(141 days)
Not Found
No
The description focuses on the physical construction and materials of a guiding catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are bench tests and biocompatibility, not related to algorithmic performance.
No
The device is described as an "intravascular introduction" tool for other interventional/diagnostic devices, not one that directly treats a condition.
No
The "Intended Use / Indications for Use" states that the device is for "intravascular introduction of interventional/diagnostic devices", meaning it introduces diagnostic devices, but is not a diagnostic device itself.
No
The device description clearly outlines physical components such as a lubricous inner liner, stainless steel braid, outer shaft made of Polyether block amide, and a Polycarbonate hub, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vasculature." This describes a device used within the body to facilitate other procedures, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description details a physical catheter designed for insertion into blood vessels. It does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological specimens.
- Providing diagnostic information based on the analysis of specimens.
- Reagents, calibrators, or controls typically associated with IVD tests.
The device is a medical device used for interventional and diagnostic procedures performed in vivo (within the living body).
N/A
Intended Use / Indications for Use
The Guiding Catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral, Coronary
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 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.
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
§ 870.1250 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).
0
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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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: | 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
4
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
| Commercial
Model Number | French
size | Shaft
Length (cm) | Outer
Diameter
(inches) | Inner
Diameter
(inches) | Marker Band
Material | 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 |
5
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.
| Technical
Characteristics /
Principle of
Operation | TXM Guiding Catheter | Vista Brite Guiding
Catheter | Substantially
Equivalent? |
|-------------------------------------------------------------|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|------------------------------|
| 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 left
and Multipurpose. | Judkins right, Judkins left,
Amplatz right, Amplatz left
and Multipurpose and others. | Yes |
| Inner Liner
Material | Polytetrafluoroethylene
(PTFE)* | Polytetrafluoroethylene
(PTFE) | Yes |
| Braid
Reinforcement
Material | Stainless Steel* | Stainless Steel | Yes |
| Radiopaque
Marker | Tungsten Material* | Radiopaque filler | Yes |
| Outer Shaft
Material | Nylon, Pebax,
Polyurethane* | Nylon | Yes |
| Luer Material | Polycarbonate* | Unknown | Yes |
| Luer Connector | Female Luer Connector* | Female Luer Connector | Yes |
| Anatomical Site
Use | Peripheral, Coronary | Peripheral, Coronary | Yes |
| Delivery to Site | Over-the-wire | Over-the-wire | 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 Guiding Catheter and the Predicate Device.
- Denotes a patient-contacting material.
6
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 | Applicable
Standard
or Internal
Test
Method | Test
Results
(T=3) | Test
| Test Name | Applicable
Standard
or Internal
Test
Method | Test
Results
(T=3) |
|-----------|-------------------------------------------------|---------------------------------------------------------|--------------------------|-----------|--------------------------------|---------------------------------------------------------|--------------------------|
| 1 | Air Leak | ISO 10555 | T=0:T=3
Pass | 12 | Corrosion
Resistance | ISO 10555 | T=0:T=3
Pass |
| 2 | In-Vitro
Track Force | Internal
Test
Method | T=0;T=3
Pass | 13 | Radiopacity | ASTM-
F640-12 | T=0;T=3
Pass |
| 3 | Stiffness | Internal
Test
Method | T=0:T=3
Pass | 14 | Torque
Response | Internal
Test
Method | T=0:T=3
Pass |
| 4 | Tensile
Strength | ISO 10555 | T=0;T=3
Pass | 15 | Torque to
Failure | Internal
Test
Method | T=0;T=3
Pass |
| 5 | Gravity Flow
Rate | ISO 10555 | T=0:T=3
Pass | 16 | Ovalization | Internal
Test
Method | T=0:T=3
Pass |
| 6 | Liquid Leak | ISO 10555 | T=0:T=3
Pass | 17 | Simulated Use | Internal
Test
Method | T=0:T=3
Pass |
| 7 | Power
Injector
(Static Burst
Pressure) | ISO 10555 | T=0;T=3
Pass | 18 | Seal Strength
(Pouch) | ASTM
F88/F88M-
09 | T=0;T=3
Pass |
| 8 | Tip Shape
Retention | Internal
Test
Method | T=0;T=3
Pass | 19 | Dye
Penetration
Test | ASTM-
F1929-12 | T=0;T=3
Pass |
| 9 | Dimensional
& Physical
Attributes | ISO 10555 | T=0:T=3
Pass | 20 | Female Luer
Verification | ISO 594 | T=0:T=3
Pass |
| 10 | Kink Testing | Internal
Test
Method | T=0;T=3
Pass | 21 | Shipping and
Transportation | ISTA 3A | T=0:T=3
Pass |
| 11 | Buckling
Test | Internal
Test
Method | T=0:T=3
Pass | 22 | Accelerated
Aging | ASTM
F1980-07 | T=0:T=3
Pass |
Table 5.7.1. Bench Testing Performed on Guiding Catheter
7
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 Maximization | |
| Murine Local Lymph Assay | ISO10993-10 | |
| Systemic Toxicity | ISO Acute Systemic Toxicity Test | ISO10993-11 |
| Pyrogenicity | Pyrogen Test in Rabbit | |
| Limulus Amebocyte Lysate | $USP$ | |
| ISO10993-11 | ||
| $USP $ 38, NF 33, 2015 | ||
| Hemocompatibility | Hemolysis-Complete (Direct and Indirect) | |
| Complement Activation | ||
| In-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.