(27 days)
Not Found
No
The summary describes a physical guidewire and its material properties and performance testing, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is described as a guidewire intended to facilitate the placement and exchange of other therapeutic devices, not to provide therapy itself.
No
The device is a guidewire intended to facilitate the placement and exchange of other therapeutic devices during medical procedures. Its function is interventional, not diagnostic, as it does not gather or process data to inform a diagnosis.
No
The device description clearly outlines a physical guidewire constructed from stainless steel and polymer, with various physical configurations and coatings. The performance studies also focus on physical properties and biocompatibility, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the V-14 ControlWire Guidewires are "intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during Percutaneous Transluminal Angioplasty (PTA) or other intravascular interventional procedures." This describes a device used within the body for a therapeutic or interventional procedure, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description details the physical construction of a guidewire used to navigate blood vessels, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological samples, nor is there any indication that the device provides diagnostic information about a patient's condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The V-14 ControlWire Guidewire is an interventional device used in vivo (within the body).
N/A
Intended Use / Indications for Use
The V-14 ControlWire Guidewires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during Percutaneous Transluminal Angioplasty (PTA) or other intravascular interventional procedures.
The V-14 ControlWire Guidewires are not intended for use in the cerebral vasculature.
The devices are provided non-pyrogenic, sterile, and intended for one procedure only.
Product codes
DQX
Device Description
The V-14 ControlWire Guidewire is a hydrophilic coated polymer tipped guide wire intended to facilitate the placement of balloon dilatation catheters, and/or other therapeutic devices during peripheral vascular procedures.
V-14 ControlWire core wire is constructed using 304V stainless steel wire. The distal portion of the core wire is tapered in diameter to provide added flexibility. The distal portion of the core wire is covered by a two part polymer sleeve. The polymer sleeve is coated with a hydrophilic coating to create a lubricious surface and improve wire handling. The proximal portion of the core wire is coated with polytretraflouroethylene (PTFE).
The V-14 ControlWire comes in two length configurations (182 cm and 300 cm), two distal tip configurations (Straight and Angled) and two taper lengths (Short Taper and Long Taper).
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)
Determination of substantial equivalence is based on an assessment of non-clinical performance data. Non-clinical performance data submitted in support of the overall safety and efficacy of the device is based on the Failure Modes/Effects Analysis (FMEA) risk analysis method completed for the V-14 ControlWire to demonstrate that the proposed devices are suitable for their intended use.
All testing performed and data demonstrate passing results according to executed verification protocols. Therefore, results of non-clinical performance data, including biocompatibility, sterility, and packaging testing, supports the safety and efficacy of the V-14 ControlWire Guidewires.
The following performance tests were performed:
Torqueability
Radiopacity
Polymer sleeve lubricity / wire movement
Magnetic segment resiliency
Magnetic performance
Distal tip tensile
Proximal tensile
Surface Inspection
Bends
Corrosion resistance
Flexing test
Biocompatibility:
Cytotoxicity
Sensitization
Intracutaneous Reactivity
Acute Systemic Toxicity
Materials Mediated
Rabbit Pyrogen
Hemolysis
Direct Partial Thromboplastin Time
In Vitro Hemocompatibility Assay
Complement Activation
USP Physicochemical Latex
Tip flexibility
Coating adherence
Coating durability - distal
Magnetic section kink resistance
Magnetic section joint kink resistance / fatigue
J-tip / angled tip retention
Torque strength
Polymer sleeve shear
Overall length
Fracture test
Clinical Evaluation was not required for these devices.
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
Special 510(k) Notification Pri:
V-14 ControlWire Guidewire Guidewire
OCT 1 8 2011
.
510(k) Summary
per 21 CFR §807.92 (c)
| Submitter's Name
and Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311 | | |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-----------------|
| Contact Name and
Information | Shannon Pettit
Senior Regulatory Affairs Specialist
Tel: 763-494-2833
Fax: 763-494-2222
E-mail: Shannon.Pettit@bsci.com | | |
| Date Prepared | 20 September 2011 | | |
| Trade Name | V-14TM ControlWire® Guidewire | | |
| Common Name | Wire, Guide, Catheter | | |
| Classification | Class II | | |
| Product Code | DQX (21 CFR 870.1330) | | |
| Predicate Device | Boston Scientific
PT Graphix Guidewire
(Formerly SCIMED
CholCE PT Vision) | K962572 | SE: 17 Dec 1996 |
| Reason for
Submission | To gain clearance for the V-14 ControlWire Guidewire based on a
narrowed intended use of the currently marketed PT Graphix
Guidewire cleared under K962572. | | |
| Device
Description | The V-14 ControlWire Guidewire is a hydrophilic coated polymer
tipped guide wire intended to facilitate the placement of balloon
dilatation catheters, and/or other therapeutic devices during peripheral
vascular procedures.
