(266 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a drainage catheter, with no mention of AI or ML capabilities.
No
The device is a drainage catheter used for removing fluids, which is a supportive or palliative measure, not a therapeutic intervention aimed at treating a disease or condition itself.
No
The device is designed for therapeutic drainage of fluids, not for identifying or diagnosing a condition.
No
The device description clearly describes a physical catheter made of plastic with a hydrophilic coating, drainage holes, and a "J", pigtail, or close loop distal end. It also mentions different sizes (5F~16F) and techniques for placement (Direct Access or Seldinger). This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Device Function: The BIOTEQ Drainage Catheter Set is a device used for the percutaneous drainage of fluids from the body. It is a physical device inserted into the body to remove accumulated fluids.
- Intended Use: The intended use clearly states it's for "percutaneous drainage of abscess fluid, cyst, gall bladders, nephrostomy, urinary, and others fluids." This is a therapeutic or interventional procedure, not a diagnostic test performed on a sample.
The device is a surgical/interventional tool used to manage fluid accumulation within the body, not a device used to analyze samples for diagnostic purposes.
N/A
Intended Use / Indications for 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.
Product codes
FGE, GBO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical Testing: A series of safety and performance tests were conducted on the subject device, BIOTEO Drainage Catheter Set (One Step Type).
- Sterilization Validation
- 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.
Clinical Testing: No clinical test data was used to support the decision of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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) | |
---|---|
☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Page 1 of 5
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
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
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.