The Bioteq Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

Device Description

Bioteq Sheath Introducer consists of a sheath introducer with side port extension and stopcock. The sheath hub includes a hemostasis valve and a suture ring. A 4-way stopcock is affixed to the proximal end of the side port extension. The Bioteq Sheath Introducer assembly includes a vessel dilator that rotates securely with the sheath introducer hub and guidewire which is cleared by the Food and Drug Administration (K920884).

The sheath introducer is available in 5 French (F) to 7F sizes in length of 11cm or 23cm. The vessel dilator is tipped specifically to accept either a 0.038 inch or a 0.035 inch diameter guidewire with the length of 45cm or 80cm.

AI/ML Overview

The provided document describes the 510(k) premarket notification for a Sheath Introducer device, demonstrating its substantial equivalence to a legally marketed predicate device. This is not a study proving the device meets acceptance criteria for an AI/ML-based medical device.

The document discusses:

The device: Sheath Introducer, used for percutaneous introduction of devices into veins/arteries.
The testing conducted: Sterilization validation, biocompatibility, and various performance tests (e.g., force at break, leakage, radiopacity, insertion force, guidewire compatibility, kink resistance).
The comparison: The proposed device is compared to the Merit Prelude™ Sheath Introducer (K050962).
The determination: The FDA found the device substantially equivalent based on intended use, design, technology/principles of operation, and performance.

Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML device testing (e.g., sample size for test/training sets, expert ground truth, MRMC studies, effect size, standalone performance) cannot be answered from this document.

This document specifically states: "No clinical test data was used to support the decision of the substantial equivalence." and focuses on bench testing and material comparisons.

However, if we interpret "acceptance criteria" and "study" in the context of this specific medical device (a physical sheath introducer) as a substantial equivalence determination, then the information would be as follows:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Bench Test Type)	Reported Device Performance (Summary)
Sterilization Validation (Bioburden, Endotoxin, Sterility, EO residual, Pyrogen, Batch release)	Met related requirements.
Packaging Validation	Met related requirements.
Biocompatibility (Cytotoxicity, Intracutaneous Reactivity, Systemic Injection, Sensitization, Salmonella typhimurium Reverse Mutation, Hemolysis, Thromboresistance, Complement Activation, Material-Mediated Pyrogenicity)	Met related requirements.
Performance (Force at Break, Conical Fittings, Liquid Leakage, Chemical Characterization, Radiopacity, Insertion Force, Guidewire Compatibility, External Surface Inspection)	Met related requirements and its intended use.
Comparison Performance (Force at Break, Size Designation, Liquid Leakage, Insertion Force, Kink Resistance and Recovery, Minimum Tensile Force to Remove Dilator, Stiffness)	Demonstrated substantial equivalence to predicate device; differences did not raise safety/effectiveness issues.

2. Sample size used for the test set and the data provenance:

Sample size: Not explicitly stated for each test, but standard test methods for medical devices typically involve specific sample sizes per ISO/ASTM standards.
Data provenance: Not specified beyond "A series of tests were performed." The tests are non-clinical, meaning they were conducted in a laboratory setting. No indication of country of origin for the data itself, but the manufacturer is in Taipei, Taiwan. The tests are "retrospective" in the sense that they are conducted on manufactured samples, not "prospective" clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as this is a physical medical device undergoing bench testing, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests comes from established engineering and material science standards and measurement techniques.

4. Adjudication method for the test set:

Not applicable. Performance is measured against pre-defined engineering and material standards, not subjective expert judgment.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a physical, non-AI medical device. No human-in-the-loop performance or AI assistance involved.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical, non-AI medical device.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" is derived from established engineering and material science standards (e.g., ISO, ASTM standards for medical devices), physical measurements, and chemical analyses. For instance, a "force at break" test's ground truth is the measured force value compared to an acceptable range.

8. The sample size for the training set:

Not applicable. This is a physical, non-AI medical device. There is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

Not applicable. There is no training set or machine learning "ground truth" for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 22, 2016

Bioteque Corp. Stella Hsu 5F-6. No. 23. Sec. 1 Chang-an E. Road Taipei 104, Taiwan

Re: K150932

Trade/Device Name: Sheath Introducer Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator For Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: May 30, 2016 Received: June 2, 2016

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Brian D. Pullin -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150932

Device Name Sheath Introducer

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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	Commercial and/or Industrial USE (Subject to Local Sewer Charges)
	Fire Suppression and/or Hydrant Use

X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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K150932

BIOTEQUE CORP. 510(k) Notification, K150932/S002 Sheath Introducer

510(k) Summary

5.1 Type of Submission:	Traditional
5.2 Date of Summary:	07/15/2016
5.3 Submitter:	BIOTEQUE CORP.
Address:	5F-6, No.23 Sec.1, Chang-An E.Rd., Taipei 104, Taiwan
Phone:	+886-2-2571-0269
Fax:	+886-2-2536-1967
Correspondent:	Stella Hsu
Registration number:	9615118
5.4 Identification of the Device:
Proprietary/Trade name:	Sheath Introducer
Classification Name:	Vessel Dilator for PercutaneousCatheterization
Device Classification:	II
Regulation Number:	870.1310
Panel:	Cardiovascular
Product Code:	DRE
5.5 Identification of the Predicate Device:
Predicate Device Name:	Merit Prelude TM Sheath Introducer

Predicate Device Name:	Merit Prelude TM Sheath Introducer
Manufacturer:	Merit Medical Systems, Inc.
Regulation Number:	870.1310
Panel:	Cardiovascular
Product Code:	DRE
510(k) Number:	K050962

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5.6 Intended Use and Indications for Use of the subject device.

