(120 days)
KinetixTM Guidewires are intended to facilitate placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or PTA or other intravascular interventional procedures. The KinetixTM Guidewires are not intended for use in the cerebral vasculature. The devices are provided non-pyrogenic, sterile, and intended for one procedure only.
The Kinetix™ Guidewires are two 0.014" PTCA guidewires utilizing a micro-slotted nitinol sleeve that replaces the traditional spring coil. The Kinetix Guidewires are similar in design and manufacture to the spring-coil IQ™ Guidewires (K040140 on February 12, 2004). The two distinct models are: Kinetix™ Guidewire - A guidewire with a soft, a-traumatic tip and a moderate rail support. Kinetix™ Plus Guidewire - A guidewire with a stiffer tip than the moderate support version and an intermediate rail support.
The provided text describes the Kinetix™ Guidewire and its substantial equivalence to a predicate device but does not detail specific acceptance criteria or an explicit study proving the device meets those criteria in the way typically expected for a detailed performance study with quantitative results. Instead, it focuses on demonstrating equivalence through non-clinical testing.
Here's an attempt to extract and infer the requested information based on the provided text, while acknowledging limitations due to the nature of the available document (a 510(k) summary).
Guidewire Acceptance Criteria and Performance (Inferred from Non-Clinical Testing Summary)
| Acceptance Criteria Category (Inferred) | Reported Device Performance (Summary Statement) |
|---|---|
| Torque Response | Met minimum requirements |
| Tip Prolapse | Met minimum requirements |
| Tip Shapeability | Met minimum requirements |
| Radiopacity | Met minimum requirements |
| Marker Location | Met minimum requirements |
| Lubricity | Met minimum requirements |
| Coating Adherence/Presence | Met minimum requirements |
| Tensile Strength | Met minimum requirements |
| Shear Strength | Met minimum requirements |
| Combined Load | Met minimum requirements |
| Visual Inspection | Met minimum requirements |
| Device Compatibility | Met minimum requirements |
| Biocompatibility | Met minimum requirements |
| Product Shelf-Life | Met minimum requirements |
Study Information:
-
Sample Size Used for the Test Set and Data Provenance:
- The document states "Testing and evaluation of the Kinetix™ Guidewires included..." followed by a list of tests. It does not specify the sample size for each test.
- The data provenance is non-clinical (in vitro) testing conducted by Boston Scientific Corporation, likely in their laboratory in Maple Grove, MN, USA. It is prospective testing designed to evaluate the new device.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This question is not applicable in the context of the provided document. The "ground truth" for non-clinical performance tests is typically established by engineering specifications, industry standards, and predicate device performance, not by expert consensus in the same way clinical ground truth (e.g., disease diagnosis) is established. The "experts" would be the engineers and scientists conducting and analyzing the tests against established criteria.
-
Adjudication Method for the Test Set:
- This question is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for clinical studies involving human interpretation or decision-making, where there might be disagreement among reviewers. For physical product testing, the results are typically quantitative and assessed against predefined pass/fail criteria.
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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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices or decisions support systems. The Kinetix™ Guidewire is a physical medical device (catheter guidewire), not an AI system.
-
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No, a standalone algorithm performance study was not done. As mentioned above, this device is a physical guidewire, not a software algorithm.
-
The Type of Ground Truth Used:
- For the non-clinical tests, the "ground truth" refers to the pre-defined engineering specifications, performance standards, material properties, and the performance characteristics of the predicate device (IQ™ Guidewire). The tests verified that the Kinetix™ Guidewires met these minimum requirements.
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The Sample Size for the Training Set:
- This question is not applicable as the device is not an AI model or a system that requires a "training set." The testing described is for a physical medical device.
-
How the Ground Truth for the Training Set Was Established:
- This question is not applicable for the same reason as point 7.
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| 510(k) Summary per21 CFR §807.92 | AUG - 8 2008 | ||
|---|---|---|---|
| Submitter's Nameand Address | Boston Scientific Corporation (BSC)One Scimed PlaceMaple Grove, MN 55311 | ||
| Contact Name andInformation | Christine ThomasSpecialist, Regulatory AffairsPhone: 763-494-2942Fax: 763-494-2981e-mail: christine.thomas@bsci.com | ||
| Date Prepared | April 9, 2008 | ||
| ProprietaryName(s) | Kinetix™ Guidewire | ||
| Common Name | Catheter Guidewire | ||
| Product Code | DQX | ||
| Classification ofDevice | Class II, 21 CFR Part 870.1330 | ||
| Predicate Device | IQ™ Guidewire | K040140 | February 12,2004 |
| DeviceDescription | The Kinetix™ Guidewires are two 0.014" PTCAguidewires utilizing a micro-slotted nitinol sleeve thatreplaces the traditional spring coil. The KinetixGuidewires are similar in design and manufacture to thespring-coil IQ™ Guidewires (K040140 on February 12,2004). | ||
| The two distinct models are: | |||
| Kinetix™ Guidewire - A guidewire with a soft, a-traumatictip and a moderate rail support. | |||
| Kinetix™ Plus Guidewire - A guidewire with a stiffer tipthan the moderate support version and an intermediaterail support. |
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| Intended Use of Device | Kinetix™ Guidewires are intended to facilitate placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or PTA or other intravascular interventional procedures. The Kinetix Guidewires are not intended for use in the cerebral vasculature. The devices are provided non-pyrogenic, sterile, and intended for one procedure only. |
|---|---|
| Technological Characteristics | The Kinetix™ Guidewires utilize similar materials and methods of construction as the IQ™ Guide Wires (K040140, cleared on February 12, 2004). The significant difference in construction is the utilization of a micro-slotted Nitinol hypotube to replace the Inconel 625 (Nickel-Chrome alloy) spring coil. In addition there are two other material changes: the shaping ribbon material is changing from 304V Stainless Steel to Inconel 625 (Nickel-Chrome alloy) and the distal lubricious coating is changing from Silicone to Polyurethane. |
| Non-Clinical Test Summary | Testing and evaluation of the Kinetix™ Guidewires included torque response, tip prolapse, tip shapeability, radiopacity, marker location, lubricity, coating adherence/presence, tensile and shear, combined load, visual inspection, device compatibility, biocompatibility, and product shelf-life. |
| Test results verified that the Kinetix™ Guidewires met all of the minimum requirements and are adequate for their intended use. | |
| The Kinetix™ Guidewires are considered substantially equivalent to guidewires currently marketed by Boston Scientific based on a comparison of intended use, design and the results of in vitro testing and evaluation. |
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a human figure embracing a globe, rendered in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Christine Thomas Regulatory Affairs Specialist Boston Scientific Corporation One Scimed Place Maple Grove, MN 55311
AUG - 8 2008
Re: K081021
Trade/Device Name: Kinetix™ Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: II Dated: July 23, 2008 Received: July 24, 2008
Dear Ms. Thomas:
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.
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 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); good manufacturing practice requirements as set
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Page 2 - Ms. Christine Thomas
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-3150. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
R. Vachner
1 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 Statement
| 510(k) Number(if known) | K081021 |
|---|---|
| Device Name | KinetixTM Guidewire |
| Indications ForUse | KinetixTM Guidewires are intended to facilitate placementand exchange of balloon dilatation catheters or othertherapeutic devices during PTCA or PTA or otherintravascular interventional procedures. The KinetixTMGuidewires are not intended for use in the cerebralvasculature. The devices are provided non-pyrogenic,sterile, and intended for one procedure only. |
X ____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Per 21 CFR §801.109)
OR Over-The-Counter Use_ ________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Lochner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) number K081021
§ 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.