TXM Guiding Sheath

K153771 · Texasmedical Technologies, Inc. · DYB · Sep 13, 2016 · Cardiovascular

Device Facts

• Record ID: K153771
• Device Name: TXM Guiding Sheath
• Applicant: Texasmedical Technologies, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Sep 13, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Guiding Sheath Introducer is intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures.

Device Story

TXM Guiding Sheath functions as a vessel introducer and guiding catheter for intravascular access. Device consists of PTFE inner liner, stainless steel coil reinforcement, and polyether block amide outer shaft with hydrophilic coating. Distal end features radiopaque platinum-iridium marker band for visualization; proximal end includes hemostatic valve (cross-cut or Tuohy Borst). Supplied with dilator (Grilamid or HDPE) to facilitate vessel entry. Used in hospital catheterization labs by clinicians to introduce interventional/diagnostic devices into veins or arteries. Operates over-the-wire or over-the-dilator. Provides atraumatic access and maintains hemostasis during procedure. Benefits include facilitated device delivery and reduced vascular trauma.

Clinical Evidence

Bench testing only. No clinical data. Testing included dimensional/physical attributes, lubricity, kink resistance, liquid/air leak, tensile strength, radiopacity, and biocompatibility (ISO 10993). All tests met predetermined acceptance criteria for both non-aged and 2-year accelerated aged devices.

Technological Characteristics

Materials: PTFE liner, stainless steel coil, polyether block amide shaft, platinum-iridium marker, polycarbonate/silicon valves, Grilamid/HDPE dilators. Dimensions: 4Fr-6Fr, 45cm-90cm lengths. Connectivity: None. Sterilization: EtO gas (SAL 10^-6). Standards: ISO 10555 (catheters), ISO 10993 (biocompatibility), ASTM F88/F1929/F640/F1980 (packaging/testing), ISO 594 (luer).

Indications for Use

Indicated for patients requiring percutaneous vascular access for diagnostic or therapeutic procedures in a hospital catheterization laboratory.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Arrow Fischell Kink Resistance Percutaneous Sheath Introducer Set (K924607)

Submission Summary (Full Text)

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

September 13, 2016

Texas Medical Technologies, Inc. % EJ Smith Consultant Smith Associates Crofton, Maryland 21114

Re: K153771

Trade/Device Name: TXM Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 7, 2016 Received: September 7, 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 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 [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) K153771

Device Name TXM Guiding Sheath

Indications for Use (Describe)

The Guiding Sheath Introducer is intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| <div><span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div><span style="font-family: Arial;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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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: | 09/08/2016 |

5.2 - Device Name & Classification

| Proprietary Name: | TXM Guiding Sheath |
|----------------------|---------------------|
| Common Name: | Catheter introducer |
| Classification Name: | Catheter introducer |
| Regulation Number: | 21 CFR 870.1340 |
| Product Code: | DYB |
| Device Class: | II |

#### 5.3 - Predicate Device

Legally Marketed Substantially Equivalent Predicate Device

| Proprietary Name: | Arrow Fischell Kink Resistance Percutaneous Sheath<br>Introducer Set |
|----------------------|----------------------------------------------------------------------|
| Company Name: | Arrow International Inc. |
| Common Name: | Catheter introducer |
| Classification Name: | Catheter introducer |
| Regulation Number: | 21 CFR 870.1340 |
| Product Code: | DYB |
| Device Class: | II |
| 510(k) Number | K924607 |

#### 5.4 - Device Description

The Guiding Sheath is intended for intravascular use for the introduction of interventional/diagnostic devices to the human vasculature. The Guiding Sheath is designed to work as a vessel introducer and a guiding catheter. It consists of a lubricous inner liner made from Teflon, and a stainless steel coil over the inner liner. The outer shaft consists of colored Polyether block amide. A Radiopaque Marker band is attached to the distal end of the shaft for radiopacity. The Distal end of the shaft is atraumatic. The Proximal end of the catheter is attached to a Hemostatic Valve. The device is available in

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three inner diameter sizes of 4Fr, 5Fr, and 6Fr; consisting of 0.063", 0.076" and 0.087" (throughout the shaft) respectably. A lubricious hydrophilic coating shall be applied to the outer diameter of the Catheter Sheath for improved trackability through the vasculature. The device contains a separate Dilator shaft made of two different materials depending on the size. For the 4Fr, Grilamid is used for the body and the Luer attached to the proximal end as well. For the 5Fr and 6F, high densiy polyethylene (HDPE) is used for the body and the Luer attached to the proximal end as well. The distal end of the Dilator is tapered for ease of access to the vessel. The device is available in lengths of 45cm and 90cm.

