Who is the manufacturer of BIOTEQ Drainage Catheter Set (One Step Type)?

Bioteque Corporation filed the 510(k) submission for BIOTEQ Drainage Catheter Set (One Step Type) (K200103).

What is the FDA product code for BIOTEQ Drainage Catheter Set (One Step Type)?

FGE. It is classified under 21 CFR 876.5010 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for BIOTEQ Drainage Catheter Set (One Step Type)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for BIOTEQ Drainage Catheter Set (One Step Type)?

General Purpose Drainage Catheter (K053245); BIOTEQ® Pigtail Drainage Catheter Set (One Step Type) (K033862).

Who can help prepare an FDA 510(k) submission like BIOTEQ Drainage Catheter Set (One Step Type)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BIOTEQ Drainage Catheter Set (One Step Type)

K200103 · Bioteque Corporation · FGE · Oct 9, 2020 · Gastroenterology, Urology

Device Facts

Record ID	K200103
Device Name	BIOTEQ Drainage Catheter Set (One Step Type)
Applicant	Bioteque Corporation
Product Code	FGE · Gastroenterology, Urology
Decision Date	Oct 9, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5010
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The BIOTEQ Drainage Catheter Set (One Step Type) is designed for percutaneous drainage of abscess fluid, cyst, gall bladders, nephrostomy, urinary, and others fluids.

Device Story

Percutaneous drainage catheter set used for abscess and fluid collection drainage; includes catheter, trocar needle, stylet, stiffening cannula, and accessories. Catheter made of radiopaque, biocompatible TPU with hydrophilic coating; distal end features pigtail, J-shape, or closed-loop configuration with drainage holes. Operator selects catheter size (5F-16F) based on fluid viscosity and placement site; utilizes Direct Access or Seldinger technique for insertion. Used in clinical settings by healthcare professionals. Output is fluid drainage; aids in managing fluid collections and patient recovery.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including sterilization validation, shelf-life testing, biocompatibility, and performance testing.

Technological Characteristics

Materials: TPU (thermoplastic polyurethane). Features: Radiopaque, hydrophilic coating, depth printing markers. Distal configurations: Pigtail, closed-pigtail, mini-pigtail, J-shape. Sizes: 5F-16F. Sterilization: Ethylene Oxide. Connectivity: None (mechanical device).

Indications for Use

Indicated for percutaneous drainage of abscess fluid, cysts, gall bladders, nephrostomy, urinary, and other fluids in patients requiring 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

General Purpose Drainage Catheter (K053245)
BIOTEQ® Pigtail Drainage Catheter Set (One Step Type) (K033862)

