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 Description

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.

AI/ML Overview

The TransAortic Medical, Inc. transGlideXT Expandable Introducer (K181817) aims to establish substantial equivalence to its predicate device, the transGlide Expandable Introducer (K152194). The device 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.

Here's an analysis of the acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific numerical acceptance criteria and performance data in a direct table format. However, it outlines various performance tests conducted and states that the results confirmed safety and functionality comparable to the predicate.

Acceptance Criteria Category	Specific Test/Evaluation	Reported Device Performance
Biocompatibility	Cytotoxicity (MEM Elution), Sensitization (Magusson-Kligman), Irritation (Intracutaneous Toxicity), Systemic Toxicity (Systemic Injection), Hemocompatibility (Thrombogenicity, Complement Activation, Partial Thromboplastin Time, Hemolysis), Pyrogenicity (Material Mediated Pyrogen, Bacterial Endotoxins-LAL)	All biocompatibility tests (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, pyrogenicity) were performed. The implicit acceptance criterion is that the device demonstrates biocompatibility comparable to or better than the predicate device. The results are not explicitly stated, but the conclusion of substantial equivalence implies these criteria were met.
Bench Testing	Visual Inspection and Dimensional Verification	Performed. Implied compliance with design specifications.
	Flush Testing	Performed. Implied proper fluid dynamics.
	Simulated Use (Advancement, Dilator Removal, Retraction & Inspection)	Performed. Implied successful device operation during simulated clinical scenarios.
	Leak Testing (BS EN ISO 11070:2014)	Performed. Implied structural integrity and prevention of leakage.
	Bend/Kink Resistance Testing	Performed. Implied resistance to kinking during use.
	Radiopacity Testing	Performed. Implied visibility under fluoroscopy.
	Interventional Device Advancement and Removal	Performed. Implied compatibility with other interventional devices.
	Hydrophilic Coating Lubricity	Performed. Implied smooth advancement through vessels.
	Hydrophilic Coating Durability	Performed. Implied coating integrity over time.
	Hydrophilic Coating Particulate Characterization	Performed. Implied minimal particulate shedding.
	Hub to Sheath Rotation	Performed. Implied proper rotational functionality of components.
	Tensile Tests (BS EN ISO 11070:2014)	Performed. Implied mechanical strength.
	Corrosion Testing (BS EN ISO 11070:2014)	Performed. Implied resistance to degradation in biological environment.
	Packaging Validation (BS EN ISO 11607-:2009 + A1:2014)	Performed. Implied maintenance of sterility and integrity during storage and transport.
	Sterilization Validation (ANSI/AAMI/ISO 11135:2014, ANSI/AAMI/ISO 10993-7:2008/(R) 2012)	Performed. Implied effective sterilization to a specified sterility assurance level (SAL).
	Shelf Life	Performed. Implied maintenance of device properties over its specified shelf life.
Animal Studies	In vivo chronic and acute studies in ovine model	Safety Acceptance Criteria: Met based on pathology and histopathology results. Performance Observations: Functional and safe for intended use, comparable to predicate. The specific numerical acceptance criteria for these studies are not detailed but are stated as "consistent with the animal testing performed and submitted for the predicate (K152194)."

2. Sample Sizes and Data Provenance:

Test Set (Animal Studies): The document states "A series of in vivo evaluations were performed." The exact number of animals in the ovine model is not specified, but it implies multiple animals were used for both acute and chronic studies.
Data Provenance: Prospective animal study conducted in an ovine (sheep) model. The country of origin is not explicitly stated.

3. Number of Experts and their Qualifications for Ground Truth - Test Set:

The document mentions "pathology and histopathology results" were used for safety acceptance criteria in the animal study. This implies that veterinary pathologists were involved in establishing the ground truth.
The exact number and specific qualifications (e.g., years of experience) of these experts are not provided.

4. Adjudication Method for the Test Set:

The document does not specify an adjudication method for the animal study (e.g., use of multiple independent evaluators with a specific tie-breaking rule). It simply states that pathology and histopathology results were used to determine if safety criteria were met. This suggests a standard pathology review process rather than a complex adjudication method for comparing interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is typically used for diagnostic imaging devices to evaluate human reader performance with and without AI assistance. The transGlideXT is an introducer device, and its evaluation focuses on physical performance, biocompatibility, and procedural safety/effectiveness rather than diagnostic accuracy.
Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance.

