(30 days)
Not Found
No
The document describes a mechanical guidewire with specific material properties and coatings for navigation. There is no mention of AI, ML, image processing, or any computational analysis of data for decision-making or control. The performance studies are based on physical bench testing and biocompatibility, not algorithmic performance.
No.
The device is a guidewire used to facilitate the placement of a catheter, which is a diagnostic or interventional tool, but the guidewire itself does not perform a therapeutic action.
No
Justification: The device is a guidewire used to facilitate the placement of a catheter during diagnostic or interventional procedures. It is an accessory device, not a diagnostic device itself.
No
The device description clearly details physical components like a stainless steel core wire, coil, and coatings, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate placement of a catheter during diagnostic or interventional procedures." This describes a device used within the body to aid in a medical procedure, not a device used outside the body to examine specimens from the body.
- Device Description: The description details a physical guidewire with specific materials and coatings designed for navigation within blood vessels. This is consistent with an invasive medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a tool used during a procedure, not a diagnostic test itself.
N/A
Intended Use / Indications for Use
The Magic Torque™ Guidewires facilitate placement of a catheter during diagnostic or interventional procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches. Not intended for use in coronary arteries.
Product codes
DQX
Device Description
The 315 cm Magic Torque™ DLVR Guidewire facilitates placement of a catheter during diagnostic or interventional procedures. The guidewire contains a stainless steel (SS) core wire. A SS coil is wound over the distal 50 cm of the core wire. The most distal 10 cm of the SS coil is coated with a proprietary hydrophilic coating from Boston Scientific that provides a slippery surface to facilitate negotiation of difficult anatomy and tight lesions. The proximal 40 cm of the coil is coated with polytetrafluoroethylene (PTFE) for lubricity. A PTFE polymer sleeve jackets the proximal end of the core wire. The guidewire is clearly visible under fluoroscopy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
tortuous arteries
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)
Non-Clinical Performance Data:
Biological Safety Testing: A biocompatibility assessment in accordance with ISO 10993-1, microbial assessments including bioburden, endotoxin, and pyrogenicity, and sterility assurance testing were conducted. The assessments show the device to be biocompatible for its intended use.
Bench Testing: The following tests were performed to demonstrate substantial equivalence to the predicate device.
• Overall Length Measurement
• Guidewire Withdrawal from the Carrier Tube
The Magic Torque DLVR Guidewire met the predetermined acceptance criteria, thereby demonstrating substantial equivalence to the predicate device. No new safety or performance issues were raised during testing.
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in smaller blue letters below.
September 26, 2018
Boston Scientific Corporation Andrea Dance Regulatory Affairs Specialist 3 Scimed Place Maple Grove, Minnesota 55311
Re: K182315
Trade/Device Name: Magic Torque DLVR Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: August 23, 2018 Received: August 27, 2018
Dear Ms. Dance:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about mediation-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.
Michael John -S 2018.09.26 16:39:04 -04'00'
for 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)
Device Name Magic Torque™ DLVR Guidewire
Indications for Use (Describe)
The Magic Torque™ Guidewires facilitate placement of a catheter during diagnostic or interventional procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches. Not intended for use in coronary arteries.
| 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) |
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SECTION 3. 510(K) Summary Per CFR 807.92
| Submitter's Name
and Address | Boston Scientific Corporation
Three Scimed Place
Maple Grove, MN 55311
USA |
|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and
Information | Andrea Dance
Regulatory Affairs Specialist
Phone: 763-494-1743
Fax: 763-494-2222
Email: andrea.dance@bsci.com |
| Date Prepared | August 23, 2018 |
| Trade Name | Magic Torque™ DLVR Guidewires |
| Common Name | Wire, Guide, Catheter |
| Product Code | DQX |
| Classification
Name | Class 2 according to 21 CFR 870.1330 |
| Predicate Device | Magic Torque™ Guidewires (K933334) 26 Jan 1994 |
| Description of
Device | The 315 cm Magic Torque™ DLVR Guidewire facilitates placement of
a catheter during diagnostic or interventional procedures. The
guidewire contains a stainless steel (SS) core wire. A SS coil is wound
over the distal 50 cm of the core wire. The most distal 10 cm of the SS
coil is coated with a proprietary hydrophilic coating from Boston
Scientific that provides a slippery surface to facilitate negotiation of
difficult anatomy and tight lesions. The proximal 40 cm of the coil is
coated with polytetrafluoroethylene (PTFE) for lubricity. A PTFE
polymer sleeve jackets the proximal end of the core wire. The
guidewire is clearly visible under fluoroscopy. |
| Intended Use | The Magic Torque™ Guidewires facilitate placement of devices during
peripheral intravascular diagnostic or interventional procedures. |
| Indications for Use | The Magic Torque™ Guidewires facilitate placement of a catheter
during diagnostic or interventional procedures. The wire can be
torqued to facilitate navigation through tortuous arteries and/or avoid
unwanted side branches. Not intended for use in coronary arteries. |
| Device Technology
Characteristics
and Comparison to
Predicate Device | Magic Torque DLVR Guidewire incorporates substantially equivalent
design, materials, packaging, fundamental technology, manufacturing
processes, sterilization method, and intended use as those featured in
the predicate Magic Torque Guidewire. |
| Non-Clinical
Performance Data | Determination of substantial equivalence is based on an assessment
of non-clinical performance data.
Biological Safety Testing:
A biocompatibility assessment in accordance with ISO 10993-1,
microbial assessments including bioburden, endotoxin, and
pyrogenicity, and sterility assurance testing were conducted. The
assessments show the device to be biocompatible for its intended use.
Bench Testing:
The following tests were performed to demonstrate substantial
equivalence to the predicate device.
• Overall Length Measurement
• Guidewire Withdrawal from the Carrier Tube
The Magic Torque DLVR Guidewire met the predetermined
acceptance criteria, thereby demonstrating substantial equivalence to
the predicate device. No new safety or performance issues were
raised during testing. |
| Clinical
Performance Data | Not applicable; determination of substantial equivalence is based on
an assessment of non-clinical performance data. |
| Conclusion | Based on the indications for use, technological characteristics and
non-clinical testing, the proposed Magic Torque DLVR Guidewire is
substantially equivalent to the predicate Magic Torque Guidewire
(K933334) and it is at least as safe and effective for its intended use. |
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