BIOTEQ Drainage Catheter BT-PDS-series

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below. The logo is simple and professional, reflecting the FDA's role in regulating food and drugs. April 13, 2022 Bioteque Corporation Stella Hsu RA Specialist 5F-6, No. 23, Sec. 1, Chang'an E. Rd., Zhongshan Dist. Taipei City, 104 Taiwan Re: K210419 Trade/Device Name: BIOTEO Drainage Catheter Set (Seldinger Type) Model Name: BT-PDS-series Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: FGE, LJE, GBO Dated: March 15, 2022 Received: March 16, 2022 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. {1}------------------------------------------------ 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); 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-regulatoryinformation/postmarketing-safety-reporting-combination-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 medical devices and radiation-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, Je Hi An. Ph.D. Assistant 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) K210419 ### Device Name BIOTEQ Drainage Catheter Set (Seldinger Type) Model Name: BT-PDS-series Indications for Use (Describe) The BIOTEQ Drainage Catheter Set (Seldinger Type) is designed for percutaneous drainage of abscess fluid, cyst, gall bladders nephrostomy, urinary and other fluids. Type of Use (Select one or both, as applicable) | <div> <span>☑</span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | |---------------------------------------------------------------------------------------| | <div> <span>☐</span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </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}------------------------------------------------ Traditional 510(k), K210419 Summary # 510(k) Summary - Traditional 5.1 Type of Submission: 5.2 Date of Summary: March 31, 2022 BIOTEQUE CORPORATION 5.3 Submitter: 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: Stella Hsu #### 5.4 Identificationof the Device: | Proprietary/T de name: | BIOTEQ Drainage Catheter Set (Seldinger Type)<br>Model Name: BT-PDS-series | |------------------------------|----------------------------------------------------------------------------| | Classification Product Code: | FGE | | Subsequent Product Code: | LJE, GBO | | Regulation Number: | 876.5010 | | Regulation Description: | Biliary catheter and accessories; | | Review Panel: | Gastroenterology/Urology; General & Plastic Surgery | | Device Class: | II | | Basis for the Submission: | New Device | #### ર્સ્ડ Identificationof the Predicate Device: | Predicate Device Name: | BIOTEQ Drainage Catheter Set (One Step Type) | | |------------------------------|----------------------------------------------|--| | | Model Name: BT-PD1-series | | | Manufacturer | BIOTEQUE CORPORATION | | | Classification Product Code: | FGE | | | Subsequent Product Code: | LJE, GBO | | | Regulation<br>number | 876.5010 | | | Device Class: | II | | | 510(k) Number: | K200103 | | {4}------------------------------------------------ Traditional 510(k), K210419 Summary #### Device Descrintion ર્સ્વ The BIOTEO Drainage Catheter Set (Seldinger Type), BT-PDS-series percutaneous drainage catheter with hydrophilic coating, are percutaneous drainage catheters 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 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 (8F~14F pertaining to various fluid viscosity) and according to the position of the accumulation. The operator should use Seldinger Technique to provide access. #### 5.7 Indications for Use The BIOTEQ Drainage Catheter Set (Seldinger Type) is designed for percutaneous drainage of abscess fluid, cyst, gall bladders nephrostomy, urinary and other fluids. #### Comparison of Technological Characteristics with Predicate Device 5.8 Equivalence, same and difference between the subject and predicate devices are cited as below. | Item | Subject device | Predicate device | Substantial equivalence<br>determination | |---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | Proprietary Name | BIOTEQ Drainage Catheter Set<br>(Seldinger Type) | BIOTEQ Drainage Catheter Set<br>(One Step Type) | Substantial equivalence<br>determination | | 510(k) No. | K210419 | K200103 | | | Intended Use | The BIOTEQ Drainage Catheter Set<br>(Seldinger Type) is designed for percutaneous drainage of abscess fluid, cyst, gall bladders nephrostomy, urinary and other fluids. | The BIOTEQ Drainage Catheter Set<br>(One Step Type) is designed for percutaneous drainage of abscess fluid, cyst, gall bladders, nephrostomy, urinary, and others fluids. | Equivalent<br>Both the devices are used for percutaneous drainage in Gastroenterology and urology. | | Type of Use | Prescription Use | Prescription Use | Same | | Intended User | Adults and recommending clinician should choose an appropriate catheter size for pediatric use. | Adults and recommending clinician should choose an appropriate