TXM Hydrophilic Guidewire

K170915 · Texasmedical Technologies, Inc. · DQX · Nov 21, 2017 · Cardiovascular

Device Facts

• Record ID: K170915
• Device Name: TXM Hydrophilic Guidewire
• Applicant: Texasmedical Technologies, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Nov 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

To facilitate the placement of devices during diagnostic or interventional procedures.

Device Story

TXM Hydrophilic Guidewire is a sterile, single-use device designed to facilitate placement of catheters or other interventional devices within the peripheral vascular system. It consists of a nitinol inner core covered by a polyurethane outer layer, finished with a lubricious hydrophilic coating to minimize friction during navigation. The device is available in various lengths (80-260 cm), shaft configurations (standard or stiff), and distal tip shapes (straight or angled). It is inserted through an introducer sheath by a clinician during vascular procedures. The device provides a trackable path for interventional equipment, aiding in precise site delivery. Its radiopaque properties allow for visualization under fluoroscopy, assisting the physician in navigating the vasculature. By reducing friction and providing controlled stiffness, the guidewire facilitates safer and more efficient access to target anatomical sites, potentially reducing procedure time and patient trauma.

Clinical Evidence

Bench testing only. Performance evaluated via ISO 11070:2014, ASTM F640-12, ASTM D747-10, and internal methods. Tests included dimensional attributes, torque strength, torqueability, guidewire compatibility, radiopacity, tensile strength, coating adherence/integrity, particulate quantitation, coating durability/lubricity, shaft stiffness, tip flexibility, fracture resistance, tip impact, corrosion resistance, trackability, and packaging integrity (ASTM F1929-15, F1886-09, F88). Biocompatibility testing performed per ISO 10993 (cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity, hemocompatibility). All tests passed for non-aged and 2-year accelerated aged devices.

Technological Characteristics

Nitinol inner core; polyurethane outer jacket with tungsten; hydrophilic lubricious coating. Dimensions: 0.035" OD, 80-260 cm length. Configurations: standard/stiff shaft, straight/angled tip. Sterilization: Ethylene Oxide (EtO) per ISO 11135. Standards: ISO 11070 (mechanical), ASTM F640 (radiopacity), ASTM D747 (stiffness), ISO 10993 (biocompatibility).

Indications for Use

Indicated for patients undergoing diagnostic or interventional procedures requiring device placement in the peripheral vascular system.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Hydrophilic Coated Guidewire (K133155)

Submission Summary (Full Text)

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November 21, 2017

Texas Medical Technologies, Inc. % Mr. E.J. Smith Consultant Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114

Re: K170915

Trade/Device Name: TXM Hydrophilic Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: October 13, 2017 Received: October 16, 2017

Dear Mr. 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 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);

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# Page 2 - Mr. Smith

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Kenneth J. Cavanaugh -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) K170915

Device Name TXM Hydrophilic Guidewire

Indications for Use (Describe)

To facilitate the placement of devices during diagnostic or interventional procedures.

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 |
| | El Paso, Texas 79925 |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Cesar Rios, Quality Assurance & Regulatory Manager |
| Date Prepared: | 02/28/2017 |

#### 5.2 - Device Name & Classification

| Proprietary Name: | TXM Hydrophilic Guidewire |
|----------------------|---------------------------|
| Common Name: | Catheter guide wire |
| Classification Name: | Wire, Guide, Catheter |
| Regulation Number: | 21 CFR 870.1330 |
| Product Code: | DQX |
| Device Class: | II |

#### 5.3 - Predicate Device

Legally Marketed Substantially Equivalent Predicate Device

| Proprietary Name: | Hydrophilic Coated Guidewire |
|----------------------|------------------------------------------|
| Company Name: | Lake Region Medical |
| Common Name: | Guides, guidewires, or spring guidewires |
| Classification Name: | Wire, Guide, Catheter |
| Regulation Number: | 21 CFR 870.1330 |
| Product Code: | DQX |
| Device Class: | II |
| 510(k) Number | K133155 |

#### 5.4 - Device Description

The TXM Hydrophilic Guidewire is a hydrophilic coated device which is constructed with a nitinol inner core which is covered with a polyurethane outer layer coated with a lubricious coating to minimize friction during use. The TXM Hydrophilic Guidewire outer diameter is 0.035" and is available in a variety of lengths ranging from 80 cm to 260 cm. The TXM Hydrophilic Guidewire is also constructed in stiff and standard shaft configuration with straight or angled distal tip. The device is supplied sterile and is intended for single use only.

