(27 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 description and intended use clearly state that this is a guide wire "intended to facilitate the placement of balloon dilatation catheters" and to "provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another." It is a tool for other therapeutic devices, not a therapeutic device itself.
No
The device is primarily intended to facilitate the placement of balloon dilatation catheters and stent devices during therapeutic procedures. While it can facilitate the substitution of one diagnostic device for another and help distinguish vasculature, 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 included accessories like a torque device and introducer. There is no mention of software as the primary or sole component of the device.
Based on the provided text, 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 arteries. This is consistent with an interventional medical device, not a diagnostic test performed on a sample.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the guide wire (tensile strength, bend strength, coating adherence, etc.) and biocompatibility. These are typical tests for implantable or interventional devices, not IVDs which would focus on analytical and clinical performance related to detecting substances or markers in a sample.
The device is an interventional medical device used in procedures within the body.
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, poplited and infra-poplited 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 processed to optimize flexibility, steering, and tip shaping. There are four nitinol lengths of the HT Command 18 family, each having multiple tip load options. HT Command 18 has a straight (shapeable) tip.
The distal portion of the wire is coated 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.
A Torque Device and Guide Wire Introducer are supplied with the wire to facilitate the procedures as physician's aids, if desired.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral, poplited and infra-poplited 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)
Performance testing was successfully completed on the Hi-Torque Command 18 Guide Wire. In vitro functional bench testing conducted on the subject device included:
- Catheter compatibility
- Radiopacity
- Tip tensile strength
- Torsional wire strength
- Dissimilar metal weld strength
- Rotary bend strength
- Tip load
- Rotational accuracy
- Coating adherence and integrity (particulate testing)
- Friction testing
Biocompatibility testing included cytotoxicity, sensitization, acute systemic toxicity, material-mediated pyrogen, hemolysis, coagulation and complement activation.
Test results from the non-clinical in vitro bench testing conducted on the Hi-Torque Command 18 Guide Wire family 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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three faces in profile, representing the department's focus on health and well-being. The logo is simple, clean, and easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21, 2015
Abbott Vascular Shu Chi Hsu, Ph.D. Project Manager, Regulatory Affairs 3200 Lakeside Drive Santa Clara, CA 95054
Re: K152404
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: August 24, 2015 Received: August 25, 2015
Dear Dr. Hsu:
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
1
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,
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)
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, poplited and infra-poplited 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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3
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) 845-1256 |
| 4. | Fax | (408) 845-3743 |
| 5. | Contact Person | Shu Chi Hsu |
| 6. | Date Prepared | August 24, 2015 |
| 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.
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 processed to optimize flexibility, steering, and tip shaping. There are four nitinol lengths of the HT Command 18 family, each having multiple tip load options. HT Command 18 has a straight (shapeable) tip.
The distal portion of the wire is coated 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.
A Torque Device and Guide Wire Introducer are supplied with the wire to facilitate the procedures as physician's aids, if desired.
4
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
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
Performance testing was successfully completed on the Hi-Torque Command 18 Guide Wire. In vitro functional bench testing conducted on the subject device included:
- Catheter compatibility, ●
- Radiopacity. ●
- Tip tensile strength, ●
- Torsional wire strength,
- . Dissimilar metal weld strength,
- . Rotary bend strength,
- Tip load, ●
- Rotational accuracy, ●
- Coating adherence and integrity (particulate testing), and ●
- Friction testing ●
Biocompatibility testing included cytotoxicity, sensitization, acute systemic toxicity. material-mediated pyrogen. hemolysis. coagulation and complement activation.
15. Conclusions
Test results from the non-clinical in vitro bench testing conducted on the Hi-Torque Command 18 Guide Wire family 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 device in regards to the indications for use, materials, fundamental technology, design, performance, biocompatibility, sterilization, and packaging.