(28 days)
Not Found
No
The description details a purely mechanical device for manipulating guidewires and makes no mention of AI or ML.
No.
Explanation: The device is described as an "accessory device" used to manipulate guidewires, not to directly treat a medical condition or restore health. Its function is to facilitate a procedure rather than provide therapy.
No
This device is used for manipulating guidewires during general intravascular procedures by applying force to them. It is an accessory device, not one that gathers information or diagnoses conditions.
No
The device description clearly outlines physical components (tubular collet, cap, tubular body) and describes a mechanical action (applying torsional and axial force) performed by these components on a guidewire. The performance studies also focus on physical characteristics and interactions (Torque Slip Force, Pull Slip Force, Guidewire Deformation, Collet Release). This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "guidewire manipulation during general intravascular procedures." This describes a device used within the body to assist in a medical procedure, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details a mechanical device used to apply force to a guidewire. This aligns with a surgical or interventional tool, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Torque Device is used for guidewire manipulation during general intravascular procedures.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The Torque Device is an accessory device used to apply torsional and/or axial force to the guidewire to manipulate its distal end in the vasculature. It is designed to accommodate guidewires with diameters from 0.010 to 0.018 inches and is composed of three main components: 1.) a tubular collet contained within the body and cap assembly; 2.) a cap and 3.) a tubular body.
A guidewire is inserted through the Torque Device from the distal (cap) end. The Torque Device is positioned optimally on the guidewire at the desired location, and then secured by rotation of the cap. Once tightened, the torque device is used to apply torsional and axial force to the guidewire to manipulate its distal end in the vasculature.
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)
Design verification was performed to verify the performance and usability of the Torque Device remains substantially equivalent to the predicate device. Biocompatibility and sterility testing were also performed to verify the overall substantial equivalence to the predicates.
Specifically the following design verification testing was performed:
- Torque Slip Force
- Pull Slip Force
- Guidewire Deformation
- Collet Release
- Biocompatibility Testing: Latex
Clinical Evaluation was not required for this device.
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.
K922706; 10 December 1992, K120694, 03 April 2012
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.
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K123624 Page 1 of 1
510(k) Summary per 21 CFR §807.92
| | 510(k) Summary
per 21 CFR §807.92 | OCT 26 2012 |
|-------------------|-------------------------------------------------------------------------------------------------------------------|-------------|
| Sponsor: | Boston Scientific Corporation
One Boston Scientific Place
Natick MA 01760 | |
| Contact Person: | Rachel Owens | |
| Phone Number: | 763-494-1491 | |
| Fax Number: | 763-494-2222 | |
| Prepared: | 27 September 2012 | |
| Trade Name: | Torque Device | |
| Common Name: | wire, guide, catheter | |
| Classification: | II | |
| Product Code: | DQX
21 CFR 870.1330 | |
| Predicate Device: | SCIMED® Sideliner™ Torque Device (K922706; 10 December 1992)
Encore 26 Advantage Kit (K120694, 03 April 2012). | |
Device Description:
The Torque Device is an accessory device used to apply torsional and/or axial force to the guidewire to manipulate its distal end in the vasculature. It is designed to accommodate guidewires with diameters from 0.010 to 0.018 inches and is composed of three main components: 1.) a tubular collet contained within the body and cap assembly; 2.) a cap and 3.) a tubular body.
A guidewire is inserted through the Torque Device from the distal (cap) end. The Torque Device is positioned optimally on the guidewire at the desired location, and then secured by rotation of the cap. Once tightened, the torque device is used to apply torsional and axial force to the guidewire to manipulate its distal end in the vasculature.
Intended Use
The Torque Device is used for guidewire manipulation during general intravascular procedures.
Substantial Equivalence
The Torque Device design, materials, manufacturing process and intended use are substantially equivalent to the Sideliner Torque Device (K922706) and Encore 26 Advantage Kit (K120694).
Summary of Non-Clinical Testing
Design verification was performed to verify the performance and usability of the Torque Device remains substantially equivalent to the predicate device. Biocompatibility and sterility testing were also performed to verify the overall substantial equivalence to the predicates.
Specifically the following design verification testing was performed:
- � Torque Slip Force
- � Pull Slip Force
- Guidewire Deformation �
- � Collet Release
- ◆ . Biocompatibility Testing: Latex
Summary of Clinical Testing
Clinical Evaluation was not required for this device.
Boston Scientific Corporation Premarket Notification - Special 510(k)
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue White Oak Building 66 Silver Spring, MD 20993
OCT 2 6 2012
Boston Scientific Corporation c/o Rachel Owens Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311
Re: K123024
Trade Name: Torque Device Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: September 27, 2012 Received: September 28, 2012
Dear Ms. Owens:
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 adviseration. 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
2
Page 2 - Ms. Rachel Owens
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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
ht
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devises Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): -
Device Name: Torque Device
Indications For Use:
The Torque Device is used for guidewire manipulation during general intravascular procedures.
Over-The-Counter Use _ Prescription Use _ X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Dhicion Sigh-Off)
Brocardiovascular Devk
Page 1 of 1
f Cardiovascular Device:
510(k) Number 4123024