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The following table lists the models and sizes available for TXM Hydrophilic Guidewire.

| Product Code | Outer Diameter<br>(inches) | | Length<br>(cm) | Shaft<br>Configuration | Tip Shape |
|--------------|----------------------------|---------|----------------|------------------------|-----------|
| | Shaft | Tip | | | |
| HGW-35080-FS | 0.0335" | 0.0305" | 80 | Standard | Straight |
| HGW-35150-FS | 0.0335" | 0.0305" | 150 | Standard | Straight |
| HGW-35180-FS | 0.0335" | 0.0305" | 180 | Standard | Straight |
| HGW-35260-FS | 0.0335" | 0.0305" | 260 | Standard | Straight |
| HGW-35080-FA | 0.0335" | 0.0305" | 80 | Standard | Angled |
| HGW-35150-FA | 0.0335" | 0.0305" | 150 | Standard | Angled |
| HGW-35180-FA | 0.0335" | 0.0305" | 180 | Standard | Angled |
| HGW-35260-FA | 0.0335" | 0.0305" | 260 | Standard | Angled |
| HGW-35080-SS | 0.0335" | 0.0305" | 80 | Stiff | Straight |
| HGW-35150-SS | 0.0335" | 0.0305" | 150 | Stiff | Straight |
| HGW-35180-SS | 0.0335" | 0.0305" | 180 | Stiff | Straight |
| HGW-35260-SS | 0.0335" | 0.0305" | 260 | Stiff | Straight |
| HGW-35080-SA | 0.0335" | 0.0305" | 80 | Stiff | Angled |
| HGW-35150-SA | 0.0335" | 0.0305" | 150 | Stiff | Angled |
| HGW-35180-SA | 0.0335" | 0.0305" | 180 | Stiff | Angled |
| HGW-35260-SA | 0.0335" | 0.0305" | 260 | Stiff | Angled |

Table 5.4 TXM Hydrophilic Guidewire Models and Sizes

# 5.5 - Indications for Use

To facilitate the placement of devices used during diagnostic and interventional procedures.

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 Hydrophilic Guidewire 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 TXM Hydrophilic Guidewire is substantially equivalent to the predicate device. Table 5.6 below provides a comparison of the TXM Hydrophilic Guidewire and the predicate.

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| Technical<br>Characteristics /<br>Principle of<br>Operation | TXM Hydrophilic<br>Guidewire | Hydrophilic Coated<br>Guidewire | Substantially<br>Equivalent? |
|-------------------------------------------------------------|------------------------------|----------------------------------------------|------------------------------|
| Length | 80cm-260cm | 80cm-260cm | Yes |
| Outer Diameter | 0.035" | 0.035" | Yes |
| Shape | Straight or Angled | Straight or Angled | Yes |
| Shaft Configuration | Standard or Stiff | Standard or Stiff | Yes |
| Inner Core Material | Nitinol | Nitinol | Yes |
| Outer Jacket<br>Material | Polyurethane,<br>Tungsten | Polyurethane, Radiopaque<br>material unknown | Yes |
| Hydrophilic Coated | Yes* | Yes | Yes |
| Anatomical Site Use | Peripheral Vascular System | Peripheral Vascular System | Yes |
| Delivery to Site | Through Introducer Sheath | Through Introducer Sheath | Yes |
| Packaging | Tyvek Pouch | Tyvek Pouch | Yes |
| Sterilization | EtO Gas | EtO Gas | Yes |

Table 5.6 Comparison of the TXM Hydrophilic Guidewire and the Predicate Device

* Denotes a patient-contacting material.

## 5.7 - Testing Summary

The following bench tests were performed to evaluate the design elements and performance characteristics of the TXM Hydrophilic Guidewire and to demonstrate substantial equivalence to the predicate device. The TXM Hydrophilic Guidewire met the predetermined acceptance criteria. Testing was performed on non-aged devices (T=0) as well as on devices subject to 2 years of accelerated aging (T=2). Tests results show that the TXM Hydrophilic Guidewire 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 TXM Hydrophilic Guidewire.

