(238 days)
The TXM Support Catheters are percutaneous, single lumen catheters designed for use in the peripheral vascular system. TXM Support Catheters are intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
The TXM Support Catheter is an over the wire (OTW) single lumen catheter with atraumatic tapered tip. The distal tip catheter shaft has 6 radiopaque markers (including the tip) that works as an aid to estimate positioning within the vasculature. It consists of a lubricious inner liner made from Teflon, and stainless steel braid over the liner and an outer layer that consists of clear Nylon 12 polymer. One gold marker band is positioned on the proximal side of the tip. A polycarbonate hub is attached to the proximal end of the TXM Support Catheter. The TXM Support Catheter system is offered in 8 models, four with a straight tip and four with an angled tip, and the angled tip configuration has an angle of 30°. All models will have an outer diameter of the 4 French size (0.052") and an inner diameter of 0.039" tapered down to 0.0355" towards the distal tip so that is compatible with a 0.035" guidewires. The device is available in lengths of 65cm, 90cm. 135cm, and 150cm. The catheter is coated with a lubricious hydrophilic coating. The device is supplied sterile and is intended for single use only.
This document describes the TXM Support Catheter and its substantial equivalence to a predicate device, focusing on bench and biocompatibility testing. It is a 510(k) submission, used for medical devices that are substantially equivalent to a legally marketed predicate device.
Here's an analysis of the provided text in relation to your request about acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a summary of bench testing performed on the TXM Support Catheter. For each test, it lists the applicable standard or internal test method and indicates "Pass" for both non-aged (T=0) and accelerated-aged (T=2) devices. While it doesn't explicitly state quantitative acceptance criteria for each test in a compact table, the "Pass" result implies that the device met these criteria.
| Test Name | Applicable Standard or Internal Test Method | Acceptance Criteria | Reported Device Performance (T=0 & T=2) |
|---|---|---|---|
| Dimensional And Physical Attributes | Internal Test Method | (Implicit: Conformance to specifications) | Pass |
| Catheter Compatibility | Internal Test Method | (Implicit: Compatibility with specified components) | Pass |
| Air Leakage | ISO 10555-1 | (Implicit: No air leakage as per standard) | Pass |
| Trackability | Internal Test Method | (Implicit: Meets specified trackability performance) | Pass |
| Crossability | Internal Test Method | (Implicit: Meets specified crossability performance) | Pass |
| Catheter Stiffness | ASTM D747-10 | (Implicit: Meets specified stiffness range) | Pass |
| Gravity Flow Rate | ISO 10555-1 | (Implicit: Meets specified flow rate) | Pass |
| Power Injection for Flow Rate | ISO 10555-1 | (Implicit: Meets specified power injection flow rate) | Pass |
| Lubricity of Hydrophilic Coating | Internal Test Method | (Implicit: Meets specified lubricity) | Pass |
| Durability of Hydrophilic Coating | Internal Test Method | (Implicit: Meets specified coating durability) | Pass |
| Liquid Leakage | ISO 10555-1 | (Implicit: No liquid leakage as per standard) | Pass |
| Static Burst Pressure | ISO 10555-1 | (Implicit: Withstands specified burst pressure) | Pass |
| Tensile Strength | ISO 10555-1 | (Implicit: Withstands specified tensile forces) | Pass |
| Radiopacity | ASTM-F640-12 | (Implicit: Meets specified radiopacity levels) | Pass |
| Torqueability | Internal Test Method | (Implicit: Meets specified torqueability performance) | Pass |
| Torque Strength | Internal Test Method | (Implicit: Withstands specified torque strength) | Pass |
| Kink Resistance | Internal Test Method | (Implicit: Resists kinking under specified conditions) | Pass |
| Corrosion Resistance | ISO 10555-1 | (Implicit: Shows no significant corrosion) | Pass |
| Coating Integrity and Particulates | Internal Test Method | (Implicit: Coating remains intact; minimal particulates) | Pass |
| Packing Integrity (Seal Strength) | ASTM F88 / F88M - 15 | (Implicit: Seal strength meets standard) | Pass |
| Packing Integrity (Packing Dye Penetration) | ASTM F1929-15 / F1886-09 | (Implicit: No dye penetration as per standard) | Pass |
| Shipping and Transit | ISTA 3A | (Implicit: Withstands shipping and transit stresses) | Pass |
| Accelerated Aging | ASTM F1980-07 | (Implicit: Demonstrates anticipated shelf-life) | Pass |
| Female Luer Verification | ISO 594 | (Implicit: Conforms to luer connection standard) | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Testing was performed on non-aged devices (T=0) as well as on devices subject to 2 years of accelerated aging (T=2)." However, the specific sample sizes for each test are not provided. The data provenance indicates that these were bench tests, meaning they were performed in a laboratory setting. There is no information regarding country of origin of the data as it's not clinical data, and the tests are inherently prospective in nature for a new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This report describes bench testing for a medical device (catheter), not a diagnostic or prognostic algorithm involving human interpretation of medical images or data. Therefore, the concept of "ground truth established by experts" and their qualifications as you might typically find in AI/CADe submissions is not applicable here. The "ground truth" for these tests is defined by the technical specifications, standards (like ISO or ASTM), and internal test methods that define acceptable performance for physical and material properties.
