(29 days)
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No
The 510(k) summary describes a mechanical guide wire and its physical characteristics. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
No.
This device is intended to facilitate the delivery of other catheter-based interventional devices, rather than provide therapy itself. It acts as a guide for therapeutic devices, and while it may be used during therapeutic procedures, it is not a therapeutic device by its function.
No
The device is a guide wire used to facilitate the delivery of other interventional devices during therapeutic procedures like angioplasty, not to diagnose a condition.
No
The device description clearly outlines physical components like guide wires, tip loads, support levels, coating lengths, tip shape, lengths, and a shaping tool. It also details in vitro bench testing on the "modified device," indicating a physical product.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "facilitate the delivery of catheter-based interventional devices during percutaneous transluminal angioplasty (PTA) and percutaneous transluminal coronary angioplasty (PTCA)." This describes a device used within the body during a medical procedure, not a device used to test samples outside the body.
- Device Description: The description details a physical guide wire used for navigating within blood vessels. This is consistent with an interventional device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the HI-TORQUE TurnTrac Guide Wire Family is an interventional medical device, not an IVD.
N/A
Intended Use / Indications for Use
The HI-TORQUE TurnTrac Guide Wire Family is intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal angioplasty (PTA) and percutaneous transluminal coronary angioplasty (PTCA). This guide wire may also be used with compatible stent devices during therapeutic procedures.
This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and /or reuse.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The HI-TORQUE (HT) TurnTrac Guide Wire Family includes steerable guide wires offered in several configurations by various support levels, tip loads, hydrophilic coating lengths, tip shape and guide wire lengths.
The HT TurnTrac Guide Wire Family will be available with the features as listed below:
- 2 tip loads: 0.6g and 0.9g
- 2 support levels: HT TurnTrac Moderate Support (MS) and HT TurnTrac Extra . Support (ES)
- 2 coating lengths: Fully Coated (HC), Uncoated Tip (pHC)
- 1 tip shape: Straight
- 2 lengths: 190 cm, 300cm
The HI-TORQUE TurnTrac Guide Wire Family has a maximum diameter of 0.0142" or 0.0145" depending on the support level and is compatible with devices designed for use with 0.014" guide wires. The HI-TORQUE TurnTrac Guide Wire Family includes a shaping tool, which is clipped on to the outer packaging coil after the final assembled product has been inserted into the packaging coil. This accessory is to aid the physician in shaping the distal portion of the guide wire, if desired.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In vitro bench testing, including tip tensile strength, torsional wire strength, torqueability, integrity (particulate testing), and friction testing were conducted on the modified device. The results from the in vitro bench tests demonstrated that the HI-TORQUE TurnTrac Guide Wire met all acceptance criteria and performed similarly to the predicate device. The results obtained from the biocompatibility testing indicate that the HI-TORQUE TurnTrac Guide Wire Family may be considered 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
§ 870.1330 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.
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January 12, 2018
Abbott Vascular Aniket Khakhadiya Regulatory Affairs Specialist 3200 Lakeside Drive Santa Clara, California 95054
Re: K173795
Trade/Device Name: HI-TOROUE TurnTrac Guide Wire Family Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: December 12, 2017 Received: December 14, 2017
Dear Aniket Khakhadiya:
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 (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.
1
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
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Indications for Use
510(k) Number (if known) K173795
Device Name HI-TORQUE® TurnTrac Guide Wire Family
Indications for Use (Describe)
The HI-TORQUE TurnTrac Guide Wire Family is intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal angioplasty (PTA) and percutaneous transluminal coronary angioplasty (PTCA). This guide wire may also be used with compatible stent devices during therapeutic procedures.
This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and /or reuse.
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) | ☐ |
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K173795 - 510(K) SUMMARY
The 510(k) Summary is submitted in accordance with 21 CFR §807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.
| 1. | Submitter's Name | Abbott Vascular |
|---|---|---|
| 2. | Submitter's Address | 3200 Lakeside Dr. Santa Clara, CA 95054 |
| 3. | Telephone | 408-845-8314 |
| 4. | Fax | 408-845-3689 |
| 5. | Contact Person | Aniket Khakhadiya |
| 6. | Date Prepared | December 7, 2017 |
| 7. | Device Trade Name | HI-TORQUE® TurnTrac Guide Wire Family |
| 8. | Device Common Name | Guide Wire |
| 9. | Device Classification Name | Catheter Guide Wire (21 CFR 870.1330; Product Code DQX) |
| 10. | Predicate Device Name | HI-TORQUE VersaTurn Guide Wire Family (K141782 cleared on August 7, 2014) |
11. Device Description
The HI-TORQUE (HT) TurnTrac Guide Wire Family includes steerable guide wires offered in several configurations by various support levels, tip loads, hydrophilic coating lengths, tip shape and guide wire lengths.
The HT TurnTrac Guide Wire Family will be available with the features as listed below:
- 2 tip loads: 0.6g and 0.9g ●
- 2 support levels: HT TurnTrac Moderate Support (MS) and HT TurnTrac Extra . Support (ES)
- 2 coating lengths: Fully Coated (HC), Uncoated Tip (pHC) ●
- 1 tip shape: Straight ●
- 2 lengths: 190 cm, 300cm ●
The HI-TORQUE TurnTrac Guide Wire Family has a maximum diameter of 0.0142" or 0.0145" depending on the support level and is compatible with devices designed for use with 0.014" guide wires. The HI-TORQUE TurnTrac Guide Wire Family includes a shaping tool, which is clipped on to the outer packaging coil after the final assembled
4
product has been inserted into the packaging coil. This accessory is to aid the physician in shaping the distal portion of the guide wire, if desired.
12. Indication for Use
The HI-TORQUE TurnTrac Guide Wire Family is intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal angioplasty (PTA) and percutaneous transluminal coronary angioplasty (PTCA). This guide wire may also be used with compatible stent devices during therapeutic procedures.
This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.
13. Technological Characteristics
Comparison of the subject device and predicate device demonstrates that the technological characteristics such as product performance, functional specification, operating principle, design and materials (with minor modifications), and indications for use are substantially equivalent to the currently marketed predicate device.
14. Performance Data
In vitro bench testing, including tip tensile strength, torsional wire strength, torqueability, integrity (particulate testing), and friction testing were conducted on the modified device. The results from the in vitro bench tests demonstrated that the HI-TORQUE TurnTrac Guide Wire met all acceptance criteria and performed similarly to the predicate device. The results obtained from the biocompatibility testing indicate that the HI-TORQUE TurnTrac Guide Wire Family may be considered substantially equivalent to the predicate device.
15. Conclusions
Test results from the in vitro bench testing conducted on the subject device demonstrate that the HI-TORQUE TurnTrac Guide Wire met all acceptance criteria and performed similarly to the predicate device. Therefore, the HI-TORQUE TurnTrac Guide Wire Family may be considered substantially equivalent to the predicate device.