Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a hemodialyzer and its intended use, with no mention of AI or ML technology in the device description, intended use, or performance studies.

Therapeutic

Yes
The intended use statement explicitly states the device is for hemodialysis in patients with renal failure and for treating intoxications, which are therapeutic interventions.

Diagnostic

No
Explanation: The device is a hemodialyzer used for treating patients with renal failure or intoxication, which is a therapeutic function rather than a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly states "Model CAHP-90 Hemodialyzer," which is a physical medical device (a dialyzer). The summary also discusses clinical data related to hemodialyzer reuse, further indicating a hardware component. There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a device used for hemodialysis, which is a treatment performed on a patient's blood outside the body to remove waste products and excess fluid. This is a therapeutic procedure, not a diagnostic test performed on samples in vitro (in a lab setting).
Device Description: The device is described as a "Hemodialyzer," which is consistent with a device used for hemodialysis.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or determine a patient's health status. The focus is on filtering the blood for therapeutic purposes.

Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

78 MSE

Device Description

Model CAHP-90 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 was collected according to the FDA Guidance for Hemodialyzer Reuse Labeling.
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 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.

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.

Not Found

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

Regulation Number and Section

§ 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.

Summary

0

X776654
Page 1 of 2

510(K) SUMMARY

NOV 1 2 1997

| 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 20, 1997 |
| Trade name:
Common name: | CAHP™ High Performance Cellulose Diacetate Hollow Fiber Dialyzer
Hemodialyzer |
| 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 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
predicate device: | The general function and materials of the subject CAHP™ Hemodialyzers are
identical to the Baxter predicate Dialyzers. |
| Clinical data: | Clinical data was collected according to the FDA Guidance for Hemodialyzer Reuse
Labeling. |
| Conclusions drawn | 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. These Dialyzers are sterilized by the Nissho
corporation using Ethylene Oxide Gas (EtO) to a sterility assurance level (SAL) of
1 x 10-6. The validation of the sterilization cycle for the CAHP™ Hemodialyzer is
based upon the Association for the Advancement of Medical Instrumentation
(AAMI) Guideline (ST-27-Industrial Ethylene Oxide (EO) Sterilization of Medical
Devices). Prior to release, 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. |

, Í

1

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 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

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

3

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