(296 days)
Not Found
No
The description focuses on the physical components and function of a hollow fiber dialyzer, with no mention of AI or ML technologies.
Yes
The device is described as being "used as part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions," which directly indicates a therapeutic purpose.
No
The device is a dialyzer, a component of an artificial kidney system used for treatment, not for diagnosis. It's designed to remove waste products from the blood, which is a therapeutic function.
No
The device description clearly describes a physical medical device (hollow fiber dialyzer) with physical components and a mechanical function (blood flow, waste removal through a membrane). There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used as part of an artificial kidney system for treating patients with renal failure or toxemic conditions. This involves directly interacting with the patient's blood extracorporeally.
- Device Description: The description details how the device filters blood outside the body, removing waste products. This is a therapeutic process, not a diagnostic one.
- Lack of Diagnostic Language: The text does not mention any diagnostic purpose, such as analyzing samples to determine a disease state or condition.
- Performance Studies: The performance studies focus on clearance rates and ultrafiltration rates, which are measures of the device's ability to filter blood, not its ability to diagnose.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The CLIRANS® T-Series Hollow Fiber Dialyzers are used to treat a condition by filtering blood, which is a therapeutic function.
N/A
Intended Use / Indications for Use
The CLIRANS® T-Series Hollow Fiber Dialyzers are devices used as part of 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. This device is indicated for single and multiple use.
Product codes (comma separated list FDA assigned to the subject device)
78 FJI and MSE
Device Description
The CLIRANS® T-Series Hollow Fiber Dialyzers consists of cellulose hollow fibers with 9μ wall thickness. Blood is pumped via a roller pump from the artery of the patient into the arterial end of the dialyzer. The blood travels down through the dialyzer fibers waste products pass through the membrane of the dialysate, which is constantly circulating through the dialyzer on the outside of the hollow fibers. Blood then exits the venous end of the dialyzer back to the patient.
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)
The performance of the CLIRANS® T-Series Hollow Fiber Dialyzers (T-Series) are substantially equivalent to the performance of the currently marketed largest effective surface area CLIRANS® TAF Hollow Fiber Dialyzer (CL*M151L). The T-Series dialyzers exhibit a somewhat higher clearance and UFR than the M151L which is to be expected with the thinner fiber walls in the T-Series dialyzer. However, none of the data raises any issues of safety or effectiveness. Therefore, the CLIRANS® T-Series Hollow Fiber Dialyzers performance are substantially equivalent to the predicate devices.
The following clearance tests were performed demonstrating the substantial equivalence of the CLIRANS® T-Series Hollow Fiber Dialyzers submitted in this 510(k) to the largest effective surface area dialyzer (CL*M151L) cleared in the CLIRANS® TAF Hollow Fiber Dialyzer 510(k) K854280.
- · Urea
- · Creatinine
- · Phosphates
- · Vitamin B12
- · UFR (In Vitro & In Vivo)
- · Priming Volume
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.
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
§ 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.
0
DEC 19 1997
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE
Proprietary Device Name: CLIRANS® T-Series Hollow Fiber Dialyzer
Classification Name: Dialyzer, Capillary, Hollow Fiber
Common Name: Hollow Fiber Dialyzer
INTENDED USE
The CLIRANS® T-Series Hollow Fiber Dialyzers are devices used as part of 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. This device is indicated for single and multiple use.
DESCRIPTION
The CLIRANS® T-Series Hollow Fiber Dialyzers consists of cellulose hollow fibers with 9μ wall thickness. Blood is pumped via a roller pump from the artery of the patient into the arterial end of the dialyzer. The blood travels down through the dialyzer fibers waste products pass through the membrane of the dialysate, which is constantly circulating through the dialyzer on the outside of the hollow fibers. Blood then exits the venous end of the dialyzer back to the patient.
SUBSTANTIAL EQUIVALENCE
The CLIRANS® T-Series Hollow Fiber Dialyzers submitted in this 510(k) are substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the largest effective surface area dialyzer (CL*M151L) cleared in the CLIRANS® TAF Hollow Fiber Dialyzer 510(k) K854280.
1
SECTION II: Summary and Certification
PRINCIPLE OF OPERATION/TECHNOLOGY
The CLIRANS® T-Series Hollow Fiber Dialyzers operate in the following manner. Blood is taken from the artery of a patient and pumped via a roller pump into the arterial end of the dialyzer. The blood travels down through the dialyzer fibers, and waste products then pass through the membrane of the dialyzer into the dialysate which is constantly circulating through the dialyzer on the outside of the hollow fibers. Blood then exits the venous end of the dialyzer, and back into the veins of the patient.
