The EMBOLD™ Fibered Detachable Coil System consists of a delivery wire, removable introducer sheath, and permanent implantable fibered embolic coil. The device is compatible with 0.021 inch to 0.027 inch microcatheters. In addition, the device features a modified mechanical detachment mechanism consisting of an inner pull wire connecting the coil and delivery wire coupler arms, activated by the user through a proximal laser etched outer wire perforation. The delivery wire design allows the coil to be fully advanced, retracted, and deployed prior to final placement.

The EMBOLD™ Fibered Detachable Coil System is provided sterile, using 100% ethylene oxide (EO) gas sterilization, and is intended for hospital and single use only.

AI/ML Overview

This document, a 510(k) Summary, describes the submission of the EMBOLD™ Fibered Detachable Coil System for FDA clearance. It does not contain information about acceptance criteria or a study proving the device meets them in the context of an AI/ML algorithm.

The document is for a medical device (a vascular embolization device), not an AI/ML diagnostic or therapeutic system. Therefore, the specific details requested in the prompt, such as test set sample size, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set information, are not relevant to this type of device submission and are not present in the provided text.

Instead, the document focuses on:

Device Description: What the EMBOLD™ system is, its components, and specifications (e.g., coil dimensions, materials).
Intended Use/Indications for Use: The medical purpose of the device (obstructing/reducing blood flow in peripheral vasculature).
Predicate Device: Identification of a legally marketed device (Interlock™ Fibered IDC™ Occlusion System) to which the new device is compared for substantial equivalence.
Comparison of Technological Characteristics: A detailed table comparing the new device to the predicate device in terms of features, materials, and other specifications.
Non-Clinical Performance Testing: A statement that biocompatibility, bench testing, and an acute GLP animal study were performed to support substantial equivalence.

Without an AI/ML component, there's no "algorithm performance" to report in the way the prompt specifies. The "acceptance criteria" for a traditional medical device are typically related to safety, functionality, material properties, and performance in non-clinical (bench and animal) testing to demonstrate it performs as intended and is as safe and effective as a legally marketed predicate device.

Therefore, I cannot provide the requested information as it is not present in the provided text. The document describes a traditional medical device clearance, not an AI/ML-driven one.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 12, 2022

Boston Scientific Corporation Heidi Shearer Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, Minnesota 55311

Re: K213398

Trade/Device Name: EMBOLD Fibered Detachable Coil System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: March 11, 2022 Received: March 14, 2022

Dear Heidi Shearer:

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 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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Finn Donaldson Assistant Director (Acting) DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213398

Device Name EMBOLD™ Fibered Detachable Coil System

Indications for Use (Describe)

The EMBOLD™ Fibered Detachable Coil system is intended to obstruct or reduce rate of blood flow in the peripheral vasculature.

This device is not intended for coronary or neurovascular use.

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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510(k) Summary

510(K) Summary Complying with 21 CFR 807.92

I. SUBMITTER INFORMATION

Submitter Name: Boston Scientific Corporation

Submitter Address:

One Scimed Place Maple Grove, MN 55311-1566 USA

Telephone: 763-255-0056 Fax: 763-494-2222 e-mail: Heidi.Shearer@bsci.com

Contact person name: Heidi Shearer Date Prepared: April 12, 2022

II. DEVICE INFORMATION

Proprietary Name: EMBOLD™ Fibered Detachable Coil System Tables 1 and 2 below summarize the relevant subject device information.

Table 1: EMBOLD™ Fibered Detachable Coil System UPNs

Universal Product Numbers(UPNs)	Coil SecondaryWind OD (mm)	Coil Length(cm)
M001394240020040	2	4
M001394240020060	2	6
M001394240030060	3	6
M001394240030120	3	12
M001394240040080	4	8
M001394240040150	4	15
M001394240050080	5	8
M001394240050150	5	15
M001394240060100	6	10
M001394240060200	6	20
M001394240080200	8	20
M001394240100200	10	20
M001394240100300	10	30
M001394240100500	10	50
M001394240120200	12	20
M001394240120300	12	30
M001394240120500	12	50
M001394240140200	14	20
M001394240140300	14	30
M001394240140500	14	50
M001394240180500	18	50
M001394240200500	20	50
M001394240220600	22	60
M001394240320600	32	60

