(383 days)
Not Found
Not Found
No
The document describes a hemodialyzer, a physical medical device for filtering blood. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device, a hemodialyzer, is explicitly indicated for treating patients with acute or chronic renal failure, and for those intoxicated with poisons or drugs. These are conditions that therapy seeks to treat or manage, making the device therapeutic.
No
Explanation: The device, a hemodialyzer, is used for treatment of renal failure and intoxication, not for diagnosing conditions.
No
The device description explicitly states "Models CAHP-110, CAHP-130, CAHP-150, CAHP-170, CAHP-210 Hemodialyzers," which are physical medical devices (dialyzers) used in hemodialysis. The summary also discusses performance studies related to these physical dialyzers and their reuse. 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 clearly describes a device used for hemodialysis, a process that filters blood outside the body to treat renal failure and intoxication. This is a therapeutic procedure performed on the patient's blood, not a diagnostic test performed on a sample in vitro (in a lab).
- Device Description: The device is described as a "Hemodialyzer," which is a component of a hemodialysis machine.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.) to detect a disease or condition.
- Providing information for diagnosis, monitoring, or prognosis.
- Using reagents or assays.
Therefore, this device falls under the category of a therapeutic medical device, 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. 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
78 MSF
Device Description
Models CAHP-110, CAHP-130, CAHP-150, CAHP-170, CAHP-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)
CAHPTM High Performance Cellulose Diacetate 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.”
0
K970653 PAGE 1 OF 2
:
510(K) SUMMARY
| Submitter's name: | Ann Marie Pahlman MPR A-2E
1620 Waukegan Rd.
McGaw Park, IL 60080 | MAR 11 1998 |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Phone: | 847 473-6078 | |
| Fax: | 847 473-6952 | |
| Contact: | Ann Marie Pahlman or Robert Wilkinson
February 20, 1997 | |
| Trade name: | CAHPTM High Performance Cellulose Diacetate Hollow Fiber Dialyzer | |
| Common name: | Hemodialyzer | |
| Classification name: | High Permeability Hemodialysis System per 21 CFR 876.5860 | |
| Equivalent predicate: | CAHPTM High Performance Cellulose Diacetate Hollow Fiber Dialyzers | |
| Device Description: | Models CAHP-110, CAHP-130, CAHP-150, CAHP-170, CAHP-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 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™ 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 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 (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. | |
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,
1
510(K) SUMMARY 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. Wilkinson
Robert L. Wilkinson Director Regulatory Affairs
2/20/97
Date
Prepared by:
Ann Marie Pahlman
G:\510(k)\reuse\cahpii\sum
Manager Regulatory Affairs
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR | | 10008
Ms. Ann Marie Pahlman Manager, Regulatory Affairs Renal Division Baxter Healthcare Corporation 1620 Waukegan Road McGaw Park, Illinois 60085-6730 Re: K970653
Multiple Use Labeling for CAHPTM High Performance Cellulose Diacetate Hollow Fiber Dialyzers Models 110, 130, 150, 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 and we have determined the device is substantially equivalent for the stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical 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 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. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification 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(x) 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 yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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 vours.
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
3
Image /page/3/Picture/2 description: The image shows the text "510(k) Number (if known):" followed by the number K970653. The number is written in a bold, handwritten style. The text indicates that this is a 510(k) number, which is a premarket submission made to the FDA to demonstrate that the device to be marketed is as safe and effective as a legally marketed device.
CAHPIM 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)
| (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
|---|---|
| 510(k) Number | K970653 |
| Prescription Use | OR | Over-The-Counter |
|---|---|---|
| Use | ||
| (Per 21 CFR 801.109) |
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