The "BIOTEQ" Angiographic Catheter is indicated for the delivery of radiopaque contrast medium to selected sites in the vascular system. The device is for use in the coronary and peripheral vasculature, and not for use in the neurovasculature.

Device Description

The BIOTEO® ANGIOGRAPHIC CATHETER is with the braided proximal shaft. The distal shaft of the catheter has variety configuration and the tip is made soft to minimize trauma to the vessel wall. It consists of the following major components: Soft Tube, Braiding tube, Screw Cap, F.L.L. Adapter, Adaptor Butterfly.

AI/ML Overview

The provided document pertains to the 510(k) premarket notification for the BIOTEQ® ANGIOGRAPHIC CATHETER. This is a medical device and the document describes performance testing rather than a study typically associated with AI/ML devices that would involve acceptance criteria, sample sizes for test/training sets, ground truth establishment, or expert reviews for diagnostic accuracy.

Therefore, the requested information regarding acceptance criteria and studies typical for AI/ML devices (e.g., sample sizes for test/training sets, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance) cannot be extracted from this document, as it focuses on the physical and biological performance of a catheter.

Here's a breakdown of the performance testing conducted for this device, which serves a similar purpose to acceptance criteria for traditional medical devices:

1. Table of Acceptance Criteria and Reported Device Performance (based on performance testing, not AI/ML metrics):

Performance Test Category	Specific Test	Acceptance Criteria (Implied by "according to protocols based on international standards and in-house requirements")	Reported Device Performance
Physical Performance	Surface Requirements	Meets established standards for surface finish and integrity.	Achieved
	Corrosion Resistance	No significant corrosion observed.	Achieved
	Strength Test	Withstands specified forces without failure (ee.g., tensile, burst).	Achieved
	Leakage Tests (positive pressure, vacuum)	No leakage under specified pressure and vacuum conditions.	Achieved
	Flow Rate Test	Achieves specified flow rates for contrast media delivery.	Achieved
	Torque Strength Test	Withstands specified torque without failure.	Achieved
	Flexibility and Kink Test	Maintains integrity and patency under bending and kinking.	Achieved
	Dimensional Verification	Meets specified dimensional tolerances.	Achieved
	Particle Test	Within limits for particle shedding.	Achieved
	Catheter Twist Transmitting Test	Transmits torque effectively to the distal tip.	Achieved
	Catheter Shape Retention	Retains intended shape after use/manipulation.	Achieved
	Freedom from leakage and damage under high static pressure conditions	No leakage or damage under specified high static pressure.	Achieved
	Aged 3-year Shelf Life Testing	Maintains all performance characteristics after simulated aging (3 years).	Achieved
Packaging Tests	N/A	Maintains sterility and device integrity.	Achieved
Biocompatibility Tests	Intracutaneous Reactivity Study	Non-reactive or low reactivity within established limits.	Achieved
	Guinea Pig Maximization Sensitization Study	Non-sensitizing.	Achieved
	Cytotoxicity Testing	Non-cytotoxic.	Achieved
	Intramuscular Implant Study (1 week)	Biocompatible; no adverse tissue reaction.	Achieved
	Acute Systemic Injection Study	No acute systemic toxicity.	Achieved
	Hemolysis (direct and indirect contact)	Non-hemolytic.	Achieved
	Thrombogenicity Study ISO	Non-thrombogenic (within limits).	Achieved
	Salmonella Typhimurium Reverse Mutation Assay (Ames Test)	Non-mutagenic.	Achieved
	Complement Activation Test	Minimal or no complement activation.	Achieved
	Material Mediated Pyrogenicity	Non-pyrogenic.	Achieved
Sterilization Validation	ETO Sterilization Validation Study	Achieves sterility assurance level (SAL).	Achieved

The study supporting these criteria:

The document states: "Performance testing was conducted on the BIOTEO® ANGIOGRAPHIC Catheter to establish substantial equivalence. Testing was conducted according to protocols based on international standards and in-house requirements and included dimensional and functional testing. Additionally, the catheters were subjected to biocompatibility testing per ISO 10993."

