(46 days)
Not Found
No
The device description focuses on the physical construction and materials of a guide wire, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
No.
The device is a guide wire intended to facilitate the placement of other therapeutic devices (balloon dilatation catheters, stent devices) and to provide a pathway, rather than directly providing a therapeutic effect itself.
No
The "Intended Use / Indications for Use" section states that the guide wire is intended to "facilitate the placement of balloon dilatation catheters" and "may also be used with compatible stent devices during therapeutic procedures." It also mentions it can "facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature" but its primary role is not diagnostic.
No
The device description clearly details a physical guide wire made of stainless steel and nitinol, with various coatings and physical dimensions. It is a tangible medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body to facilitate medical procedures (percutaneous transluminal angioplasty, stent placement). IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: The description details a physical guide wire designed for insertion into blood vessels. This is consistent with an interventional medical device, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, this device is an interventional medical device, not an IVD.
N/A
Intended Use / Indications for Use
This Hi-Torque Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA) in arteries such as the femoral, popliteal arteries. 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 (comma separated list FDA assigned to the subject device)
DQX
Device Description
The Abbott Vascular Hi-Torque (HT) Command 18 Guide Wire with hydrophilic coating is a guide wire with a maximum diameter of 0.0180" and is provided in 210 cm and 300 cm lengths.
The Abbott Vascular HT Command 18 Guide Wire consists of a 304V stainless steel proximal core and a nitinol distal core. The distal core is attached to the stainless steel proximal core using a dissimilar metal solid-state resistance weld. The core wire at the tip is flattened to provide optimize flexibility, steering, and tip shaping. There are four nitinol lengths of the HT Command 18 family, each having multiple tip load options. The HT Command 18 has a straight (shapeable) tip.
The distal portion of the wire is covered with a polyurethane jacket and a hydrophilic coating. The proximal section of the wire is coated with polytetrafluoroethylene (PTFE) and a single coat of a silicone-based hydrophobic coating. Brachial and femoral markers are located on the proximal segment of the 210 cm and 300 cm guide wires.HT Command 18 Guide Wire is offered in two (2) packaging configuration options: With Accessory Devices (Torque Device and Guide Wire Introducer) and Without Accessory Devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral, popliteal, and infra-popliteal arteries
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)
Hi-Torque Command 18 Guide Wire testing successfully met functional and dimensional acceptance criteria and external requirements.
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.
0
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines suggesting movement or connection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2017
Abbott Vascular Ms. Kathyrene Logrono Project Manager, Regulatory Affairs 3200 Lakeside Drive Santa Clara, California 95054
Re: K172073
Trade/Device Name: Hi-Torque Command 18 Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: July 27, 2017 Received: July 28, 2017
Dear Ms. Logrono:
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
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 (DICE) 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 (DICE) 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,
for
Kenneth J. Cavanaugh -S
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) K172073
Device Name Hi-Torque Command 18 Guide Wire
Indications for Use (Describe)
This Hi-Torque Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA) in arteries such as the femoral, popliteal arteries. 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.
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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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) 845-0597 |
| 4. | Fax | (408) 845-3743 |
| 5. | Contact Person | Kathyrene Logrono |
| 6. | Date Prepared | July 07, 2017 |
| 7. | Device Trade Name | Hi-Torque Command 18 Guide Wire |
| 8. | Device Common Name | Guide Wire |
| 9. | Device Classification Name | Catheter Guide Wire (DQX) |
| 10. | Predicate Device Name | Hi-Torque Command Guide Wire Family |
| (K122573, cleared on November 20, 2012) |
11. Device Description
The Abbott Vascular Hi-Torque (HT) Command 18 Guide Wire with hydrophilic coating is a guide wire with a maximum diameter of 0.0180" and is provided in 210 cm and 300 cm lengths.
(K152404, cleared on September 21, 2015)
The Abbott Vascular HT Command 18 Guide Wire consists of a 304V stainless steel proximal core and a nitinol distal core. The distal core is attached to the stainless steel proximal core using a dissimilar metal solid-state resistance weld. The core wire at the tip is flattened to provide optimize flexibility, steering, and tip shaping. There are four nitinol lengths of the HT Command 18 family, each having multiple tip load options. The HT Command 18 has a straight (shapeable) tip.
The distal portion of the wire is covered with a polyurethane jacket and a hydrophilic coating. The proximal section of the wire is coated with polytetrafluoroethylene (PTFE) and a single coat of a silicone-based hydrophobic coating. Brachial and femoral markers are located on the proximal segment of the 210 cm and 300 cm guide wires.HT Command 18
4
Guide Wire is offered in two (2) packaging configuration options: With Accessory Devices (Torque Device and Guide Wire Introducer) and Without Accessory Devices.
12. Indications for Use
This Hi-Torque Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA) in arteries such as the femoral, popliteal, and infra-popliteal arteries. 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
The new device includes an additional packaging configuration (without accessory devices) and associated labeling changes, alternate packaging pouch from a different supplier, changes to the distal tip design, changes to the distal nitinol core wire and proximal stainless steel wire dimensions, changes to the proximal joint material, and changes to the coating and distal tip flattening process.
Comparison of the new device and predicate device demonstrate that the technological characteristics such as product performance, design (with minor modifications) and indications for use are substantially equivalent to the current marketed predicate device.
14. Performance Data
Hi-Torque Command 18 Guide Wire testing successfully met functional and dimensional acceptance criteria and external requirements.
- Surface Appearance ●
- Polyurethane Coating ●
- PTFE Coating ●
- Tip Appearance
- Outside Diameter
- Hydrophilic Coating Friction Test
- Guide Wire Particulates
- Torsional Wire Strength
- Tip Tensile Strength
- Overall Length ●
- Proximal Marker Locations ●
- Dissimilar Metal Weld Strength
- Rotary Bend Strength
- U-Bend Tensile Strength ●
5
- Tip Load
- Rotational Accuracy Testing (Torqueability)
Design (minor) changes were deemed non-impactful to biocompatibility as there are no new materials of construction, manufacturing aids, tooling materials and primary packaging materials and sterilization methods. Previous test results showed substantial equivalence to the current marketed predicate devices.
15. Conclusions
Test results from the functional and dimensional testing conducted on the subject Hi-Torque Command 18 Guide Wire met all acceptance criteria and show that it performed similarly to the predicate devices. There were no new safety or effectiveness issues raised during the testing program.
The Hi-Torque Command 18 Guide Wire is substantially equivalent to the predicate devices in regards to the indications for use, materials, fundamental technology, design, performance, biocompatibility, sterilization, and packaging and is safe and effective for clinical use.