(89 days)
Not Found
No
The description details a physical guide wire and its mechanical properties and intended use, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is a guide wire used to facilitate the placement of other devices (like balloon dilatation catheters and stent devices) and to navigate vasculature, rather than directly treating a disease or condition itself.
No
The device is a guide wire used to facilitate the placement of other devices (like balloon dilatation catheters and stent devices) and to distinguish vasculature during interventional procedures, not to diagnose a condition itself.
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.
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 (placement of catheters and stents during angioplasty). IVDs are used to examine specimens from the body (like blood, urine, or tissue) to provide information about a person's health.
- 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 Diagnostic Function: There is no mention of the device being used to analyze biological samples or provide diagnostic information about a patient's condition. Its function is purely procedural.
Therefore, this device falls under the category of an interventional medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Hi-Torque Command 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 teach and cross a target lesion, provide a pathway within a 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 0.014" Hi-Torque Command (HT Command) 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 Command Guide Wire Family consists of two models with differing flexibility and performance; the HT Command and the HT Command ES. 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 Command 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
femoral, popliteal and infra-popliteal arteries, vessel structure
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 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 Command 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): 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.
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire (K072460, cleared April 11, 2008), HI-TORQUE BALANCE HEAVYWEIGHT (K021228, cleared May15, 2002), HI-TORQUE BMW ELITE (K103101, cleared Feb. 10, 2011), HI-TORQUE WHISPER, (K101116, cleared June 23, 2010); and HI-TORQUE POWERTURN (K112957, cleared Feb. 8, 2011).
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
510(k) Summary
NOV 2 0 2012
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.
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Submitter's Name
-
Submitter's Address
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Telephone
-
Fax
-
Contact Person
-
Date Prepared
-
Device Trade Name
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Device Common Name
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Device Classification Name
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Predicate Device(s) Name
Abbott Vascular Inc.
P.O. Box 9018, Temecula, CA 92589
(951) 914-3242
(951) 914-0339
Kay Setzer
August 22, 2012
Hi-Torque Command Guide Wire Family
Guide Wire
Catheter Guide Wire (DQX)
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire (K072460, cleared April 11, 2008); HI-TORQUE BALANCE HEAVYWEIGHT (K021228, cleared May15, 2002), HI-TORQUE BMW ELITE (K103101, cleared Feb. 10, 2011), HI-TORQUE WHISPER, (K101116, cleared June 23, 2010); and HI-TORQUE POWERTURN (K112957, cleared Feb. 8, 2011).
11. Device Description
The Abbott Vascular 0.014" Hi-Torque Command (HT Command) 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 Command Guide Wire Family consists of two models with differing flexibility and performance; the HT Command and the HT Command ES. 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 Command guide wire family is compatible with devices designed for use with 0.014" guide wires.
1
12. Indication for Use
The Hi-Torque Command 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 teach and cross a target lesion, provide a pathway within a 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 Command 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 Command 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 Command 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 Command Guide Wire Family is substantially equivalent to the predicate devices in regards to the indications for use, materials, fundamental technology, design, performance, shelf life, biocompatibility, sterilization, and packaging and is safe and effective for clinical use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the bird in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Abbott Vascular, Inc. c/o Ms. Kay Setzer Sr. Regulatory Affairs Specialist P.O. Box 9018 Temecula, CA 92589
NOV 2 0 2012
Re: K122573
Trade/Device Name: Hi-Torque Command Guide Wire Family Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II (two) Product Code: DQX Dated: August 22, 2012 Received: August 23, 2012
Dear Ms. Setzer:
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
3
Page 2 - Ms. Kay Setzer
device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
Matthew G. Hillebrenner
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): F122573
Device Name:
Hi-Torque Command Guide Wire Family
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 a 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)
CMA Stelle
ivision Sign-C (Division Sign-Om)
Division of Cardiovascular Devices
Division of Cardiovascular 2
510(k) Number_