The device is supplied sterile and is intended for single use

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

Table 5.4.1. TXM Guiding Sheath Models and Sizes

| Commercial<br>Model Number | French<br>size | Shaft<br>Length (cm) | Inner<br>Diameter<br>(inches) | Marker Band<br>Material | Hemostatic<br>Valve |
|----------------------------|----------------|----------------------|-------------------------------|-------------------------|---------------------|
| GS-445-CS | 4 | 45 | 0.063 | Platinum-Iridium | Cross Cut |
| GS-445-TS | 4 | 45 | 0.063 | Platinum-Iridium | Tuohy Borst |
| GS-490-CS | 4 | 90 | 0.063 | Platinum-Iridium | Cross Cut |
| GS-490-TS | 4 | 90 | 0.063 | Platinum-Iridium | Tuohy Borst |
| GS-545-CS | 5 | 45 | 0.076 | Platinum-Iridium | Cross Cut |
| GS-545-TS | 5 | 45 | 0.076 | Platinum-Iridium | Tuohy Borst |
| GS-590-CS | 5 | 90 | 0.076 | Platinum-Iridium | Cross Cut |
| GS-590-TS | 5 | 90 | 0.076 | Platinum-Iridium | Tuohy Borst |
| GS-645-CS | 6 | 45 | 0.087 | Platinum-Iridium | Cross Cut |
| GS-645-TS | 6 | 45 | 0.087 | Platinum-Iridium | Tuohy Borst |
| GS-690-CS | 6 | 90 | 0.087 | Platinum-Iridium | Cross Cut |
| GS-690-TS | 6 | 90 | 0.087 | Platinum-Iridium | Tuohy Borst |

## 5.5 - Indications for Use

The Guiding Sheath Introducer is intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures.

- 5.5.1 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 Sheath 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 Guiding Sheath is substantially equivalent to the predicate device.

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Table 5.6 below provides a comparison of the TXM Guiding Sheath and the predicate.

| Technical Characteristics<br>/ Principle of Operation | TXM Guiding Sheath | Super Arrow Flex®<br>Percutaneous<br>Sheath Introducer<br>Set | Substantially<br>Equivalent? |
|-------------------------------------------------------|-----------------------------------|---------------------------------------------------------------|------------------------------|
| Sheath Length | 45 cm - 90 cm | 11 cm, 24 cm, 45 cm,<br>65 cm, 90 cm | Yes |
| Sheath Size | 4 Fr, 5 Fr and 6 Fr | 5 Fr, 6 Fr, 7 Fr, 8 Fr, 9 Fr,<br>10 Fr | Yes |
| Shape | Straight | Straight | Yes |
| Inner Liner Material | Polytetrafluoroethylene<br>(PTFE) | Unknown | Yes |
| Wire Reinforcement<br>Material | Stainless Steel | Stainless Steel | Yes |
| Radiopaque Marker | Platinum/Iridium marker band | Radiopaque marker band | Yes |
| Outer Shaft Material | Polyeter Block Amide | Polyurethane | Yes |
| Luer Material | Polycarbonate | Not Applicable | Yes |
| Cross Cut Valve with three<br>way stopcock | Polycarbonate/Silicon Valve | Unknown | Yes |
| Touhy Borst Adapeter with<br>side arm extension | Polycarbonate, Polyurethane | Unknown | Yes |
| Luer Connector | Female Luer Connector | Female Luer Connector | Yes |
| Hydrophilic Coated | Yes* | Yes | Yes |
| Anatomical Site Use | Percutaneous access | Percutaneous access | Yes |
| Delivery to Site | Over dilator and Over the wire | Over dilator and Over the | Yes |
| Dilator | HDPE and Nylon | Polymer | Yes |
| Guidewire 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 TXM Guiding Sheath 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 Guiding Sheath and to demonstrate substantial equivalence to the predicate device. The TXM Guiding Sheath 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 Guiding Sheath is substantially equivalent to the predicate device.

