BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK

K033862 · Bioteque Corp. · FGE · Feb 14, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K033862
• Device Name: BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK
• Applicant: Bioteque Corp.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Feb 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

BIOTEQ® Pigtail Drainage Catheter Set (One Step Type) facilitates percutaneous fluid drainage; includes catheter, trocar stylet, trocar needle, sheath, and optional safety string lock mechanism. Device used by clinicians for drainage of abscesses, cysts, gall bladders, and nephrostomies. Operates via percutaneous insertion to create drainage pathway; catheter pigtail configuration secures position. Output is fluid drainage from target site. Benefits include minimally invasive fluid removal.

Clinical Evidence

Bench testing only. Device conforms to applicable standards including ISO 10993 (biocompatibility), ISO 11607-1 (packaging), ISO 11135 (sterilization), and USP pyrogenic standards.

Technological Characteristics

Catheter-based drainage system; components include F.L.L. adapter, screw cap, catheter, curve straightener, trocar stylet, trocar needle, sheath, suture wire. Materials conform to ISO 10993. Sterilization via validated methods per ISO 11135. Mechanical pigtail retention mechanism.

Indications for Use

Indicated for percutaneous drainage of abscesses, cysts, gall bladders, and nephrostomies in patients requiring fluid drainage.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• URESIL General Purpose Drainage Set (K003753)

Submission Summary (Full Text)

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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, diagnostic<br>Catheter, nephrostomy | |
| 3. Classification: | Class II | |
| 4. Predicate Device: | URESIL General Purpose Drainage Set (k003753) marketed by<br>URESIL 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:<br>① F.L.L. Adapter<br>② Screw Cap<br>③ Catheter<br>④ Curve Straightener (Sleeve)<br>⑤ Wire Cap --- (For With Safety String Lock model only)<br>⑥ Trocar Stylet<br>⑦ Trocar Needle<br>⑧ Sheath<br>⑨ 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 [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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# 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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