The Interlock™ Fibered IDC™ Occlusion System is a modified interlocking detachable coil indicated to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for neurovascular use.

Device Description

The Interlock Fibered IDC Occlusion System includes a coil (manufactured from platinum-tungsten alloy) that is mechanically attached to a coil delivery wire. This assembly is contained within an introducer sheath. The platinum coil contains synthetic fibers for greater thrombogenicity. The Interlock Fibered IDC Occlusion Coil is designed to be delivered under fluoroscopy with a 0.0 21 in (0.53 mm) inner diameter (I.D.) microcatheter (e.g. Renegade™ Microcatheter) with one or two radiopaque (RO) tip markers. The interlocking delivery wire design allows the coil to be advanced and retracted before final placement in the vessel, thus aiding in more controlled delivery including the ability to withdraw the coil prior to deployment.

AI/ML Overview

This document describes a medical device, the "Interlock™ Fibered IDC™ Occlusion System," and its premarket notification (510(k)) to the FDA. It details device characteristics, intended use, and non-clinical testing performed to establish its safety and substantial equivalence to a predicate device for regulatory clearance.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving performance:

The provided text is a 510(k) summary and FDA clearance letter for a medical device (Interlock™ Fibered IDC™ Occlusion System). It focuses on demonstrating substantial equivalence for regulatory clearance, not on providing a study that proves specific acceptance criteria for device performance in the way you've outlined for AI/diagnostic systems.

Therefore, I will extract the information available and explicitly state where information is not present in the provided document, as it pertains to a different type of evaluation.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document does not explicitly present a table of acceptance criteria for device performance in terms of clinical outcomes or diagnostic accuracy. Instead, the "acceptance criteria" were implied by the regulatory standard of demonstrating substantial equivalence to a predicate device (Fibered IDC™ Occlusion System, K060078) and meeting safety standards for its intended use, particularly regarding MRI compatibility.
- For MRI compatibility, the acceptance criteria are implicit in the ASTM standards cited:
  - ASTM F2182-02a: Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging.
  - ASTM F2052-06e1: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.
  - ASTM F2213-06: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment.
  - ASTM F2119-07: Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants.
- The overall acceptance criterion for the 510(k) submission is that the new device presents "no additional risk to a patient" compared to gravitational and normal daily activities, or a feverish condition, in an MRI environment, and can be "scanned safely under a static magnetic field of 1.5 Tesla or 3.0 Tesla."

Reported Device Performance:

Performance Metric (Implied)	Reported Performance (Non-Clinical)
MRI Safety (Heating)	Demonstrated safe under 1.5T or 3.0T MRI (ASTM F2182-02a)
MRI Safety (Displacement)	Demonstrated safe under 1.5T or 3.0T MRI (ASTM F2052-06e1)
MRI Safety (Torque)	Demonstrated safe under 1.5T or 3.0T MRI (ASTM F2213-06)
MRI Safety (Image Artifacts)	Demonstrated safe under 1.5T or 3.0T MRI (ASTM F2119-07)
Overall Risk Profile	"will not present additional risk to a patient during a MRI procedure"

Note: This is a physical medical device, not an AI/diagnostic software. The "performance" being evaluated here relates to mechanical and material safety under specific conditions, not diagnostic accuracy, sensitivity, or specificity.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document refers to "non-clinical testing" and does not specify a "sample size" in the context of patients or data points characteristic of diagnostic studies. The "test set" here would refer to the physical coils themselves that underwent MRI compatibility testing. The number of physical coils tested is not provided, and there is no patient data involved in this type of non-clinical testing.
Data Provenance: Not applicable in the context of sensor data or patient data. The "tests" were conducted in a laboratory setting. No country of origin for data or retrospective/prospective nature is relevant.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study requiring expert consensus or ground truth establishment for diagnostic purposes. The ground truth for MRI compatibility is established by the physical properties of the device and its interaction with magnetic fields, measured according to established ASTM standards by engineering/physics experts, not medical experts for diagnostic tasks.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no adjudication method described as it's not a diagnostic study involving human interpretation or subjective assessment. The ASTM test methods likely have predefined pass/fail criteria that are objectively measured.

5. 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

Not applicable. This is a physical medical device, not an AI or diagnostic tool. No MRMC study was performed, nor is there any AI component involved to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device. There is no "algorithm only" performance to evaluate. The device functions as an embolization coil.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical MRI compatibility testing is defined by the physical performance measurements against established ASTM standards. For example, the maximum temperature rise measured must be below a certain threshold according to ASTM F2182-02a to be considered safe for MRI. This is an objective, quantitative ground truth.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

Summary

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MAR - 3 2011

Premarket Notification 510(k) Detachable Platinum Coils

Section 2

510(k) Summary

(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	Fibered IDC
Proprietary Name	Interlock™ Fibered IDC™ Occlusion System
Name of Predicate Device	Fibered Interlocking Detachable Coil (Fibered IDCOcclusion System) (K060078)

Device Description	The Interlock Fibered IDC Occlusion Systemincludes a coil (manufactured from platinum-tungsten alloy) that is mechanically attached to acoil delivery wire. This assembly is containedwithin an introducer sheath. The platinum coilcontains synthetic fibers for greaterthrombogenicity. The Interlock Fibered IDCOcclusion Coil is designed to be delivered underfluoroscopy with a 0.0 21 in (0.53 mm) innerdiameter (I.D.) microcatheter (e.g. Renegade™Microcatheter) with one or two radiopaque (RO)tip markers. The interlocking delivery wire designallows the coil to be advanced and retracted beforefinal placement in the vessel, thus aiding in morecontrolled delivery including the ability towithdraw the coil prior to deployment.
Intended Use	The Interlock Fibered IDC Occlusion System is amodified interlocking detachable coil indicated toobstruct or reduce rate of blood flow in theperipheral vasculature. This device is not intendedfor neurovascular use.
Non-Clinical and Clinical TestSummary	Non-clinical testing demonstrates that the InterlockFibered IDC Occlusion System will not presentadditional risk to a patient during a MRI procedurein comparison to risks imposed by gravitational,and other normal daily activities, or a temperaturerise that is experienced during a feverish condition.The results of testing conducted under methodsdescribed by ASTM F2182-02a, ASTM F2052-06e1. ASTM F2213-06 and ASTM F2119-07 havedemonstrated that the Coils are MR Conditionaland can be scanned safely under a static magneticfield of 1.5 Tesla or 3.0 Tesla.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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle image. The seal is black and white.

Public Health Service

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

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

MAR - 3 2011

Re: K102912

Trade/Device Name: Interlock™ Fibered IDC™ Occlusion System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: February 18, 2011 Received: February 22, 2011

Dear Ms. Pettit:

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 indives 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 Fedral 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, list in 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 micleading.

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

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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 is 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Dana R. Bohmer

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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Section 1

Indications for Use Statement

510(k) Number (if known): K102912

Device Name: Interlock™ Fibered IDC™ Occlusion System

Indications for Use:

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 OF NEEDED)

ه سربه مارك Concentrance of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Nighfiggpian (ng Doginean Do Boston Scientific Corporation

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).