(238 days)
Not Found
No
The device description and performance studies focus on the physical properties and performance of a guidewire, with no mention of AI or ML capabilities.
No.
The device's intended use is to "facilitate the placement of devices" like diagnostic or interventional tools, not to directly treat a medical condition.
No
The device is described as facilitating the placement of other devices during procedures, not performing a diagnostic function itself. While it can be used during "diagnostic procedures," its role is interventional (guidance), not diagnostic data acquisition or analysis.
No
The device description clearly describes a physical guidewire constructed with hardware components (nitinol core, polyurethane layer, coating). It is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To facilitate the placement of devices during diagnostic or interventional procedures." This describes a device used within the body to aid in procedures, not a device used to test samples outside the body to diagnose conditions.
- Device Description: The description details a physical guidewire designed for insertion into the peripheral vascular system. This is consistent with an interventional or diagnostic tool used in vivo.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the TXM Hydrophilic Guidewire is a medical device used in clinical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To facilitate the placement of devices during diagnostic or interventional procedures.
Product codes
DQX
Device Description
The TXM Hydrophilic Guidewire is a hydrophilic coated device which is constructed with a nitinol inner core which is covered with a polyurethane outer layer coated with a lubricious coating to minimize friction during use. The TXM Hydrophilic Guidewire outer diameter is 0.035" and is available in a variety of lengths ranging from 80 cm to 260 cm. The TXM Hydrophilic Guidewire is also constructed in stiff and standard shaft configuration with straight or angled distal tip. The device is supplied sterile and is intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral Vascular System
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 TXM Hydrophilic Guidewire and to demonstrate substantial equivalence to the predicate device. The TXM Hydrophilic Guidewire 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). Test results show that the TXM Hydrophilic Guidewire is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Image /page/0/Picture/0 description: The image contains 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 21, 2017
Texas Medical Technologies, Inc. % Mr. E.J. Smith Consultant Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114
Re: K170915
Trade/Device Name: TXM Hydrophilic Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX 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 manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Mr. Smith
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 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,
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) K170915
Device Name TXM Hydrophilic Guidewire
Indications for Use (Describe)
To facilitate the placement of devices during diagnostic or interventional procedures.
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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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 Hydrophilic Guidewire |
|---|---|
| Common Name: | Catheter guide wire |
| Classification Name: | Wire, Guide, Catheter |
| Regulation Number: | 21 CFR 870.1330 |
| Product Code: | DQX |
| Device Class: | II |
5.3 - Predicate Device
Legally Marketed Substantially Equivalent Predicate Device
| Proprietary Name: | Hydrophilic Coated Guidewire |
|---|---|
| Company Name: | Lake Region Medical |
| Common Name: | Guides, guidewires, or spring guidewires |
| Classification Name: | Wire, Guide, Catheter |
| Regulation Number: | 21 CFR 870.1330 |
| Product Code: | DQX |
| Device Class: | II |
| 510(k) Number | K133155 |
5.4 - Device Description
The TXM Hydrophilic Guidewire is a hydrophilic coated device which is constructed with a nitinol inner core which is covered with a polyurethane outer layer coated with a lubricious coating to minimize friction during use. The TXM Hydrophilic Guidewire outer diameter is 0.035" and is available in a variety of lengths ranging from 80 cm to 260 cm. The TXM Hydrophilic Guidewire is also constructed in stiff and standard shaft configuration with straight or angled distal tip. The device is supplied sterile and is intended for single use only.
4
The following table lists the models and sizes available for TXM Hydrophilic Guidewire.
| Product Code | Outer Diameter
(inches) | | Length
(cm) | Shaft
Configuration | Tip Shape |
|--------------|----------------------------|---------|----------------|------------------------|-----------|
| | Shaft | Tip | | | |
| HGW-35080-FS | 0.0335" | 0.0305" | 80 | Standard | Straight |
| HGW-35150-FS | 0.0335" | 0.0305" | 150 | Standard | Straight |
| HGW-35180-FS | 0.0335" | 0.0305" | 180 | Standard | Straight |
| HGW-35260-FS | 0.0335" | 0.0305" | 260 | Standard | Straight |
| HGW-35080-FA | 0.0335" | 0.0305" | 80 | Standard | Angled |
| HGW-35150-FA | 0.0335" | 0.0305" | 150 | Standard | Angled |
| HGW-35180-FA | 0.0335" | 0.0305" | 180 | Standard | Angled |
| HGW-35260-FA | 0.0335" | 0.0305" | 260 | Standard | Angled |
| HGW-35080-SS | 0.0335" | 0.0305" | 80 | Stiff | Straight |
| HGW-35150-SS | 0.0335" | 0.0305" | 150 | Stiff | Straight |
| HGW-35180-SS | 0.0335" | 0.0305" | 180 | Stiff | Straight |
| HGW-35260-SS | 0.0335" | 0.0305" | 260 | Stiff | Straight |
| HGW-35080-SA | 0.0335" | 0.0305" | 80 | Stiff | Angled |
| HGW-35150-SA | 0.0335" | 0.0305" | 150 | Stiff | Angled |
| HGW-35180-SA | 0.0335" | 0.0305" | 180 | Stiff | Angled |
| HGW-35260-SA | 0.0335" | 0.0305" | 260 | Stiff | Angled |
Table 5.4 TXM Hydrophilic Guidewire Models and Sizes
5.5 - Indications for Use
To facilitate the placement of devices used during diagnostic and interventional procedures.
