(45 days)
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 capabilities.
No.
Explanation: The device is a guide wire intended for general intravascular use to facilitate the placement of other catheters, including therapeutic ones, but it does not perform a therapeutic action itself.
No
The device is a guide wire used to facilitate the placement of other catheters (diagnostic or therapeutic). It is not diagnostic itself but aids in the positioning of diagnostic tools.
No
The device description clearly details a physical guide wire made of stainless steel and polyurethane, including a torque device. This is a hardware medical device, not software.
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 for guiding catheters during procedures (intravascular use, placement of PTA balloon catheters). This is an in vivo use, not an in vitro (outside the body) diagnostic test.
- Device Description: The description details a physical wire designed for navigation within blood vessels, not for analyzing samples like blood, urine, or tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
The device is a medical device used for interventional procedures, specifically a guide wire.
N/A
Intended Use / Indications for Use
The 110cm V-18 Control Wire is intended for general intravascular use including the placement of PTA balloon catheters requiring an 0.018" guide wire in hemodialysis AV access procedures. The wire can be torqued to facilitate placement of diagnostic or therapeutic catheters. This device is intended for peripheral vascular use only. A torque device is included with each wire to facilitate directional manipulation of the guide wire.
Product codes
74DQX, DQX
Device Description
The 110 cm V-18 Control Wire wire is for use in the percutaneous introduction of catheters including Hemodialysis Access Management procedures. The 110 cm V-18 Control Guide Wire is a sterile, single-use wire that is available in a 110cm nominal wire length, a nominal of 0.018" diameter, a nominal 8 cm taper length, and a shapeable tip.
The 110 cm V-18 Control Wire is identical to Boston Scientific's currently marketed V-18 Strike Control Wire with the exception of the length and indication. The length of the 110 cmV-18 Control Wire is 110cm, while the lengths of the V-18 Strike Control Wire includes 150cm, 200cm, and 300cm offerings. With the exception of the length, the guide wire design is identical to the V-18 Strike Control Wirc (K934359, cleared October 7, 1993). The V-18 Strike Control Wire guide wire is for use in the percutaneous introduction of catheters. The 110cm V-18 Control Wire includes this indication and also includes hemodialysis AV access management interventions.
The core is a tapered stainless steel wire which provides the pushability, flexibility, torquability and steerability needed to maneuver into tortuous vessels. The most distal portion of the wire is shapeable. The distal end of the core is covered with a heat-flow polyurethane compounded with tungsten. The tungsten provides the radiopacity necded for visualization. The heatflow is coated with a hydrophillic polymer for ease of use and enhances appearance.
A torque device, also cleared in the V-18 Strike 510(k) (K934359) is included in the package and is intended for use at the proximal end of the guide wire to allow manipulation of the wire during the percutaneous procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral vascular
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)
Device compatibility testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests met minimum requirements and are adequate for it's intended use. No new safety or performance issues were raised during the testing regimen.
Since the 110cm V-18 guide wire design is identical to the currently marketed V-18 Strike Control Wire, except for the length, all data that was submitted for the V-18 Strike Control Wire is applicable to the 110cm V-18 Guide Wire. The following previous test data for V-18 Strike Control Wire was not repeated, but is representative of the 110cm V-18 Control Wire, since the distal wire segments are identical. These tests include: Distal Tip Torsion, Combined Load Failure, Torque Response, Tip Flexibility, Polyurethane/PTFE Coating Adherence Test, Torque Slip Force, Pull Tensile Test, Collett Release Test, and Deformation Test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JAN 1 2 2004
Section 4
Summary of Safety and Effectiveness
(Pursuant To Section 12 per 21 CFR 807.92 of the SAFE MEDICAL DEVICES ACT of 1990)
General Provisions
| 1. Submitter's Name and Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, Minnesota 55311 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------|
| 2. Contact Person | Deborah Thomas
Regulatory Affairs Specialist
763-494-2078 (phone)
763-494-2981 (fax)
thomasd@bsci.com |
| 3. Date Prepared | November 26, 2003 |
| 4. Proprietary Name | Boston Scientific Corporation V-18
Control Wire |
| 5. Common or Usual Name | Catheter Guide Wire |
| 6. Product Code | 74DQX |
| 7. Classification of Device | Class II, 21 CFR Part 870.1330 |
Predicate Devices
Boston Scientific Strike™ (V-18) Control Guide Wire (K934359; cleared October 7, 1993)
Device Description
The 110 cm V-18 Control Wire wire is for use in the percutaneous introduction of catheters including Hemodialysis Access Management procedures. The 110 cm V-18 Control Guide Wire is a sterile, single-use wire that is available in a 110cm nominal wire length, a nominal of 0.018" diameter, a nominal 8 cm taper length, and a shapeable tip
1
Section 4
The 110 cm V-18 Control Wire is identical to Boston Scientific's currently marketed V-18 Strike Control Wire with the exception of the length and indication. The length of the 110 cmV-18 Control Wire is 110cm, while the lengths of the V-18 Strike Control Wire includes 150cm, 200cm, and 300cm offerings. With the exception of the length, the guide wire design is identical to the V-18 Strike Control Wirc (K934359, cleared October 7, 1993). The V-18 Strike Control Wire guide wire is for use in the percutaneous introduction of catheters. The 110cm V-18 Control Wire includes this indication and also includes hemodialysis AV access management interventions.