6. Standalone Performance Study:

Yes, the performance testing described (biocompatibility, bench testing, and animal studies) represents a standalone evaluation of the device's performance. The device's functionality, safety, and performance characteristics were assessed independently, comparing them against established standards and the predicate device, rather than only in conjunction with human-in-the-loop performance.

7. Type of Ground Truth Used:

For the animal studies, the ground truth was established through pathology and histopathology results. This involves microscopic examination of tissues to identify and characterize any device-related adverse effects or tissue reactions.
For bench testing, the ground truth is based on engineering specifications and established test standards (e.g., BS EN ISO 11070:2014, ANSI/AAMI/ISO 11135:2014).

8. Sample Size for the Training Set:

This information is not applicable to the type of device and study described. The transGlideXT Expandable Introducer is a physical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of machine learning. The studies described are physical performance validations.

9. How Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for an AI/machine learning algorithm.

Summary

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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

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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Indications for Use

510(k) Number (if known) K181817

Device Name transGlideXT Expandable Introducer

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over The Counter Use (21 CFR 801 Subpart G)

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

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

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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: (408) 779-4200 Fax: (408) 779-4288

Contact Person Diana DeGregorio Lincé Consulting, LLC Regulatory Affairs Consultant Phone: (925) 980-8047 ddegregorio@linceconsulting.com

Alternate Contact: Nancy Lincé Regulatory & Clinical Affairs Consultant Lincé Consulting, LLC Phone: (650) 759-6186 nlince@linceconsulting.com

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

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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.

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V. INDICATIONS FOR USE

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.
ManufacturerModel Name510(k) Number	transGlide Expandable IntroducerK152194	transGlideXT Expandable IntroducerK181817
Intended Use	To provide an access conduit for theintroduction of devices into theperipheral vasculature	Same
Indications for Use	The transGlide Expandable Introducer isintended to be inserted into the femoralartery, over a guidewire, and onceexpanded, to provide a guide forcatheters and/or devices introduced intothe femoral iliac arteries.	Same
Product Code	DYB21 CFR 870.1340Catheter IntroducerClass II	Same
AnatomicalLocations	Peripheral Vasculature	Same
French SizesAvailable	16-20F	Up to 22F
Usable Length	30cm	Same
ExpansionMechanism	Insertion of sheath through mesh	Insertion of catheter or device throughmesh
Insertion Profile	Inner Diameter: 4.3mm (13F)Outer Diameter: 5.0mm (15F)	Inner Diameter: 4.0mm (12F)Outer Diameter: 4.7mm (14F)

Table 1: Predicate and Subiect Comparison Substantial Equivalence Table

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ManufacturerModel Name510(k) Number	TransAortic Medical, Inc.transGlide Expandable IntroducerK152194	TransAortic Medical, Inc.transGlideXT Expandable IntroducerK181817
Expansion Profile	Inner Diameter: 5.3-6.7mm (16-20F)Outer Diameter: 6.7-8.0mm (20-24F)	Inner Diameter: up to 7.3mm (up to 22F)Outer Diameter: up to 8.3mm (up to 25F)
Materials	• Polymer Sheath with radiopaquemarker and removal indicator• Polymer Hub with Hemostasis Valveand Extension Tube/3-Way Stopcock• Polymer Sheath Dilators with Luer• Expandable polymer Mesh• Polymer Docking Port with Seal• Polymer/Stainless Steel Mesh Dilatorwith Luer• Hydrophilic coating	• Expandable polymer Mesh withradiopaque marker• Polymer Hub with Hemostasis Valveand Extension Tube/3-Way Stopcock• Polymer/Stainless Steel Mesh Dilatorwith Luer• Hydrophilic coating
Radiopacity	Radiopaque marker at distal tip	Same
Sterilization Method	Gamma Irradiation	Ethylene Oxide
Placement	Standard techniques for placement ofvascular access sheaths	Same
Guidewirecompatibility	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 ●

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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.

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).