Guiding Catheter

K153703 · Texasmedical Technologies, Inc. · DQY · May 12, 2016 · Cardiovascular

Device Facts

• Record ID: K153703
• Device Name: Guiding Catheter
• Applicant: Texasmedical Technologies, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: May 12, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Guiding Catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vasculature.

Device Story

The Guiding Catheter is a sterile, single-use device designed for the intravascular delivery of interventional or diagnostic instruments. It features a lubricous PTFE inner liner, a stainless steel braid for structural reinforcement, and an outer shaft composed of varying durometer Polyether block amide (Pebax), Nylon, and Polyurethane. A polycarbonate hub is attached to the proximal end. The device is available in 5 French and 6 French sizes with various tip shapes (Judkins, Amplatz, Multipurpose) and a 100cm length. It is operated by a physician in a clinical setting to navigate the coronary or peripheral vasculature over a guidewire (up to 0.038"). The device provides a conduit for secondary devices, facilitating clinical procedures such as angiography or intervention. It benefits the patient by enabling precise, minimally invasive access to target vascular sites.

Clinical Evidence

Bench testing only. Performance evaluated via ISO 10555 and internal test methods, including air/liquid leak, tensile strength, torque response, kink/buckling, and simulated use. Biocompatibility confirmed per ISO 10993. All tests met predetermined acceptance criteria for both T=0 and T=3 (accelerated aging) samples.

Technological Characteristics

Materials: PTFE inner liner, stainless steel braid, Nylon/Pebax/Polyurethane outer shaft, polycarbonate hub, tungsten marker bands. Dimensions: 5F (0.070" OD, 0.058" ID) and 6F (0.082" OD, 0.070" ID), 100cm length. Principle: Over-the-wire intravascular delivery. Sterilization: Ethylene Oxide (EtO) gas (SAL 10^-6). Standards: ISO 10555, ISO 10993, ASTM F640-12, ASTM F88/F88M-09, ASTM F1929-12, ASTM F1980-07, ISO 594.

Indications for Use

Indicated for patients requiring intravascular introduction of interventional or diagnostic devices into the coronary or peripheral vasculature.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Vista Brite Tip (K972978)

Submission Summary (Full Text)

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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 stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The symbol is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

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

May 12, 2016

Texas Medical Technologies, Inc. % EJ Smith Consultant Smith Associates 1468 Harwell Avenue Crofton. Marvland 21114

Re: K153703

Trade/Device Name: Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: April 12, 2016 Received: April 12, 2016

Dear EJ Smith:

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

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the quality systems (OS) 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 your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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 [phone] or [phone] 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) K153703

Device Name Guiding Catheter

Indications for Use (Describe)

The Guiding Catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vasculature.

| | Type of Use (Select one or both, as applicable) | | |
|--|-------------------------------------------------|--|--|
|--|-------------------------------------------------|--|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### 5.1 - Company Information & Contact Person

| Company Name: | Texas Medical Technologies Inc. |
|------------------|----------------------------------------------------|
| Company Address: | 9005 Montana Ave. Ste. A<br>El Paso, Texas 79925 |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Cesar Rios, Quality Assurance & Regulatory Manager |
| Date Prepared: | 4/11/2016 |

5.2 - Device Name & Classification

| Proprietary Name: | Guiding Catheter |
|----------------------|-----------------------|
| Common Name: | Catheter |
| Classification Name: | Percutaneous Catheter |
| Regulation Number: | 21 CFR 870.1250 |
| Product Code: | DQY |
| Device Class: | II |

#### 5.3 - Predicate Device

Legally Marketed Substantially Equivalent Predicate Device

| Proprietary Name: | Vista Brite Tip |
|----------------------|-----------------------|
| Company Name: | Cordis Corporation |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter |
| Regulation Number: | 21 CFR 870.1250 |
| Product Code: | DQY |
| Device Class: | II |
| 510(k) Number | K972978 |

#### 5.4 - Device Description

The TXM Guiding Catheter is a guiding catheter, for application in intravascular vessels. It consists of a lubricous inner liner made from Teflon, a stainless steel braid over the inner liner. The outer shaft consists of durometer hardness and different lengths of colored Polyether block amide. A Polycarbonate hub is attached to the proximal end of the Guiding Catheter. A strain relief is placed at the proximal end of the Guiding Catheter and over the distal end of the device shafts will have an outer diameter of 5 French sizes (0.070") and 6 French sizes (0.082) respectively for each catheter. The 5 French sizes will have an inner diameter of 0.058" and the 6

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French sizes will have an inner diameter of 0.070". The device is available in length of 100cm. The device is supplied sterile and is intended for single use.

