(141 days)
The Guiding Catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vasculature.
The TXM Guiding Catheter is a guiding catheter, for application in intravascular vessels. It consists of a lubricous inner liner made from Teflon, a stainless steel braid over the inner liner. The outer shaft consists of durometer hardness and different lengths of colored Polyether block amide. A Polycarbonate hub is attached to the proximal end of the Guiding Catheter. A strain relief is placed at the proximal end of the Guiding Catheter and over the distal end of the device shafts will have an outer diameter of 5 French sizes (0.070") and 6 French sizes (0.082) respectively for each catheter. The 5 French sizes will have an inner diameter of 0.058" and the 6 French sizes will have an inner diameter of 0.070". The device is available in length of 100cm. The device is supplied sterile and is intended for single use.
This document is a 510(k) premarket notification for a guiding catheter, indicating its substantial equivalence to a predicate device. It doesn't describe the evaluation of an AI/ML powered device, but rather a traditional medical device (catheter). Therefore, most of the requested information regarding AI/ML device evaluation (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable or cannot be extracted from this document.
However, I can extract the acceptance criteria and results for the bench testing and biocompatibility testing as presented for this traditional medical device.
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device, the "acceptance criteria" are implied by meeting the specified standards or internal test methods, and the "reported device performance" is a simple "Pass" or "Fail" against those criteria.
| Test Name | Applicable Standard or Internal Test Method | Acceptance Criteria (Implied by standard and "Pass" result) | Reported Device Performance |
|---|---|---|---|
| Air Leak | ISO 10555 | Meet ISO 10555 requirements | Pass |
| In-Vitro Track Force | Internal Test Method | Meet internal method requirements | Pass |
| Stiffness | Internal Test Method | Meet internal method requirements | Pass |
| Tensile Strength | ISO 10555 | Meet ISO 10555 requirements | Pass |
| Gravity Flow Rate | ISO 10555 | Meet ISO 10555 requirements | Pass |
| Liquid Leak | ISO 10555 | Meet ISO 10555 requirements | Pass |
| Power Injector (Static Burst Pressure) | ISO 10555 | Meet ISO 10555 requirements | Pass |
| Tip Shape Retention | Internal Test Method | Meet internal method requirements | Pass |
| Dimensional & Physical Attributes | ISO 10555 | Meet ISO 10555 requirements | Pass |
| Kink Testing | Internal Test Method | Meet internal method requirements | Pass |
| Buckling Test | Internal Test Method | Meet internal method requirements | Pass |
| Corrosion Resistance | ISO 10555 | Meet ISO 10555 requirements | Pass |
| Radiopacity | ASTM-F640-12 | Meet ASTM-F640-12 requirements | Pass |
| Torque Response | Internal Test Method | Meet internal method requirements | Pass |
| Torque to Failure | Internal Test Method | Meet internal method requirements | Pass |
| Ovalization | Internal Test Method | Meet internal method requirements | Pass |
| Simulated Use | Internal Test Method | Meet internal method requirements | Pass |
| Seal Strength (Pouch) | ASTM F88/F88M-09 | Meet ASTM F88/F88M-09 requirements | Pass |
| Dye Penetration Test | ASTM-F1929-12 | Meet ASTM-F1929-12 requirements | Pass |
| Female Luer Verification | ISO 594 | Meet ISO 594 requirements | Pass |
| Shipping and Transportation | ISTA 3A | Meet ISTA 3A requirements | Pass |
| Accelerated Aging | ASTM F1980-07 | Meet ASTM F1980-07 requirements | Pass |
| Biocompatibility Tests | |||
| Cytotoxicity | ISO10993-5 | Meet ISO10993-5 requirements | Pass |
| Irritation | ISO10993-10 | Meet ISO10993-10 requirements | Pass |
| Sensitization | ISO10993-10 | Meet ISO10993-10 requirements | Pass |
| Systemic Toxicity | ISO10993-11 | Meet ISO10993-11 requirements | Pass |
| Pyrogenicity | USP<151>, ISO10993-11, USP <85> | Meet specified USP and ISO requirements | Pass |
| Hemocompatibility | ISO10993-4 | Meet ISO10993-4 requirements | Pass |
| Toxicological Hazard | ISO10993-17 | Meet ISO10993-17 requirements (Risk Assessment) | Pass |
| Sterilization Test | |||
| Ethylene Oxide Gas | Relevant validation standards (implicit) | Sterility Assurance Level (SAL) of 10-6 | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "non-aged devices (T=0)" and "devices subject to 3 years of accelerated aging (T=3)" for bench testing, but the specific number of devices tested for each test is not detailed. The data provenance is also not specified, as this is a device submission focused on bench and biocompatibility testing, not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a traditional medical device (catheter) and does not involve AI/ML or expert evaluation for establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a traditional medical device (catheter) and does not involve AI/ML or expert adjudication for test sets.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a traditional medical device (catheter) and does not involve AI/ML.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a traditional medical device (catheter) and does not involve AI/ML.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's evaluation is primarily based on meeting the specifications outlined in recognized international and national standards (e.g., ISO 10555, ASTM F640-12, ISO 10993 series, USP) and internal test methods. For example, for tensile strength, the ground truth is simply whether the device withstood the specified force according to the standard. For biocompatibility, it's whether the biological responses fall within acceptable limits defined by the ISO 10993 series.