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| Test<br>No. | Test Name | Applicable Standard or Internal Test<br>Method | Test Results | |
|-------------|--------------------------------------------------------------|-------------------------------------------------------------------------------|--------------|------|
| 1 | Dimensional and Physical Attributes | ISO 11070:2014 | T=0<br>T=2 | Pass |
| 2 | Torque Strength | FDA Coronary and Cerebrovascular<br>Guidewire Guidance / Internal Test Method | T=0<br>T=2 | Pass |
| 3 | Torqueability | FDA Coronary and Cerebrovascular<br>Guidewire Guidance / Internal Test Method | T=0<br>T=2 | Pass |
| 4 | Guidewire compatibility | FDA Coronary and Cerebrovascular<br>Guidewire Guidance / Internal Test Method | T=0<br>T=2 | Pass |
| 5 | Radiopacity | ASTM-F640-12 | T=0<br>T=2 | Pass |
| 6 | Tensile Strength | FDA Coronary and Cerebrovascular<br>Guidewire Guidance / ISO 11070:2014 | T=0<br>T=2 | Pass |
| 7 | Coating Adherence and Integrity;<br>Particulate Quantitation | FDA Coronary and Cerebrovascular<br>Guidewire Guidance / Internal Test Method | T=0<br>T=2 | Pass |
| 8 | Durability of Hydrophilic Coating | Internal Test Method | T=0<br>T=2 | Pass |
| 9 | Lubricity of Hydrophilic Coating | Internal Test Method | T=0<br>T=2 | Pass |
| 10 | Shaft stiffness and Tip Flexibility | FDA Coronary and Cerebrovascular<br>Guidewire Guidance / ASTM D747-10 | T=0<br>T=2 | Pass |
| 11 | Fracture | ISO 11070:2014 | T=0<br>T=2 | Pass |
| 12 | Tip Impact | FDA Coronary and Cerebrovascular<br>Guidewire Guidance / Internal Test Method | T=0<br>T=2 | Pass |
| 13 | Corrosion Resistance | ISO 11070:2014 | T=0<br>T=2 | Pass |
| 14 | Trackability | Internal Test Method | T=0<br>T=2 | Pass |
| 15 | Packing Dye Penetration | ASTM F1929-15/F1886-09 | T=0<br>T=2 | Pass |
| 16 | Seal Strength | ASTM F88 / F88M - 15 | T=0<br>T=2 | Pass |
| 17 | Shipping and Transit | ISTA 3A | T=0<br>T=2 | Pass |
| 18 | Accelerated Aging | ASTM-E1980-07 | T=0<br>T=2 | Pass |

#### Table 5.7.1 Bench Testing Performed on TXM Hydrophilic Guidewire

### 5.7.2 - Biocompatibility

The TXM Hydrophilic Guidewire 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.

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| Biological Effect | Test | Compliance<br>Standard |
|-----------------------------------|---------------------------------------------------------|-------------------------|
| Cytotoxicity | L929 MEM Elution<br>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 |
| Material Mediated<br>Pyrogenicity | Pyrogen Test in Rabbit | USP<151><br>ISO10993-11 |
| Material Mediated<br>Pyrogenicity | Limulus Amebocyte Lysate | USP 38, NF 33, 2015 |
| Hemocompatibility | Hemolysis-Complete (Direct and Indirect) | ISO10993-4 |
| Hemocompatibility | Complement Activation | ISO10993-4 |
| Hemocompatibility | In-Vivo Thrombogenicity | ISO10993-4 |

Table 5.7.2 Biocompatibility Testing for the TXM Hydrophilic Guidewire

### 5.8 - Sterilization Testing Summary

| Table 5.8 Sterilization Testing for the TXM Hydrophilic Guidewire | | | | |
|-------------------------------------------------------------------|--|--|--|--|
| | | | | |

| Validation Sterilization<br>Process | Compliance Standard | Sterility Assurance<br>Level (SAL) | Validation<br>Result |
|-------------------------------------|---------------------|------------------------------------|----------------------|
| Ethylene Oxide Gas | ISO 11135 | 10-6 | Pass |

### 5.9 – Conclusion

The TXM Hydrophilic Guidewire 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.