(258 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a guiding sheath introducer, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an introducer to deliver other devices for diagnostic and therapeutic procedures, but it is not therapeutic itself.
No
The device is a Guiding Sheath Introducer, which is explicitly stated in the "Intended Use" section as being for the "percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures." This indicates it is an accessory device used with diagnostic devices, not a diagnostic device itself. The "Device Description" also refers to it as an "introducer for interventional/diagnostic devices."
No
The device description clearly outlines a physical medical device consisting of a sheath, dilator, and various material components (Teflon, stainless steel, Polyether block amide, Grilamid, HDPE). There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures." This describes a device used within the body for access and guidance during medical procedures.
- Device Description: The description details a physical device designed for intravascular use, including components like a sheath, dilator, and hemostatic valve. These are all characteristics of devices used for accessing and navigating the vascular system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or compatibility. IVDs typically involve reagents, assays, or instruments for analyzing biological samples like blood, urine, or tissue.
Therefore, the Guiding Sheath Introducer is a medical device used for interventional and diagnostic procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DYB
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 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Percutaneous access into veins and/or arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital catheterization laboratory
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)
Bench testing was performed on non-aged devices (T=0) and devices subject to 2 years of accelerated aging (T=2) to evaluate design elements and performance characteristics. Tests included: Dimensional & Physical Attributes, Lubricity of Hydrophilic Coating, Dilator Guidewire and Sheath Catheter Compatibility, Liquid Leak, Air Leak, Seal Strength (Pouch), Dye Penetration Test, Radiopacity, In-Vitro Track Force, Kink Resistance, Durability of Hydrophilic Coating, Tensile Strength, Coating Integrity, Corrosion Resistance, Female Luer Verification, and Accelerated Aging. All tests met predetermined acceptance criteria.
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). Tests included: Intracutaneous Injection, Kligman Maximization/Murine Local Lymph Assay, ISO Acute Systemic Toxicity Test, L929 Neutral Red Uptake Cytotoxicity Test, Pyrogen Test in Rabbit, Hemolysis-Complete (Direct and Indirect), Complement Activation, and In-Vivo Thrombogenicity. All testing met predetermined acceptance criteria.
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.
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.
Not Found
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health & Human Services.
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.
1
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,
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
2
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) | |
|---|---|
| ☑ 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 PRAStaff@fda.hhs.gov
"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
5.1 - Company Information & Contact Person
| Company Name: | Texas Medical Technologies Inc. |
|---|---|
| Company Address: | 9005 Montana Ave. Ste. A |
| El Paso, Texas 79925 | |
| Telephone: | (915) 774-4321 |
| Fax: | (915) 774-4323 |
| 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
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
4
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
Model Number | French
size | Shaft
Length (cm) | Inner
Diameter
(inches) | Marker Band
Material | Hemostatic
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.
5
Table 5.6 below provides a comparison of the TXM Guiding Sheath and the predicate.
| Technical Characteristics
/ Principle of Operation | TXM Guiding Sheath | Super Arrow Flex®
Percutaneous
Sheath Introducer
Set | Substantially
Equivalent? |
|-------------------------------------------------------|-----------------------------------|---------------------------------------------------------------|------------------------------|
| Sheath Length | 45 cm - 90 cm | 11 cm, 24 cm, 45 cm,
65 cm, 90 cm | Yes |
| Sheath Size | 4 Fr, 5 Fr and 6 Fr | 5 Fr, 6 Fr, 7 Fr, 8 Fr, 9 Fr,
10 Fr | Yes |
| Shape | Straight | Straight | Yes |
| Inner Liner Material | Polytetrafluoroethylene
(PTFE) | Unknown | Yes |
| Wire Reinforcement
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
way stopcock | Polycarbonate/Silicon Valve | Unknown | Yes |
| Touhy Borst Adapeter with
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.
6
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
| Test Name | Applicable
Standard
or Internal
Test
Method | Test
Results
(T=2) | Test
| Test Name | Applicable
Standard
or Internal
Test
Method | Test
Results
(T=2) |
|-----------|-----------------------------------------------------------------|---------------------------------------------------------|--------------------------|-----------|-----------------------------------------|---------------------------------------------------------|--------------------------|
| 1 | Dimensional
& Physical
Attributes | ISO 10555 | T=0;T=2
Pass | 9 | In-Vitro Track
Force | Internal
Test
Method | T=0;T=2
Pass |
| 2 | Lubricity of
Hydrophilic
Coating | Internal
Test
Method | T=0;T=2
Pass | 10 | Kink
Resistance | Internal
Test
Method | T=0;T=2
Pass |
| 3 | Dilator
Guidewire
and Sheath
Catheter
Compatibility | Internal
Test
Method | T=0;T=2
Pass | 11 | Durability of
Hydrophilic
Coating | Internal
Test
Method | T=0;T=2
Pass |
| 4 | Liquid Leak | ISO 10555 | T=0;T=2
Pass | 12 | Tensile
Strength | ISO 10555 | T=0;T=2
Pass |
| 5 | Air Leak | ISO 10555 | T=0;T=2
Pass | 13 | Coating
Integrity | Internal
Test
Method | T=0;T=2
Pass |
| 6 | Seal Strength
(Pouch) | ASTM
F88/F88M-
09 | T=0;T=2
Pass | 14 | Corrosion
Resistance | ISO 10555 | T=0;T=2
Pass |
| 7 | Dye
Penetration
Test | ASTM-
F1929-12 | T=0;T=2
Pass | 15 | Female Luer
Verification | ISO 594 | T=0;T=2
Pass |
| 8 | Radiopacity | ASTM-
F640-12 | T=0;T=2
Pass | 16 | Accelerated
Aging | ASTM
F1980-07 | T=0;T=2
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.
7
| Biological Effect | Test | Compliance Standard |
|---|---|---|
| Irritation | Intracutaneous Injection - ISO | ISO10993-10 |
| Sensitization | Kligman Maximization | |
| 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 |
| 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
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.