(89 days)
Not Found
Not Found
No
The summary describes a hemodialyzer, a physical device for filtering blood, and makes no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is indicated for hemodialysis in patients with renal failure and for treating intoxications with poisons or drugs, which are therapeutic interventions.
No
Explanation: The device is a hemodialyzer, which is a therapeutic device used for patients with renal failure or intoxication, not for diagnosing conditions.
No
The device description explicitly lists "Hemodialyzer" models, which are hardware components used in hemodialysis. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a treatment for patients with renal failure or intoxication. This is a therapeutic intervention performed on the patient's body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a hemodialyzer, which is a medical device used to filter blood outside the body. This is a treatment device, not a diagnostic device.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or screening
- Using reagents or assays
Therefore, the information clearly indicates that this device is a therapeutic medical device used for hemodialysis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Intended specifically for use in 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
78 FJI
Device Description
Model PSN-130 Hemodialyzer
Model PSN-150 Hemodialyzer
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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 .
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
CA® Hollow Fiber Dialyzers, PSNTM Polysynthane Dialyzers
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
1 0 1998 MAY
4980658
510(K) SUMMARY
| Submitter's name:
Address: | Ann Marie Pahlman MPR A-2E
1620 Waukegan Rd.
McGaw Park, IL 60080 |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone:
Fax: | 847 473-6078
847 473-6952 |
| Contact:
Date Prepared: | Ann Marie Pahlman or Robert Wilkinson
February 16, 1998 |
| Trade name:
Common name:
Classification name: | Polysynthane (PSNTM) Hemodialyzer
Hemodialyzer
Hemodialysis System and Accessories per 21 CFR 876.5820 |
| Equivalent predicate: | CA® Hollow Fiber Dialyzers,
PSNTM Polysynthane Dialyzers |
| Device Description: | Model PSN-130 Hemodialyzer
Model PSN-150 Hemodialyzer |
| Intended Use: | Intended specifically for use in 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. |
| Summary of the
technological
Dialyzers. | The general function and materials of the subject PSNTM Hemodialyzers are the same
as 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.
1
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 .
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
2
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
3
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)