transGlideXT Expandable Introducer

K181817 · Transaortic Medical, Inc. · DYB · Mar 26, 2019 · Cardiovascular

Device Facts

• Record ID: K181817
• Device Name: transGlideXT Expandable Introducer
• Applicant: Transaortic Medical, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Mar 26, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The transGlideXT Expandable Introducer is intended to be inserted into the femoral artery, over a guidewire, and once expanded, to provide a guide for catheters and/or devices introduced into the femoral iliac arteries.

Device Story

The transGlideXT Expandable Introducer is a sterile, single-use, expandable mesh introducer designed to facilitate the insertion of large-profile catheters or devices (up to 22F) into the femoral iliac arteries. The device consists of a polymer mesh assembly with an indwelling dilator, inserted over a 0.035" guidewire. The mesh features a hydrophilic coating on both inner and outer diameters to reduce friction during insertion. Once positioned, the dilator is removed, and the mesh expands to accommodate the therapeutic device, providing a bearing surface that reduces axial forces on the arterial wall. The proximal 11 cm is sealed to prevent blood loss. Used in clinical settings by physicians, the device simplifies access by eliminating the need for a separate sheath assembly compared to its predecessor. It benefits patients by providing a lower-profile insertion method for large-bore interventional procedures, potentially reducing vascular trauma.

Clinical Evidence

No human clinical data provided. Evidence consists of comprehensive bench testing and in vivo animal studies. Bench testing included visual inspection, dimensional verification, leak testing (BS EN ISO 11070:2014), tensile tests, corrosion testing, and hydrophilic coating characterization. Animal studies (ovine model) compared the subject device to the predicate, evaluating safety and performance via pathology and histopathology. Results confirmed the device is functional, safe, and comparable to the predicate, meeting all pre-defined acceptance criteria.

Technological Characteristics

Expandable polymer mesh with radiopaque marker; polymer hub with hemostasis valve, extension tube, and 3-way stopcock; polymer/stainless steel mesh dilator with luer. Features hydrophilic coating. Dimensions: 30 cm usable length, 12F ID/14F OD insertion profile, expandable up to 22F ID/25F OD. Sterilization: Ethylene Oxide. Standards: BS EN ISO 11070:2014 (leak/tensile/corrosion), ANSI/AAMI/ISO 11135:2014 (sterilization), ANSI/AAMI/ISO 10993-7:2008 (sterilization residuals), BS EN ISO 11607:2009 (packaging).

Indications for Use

Indicated for patients requiring catheter or device introduction into the femoral iliac arteries via the femoral artery. Compatible with 0.035" or smaller guidewires.

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

• transGlide Expandable Introducer (K152194)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 26, 2019

TransAortic Medical, Inc. c/o Ms. Diana DeGregorio Regulatory Affairs Consultant Lince Consulting, LLC 135 E. Main Ave., Suite 170 Morgan Hill, CA 95037

Re: K181817

Trade/Device Name: transGlideXT Expandable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: February 15, 2019 Received: February 19, 2019

Dear Ms. DeGregorio:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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.

Digitally signed by Misti L. Misti L. Malone -S Date: 2019.03.26 12:28:00 -04'00"

For

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K181817

Device Name transGlideXT Expandable Introducer

Indications for Use (Describe)

The transGlideXT Expandable Introducer is intended to be inserted into the femoral artery, over a guidewire, and once expanded, to provide a guide for catheters and/or devices introduced into the femoral iliac arteries.

| Type of Use (Select one or both, as applicable) |
|--------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D)</div> |
| <div style="display:flex; align-items:center;"><input type="checkbox"/>Over The Counter Use (21 CFR 801 Subpart G)</div> |

| X Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

#### l. SUBMITTER

TransAortic Medical, Inc. 135 E. Main Avenue Suite 170 Morgan Hill, CA 95037 Phone: [phone] Fax: [phone]

Contact Person Diana DeGregorio Lincé Consulting, LLC Regulatory Affairs Consultant Phone: [phone] [e-mail]

Alternate Contact: Nancy Lincé Regulatory & Clinical Affairs Consultant Lincé Consulting, LLC Phone: [phone] [e-mail]

Date Prepared July 6, 2018

#### II. DEVICE

Trade Name: transGlideXT Expandable Introducer Common Name: Catheter Introducer Classification Name: Catheter Introducer Classification: 21 CFR§ 870.1340 Product Code: DYB Device Class: Class II

{4}------------------------------------------------

#### III. PREDICATE

TransAortic Medical, Inc. transGlide Expandable Introducer (K152194) This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

#### DEVICE DESCRIPTION IV.

TransAortic Medical, Inc. is the manufacturer of the transGlideXT Expandable Introducer, a device intended as a guide for catheters and/or devices introduced into the femoral iliac arteries.

