(30 days)
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.
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.
The provided text describes the 510(k) premarket notification for the Magic Torque DLVR Guidewire. It does not describe an AI/ML-driven medical device or a study involving human readers, ground truth establishment by experts, or any of the elements typically associated with an AI/ML performance study.
Instead, this document pertains to a traditional medical device (a guidewire) and its clearance based on non-clinical performance data demonstrating substantial equivalence to a predicate device.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance as the provided document explicitly states:
- Clinical Performance Data: "Not applicable; determination of substantial equivalence is based on an assessment of non-clinical performance data."
The document focuses on:
- Bench Testing: Overall Length Measurement, Guidewire Withdrawal from the Carrier Tube.
- Biological Safety Testing: Biocompatibility (ISO 10993-1), microbial assessments (bioburden, endotoxin, pyrogenicity), and sterility assurance testing.
There is no information in this document about:
- AI/ML performance metrics (e.g., sensitivity, specificity, accuracy).
- Sample sizes for test sets or training sets related to imaging data.
- Experts establishing ground truth for image interpretation.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Types of ground truth (e.g., pathology, outcomes data).
- How ground truth for a training set was established.
This device's clearance is based on its physical and biological characteristics being equivalent to a previously cleared guidewire, not on its performance in interpreting medical images or assisting human readers with diagnoses.
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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 Nameand Address | Boston Scientific CorporationThree Scimed PlaceMaple Grove, MN 55311USA |
|---|---|
| Contact Name andInformation | Andrea DanceRegulatory Affairs SpecialistPhone: 763-494-1743Fax: 763-494-2222Email: andrea.dance@bsci.com |
| Date Prepared | August 23, 2018 |
| Trade Name | Magic Torque™ DLVR Guidewires |
| Common Name | Wire, Guide, Catheter |
| Product Code | DQX |
| ClassificationName | Class 2 according to 21 CFR 870.1330 |
| Predicate Device | Magic Torque™ Guidewires (K933334) 26 Jan 1994 |
| Description ofDevice | The 315 cm Magic Torque™ DLVR Guidewire facilitates placement ofa catheter during diagnostic or interventional procedures. Theguidewire contains a stainless steel (SS) core wire. A SS coil is woundover the distal 50 cm of the core wire. The most distal 10 cm of the SScoil is coated with a proprietary hydrophilic coating from BostonScientific that provides a slippery surface to facilitate negotiation ofdifficult anatomy and tight lesions. The proximal 40 cm of the coil iscoated with polytetrafluoroethylene (PTFE) for lubricity. A PTFEpolymer sleeve jackets the proximal end of the core wire. Theguidewire is clearly visible under fluoroscopy. |
| Intended Use | The Magic Torque™ Guidewires facilitate placement of devices duringperipheral intravascular diagnostic or interventional procedures. |
| Indications for Use | The Magic Torque™ Guidewires facilitate placement of a catheterduring diagnostic or interventional procedures. The wire can betorqued to facilitate navigation through tortuous arteries and/or avoidunwanted side branches. Not intended for use in coronary arteries. |
| Device TechnologyCharacteristicsand Comparison toPredicate Device | Magic Torque DLVR Guidewire incorporates substantially equivalentdesign, materials, packaging, fundamental technology, manufacturingprocesses, sterilization method, and intended use as those featured inthe predicate Magic Torque Guidewire. |
| Non-ClinicalPerformance Data | Determination of substantial equivalence is based on an assessmentof non-clinical performance data.Biological Safety Testing:A biocompatibility assessment in accordance with ISO 10993-1,microbial assessments including bioburden, endotoxin, andpyrogenicity, and sterility assurance testing were conducted. Theassessments show the device to be biocompatible for its intended use.Bench Testing:The following tests were performed to demonstrate substantialequivalence to the predicate device.• Overall Length Measurement• Guidewire Withdrawal from the Carrier TubeThe Magic Torque DLVR Guidewire met the predeterminedacceptance criteria, thereby demonstrating substantial equivalence tothe predicate device. No new safety or performance issues wereraised during testing. |
| ClinicalPerformance Data | Not applicable; determination of substantial equivalence is based onan assessment of non-clinical performance data. |
| Conclusion | Based on the indications for use, technological characteristics andnon-clinical testing, the proposed Magic Torque DLVR Guidewire issubstantially 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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§ 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.