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 018 Spiral / Helical 2D Interlock Fibered IDC Occlusion System is a product line consisting of 0.018 inch (0.457 mm) system compatible fibered interlocking detachable coils. 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 0.021 inch (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

The provided text describes a 510(k) summary for the Interlock™ 018 Fibered IDC™ Occlusion System, a vascular embolization device. The submission focuses on demonstrating substantial equivalence to predicate devices through bench testing and biocompatibility assessments, rather than clinical performance studies involving patient data or human readers. Therefore, many of the requested categories related to clinical study design and performance metrics are not applicable in this context.

Here's a breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission primarily based on bench and biocompatibility testing for substantial equivalence, the "acceptance criteria" are generally that the new device performs comparably to the predicate device in these tests, and meets established standards for safety (biocompatibility) and functional performance. Specific quantitative acceptance values are not explicitly stated in this summary for each test, but rather the successful completion of these tests.

Acceptance Criteria (General)	Reported Device Performance
Biocompatibility:
Cytotoxicity	Tested and completed
Sensitization	Tested and completed
Intracutaneous Reactivity	Tested and completed
Acute Systemic Toxicity	Tested and completed
Materials Mediated Pyrogenicity	Tested and completed
Hemolysis (Extract Method)	Tested and completed
Complement Activation	Tested and completed
Implantation	Tested and completed
Genotoxicity (Ames Assay and Mouse Lymphoma)	Tested and completed
Subacute Toxicity (IP and IV)	Tested and completed
USP Physicochemical	Tested and completed
Latex	Tested and completed
Partial Thromboplastin Time	Tested and completed
In-vitro Performance:
Anchorability	Tested and completed
Fiber Retention	Tested and completed
Microcatheter Compatibility (lumen)	Tested and completed
Deliverability/Pushability	Tested and completed
Stretch Resistance	Tested and completed
Overall (Substantial Equivalence):	"No new safety or performance issues were raised during the testing."
	"considered substantially equivalent to the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size (Test Set): Not specified in terms of number of units tested for each in-vitro or biocompatibility test. These tests typically involve a defined number of samples per test according to relevant standards, but the exact count is not detailed.
Data Provenance: The tests are described as "bench testing" and "biocompatibility testing," which are laboratory-based studies. There is no patient data or geographical origin specified as it's not a clinical study. It's a prospective evaluation of the manufactured device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The "ground truth" here is determined by the results of the laboratory tests against established scientific and regulatory standards (e.g., ISO standards for biocompatibility). There's no involvement of clinical experts establishing ground truth for a diagnostic outcome.

4. Adjudication Method for the Test Set:

Not applicable. This pertains to clinical studies often involving expert interpretation of images or patient data. Laboratory testing results are generally objective measurements directly from the test.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. An MRMC study is a clinical study design used to evaluate diagnostic systems involving multiple readers interpreting multiple cases, often with and without AI assistance. This submission relies on bench and biocompatibility testing for a device, not a diagnostic algorithm.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a physical medical device (embolization coil), not an algorithm or AI software. The performance testing is for the device itself, not a separate algorithm. The closest equivalent is the standalone "in-vitro performance tests" and "biocompatibility tests."

7. Type of Ground Truth Used:

For biocompatibility, the ground truth is established by recognized international standards (e.g., ISO 10993 series) for evaluating biological effects of medical devices.
For in-vitro performance, the ground truth is established by engineering specifications and functional requirements derived from the device's intended use and comparison to predicate devices, verified through direct physical measurements and observations in a controlled lab setting.

8. Sample Size for the Training Set:

Not applicable. This submission is for a physical medical device and its manufacturing/material characteristics, not a machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As above, there is no training set for this type of device submission.

Summary

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25-78

SEP 1 3 2013

. :

