(264 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. This dialyzer is indicated for single use or reuse. If the dialyzer is reused on the same patient, the reuse procedure and disinfectant specified in the Direction Insert must be followed. No other reuse procedure or disinfectant has been evaluated for clinical acceptability.
Models CA-90, CA-110, CA-130, and CA-150 Hemodialyzers
The provided text describes a 510(k) summary for the CA® Cellulose Acetate Hollow Fiber Dialyzer. The information focuses on the device's equivalence to a predicate device and its compliance with various standards and regulations. However, it does not contain the specific details required to answer your questions about acceptance criteria, device performance from a test set, ground truth establishment, or studies showing performance metrics as typically expected for AI/ML device evaluations.
This document is for a medical device (hemodialyzer) from 1997, which predates many of the standardized evaluation methodologies common for AI/ML-driven devices. Therefore, the information you're requesting regarding "acceptance criteria and reported device performance" (with specific metrics like sensitivity, specificity), "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication methods," "MRMC studies," "standalone performance," "type of ground truth," "sample size for training set," and "how ground truth for training set was established" is not present in the provided text.
The closest analogue to "acceptance criteria" and "device performance" in this document refers to how the device meets biological requirements, sterilization levels, residue limits, pyrogen testing, particle limits, and functional testing against manufacturing specifications, rather than performance in detecting a condition or making a diagnosis. The study mentioned, "Clinical data was collected according to the FDA Guidance for Hemodialyzer Reuse Labeling," is focused on the reuse aspect, not on a diagnostic or AI-driven performance metric.
Given the nature and age of the document, it's not possible to extract the information you've requested in the format applicable to modern AI/ML device evaluations.
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K970661 PAGE 1 OF 2
510(K) SUMMARY
NOV I 2 1997
| Submitter's name: | Ann Marie Pahlman MPR A-2E |
|---|---|
| Address: | 1620 Waukegan Rd.McGaw Park, IL 60080 |
| Phone: | 847 473-6078 |
| Fax: | 847 473-6952 |
| Contact: | Ann Marie Pahlman or Robert Wilkinson |
| Date Prepared: | February 20, 1997 |
| Trade name: | CA® Cellulose Acetate Hollow Fiber Dialyzer |
| Common name: | Hemodialyzer |
| Classification name: | Hemodialysis System and Accessories per 21 CFR 876.5820 |
| Equivalent predicate: | CA® Cellulose Acetate Hollow Fiber Dialyzers |
| Device Description: | Models CA-90, CA-110, CA-130, and CA-150 Hemodialyzers |
| 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 CA® Hemodialyzers areidentical to the Baxter predicate Dialyzers. |
| Clinical data: | Clinical data was collected according to the FDA Guidance for Hemodialyzer ReuseLabeling. |
| Conclusions drawn | All patient contact components of the subject CA® Hemodialyzer have previouslymet the biological requirements of the guidelines for safety screening of materialsfor USP XXI Class VI materials. These Dialyzers are sterilized by the Nisshocorporation using Ethylene Oxide Gas (EtO) to a sterility assurance level (SAL) of1 x 106. The validation of the sterilization cycle for the CA® Hemodialyzer isbased upon the Association for the Advancement of Medical Instrumentation(AAMI) Guideline (ST-27-Industrial Ethylene Oxide (EtO) Sterilization of MedicalDevices). Prior to release, sterilant residues of EtO, ECH and EG are consistent withthe proposed limits for the "blood ex vivo" device category as published in theJune 23, 1978 Federal Register. |
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K970662 PAGE 2 OF 2
510(K) SUMMARY February 20, 1997 CA® Cellulose Acetate Hollow Fiber Dialyzers Page 2 of 2
'ﺩ ﮨﯽ
Pyrogen testing meets the requirements of JMHW Notification No. 494, "Approval Requirements for Dialyzers" and the Japanese Pharmacopeia "Pyrogen test."
Particles are compared to USP 23 <788> limits for Large Volume Injections (LVI) solutions and ASTM F25-68.
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.
In Vivo and In Vitro performance data, and directions for reuse have been included in the labeling.
Additional information requested by FDA: none to date
Official Correspondent:
Robert L. Robinson
2/20/97
Date
Robert L. Wilkinson Director Regulatory Affairs
Prepared by:
Jan Marie Lane
Ann Marie Pahlman Manager Regulatory Affairs
2/20/97
Date
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nov 1 2 1997
Ms. Ann Marie Pahlman Manager, Regulatory Affairs Renal Division Baxter Healthcare Corporation 1620 Waukegan Road McGaw Park, Illinois 60085-6730
Re: K970661
Multiple Use Labeling for CA® Cellulose Acetate Hollow Fiber Dialyzers - Models 90, 110, 130, and 150 Dated: August 11, 1997 Received: August 14, 1997 Regulatory class: II 21 CFR §876.5820/Product code: 78 MSE
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 (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 requirement, 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 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 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 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/dsmamain.html".
Sincerely yours.
William Yu, Ph.D.
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): K970661
CA Cellulose Acetate Hollow Fiber Dialyzers Device Name:
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. This dialyzer is indicated for single use or reuse. If the dialyzer is reused on the same patient, the reuse procedure and disinfectant specified in the Direction Insert must be followed. No other reuse procedure or disinfectant has been evaluated for clinical acceptability.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert P. Aethurg/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use
Use
(Per 21 CFR 801.109)
OR
Over-The-Counter
G: S 10(k) reuse cainindicuse
§ 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.