(27 days)
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.
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).
This is a 510(k) summary for a medical device (guidewire), not an AI/ML device. Therefore, the requested information regarding AI/ML device performance, such as sample sizes for test and training sets, expert consensus for ground truth, MRMC studies, or standalone algorithm performance, is not applicable and not present in the provided document.
The document describes the V-14 ControlWire Guidewire and its substantial equivalence to a predicate device based on non-clinical performance data.
Here's a breakdown of the requested information that can be extracted or noted as not applicable:
1. Table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with specific numerical targets and corresponding reported device performance values in the way you might see for an AI/ML device. Instead, it lists a series of performance tests and states that "All testing performed and data demonstrate passing results according to executed verification protocols." This implies meeting internal safety and performance standards for each test.
Performance Tests Performed (as listed in the document):
- 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
Reported Device Performance: "All testing performed and data demonstrate passing results according to executed verification protocols." This indicates the device successfully met the internal acceptance criteria for each listed test, supporting its safety and efficacy for the intended use.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a medical device (guidewire) submission based on non-clinical (bench) testing, not an AI/ML device with test sets of clinical data. The document does not specify sample sizes for these physical and material tests, nor does it refer to data provenance in the context of clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth, in the context of expert consensus, is typically relevant for diagnostic AI/ML devices interpreting images or other complex data. For a physical medical device, "ground truth" refers to established engineering specifications and objective test results, not expert human interpretation for establishing disease presence or absence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI/ML performance evaluation where human interpretation disagreement needs to be resolved. This document pertains to non-clinical bench testing of a physical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device, and no MRMC comparative effectiveness study was conducted. The submission specifically states, "Clinical Evaluation was not required for these devices."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable in the context of clinical "ground truth" as typically understood for AI/ML or diagnostic devices. For this guidewire, the "ground truth" for its performance is derived from objective engineering specifications and physical test methods designed to assess properties like torqueability, lubricity, strength, and biocompatibility, as outlined in the listed performance tests.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, and therefore no training set was used.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for one.
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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 Nameand Address | Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311 | ||
|---|---|---|---|
| Contact Name andInformation | Shannon PettitSenior Regulatory Affairs SpecialistTel: 763-494-2833Fax: 763-494-2222E-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 ScientificPT Graphix Guidewire(Formerly SCIMEDCholCE PT Vision) | K962572 | SE: 17 Dec 1996 |
| Reason forSubmission | To gain clearance for the V-14 ControlWire Guidewire based on anarrowed intended use of the currently marketed PT GraphixGuidewire cleared under K962572. | ||
| DeviceDescription | The V-14 ControlWire Guidewire is a hydrophilic coated polymertipped guide wire intended to facilitate the placement of balloondilatation catheters, and/or other therapeutic devices during peripheralvascular procedures.V-14 ControlWire core wire is constructed using 304V stainless steelwire. The distal portion of the core wire is tapered in diameter toprovide added flexibility. The distal portion of the core wire is coveredby a two part polymer sleeve. The polymer sleeve is coated with ahydrophilic coating to create a lubricious surface and improve wirehandling. The proximal portion of the core wire is coated withpolytretraflouroethylene (PTFE).The V-14 ControlWire comes in two length configurations (182 cm and300 cm), two distal tip configurations (Straight and Angled) and twotaper lengths (Short Taper and Long Taper). |
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K112745
P.2 of 3
Special 510(k) Notification
V-14 ControlWire Guidewire
| Indications forUse | The V-14 ControlWire Guidewires are intended to facilitate theplacement and exchange of balloon dilatation catheters or othertherapeutic devices during Percutaneous Transluminal Angioplasty(PTA) or other intravascular interventional procedures.The V-14 ControlWire Guidewires are not intended for use in thecerebral vasculature.The devices are provided non-pyrogenic, sterile, and intended for oneprocedure only. |
|---|---|
| Comparison ofTechnologicalCharacteristics | The narrowed intended use of the V-14 ControlWire Guidewire ascompared to PT Graphix Guidewire does not affect or alter thefundamental scientific technology of the cleared components. Thedesign, operating principles, shelf-life, materials, construction,accessories, performance, sterilization method, and manufacturing ofthe devices will remain unchanged. |
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| Non-ClinicalPerformance Data | Determination of substantial equivalence is based on an assessmentof non-clinical performance data. Non-clinical performance datasubmitted in support of the overall safety and efficacy of the device isbased on the Failure Modes/Effects Analysis (FMEA) risk analysismethod completed for the V-14 ControlWire to demonstrate that theproposed devices are suitable for their intended use.All testing performed and data demonstrate passing results accordingto executed verification protocols. Therefore, results of non-clinicalperformance data, including biocompatibility, sterility, and packagingtesting, 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 | ||
| ClinicalPerformance Data | Clinical Evaluation was not required for these devices. | ||
| Conclusion | Based on the Indications for Use, unaltered technologicalcharacteristics, and submitted non-clinical performance data, theBoston Scientific V-14 ControlWire Guidewire is shown to beappropriate for its intended use and is considered to be substantiallyequivalent to the PT Graphix Guidewire (K962572). |
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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
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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
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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.
Page 1 of _ 1
§ 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.