8. The sample size for the training set
Not applicable. This is a traditional medical device (catheter) and does not involve AI/ML or training sets.
9. How the ground truth for the training set was established
Not applicable. This is a traditional medical device (catheter) and does not involve AI/ML or training sets.
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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 stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The symbol is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 12, 2016
Texas Medical Technologies, Inc. % EJ Smith Consultant Smith Associates 1468 Harwell Avenue Crofton. Marvland 21114
Re: K153703
Trade/Device Name: Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: April 12, 2016 Received: April 12, 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
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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.
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
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Indications for Use
510(k) Number (if known) K153703
Device Name Guiding Catheter
Indications for Use (Describe)
The Guiding Catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vasculature.
| Type of Use (Select one or both, as applicable) | |||
|---|---|---|---|
| -- | ------------------------------------------------- | -- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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5.1 - Company Information & Contact Person
| Company Name: | Texas Medical Technologies Inc. |
|---|---|
| Company Address: | 9005 Montana Ave. Ste. AEl Paso, Texas 79925 |
| Telephone: | (915) 774-4321 |
| Fax: | (915) 774-4323 |
| Contact Person: | Cesar Rios, Quality Assurance & Regulatory Manager |
| Date Prepared: | 4/11/2016 |
5.2 - Device Name & Classification
| Proprietary Name: | Guiding Catheter |
|---|---|
| Common Name: | Catheter |
| Classification Name: | Percutaneous Catheter |
| Regulation Number: | 21 CFR 870.1250 |
| Product Code: | DQY |
| Device Class: | II |
5.3 - Predicate Device
Legally Marketed Substantially Equivalent Predicate Device
| Proprietary Name: | Vista Brite Tip |
|---|---|
| Company Name: | Cordis Corporation |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter |
| Regulation Number: | 21 CFR 870.1250 |
| Product Code: | DQY |
| Device Class: | II |
| 510(k) Number | K972978 |
5.4 - Device Description
The TXM Guiding Catheter is a guiding catheter, for application in intravascular vessels. It consists of a lubricous inner liner made from Teflon, a stainless steel braid over the inner liner. The outer shaft consists of durometer hardness and different lengths of colored Polyether block amide. A Polycarbonate hub is attached to the proximal end of the Guiding Catheter. A strain relief is placed at the proximal end of the Guiding Catheter and over the distal end of the device shafts will have an outer diameter of 5 French sizes (0.070") and 6 French sizes (0.082) respectively for each catheter. The 5 French sizes will have an inner diameter of 0.058" and the 6
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French sizes will have an inner diameter of 0.070". The device is available in length of 100cm. The device is supplied sterile and is intended for single use.
The device is supplied sterile and is intended for single use
The following table lists the models and sizes available for Guiding Catheter.