4. Adjudication Method for the Test Set:
Similar to point 3, adjudication methods are not applicable for these types of bench tests. The evaluation of test results against predefined acceptance criteria is typically a technical assessment by engineers or technicians, not a consensus-based adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a MRMC comparative effectiveness study was not done. This document is for a physical medical device (catheter), not an AI or imaging diagnostic software. Therefore, the concept of human readers improving with or without AI assistance is not relevant.
6. Standalone (Algorithm Only) Performance:
No, a standalone (algorithm only) performance study was not done. This is a physical support catheter, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for the performance testing cited is based on engineering specifications, recognized industry standards (ISO, ASTM), and internal test methods. These standards and specifications define the expected physical, chemical, and functional properties of the device. For example, for "Air Leakage," the ground truth is defined by the criteria within ISO 10555-1.
8. Sample Size for the Training Set:
Not applicable. This document describes a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set for a physical device, there is no ground truth to be established for it in this context.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
November 21, 2017
Texas Medical Technologies, Inc. % Mr. E.J. Smith Consultant Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114
Re: K170914
Trade/Device Name: TXM Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: October 13, 2017 Received: October 16, 2017
Dear Mr. 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 of medical device-related adverse events) (21 CFR 803); good
{1}------------------------------------------------
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-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.
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K170914
Device Name TXM Support Catheter
Indications for Use (Describe)
The TXM Support Catheters are percutaneous, single lumen catheters designed for use in the peripheral vascular system. TXM Support Catheters are intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
| 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: | 02/28/2017 |
5.2 – Device Name & Classification
| Proprietary Name: | TXM Support Catheter |
|---|---|
| Common Name: | Catheter, Support |
| Classification Name: | Catheter, Percutaneous |
| Regulation Number: | 21 CFR 870.1250 |
| Product Code: | DQY |
| Device Class: | II |
5.3 – Predicate Device
Legally Marketed Substantially Equivalent Predicate Device
| Proprietary Name:Company Name:Common Name:Classification Name:Regulation Number:Product Code:Device Class:510(k) NumberReference Devices | TrailBlazer™ Support Catheterev3 Inc.Catheter, SupportCatheter, Percutaneous21 CFR 870.1250DQYIIK092299 |
|---|---|
| Proprietary Name: | TrailBlazer™ Angled Support Catheter |
| Company Name: | ev3 Inc. |
| Common Name: | Catheter, Support |
| Classification Name: | Catheter, Percutaneous |
| Regulation Number: | 21 CFR 870.1250 |
| Product Code: | DQY |
| Device Class: | II |
| 510(k) Number | K162384 |
{4}------------------------------------------------
| Proprietary Name: | Spectranetics Quick-Cross Extreme Support Catheters |
|---|---|
| Company Name: | Spectranetics Corp. |
| Common Name: | Catheter, Support |
| Classification Name: | Catheter, Percutaneous |
| Regulation Number: | 21 CFR 870.1330 |
| Product Code: | DQY |
| Device Class: | II |
| 510(k) Number | K082561 |
Note: Reference devices are only to support the substantial equivalence of the subject device in regards to the angled tip.
