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 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.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (BIOTEQ Drainage Catheter Set (One Step Type)). It details the device's indications for use, description, and a comparison to predicate devices to establish substantial equivalence.

However, the document explicitly states in "5.10 Clinical Testing" that "No clinical test data was used to support the decision of substantial equivalence."

Therefore, I cannot provide the details requested in your prompt regarding acceptance criteria and studies that prove the device meets those criteria from this document, as no clinical testing was performed or submitted for this 510(k) clearance.

Specifically, the following information cannot be extracted because no clinical study was conducted:

A table of acceptance criteria and the reported device performance: No performance data from clinical studies is presented.
Sample sizes used for the test set and the data provenance: No test set was used for clinical performance evaluation.
Number of experts used to establish the ground truth... and qualifications: Not applicable as no clinical ground truth was established by experts.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (this device is not an algorithm).
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable (this is not an AI/ML device that requires a training set).
How the ground truth for the training set was established: Not applicable.

The document focuses on non-clinical testing (Sterilization Validation, Shelf-life, Biocompatibility, Performance) to demonstrate substantial equivalence to legally marketed predicate devices, rather than clinical performance data against specific acceptance criteria. The "Performance" referred to in Section 5.9 is likely related to physical performance characteristics of the device (e.g., flow rate, material strength, radiopacity, etc.), and not clinical outcomes.

Summary

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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

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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

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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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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

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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 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,

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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	Substantialequivalencedetermination
Proprietary Name	BIOTEQ DrainageCatheter Set (One StepType)	General PurposeDrainage Catheter	BIOTEQ® PigtailDrainage Catheter Set(One Step Type)
510(k) No.	(to be assigned)	K053245	K033862
Intended Use	The BIOTEQ DrainageCatheter Set (One StepType) is designed forpercutaneous drainage ofabscess fluid, cyst, gallbladders, nephrostomy,urinary, and others fluids.	For percutaneousdrainage of abscesses,nephrostomy and otherfluids.	BIOTEQ® PigtailDrainage Catheter Set(One Step Type) isintended to be used forpercutaneous drainageof abscesses, cysts, gallbladders,nephrostomies andother fluids.	EquivalentAll the devices areused for percutaneousdrainage ingastroenterology andurology.
Type of use	Prescription Use	Prescription Use	Prescription Use	Same
Catheter ShaftMaterial	TPU	TPU	TPU	Same
Distalconfiguration	String Locking Pigtail,Non-String LockingPigtail	String Locking Pigtail,Non-String LockingPigtail	String Locking Pigtail,Non-String LockingPigtail	Same
Distal shape	Pigtail, Closed-Pigtail,Mini-Pigtail, Mini-closedPigtail, J shape	Pigtail, Closed-Pigtail,Mini-Pigtail, J shape	Pigtail	EquivalentAll the devices havepigtail, closed, mini,and J shape.
Distal HydrophilicCoating	Yes	Yes	Yes	Same
Shaft DepthPrinting Markers	Yes	Yes	Yes	Same
Proximal HubAssembly	Hub (for String LockPigtail),F.L.L. Adapter	Hub (for String LockPigtail),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 notraise new issues ofSE.
Useable Length	20, 25, 30, 35, 40, 45, 50cm	12, 18, 19, 20, 25, 28,40, 41, 50 cm	20, 30, 40 cm	Different but do notraise new issues ofSE.
Included InsertAccessory	• Trocar Needle (MetalStiffening Cannula)• Trocar Stylet• Flexible (plastic)Stiffening Cannula• Wire cap (for stringLock Pigtail)• Suture Wire• Curve Straightener• Radiopaque band	• Trocar Needle (MetalStiffening Cannula)• Trocar Stylet• Trocar(Trocar)• Flexible Cannula• Wire-Ring• Suture Wire• Radiopaque marker	• Trocar Needle (MetalStiffening Cannula)• Trocar Stylet• Wire cap (for stringLock Pigtail)• Suture Wire• Curve Straightener	Different but do notraise new issues ofSE.
Packaging	Tyvek/Mylar(PET/LDPE) pouch	Tyvek/Mylar pouch	Tyvek/Mylar(PET/LDPE) pouch	Same as predicate II
SterilizationMethod	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide	Same

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K200103

BIOTEQUE CORPORATION

BIOTEQ Drainage Catheter Set (One Step Type)

Section 5 - 510 (k) Summary

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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.

Regulation Number and Section

§ 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.