Table 5.4.1. Guiding Catheter Models and Sizes
| CommercialModel Number | Frenchsize | ShaftLength (cm) | OuterDiameter(inches) | InnerDiameter(inches) | Marker BandMaterial | Tip Shape |
|---|---|---|---|---|---|---|
| GC-510-JL35 | 5 | 100 | 0.070 | 0.058 | Tungsten | JL 3.5 |
| GC-510-JL40 | 5 | 100 | 0.070 | 0.058 | Tungsten | JL 4 |
| GC-510-JL45 | 5 | 100 | 0.070 | 0.058 | Tungsten | JL 4.5 |
| GC-510-JL50 | 5 | 100 | 0.070 | 0.058 | Tungsten | JL 5 |
| GC-510-JL60 | 5 | 100 | 0.070 | 0.058 | Tungsten | JL 6 |
| GC-510-JR35 | 5 | 100 | 0.070 | 0.058 | Tungsten | AL 1 |
| GC-510-JR40 | 5 | 100 | 0.070 | 0.058 | Tungsten | AL 2 |
| GC-510-JR50 | 5 | 100 | 0.070 | 0.058 | Tungsten | AL 3 |
| GC-510-JR60 | 5 | 100 | 0.070 | 0.058 | Tungsten | JR 3.5 |
| GC-510-AL10 | 5 | 100 | 0.070 | 0.058 | Tungsten | JR 4 |
| GC-510-AL20 | 5 | 100 | 0.070 | 0.058 | Tungsten | JR 5 |
| GC-510-AL30 | 5 | 100 | 0.070 | 0.058 | Tungsten | JR 6 |
| GC-510-AR10 | 5 | 100 | 0.070 | 0.058 | Tungsten | AR 1 |
| GC-510-AR20 | 5 | 100 | 0.070 | 0.058 | Tungsten | AR 2 |
| GC-510-AR30 | 5 | 100 | 0.070 | 0.058 | Tungsten | AR 3 |
| GC-510-MPA1 | 5 | 100 | 0.070 | 0.058 | Tungsten | MPA 1 |
| GC-510-MPA1 | 5 | 100 | 0.070 | 0.058 | Tungsten | MPA 2 |
| GC-510-MPB1 | 5 | 100 | 0.070 | 0.058 | Tungsten | MPB 1 |
| GC-510-MPB2 | 5 | 100 | 0.070 | 0.058 | Tungsten | MPB 2 |
| GC-610-JL35 | 6 | 100 | 0.082 | 0.070 | Tungsten | JL 3.5 |
| GC-610-JL40 | 6 | 100 | 0.082 | 0.070 | Tungsten | JL 4 |
| GC-610-JL45 | 6 | 100 | 0.082 | 0.070 | Tungsten | JL 4.5 |
| GC-610-JL50 | 6 | 100 | 0.082 | 0.070 | Tungsten | JL 5 |
| GC-610-JL60 | 6 | 100 | 0.082 | 0.070 | Tungsten | JL 6 |
| GC-610-JR35 | 6 | 100 | 0.082 | 0.070 | Tungsten | AL 1 |
| GC-610-JR40 | 6 | 100 | 0.082 | 0.070 | Tungsten | AL 2 |
| GC-610-JR50 | 6 | 100 | 0.082 | 0.070 | Tungsten | AL 3 |
| GC-610-JR60 | 6 | 100 | 0.082 | 0.070 | Tungsten | JR 3.5 |
| GC-610-AL10 | 6 | 100 | 0.082 | 0.070 | Tungsten | JR 4 |
| GC-610-AL20 | 6 | 100 | 0.082 | 0.070 | Tungsten | JR 5 |
| GC-610-AL30 | 6 | 100 | 0.082 | 0.070 | Tungsten | JR 6 |
| GC-610-AR10 | 6 | 100 | 0.082 | 0.070 | Tungsten | AR 1 |
| GC-610-AR20 | 6 | 100 | 0.082 | 0.070 | Tungsten | AR 2 |
| GC-610-AR30 | 6 | 100 | 0.082 | 0.070 | Tungsten | AR 3 |
| GC-610-MPA1 | 6 | 100 | 0.082 | 0.070 | Tungsten | MPA 1 |
| GC-610-MPA1 | 6 | 100 | 0.082 | 0.070 | Tungsten | MPA 2 |
| GC-610-MPB1 | 6 | 100 | 0.082 | 0.070 | Tungsten | MPB 1 |
| GC-610-MPB2 | 6 | 100 | 0.082 | 0.070 | Tungsten | MPB 2 |
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5.5 - Indications for Use
The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vasculature.
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 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 Guiding Catheter is substantially equivalent to the predicate device. Table 5.6 below provides a comparison of the Guiding Catheter and the predicate.
| TechnicalCharacteristics /Principle ofOperation | TXM Guiding Catheter | Vista Brite GuidingCatheter | SubstantiallyEquivalent? |
|---|---|---|---|
| Length | 100 cm | 90 cm, 100 cm, 110 cm, 125 cm | Yes |
| Outer Diameter | 0.070"-0.082" | 0.068"-0.082" | Yes |
| Inner Diameter | 0.058"-0.070" | 0.056"-0.070" | Yes |
| Shape | Judkins right, Judkins left,Amplatz right, Amplatz leftand Multipurpose. | Judkins right, Judkins left,Amplatz right, Amplatz leftand Multipurpose and others. | Yes |
| Inner LinerMaterial | Polytetrafluoroethylene(PTFE)* | Polytetrafluoroethylene(PTFE) | Yes |
| BraidReinforcementMaterial | Stainless Steel* | Stainless Steel | Yes |
| RadiopaqueMarker | Tungsten Material* | Radiopaque filler | Yes |
| Outer ShaftMaterial | Nylon, Pebax,Polyurethane* | Nylon | Yes |
| Luer Material | Polycarbonate* | Unknown | Yes |
| Luer Connector | Female Luer Connector* | Female Luer Connector | Yes |
| Anatomical SiteUse | Peripheral, Coronary | Peripheral, Coronary | Yes |
| Delivery to Site | Over-the-wire | Over-the-wire | Yes |
| GuidewireCompatibility | 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 Guiding Catheter and the Predicate Device.