DESIGN/MATERIALS
| Parts | CLIRANS T-Series Hollow
Fiber Dialyzer | Cleared CLIRANS TAF Hollow
Fiber Dialyzer K854280 |
|-----------------------------|-------------------------------------------|------------------------------------------------------|
| Hollow Fiber | Cellulose | Cellulose |
| Housing | Acrylonitrile-Styrene copolymer | Acrylonitrile-Styrene copolymer |
| Blood Port | Polypropylene | Polypropylene |
| Screw ring | Acrylonitrile-Styrene copolymer | Acrylonitrile-Styrene copolymer |
| O-ring | Silicone rubber | Silicone rubber |
| Adhesive | Polyurethane | Polyurethane |
| Blood/Dialysate
Port cap | Polyethylene | Polyethylene |
K 170708
p. 2/4
2
SECTION II Summary and Certification
SPECIFICATIONS
| Parts | CLIRANS T-Series Hollow ·
Fiber Dialyzer | | | Cleared CLIRANS TAF
Hollow Fiber Dialyzer
K854280 - Largest Effective
Surface Area (CLM151L) |
|-------------------|---------------------------------------------|-----------|-----------|--------------------------------------------------------------------------------------------------------|
| Hollow Fiber | CLT150L | CLT175L | CLT220L | CL*M151L |
| Inside Diameter | 200μ | 200μ | 200μ | 220μ |
| Wall Thickness | 9μ | 9μ | 9μ | 12μ |
| Effective Length | 235mm | 235mm | 235mm | 235mm |
| Quantity of Fiber | 10,000pcs | 11,800pcs | 15,000pcs | 9300pcs |
| Priming Blood Vol | 101ml | 120ml | 148ml | 115ml |
| Eff. Surface Area | 1.5m² | 1.75m² | 2.2m² | 1.5m² |
PERFORMANCE
The performance of the CLIRANS® T-Series Hollow Fiber Dialyzers (T-Series) are substantially equivalent to the performance of the currently marketed largest effective surface area CLIRANS® TAF Hollow Fiber Dialyzer (CL*M151L). The T-Series dialyzers exhibit a somewhat higher clearance and UFR than the M151L which is to be expected with the thinner fiber walls in the T-Series dialyzer. However, none of the data raises any issues of safety or effectiveness. Therefore, the CLIRANS® T-Series Hollow Fiber Dialyzers performance are substantially equivalent to the predicate devices.
The following clearance tests were performed demonstrating the substantial equivalence of the CLIRANS® T-Series Hollow Fiber Dialyzers submitted in this 510(k) to the largest effective surface area dialyzer (CL*M151L) cleared in the CLIRANS® TAF Hollow Fiber Dialyzer 510(k) K854280.
- · Urea
- · Creatinine
- · Phosphates
- · Vitamin B12
- · UFR (In Vitro & In Vivo)
- · Priming Volume
3
SECTION II: Summary and Certification
ADDITIONAL SAFETY INFORMATION
Sterilization conditions have been validated according to the AAMI guidelines to provide a Sterility Assurance Level (SAL) of 10 to the negative sixth.
Ethylene oxide residuals will not exceed the maximum residue limits proposed for Part 821 of Title 21 in the Federal register of June 23, 1978 (or as finalized or amended).
Manufacturing control test methods include: functional, extraction and sterility tests.
Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing." [External Communicating Devices, Circulating Blood, Prolonged (24 hours-30 days) contact duration]. The blood contacting materials were found to be biocompatible.
The expiration dating for the CLRANS® T-Series Hollow Fiber Dialyzers will be 36 months. This dating period is adopted from legally marketed CLIRANS® TAF Hollow Fiber Dialyzer 510(k) K854280. The sterilization process and packaging materials are the same for these products. Verification testing of aged product consists of package permeability, sterility and shelf life functional testing.
CONCLUSION
The CLIRANS® T-Series Hollow Fiber Dialyzers submitted in this 510(k) are substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the largest effective surface area dialyzer (CL*M151L) cleared in the CLIRANS® TAF Hollow Fiber Dialyzer 510(k) K854280. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.
| Date Prepared | February 23, 1997 |
|---|---|
| Prepared by | Keith M. Smith |
| Senior Regulatory Affairs Specialist | |
| Regulatory Affairs | |
| Prepared for | Terumo Medical Corporation |
| 125 Blue Ball Road | |
| Elkton, MD 21921 | |
| Phone (410) 392-7375 or (410) 392-7231 | |
| Fax (410) 398-6079 |
DEC 1 9 1997
Mr. Keith M. Smith Senior Regulatory Affairs Specialist Terumo Medical Corporation Regulatory Affairs Department 125 Blue Ball Road Elkton, Maryland 21921
Re: K970708
CLIRANS® T-Series Hollow Fiber Coventional Dialyzers for Single and Multiple Use Dated: November 26, 1997 Received: November 28, 1997 Regulatory Class: II 21 CFR §876.5820/Product Code: 78 FJI and MSE
Dear Mr. Smith:
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 Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Fecteral 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 Ouality System Regulation (OS) 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 (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 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.
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
5
510(k) Number (if known):
CLIRANS® T-Series Hollow Fiber Dialyzers Device Name:
Indications For Use:
The CLIRANS® T-Series Hollow Fiber Dialyzers are devices used as part of 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. This device is indicated for single and multiple use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert D. Cathey
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K970705
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)