The transGlide 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 transGlide Expandable Introducer consists of an expandable Mesh Assembly and a flexible Sheath Assembly. The Mesh Assembly, with an indwelling Dilator, is inserted into the femoral artery over a 0.035" (or smaller) guidewire. The Mesh Assembly is introduced at a small diameter of 13F inner diameter (ID) and is designed with a hydrophilic coating on the outer diameter (OD) of the usable length (effective length), thus facilitating passage through the femoral artery. The proximal 11cm of the Mesh is sealed to prevent blood loss at the access site. Once at the target location, the Mesh Dilator is removed and the Sheath Assembly is inserted, with an indwelling Dilator, through the Mesh Assembly over the guidewire.

Prior to removal, the Sheath Assembly is withdrawn through the Mesh Assembly until the Sheath Removal Indicator is visible just proximal to the Docking Port, leaving 8cm of Sheath usable length in place to prevent blood loss while the entire assembly is withdrawn and removed from the patient.

The Mesh consists of a polymer braid, which expands to accommodate the profile of the Sheath. The Mesh provides a bearing surface for the Sheath, which is designed to reduce the axial forces applied to the artery wall while the Sheath is being inserted. The Sheath Assembly Dilator is removed leaving a large (16F, 18F or 20F) central lumen extending from the proximal end to the distal end of the Sheath with a usable length of 30cm.

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

AI/ML Overview

The provided text describes the transGlide Expandable Introducer and its substantial equivalence to a predicate device, the Terumo SoloPath® Balloon Expandable TransFemoral Introducer (K100819). However, the document does not contain the specific acceptance criteria and detailed device performance results in a table format as requested in point 1 of your prompt. It lists the types of tests performed but not the quantitative pass/fail criteria or the actual results.

Therefore, the following information will be provided based on what is available in the document, and will explicitly state what is not present.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, the document does not provide a table of acceptance criteria with specific quantitative pass/fail values, nor does it present detailed numerical device performance results for most of the listed tests. It generally states that "the safety acceptance criteria for the study were met" for the animal study, and that non-clinical testing "demonstrate[s] that the device is substantially equivalent... and functions as intended and meets design specifications."

Here's a summary of the types of performance evaluated:

Test Category	Specific Tests Performed	Acceptance Criteria / Reported Performance
Biocompatibility	- Cytotoxicity: MEM Elution (L-929) - Sensitization: Magusson-Kligman Method - Irritation: Intracutaneous Toxicity (ISO) - Systemic Toxicity: Systemic Injection (ISO) - Hemocompatibility (Thrombogenicity, Complement Activation C3a and SC5b-9, Partial Thromboplastin Time, Hemolysis - Direct and Extract) - Pyrogenicity (Material Mediated Pyrogen, Bacterial Endotoxins-Limulus Amebocyte Lysate (LAL))	The implication is that the device met the biocompatibility requirements for substantial equivalence. Specific criteria and results are not provided.
Bench Testing	- Visual Inspection and Dimensional Verification - Flush Testing - Simulated Use: Advancement, Dilator Removal, Retraction & Inspection - Leak Testing (BS EN 11070:1999) - 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 11070:1999) - Corrosion Testing (BS EN 11070:1999) - Packaging Validation (BS EN ISO 11607-111607-112009 + A1:2014) - Sterilization Validation (ANSI/AAMI/ISO 11137-2:2013) - Shelf Life	The document states these tests were performed to "verify and validate the performance of the device and ensure the transGlide Expandable Introducer functions as intended and meets design specifications." Specific criteria and results are not provided.
Animal Studies	GLP animal study in an ovine model, comparing transGlide against the predicate (Terumo SoloPath® K100819). Evaluated safety and performance.	"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. No untoward observations were found by the clinician."

2. Sample Size Used for the Test Set and the Data Provenance

Test Set Sample Size:
- Animal Study: The document states "A GLP animal study was performed... in an ovine model." It does not specify the number of animals (sample size) used in this study.
- Bench Testing: For individual bench tests (e.g., tensile tests, leak tests), the sample sizes are not provided.
Data Provenance: The document does not specify the country of origin for the data for the animal study or bench testing, but the context implies it was likely conducted in the US or under US regulatory standards (given the FDA submission). It is not stated whether the animal study was purely prospective or if any retrospective data was included. Bench testing is typically prospective, performed specifically for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Animal Study: The document mentions "pathology and histopathology results" and "observations were made by the clinician." This implies input from veterinary pathologists and clinicians, but it does not specify the number of experts or their detailed qualifications (e.g., specific years of experience, board certifications).
Bench Testing: Ground truth for bench testing is generally based on engineering standards and measurement accuracy, not typically human expert consensus in the same way clinical data is.

4. Adjudication Method for the Test Set

Animal Study: The document does not specify an adjudication method (e.g., 2+1, 3+1) for the pathology, histopathology, or clinical observations. It simply states the results met safety acceptance criteria and no untoward observations were found.
Bench Testing: Adjudication methods are not typically applicable to the objective measurements derived from bench testing.

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

No, an MRMC comparative effectiveness study was not done. This type of study typically involves multiple human readers interpreting medical images or data, with and without an AI algorithm's assistance, to measure the AI's impact on human performance. The device described (transGlide Expandable Introducer) is a physical medical device, not an AI/software as a medical device (SaMD), so an MRMC study is not relevant here.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done. As mentioned above, this device is a physical medical device, not an AI algorithm. Therefore, an "algorithm only" performance study is not applicable.

