BIOTEQUE HEMODIALYSIS BLOOD TUBING SET

K992930 · Bioteque Corp. · FJK · Feb 9, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K992930
• Device Name: BIOTEQUE HEMODIALYSIS BLOOD TUBING SET
• Applicant: Bioteque Corp.
• Product Code: FJK · Gastroenterology, Urology
• Decision Date: Feb 9, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The BIOTEQUE Hemodialysis Blood Tubing Set(Models BT-102A, BT-102B and BT-190) is intended to serve as a conduit through which blood is taken from the patient, delivered to the dialyzer, and returned to the patient during hemodialysis therapy. The device is intended to be used for patients suffering from renal disease only. USERS TO INSTALL THE DEVICE: Trained nurses or the doctors. ENVIRONMENT FOR THE DEVICE TO BE USED: The hemodialysis center. SPECIAL NOTES: The hemodialysis blood tubing sets must be installed by trained nurses and doctors. The patients can not influence the use of the device.

Device Story

Bioteque Hemodialysis Blood Tubing Set (Models BT-102A, BT-102B, BT-190) functions as a conduit for extracorporeal blood circulation; transports blood from patient to dialyzer and returns it to patient during hemodialysis. Used exclusively in hemodialysis centers; installed by trained nurses or physicians. Device operation is entirely controlled by clinical staff; patient has no influence on device function.

Clinical Evidence

Bench testing only. Device conforms to ISO 10993 series (biocompatibility), ISO 11607-1 (packaging), ISO 11135 (sterilization), and USP pyrogenic standards.

Technological Characteristics

Hemodialysis blood tubing set consisting of arterial and venous lines. Conforms to ISO 10993, ISO 11607-1, ISO 11135, and USP standards. Sterilized device.

Indications for Use

Indicated for patients with renal disease requiring hemodialysis therapy.

Regulatory Classification

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.

Predicate Devices

• FRESENIUS DISPOSABLE BLOOD LINES (K853851)

Submission Summary (Full Text)

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### 510(K) SUMMARY 9 2000 FEB

K992930

.his summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92

1. Submitter's Name: BIOTEQUE CORPORATION

| Address: | Suite 402, 4th Fl, No. 136, Sec.3,Jen-Ai Road, Taipei, R.O.C. |
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| Phone: | 886-2-2708-6716 |
| Fax: | 886-2-2707-6610 |
| Contact: | Mr. William Lee (General Manager) |

2. Device Name

| Trade Name: | BIOTEQUE HEMODIALYSIS BLOOD TUBING SET |
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| Common Name: | HEMODIALYSIS BLOOD TUBING SET |
| Classification name: | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE |

3. Classification:

| Classification: | Class II |
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4. Predicate Device:

| Predicate Device: | FRESENIUS DISPOSABLE BLOOD LINES (K853851) |
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5. Device Description:

| Device Description: | Bioteque Hemodialysis Blood Tubing Set, consists of Arterial Line & Venous Line, is used as the conduit through which blood is taken from the patient, delivered to the dialyzer, and returned to the patient during dialysis therapy. |
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6. Intended Use:

| Intended Use: | INTENDED USE:<br>The BIOTEQUE Hemodialysis Blood Tubing Set(Models BT-102A, BT-102B and BT-190) is intended to serve as a conduit through which blood is taken from the patient, delivered to the dialyzer, and returned to the patient during hemodialysis therapy. The device is intended to be used for patients suffering from renal disease only.<br>USERS TO INSTALL THE DEVICE:<br>Trained nurses or the doctors.<br>ENVIRONMENT FOR THE DEVICE TO BE USED:<br>The hemodialysis center.<br>SPECIAL NOTES:<br>The hemodialysis blood tubing sets <i>must</i> be installed by trained nurses and doctors.<br>The patients can not influence the use of the device. |
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FDA 510(K) SUMMARY 【A2】 Page Revision

Page 1 of 2

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7. Performance Summary: In terms of Physical specification, Chemical specification, Biological specification & Sterilization Specification, the device conforms to applicable standards included ISO 10993 series, ISO 11607-1, ISO 11135, USP Pyrogenic standards & related standards ---- etc.

#### 8. Conclusions:

The BIOTEQUE HEMODIALYSIS BLOOD TUBING SET have the same intended use and similar technological characteristics as the FRESENIUS DISPOSABLE BLOOD LINES ( K853851 ). Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the BIOTEQUE HEMODIALYSIS BLOOD TUBING SET is substantially equivalent to the predicate devices.

FDA 510(K) SUMMARY

Page Revision 【A2】

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

9 2000 FEB

Bioteque Corporation c/o Mr. Allen Reich Harvest Consulting, Inc. 900 N. Switzer Canyon Dr., #142 Flaggstaff, AZ 86001

Re: K992930

Bioted® Hemodialysis Blood Tubing Sets Models BT-102A; BT-102B; and, BT-190 Dated: December 11, 1999 Received: December 14, 1999 Regulatory Class: II 21 CFR §876.5820/Procode: 78 FJK

Dear Mr. Reich:

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). 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 requlations affecting your device can be found in the Code of Federal Reculations, 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT 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

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#### NUMBER (IF KNOWN): 510 (K)

## BIOTEQ Hemodialysis Blood Tubing Set DEVICE NAME: BIOTEQUE CORPORATION

# INDICATIONS FOR USE:

The BIOTEQ Hemodialysis Blood Tubing Set (Models BT-102A, BT-102B, and BT-190) is intended to serve as a conduit through which blood is taken from the patient, delivered to the dialyzer, and returned to the patient during hemodialysis therapy. The device is intended to be used for patients suffering from renal disease only.

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

| Concurrence of CDRH, Office of Device Evaluation |
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| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter (Optional Format) |
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(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices

| 510(k) Number | K992930 |
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