Related Devices

K251019 — BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G · Bioteque Corporation · Dec 22, 2025
K210419 — BIOTEQ Drainage Catheter BT-PDS-series · Bioteque Corporation · Apr 13, 2022
K093392 — MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS · Navilyst Medical, Inc. · Dec 31, 2009
K173035 — Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets · Cook Incorporated · May 1, 2018
K111315 — MULTIPURPOSE DRAINAGE CATHETER · Navilyst Medical, Inc. · Jun 8, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration". October 9, 2020 Bioteque Corporation Stella Hsu RA Specialist 5F-6, No. 23, Sec. 1, Chang'an E. Rd., Zhongshan Dist. Taipei City, 10441 TAIWAN Re: K200103 > Trade/Device Name: BIOTEQ Drainage Catheter Set (One Step Type) Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE, GBO Dated: September 4, 2020 Received: September 8, 2020 Dear Stella Hsu: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Glenn B. Bell, Ph.D. Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K200103 Device Name BIOTEQ Drainage Catheter Set (One Step Type) Model Name: BT-PD1-series Indications for Use (Describe) The BIOTEQ Drainage Catheter Set (One Step Type) is designed for percutaneous drainage of abscess fluid, cyst, gall bladders, nephrostomy, urinary, and others fluids. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------|--------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Page 1 of 5 K200103 BIOTEQUE CORPORATION BIOTEQ Drainage Catheter Set (One Step Type) Section 5 - 510 (k) Summary # 510(k) SUMMARY | 5.1 | Type of Submission: | Traditional | |-----|----------------------------------------------------------|--------------------------------------------------------------------------------------| | 5.2 | Date of Summary: | January 16, 2020 | | 5.3 | Submitter: | BIOTEQUE CORPORATION | | | Address: | 5F-6, No. 23, Sec. 1, Chang'an E. Rd., Zhongshan Dist. Taipei City 10441, Taiwan | | | Phone: | +886-2-2571-0269 | | | Fax: | +886-2-2536-1967 | | | Contact: | William Lee (General Manager) | | 5.4 | Identification of the Device: Proprietary/Trade name: | BIOTEQ Drainage Catheter Set (One Step Type) Model Name: BT-PD1-series | | | Classification Product Code: | FGE | | | Subsequent Product Code: | GBO | | | Regulation Number: | 876.5010; 878.4200 | | | Regulation Description: | Biliary catheter and accessories; Introduction/drainage catheter and accessories. | | | Review Panel: | Gastroenterology/Urology; General & Plastic Surgery | | | Device Class: | II | | | Basis for the Submission: | New Device | #### 5.5 Identification of the Predicate Device I: | Predicate Device Name: | General Purpose Drainage Catheter | |------------------------------|-----------------------------------| | Manufacturer: | UreSil, LLC | | Classification Product Code: | FGE | | Subsequent Product Code: | GBO, GBX, LJE | | Regulation number: | 876.5010 | | Device Class: | II | {4}------------------------------------------------ Page 2 of 5 K200103 BIOTEQUE CORPORATION BIOTEQ Drainage Catheter Set (One Step Type) Traditional 510(k) Section 5 - 510 (k) Summary K053245 510(k) Number: 5.6 Identification of the Predicate Device II: BIOTEQ® Pigtail Drainage Catheter Set (One Predicate Device Name: Step Type) BIOTEQUE CORPORATION Manufacturer: Classification Product Code: LHI Subsequent Product Code: NEP Regulation number: 880.5440 Device Class: II 510(k) Number: K033862 #### 5.7 Intended Use The BIOTEQ Drainage Catheter Set (One Step Type) is designed for percutaneous drainage of abscess fluid, cyst, gall bladders, nephrostomy, urinary, and others fluids. #### 5.8 Device Description The BIOTEQ Drainage Catheter Set (One Step Type), BT-PD1-series percutaneous drainage catheter with hydrophilic coating, is a percutaneous drainage catheter used for drainage of abscess and fluid collections. The catheter is made from a soft, biocompatible plastic, a material that is radiopaque for X-rays. The distal end of catheter contains a "J", a pigtail or close loop and drainage holes. The operator can use different drainage sets according to the type of accumulated fluid and place of accumulation. These sets are classified according to the catheter size (5F~16F pertaining to various fluid viscosity) and according to the position of the accumulation. The operator can choose either Direct Access Technique or Seldinger Technique to provide access. ### 5.9 Non-clinical Testing A series of safety and performance tests were conducted on the subject device, {5}------------------------------------------------ K200103 BIOTEQUE CORPORATION BIOTEQ Drainage Catheter Set (One Step Type) Traditional 510(k) Section 5 - 