(120 days)
Not Found
No
The document describes a physical medical device (guidewire) and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The guidewire facilitates the placement of other therapeutic devices but is not a therapeutic device itself, as stated in its intended use: "to facilitate placement and exchange of balloon dilatation catheters or other therapeutic devices."
No
The device is a guidewire used to facilitate the placement and exchange of other therapeutic devices, not for diagnosis.
No
The device description clearly describes a physical guidewire made of nitinol, which is a hardware component. There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The description and intended use clearly state that the KinetixTM Guidewires are used inside the body during interventional procedures (PTCA, PTA, etc.) to facilitate the placement of other devices. They are physical tools used within the vascular system.
The information provided describes a medical device used for a therapeutic or interventional purpose, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
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.
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)
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.
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.
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.
0
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| | 510(k) Summary per
21 CFR §807.92 | | AUG - 8 2008 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|----------------------|
| Submitter's Name
and Address | Boston Scientific Corporation (BSC)
One Scimed Place
Maple Grove, MN 55311 | | |
| Contact Name and
Information | Christine Thomas
Specialist, Regulatory Affairs
Phone: 763-494-2942
Fax: 763-494-2981
e-mail: christine.thomas@bsci.com | | |
| Date Prepared | April 9, 2008 | | |
| Proprietary
Name(s) | Kinetix™ Guidewire | | |
| Common Name | Catheter Guidewire | | |
| Product Code | DQX | | |
| Classification of
Device | Class II, 21 CFR Part 870.1330 | | |
| Predicate Device | IQ™ Guidewire | K040140 | February 12,
2004 |
| Device
Description | 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. | | |
.
1
| 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. |
:
:
2
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
3
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
4
Indications for Use Statement
| 510(k) Number
| (if known) | K081021 |
|---|---|
| Device Name | KinetixTM Guidewire |
| Indications For | |
| Use | 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. |
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