(260 days)
No reference devices were used in this submission.
No
The description focuses on the mechanical and material properties of the introducer, with no mention of AI or ML.
No
The device is an introducer for other catheters and devices, facilitating their passage but not providing direct therapeutic action itself.
No
Explanation: The device is described as an introducer for catheters and devices into the femoral artery, facilitating their passage. It does not perform any diagnostic function such as identifying a disease or condition. Its purpose is purely interventional/procedural.
No
The device description clearly describes a physical, implantable medical device made of a polymer braid, dilator, and hydrophilic coating, intended for insertion into the femoral artery. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The transGlideXT Expandable Introducer is a device that is inserted into the femoral artery to facilitate the introduction of other catheters and devices into the body. It is a tool used during a medical procedure, not a device that analyzes samples.
- Intended Use: The intended use clearly states it's for insertion into the femoral artery to provide a guide for other devices. This is an in vivo (within the living body) application.
The description and intended use of the transGlideXT Expandable Introducer align with a surgical or interventional device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral artery, femoral iliac arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- Complement Activation C3a and SC5b-9
- Partial Thromboplastin Time
- Hemolysis (Direct and Extract)
- Pyrogenicity
- Material Mediated Pyrogen
- Bacterial Endotoxins-Limulus Amebocyte Lysate (LAL)
Bench Testing
- Visual Inspection and Dimensional Verification
- Flush Testing
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
TransAortic Medical, Inc. transGlide Expandable Introducer (K152194)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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 (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
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) |
|---|
| 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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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: (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
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 | ||
| Model Name | ||
| 510(k) Number | transGlide Expandable Introducer | |
| K152194 | transGlideXT Expandable Introducer | |
| K181817 | ||
| Intended Use | To provide an access conduit for the | |
| introduction of devices into the | ||
| peripheral vasculature | Same | |
| Indications for Use | 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. | Same | |
| Product Code | DYB | |
| 21 CFR 870.1340 | ||
| Catheter Introducer | ||
| Class II | Same | |
| Anatomical | ||
| Locations | Peripheral Vasculature | Same |
| French Sizes | ||
| Available | 16-20F | Up to 22F |
| Usable Length | 30cm | Same |
| Expansion | ||
| Mechanism | Insertion of sheath through mesh | Insertion of catheter or device through |
| mesh | ||
| 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
6
| Manufacturer
Model Name
510(k) Number | TransAortic Medical, Inc.
transGlide Expandable Introducer
K152194 | TransAortic Medical, Inc.
transGlideXT Expandable Introducer
K181817 |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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 | • Expandable polymer Mesh with
radiopaque marker
• Polymer Hub with Hemostasis Valve
and Extension Tube/3-Way Stopcock
• Polymer/Stainless Steel Mesh Dilator
with Luer
• Hydrophilic coating |
| Radiopacity | Radiopaque marker at distal tip | Same |
| Sterilization Method | Gamma Irradiation | Ethylene Oxide |
| Placement | Standard techniques for placement of
vascular access sheaths | Same |
| Guidewire
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.