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 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.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the BIOTEQ® A. V. FISTULA NEEDLE SET WITH SAFETY FLEX. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with specific acceptance criteria related to device performance in a clinical setting.

Therefore, the document does not contain detailed information about acceptance criteria or a study proving the device meets them in the way clinical performance studies typically do. Instead, it focuses on demonstrating that the device meets safety and effectiveness requirements by conforming to applicable standards and showing equivalence to a legally marketed predicate device.

Here's a breakdown of the information that is and is not available based on your request:

1. A table of acceptance criteria and the reported device performance

Not Applicable in the traditional sense. This 510(k) summary does not present specific clinical acceptance criteria (e.g., sensitivity, specificity, accuracy for an AI device) or reported performance metrics against such criteria.
What is reported: The document states, "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". This is the closest equivalent to "acceptance criteria" here, indicating that the device meets established industry standards for these categories.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Provided. This information is not typically included in a 510(k) summary focused on substantial equivalence through bench testing. The "test set" here refers to "bench testing" rather than a clinical dataset.
The document mentions "bench testing contained in this submission," but does not specify sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. For a device like an A.V. Fistula Needle Set, "ground truth" is not established by human experts in the same way it would be for an AI diagnostic device evaluating images. Device performance is assessed against engineering and biological standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods are relevant for studies where human interpretation or consensus is needed to establish ground truth, which is not the case for the type of testing described (physical, chemical, biological, sterilization specifications).

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, not for a physical medical device like a needle set.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is a physical medical instrument, not an algorithm, so "standalone performance" in the context of AI is not relevant. The device itself is "standalone" in its function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Ground truth for this device type is based on established engineering, biological, and sterilization standards. For example, "Physical specification" would refer to tensile strength, needle sharpness, flow rates; "Chemical specification" to material composition and biocompatibility; "Biological specification" to absence of certain toxins, and "Sterilization Specification" to sterility assurance levels.

8. The sample size for the training set

Not Applicable. There is no "training set" for this type of device. The document describes a manufactured product, not an AI/ML algorithm that requires training.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set for this device type, the establishment of ground truth for it is irrelevant.

Summary of the Study (as described in the 510(k)):

The study described is bench testing to demonstrate substantial equivalence to a predicate device (JMS A.V. FISTULA NEEDLE WingEater, K 010406).

Purpose: To show that any differences in technological characteristics between the BIOTEQ® A. V. FISTULA NEDDLE SET WITH SAFETY FLEX and the predicate device "do not raise any new questions of safety or effectiveness."
Methods: The device was tested "in terms of Physical specification, Chemical specification, Biological specification & Sterilization Specification." It "conforms to applicable standards included ISO 10993 series, ISO 11607-1, ISO 11135, USP Pyrogenic standards & related standards."
Conclusion: Based on this bench testing and comparison of intended use and technological characteristics, the device was deemed "substantially equivalent to the predicate devices."

In essence, this 510(k) summary provides evidence of compliance with established standards and equivalence to a predicate, rather than reporting on a clinical trial with specific performance metrics against defined acceptance criteria.

Summary

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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:Address:Phone:Fax:Contact:	BIOTEQUE CORPORATIONSuite 402, 4F, No.136, Sec.3,Jen-Ai Road, Taipei, Taiwan, R.O.C.886-2-2708-6716886-2-2707-6610Mr. William Lee (General Manager)
2. Device NameTrade Name:Common Name:Classification Name:	BIOTEQ® A. V. FISTULA NEDDLE SET WITH SAFETY FLEXA. V. FISTULA NEDDLE SET WITH SAFETY FEATURECatheter, 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 FLEXconsists of the following major components:① Protection Cap② Needle Cannula③ Butterfly Wing④ Needle Hub⑤ Safety Flex⑥ Small Pinch Clamp⑦ PVC Tubing⑧ Female Luer⑨ Cap for Female LuerThese components assembled together as BIOTEQ® Arterial-VenousFistula (A.V.F) Needle Set with Safety Flex for use during hemodialysisprocedures. The Safety Feature(Safety Flex) aids in prevention ofneedle-sticks injuries when removing and discarding needles afterdialysis session. Various models of needle size manufactured such as14 gauge, 15 gauge, 16 gauge, 17 gauge.
6. Intended Use:	Indication For Use:The BIOTEQ® Arterial-Venous Fistula (A.V.F) Needle Set with SafetyFlex is used for temporary cannulation for vascular access forextracorporeal blood treatment. The device is intended for single useonly and is for temporary catheterization of less than 30 days. TheSafety 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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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	(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

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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.

(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

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).