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.

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 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.

AI/ML Overview

The provided text describes the 510(k) submission for the DYNAMIC Hollow Fiber Dialyzer DC-Series. The study conducted is an in vitro performance comparison to predicate devices, not a clinical study involving human patients or detailed statistical analysis for AI model validation. As such, many of the requested categories are not applicable to this type of device submission.

Here's the information based on the provided text, with clarifications where data is not available or relevant:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the DYNAMIC Hollow Fiber Dialyzer DC-Series appear to be substantial equivalence to existing predicate devices (Cobe CentrySystem 160E, Baxter CF25, and Terumo Clirans T175 dialyzers) in terms of in vitro performance. The table below presents the reported performance of the DYNAMIC DC-160 and DC-190 models alongside the predicate devices. The implicit acceptance criterion is that the DYNAMIC devices' performance values are comparable to or better than those of the predicate devices.

Metric	DYNAMIC DC-160 (Reported Performance)	DYNAMIC DC-190 (Reported Performance)	TERUMO CLIRANS T1.75 (Predicate Performance)	Baxter CF25 (Predicate Performance)	COBE CentrySystem 160E (Predicate Performance)	Acceptance Criteria (Implicit)
BUN Clearance (ml/min)	185	190	192	191	-	Comparable to predicate devices (e.g., 191-192 ml/min for Terumo/Baxter)
Creatinine Clearance (ml/min)	167	179	177	170	130	Comparable to predicate devices (e.g., 130-177 ml/min)
Phosphate Clearance (ml/min)	155	155	151	159	-	Comparable to predicate devices (e.g., 151-159 ml/min)
Vitamin B12 Clearance (ml/min)	67	73	79	62	35	Comparable to predicate devices (e.g., 35-79 ml/min)
In Vitro Ultrafiltration Coefficient (ml/hr/mmHg)	7.5	8.5	8.3	6.5	4.3	Comparable to predicate devices (e.g., 4.3-8.3 ml/hr/mmHg)
Effective Surface Area (m²)	1.6	1.9	1.75	1.6	0.9	Comparable to predicate devices (e.g., 0.9-1.75 m²)
Number of Fibers	10,300	12,000	11,800	12,000	6,240	Comparable to predicate devices (e.g., 6,240-12,000)
Inner Diameter (µm)	200	200	200	200	-	Comparable to predicate devices (e.g., 200 µm)
Wall Thickness (µm)	8	8	9	8	8	Comparable to predicate devices (e.g., 8-9 µm)
Sterilization Method	ETO	ETO	ETO	ETO	ETO	Same sterilization method as predicate devices (ETO)
Priming Volume (ml)	91	104	123	112	42	Comparable to predicate devices (e.g., 42-123 ml)
Max. TMP (mmHg)	500	500	500	500	-	Comparable to predicate devices (e.g., 500 mmHg)

The conclusion states: "The result indicates that the proposed device is substantially equivalent to Terumo Clirans T175 and Baxter CF25 for in vitro performance." This indicates that the reported values were determined to be within an acceptable range of the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a distinct "test set" sample size in terms of number of dialyzers tested. The data presented are reported performance metrics, likely averages or representative values from multiple measurements.
Data Provenance: The study was an "in vitro performance" study conducted by Dynamic Technology Corporation, located in Hsinchu, Taiwan, R.O.C. The data are therefore laboratory-generated, not from patient studies. It is retrospective in the sense that it compares new device data to established data from predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable as the study involved in vitro performance testing of a physical device, not an AI model or clinical assessment requiring expert human interpretation for "ground truth." The "ground truth" here is the measured physical performance parameters of the device as per standard laboratory protocols for dialyzer testing.

4. Adjudication Method for the Test Set

Not applicable. There was no need for adjudication as the study measured objective physical parameters in an in vitro setting.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI device, and no MRMC study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI device or algorithm. The performance described is of the physical device itself.

7. The Type of Ground Truth Used

The "ground truth" for this study is based on in vitro measurements and established engineering/medical device performance standards for clearance rates, ultrafiltration, and physical characteristics of dialyzers. This is an objective measurement of device function in a laboratory setting. The comparison is made against the reported performance of predicate devices which would have been established through similar in vitro testing.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device trained on a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI device, so there is no training set or associated ground truth establishment process in the context of machine learning.

Summary

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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).

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.

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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.

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Model	DYNAVICDC-160	DYNAMICDC-190	TERUMOCLIRANST1.75	BaxterCF25	COBECentrySystem160E
BUNClearance (ml/min)	185	190	192	191	-
CreatinineClearance (ml/min)	167	179	177	170	130
PhosphateClearance (ml/min)	155	155	151	159	-
Vitamin B12Clearance (ml/min)	67	73	79	62	35
In Vitro UltrafiltrationCoefficient (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	-

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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

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510(k) Number (if known): K973291 Device Name: DYNAMIC Hollow Fiber Dialyzer DC-Series Indications For Use:

(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 .

1 Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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.