Predicate Devices

K 010406

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical components, safety features, and conformance to standards for a needle set used in hemodialysis, with no mention of AI or ML.

Therapeutic

No.
The device is described as a needle set for temporary cannulation for vascular access for extracorporeal blood treatment, specifically for hemodialysis procedures. It facilitates the process but does not directly treat a disease or condition itself.

Diagnostic

No

The device is described as an "Arterial-Venous Fistula (A.V.F) Needle Set with Safety Flex" used for "temporary cannulation for vascular access for extracorporeal blood treatment" during "hemodialysis procedures." Its function is to facilitate blood transport for treatment, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly lists multiple physical components (needle cannula, butterfly wing, tubing, etc.) and describes a physical safety feature, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "temporary cannulation for vascular access for extracorporeal blood treatment," specifically for hemodialysis procedures. This involves accessing the patient's bloodstream directly for treatment, not for testing or analyzing biological samples in vitro (outside the body).
Device Description: The device is a needle set designed for physical access to the vascular system. Its components are related to insertion, blood flow, and safety during the procedure. There is no mention of components or functions related to analyzing blood or other biological samples.
Lack of IVD Characteristics: The description does not mention any features related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information based on sample analysis

The device is a medical device used for a therapeutic procedure (hemodialysis), not for diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

FOZ, FIE

Device Description

The BIOTEQ® A. V. FISTULA NEDDLE SET WITH SAFETY FLEX consists of the following major components: ① Protection Cap ② Needle Cannula ③ Butterfly Wing ④ Needle Hub ⑤ Safety Flex ⑥ Small Pinch Clamp ⑦ PVC Tubing ⑧ Female Luer ⑨ Cap for Female Luer These components assembled together as BIOTEQ® Arterial-Venous Fistula (A.V.F) Needle Set with Safety Flex for use during hemodialysis procedures. The Safety Feature(Safety Flex) aids in prevention of needle-sticks injuries when removing and discarding needles after dialysis session. Various models of needle size manufactured such as 14 gauge, 15 gauge, 16 gauge, 17 gauge.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

vascular access

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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

Key Metrics

Not Found

Predicate Device(s)

K 010406

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

0

MAR 2 2 2004

: 2

:

K 03 2292
Page 1 of 2

. 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:
Address:
Phone:
Fax:
Contact: | BIOTEQUE CORPORATION
Suite 402, 4F, No.136, Sec.3,Jen-Ai Road, Taipei, Taiwan, R.O.C.
886-2-2708-6716
886-2-2707-6610
Mr. William Lee (General Manager) | | | | |
|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| 2. Device Name
Trade Name:
Common Name:
Classification Name: | BIOTEQ® A. V. FISTULA NEDDLE SET WITH SAFETY FLEX
A. V. FISTULA NEDDLE SET WITH SAFETY FEATURE
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
consists of the following major components:
① Protection Cap
② Needle Cannula
③ Butterfly Wing
④ Needle Hub
⑤ Safety Flex
⑥ Small Pinch Clamp
⑦ PVC Tubing
⑧ Female Luer
⑨ Cap for Female Luer
These components assembled together as BIOTEQ® Arterial-Venous
Fistula (A.V.F) Needle Set with Safety Flex for use during hemodialysis
procedures. The Safety Feature(Safety Flex) aids in prevention of
needle-sticks injuries when removing and discarding needles after
dialysis session. Various models of needle size manufactured such as
14 gauge, 15 gauge, 16 gauge, 17 gauge. | | | | |
| 6. Intended Use: | Indication For 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 | | | | |

Page 1 of 2

FDA 510(K) SUMMARY

Page Revision

1

K032292
Page 2 of 2

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

2

Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in a simple, bold font. The text is arranged vertically, with "Public Health" on the first line and "Service" on the second line. The words are black against a white background.

Image /page/2/Picture/2 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with text around the perimeter. The central image is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare.

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.

3

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	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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" (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 (800) 638-2041 or (301) 443-6597 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

Page 2

4

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.

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

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