultrafiltration are compared to predicate devices, showing "slight change" but overall similarity.
There were "no clinical data" provided as explicitly stated in the document, which is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical means.
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1 0 1998 MAY
4980658
510(K) SUMMARY
| Submitter's name:Address: | Ann Marie Pahlman MPR A-2E1620 Waukegan Rd.McGaw Park, IL 60080 |
|---|---|
| Phone:Fax: | 847 473-6078847 473-6952 |
| Contact:Date Prepared: | Ann Marie Pahlman or Robert WilkinsonFebruary 16, 1998 |
| Trade name:Common name:Classification name: | Polysynthane (PSNTM) HemodialyzerHemodialyzerHemodialysis System and Accessories per 21 CFR 876.5820 |
| Equivalent predicate: | CA® Hollow Fiber Dialyzers,PSNTM Polysynthane Dialyzers |
| Device Description: | Model PSN-130 HemodialyzerModel PSN-150 Hemodialyzer |
| Intended Use: | Intended specifically for use in patients with acute or chronic renal failure whenconservative therapy is judged to be inadequate. It may also be indicated in thetreatment of patients intoxicated with poisons or drugs. |
| Summary of thetechnologicalDialyzers. | The general function and materials of the subject PSNTM Hemodialyzers are the sameas the Baxter predicate Dialyzers with a slight change in clearance values for urea,creatinine, Vitamin B 12, and ultrafiltration similar to that of the CA® Hollow Fiber |
Clinical data: N/A
Components of the subject PSNTM Hemodialyzers have met the biological Conclusions drawn requirements of ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Guidance on slection of tests. The validation of the sterilization cycle for the PSNTM Hemodialyzer is based upon the Association for the Advancement of Medical Instrumentation (AAMI) Guideline (ST-27-Industrial Ethylene Oxide (EO) Sterilization of Medical Devices) to ensure a sterility assurance level (SAL) of 1x10 -. Prior to release, sterilant residues of EO, ECH and EG are consistent with the proposed limits for the "blood ex vivo" device category as published in the June 23, 1978 Federal Register.
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510(K) SUMMARY February 16, 1998 Polysynthane (PSNTM) Hemodialyzer Page 2 of 2
Pyrogen testing of the subject dialyzers meets the requirements of Chapter 161, Transfusion and Infusion Assemblies and Similar Medical Devices of Supplement 2 of the USP.
Particles are counted per USP XXIII <788>.
Functional testing for blood side integrity and conformance to manufacturing specifications are performed as in-process and/or final inspections prior to product release ensuring a quality product.
Additional information requested by FDA: none to date
Official Correspondent:
Robert L. Wilkinson
Robert L. Wilkinson Director Regulatory Affairs
Prepared by:
Ann Marie Dahlman
Ann Marie Pahlman Manager Regulatory Affairs
2/16/98
Date
2/16/98
Date
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Image /page/2/Picture/2 description: The image is a blank white canvas with a thin, dark line running across the top. The line is straight and appears to be a border or edge of something. The rest of the image is devoid of any other features or details.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 1998
Ms. Ann-Marie Pahlman Manager, Regulatory Affairs Baxter Healthcare Corporation 1620 Waukegan Road McGaw Park, IL 60085-6730 Re: K980658 PSN® Polysynthane Hemodialyzers Models 130 and 150 Dated: February 16, 1998 Received: February 19, 1998 Regulatory Class: II 21 CFR 876.5820/Procode: 78 FJI
Dear Ms. Pahlman:
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 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 (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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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 predication 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 80) 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/cdrb/dsmaldsmam.html",
Sincerely yours
Lillian Yin, Ph D
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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510(k) Number (if known):
Device Name: PSN Hollow Fiber Dialyzer
Indications for Use:
Hemodialysis with these dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It may also be indicated in the treatment of patients intoxicated with poisons or drugs.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Satting
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K970658
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.