BIOTEQ® Pigtail Drainage Catheter Set( One Step Type) is intended to be used for percutaneous drainage of abscesses, cysts, gall bladders and nephrostomies.

Device Description

The BIOTEQ® Pigtail Drainage Catheter Set ( One Step Type) is used for the drainage pathway of patients' fluids through the catheter out of body . It consist of the following major components: ① F.L.L. Adapter ② Screw Cap ③ Catheter ④ Curve Straightener (Sleeve) ⑤ Wire Cap --- (For With Safety String Lock model only) ⑥ Trocar Stylet ⑦ Trocar Needle ⑧ Sheath ⑨ Suture Wire --- (For With Safety String Lock model only)

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the BIOTEQ® Pigtail Drainage Catheter Set, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes performance in general terms rather than specific numerical acceptance criteria.

Acceptance Criteria Category	Reported Device Performance
Physical Specification	Conforms to applicable standards.
Chemical Specification	Conforms to applicable standards.
Biological Specification	Conforms to applicable standards (including ISO 10993 series, USP Pyrogenic standards).
Sterilization Specification	Conforms to applicable standards (including ISO 11135, ISO 11607-1).
Technological Equivalence	Differences in technological characteristics do not raise new questions of safety or effectiveness compared to the predicate device.

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

Sample Size for Test Set: Not explicitly stated. The document indicates "bench testing" was performed, but the number of units tested is not specified.
Data Provenance: Not explicitly stated, but given the manufacturer (BIOTEQUE CORPORATION) is in Taiwan, it's likely the testing was conducted by or for the manufacturer. The testing is described as "bench testing," which refers to in-vitro laboratory tests, not human data. Therefore, the data would not have a country of origin in the context of patient data, nor is it retrospective or prospective.

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

Number of Experts: Not applicable. The "ground truth" for this type of device (a medical catheter set) is established through performance against industry standards and specifications during bench testing, not through expert interpretation of a test set.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

Adjudication Method: Not applicable. As the testing involves objective measurement against engineering and biological standards, there is no need for expert 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:

MRMC Study: No. This is a medical device (catheter set), not an AI-powered diagnostic or interpretive tool. Therefore, a multi-reader multi-case comparative effectiveness study or AI assistance is not relevant or applicable.

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

Standalone Performance Study: Not applicable. This device does not involve an algorithm. The study described is bench testing of the physical, chemical, biological, and sterilization properties of the catheter set.

7. The type of ground truth used:

Type of Ground Truth: The ground truth for this device's performance is derived from established international and national standards for medical devices, specifically for physical, chemical, biological compatibility, and sterility. Examples include ISO 10993 series, ISO 11607-1, ISO 11135, and USP Pyrogenic standards.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable. This device does not involve machine learning or AI, so there is no concept of a "training set."

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

Ground Truth for Training Set Establishment: Not applicable.

Summary

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510(K) SUMMARY

K03386

page lofe

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

		FEB 1 4 2005
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® Pigtail Drainage Catheter Set ( One Step Type) with Safety String Lock , or without Safety String Lock
Common Name:	General Purpose drainage set
Classification name:	Catheter, biliary, diagnosticCatheter, nephrostomy
3. Classification:	Class II
4. Predicate Device:	URESIL General Purpose Drainage Set (K003753) marketed byURESIL CORP.
5. Device Description:	The BIOTEQ® Pigtail Drainage Catheter Set ( One Step Type) is used for the drainage pathway of patients' fluids through the catheter out of body . It consist of the following major components:① F.L.L. Adapter② Screw Cap③ Catheter④ Curve Straightener (Sleeve)⑤ Wire Cap --- (For With Safety String Lock model only)⑥ Trocar Stylet⑦ Trocar Needle⑧ Sheath⑨ Suture Wire --- (For With Safety String Lock model only)
6. Intended Use:	BIOTEQ® Pigtail Drainage Catheter Set ( One Step Type) is intended to be used for percutaneous drainage of abscesses, cysts, gall bladders, nephrostomies and other fluids.
7. 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 11607-1, ISO 11135, USP Pyrogenic standards & related standards----etc.

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୪. Conclusions:

The BIOTEQ® Pigtail Drainage Catheter Set ( One Step Type) have the same intended use similar technological characteristics as the URESIL General Purpose Drainage Set (K003753) marketed by URESIL CORP.. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety ~ effectiveness. Thus, the BIOTEQ® Pigtail Drainage Catheter Set ( One Step Type) is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2005

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

K033862 Re:

Trade/Device Name: BIOTEQ® PIGTAIL Drainage Catheter Set (One Step Type) with or without Safety String Lock Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Product Code: 78 FGE Regulation Number: 21 CFR §876.5090 Regulation Name: Suprapubic urological catheter and accessories Product Code: 78 LJE Regulatory Class: II Dated: December 13, 2004 Received: December 17, 2004

Dear Ms. Reich:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use suated in the encreations) it the enactment date of the Medical Device Amendments, or to conimoted provises that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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 r ou may, therefore, market of the Act include requirements for annual registration, listing of general concess provisions a ractice, 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 your device is classified (500 a0010) ... Existing major regulations affecting your device can be it may be subject to additions, 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 I Toase of advised that I Dr Crisean that your device complies with other requirements of the Act that I Dri has made a actorned ations administered by other Federal agencies. You must of any I ederal statutes and regaratents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 807), laborning (21 CFR Part 820); and if applicable, the electronic fordline the quality by stems (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 rr you atte office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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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Indications for Use

510(k) Number (if known): ___K033862

Device Name: BIOTEQ® Pigtail Drainage Catheter Set ( One Step Type) with Safety String Lock , or without Safety String Lock

BIOTEQUE CORPORATION

Indications For Use:

BIOTEQ® Pigtail Drainage Catheter Set( One Step Type) is intended to be used for percutaneous drainage of abscesses, cysts, gall bladders and nephrostomies.

V 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)

David A. Lynn

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number _

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Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.