The core is a tapered stainless steel wire which provides the pushability, flexibility, torquability and steerability needed to maneuver into tortuous vessels. The most distal portion of the wire is shapeable. The distal end of the core is covered with a heat-flow polyurethane compounded with tungsten. The tungsten provides the radiopacity necded for visualization. The heatflow is coated with a hydrophillic polymer for ease of use and enhances appearance.
A torque device, also cleared in the V-18 Strike 510(k) (K934359) is included in the package and is intended for use at the proximal end of the guide wire to allow manipulation of the wire during the percutaneous procedure.
Intended Use
The 110cm V-18 Control Wire is intended for general intravascular usc including the placement of PTA balloon catheters requiring an 0.018" guide wire in hemodialysis AV access procedures. The wire can be torqued to facilitate placement of diagnostic or therapeutic catheters. This device is intended for peripheral vascular use only. A torque device is included with cach wire to facilitate directional manipulation of the guide wire.
2
Section 4
Summary of Safety and Effectiveness
Technological Characteristics
The 110 cm V-18 Control Guide Wire will incorporate equivalent packaging, fundamental technology, manufacturing, and sterilization as those featured in the predicate Boston Scientific legally marketed guide wire, the V-18 Strike Control Guide Wire. The 110 cm V-18 Control Wire will incorporate an equivalent design as the V-18 Strike Control Guide Wire, except for the 110cm length. The currently marketed V-18 Strike Control Wire is offered in 150cm, 200cm, and 300cm lengths. The 110 cm V-18 Control Wire design is identical to the V-18 Strike Control Wire except for the length.
Non-Clinical Test Summary
Device compatibility testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests met minimum requirements and are adequate for it's intended use. No new safety or performance issues were raised during the testing regimen.
Since the 110cm V-18 guide wire design is identical to the currently marketed V-18 Strike Control Wire, except for the length, all data that was submitted for the V-18 Strike Control Wire is applicable to the 110cm V-18 Guide Wire. The following previous test data for V-18 Strike Control Wire was not repeated, but is representative of the 110cm V-18 Control Wire, since the distal wire segments are identical. These tests include: Distal Tip Torsion, Combined Load Failure, Torque Response, Tip Flexibility, Polyurethane/PTFE Coating Adherence Test, Torque Slip Force, Pull Tensile Test, Collett Release Test, and Deformation Test.
Conclusion
Based on the Indications for Use, technological characteristics, and results of the invitro testing and evaluation, the 110cm V-18 Control Wire has been shown to be adequate for its intended use and is considered to be substantially cquiva-lent to the V-18 Strike Guide Wire (K934359; cleared October 7, 1993).
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 2004
Boston Scientific Corporation c/o Ms. Deborah Thomas Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311
K033742 Re:
Trade/Device Name: Boston Scientific V-18 Control Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: November 26, 2003 Received: November 28, 2003
Dear Ms. Thomas:
We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use black in the May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce prior to may 20, 2011 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Coometic Fore, market the device, subject to the general controls provisions of the Act. The r ou may, therefore, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may of subject to sater additions, 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 I loast be act now i be mination that your device complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
4
Page 2 – Ms. Deborah Thomas
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
s (21 CFR) (2000) (2008) (2005) (2005-12-12) (2) CFR 1000-1050, forth in the quality systems (QS) regulation (2 -51 v as the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 53 -542 of the Action Section 5 product radiation control provisions (Sections 351-742 or uce received in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a le This letter will allow you to begin marketing your revies of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalevice of y premarket notification. The PDA finding of substantial equive and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs the regulation of the man 1961 - 1941 - also and the regulation entitled If you desire specific advice for your device in ca. Also, please contact the Office of Computation at (301) 57 - - - - - - - (21CFR Patt 807.97). You may obtain
"Misbranding by reference to premarket notification of Small "Misbranding by reference to premarket nonfication (es oct from the Division of Small)
other general information on your responsibilities under (800) 638-204 other general information on your responsibilities and consumer (800) 638-2041 or (301) 443-6597 or at its Internet address
(301) 443-0597 or at its intornet audioss
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Ashley B. Brane
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: V-18 Control Guide Wire
Indications For Use:
The 110cm V-18 Control Wire is intended for general intravascular use including the The Troun' V To Control viatheters requiring an 0.018" guide wire in hemodialysis AV placemont of 1 17 . Balley can be torqued to facilitate placement of diagnostic or therapeutic catheters. This device is intended for peripheral vascular use only. A therupourily outherer is included with each wire to facilitate directional manipulation of the quide wire.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ashley B. Brown
SM. KJ
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