(426 days)
The BIOTEQ Drainage Catheter Set (Seldinger Type) is designed for percutaneous drainage of abscess fluid, cyst, gall bladders nephrostomy, urinary and other fluids.
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.
The document is a 510(k) summary for the BIOTEQ Drainage Catheter Set (Seldinger Type), K210419. This document pertains to a medical device (catheter set) and not an AI/ML powered device. As such, information regarding AI/ML specific criteria such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable and not present in the provided text.
Therefore, I cannot provide a response for the requested information as it is not contained in the provided document. The document describes non-clinical performance data for substantial equivalence with a predicate device, focusing on sterilization, shelf-life, biocompatibility, and general performance testing against various ISO and ASTM standards.
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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.
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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
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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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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)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 | |
| Regulationnumber | 876.5010 | |
| Device Class: | II | |
| 510(k) Number: | K200103 |
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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 equivalencedetermination |
|---|---|---|---|
| Proprietary Name | BIOTEQ Drainage Catheter Set(Seldinger Type) | BIOTEQ Drainage Catheter Set(One Step Type) | Substantial equivalencedetermination |
| 510(k) No. | K210419 | K200103 | |
| Intended Use | The BIOTEQ Drainage Catheter Set(Seldinger Type) is designed for percutaneous drainage of abscess fluid, cyst, gall bladders nephrostomy, urinary and other fluids. | The BIOTEQ Drainage Catheter Set(One Step Type) is designed for percutaneous drainage of abscess fluid, cyst, gall bladders, nephrostomy, urinary, and others fluids. | EquivalentBoth 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(Seldinger Type) | BIOTEQ Drainage Catheter Set(One Step Type) | Substantial equivalencedetermination |
| 510(k) No. | K210419 | K200103 | |
| Catheter ShaftMaterial | TPU | TPU | Same |
| Distal Configuration | String Locking Pigtail,Non-String Locking Pigtail | String Locking Pigtail,Non-String Locking Pigtail | Same |
| Distal Shape | Pigtail, Closed-Pigtail | Pigtail, Closed-Pigtail, Mini-Pigtail,Mini-closed Pigtail, J shape | EquivalentBoth the devices havepigtail and closed shape. |
| Distal HydrophilicCoating | Yes | Yes | Same |
| Shaft Depth PrintingMarkers | Yes | Yes | Same |
| Proximal HubAssembly | Hub (for String Lock Pigtail),F.L.L. Adapter | Hub (for String Lock Pigtail),F.L.L. Adapter | Same |
| Size | 8, 10, 12, 14 Fr | 5 Fr (Non-String Lock), 6, 7, 8, 10,12, 14, 16 Fr | EquivalentThe size range of subjectdevice is equivalent tothe predicate device. |
| Useable Length | 40, 45, 50 cm | 20, 25, 30, 35, 40, 45, 50 cm | EquivalentThe length range ofsubject device isequivalent to thepredicate device. |
| Included InsertAccessory | • Metal Stiffening Cannula• Flexible (plastic) StiffeningCannula• Wire cap• Suture Wire• Curve Straightener | • Trocar Needle• Trocar Stylet• Flexible (plastic) StiffeningCannula• Wire cap• Suture Wire | EquivalentThe accessories ofsubject device equivalentto the predicate device. |
| Item | Subject device | Predicate device | Substantial equivalence determination |
| Proprietary Name | BIOTEQ Drainage Catheter Set(Seldinger Type) | BIOTEQ Drainage Catheter Set(One Step Type) | |
| 510(k) No. | K210419 | K200103 | |
| • Radiopaque band | • Curve Straightener• Radiopaque band | ||
| Packaging | Tyvek/Mylar (PET/LDPE) pouch | Tyvek/Mylar (PET/LDPE) pouch | Same |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Same |
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Traditional 510(k), K210419 Summary
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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
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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.
§ 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.