BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX

K032292 · Bioteque Corp. · FOZ · Mar 22, 2004 · General Hospital

Device Facts

• Record ID: K032292
• Device Name: BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX
• Applicant: Bioteque Corp.
• Product Code: FOZ · General Hospital
• Decision Date: Mar 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BIOTEQ® Arterial-Venous Fistula (A.V.F) Needle Set with Safety Flex is used for temporary cannulation for vascular access for extracorporeal blood treatment. The device is intended for single use only and is for temporary catheterization of less than 30 days. The Safety Feature(Safety Flex) aids in prevention of needle-sticks injuries when removing and discarding needles after dialysis session.

Device Story

The BIOTEQ® A.V. Fistula Needle Set is a sterile, single-use device for vascular access during hemodialysis. It consists of a needle cannula, butterfly wing, hub, PVC tubing, female luer, and a 'Safety Flex' mechanism. The device is used by clinicians in a clinical setting to cannulate a fistula for extracorporeal blood treatment. The Safety Flex feature is manually engaged by the clinician after the dialysis session to cover the needle, preventing accidental needle-stick injuries during disposal. The device facilitates blood flow between the patient and the dialysis machine. It provides a physical connection for blood treatment and enhances safety for healthcare workers during post-procedure needle handling.

Clinical Evidence

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

Technological Characteristics

Needle set with safety mechanism (Safety Flex). Components: needle cannula, butterfly wing, hub, PVC tubing, female luer. Conforms to ISO 10993 (biocompatibility), ISO 11607-1 (packaging), ISO 11135 (sterilization), and USP pyrogenic standards. Available in 14G, 15G, 16G, and 17G sizes.

Indications for Use

Indicated for patients requiring temporary vascular access for extracorporeal blood treatment (hemodialysis). Intended for single use, temporary catheterization (<30 days).

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• JMS A.V. FISTULA NEEDLE WingEater (K 010406)

Submission Summary (Full Text)

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MAR 2 2 2004

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K 03 2292
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# . 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with This Summonts of SMDA and 21 CFR §807.92

| 1. Submitter's Name:<br>Address:<br>Phone:<br>Fax:<br>Contact: | BIOTEQUE CORPORATION<br>Suite 402, 4F, No.136, Sec.3,Jen-Ai Road, Taipei, Taiwan, R.O.C.<br>886-2-2708-6716<br>886-2-2707-6610<br>Mr. William Lee (General Manager) | | | | |
|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| 2. Device Name<br>Trade Name:<br>Common Name:<br>Classification Name: | BIOTEQ® A. V. FISTULA NEDDLE SET WITH SAFETY FLEX<br>A. V. FISTULA NEDDLE SET WITH SAFETY FEATURE<br>Catheter, Intravascular, Therapeutic, Short-term Less Than 30 days | | | | |
| 3. Classification: | Class II Panel: 78 Product Code: FOZ & FIE | | | | |
| 4. Predicate Device: | JMS A.V. FISTULA NEEDLE WingEater (K 010406) | | | | |
| 5. Device Description: | The BIOTEQ® A. V. FISTULA NEDDLE SET WITH SAFETY FLEX<br>consists of the following major components:<br>① Protection Cap<br>② Needle Cannula<br>③ Butterfly Wing<br>④ Needle Hub<br>⑤ Safety Flex<br>⑥ Small Pinch Clamp<br>⑦ PVC Tubing<br>⑧ Female Luer<br>⑨ Cap for Female Luer<br>These components assembled together as BIOTEQ® Arterial-Venous<br>Fistula (A.V.F) Needle Set with Safety Flex for use during hemodialysis<br>procedures. The Safety Feature(Safety Flex) aids in prevention of<br>needle-sticks injuries when removing and discarding needles after<br>dialysis session. Various models of needle size manufactured such as<br>14 gauge, 15 gauge, 16 gauge, 17 gauge. | | | | |
| 6. Intended Use: | Indication For Use:<br>The BIOTEQ® Arterial-Venous Fistula (A.V.F) Needle Set with Safety<br>Flex is used for temporary cannulation for vascular access for<br>extracorporeal blood treatment. The device is intended for single use<br>only and is for temporary catheterization of less than 30 days. The<br>Safety Feature(Safety Flex) aids in prevention of needle-sticks injuries | | | | |

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FDA 510(K) SUMMARY

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K032292
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7. Performance Summary:

when removing and discarding needles after dialysis session. In terms of Physical specification, Chemical specification, Blological specification & Sterlilzation 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 BIOTEQ® Arterial-Venous Fistula (A.V.F) Needle Set with Safety Flex have intended use and similar technological characteristics as the JMS A.V. FISTULA NEEDLE WingEater (K 010406). 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 BIOTEO® Arterial-Venous Elstula (A.V.E) Needle Set with Safety Flex) is substantially equivalent to the predicate devices.

### FDA 510(K) SUMMARY

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MAR 2 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bioteque Corporation c/o Ms. Jennifer Reich Harvest Consulting Corporation 3892 South America West Trail FLAGpSTAFF AZ 86001

Re: K032292

Trade/Device Name: BIOTEQ® A. V. Fistula Needle Set with Safety Flex Regulation Number: 21 CFR \$876.5540 Regulation Name: Blood access device and accessories Procluct Code: 78 FIE Regulation Number: 21 CFR §880.5200 Regulation Name: Intravascular catheter Product Code: 78 FOZ Regulatory Class: II Dated: October 22, 2003 Received: December 23, 2003

#### 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) that do not require approval of a premarket approval application (PMA), 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 (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.

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 and 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.

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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 our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21CFR Part 807.97) you may obtain. 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 yours,

Nancy C. Brogdon

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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#### NUMBER (IF KNOWN): ___________________________________________________________________________________________________________________________________________________________ 510 (k) 510 (K) NUMBER (II RNOWN): ______________________________________________________________________________________________________________________________________________ BIOTEQUE CORPORATION

## INDICATIONS FOR USE:

The BIQTEQ® Arterial-Venous Fistule (A.V.E) Needle Set with Sefecty Flex is used for temporary cannulation for vascular access for extracorporeal blood treatment. The device is intended for single use only and is for temporary catheterization of less than 30 days. The Safety offigit as only also in prevention of needle-sticks injuries when removing and discarding needles after dialysis session.

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Concurrence of CDRH, Office of Device Evaluation

| Prescription Use | X | OR | Over-The-Counter | | | | |
|----------------------|--------------------------------------|----|------------------|--|--|--|--|
| (Per 21 CFR 801.109) | | | | | | | |
| Nancy Brugdon | | | | | | | |
| | (Division Sign-Off) | | | | | | |
| | Division of Reproductive, Abdominal, | | | | | | |
| | and Radiological Devices, | | | | | | |
| 510(k) Number | K032292 | | | | | | |