V-14 ControlWire core wire is constructed using 304V stainless steel
wire. The distal portion of the core wire is tapered in diameter to
provide added flexibility. The distal portion of the core wire is covered
by a two part polymer sleeve. The polymer sleeve is coated with a
hydrophilic coating to create a lubricious surface and improve wire
handling. The proximal portion of the core wire is coated with
polytretraflouroethylene (PTFE).
The V-14 ControlWire comes in two length configurations (182 cm and
300 cm), two distal tip configurations (Straight and Angled) and two
taper lengths (Short Taper and Long Taper). | | |
1
K112745
P.2 of 3
Special 510(k) Notification
V-14 ControlWire Guidewire
| Indications for
Use | The V-14 ControlWire Guidewires are intended to facilitate the
placement and exchange of balloon dilatation catheters or other
therapeutic devices during Percutaneous Transluminal Angioplasty
(PTA) or other intravascular interventional procedures.
The V-14 ControlWire Guidewires are not intended for use in the
cerebral vasculature.
The devices are provided non-pyrogenic, sterile, and intended for one
procedure only. |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of
Technological
Characteristics | The narrowed intended use of the V-14 ControlWire Guidewire as
compared to PT Graphix Guidewire does not affect or alter the
fundamental scientific technology of the cleared components. The
design, operating principles, shelf-life, materials, construction,
accessories, performance, sterilization method, and manufacturing of
the devices will remain unchanged. |
ﺪ
2
| Non-Clinical
Performance Data | Determination of substantial equivalence is based on an assessment
of non-clinical performance data. Non-clinical performance data
submitted in support of the overall safety and efficacy of the device is
based on the Failure Modes/Effects Analysis (FMEA) risk analysis
method completed for the V-14 ControlWire to demonstrate that the
proposed devices are suitable for their intended use.
All testing performed and data demonstrate passing results according
to executed verification protocols. Therefore, results of non-clinical
performance data, including biocompatibility, sterility, and packaging
testing, supports the safety and efficacy of the V-14 ControlWire | | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Guidewires.
The following performance tests were performed:
Torqueability Radiopacity Polymer sleeve lubricity / wire movement Magnetic segment resiliency Magnetic performance Distal tip tensile Proximal tensile Surface Inspection Bends Corrosion resistance Flexing test Biocompatibility: Cytotoxicity Sensitization Intracutaneous Reactivity Acute Systemic Toxicity Materials Mediated Rabbit Pyrogen Hemolysis Direct Partial Thromboplastin Time In Vitro Hemocompatibility Assay Complement Activation USP Physicochemical Latex | Tip flexibility Coating adherence Coating durability - distal Magnetic section kink resistance Magnetic section joint kink resistance / fatigue J-tip / angled tip retention Torque strength Polymer sleeve shear Overall length Fracture test | |
| Clinical
Performance Data | Clinical Evaluation was not required for these devices. | | |
| Conclusion | Based on the Indications for Use, unaltered technological
characteristics, and submitted non-clinical performance data, the
Boston Scientific V-14 ControlWire Guidewire is shown to be
appropriate for its intended use and is considered to be substantially
equivalent to the PT Graphix Guidewire (K962572). | | |
·
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Boston Scientific Corporation % Ms. Shannon Pettit One Scimed Place Maple Grove, MN 55311-1566
OCT 1 8 2011
Re: K112745
Trade/Device Name: V-14 ControlWire Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: September 20, 2011 Received: September 21, 2011
Dear Ms. Pettit:
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 contractly and i 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 (111) e 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
4
Page 2 - Ms. Shannon Pettit
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
Bram D. Zuckerman, M.D.
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): KU2745
Device Name: V-14™ ControlWire® Guidewire
Indications for Use:
The V-14 ControlWire Guidewires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during Percutaneous Transluminal Angioplasty (PTA) or other intravascular interventional procedures.
The V-14 ControlWire Guidewires are not intended for use in the cerebral vasculature.
The devices are provided non-pyrogenic, sterile, and intended for one procedure only.
Prescription Use X· (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (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)
Signature
Division Sign-Off)
Pasion for Cardiovasculc.ices
5!ük Number #1121945.
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