- Denotes a patient-contacting material.
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5.7 - Testing Summary
The following bench tests were performed to evaluate the design elements and performance characteristics of the Guiding Catheter and to demonstrate substantial equivalence to the predicate device. The Guiding Catheter met the predetermined acceptance criteria. Testing was performed on non-aged devices (T=0) as well as on devices subject to 3 years of accelerated aging (T=3). Tests results show that the Guiding Catheter is substantially equivalent to the predicate device.
5.7.1- Bench Testing Table
Table 5.7.1 below provides a summary of the bench testing performed on the Guiding Catheter.
| Test# | Test Name | ApplicableStandardor InternalTestMethod | TestResults(T=3) | Test# | Test Name | ApplicableStandardor InternalTestMethod | TestResults(T=3) |
|---|---|---|---|---|---|---|---|
| 1 | Air Leak | ISO 10555 | T=0:T=3Pass | 12 | CorrosionResistance | ISO 10555 | T=0:T=3Pass |
| 2 | In-VitroTrack Force | InternalTestMethod | T=0;T=3Pass | 13 | Radiopacity | ASTM-F640-12 | T=0;T=3Pass |
| 3 | Stiffness | InternalTestMethod | T=0:T=3Pass | 14 | TorqueResponse | InternalTestMethod | T=0:T=3Pass |
| 4 | TensileStrength | ISO 10555 | T=0;T=3Pass | 15 | Torque toFailure | InternalTestMethod | T=0;T=3Pass |
| 5 | Gravity FlowRate | ISO 10555 | T=0:T=3Pass | 16 | Ovalization | InternalTestMethod | T=0:T=3Pass |
| 6 | Liquid Leak | ISO 10555 | T=0:T=3Pass | 17 | Simulated Use | InternalTestMethod | T=0:T=3Pass |
| 7 | PowerInjector(Static BurstPressure) | ISO 10555 | T=0;T=3Pass | 18 | Seal Strength(Pouch) | ASTMF88/F88M-09 | T=0;T=3Pass |
| 8 | Tip ShapeRetention | InternalTestMethod | T=0;T=3Pass | 19 | DyePenetrationTest | ASTM-F1929-12 | T=0;T=3Pass |
| 9 | Dimensional& PhysicalAttributes | ISO 10555 | T=0:T=3Pass | 20 | Female LuerVerification | ISO 594 | T=0:T=3Pass |
| 10 | Kink Testing | InternalTestMethod | T=0;T=3Pass | 21 | Shipping andTransportation | ISTA 3A | T=0:T=3Pass |
| 11 | BucklingTest | InternalTestMethod | T=0:T=3Pass | 22 | AcceleratedAging | ASTMF1980-07 | T=0:T=3Pass |
Table 5.7.1. Bench Testing Performed on Guiding Catheter
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5.7.2 - Biocompatibility
The Guiding 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. All testing met the predetermined acceptance criteria.
| Biological Effect | Test | Compliance Standard |
|---|---|---|
| Cytotoxicity | L929 Neutral Red Uptake (NRU) - ISO | ISO10993-5 |
| Irritation | Intracutaneous Injection - ISO | ISO10993-10 |
| Sensitization | Kligman MaximizationMurine Local Lymph Assay | ISO10993-10 |
| Systemic Toxicity | ISO Acute Systemic Toxicity Test | ISO10993-11 |
| Pyrogenicity | Pyrogen Test in RabbitLimulus Amebocyte Lysate | $USP<151>$ISO10993-11$USP <85>$ 38, NF 33, 2015 |
| Hemocompatibility | Hemolysis-Complete (Direct and Indirect)Complement ActivationIn-Vivo Thrombogenicity | ISO10993-4 |
| Toxicological Hazard | Risk Assessment of Extractables and Leachables | ISO10993-17 |
Table 5.7.2. Summary of Biocompatibility Testing for the Guiding Catheter
5.8 - Sterilization Testing Summary
| Validation Sterilization Process | Sterility Assurance Level (SAL) | Validation Result |
|---|---|---|
| Ethylene Oxide Gas | 10-6 | Pass |
5.9 – Conclusion
The Guiding 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).