catheter size for pediatric use. | Same | | Item | Subject device | Predicate device | Substantial equivalence determination | | Proprietary Name | BIOTEQ Drainage Catheter Set<br>(Seldinger Type) | BIOTEQ Drainage Catheter Set<br>(One Step Type) | Substantial equivalence<br>determination | | 510(k) No. | K210419 | K200103 | | | Catheter Shaft<br>Material | TPU | TPU | Same | | Distal Configuration | String Locking Pigtail,<br>Non-String Locking Pigtail | String Locking Pigtail,<br>Non-String Locking Pigtail | Same | | Distal Shape | Pigtail, Closed-Pigtail | Pigtail, Closed-Pigtail, Mini-Pigtail,<br>Mini-closed Pigtail, J shape | Equivalent<br>Both the devices have<br>pigtail and closed shape. | | Distal Hydrophilic<br>Coating | Yes | Yes | Same | | Shaft Depth Printing<br>Markers | Yes | Yes | Same | | Proximal Hub<br>Assembly | Hub (for String Lock Pigtail),<br>F.L.L. Adapter | Hub (for String Lock Pigtail),<br>F.L.L. Adapter | Same | | Size | 8, 10, 12, 14 Fr | 5 Fr (Non-String Lock), 6, 7, 8, 10,<br>12, 14, 16 Fr | Equivalent<br>The size range of subject<br>device is equivalent to<br>the predicate device. | | Useable Length | 40, 45, 50 cm | 20, 25, 30, 35, 40, 45, 50 cm | Equivalent<br>The length range of<br>subject device is<br>equivalent to the<br>predicate device. | | Included Insert<br>Accessory | • Metal Stiffening Cannula<br>• Flexible (plastic) Stiffening<br>Cannula<br>• Wire cap<br>• Suture Wire<br>• Curve Straightener | • Trocar Needle<br>• Trocar Stylet<br>• Flexible (plastic) Stiffening<br>Cannula<br>• Wire cap<br>• Suture Wire | Equivalent<br>The accessories of<br>subject device equivalent<br>to the predicate device. | | Item | Subject device | Predicate device | Substantial equivalence determination | | Proprietary Name | BIOTEQ Drainage Catheter Set<br>(Seldinger Type) | BIOTEQ Drainage Catheter Set<br>(One Step Type) | | | 510(k) No. | K210419 | K200103 | | | | • Radiopaque band | • Curve Straightener<br>• Radiopaque band | | | Packaging | Tyvek/Mylar (PET/LDPE) pouch | Tyvek/Mylar (PET/LDPE) pouch | <i>Same</i> | | Sterilization Method | Ethylene Oxide | Ethylene Oxide | <i>Same</i> | {5}------------------------------------------------ ### Traditional 510(k), K210419 Summary {6}------------------------------------------------ Traditional 510(k), K210419 Summary #### રું. જેવી સાથે તે જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુ Similarity and Difference The BIOTEQ Drainage Catheter Set (Seldinger Type) has been compared with "BIOTEQ Drainage Catheter Set (One Step Type)". The subject device has the same intended use, and similar principle of operation and technological characteristics as the predicate device. 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 do not raise different types of safety and effectiveness questions. The subject device is substantially equivalent to the predicate device in intended use, design and performance claims. # 5.10 Performance Data - Non-clinical Testing The following performance data were provided in support of the substantial equivalence determination. - Sterilization Validation The ethylene oxide (EO) sterilization and related validation testing were conducted in accordance and complied with ISO 11135, ISO 10993-7, ISO 11737-1, ISO 11737-2, USP <85>, and ASTM F1140/F1140M. - . Shelf-life The shelf-life testing were conducted in accordance and complied with ASTM F1980, ASTM F1929, and ASTM F1140/F1140M. - . Biocompatibility The biocompatibility evaluation was conducted in accordance and complied with the FDA {7}------------------------------------------------ Traditional 510(k), K210419 Summary Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process''' and International Standard ISO 10993-1:2018. Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process as recognized by FDA. The endpoint testing included the following tests: - -Cytotoxicity - -Sensitization - -Irritation - Acute Systemic Toxicity - - Pyrogenicity - - Subchronic Systemic Toxicity - - Genotoxicity - - -Implantation - Performance The performance testing were conducted in accordance and complied with EN 1617, ISO 20697, ASTM F640, EN 1618, ISO 594-2, ISO 80369-7, ISO 11070, ASTM F1828 and ISO 7864. All the test results demonstrate BIOTEQ Drainage Catheter Set (Seldinger Type) meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device. # 5.11 Performance Data - Clinical Testing No clinical test data was used to support the decision of substantial equivalence. # 5.12 Conclusion The data demonstrate the subject device is as safe and effective as the primary predicate device. The data support the safety and performance of the subject device, and demonstrate that the subject device should perform as intended in the specified use conditions. The data demonstrates that the BIOTEQ Drainage Catheter Set (Seldinger Type) performs comparably to the predicate device that is currently marketed for the same intended use.