Boston Scientific's 0.018 Fibered Platinum Coils consist of platinum-tungsten alloy coils with synthetic fibers and are available in six different shapes; Vortx, Vortx Diamond, Complex Helical, Figure-8, Multi-Loop and Straight. The coil is provided with an introducer that is secured at both ends by a retaining clip during shipping and storage. The coil plunger, supplied with the coil, is used to push the coil out of the introducer and into the microcatheter.

Boston Scientific VortX-35 and 2D Helical-35 Fibered Platinum Coils are helically-shaped platinum-tungstent alloy coils with synthetic fibers. The coils are provided with an introducer that is secured at both ends by a retaining clip during shipping and storage. A coil plunger, supplied with the coil, is used to push the coil out of the introducer and into the catheter.

AI/ML Overview

The provided text is a 510(k) summary for Boston Scientific's Fibered Platinum Coils, specifically related to modifications for MRI compatibility. It details regulatory information, device descriptions, and non-clinical testing for MRI safety. However, the document does NOT contain information about acceptance criteria or a study proving that the device meets specific performance criteria for its primary function (embolization effectiveness).

The "Non-Clinical and Clinical Test Summary" section exclusively discusses MRI compatibility testing.

Therefore, based on the provided text, I cannot complete the requested information regarding acceptance criteria and a study proving the device meets those criteria for its primary function.

Here's a breakdown of what can be extracted concerning the MRI compatibility testing, and what cannot be derived from the document for the other requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (MRI Compatibility)	Reported Device Performance (MRI Compatibility)
No additional risk during MRI procedure compared to gravitational, normal daily activities, or feverish conditions.	Non-clinical testing demonstrates that coils will not present additional risk during an MRI procedure in comparison to risks imposed by gravitational, and other normal daily activities, or a temperature rise that is experienced during a feverish condition.
MR Conditional for 1.5 Tesla or 3.0 Tesla static magnetic fields in normal operating mode.	Coils are MR Conditional and can be scanned safely under a static magnetic field of 1.5 Tesla or 3.0 Tesla in normal operating mode.
MR Conditional for a static magnetic field gradient less than 25 T/m.	Coils are MR Conditional and can be scanned safely in a static magnetic field gradient less than 25 T/m.
(Implicit) Compliance with ASTM standards for MRI safety.	Testing conducted under methods described by ASTM F2182-09, ASTM F2052-06e1, ASTM F2213-06, and ASTM F2119-07.

Missing Information/Cannot Answer based on the provided text for the following points as they relate to the primary function of the embolization device:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No information on test set sample sizes or provenance for the embolization function. The MRI testing is non-clinical (in-vitro).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for the non-clinical MRI testing. No information for the embolization function.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the non-clinical MRI testing. No information for the embolization function.
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: This is a physical medical device (embolization coils), not an AI/imaging diagnostic device. Therefore, an MRMC study is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For MRI compatibility, the "ground truth" is defined by the physical properties measured according to the ASTM standards. For the embolization function, this information is not provided.
The sample size for the training set: Not applicable as this is a physical medical device. There is no "training set" in the context of an algorithmic device.
How the ground truth for the training set was established: Not applicable.

Summary

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FEB 1 1 201

K | O 2714

Summary 510(k) Summary

Section 2

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(Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)