Missing Information (as per AI/ML context):

The following points are not applicable or not provided in the context of this traditional medical device submission for an angiographic catheter:

Sample size used for the test set and the data provenance: Not applicable. Performance testing for physical and biological characteristics does not involve "test sets" in the AI/ML sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device is established through engineering and biological testing standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device is not an AI/ML diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is defined by established engineering standards, material science properties, biocompatibility guidelines (e.g., ISO 10993), and functional performance specifications.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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KIBZle33

510(k) SUMMARY

SEP - 9 2011

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92

1. Submitter's Name:	BIOTEQUE CORPORATION
Address:	5F-6, No.23 Sec.1, Chang-An E. Rd., Taipei 104, Taiwan
Phone:	+886-2-2571-0269
Fax:	+886-2-2536-1967
Contact:	William Lee / President
2. Device Name :
Trade Name:	BIOTEQ® ANGIOGRAPHIC CATHETER
	Model No. BT-ACX Series , X=4,5,6
Common Name:	ANGIOGRAPHIC CATHETER
	Classification name: catheter, intravascular, diagnostic
3. Device Class:	BIOTEQ® ANGIOGRAPHIC CATHETER has been classified
	as
	Regulatory Class: II
	Product Code: DQO
	Panel : Cardiovascular
	Regulation Number: 21CFR 870.1200
4. Predicate Device:	•5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER
	(K970854) marketed by CORDIS CORP.
	•Summary of Technological Characteristics in
	Comparison to Predicate device: BIOTEQ®
	ANGIOGRAPHIC Catheter has the same intended use and
	employs a similar method of operation and design as
	compared to the predicate devices. Both the new and
	predicate devices consist of a proximal connector, shaft,and distal tip. Both the new and predicate devices are
	comprised of similar materials and serve as passive
	conduits for the delivery of contrast media under high
	pressure.

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5. Device Description:

· Soft Tube
· Braiding tube
· Screw Cap
· F.L.L. Adapter
· Adaptor Butterfly

6. Intended Use: The BIOTEQ® ANGIOGRAPHIC Catheter is intended for use in the delivery of radiopaque contrast media to selected sites in the coronary and peripheral vasculature. The device is for single use only. This device is not intended for use in the neurovasculature

Performance testing was conducted on the BIOTEO® 7. Performance ANGIOGRAPHIC Catheter to establish substantial equivalence. Summary: Testing was conducted according to protocols based on international standards and in-house requirements and included dimensional and functional testing. Additionally, the catheters were subjected to biocompatibility testing per ISO 10993.

· Physical performance test including: Surface Requirements, Corrosion Resistance, Strength Test , Leakage Tests (under positive pressure and vacuum), Flow Rate Test, Torque Strength Test, Fiexibility and Kink test, and Dimensional Verification, Particle Test , the Catheter Twist Transmitting Test, Catheter Shape Retention, Test for freedom from leakage and damage under high static pressure conditions, aged 3-year shelf life testing.
· Packaging Tests
· Biocompatibility Tests:

BIOTEQ® ANGIOGRAPHIC CATHETER Section 4 - 510(k) Summary REV. 【D】

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Intracutaneous Reactivity Study
Guinea Pig Maximization Sensitization Study
Cytotoxicity Testing
Intramuscular Implant Study 1 week Duration
Acute Systemic Injection Study
Hemolysis direct and indirect contact
Thrombogenicity Study ISO
Salmonella Typhimurium Reverse Mutation Assay (Ames Test)
Complement Activation Test
Material Mediated Pyrogenicity
· Eto sterilization Validation Study

8. Conclusions:

The information and data provided in this 510(k) Notification establish that the BIOTEQ® ANGIOGRAPHIC Catheter is substantially equivalent to the legally . marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings and body. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WQ66-G609 Silver Spring, MD 20993-0002

Bioteque Corporation c/o Ms. Jennifer Reich Harvest Consulting Corp. 2904 N Boldt Drive Flagstaff, AZ 86001

Re: K102633

Trade Name: Bioteq® Angiographic Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class H Product Code: DQO Dated: August 11, 2011 Received: August 22, 2011

Dear Ms. Reich:

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. Iisting 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

g 2011

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Page 2 - Ms. Jennifer Reich

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 device-related 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.

If you desire specific advice for vour device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/Safetv/ReportalProblem/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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

$\kappa$

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): _K102633

Device Name: "BIOTEQ" Angiographic Catheter BIOTEQUE CORPORATION

Indications for Use:

The "BIOTEQ" Angiographic Catheter is indicated for the delivery of radiopaque contrast medium to selected sites in the vascular system.

The device is for use in the coronary and peripheral vasculature, and not for use in the neurovasculature.

V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ivision Sian-Off) Division of Čardiovascular Devices

510(k) Number_

Page 1 of 1

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).