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 Hydrophilic Guidewire 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 Hydrophilic Guidewire is substantially equivalent to the predicate device. Table 5.6 below provides a comparison of the TXM Hydrophilic Guidewire and the predicate.
5
| Technical
Characteristics /
Principle of
Operation | TXM Hydrophilic
Guidewire | Hydrophilic Coated
Guidewire | Substantially
Equivalent? |
|-------------------------------------------------------------|------------------------------|----------------------------------------------|------------------------------|
| Length | 80cm-260cm | 80cm-260cm | Yes |
| Outer Diameter | 0.035" | 0.035" | Yes |
| Shape | Straight or Angled | Straight or Angled | Yes |
| Shaft Configuration | Standard or Stiff | Standard or Stiff | Yes |
| Inner Core Material | Nitinol | Nitinol | Yes |
| Outer Jacket
Material | Polyurethane,
Tungsten | Polyurethane, Radiopaque
material unknown | Yes |
| Hydrophilic Coated | Yes* | Yes | Yes |
| Anatomical Site Use | Peripheral Vascular System | Peripheral Vascular System | Yes |
| Delivery to Site | Through Introducer Sheath | Through Introducer Sheath | Yes |
| Packaging | Tyvek Pouch | Tyvek Pouch | Yes |
| Sterilization | EtO Gas | EtO Gas | Yes |
Table 5.6 Comparison of the TXM Hydrophilic Guidewire 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 Hydrophilic Guidewire and to demonstrate substantial equivalence to the predicate device. The TXM Hydrophilic Guidewire 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 Hydrophilic Guidewire 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 TXM Hydrophilic Guidewire.
6
| Test
No. | Test Name | Applicable Standard or Internal Test
Method | Test Results | |
|-------------|--------------------------------------------------------------|-------------------------------------------------------------------------------|--------------|------|
| 1 | Dimensional and Physical Attributes | ISO 11070:2014 | T=0
T=2 | Pass |
| 2 | Torque Strength | FDA Coronary and Cerebrovascular
Guidewire Guidance / Internal Test Method | T=0
T=2 | Pass |
| 3 | Torqueability | FDA Coronary and Cerebrovascular
Guidewire Guidance / Internal Test Method | T=0
T=2 | Pass |
| 4 | Guidewire compatibility | FDA Coronary and Cerebrovascular
Guidewire Guidance / Internal Test Method | T=0
T=2 | Pass |
| 5 | Radiopacity | ASTM-F640-12 | T=0
T=2 | Pass |
| 6 | Tensile Strength | FDA Coronary and Cerebrovascular
Guidewire Guidance / ISO 11070:2014 | T=0
T=2 | Pass |
| 7 | Coating Adherence and Integrity;
Particulate Quantitation | FDA Coronary and Cerebrovascular
Guidewire Guidance / Internal Test Method | T=0
T=2 | Pass |
| 8 | Durability of Hydrophilic Coating | Internal Test Method | T=0
T=2 | Pass |
| 9 | Lubricity of Hydrophilic Coating | Internal Test Method | T=0
T=2 | Pass |
| 10 | Shaft stiffness and Tip Flexibility | FDA Coronary and Cerebrovascular
Guidewire Guidance / ASTM D747-10 | T=0
T=2 | Pass |
| 11 | Fracture | ISO 11070:2014 | T=0
T=2 | Pass |
| 12 | Tip Impact | FDA Coronary and Cerebrovascular
Guidewire Guidance / Internal Test Method | T=0
T=2 | Pass |
| 13 | Corrosion Resistance | ISO 11070:2014 | T=0
T=2 | Pass |
| 14 | Trackability | Internal Test Method | T=0
T=2 | Pass |
| 15 | Packing Dye Penetration | ASTM F1929-15/F1886-09 | T=0
T=2 | Pass |
| 16 | Seal Strength | ASTM F88 / F88M - 15 | T=0
T=2 | Pass |
| 17 | Shipping and Transit | ISTA 3A | T=0
T=2 | Pass |
| 18 | Accelerated Aging | ASTM-E1980-07 | T=0
T=2 | Pass |
Table 5.7.1 Bench Testing Performed on TXM Hydrophilic Guidewire
5.7.2 - Biocompatibility
The TXM Hydrophilic Guidewire 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.
7
| Biological Effect | Test | Compliance
Standard |
|-----------------------------------|---------------------------------------------------------|-------------------------|
| Cytotoxicity | L929 MEM Elution
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 |
| Material Mediated
Pyrogenicity | Pyrogen Test in Rabbit | USP
ISO10993-11 |
| Material Mediated
Pyrogenicity | Limulus Amebocyte Lysate | USP 38, NF 33, 2015 |
| Hemocompatibility | Hemolysis-Complete (Direct and Indirect) | ISO10993-4 |
| Hemocompatibility | Complement Activation | ISO10993-4 |
| Hemocompatibility | In-Vivo Thrombogenicity | ISO10993-4 |
Table 5.7.2 Biocompatibility Testing for the TXM Hydrophilic Guidewire
5.8 - Sterilization Testing Summary
| Table 5.8 Sterilization Testing for the TXM Hydrophilic Guidewire | ||||
|---|---|---|---|---|
| Validation Sterilization
Process | Compliance Standard | Sterility Assurance
Level (SAL) | Validation
Result |
|-------------------------------------|---------------------|------------------------------------|----------------------|
| Ethylene Oxide Gas | ISO 11135 | 10-6 | Pass |
5.9 – Conclusion
The TXM Hydrophilic Guidewire 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.