(113 days)
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.
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.
The Abbott Vascular Hi-Torque JET Guide Wire Family's acceptance criteria and performance are detailed in the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the in vitro bench tests demonstrated that the Hi-Torque Jet Guide Wire met all acceptance criteria for the following performance aspects:
| Acceptance Criteria Aspect | Reported Device Performance |
|---|---|
| Catheter Compatibility | Met all acceptance criteria |
| Radiopacity | Met all acceptance criteria |
| Tensile Strength | Met all acceptance criteria |
| Torque Strength | Met all acceptance criteria |
| Torque Accuracy | Met all acceptance criteria |
| Coating Adherence & Integrity | Met all acceptance criteria (particulate testing) |
| Friction Testing | Met all acceptance criteria |
The overall conclusion is that the device performed similarly to the predicate devices and met all established acceptance criteria, indicating its substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each of the in vitro bench tests. It simply states that "in vitro bench testing" was conducted.
The data provenance is retrospective, as the tests were performed on the device after its design, and the results are presented as a summary of the outcomes of these tests. The country of origin of the data is not explicitly stated, but the submission is from Abbott Vascular Inc., located in Temecula, CA, USA, suggesting the testing was conducted or overseen in the USA.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable as the study described is an in vitro bench testing study, not an expert-based clinical or image-based diagnostic study. The "ground truth" for these performance tests is based on objective measurements against predefined engineering and performance specifications.
4. Adjudication Method for the Test Set
The concept of an adjudication method (e.g., 2+1, 3+1) is not applicable here. Adjudication methods are typically used in clinical trials or studies where subjective interpretations (e.g., by experts) need to be reconciled. For in vitro bench testing, acceptance is determined by direct measurement against pre-defined quantitative or qualitative criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of a diagnostic device (often AI-assisted) on human reader performance, typically in medical image interpretation. The device in question is a guide wire, and the testing involved objective in vitro bench tests, not human interpretation tasks.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The study conducted was a standalone performance evaluation in the sense that the device's physical and mechanical properties were tested directly, without human intervention in the 'performance' of the device itself during testing. However, it's important to distinguish that this is not an "algorithm only" study, as the device is a physical medical instrument, not a software algorithm. The tests evaluate the intrinsic performance of the guide wire itself.
7. The Type of Ground Truth Used
The type of ground truth used for the in vitro bench testing is based on engineering specifications and predefined performance criteria. For example:
- Tensile strength: Measured against a minimum required breaking strength.
- Torque strength: Measured against torsional force limits.
- Radiopacity: Assessed against a standard for visibility under fluoroscopy.
- Friction: Measured against specified friction coefficients.
These are objective, quantifiable standards for the device's physical properties.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical instrument (guide wire), not an AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this physical medical device.
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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 thedelivery of catheter-based interventional devices duringpercutaneous transluminal coronary angioplasty (PTCA). Thisguide wire may also be used with compatible stent devicesduring therapeutic procedures.The guide wire may also be used to reach and cross a targetlesion, provide a pathway within the vessel structure, facilitatethe substitution of one diagnostic or interventional device foranother, 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, clearedNovember 20, 2012), and HI-TORQUEPOWERTURN (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.
§ 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.