(419 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-120 PSN Hemodialyzer
Model PSN-140 PSN Hemodialyzer
Here's an analysis of the provided documents regarding the Polysynthane (PSN) Hemodialyzer, focusing on the acceptance criteria and the study that proves the device meets these criteria.
It's important to note that the provided documents are a 510(k) summary and an FDA clearance letter from 1996/1997. This type of submission generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive clinical trial with detailed acceptance criteria and performance metrics for an entirely novel device. Therefore, much of the requested information, particularly regarding specifics of clinical studies, AI performance, and expert ground truth, is not present or applicable.
Acceptance Criteria and Device Performance
The acceptance criteria for the Polysynthane (PSN) Hemodialyzer are derived from demonstrating equivalence to predicate devices and meeting established safety and performance standards for hemodialyzers. The "reported device performance" columns below reflect how the device was shown to meet these criteria, primarily through bench testing and adherence to existing standards rather than clinical study outcomes.
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance |
|---|---|---|
| Biocompatibility | USP XXI Class VI materials guidelines | Components (excluding fiber bundle) previously met USP XXI Class VI. |
| ISO 10993-1: Biological Evaluation of Medical Devices - Part 1 | Fiber bundle tested as suggested by ISO 10993-1 guidelines. | |
| Sterilization | AAMI Guideline (ST-27) for industrial EO | Validation of sterilization cycle to ensure SAL of 1x10^-6. |
| Sterilant Residues (EO, ECH, EG) | Residues consistent with proposed limits for "blood ex vivo" device category. | |
| Pyrogenicity | USP Chapter 161 (Transfusion and Infusion Assemblies and Similar Medical Devices) | Subject bloodlines meet requirements of USP Chapter 161. |
| Particulate Matter | USP 23 limits for Large Volume Injections (LVI) solutions | Particles compared to and implied to meet USP 23 limits. |
| Integrity & Manufacturing Specifications | In-process and/or final inspections | Functional testing for blood side integrity and conformance to manufacturing specifications performed. |
| Functional Performance (Clearances) | Equivalence to predicate dialyzers | Slight changes in clearance values for urea, creatinine, and Vitamin B12 compared to predicate, but still considered substantially equivalent. The specific values demonstrating equivalence are not provided in the summary. |
Note: The 510(k) summary explicitly states "Clinical data: N/A". This indicates that the regulatory clearance was not based on a clinical study demonstrating patient outcomes or comparative effectiveness in a clinical setting. Instead, it relied on bench testing, material compatibility, and adherence to established performance standards for similar devices.
Study Details
Given that the "Clinical data" section is marked as "N/A" and the submission is a 510(k) summary for a hemodialyzer, many of the requested details about human-in-the-loop studies, ground truth establishment by experts, and sample sizes for clinical trials are not applicable. The "study" here refers to the non-clinical testing and validation summarized in the document.
1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified in terms of clinical subjects. For non-clinical tests (material, sterilization, pyrogenicity, etc.), the sample sizes would refer to the number of device units or material samples tested, which are not detailed in this summary.
- Data Provenance: Not specified. Testing for biocompatibility, sterility, etc., would typically be conducted in laboratories adhering to relevant standards.
2. 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)
- Not Applicable. The ground truth for this medical device submission is established through adherence to recognized international and national standards (e.g., USP, ISO, AAMI) for material safety, sterilization efficacy, and physical performance. It does not involve expert consensus on clinical diagnoses or interpretations in the way AI/radiology devices might.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical or image-based studies where expert consensus is needed. For this device, "ground truth" is determined by empirical measurements against pre-defined physical, chemical, and biological standards.
4. 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
- No. This is a hemodialyzer, not an AI-assisted diagnostic or assistive tool. MRMC studies are not relevant to its type of evaluation.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this device's submission is derived from:
- Validated Standards: Meeting specifications outlined in USP, ISO, AAMI guidelines for material biocompatibility, sterility, and pyrogenicity.
- Bench Test Results: Direct measurements of physical integrity and clearance characteristics.
- Equivalence to Predicate: Comparison of performance characteristics (like clearance values) to legally marketed predicate devices to establish substantial equivalence.
7. The sample size for the training set
- Not Applicable. This is a physical medical device, not an algorithm that requires a training set.
8. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
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510(K) SUMMARY
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| Submitter's name: | Ann Marie Pahlman MPR A-2E |
|---|---|
| Address: | 1620 Waukegan Rd.McGaw Park, IL 60080 |
| NOV 24 1997 | |
| Phone: | 847 473-6078 |
| Fax: | 847 473-6952 |
| Contact: | Ann Marie Pahlman or Robert Wilkinson |
| Date Prepared: | September 20, 1996 |
| Trade name: | Polysynthane (PSN) Hemodialyzer |
| Common name: | Hemodialyzer |
| Classification name: | Hemodialysis System and Accessories per 21 CFR 876.5820 |
| Equivalent predicate: | CF Capillary Flow Dialyzers, CA Cellulose Acetate Hollow Fiber Dialyzers,HT Hollow Fiber Dialyzers |
| Device Description: | Model PSN-120 PSN HemodialyzerModel PSN-140 PSN 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 thetechnologicalpredicate device: | The general function and materials of the subject PSN Hemodialyzers are the sameas the Baxter predicate Dialyzers. Differences in the subject PSN Hemodialyzersto the predicate Baxter Dialyzers consist of a change in the fiber bundle materialand a slight change in clearance values for urea, creatinine and Vitamin B 12. |
| Clinical data: | N/A |
| Conclusions drawnfrom tests: | Components of the subject PSN Hemodialyzers, with the exception of the fiberbundle, have previously met the biological requirements of the guidelines for safetyscreening of materials for USP XXI Class VI materials. The fiber bundle was testedas suggested by to ISO 10993-1: Biological Evaluation of Medical Devices - Part 1.guidelines. The validation of the sterilization cycle for the PSN Hemodialyzer isbased upon the Association for the Advancement of Medical Instrumentation(AAMI) Guideline (ST-27-Industrial Ethylene Oxide (EO) Sterilization of MedicalDevices) to ensure a sterility assurance level (SAL) of 1x106. Prior to release,sterilant residues of EO, ECH and EG are consistent with the proposed limitsfor the "blood ex vivo" device category as published in the June 23, 1978Federal Register. |
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14963933 Proj2
510(K) SUMMARY September 20, 1996 Polysynthane (PSN) Hemodialyzer Page 2 of 2
Pyrogen testing of the subject bloodlines meets the requirements of Chapter 161, Transfusion and Infusion Assemblies and Similar Medical Devices of Supplement 2 of the USP.
Particles are compared to USP 23 limits for Large Volume Injections (LVI) solutions.
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 Pahlman
Ann Marie Pahlman Manager Regulatory Affairs
9/23/96
Date
9/23/94
Date
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Image /page/2/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 often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is simple and recognizable, representing the department's role in promoting health and well-being in the United States.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ann Marie Pahlman Manager, Regulatory Affairs Renal Division Baxter Healthcare Corporation 1620 Waukegan Road McGaw Park, Illinois 60085-6730 Re: K963933 PNS Hollow Fiber Dialyzer - Models 120 and 140 Dated: October 21, 1997 NOV 2 4 1997 Received: October 23, 1997 Regulatory class: II 21 CFR §876.5820/Product code: 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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 requirement, as set forth in the Quality System Regulation (QS) 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 does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 vour 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 (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally. for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation wititled, "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/dsmamain.html".
Sincerely yours,
W.Liau Yu
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:
ﻟﻤﺴﻠﺴ
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 D. Sutherlin/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K 9
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.