(16 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a guidewire, with no mention of AI or ML capabilities.
No
The device is described as a guidewire intended to facilitate the placement of other therapeutic devices, not to provide therapy itself.
No
The guidewires are intended to facilitate the placement of other therapeutic devices, not to diagnose a condition. While they allow for visualization using fluoroscopy, this is for guidance during a procedure, not for diagnostic imaging.
No
The device description clearly details physical components made of stainless steel, platinum/nickel, and PTFE, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Boston Scientific JUDO Guidewires are physical devices used within the body during medical procedures (PTCA and other intravascular interventions). They facilitate the placement of other devices.
- Intended Use: The intended use clearly describes a procedural function within the body, not a diagnostic test performed on a sample outside the body.
- Device Description: The description details the physical components and coatings of a guidewire, not the reagents or components of a diagnostic test.
Therefore, based on the provided information, the Boston Scientific JUDO Guidewires are medical devices used for interventional procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Boston Scientific JUDO 1, JUDO 3, and JUDO 6 Guidewires are intended to facilitate the placement of balloon dilatation catheters or other interventional therapeutic devices during percutaneous transluminal coronary angioplasty (PTCA) or other intravascular interventional procedures. These guidewires are not intended for use in the cerebral vasculature.
Product codes
DOX
Device Description
The Boston Scientific JUDO 1, JUDO 3, and JUDO 6 Guidewires are available with a nominal diameter of 0.014 inches (0.37 mm) and in nominal lengths of 190 cm or 300 cm. The guidewires are composed of a stainless steel core wire which tapers at the distal end. The tapered distal end of the guidewire is covered with a proximal stainless steel coil and a distal platinum/nickel radiopaque coil that allows for visualization while using fluoroscopy. The proximal end of the guidewire contains a polytetrafluoroethylene (PTFE) coating and the distal portion of the wire is coated with a hydrophilic coating. The guidewires are available in a straight tip shape only.
The 190 cm guidewires are designed with a 2.1 cm friction fit extension section for exchange of Over-the-Wire systems by using the Stretch Extension Wire (K151840). The 300 cm guidewire allows exchange of therapeutic devices without the use of an extension wire or exchange system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intravascular, not intended for use in the cerebral vasculature.
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
Bench testing was performed to support a determination of substantial equivalence. The result of the test provides reasonable assurance that the proposed devices with the modified distal core wire diameter have been designed and tested to assure conformance to the requirements for their intended use. No new safety or performance issues were raised during the testing.
The following device performance test was completed:
Tip Flexibility
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
April 12, 2018
Boston Scientific Nikki Ibis Principal Regulatory Affairs Specialist Three Scimed Place Maple Grove, Minnesota 55311-1566
Re: K180795
Trade/Device Name: JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: March 23, 2018 Received: March 27, 2018
Dear Nikki Ibis:
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 contract liability 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 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | Form Approved: OMB No. 0910-0120 |
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. | |
| 510(k) Number (if known) | K180795 |
| Device Name | JUDOTM 1 Guidewire |
| JUDOTM 3 Guidewire | |
| JUDOTM 6 Guidewire | |
| Indications for Use (Describe) | Boston Scientific JUDO 1, JUDO 3, and JUDO 6 Guidewires are intended to facilitate the placement of balloon dilatation |
| catheters or other interventional therapeutic devices during percutaneous transluminal coronary angioplasty (PTCA) or | |
| other intravascular interventional procedures. These guidewires are not intended for use in the cerebral vasculature. | |
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| FORM FDA 3881 (7/17) | Page 1 of 1 |
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| ---------------------- | ------------- |
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510(k) Summary
per 21 CFR §807.92
| Sponsor: | Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, Massachusetts 01752
USA | | |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------|------------------|
| Contact Name and
Information | Nikki M Ibis
Three Scimed Place
Maple Grove, MN 55311-1566
Phone: 763-494-2381
Fax: 763-494-2981
e-mail: Nikki.Ibis@bsci.com | | |
| Prepared | 23 March 2018 | | |
| Proprietary Name | JUDO™ 1 Guidewire
JUDO™ 3 Guidewire
JUDO™ 6 Guidewire | | |
| Common Name | Catheter Guide Wire | | |
| Product Code | DQX | | |
| Classification | Class II, 21 CFR Part 870.1330 | | |
| Predicate Device | Hornet™ Guidewire | K152231 | 12 February 2016 |
| Reference
Device(s) | Hornet™ 10 Guidewire
Hornet™ 14 Guidewire | K152231 | 12 February 2016 |
4
Device Description
The Boston Scientific JUDO 1, JUDO 3, and JUDO 6 Guidewires are available with a nominal diameter of 0.014 inches (0.37 mm) and in nominal lengths of 190 cm or 300 cm. The guidewires are composed of a stainless steel core wire which tapers at the distal end. The tapered distal end of the guidewire is covered with a proximal stainless steel coil and a distal platinum/nickel radiopaque coil that allows for visualization while using fluoroscopy. The proximal end of the guidewire contains a polytetrafluoroethylene (PTFE) coating and the distal portion of the wire is coated with a hydrophilic coating. The guidewires are available in a straight tip shape only.
The 190 cm guidewires are designed with a 2.1 cm friction fit extension section for exchange of Over-the-Wire systems by using the Stretch Extension Wire (K151840). The 300 cm guidewire allows exchange of therapeutic devices without the use of an extension wire or exchange system.
Indications for Use / Intended Use
Boston Scientific JUDO 1, JUDO 3, and JUDO 6 Guidewires are intended to facilitate the placement of balloon dilatation catheters or other interventional therapeutic devices during percutaneous transluminal coronary angioplasty (PTCA) or other intravascular interventional procedures. These guidewires are not intended for use in the cerebral vasculature.
Comparison of Technological Characteristics
The JUDO 1, JUDO 3, and JUDO 6 Guidewires incorporate substantially equivalent design, packaging, fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate, Hornet™ Guidewire, K152231.
Non-Clinical Test Summary
Bench testing was performed to support a determination of substantial equivalence. The result of the test provides reasonable assurance that the proposed devices with the modified distal core wire diameter have been designed and tested to assure conformance to the requirements for their intended use. No new safety or performance issues were raised during the testing.
The following device performance test was completed:
Tip Flexibility
5
Conclusion
Based on the indications for use, technological characteristics, safety and performance testing, the JUDO™ 1 Guidewire, JUDO™ 3 Guidewire, and JUDO™ 6 Guidewires are appropriate for the stated intended use and are considered to be substantially equivalent to the predicate device (K152231).