(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. These dialyzers are 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.
Model CAHP-90 Hemodialyzer
The provided text describes specific acceptance criteria and the study that proves the device meets those criteria.
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biological Safety (USP XXI Class VI materials) | All patient contact components of the subject CAHP™ Hemodialyzer have previously met the biological requirements of the guidelines for safety screening of materials for USP XXI Class VI materials. |
| Sterility Assurance Level (SAL) of 1 x 10-6 | Sterilized by the Nissho corporation using Ethylene Oxide Gas (EtO) to a sterility assurance level (SAL) of 1 x 10-6. Validation based upon AAMI Guideline (ST-27-Industrial Ethylene Oxide (EO) Sterilization of Medical Devices). |
| Sterilant Residues (EtO, ECH, EG) | Sterilant residues of EtO, 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 (JMHW Notification No. 494 and Japanese Pharmacopeia "Pyrogen test") | Pyrogen testing meets the requirements of JMHW Notification No. 494, "Approval Requirements for Dialyzers" and the Japanese Pharmacopeia "Pyrogen test." |
| Particles (USP 23 <788> for LVI solutions and ASTM F25-68) | Particles are compared to USP 23 <788> limits for Large Volume Injections (LVI) solutions and ASTM F25-68. |
| Functional Testing (Blood side integrity and manufacturing specifications conformance) | 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 included in the labeling | In Vivo and In Vitro performance data, and directions for reuse have been included in the labeling. This indicates that the necessary data and instructions are available, implying the device performs as expected for both single-use and reuse scenarios. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample size for a "test set" in the context of device performance. The clinical data was collected "according to the FDA Guidance for Hemodialyzer Reuse Labeling," which suggests a prospective clinical study, though the exact nature (e.g., number of patients) is not provided. The origin of the clinical data is not specified. Other tests, like pyrogen testing, refer to JMHW Notification (Japanese) and Japanese Pharmacopeia, implying that some testing relates to Japanese regulatory standards, but doesn't specify if the samples themselves were from Japan.
3. 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):
This information is not provided in the document. The document describes compliance with established standards and guidelines (e.g., USP, AAMI, FDA guidance, Japanese Pharmacopeia) for device testing, rather than a system where human experts establish ground truth for a discrete test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. The document outlines a typical regulatory submission for a medical device involving adherence to performance standards and safety guidelines, not a comparative study relying on expert adjudication of a test set.
5. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device, a hemodialyzer, is a piece of medical equipment, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This concept is not applicable to the device described. The hemodialyzer is a physical device used in treatment, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is established by adherence to documented performance standards and regulatory guidelines rather than a clinical ground truth like pathology or outcomes data in the typical sense of diagnostic devices. For example:
- Biological safety: Compliance with USP XXI Class VI materials.
- Sterility: Achieved SAL of 1 x 10-6 validated by AAMI guidelines.
- Pyrogenicity: Meeting standards of JMHW Notification and Japanese Pharmacopeia.
- Particle limits: Comparison to USP 23 <788> and ASTM F25-68.
- Functional integrity: Conformance to manufacturing specifications.
- Clinical performance: Demonstrated by "In Vivo and In Vitro performance data" and compliance with "FDA Guidance for Hemodialyzer Reuse Labeling."
8. The sample size for the training set:
Not applicable. The CAHP™ Hemodialyzer is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
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X776654
Page 1 of 2
510(K) SUMMARY
NOV 1 2 1997
| 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 20, 1997 |
| Trade name:Common name: | CAHP™ High Performance Cellulose Diacetate Hollow Fiber DialyzerHemodialyzer |
| Classification name: | Hemodialysis System and Accessories per 21 CFR 876.5820 |
| Equivalent predicate: | CAHP™ High Performance Cellulose Diacetate Hollow Fiber Dialyzers |
| Device Description: | Model CAHP-90 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 CAHP™ 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 CAHP™ 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 10-6. The validation of the sterilization cycle for the CAHP™ Hemodialyzer isbased upon the Association for the Advancement of Medical Instrumentation(AAMI) Guideline (ST-27-Industrial Ethylene Oxide (EO) 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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Page 2 of 2
510(K) SUMMARY February 20, 1997 February 20, 1997
CAHP™ High Performance Cellulose Diacetate Hollow Fiber Dialyzers Page 2 of 2
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
Robert L. Wilkinson Director Regulatory Affairs
Prepared by:
Ann Marie Grace
Ann Marie Pahlman Manager Regulatory Affairs
G:\510(k)\reuse\cahpii\sum
2/20/97
Date
2/20/97
Date
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle.
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: K970654
Multiple Use Labeling for CAHP™ Cellulose Diacetate Hollow Fiber Dialyzer - Model 90 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 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 Aproval), 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally market 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 (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/dsmamain.html".
Sincerely yours
William 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):
CAHPTM High Performance Cellulose Diacetate 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. These dialyzers are 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 D. Talley
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_1970
Prescription Use /
Use
(Per 21 CFR 801.109)
OR
Over-The-Counter
G:1510(k)\reuse\cahp\i\indicuse
§ 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.