The device is supplied sterile and is intended for single use

The following table lists the models and sizes available for Guiding Catheter.

Table 5.4.1. Guiding Catheter Models and Sizes

| Commercial<br>Model Number | French<br>size | Shaft<br>Length (cm) | Outer<br>Diameter<br>(inches) | Inner<br>Diameter<br>(inches) | Marker Band<br>Material | Tip Shape |
|----------------------------|----------------|----------------------|-------------------------------|-------------------------------|-------------------------|-----------|
| GC-510-JL35 | 5 | 100 | 0.070 | 0.058 | Tungsten | JL 3.5 |
| GC-510-JL40 | 5 | 100 | 0.070 | 0.058 | Tungsten | JL 4 |
| GC-510-JL45 | 5 | 100 | 0.070 | 0.058 | Tungsten | JL 4.5 |
| GC-510-JL50 | 5 | 100 | 0.070 | 0.058 | Tungsten | JL 5 |
| GC-510-JL60 | 5 | 100 | 0.070 | 0.058 | Tungsten | JL 6 |
| GC-510-JR35 | 5 | 100 | 0.070 | 0.058 | Tungsten | AL 1 |
| GC-510-JR40 | 5 | 100 | 0.070 | 0.058 | Tungsten | AL 2 |
| GC-510-JR50 | 5 | 100 | 0.070 | 0.058 | Tungsten | AL 3 |
| GC-510-JR60 | 5 | 100 | 0.070 | 0.058 | Tungsten | JR 3.5 |
| GC-510-AL10 | 5 | 100 | 0.070 | 0.058 | Tungsten | JR 4 |
| GC-510-AL20 | 5 | 100 | 0.070 | 0.058 | Tungsten | JR 5 |
| GC-510-AL30 | 5 | 100 | 0.070 | 0.058 | Tungsten | JR 6 |
| GC-510-AR10 | 5 | 100 | 0.070 | 0.058 | Tungsten | AR 1 |
| GC-510-AR20 | 5 | 100 | 0.070 | 0.058 | Tungsten | AR 2 |
| GC-510-AR30 | 5 | 100 | 0.070 | 0.058 | Tungsten | AR 3 |
| GC-510-MPA1 | 5 | 100 | 0.070 | 0.058 | Tungsten | MPA 1 |
| GC-510-MPA1 | 5 | 100 | 0.070 | 0.058 | Tungsten | MPA 2 |
| GC-510-MPB1 | 5 | 100 | 0.070 | 0.058 | Tungsten | MPB 1 |
| GC-510-MPB2 | 5 | 100 | 0.070 | 0.058 | Tungsten | MPB 2 |
| GC-610-JL35 | 6 | 100 | 0.082 | 0.070 | Tungsten | JL 3.5 |
| GC-610-JL40 | 6 | 100 | 0.082 | 0.070 | Tungsten | JL 4 |
| GC-610-JL45 | 6 | 100 | 0.082 | 0.070 | Tungsten | JL 4.5 |
| GC-610-JL50 | 6 | 100 | 0.082 | 0.070 | Tungsten | JL 5 |
| GC-610-JL60 | 6 | 100 | 0.082 | 0.070 | Tungsten | JL 6 |
| GC-610-JR35 | 6 | 100 | 0.082 | 0.070 | Tungsten | AL 1 |
| GC-610-JR40 | 6 | 100 | 0.082 | 0.070 | Tungsten | AL 2 |
| GC-610-JR50 | 6 | 100 | 0.082 | 0.070 | Tungsten | AL 3 |
| GC-610-JR60 | 6 | 100 | 0.082 | 0.070 | Tungsten | JR 3.5 |
| GC-610-AL10 | 6 | 100 | 0.082 | 0.070 | Tungsten | JR 4 |
| GC-610-AL20 | 6 | 100 | 0.082 | 0.070 | Tungsten | JR 5 |
| GC-610-AL30 | 6 | 100 | 0.082 | 0.070 | Tungsten | JR 6 |
| GC-610-AR10 | 6 | 100 | 0.082 | 0.070 | Tungsten | AR 1 |
| GC-610-AR20 | 6 | 100 | 0.082 | 0.070 | Tungsten | AR 2 |
| GC-610-AR30 | 6 | 100 | 0.082 | 0.070 | Tungsten | AR 3 |
| GC-610-MPA1 | 6 | 100 | 0.082 | 0.070 | Tungsten | MPA 1 |
| GC-610-MPA1 | 6 | 100 | 0.082 | 0.070 | Tungsten | MPA 2 |
| GC-610-MPB1 | 6 | 100 | 0.082 | 0.070 | Tungsten | MPB 1 |
| GC-610-MPB2 | 6 | 100 | 0.082 | 0.070 | Tungsten | MPB 2 |