510 (k) Summary BIOTEO Drainage Catheter Set (One Step Type). - Sterilization Validation - o Shelf-life - Biocompatibility - Performance All the test results demonstrate BIOTEQ Drainage Catheter Set (One Step Type) meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate devices. # 5.10 Clinical Testing No clinical test data was used to support the decision of substantial equivalence. ## 5.11 Substantial Equivalence Determination Equivalence, same and difference between the subject and predicate devices are cited as below. | Item | Subject device | Predicate device I | Predicate device II | Substantial equivalence determination | |---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | Proprietary Name | BIOTEQ Drainage Catheter Set (One Step Type) | General Purpose Drainage Catheter | BIOTEQ® Pigtail Drainage Catheter Set (One Step Type) | | | 510(k) No. | (to be assigned) | K053245 | K033862 | | | Intended Use | The BIOTEQ Drainage Catheter Set (One Step Type) is designed for percutaneous drainage of abscess fluid, cyst, gall bladders, nephrostomy, urinary, and others fluids. | For percutaneous drainage of abscesses, nephrostomy and other fluids. | 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. | Equivalent All the devices are used for percutaneous drainage in gastroenterology and urology. | | Type of use | Prescription Use | Prescription Use | Prescription Use | Same | | Catheter Shaft Material | TPU | TPU | TPU | Same | | Distal configuration | String Locking Pigtail, Non-String Locking Pigtail | String Locking Pigtail, Non-String Locking Pigtail | String Locking Pigtail, Non-String Locking Pigtail | Same | | Distal shape | Pigtail, Closed-Pigtail, Mini-Pigtail, Mini-closed Pigtail, J shape | Pigtail, Closed-Pigtail, Mini-Pigtail, J shape | Pigtail | Equivalent All the devices have pigtail, closed, mini, and J shape. | | Distal Hydrophilic Coating | Yes | Yes | Yes | Same | | Shaft Depth Printing Markers | Yes | Yes | Yes | Same | | Proximal Hub Assembly | Hub (for String Lock Pigtail), F.L.L. Adapter | Hub (for String Lock Pigtail), F.L.L. Adapter | Screw Cap, F.L.L Adapter | Same as predicate I | | Size | 5 Fr (Non-String Lock), 6, 7, 8, 10, 12, 14, 16 Fr | 6, 8, 10, 12, 14, 16 Fr | 7, 8, 9, 10, 12, 14 Fr | Different but do not raise new issues of SE. | | Useable Length | 20, 25, 30, 35, 40, 45, 50 cm | 12, 18, 19, 20, 25, 28, 40, 41, 50 cm | 20, 30, 40 cm | Different but do not raise new issues of SE. | | Included Insert Accessory | • Trocar Needle (Metal Stiffening Cannula) • Trocar Stylet • Flexible (plastic) Stiffening Cannula • Wire cap (for string Lock Pigtail) • Suture Wire • Curve Straightener • Radiopaque band | • Trocar Needle (Metal Stiffening Cannula) • Trocar Stylet • Trocar (Trocar) • Flexible Cannula • Wire-Ring • Suture Wire • Radiopaque marker | • Trocar Needle (Metal Stiffening Cannula) • Trocar Stylet • Wire cap (for string Lock Pigtail) • Suture Wire • Curve Straightener | Different but do not raise new issues of SE. | | Packaging | Tyvek/Mylar (PET/LDPE) pouch | Tyvek/Mylar pouch | Tyvek/Mylar (PET/LDPE) pouch | Same as predicate II | | Sterilization Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Same | {6}------------------------------------------------ #### K200103 # BIOTEQUE CORPORATION BIOTEQ Drainage Catheter Set (One Step Type) # Section 5 - 510 (k) Summary {7}------------------------------------------------ #### K200103 #### BIOTEQUE CORPORATION BIOTEQ Drainage Catheter Set (One Step Type) Traditional 510(k) Section 5 - 510 (k) Summary # 5.12 Similarity and Difference The BIOTEQ Drainage Catheter Set (One Step Type) has been compared with "General Purpose Drainage Catheter" and "BIOTEQ® Pigtail Drainage Catheter Set (One Step Type)". The subject device has same intended use, principle of operation and similar technological characteristics as the predicate devices. The subject device has undergone safety and performance tests, and the results complied with the test requests. Although there are some different specifications between these devices, the performance test has been completed to demonstrate that the differences between these parameters would not impact the safety and effectiveness of the subject device. Therefore, the difference between the subject device and the predicate devices did not raise any new issue of substantial equivalence. The subject device is substantially equivalent to the predicate devices in intended use, design and performance claims. ### 5.13 Conclusion After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that the BIOTEQ Drainage Catheter Set (One Step Type) is substantially equivalent to the predicate devices.