(108 days)
None
K8G4831
No
The summary describes a hollow fiber dialyzer, a mechanical device for hemodialysis. There is no mention of AI, ML, or any software-driven analytical capabilities. The performance studies focus on in vitro clearances and ultrafiltration, which are standard metrics for dialyzer function.
Yes
The device is indicated for use in patients with acute or chronic renal failure, and its function involves hemodialysis to treat this medical condition, which is a therapeutic intervention.
No
Explanation: The device is a dialyzer used for hemodialysis in patients with renal failure. It performs a treatment function (removing waste products from blood) rather than diagnosing a condition. The performance studies measure clearances and ultrafiltration, which are related to the device's therapeutic function, not diagnostic capabilities.
No
The device description clearly details physical components like hollow fibers, blood inlet/exit ports, and membranes, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. They perform tests outside the body.
- Device Function: The description clearly states that this device is a "Hollow Fiber Dialyzer." Dialyzers are used in hemodialysis, a process where blood is filtered outside the body to remove waste products and excess fluid when the kidneys are not functioning properly. The blood is returned to the patient's body after filtration.
- Intended Use: The intended use is for patients in "acute or chronic renal failure and hemodialysis is prescribed." This is a treatment for a medical condition, not a diagnostic test performed on a specimen.
- Performance Studies: The performance studies focus on "clearances" (how effectively waste products are removed from the blood) and "ultrafiltration coefficient" (how effectively fluid is removed). These are measures of the device's ability to perform its filtering function, not diagnostic measurements of substances in a specimen.
Therefore, based on the provided information, the DYNAMIC Hollow Fiber Dialyzer DC-Series is a therapeutic device used for hemodialysis, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DYNAMIC Hollow Fiber Dialyzer DC-Series are indicated for use whenever a patient is in acute or chronic renal failure and hemodialysis is prescribed by a physician. Therefore, use of this device should be only on the direction of a physician who has evaluated all of the aspects of the patient's illness.
Product codes
78 FJI
Device Description
The membrane used in this device which is substantially equivalent to the membranes utilized in the Cobe CentrySystem 160E and Baxter CF25 Dialyzers, which have been previously approved under a 510(k) Notification (K8G4831).
Blood enters a blood inlet port where it is distributed to hollow fibers. Each hollow fiber has an inner diameter of 200 microns and a wall thickness of 8 microns. The fibers used in this device are substantially equivalent in design to the previously approved Cobe CentrySystem 160E Dialyzers. The wall thickness of the hollow fibers in Cobe CentrySystem 160E Dialyzers, Baxter CF25 Dialyzers and the proposed device is 8 microns. The inner diameter of hollow fibers in both Baxter CF25 Dialyzers and the proposed device is 200 microns. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port.
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
In vitro testing was performed on the proposed device to determine the following: BUN, creatinine, phosphate, and vitamin B12 clearances, and ultrafiltration coefficient. The results are listed on the next page with the data from the predicate devices. The result indicates that the proposed device is substantially equivalent to Terumo Clirans T175 and Baxter CF25 for in vitro performance.
Key Metrics
BUN Clearance (ml/min): DYNAMIC DC-160 - 185, DYNAMIC DC-190 - 190, TERUMO CLIRANS T1.75 - 192, Baxter CF25 - 191
Creatinine Clearance (ml/min): DYNAMIC DC-160 - 167, DYNAMIC DC-190 - 179, TERUMO CLIRANS T1.75 - 177, Baxter CF25 - 170
Phosphate Clearance (ml/min): DYNAMIC DC-160 - 155, DYNAMIC DC-190 - 155, TERUMO CLIRANS T1.75 - 151, Baxter CF25 - 159
Vitamin B12 Clearance (ml/min): DYNAMIC DC-160 - 67, DYNAMIC DC-190 - 73, TERUMO CLIRANS T1.75 - 79, Baxter CF25 - 62
In Vitro Ultrafiltration Coefficient (ml/hr/mmHg): DYNAMIC DC-160 - 7.5, DYNAMIC DC-190 - 8.5, TERUMO CLIRANS T1.75 - 8.3, Baxter CF25 - 6.5
Predicate Device(s)
Cobe CentrySystem 160E, Baxter CF25, Terumo Clirans T175 Dialyzers
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Kevised
510(K) SUMMARY 510(K) NUMBER: K973291 SUBMITTER: Dynamic Technology Corporation 2F, No. 53, Park Ave. II Sciencc-Based Industrial Park Hsinchu Taiwan, R.O.C DATE PREPARED: October 8, 1997 DEVICE NAME. I >YNAMIC Hollow Fiber Dialyzer DC-Series PREDICATE DEVICES: Cobe CentrySystem 160E. Baxter CF25, Terumo Clirans T175 Dialyzers
Device Description
The membranc used in this device which is substantially equivalent to the membranes utilized in the Cobe CentrySystem 160E and Baxter CF25 Dialyzers, which have been previously approved under a 510(k) Notification (K8G4831).
