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K Number
K102633
Device Name
BIOTEQ ANGIOGRAPHIC CATHETER
Manufacturer
BIOTEQUE CORP.
Date Cleared
2011-09-09

(361 days)

Product Code
DQO
Regulation Number
870.1200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
More Information

K970854

Not Found

No
The document describes a physical medical device (angiographic catheter) and its components, with no mention of software, algorithms, or AI/ML capabilities.

No.

The device is an angiographic catheter used for delivering contrast medium, which is a diagnostic procedure, not a therapeutic treatment.

No

The device is an angiographic catheter, which is used for the delivery of contrast medium. While it facilitates imaging by delivering contrast, it does not itself perform diagnosis; it is an instrumental device in a diagnostic procedure.

No

The device description clearly outlines physical components like a soft tube, braiding tube, screw cap, F.L.L. Adapter, and Adaptor Butterfly, indicating it is a hardware device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for the delivery of radiopaque contrast medium to selected sites in the vascular system. This is a procedure performed within the body (in vivo) to visualize blood vessels.
  • Device Description: The description details a catheter, which is a physical device inserted into the body.
  • Lack of IVD Characteristics: There is no mention of analyzing samples outside the body (in vitro), such as blood, urine, or tissue. There is no mention of reagents, assays, or any other components typically associated with IVD devices.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for a diagnostic imaging procedure performed directly on the patient.

N/A

Intended Use / Indications for 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

Product codes (comma separated list FDA assigned to the subject device)

DQO

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

coronary and peripheral vasculature.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

  • 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:
    • 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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K970854

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

0

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.

1

5. 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

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】

2

  • 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.

3

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

4

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)

L

ivision Sian-Off) Division of Čardiovascular Devices

510(k) Number_

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