BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK

K013634 · Bioteque Corp. · FJK · Jul 9, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K013634
• Device Name: BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK
• Applicant: Bioteque Corp.
• Product Code: FJK · Gastroenterology, Urology
• Decision Date: Jul 9, 2002
• Decision: SESK
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs ( BT-102DA · BT-102DB · BT-102DC · BT-102DD) are sets of single-use disposable components intended to provide extracorporeal access to blood of patients suffering from end stage renal disease during Hemodialysis therapy. Each set will include an arterial/venous bloodline set, and any combination of two or three component of the following items: An intravenous administration set for (use in administration of intravenous fluids to a dialysis set in conjunction with hemodialysis procedures.) , AV fistula needle set to (apply on the access site of patient vessel to draw the blood flow adequate to pass through the dialyer and reinfusion of dialysed blood back to patient vessel via the A.V. Fistula Needle Set during hemodialysis procedures.) , and/or A transducer protector for (use as protective devices for pressure monitors and to help protect the sterility of the fluid pathway).

Device Story

BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs are single-use disposable kits providing extracorporeal blood access for hemodialysis. Kits contain an arterial/venous bloodline set combined with various components: IV administration sets for fluid delivery, AV fistula needle sets for vessel access/blood flow, and transducer protectors for pressure monitoring and sterility. Used in clinical hemodialysis settings by healthcare professionals. The device facilitates the connection between the patient's vascular access and the dialyzer, enabling blood withdrawal, processing, and reinfusion. Benefits include simplified setup for clinicians and maintained sterility of the fluid pathway during therapy.

Clinical Evidence

No clinical data. Bench testing only, including physical, chemical, biological, and sterilization specifications conforming to ISO 10993, ISO 11607-1, ISO 11135, and USP pyrogenic standards.

Technological Characteristics

Single-use disposable extracorporeal bloodline kits. Components include tubing, IV sets, AV fistula needles, and transducer protectors. Conforms to ISO 10993 (biocompatibility), ISO 11607-1 (packaging), ISO 11135 (sterilization), and USP pyrogenic standards. No software or electronic components.

Indications for Use

Indicated for patients with end stage renal disease requiring hemodialysis therapy to provide extracorporeal blood access.

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

• Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming set (K972206)
• Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming set (K001465)

Submission Summary (Full Text)

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## 510(K) SUMMARY JUL - 9 2002

This 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: | 8 F-3, No. 136, Sec.3,Jen-Ai Road, Taipei, Taiwan, R.O.C. |
| | Phone: | 886-2-2708-3188 |
| | Fax: | 886-2-2707-6610 |
| | Contact: | Mr. William Lee (General Manager) |
| 2. | Device Name | |
| | Trade Name: | BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Pack |
| | Common Name: | Blood Tubing Set With Transducer Protector , I.V.(INTRAVENOUS) SET and<br>A.V.F.FISTULA NEEDLE SET |
| | Classification name: | ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS |
| 3. | Classification: | Class II |
| | Predicate Device: | Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and<br>Priming set (K972206) & (K001465) |
| 5. | Device Description: | The BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs (BT-102DA 、BT-<br>102DB、BT-102DC、BT-102DD) are sets of single-use disposable components<br>intended to provide extracorporeal access to blood of patients suffering from end<br>stage renal disease during Hemodialysis therapy. Each set will include an<br>arterial/venous bloodline set, and any combination of two or three component of<br>the following items:<br>An intravenous administration set for use in administration of intravenous<br>fluids to a dialysis set in conjunction with hemodialysis procedures. , AV fistula needle set to apply on the access site of patient vessel to draw the<br>blood flow adequate to pass through the dialyer and reinfusion of dialysed<br>blood back to patient vessel via the A.V. Fistula Needle Set during<br>hemodialysis procedures. , and/or A transducer protector for use as protective devices for pressure monitors<br>and to help protect the sterility of the fluid pathway. BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs includes 4 models (BT-<br>102DA 、BT-102DB、BT-102DC、BT-102DD) |

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> BT-102DA BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Pack consists of three components: a BIOTEQ® Hemodialysis Blood Tubing Set, a BIOTEQ® I.V.(INTRAVENOUS) SET, and a TRANSDUCER PROTECTOR.

> BT-102DB BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Pack consists of three components: a BIOTEO® Hemodialysis Blood Tubing Set, a BIOTEO® A.V.F.FISTULA NEEDLE SET, and a TRANSDUCER PROTECTOR

→ BT-102DC BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Pack consists of four components : a BIOTEQ® Hemodialysis Blood Tubing Set , a BIOTEQ® I.V.(INTRAVENOUS) SET , a BIOTEQ® A.V.F.FISTULA NEEDLE SET, and a TRANSDUCER PROTECTOR.

> BT-102DD BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Pack consists of three components: a BIOTEQ® Hemodialysis Blood Tubing Set , a BIOTEQ® I.V.(INTRAVENOUS) SET , and a BIOTEQ® A.V.F.FISTULA NEEDLE SET.

The BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs ( BT-102DA · BT-Intended Use: 6. 102DB · BT-102DC · BT-102DD) are disposable bloodlines intended to provide extracorporeal access to the patient's blood during Hemodialysis therapy. The compatibility of available configurations is the responsibility of the physician in charge.

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.

## Conclusions: 8.

The BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs have the same intended use and similar technological characteristics as the Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming set (K972206) & (K001465). 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 BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or other bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

9 2002 JUL

BIOTEQUE CORPORATION c/o Ms. Jennifer Reich Harvest Consulting, Inc. 3892 South America West Trail FLAGSTAFF AZ 86001

Re: K013634

.

Trade/Device Name: BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Pack Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 FJK Dated: April 6, 2002 Received: April 10, 2002

Dear Ms. Reich:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Jennifer Reich

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration (21 CFR Part 807); listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 the labeling regulation (21 CFR Part 801 and additionally Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll free number [phone] or [phone], or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

David A. Lyman

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510 (k) NUMBER (IF KNOWN): BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs DEVICE NAME: BIOTEQUE CORPORATION

INDICATIONS FOR USE:

The BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs ( BT-102DA · BT-102DB · BT-102DC · BT-102DD) are sets of single-use disposable components intended to provide extracorporeal access to blood of patients suffering from end stage renal disease during Hemodialysis therapy. Each set will include an arterial/venous bloodline set, and any combination of two or three component of the following items:

← An intravenous administration set for (use in administration of intravenous fluids to a dialysis set in conjunction with hemodialysis procedures.) ,

· AV fistula needle set to (apply on the access site of patient vessel to draw the blood flow adequate to pass through the dialyer and reinfusion of dialysed blood back to patient vessel via the A.V. Fistula Needle Set during hemodialysis procedures.) , and/or

← A transducer protector for (use as protective devices for pressure monitors and to help protect the sterility of the fluid pathway).

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

Concurrence of CDRH, Office of Deyice Evaluation

Daniel G. Dygert

510k) Nu

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)