Blood enters a blood inlet port where it is distributed to hollow fibers. Each hollow fiber has an inner diameter of 200 microns and a wall thickness of 8 microns. The fibers used in this device are substantially equivalent in design to the previously approved Cobe CentrySystem 160E Dialyzers. The wall thickness of the hollow fibers in Cobe CentrySystem 160)E Dialyzers, Baxter CF25 Dialyzers and the proposed device is 8 microns. The inner diameller of hollow fibers in both Baxter CF25 Dialyzers and the proposed device is 200 microns. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port.
Predicate Devices
The DYNAMIC Hollow Fiber Dialyzer DC-Series Dialyzers are substantially equivalent in construction, design, intended use, and function to other hemodialyzers currently marketed in the United States. The DYNAMIC Hollow Fiber Dialyzer U.C.Series Dialyzers are substantially equivalent in finneritor design, and operation to the Cube CentrySystem 160E, Baxter CF25, and Terumo Clirans T17.5 Dialyzers, Which have been previously approved for marketing in the United States.
1
Interided Use
The DYNAMIC Hollow Fiber Dialyzer DC-Series are indicated for use whenever a patient is in acute or chronic renal failure and hemodialysis is prescribed by a physician. Therefore, use of the device should be urily on direction of a physician who has evaluated all of the aspects of the patient's illness. The indication statcment is essentially the same as the indication statement of the predicate devices.
Technological Characteristics
Comparing the proposed device to the predicate devices, some similarities are noted in the design and materials employed to accomplish the same intended usc. Both the proposed device and Cobe CentrySystem 160E Dialyzers utilize the same hollow fiber membrane. Both the proposed device and Cobe CentrySystem 160E Dialyzers utilize polycarbonate for the header material and polyurelhane for the membrane potting material. The proposed devices are sterilized by ethylene oxide gas.
In Vitro Pertormance
In vitro testing was performed on the proposed device to determine the following: BUN, creatinine, phosphate, and vitamin B12 clearances, and ultrafiltration coefficient. The results are listed on the next page with the data from the predicate devices. The rosult indicates that the proposed device is substantially equivalent to Terumo Clirans T175 and Baxter CF25 tor in vitro performance
Coriclusions
Testing performed on the DYNAMIC Hollow Fiber DC-Series indicated that it is safe, effective, and performs as well as the predicate devices, when used in accordance with the instructions for use.
2
| œ |
|---|
| 2 mar |
| 4 |
| 1 |
| œ |
j
| Model | DYNAVIC
DC-160 | DYNAMIC
DC-190 | TERUMO
CLIRANS
T1.75 | Baxter
CF25 | COBE
CentrySystem
160E |
|------------------------------------------------------|-------------------|-------------------|----------------------------|----------------|------------------------------|
| BUN
Clearance (ml/min) | 185 | 190 | 192 | 191 | - |
| Creatinine
Clearance (ml/min) | 167 | 179 | 177 | 170 | 130 |
| Phosphate
Clearance (ml/min) | 155 | 155 | 151 | 159 | - |
| Vitamin B12
Clearance (ml/min) | 67 | 73 | 79 | 62 | 35 |
| In Vitro Ultrafiltration
Coefficient (ml/hr/mmHg) | 7.5 | 8.5 | 8.3 | 6.5 | 4.3 |
| Effective Surface Area (m²) | 1.6 | 1.9 | 1.75 | 1.6 | 0.9 |
| Number of Fibers | 10,300 | 12,000 | 11,800 | 12,000 | 6,240 |
| Inner Diameter (µm) | 200 | 200 | 200 | 200 | - |
| Wall Thickness (µm) | 8 | 8 | 9 | 8 | 8 |
| Sterilization Method | ETO | ETO | ETO | ETO | ETO |
| Priming Volume (ml) | 91 | 104 | 123 | 112 | 42 |
| Max. TMP (mmHg) | 500 | 500 | 500 | 500 | - |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is oriented to follow the curve of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 19 1997
Dynamic Technology Corporation c/o Eric Luo, Ph.D. 6833 Saint Lawrence Street Plano, Texas 75024
Re: K973291
DYNAMIC DC-160 and DC-190 Hollow Fiber Hemodialyzers Dated: November 10, 1997 Received: November 18, 1997 Regulatory Class: II 21 CFR §876.5820/Product Code: 78 FJI
Dear Dr. Luo:
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 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 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. 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.
Sincerely yours,
William Yun
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
4
510(k) Number (if known): K973291 Device Name: DYNAMIC Hollow Fiber Dialyzer DC-Series Indications For Use:
The DYNAMIC Hollow Fiber Dialyzer DC-Series are indicated for use whenever a patient is in acute or chronic renal failure and hemodialysis is prescribed by a physician. Therefore, use of this device should be only on the direction of a physician who has evaluated all of the aspects of the patient's illness.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert D. Anthony
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .
OR
1 Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)