510(k) Summary

per 21 CFR §807.92

Submitter'sName andAddress	Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311Phone: 763-494-1700763-494-2222Fax:
Contact NameandInformation	Todd KornmannPrincipal Regulatory Affairs SpecialistPhone: 763-494-1348763-494-2222Fax:e-mail: todd.kornmann@bsci.com
Date Prepared	15 August 2013
ProprietaryName	Interlock™ 018 Fibered IDC ™ Occlusion System
Common Name	Vascular embolization device
Product Code	KRD
Classification	Class II, 21 CFR Part 870.3300
PredicateDevices	K102912, March 3, 2011Interlock -18 Fibered IDCK060078, January 31, 2006Occlusion System
DeviceDescription	The 018 Spiral / Helical 2D Interlock Fibered IDC Occlusion System is aproduct line consisting of 0.018 inch (0.457 mm) system compatiblefibered interlocking detachable coils. The Interlock Fibered IDC OcclusionSystem includes a coil (manufactured from platinum tungsten alloy) that ismechanically attached to a coil delivery wire. This assembly is containedwithin an introducer sheath. The platinum coil contains synthetic fibers forgreater thrombogenicity. The Interlock Fibered IDC Occlusion Coil isdesigned to be delivered under fluoroscopy with a 0.021 inch (0.53 mm)inner diameter (I.D.) microcatheter (e.g. Renegade™ Microcatheter) withone or two radiopaque (RO) tip markers. The interlocking delivery wiredesign allows the coil to be advanced and retracted before final placementin the vessel, thus aiding in more controlled delivery including the ability towithdraw the coil prior to deployment.
Intended Use/Indications forUse	The Interlock Fibered IDC Occlusion System is a modified interlockingdetachable coil indicated to obstruct or reduce rate of blood flow in theperipheral vasculature. This device is not intended for neurovascular use.
Comparison ofTechnologicalCharacteristics	The proposed line extension of the 018 Spiral / Helical 2D InterlockFibered IDC Occlusion System incorporates substantially equivalentdesign, packaging, fundamental technology, manufacturing processes,sterilization process and intended use as those featured in the predicateBSC Interlock Fibered IDC Occlusion System.
PerformanceData	Determination of substantial equivalence for the 018 Spiral / Helical 2DInterlock Fibered IDC Occlusion System bench testing is based on anassessment of non-clinical bench and biocompatibility testing. The resultsof these tests provide reasonable assurance that the proposed device hasbeen designed and tested to assure conformance to the requirements forits intended use. No new safety or performance issues were raised duringthe testing and, therefore, these devices may be considered substantiallyequivalent to the predicate devices.
	The following biocompatibility and chemical characterization tests werecompleted on the 018 Spiral / Helical 2D Interlock Fibered IDC OcclusionSystem:
	Cytotoxicity	Hemolysis (Extract Method)
	Sensitization	Complement Activation
	Intracutaneous Reactivity	Implantation
	Acute Systemic Toxicity	Genotoxicity (Ames Assay andMouse Lymphoma)
	Materials Mediated Pyrogenicity	Subacute Toxicity (IP and IV)
	USP Physicochemical	Latex
	Partial Thromboplastin Time
	The following in-vitro performance tests were completed on the 018 Spiral/ Helical 2D Interlock Fibered IDC Occlusion System:
	Anchorability	Deliverability/Pushability
	Fiber Retention	Stretch Resistance
	Microcatheter Compatibility (lumen)
Conclusion	The modifications do not affect the intended use or alter the fundamentalscientific technology of the predicate Boston Scientific Interlock FiberedIDC Occlusion System (K102912, cleared March 3, 2011 and K060078,cleared January 31, 2006).
	Based on the indications for use, technological characteristics, safety andperformance testing, the proposed line extension of the 018 Spiral /Helical 2D Interlock Fibered IDC Occlusion System is appropriate for theintended uses and are considered to be substantially equivalent to thepredicate Interlock Fibered IDC Occlusion Systems (K102912, clearedMarch 3, 2011 and K060078, cleared January 31, 2006).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a caduceus, rendered in a bold, flowing line.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Go05 Silver Spring, MD 20993-0002

September 13, 2013

Boston Scientific Corporation C/O Todd Kornmann One Scimed Place Maple Grove, MN 55311

Re: K132578

Trade/Device Name: Interlock™ - 18 Fibered ICD™ Occlusion System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: August 15, 2013 Received: August 16, 2013

Dear Mr. Kornmann:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have to to to to the determined the 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 enotiment date of the Medical Device Amendments. or to continered prof to may 2011 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 cither class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be may be subject to additions, 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 complics with other requirements of the Act that 117A has made a determinations administered by other Federal agencies. You must of any I cachar statues and regionnents. including, but not limited to: registration and listing (21 CFR Part 807); labeling (2) CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set ocelection in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic (200 product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Todd Kornmann

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,

Melissa A. Torres -S

Bram D. Zuckerman, M.D. For Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): _ K132578

Device Name: Interlock™ -18 Fibered IDC™ Occlusion System

Indications for Use:

Prescription Use × (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)

Melissa A. Torres -S

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).