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#### 5.5 - Indications for Use

The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vasculature.

The Indications for Use are identical, the devices are both intended for intravascular use and the Indications for Use do not change the intended use of the TXM Guiding Catheter when compared to the predicate device.

## 5.6 - Summary of Technological Characteristics Comparison

Based on a comparison of the indications for use, fundamental design, technology and principles of operation, materials, performance, sterilization, and packaging, it is determined that the Guiding Catheter is substantially equivalent to the predicate device. Table 5.6 below provides a comparison of the Guiding Catheter and the predicate.

| Technical<br>Characteristics /<br>Principle of<br>Operation | TXM Guiding Catheter | Vista Brite Guiding<br>Catheter | Substantially<br>Equivalent? |
|-------------------------------------------------------------|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|------------------------------|
| Length | 100 cm | 90 cm, 100 cm, 110 cm, 125 cm | Yes |
| Outer Diameter | 0.070"-0.082" | 0.068"-0.082" | Yes |
| Inner Diameter | 0.058"-0.070" | 0.056"-0.070" | Yes |
| Shape | Judkins right, Judkins left,<br>Amplatz right, Amplatz left<br>and Multipurpose. | Judkins right, Judkins left,<br>Amplatz right, Amplatz left<br>and Multipurpose and others. | Yes |
| Inner Liner<br>Material | Polytetrafluoroethylene<br>(PTFE)* | Polytetrafluoroethylene<br>(PTFE) | Yes |
| Braid<br>Reinforcement<br>Material | Stainless Steel* | Stainless Steel | Yes |
| Radiopaque<br>Marker | Tungsten Material* | Radiopaque filler | Yes |
| Outer Shaft<br>Material | Nylon, Pebax,<br>Polyurethane* | Nylon | Yes |
| Luer Material | Polycarbonate* | Unknown | Yes |
| Luer Connector | Female Luer Connector* | Female Luer Connector | Yes |
| Anatomical Site<br>Use | Peripheral, Coronary | Peripheral, Coronary | Yes |
| Delivery to Site | Over-the-wire | Over-the-wire | Yes |
| Guidewire<br>Compatibility | Maximum 0.038" | Maximum 0.038" | Yes |
| Packaging | Tyvek Pouch | Tyvek Pouch | Yes |
| Sterilization | EtO Gas | EtO Gas | Yes |

Table 5.6.1 Comparison of the Guiding Catheter and the Predicate Device.

* Denotes a patient-contacting material.

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#### 5.7 - Testing Summary

The following bench tests were performed to evaluate the design elements and performance characteristics of the Guiding Catheter and to demonstrate substantial equivalence to the predicate device. The Guiding Catheter met the predetermined acceptance criteria. Testing was performed on non-aged devices (T=0) as well as on devices subject to 3 years of accelerated aging (T=3). Tests results show that the Guiding Catheter is substantially equivalent to the predicate device.

