(383 days)
Not Found
Not Found
No
The summary describes a hemodialyzer and its intended use, with no mention of AI or ML technology in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is a hemodialyzer used to treat renal failure and intoxication, which qualifies it as a therapeutic device.
No
The provided text describes a hemodialyzer used for treating patients with renal failure or intoxication. It functions as a therapy device, not a diagnostic one. There is no mention of it identifying, detecting, or monitoring diseases or conditions.
No
The device description explicitly states "Models CA-170, and CA-210 Hemodialyzers," which are physical hardware components used in hemodialysis. The summary also discusses clinical data related to the performance and reuse of these dialyzers, further indicating a hardware device.
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 blood outside the body, but it's not about diagnosing a condition by analyzing a sample in vitro.
- Device Description: The device is a hemodialyzer, which is a medical device used to filter blood.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, or tissue) to provide diagnostic information about a patient's condition. The device's function is to remove waste products from the blood.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This hemodialyzer does not fit that description.
N/A
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. 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.
Product codes
78 MSF
Device Description
Models CA-170, and CA-210 Hemodialyzers
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
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
Not Found
Predicate Device(s)
CA® Cellulose Acetate Hollow Fiber Dialyzers
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”
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K970662
Page 1 of 2
.
510(K) SUMMARY
MAR III 1998
| 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:
Classification name: | CA® Cellulose Acetate Hollow Fiber Dialyzer
Hemodialyzer
High Permeability Hemodialysis System per 21 CFR 876.5860 |
| Equivalent predicate: | CA® Cellulose Acetate Hollow Fiber Dialyzers |
| Device Description: | Models CA-170, and CA-210 Hemodialyzers |
| 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 CA® 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 CA® Hemodialyer 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 asurance level (SAL) of
1 x 10-6. The validation of the sterilization cycle for the CA® Hemodialyzer is
based upon the Association for the Advancement of Medical Instrumentation
(AAMI) Guideline (ST-27-Industrial Ethylene Oxide (EtO) 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. |
1
K970662
Page 2 of 2
510(K) SUMMARY February 20, 1997 CA® Cellulose Acetate 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. Lisbinism
2/20/97
Date
Robert L. Wilkinson Director Regulatory Affairs
Prepared by:
Ann Marie Palmer
Ann Marie Pahlman Manager Regulatory Affairs
G:\510(k)\reuse\caiii\sum
2/20/97
Date
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1008
Ms. Ann Marie Pahlman Manager, Regulatory Affairs Renal Division Baxter Healthcare Corporation 1620 Waukegan Road McGaw Park, Illinois 60085-6730 Re: K970662
Multiple Use Labeling for CA® Cellulose Acetate Hollow Fiber Dialyzers - Models 170 and 210 Dated: August 11, 1997 Received: August 14, 1997 Regulatory class: III 21 CFR §876.5860/Product code: 78 MSF
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, 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 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 (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. 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 desoribed 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 (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.
W.Liau Yu
Lillian Yin, 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
3
| 510(k) Number (if known): | K970662 |
|---|---|
| --------------------------- | --------- |
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 D. Sattler
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K970661
Prescription Use
Use
(Per 21 CFR 801.109)
OR
Over-The-Counter
G:\S 10(k)\reuse\caii\indicuse