5.7 Device Description

5.8 Non-clinical Testing

A series of tests were performed to assess the substantial equivalence of the Sheath Introducer.

Sterilization Validation
- Bioburden test -
- -Bioburden recovery test
- -Endotoxin test
- Sterility test -
- -Biological Indicator test
- Bacteriostatic/Fungistatic test -
- EO residual test -
- । Pyrogen test
- Batch release report -
A Packaging validation test

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Sheath Introducer

BIOTEQUE CORP. 510(k) Notification, K150932/S002

Biocompatibility
- Cytotoxicity Test -
- -Intracutaneous Reactivity Test
- Acute Systemic Injection Test -
- -Sensitization Test
- The Salmonella typhimurium Reverse Mutation Assay -
- Hemolysis Test -
- Thromboresistance Test -
- Complement Activation -
- Material-Mediated Pyrogenicity -
Performance A
- Force at Break Testing -
- Conical Fittings with 6% (Luer) Taper -
- -Size Designation
- Liquid Leakage of Sheath Introducer & Liquid Leakage through -Hemostasis Valve
- Chemical characterization -
- Radiopacity Test -
- Insertion force Test -
- Guidewire compatibility Test -
- -Inspection the external surface
Comparison Performance Testing A
- Force at Break Testing -
- Size Designation -
- Liquid Leakage -
- Insertion force -
- Kink Resistance and Recovery -
- Minimum Tensile Force Required to Remove the Dilator From the -Sheath Hub
- Stiffness -

All the test results demonstrate the substantial equivalence of Sheath Introducer, which meets the related requirements and its intended use.

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5.9 Clinical Testing

No clinical test data was used to support the decision of the substantial equivalence.

5.10 EMC and Electrical safety

The devices do not require EMC/Electrical Safety evaluation.

5.11 Substantial Equivalence Determination

The Sheath Introducer submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation and performance to the cleared Merit Prelude™ Sheath Introducer which is the subject of K050962. Differences between the devices do not raise any new issues of substantial equivalence.

Itemsproduct	Proposed device	Predicate device
	Sheath Introducer	Merit PreludeTM SheathIntroducer
Manufacturer	Bioteque Corporation	Merit Medical Systems, Inc.
Indication for Use	The Bioteq Sheath Introduceris intended to provide accessand facilitate the percutaneousintroduction of various devicesinto veins and/or arteries whilemaintaining hemostasis for avariety of diagnostic andtherapeutic procedures.	The Merit PreludeTM SheathIntroducer is intended toprovide access and facilitate thepercutaneous introduction ofvarious devices into veinsand/or arteries whilemaintaining hemostasis for avariety of diagnostic andtherapeutic procedures.
Regulation Number	870.1310	870.1310
FDA 510(k) No.	N/A	K050962

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BIOTEQUE CORP. 510(k) Notification, K150932/S002 Sheath Introducer

Classification	Class II	Class II
Device Description	Bioteq Sheath Introducerconsists of a sheath introducerwith side port extension andstopcock. The sheath hubincludes a hemostasis valveand a suture ring. A 4-waystopcock is affixed to theproximal end of the side portextension. The Bioteq SheathIntroducer assembly includes avessel dilator that rotatessecurely with the sheathintroducer hub and guidewire.	Merit's Prelude consists of asheath introducer with side portextension and stopcock.The sheath hub includes ahemostasis valve and a suturering. A 3-way stopcock isaffixed to the proximal end ofthe side port extension. ThePrelude assembly includes avessel dilator that snapssecurely into the sheathintroducer hub.
	Product specifications
	Sheath length	11/23 cm	11/23 cm
	Sheath French Size	5~7 Fr	4~8 Fr
	Guidewire Diameter	0.038" & 0.035"	0.038" & 0.035"
	Guidewire Length	45/80 cm	80 cm
	Contents	Sheath Introducer, Dilator,Guidewire	Sheath Introducer, Dilator,Guidewire
		Sterilization method	Ethylene Oxide GasSterilization
	Materials
	Sheath tube	ETFE	HDPE
Dilator tube	Polypropylene	Polypropylene
Guide wire	Stainless steel	Stainless steel
Side tube	PVC	polyurethane

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5.12 Similarity and differences

The proposed device has the same technological characteristics as the predicate device. The differences between the proposed device and the predicate device are Sheath French Size, Guidewire Length and the materials of Sheath tube and Side tube. ETFE and HDPE are commonly used materials in sheath introducer. We have evaluated and reviewed these materials, and the proposed device has tested on safety and performance tests and the results were complied with the test requests. Therefore, the differences of proposed device and predicate device did not raise any problems of safety or effectiveness. The proposed device is substantially equivalent to the predicate device in design, operation, intended use, method of preparation, and performance claims.

5.13 Conclusion

After analyzing bench tests, device description and intended use/indications for use, it can be concluded that Sheath Introducer is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.1310 Vessel dilator for percutaneous catheterization.

(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).