5.7.1- Bench Testing Table

Table 5.7.1 below provides a summary of the bench testing performed on the Guiding Catheter.

| Test<br># | Test Name | Applicable<br>Standard<br>or Internal<br>Test<br>Method | Test<br>Results<br>(T=3) | Test<br># | Test Name | Applicable<br>Standard<br>or Internal<br>Test<br>Method | Test<br>Results<br>(T=3) |
|-----------|-------------------------------------------------|---------------------------------------------------------|--------------------------|-----------|--------------------------------|---------------------------------------------------------|--------------------------|
| 1 | Air Leak | ISO 10555 | T=0:T=3<br>Pass | 12 | Corrosion<br>Resistance | ISO 10555 | T=0:T=3<br>Pass |
| 2 | In-Vitro<br>Track Force | Internal<br>Test<br>Method | T=0;T=3<br>Pass | 13 | Radiopacity | ASTM-<br>F640-12 | T=0;T=3<br>Pass |
| 3 | Stiffness | Internal<br>Test<br>Method | T=0:T=3<br>Pass | 14 | Torque<br>Response | Internal<br>Test<br>Method | T=0:T=3<br>Pass |
| 4 | Tensile<br>Strength | ISO 10555 | T=0;T=3<br>Pass | 15 | Torque to<br>Failure | Internal<br>Test<br>Method | T=0;T=3<br>Pass |
| 5 | Gravity Flow<br>Rate | ISO 10555 | T=0:T=3<br>Pass | 16 | Ovalization | Internal<br>Test<br>Method | T=0:T=3<br>Pass |
| 6 | Liquid Leak | ISO 10555 | T=0:T=3<br>Pass | 17 | Simulated Use | Internal<br>Test<br>Method | T=0:T=3<br>Pass |
| 7 | Power<br>Injector<br>(Static Burst<br>Pressure) | ISO 10555 | T=0;T=3<br>Pass | 18 | Seal Strength<br>(Pouch) | ASTM<br>F88/F88M-<br>09 | T=0;T=3<br>Pass |
| 8 | Tip Shape<br>Retention | Internal<br>Test<br>Method | T=0;T=3<br>Pass | 19 | Dye<br>Penetration<br>Test | ASTM-<br>F1929-12 | T=0;T=3<br>Pass |
| 9 | Dimensional<br>& Physical<br>Attributes | ISO 10555 | T=0:T=3<br>Pass | 20 | Female Luer<br>Verification | ISO 594 | T=0:T=3<br>Pass |
| 10 | Kink Testing | Internal<br>Test<br>Method | T=0;T=3<br>Pass | 21 | Shipping and<br>Transportation | ISTA 3A | T=0:T=3<br>Pass |
| 11 | Buckling<br>Test | Internal<br>Test<br>Method | T=0:T=3<br>Pass | 22 | Accelerated<br>Aging | ASTM<br>F1980-07 | T=0:T=3<br>Pass |

Table 5.7.1. Bench Testing Performed on Guiding Catheter

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## 5.7.2 - Biocompatibility

The Guiding Catheter is classified as an Externally Communicating Device, Circulating Blood, Limited Contact (≤24 hours). Biocompatibility testing was performed in accordance with ISO 10993 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process'' (2009). Table 5.7.2 below describes the testing performed to determine biocompatibility. All testing met the predetermined acceptance criteria.

| Biological Effect | Test | Compliance Standard |
|----------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Cytotoxicity | L929 Neutral Red Uptake (NRU) - ISO | ISO10993-5 |
| Irritation | Intracutaneous Injection - ISO | ISO10993-10 |
| Sensitization | Kligman Maximization<br>Murine Local Lymph Assay | ISO10993-10 |
| Systemic Toxicity | ISO Acute Systemic Toxicity Test | ISO10993-11 |
| Pyrogenicity | Pyrogen Test in Rabbit<br>Limulus Amebocyte Lysate | $USP<151>$<br>ISO10993-11<br>$USP <85>$ 38, NF 33, 2015 |
| Hemocompatibility | Hemolysis-Complete (Direct and Indirect)<br>Complement Activation<br>In-Vivo Thrombogenicity | ISO10993-4 |
| Toxicological Hazard | Risk Assessment of Extractables and Leachables | ISO10993-17 |

Table 5.7.2. Summary of Biocompatibility Testing for the Guiding Catheter

#### 5.8 - Sterilization Testing Summary

| Validation Sterilization Process | Sterility Assurance Level (SAL) | Validation Result |
|----------------------------------|---------------------------------|-------------------|
| Ethylene Oxide Gas | 10-6 | Pass |

#### 5.9 – Conclusion

The Guiding Catheter is substantially equivalent in intended use, fundamental design, technology and principles of operation, materials, performance, sterilization, and packaging to the predicate device. Differences between the devices do not raise any new issues of safety or effectiveness.