7. Type of Ground Truth Used

Animal Study: The ground truth for the animal study seems to be based on a combination of histopathology results and clinical observations by experts (veterinary pathologists and clinicians) following GLP guidelines. This is a form of expert assessment integrated with objective pathological findings.
Bench Testing: The ground truth for bench testing is based on established engineering standards and measurements.

8. Sample Size for the Training Set

This question is not applicable as the transGlide Expandable Introducer is a physical medical device, not an AI algorithm that requires a "training set" in the machine learning sense.

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

This question is not applicable for the same reason as point 8; there is no AI training set.

Summary

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three overlapping profiles.

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

April 7, 2016

TransAortic Medical, Inc. % Diana DeGregorio Regulatory Affairs Consultant 135 E. Main Ave., Suite 170 Morgan Hill, California 95037

Re: K152194

Trade/Device Name: transGlide Expandable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: March 7, 2016 Received: March 8, 2016

Dear Diana 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 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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 Statement

510(k) Number (if known): K152194

Device Name: transGlide Expandable Introducer

Indications for Use:

× Over-The-Counter Use __________________ Or Prescription Use (per 21 CFR 801.109)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

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K152194 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 Regulatory Affairs Consultant (925) 980-8047 ddeqregorio@linceconsulting.com

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

Date Prepared August 3, 2015

II. DEVICE

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

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��. PREDICATE

Terumo (formerly Onset Medical Corporation) Solo Path® Balloon Expandable TransFemoral Introducer (K100819)

This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

TransAortic Medical, Inc. is the manufacturer of the transGlide 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 transGlide Expandable Introducer has similar features as compared to the predicate device as shown in the following table:

Manufacturer	Terumo (formerly Onset MedicalCorporation)	TransAortic Medical, Inc.
Model Name	SoloPath® Balloon ExpandableTransFemoral Introducer	transGlide Expandable Introducer
510(k) Number	K100819	TBD
Intended Use	To provide an access conduit for theintroduction of devices into the peripheralvasculature	To provide an access conduit for theintroduction of devices into the peripheralvasculature
Indication for Use	The SoloPath Balloon ExpandableTransFemoral Introducer is intended tobe inserted percutaneously into thefemoral artery, over a guidewire, andonce expanded, to provide a guide forcatheters and/or devices introduced intothe femoral iliac arteries.	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.
Product Code	DYB21 CFR 870.1340Catheter IntroducerClass II	DYB21 CFR 870.1340Catheter IntroducerClass II
Anatomical Locations	Peripheral Vasculature	Same
French SizesAvailable	14-21F	16-20F
Usable Length	25—35cm	30cm
ExpansionMechanism	injecting fluid through the applicable portto inflate balloon	insertion of sheath through mesh
Insertion Profile	Outer Diameter: 3.8-5.0mm (11.5-15F)	Outer Diameter: 5.0mm (15F)
Expansion Profile	Inner Diameter: 4.7-7.0mm (14-21F)Outer Diameter: 5.7-8.0mm (17-24F)	Inner Diameter: 5.3-6.7mm (16-20F)Outer Diameter: 6.7-8.0mm (20-24F)
Materials	Polymer Sheath (reinforced with stainless steel ribbon) with radiopaque marker Polymer Hub with Hemostasis Valve and Extension Tube/3-Way Stopcock Polymer Sheath Dilator with balloon and proximal Luer Hydrophilic coating	Polymer Sheath with radiopaque marker and removal indicator Polymer Hub with Hemostasis Valve and Extension Tube/3-Way Stopcock Polymer Sheath Dilators with Luer Expandable polymer Mesh Polymer Docking Port with Seal Polymer/Stainless Steel Mesh Dilator with Luer Hydrophilic coating
Radiopacity	Radiopaque marker at distal tip	Same
Sterilization Method	EO	Gamma Irradiation

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Manufacturer	Terumo (formerly Onset MedicalCorporation)	TransAortic Medical, Inc.
Model Name	SoloPath® Balloon ExpandableTransFemoral Introducer	transGlide Expandable Introducer
510(k) Number	K100819	TBD
Placement	Standard techniques for placement ofvascular access sheaths	Same
Guidewirecompatibility	0.038" (or smaller) compatible guidewire	0.035" (or smaller) compatible guidewire

The technological characteristics and principals of operation of the transGlide Expandable Introducer is substantially equivalent to the named predicate device.

VII. PERFORMANCE DATA

The following performance testing was conducted on the transGlide 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) o
Pyrogenicity ●
- Material Mediated Pyrogen O
- Bacterial Endotoxins-Limulus Amebocyte Lysate (LAL) o

Bench Testing

Visual Inspection and Dimensional Verification ●
. Flush Testing
Simulated Use: Advancement, Dilator Removal, Retraction & Inspection ●
Leak Testing (BS EN 11070:1999) .
Bend/Kink Resistance Testing .
Radiopacity Testing
. Interventional Device Advancement and Removal
Hydrophilic Coating Lubricity ●
Hydrophilic Coating Durability

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Hydrophilic Coating Particulate Characterization ●
Hub to Sheath Rotation .
Tensile Tests (BS EN 11070:1999) ●
. Corrosion Testing (BS EN 11070:1999)
Packaging Validation (BS EN ISO 11607-111607-112009 + A1:2014) ●
Sterilization Validation (ANSI/AAMI/ISO 11137-2:2013) ●
Shelf Life

Animal Studies

A GLP animal study was performed to evaluate the safety and performance of the transGlide Expandable Introducer as compared to a control device (Terumo SoloPath® Balloon Expandable TransFemoral Introducer (K100819)) in an ovine model. 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. No untoward observations were found by the clinician.

VIII. CONCLUSIONS

The transGlide 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 transGlide 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).