Submitter's Name and Address	Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311
Contact Person	Debbie McIntireSenior Regulatory Affairs SpecialistBoston ScientificDebbie.McIntire@bsci.comPhone: (408) 935-4679Fax: (763) 494-2222
Classification Name	Vascular embolization device
Product Code	KRD
Common or Usual Name	1) 0.018 Fibered Platinum Coils2) 0.035 Fibered Platinum Coils
Proprietary Name	1) VortX-18TM, VortXTM Diamond -18, Straight-18, Figure 8-18, Multi-Loop-18, Complex Helical-18 Fibered Platinum Coil2) VortXTM-35, 2D Helical-35 Fibered Platinum Coils
Names of Predicate Devices	1) Target Therapeutics Peripheral Coils (K914786)2) Target Therapeutics Fibered Platinum Coils (K955293)
Reason for Submission	Modifications to the device labeling related to MRI compatibility
Device Description	Boston Scientific's 0.018 Fibered Platinum1)Coils consist of platinum-tungsten alloy coilswith synthetic fibers and are available in sixdifferent shapes; Vortx, Vortx Diamond,Complex Helical, Figure-8, Multi-Loop andStraight. The coil is provided with anintroducer that is secured at both ends by aretaining clip during shipping and storage.The coil plunger, supplied with the coil, isused to push the coil out of the introducer andinto the microcatheter.
	Boston Scientific VortX-35 and 2D Helical-352)Fibered Platinum Coils are helically-shapedplatinum-tungstent alloy coils with syntheticfibers. The coils are provided with anintroducer that is secured at both ends by aretaining clip during shipping and storage. Acoil plunger, supplied with the coil, is used topush the coil out of the introducer and into thecatheter.
Intended Use	Boston Scientific's 0.018 and 0.035 FiberedPlatinum Coils are intended for arterial and venousembolizations in the peripheral vasculature.
Non-Clinical and Clinical TestSummary	Non-clinical testing demonstrates that the Vortx-18, Vortx Diamond-18, Straight-18, Figure 8-18,Multi-Loop-18, Complex Helical-18, Vortx-35 and2D Helical-35 Fibered Platinum Coils will notpresent additional risk to a patient during a MRIprocedure in comparison to risks imposed bygravitational, and other normal daily activities, or atemperature rise that is experienced during afeverish condition. The results of testingconducted under methods described by ASTMF2182-09, ASTM F2052-06e1, ASTM F2213-06and ASTM F2119-07 have demonstrated that theCoils are MR Conditional and can be scannedsafely under a static magnetic field of 1.5 Tesla or3.0 Tesla in normal operating mode,and in a staticmagnetic field gradient less than 25 T/m.Testing at field strengths other than 1.5 Tesla or 3Tesla has not been performed to evaluate coilmigration or heating.

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Date prepared: September 2010

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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 stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

Boston Scientific Corp. c/o Ms. Shannon Pettit Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311

FEB 1 1 201

Re: K102714

VortXTM-18, VortXTM Diamond-18, Straight-18, Figure 8-18, Multi-Loop-18, and Complex Helical-18 Febered Platinum Coils VortX™-35 and 2D Helical-35 Fibered Platinum Coils Regulation Number: 21 CFR 870.3300 Regulation Name: Device, Embolization, Vascular Regulatory Class: Class II (two) Product Code: KRD Dated: January 6, 2011 Received: January 7, 2011

Dear Ms. Pettit:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave rovewod your occasion or (-) fe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered print to 1125 20, 2017 11:12 provisions of the Federal Food, Drug, devices that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, morelove, mains of the Act include requirements for annual registration, listing of genoral controls provisions practice, labeling, and prohibitions against misbranding and de rices, good mananablaring practice, and evaluate information related to contract liability addition. Ticasonote. ODAY as , 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 If your device is classified (500 above) and interest affecting your device can be

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Page 2 -- Ms. Shannon Pettit

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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Dina R. Vahmir

A 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):

VortX-18TM , VortXTM Diamond -18, Straight-18, Figure 8-18, Multi-Device Name: Loop-18, Complex Helical-18 Fibered Platinum Coil and VortXTM-35, 2D Helical-35 Fibered Platinum Coils

Indications For Use:

Boston Scientific's 0.018 and 0.035 Fibered Platinum Coils are intended for arterial and venous embolizations in the peripheral vasculature.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duana R. Vihmer

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K102714

Page 1 of 1_

Regulation Number and Section

§ 870.3300 Vascular embolization device.

(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).