The DYNAMIC Hollow Fiber Dialyzer DS-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

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 40 microns. The fibers used in this device which is substantially equivalent to the fibers utilized in the Minntech Primus™ Hollow Fiber Dialyzer (K923727), Fresenius Hemoflow HF Dialyzer (K870724), and Minntech Renaflo™ HDF Hemodiafilter (K910236), which have been previously approved under a 510(k) Notification. The wall thickness of the hollow fibers in Minntech Primus™ Hollow Fiber Dialyzer, Fresenius Hemoflow HF Dialyzer, and the proposed device is 40 microns. The inner diameter of hollow fibers in predicate devices 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

Here's an analysis of the provided text regarding the DYNAMIC Hollow Fiber Dialyzer DS-Series, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list "acceptance criteria" with specific numerical thresholds for each performance metric. Instead, the study aims to demonstrate substantial equivalence to predicate devices. The performance is reported in terms of achievement of this equivalence.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Urea Clearance	Substantially equivalent to Minntech Primus™ 2000 & Fresenius Hemoflow HF80 Dialyzer	Device is substantially equivalent to predicate devices.
Creatinine Clearance	Substantially equivalent to Minntech Primus™ 2000 & Fresenius Hemoflow HF80 Dialyzer	Device is substantially equivalent to predicate devices.
Phosphate Clearance	Substantially equivalent to Minntech Primus™ 2000 & Fresenius Hemoflow HF80 Dialyzer	Device is substantially equivalent to predicate devices.
Vitamin B12 Clearance	Substantially equivalent to Minntech Primus™ 2000 & Fresenius Hemoflow HF80 Dialyzer	Device is substantially equivalent to predicate devices.
Ultrafiltration Coefficient	Substantially equivalent to Minntech Primus™ 2000 & Fresenius Hemoflow HF80 Dialyzer	Device is substantially equivalent to predicate devices.
Sieving Coefficient	Substantially equivalent to Minntech Primus™ 2000 & Fresenius Hemoflow HF80 Dialyzer	Device is substantially equivalent to predicate devices.
Safety and Effectiveness	Safe and effective as predicate devices	Device is safe, effective, and performs as well as predicate devices.

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

The document does not specify the sample size used for the in vitro performance testing (test set). It only states that "In vitro testing was performed on the proposed device."

The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. However, given it's a 510(k) submission for a medical device prior to market, it's highly likely the in vitro testing was prospective.

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

This type of information is not applicable to the reported study. The "ground truth" for hollow fiber dialyzers in this context is established by the functional performance characteristics (clearances, ultrafiltration, sieving coefficients) as measured by laboratory equipment and standardized protocols, not by expert interpretation.

4. Adjudication Method for the Test Set

This is not applicable to the in vitro performance testing of a dialyzer. Performance metrics are measured objectively, not adjudicated by human review.

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

No MRMC study was performed. This device is a medical device (dialyzer), not an AI-based diagnostic or imaging device, so such a study would not be relevant.

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

This question is not applicable. The device is a physical hemodialyzer, not an algorithm. The "standalone" performance refers to the in vitro performance of the device itself.

7. The Type of Ground Truth Used

The "ground truth" for the in vitro performance testing consisted of measured functional performance characteristics such as urea, creatinine, phosphate, and vitamin B12 clearances, ultrafiltration coefficient, and sieving coefficient. These measurements were then compared against the established performance of the predicate devices.

8. The Sample Size for the Training Set

There is no "training set" in the context of this 510(k) submission for a physical medical device. The device's design and manufacturing processes are based on established engineering principles and materials, not on a machine learning training phase.

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

Not applicable as there is no training set for this type of device.

Summary

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APR 1 4 1999

510(K) SUMMARY

1982134

SUBMITTER: Yaw C. Yang, Ph.D. 2F, 53, Park Ave. II, Science-Based Industrial Park. Hsinchu, Taiwan, R.O.C. Tel.: 886-3-578-9566 Fax: 886-3-579-9541

DATE PREPARED:	Jun/12/1998
DEVICE NAME :	DYNAMIC Hollow Fiber Dialyzer DS-Series

PREDICATE DEVICE :	Minntech Primus™ Hollow Fiber Dialyzer
	Fesenius Hemoflow HF Dialyzer
	Minntech Renaflo™ HDF Hemodiafilter
	Dynamic Hollow Fiber Dialyzer DC-Series

Device Description

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Predicate Devices

The DYNAMIC Hollow Fiber Dialyzer DS-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 DS-Series Dialyzers are substantially equivalent in function, design, and operation to the Minntech Primus™ Hollow Fiber Dialyzer, Fresenius Hemoflow HF Dialyzer, Minntech Renaflo™ HDF Hemodiafilter, and DYNAMIC Hollow Fiber Dialyzer DC-Series (K973291), which have been previously approved for marketing in the United States under 510(K) Notification.

Intended Use

The DYNAMIC Hollow Fiber Dialyzer DS-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 only on direction of a physician who has evaluated all of the aspects of the patient's illness. The indication statement is essentially the same as the indication statement of the predicate devices.

Technological Characteristics

Comparing the proposed device to the predicate devices, similarities are noted in the design and materials employed to accomplish the same intended use. The proposed device and Minntech Primus™ Hollow Fiber Dialyzer, and Fresenius Hemoflow HF Dialyzer, utilize polycarbonate for the header material and polyurethane for the membrane potting material. The proposed and predicate devices are all sterilized by ethylene oxide gas.

In Vitro Performance

In vitro testing was performed on the proposed device to determine the following: urea, creatinine, phosphate, and vitamin B12 clearances, ultrafiltration coefficient, and sieving coefficient. The result indicates that the proposed device is substantially equivalent to Minntech Primus™ Hollow Fiber Dialyzer 2000, and Fresenius Hemoflow HF80 Dialyzer, for in vitro performance.

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Conclusions

Testing performed on the DYNAMIC Hollow Fiber DS-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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

APR 1 4 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Yaw C. Yang, Ph.D. President & CEO DYNAMIC TECHNOLOGY CORP. 2F, No. 53 Park AVE. II Science-Based Industrial Park Hsinchu, Taiwan, R.O.C.

Re: K982134

DYNAMIC Hollow Fiber Dialyzer DS-Series Dated: January 12, 1999 Received: January 14, 1999 Regulatory Class: III 21 CFR 876.5860/Procode: 78 KDI

Dear Dr. Yang:

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 legally marketed predicate 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, 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 II (Special Controls) or 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 requirements, as set forth in the Quality System Regulation (QS) 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 the Electronic Product 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 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/dsma/dsmamain.html".

Sincerely yours,

APT Daniel G. Schultz, M.D. Acting Director. Division of Reproductive. Abdominal, Ear. Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/3/Picture/15 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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510(k) Number (if known):_

Device Name: _DYNAMIC Hollow Fiber Dialyzer DS-Series

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

Concurrence of CDRH, Office Device Exaluation (ODE)

(Division Šign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use	✓
(Per 21 CFR 801.109)

Over-The-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,

and Radiological Devices

510(k) Number.

Regulation Number and Section

§ 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.”