5.4 - Device Description
The TXM Support Catheter is an over the wire (OTW) single lumen catheter with atraumatic tapered tip. The distal tip catheter shaft has 6 radiopaque markers (including the tip) that works as an aid to estimate positioning within the vasculature. It consists of a lubricious inner liner made from Teflon, and stainless steel braid over the liner and an outer layer that consists of clear Nylon 12 polymer. One gold marker band is positioned on the proximal side of the tip. A polycarbonate hub is attached to the proximal end of the TXM Support Catheter. The TXM Support Catheter system is offered in 8 models, four with a straight tip and four with an angled tip, and the angled tip configuration has an angle of 30°. All models will have an outer diameter of the 4 French size (0.052") and an inner diameter of 0.039" tapered down to 0.0355" towards the distal tip so that is compatible with a 0.035" guidewires. The device is available in lengths of 65cm, 90cm. 135cm, and 150cm. The catheter is coated with a lubricious hydrophilic coating. The device is supplied sterile and is intended for single use only.
The following table lists the models and sizes available for TXM Support Catheter.
| ProductCode | Frenchsize | ShaftLength(cm) | OuterDiameter(inches) | Inner Diameter (inches) | MarkerBandMaterial | TipShape |
|---|---|---|---|---|---|---|
| SC-35065-S | 4 | 65 | 0.052" | 0.039" - 0.0355" | Gold | Straight |
| SC-35090-S | 4 | 90 | 0.052" | 0.039" - 0.0355" | Gold | Straight |
| SC-35135-S | 4 | 135 | 0.052" | 0.039" - 0.0355" | Gold | Straight |
| SC-35150-S | 4 | 150 | 0.052" | 0.039" - 0.0355" | Gold | Straight |
| SC-35065-A | 4 | 65 | 0.052" | 0.039" - 0.0355" | Gold | Angled |
| SC-35090-A | 4 | 90 | 0.052" | 0.039" - 0.0355" | Gold | Angled |
| SC-35135-A | 4 | 135 | 0.052" | 0.039" - 0.0355" | Gold | Angled |
| SC-35150-A | 4 | 150 | 0.052" | 0.039" - 0.0355" | Gold | Angled |
Table 5.4 TXM Support Catheter Models and Sizes
{5}------------------------------------------------
5.5 - Indications for Use
The TXM Support Catheters are percutaneous, single lumen catheters designed for use in the peripheral vascular system. TXM Support Catheters are intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
The Indications for Use are identical, the devices are both intended for peripheral vascular use and the Indications for Use do not change the intended use of the TXM Support Catheter 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 Support Catheter is substantially equivalent to the predicate device. Table 5.6 below provides a comparison of the TXM Support Catheter and the predicate.
| Technical Characteristics /Principle of Operation | TXM Support Catheter | TrailBlazer ™ SupportCatheter | SubstantiallyEquivalent? |
|---|---|---|---|
| Length | 65cm, 90cm, 135 cm,150cm | 65cm, 90cm, 135 cm,150cm | Yes |
| Outer Diameter | 0.052" | 0.063" | Yes |
| Inner Diameter | 0.039"- 0.0355" | 0.042"-0.036" | Yes |
| Shape | Straight and Angled | Straight | Yes |
| Inner Liner Material | Polytetrafluoroethylene(PTFE)* | Unknown | Yes |
| Braid Reinforcement Material | Stainless Steel* | Not Applicable | Yes |
| Radiopaque Markers | A Gold marked band andradiopaque markers ofNylon 12 loaded withTungsten. * | Platinum/Iridium | Yes |
| Outer Shaft Material | Nylon 12* | Unknown | Yes |
| Luer Material | Polycarbonate* | Unknown | Yes |
| Luer Connector | Female Luer Connector* | Female Luer Connector | Yes |
| Anatomical Site Use | Peripheral Vascular system | Peripheral Vascular system | Yes |
| Delivery to Site | Over-the-wire | Over-the-wire | Yes |
| Guidewire Compatibility | Maximum 0.035" | Maximum 0.035" | Yes |
| Packaging | Tyvek Pouch | Tyvek Pouch | Y es |
| Sterilization | EtO Gas | EtO Gas | Yes |
Table 5.6 Comparison of the TXM Support Catheter and the Predicate Device
- Denotes a patient-contacting material.