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#### 5.7.1- Bench Testing Table

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

| Test<br># | Test Name | Applicable<br>Standard<br>or Internal<br>Test<br>Method | Test<br>Results<br>(T=2) | Test<br># | Test Name | Applicable<br>Standard<br>or Internal<br>Test<br>Method | Test<br>Results<br>(T=2) |
|-----------|-----------------------------------------------------------------|---------------------------------------------------------|--------------------------|-----------|-----------------------------------------|---------------------------------------------------------|--------------------------|
| 1 | Dimensional<br>& Physical<br>Attributes | ISO 10555 | T=0;T=2<br>Pass | 9 | In-Vitro Track<br>Force | Internal<br>Test<br>Method | T=0;T=2<br>Pass |
| 2 | Lubricity of<br>Hydrophilic<br>Coating | Internal<br>Test<br>Method | T=0;T=2<br>Pass | 10 | Kink<br>Resistance | Internal<br>Test<br>Method | T=0;T=2<br>Pass |
| 3 | Dilator<br>Guidewire<br>and Sheath<br>Catheter<br>Compatibility | Internal<br>Test<br>Method | T=0;T=2<br>Pass | 11 | Durability of<br>Hydrophilic<br>Coating | Internal<br>Test<br>Method | T=0;T=2<br>Pass |
| 4 | Liquid Leak | ISO 10555 | T=0;T=2<br>Pass | 12 | Tensile<br>Strength | ISO 10555 | T=0;T=2<br>Pass |
| 5 | Air Leak | ISO 10555 | T=0;T=2<br>Pass | 13 | Coating<br>Integrity | Internal<br>Test<br>Method | T=0;T=2<br>Pass |
| 6 | Seal Strength<br>(Pouch) | ASTM<br>F88/F88M-<br>09 | T=0;T=2<br>Pass | 14 | Corrosion<br>Resistance | ISO 10555 | T=0;T=2<br>Pass |
| 7 | Dye<br>Penetration<br>Test | ASTM-<br>F1929-12 | T=0;T=2<br>Pass | 15 | Female Luer<br>Verification | ISO 594 | T=0;T=2<br>Pass |
| 8 | Radiopacity | ASTM-<br>F640-12 | T=0;T=2<br>Pass | 16 | Accelerated<br>Aging | ASTM<br>F1980-07 | T=0;T=2<br>Pass |

Table 5.7.1. Bench Testing Performed on TXM Guiding Sheath.

#### 5.7.2 - Biocompatibility

The TXM Guiding Sheath 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.

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| Biological Effect | Test | Compliance Standard |
|-------------------|--------------------------------------------------|-------------------------|
| 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 |
| Cytotoxicity | L929 Neutral Red Uptake Cytotoxicity Test | ISO 10993-5 |
| Pyrogenicity | Pyrogen Test in Rabbit | USP<151><br>ISO10993-11 |
| Hemocompatibility | Hemolysis-Complete (Direct and Indirect) | ISO10993-4 |
| Hemocompatibility | Complement Activation | ISO10993-4 |
| Hemocompatibility | In-Vivo Thrombogenicity | ISO10993-4 |

Table 5.7.2. Summary of Biocompatibility Testing for the TXM Guiding Sheath.

## 5.8 - Sterilization Testing Summary

| Validation Sterilization Process | Sterility Assurance Level (SAL) | Adoption Cycle<br>Result |
|----------------------------------|---------------------------------|--------------------------|
| Ethylene Oxide Gas | 10-6 | Pass |

## 5.9 – Conclusion

The TXM Guiding Sheath 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.