The transGlideXT Expandable Introducer (also referred to as "transGlideXT") is the next generation expandable Mesh Introducer consisting of a polymer braid which expands to accommodate catheters and/or devices with profiles up to 22F. The Mesh Introducer, with an indwelling Dilator (also referred to as "Mesh Assembly"), is inserted into the femoral artery, over a 0.035" guidewire (or smaller). The device is introduced at a small diameter of 12F inner diameter (ID) and is designed with a hydrophilic coating on the outer diameter (OD) and ID along the 30 cm usable length, thus facilitating passage through the femoral artery and passage of the commercial catheter and/or device. The proximal 11 cm of the Mesh usable length is sealed to prevent blood loss at the access site. Once at the target location, the Dilator is removed and the Mesh Introducer provides a bearing surface for the commercial catheter and/ or device, which is designed to reduce the axial forces applied to the artery wall while the commercial catheter and/or device is being inserted.

The transGlideXT Expandable Introducer is a sterile, non-pyrogenic, single-use prescription device. The transGlideXT Expandable Introducer does not supply but recommends use with commercially available 0.035" (or smaller) Guidewires.

{5}------------------------------------------------

#### V. INDICATIONS FOR USE

The transGlideXT Expandable Introducer is intended to be inserted into the femoral artery, over a guidewire, and once expanded, to provide a guide for catheters and/or devices introduced into the femoral iliac arteries.

### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject and predicate devices are designed to be inserted into the femoral artery, over a guidewire, and once expanded, to provide a guide for catheters and/or devices introduced into the femoral iliac arteries. The subject device requires fewer procedural steps compared to the predicate as there is no introduction of a separate Sheath Assembly required. The primary difference between the previously cleared transGlide and the transGlideXT models is the removal of the Sheath Assembly and associated modification to the Mesh Assembly. The transGlideXT model is being offered to provide an Introducer that can accommodate devices up to 22F with fewer procedural steps and an effective thinner insertion profile.

A summary table comparing the subject and predicate device is provided in Table 1.

| | TransAortic Medical, Inc. | TransAortic Medical, Inc. |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Manufacturer<br>Model Name<br>510(k) Number | transGlide Expandable Introducer<br>K152194 | transGlideXT Expandable Introducer<br>K181817 |
| Intended Use | To provide an access conduit for the<br>introduction of devices into the<br>peripheral vasculature | Same |
| Indications for Use | The transGlide Expandable Introducer is<br>intended to be inserted into the femoral<br>artery, over a guidewire, and once<br>expanded, to provide a guide for<br>catheters and/or devices introduced into<br>the femoral iliac arteries. | Same |
| Product Code | DYB<br>21 CFR 870.1340<br>Catheter Introducer<br>Class II | Same |
| Anatomical<br>Locations | Peripheral Vasculature | Same |
| French Sizes<br>Available | 16-20F | Up to 22F |
| Usable Length | 30cm | Same |
| Expansion<br>Mechanism | Insertion of sheath through mesh | Insertion of catheter or device through<br>mesh |
| Insertion Profile | Inner Diameter: 4.3mm (13F)<br>Outer Diameter: 5.0mm (15F) | Inner Diameter: 4.0mm (12F)<br>Outer Diameter: 4.7mm (14F) |