{6}------------------------------------------------
5.7 - Performance Testing Summary
The following bench tests were performed to evaluate the design elements and performance characteristics of the TXM Support Catheter and to demonstrate substantial equivalence to the predicate device. The TXM Support Catheter 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 Support Catheter is substantially equivalent to the predicate device.
5.7.1- Bench Testing Summary
Table 5.7.1 below provides a summary of the bench testing performed on the TXM Support Catheter.
| TestNo. | Test Name | Applicable Standard orInternal Test Method | Test Results | |
|---|---|---|---|---|
| 1 | Dimensional And Physical Attributes | Internal Test Method | T=0T=2 | Pass |
| 2 | Catheter Compatibility | Internal Test Method | T=0T=2 | Pass |
| 3 | Air Leakage | ISO 10555-1 | T=0T=2 | Pass |
| 4 | Trackability | Internal Test Method | T=0T=2 | Pass |
| 5 | Crossability | Internal Test Method | T=0T=2 | Pass |
| 6 | Catheter Stiffness | ASTM D747-10 | T=0T=2 | Pass |
| 7 | Gravity Flow Rate | ISO 10555-1 | T=0T=2 | Pass |
| 8 | Power Injection for Flow Rate | ISO 10555-1 | T=0T=2 | Pass |
| 9 | Lubricity of Hydrophilic Coating | Internal Test Method | T=0T=2 | Pass |
| 10 | Durability of Hydrophilic Coating | Internal Test Method | T=0T=2 | Pass |
| 11 | Liquid Leakage | ISO 10555-1 | T=0T=2 | Pass |
| 12 | Static Burst Pressure | ISO 10555-1 | T=0T=2 | Pass |
| 13 | Tensile Strength | ISO 10555-1 | T=0T=2 | Pass |
| 14 | Radiopacity | ASTM-F640-12 | T=0T=2 | Pass |
| 15 | Torqueability | Internal Test Method | T=0T=2 | Pass |
| 16 | Torque Strength | Internal Test Method | T=0T=2 | Pass |
Table 5.7.1 Bench Testing TXM Support Catheter
{7}------------------------------------------------
| 17 | Kink Resistance | Internal Test Method | T=0T=2 | Pass |
|---|---|---|---|---|
| 18 | Corrosion Resistance | ISO 10555-1 | T=0T=2 | Pass |
| 19 | Coating Integrity and Particulates | Internal Test Method | T=0T=2 | Pass |
| 20 | Packing Integrity (Seal Strength) | ASTM F88 / F88M - 15 | T=0T=2 | Pass |
| 21 | Packing Integrity (Packing DyePenetration) | ASTM F1929-15/F1886-09 | T=0T=2 | Pass |
| 22 | Shipping and Transit | ISTA 3A | T=0T=2 | Pass |
| 23 | Accelerated Aging | ASTM F1980-07 | Pass | |
| 24 | Female Luer Verification | ISO 594 | Pass |
5.7.2 - Biocompatibility Testing Summary
The TXM Support Catheter 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.
| Biological Effect | Test | Compliance Standard |
|---|---|---|
| Cytotoxicity | L929 MEM ELUTION | ISO10993-5 |
| Irritation | Intracutaneous Injection | ISO10993-10 |
| Sensitization | Kligman MaximizationMurine Local Lymph Assay | ISO10993-10 |
| Systemic Toxicity | Systemic Injection | ISO10993-11 |
| Material Mediated | Rabbit Pyrogen | USP<151> |
| Pyrogenicity | Limulus Amebocyte Lysate | ISO10993-11 |
| Hemocompatibility | Hemolysis Complete (Direct and Indirect) | ISO10993-4 |
| Complement Activation | ISO10993-4 | |
| Thromboresistance Evaluation In vivo | ISO10993-4 |
Table 5.7.2. Summary of Biocompatibility Testing for the TXM Support Catheter
5.8 - Sterilization Testing Summary
Table 5.8 Summary of Sterilization Testing
| Validation SterilizationProcess | ComplianceStandard | Sterility Assurance Level(SAL) | ValidationResult |
|---|---|---|---|
| Ethylene Oxide Gas | ISO 11135 | $10^{-6}$ | Pass |
{8}------------------------------------------------
5.9 – Conclusion
The TXM Support Catheter 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.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).