BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET is intended to facilitate the temporary internal drainage of urine from the kidney to the bladder via placement endoscopically by a trained physician.

Device Description

The BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET consist of a ureter stent that is completely radiopaque, coiled cylindrical or open tip with drainage holes at intervals of 5-20 mm, centimeter graduations, continuous black positioning line to indicate the direction in which the catheter tip coils, and black marking at the catheter end. The Pusher Catheter (Introducer sheath) is approximately 45cm long. The Guide Wire (Spiral stylet) is made of stainless steel with PTFE coating and a flexible safety tip and a marked rigid tip and is approximately 120 cm long. The plastic dispenser is used to protect the Guide Wire (Spiral stylet). There are also plastic clips in the set.

AI/ML Overview

The provided text describes a 510(k) summary for the BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET. For medical devices, particularly those submitted under 510(k), the "acceptance criteria" and "study" typically refer to demonstrating substantial equivalence to a legally marketed predicate device through bench testing, performance testing, and adherence to relevant standards, rather than clinical studies with human participants that establish a device's performance in terms of diagnostic accuracy or effect sizes.

Based on the provided text, here's an analysis of the requested information:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Specific Criteria/Standard Adhered To	Reported Device Performance / Compliance
Physical Specification	Applicable standards (unspecified detail)	"conforms to applicable standards"
Chemical Specification	Applicable standards (unspecified detail)	"conforms to applicable standards"
Sterilization Specification	ISO 11135 (Sterilization of health care products - Ethylene oxide), ISO 11607-1 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems), USP Pyrogenic standards, & related standards	"conforms to applicable standards"
Biocompatibility	ISO 10993 series (Biological evaluation of medical devices)	"conforms to applicable standards"
Substantial Equivalence	Same intended use and similar technological characteristics as predicate device (Rusch Ureter Stent Integral Set and Rusch Ureter DD Stent Sets - K982974). Any differences in technological characteristics do not raise new questions of safety or effectiveness.	"The BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET have the same intended use and similar technological characteristics as the Rusch Ureter Stent Integral Set and Rusch Ureter DD Stent Sets (K982974) marketed by RUSCH INTL.. 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."

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify a "sample size" in the context of a traditional test set with individual patient cases or data points. The assessment is based on bench testing and adherence to standards for the device itself and its material properties.
Data Provenance: Not applicable in the context of clinical data. The "data" refers to the results of the bench tests and compliance with international standards for manufacturing, materials, and sterilization.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to this 510(k) submission. The "ground truth" for a medical device cleared via 510(k) is typically established by demonstrating that the device meets engineering specifications, material standards, biocompatibility requirements, and sterilization efficacy, which are evaluated by technical experts, engineers, and regulatory bodies against established standards, not clinical experts establishing diagnostic "ground truth" for a dataset.

4. Adjudication method for the test set:

Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies, particularly for diagnostic devices, to resolve discrepant expert opinions on case classifications. This 510(k) relies on bench testing and adherence to standards, which do not involve such adjudication.

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 diagnostic imaging devices, especially those incorporating AI, where the performance of human readers with and without AI assistance is evaluated across multiple cases. The BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET is an implantable medical device, not a diagnostic imaging or AI-enabled device.

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

No, a standalone algorithm performance study was NOT done. This device is a physical medical instrument (ureteral stent) and does not involve an algorithm.

7. The type of ground truth used:

The "ground truth" in this context is defined by engineering specifications, material safety and performance standards (e.g., ISO, USP), and biocompatibility requirements. It's about meeting pre-defined physical, chemical, and biological performance benchmarks, not clinical outcomes or pathology.

8. The sample size for the training set:

Not applicable. There is no "training set" as this device does not utilize machine learning or AI algorithms. The device undergoes manufacturing processes and quality controls to ensure each unit meets the required specifications.

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

Not applicable. As there is no training set involving algorithms, there is no ground truth to be established for it. The "ground truth" for the device's design and manufacturing is established through adherence to recognized international and national standards and regulatory requirements.

Summary

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DEC 3 0 2004

510(K) SUMMARY

Image /page/0/Picture/2 description: The image shows the text "K033210" in a handwritten style. The text is slightly slanted and has a somewhat rough appearance. There is some additional illegible text below the main text, which appears to be handwritten as well. The background is plain white.

" " is 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® DOUBLE PIGTAIL URETERAL STENT SET, orBIOTEQ® URETERAL STENT SET(Double J Type)
	Common Name:	Ureteral Stent
	Classification name:	Ureteral Stent
3.	Classification:	Class II
	Predicate Device:	Rusch Ureter Stent Integral Set and Rusch Ureter DD Stent Sets(K982974) marketed by RUSCH INTL.
5.	Device Description:	The BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET consist ofa ureter stent that is completely radiopaque, coiled cylindrical or opentip with drainage holes at intervals of 5-20 mm, centimetergraduations, continuous black positioning line to indicate the directionin which the catheter tip coils, and black marking at the catheter end.The Pusher Catheter (Introducer sheath) is approximately 45cm long.The Guide Wire (Spiral stylet) is made of stainless steel with PTFEcoating and a flexible safety tip and a marked rigid tip and isapproximately 120 cm long. The plastic dispenser is used to protectthe Guide Wire (Spiral stylet). There are also plastic clips in the set.
6.	Intended Use:	INDICATION FOR USEBIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET is intended tofacilitate the temporary internal drainage of urine from the kidney tothe bladder via placement endoscopically by a trained physician.

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In terms of Physical specification, Chemical specification 7. Performance Summary: 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® DOUBLE PIGTAIL URETERAL STENT SET have the same intended use and similar technological characteristics as the Rusch Ureter Stent Integral Set and Rusch Ureter DD Stent Sets (K982974) marketed by RUSCH INTL.. 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® DOUBLE PIGTAIL URETERAL STENT SET is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 3 0 2004

Bioteque Corporation c/o Ms. Jennifer Reich 3892 South America West Trail FLAGGSTAFF, AZ 86001

RE: K033210

Trade/Device Name: Bioteq Double Pigtail Ureteral Stent Set Regulation Number: 21 CFR§876.4620 Regulation Name: Ureteral Stent Regulatory Class: II Product Code: 78 FAD Dated: December 13, 2004 Received: December 16, 2004

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 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 this 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" (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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/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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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET BIOTEQUE CORPORATION

INDICATIONS FOR USE:

BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET is intended to facilitate the temporary internal drainage of urine from the kidney to the bladder via placement endoscopically by a trained physician.

Nancy C hogdon

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K0 332/0

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

See above.
Wbrogdon

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Regulation Number and Section

§ 876.4620 Ureteral stent.

(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).