### Table 1: Predicate and Subiect Comparison Substantial Equivalence Table

{6}------------------------------------------------

| Manufacturer<br>Model Name<br>510(k) Number | TransAortic Medical, Inc.<br>transGlide Expandable Introducer<br>K152194 | TransAortic Medical, Inc.<br>transGlideXT Expandable Introducer<br>K181817 |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Expansion Profile | Inner Diameter: 5.3-6.7mm (16-20F)<br>Outer Diameter: 6.7-8.0mm (20-24F) | Inner Diameter: up to 7.3mm (up to 22F)<br>Outer Diameter: up to 8.3mm (up to 25F) |
| Materials | • Polymer Sheath with radiopaque<br>marker and removal indicator<br>• Polymer Hub with Hemostasis Valve<br>and Extension Tube/3-Way Stopcock<br>• Polymer Sheath Dilators with Luer<br>• Expandable polymer Mesh<br>• Polymer Docking Port with Seal<br>• Polymer/Stainless Steel Mesh Dilator<br>with Luer<br>• Hydrophilic coating | • Expandable polymer Mesh with<br>radiopaque marker<br>• Polymer Hub with Hemostasis Valve<br>and Extension Tube/3-Way Stopcock<br>• Polymer/Stainless Steel Mesh Dilator<br>with Luer<br>• Hydrophilic coating |
| Radiopacity | Radiopaque marker at distal tip | Same |
| Sterilization Method | Gamma Irradiation | Ethylene Oxide |
| Placement | Standard techniques for placement of<br>vascular access sheaths | Same |
| Guidewire<br>compatibility | 0.035" (or smaller) compatible guidewire | Same |

#### VII. PERFORMANCE DATA

The following performance testing was conducted on the transGlideXT Expandable Introducer to support a determination of substantial equivalence to the predicate device.

Biocompatibility

- Cytotoxicity: MEM Elution (L-929) ●
- Sensitization: Magusson-Kligman Method .
- Irritation: Intracutaneous Toxicity (ISO) .
- Systemic Toxicity: Systemic Injection (ISO) ●
- Hemocompatibility: ●
- Thrombogenicity o
- Complement Activation C3a and SC5b-9 o
- Partial Thromboplastin Time o
- Hemolysis (Direct and Extract)
- Pyrogenicity ●
- o Material Mediated Pyrogen
- Bacterial Endotoxins-Limulus Amebocyte Lysate (LAL) o

## Bench Testing

- . Visual Inspection and Dimensional Verification
- Flush Testing ●

{7}------------------------------------------------

- Simulated Use: Advancement, Dilator Removal, Retraction & Inspection .
- Leak Testing (BS EN ISO 11070:2014) .
- Bend/Kink Resistance Testing ●
- Radiopacity Testing
- Interventional Device Advancement and Removal ●
- Hydrophilic Coating Lubricity ●
- Hydrophilic Coating Durability .
- Hydrophilic Coating Particulate Characterization
- Hub to Sheath Rotation ●
- Tensile Tests (BS EN ISO 11070:2014)
- Corrosion Testing (BS EN ISO 11070:2014) ●
- Packaging Validation (BS EN ISO 11607-:2009 + A1:2014) ●
- . Sterilization Validation (ANSI/AAMI/ISO 11135:2014, ANSI/AAMI/ISO 10993-7:2008/(R) 2012)
- . Shelf Life

# Animal Studies

A series of in vivo evaluations were performed to evaluate the safety and performance of the transGlideXT Expandable Introducer as compared to the transGlide Expandable Introducer predicate device in the ovine model. Testing Methods and acceptance criteria were consistent with the animal testing performed and submitted for the predicate (K152194). The results of the in vivo chronic and acute studies confirm that the transGlideXT Expandable Introducer is functional and safe for its intended use when used in accordance with the manufacturers labeling. In addition, the results demonstrate that the transGlideXT Expandable Introducer safety and functionality is comparable to the transGlide Expandable Introducer (predicate). Based on pathology and histopathology results, the safety acceptance criteria for the study were met. Performance observations were made based on detailed characteristics of the device.

#### CONCLUSIONS VIII.

The transGlideXT Expandable Introducer has been carefully compared to the legally marketed predicate device with respect to intended use/indications for use, technological characteristics, anatomical sites, performance, safety characteristics, and labeling. In addition, non-clinical testing was conducted to verify and validate the performance of the device and ensure the transGlideXT Expandable Introducer functions as intended and meets design specifications. The comparison, non-clinical and clinical performance testing results demonstrate that the device is substantially equivalent to the predicate device for its intended use.