(113 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a guide wire, with no mention of AI or ML technologies.
No
The device is a guide wire that facilitates the delivery of other interventional devices and provides a pathway, but it does not directly perform a therapeutic action itself. It is used with compatible stent devices during therapeutic procedures, but it is not the therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The guide wire may also be used...to distinguish the vasculature," which is a diagnostic function.
No
The device description clearly describes a physical guide wire made of stainless steel and nitinol, with specific dimensions and coatings. It is a hardware device used in interventional procedures.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a guide wire intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA). It is used within the body to guide other devices.
- Lack of Sample Analysis: There is no mention of this device analyzing any biological samples or providing diagnostic information based on such analysis.
The device is an interventional medical device used in a surgical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
This HI-TORQUE guide wire is intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA). This guide wire may also be used with compatible stent devices during therapeutic procedures.
The guide wire may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.
Product codes
DQX
Device Description
The Abbott Vascular 0.014" Hi-Torque Jet (HT Jet) Guide Wire with hydrophilic and hydrophobic coatings is a stainless steel and nitinol steerable guide wire with a maximum diameter of 0.0145", provided in 190 cm extendable, 250 cm, and 300 cm exchange lengths. The distal tip has a radiopaque length of 3.0 cm. The distal tip is straight and shapeable. The HT Jet Guide Wire Family consists of two models with differing flexibility and performance: the HT Jet 15C and the HT Jet 25C. The proximal end of the 190 cm model is plunge ground and coined to fit into the hypotube portion of the DOC® Guide Wire Extension. The HT Jet guide wire family is compatible with devices designed for use with 0.014" guide wires.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In vitro bench testing was conducted on the subject device, which included: catheter compatibility, radiopacity, tensile strength, torque strength, torque accuracy, coating adherence and integrity (particulate testing), and friction testing. The in vitro bench tests demonstrated that the Hi-Torque Jet Guide Wire met all acceptance criteria and performed similarly to the predicate devices.
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.
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2014
Abbott Vascular, Inc. Janet Benson Director, Regulatory Affairs 26531 Ynez Road Temecula, CA 92591
Re: K142415
Trade/Device Name: Hi - Torque JET Guide Wire Family Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX Dated: November 13, 2014 Received: November 17, 2014
Dear Ms. Benson:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Melissa A. Torres -S
For Bram 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
K142415 510(k) Number (if known): _
| Device Name: | Hi-Torque JET Guide Wire Family |
|---|---|
| Indications for Use: | This HI-TORQUE guide wire is intended to facilitate the |
| delivery of catheter-based interventional devices during | |
| percutaneous transluminal coronary angioplasty (PTCA). This | |
| guide wire may also be used with compatible stent devices | |
| during therapeutic procedures. |
The guide wire may also be used to reach and cross a target
lesion, provide a pathway within the vessel structure, facilitate
the substitution of one diagnostic or interventional device for
another, and to distinguish the vasculature. |
______________________________________________________________________________________________________________________________________________________________________________ Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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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 Inc. |
|---|---|
| 2. Submitter's Address | 26531 Ynez Road, Temecula, CA 92591 |
| 3. Telephone | (951)-914-3318 |
| 4. Fax | (951)-914-0339 |
| 5. Contact Person | Jochen Reich |
| 6. Date Prepared | August 27, 2014 |
| 7. Device Trade Name | Hi-Torque Jet Guide Wire Family |
| 8. Device Common Name | Guide Wire |
| 9. Device Classification Name | Catheter Guide Wire (DQX) |
| 10. Predicate Device(s) Name | HI-TORQUE COMMAND (K122573, cleared |
| November 20, 2012), and HI-TORQUE | |
| POWERTURN (K112957, cleared February 8, | |
| 2011). |
11. Device Description
The Abbott Vascular 0.014" Hi-Torque Jet (HT Jet) Guide Wire with hydrophilic and hydrophobic coatings is a stainless steel and nitinol steerable guide wire with a maximum diameter of 0.0145", provided in 190 cm extendable, 250 cm, and 300 cm exchange lengths. The distal tip has a radiopaque length of 3.0 cm. The distal tip is straight and shapeable. The HT Jet Guide Wire Family consists of two models with differing flexibility and performance: the HT Jet 15C and the HT Jet 25C. The proximal end of the 190 cm model is plunge ground and coined to fit into the hypotube portion of the DOC® Guide Wire Extension. The HT Jet guide wire family is compatible with devices designed for use with 0.014" guide wires.
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12. Indication for Use
This HI-TORQUE guide wire is intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA). This guide wire may also be used with compatible stent devices during therapeutic procedures.
The guide wire may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.
13. Technological Characteristics
Comparisons of the new and predicate devices show that the technological characteristics such as product performance, design and indications for use are substantially equivalent to the currently marketed predicate devices.
14. Performance Data
In vitro bench testing conducted on the subject device included:
- catheter compatibility, .
- radiopacity, ●
- tensile strength, ●
- torque strength. ●
- . torque accuracy,
- coating adherence and integrity (particulate testing), and ●
- friction testing. ●
The in vitro bench tests demonstrated that the Hi-Torque Jet Guide Wire met all acceptance criteria and performed similarly to the predicate devices.
15. Leveraged testing
Biocompatibility, packaging, and sterilization testing were not necessary as the Hi-Torque Jet is identical in materials, packaging, and sterilization as the predicate devices.
16. Conclusions
Test results from the non-clinical in vitro bench testing conducted on the Hi-Torque Jet Guide Wire met all acceptance criteria and performed similarly to the predicate devices. There were no new safety or effectiveness issues raised during the testing program.
The Hi-Torque Jet Guide Wire Family is substantially equivalent to the predicate devices in regards to the indications for use, materials, fundamental technology, design, performance, shelf
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life, biocompatibility, sterilization, and packaging. Therefore, the Hi-Torque Jet Guide Wire may be considered substantially equivalent to the predicate devices.