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Table 2: Additional Device Information

Common orUsual name	RegulatoryNumber	RegulatoryName	Product Code	Product CodeName	RegulatoryClass
Vascularembolic coilsystem	21 CFR Part870.3300	VascularEmbolizationDevice	KRD	Device,Vascular, ForPromotingEmbolization	II

III. PREDICATE DEVICE IDENTIFICATION

Name of Predicate Device

Interlock™ Fibered IDC™ Occlusion System (K132578, Cleared September 13, 2013) Predicate device referenced above has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

The EMBOLD™ Fibered Detachable Coil System is provided sterile, using 100% ethylene oxide (EO) gas sterilization, and is intended for hospital and single use only.

Table 3 below provides information on the differences between the EMBOLD™ Fibered Detachable Coil System models, in relation to specific features such as coil secondary OD, length, and shape. The delivery wire and introducer sheath utilize the same design throughout the product matrix.

Coil Secondary Wind OD (mm)	Coil Length (cm)	Coil Shape
2	4	Helical
2	6
3	6	2-Diameter (2D)
3	12
4	8
4	15
5	8
5	15
6	10
6	20
8	20
10	20
10	30
10	50
12	20
12	30
12	50
14	20
14	30
14	50
18	50
20	50

Table 3: EMBOLD™ Fibered Detachable Coil System Device Features

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Coil Secondary Wind OD (mm)	Coil Length (cm)	Coil Shape
22	60
32	60

V. INTENDED USE AND INDICATION FOR USE

Predicate and subject device intended use/indication for use is the same.

EMBOLD™ Fibered Detachable Coil System Intended Use / Indication for Use

The EMBOLD™ Fibered Detachable Coil system is intended to obstruct or reduce rate of blood flow in the peripheral vasculature.

This device is not intended for coronary or neurovascular use.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The EMBOLD™ Fibered Detachable Coil System has similar technological characteristics to the predicate device as shown in the table below.

Characteristic	Subject DeviceEMBOLD™ FiberedDetachable Coil System	Predicate DeviceInterlock™ Fibered IDC ™Occlusion System(K132578)	Comparison
Coil PrimaryWind OD(inches)	0.015	0.012	SIMILARMinimal dimensionaldifferences supportadditional microcatheter
MicrocatheterCompatibility(inches)	0.021 (0.53mm) to 0.027(0.6mm)	0.0021 (0.53mm)	compatibility.
Coil Lengths(cm)	4-60	4-60	SAME
SecondaryCoil OD (mm)	2-32	2-22	SIMILARAdditional OD treatssame anatomy aspredicate.
Coil Shapes	2mm: Helical3-32mm: 2D	2-22mm: 2D	SIMILARHelical loops same as2D, with no smallerloops.
Delivery WireLength	177cm effective length	175cm effective length	SIMILARSubject device deliveredthrough same standardmicrocatheter lengths aspredicate.
CoilDetachmentMechanism	Mechanical, user activated,interlocking coupler armsdetach when outside ofmicrocatheter and when usermanually retracts inner pullwire from coupler arms	Mechanical, user activated,interlocking coupler armsdetach when pushed out ofmicrocatheter	SIMILARSame mechanicaldetachment with couplerarm separation, withadditional feature.
IntroducerSheath	1 lengthReinforced tapered tipSeparate lock component	2 lengthsTapered tipIntegrated lock	SIMILARSame function aspredicate withmodifications to alignwith EMBOLD Fibered

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Characteristic	Subject DeviceEMBOLDTM FiberedDetachable Coil System	Predicate DeviceInterlockTM Fibered IDCTMOcclusion System(K132578)	Comparison
MRICompatibility	MR Conditional	MR Conditional	SAME
SterilizationMethod	EO	EO	SAME
SAL	10-6	10-6	SAME
Coil Materials	Platinum /Tungsten alloy coilMetal alloy coil coupler armSynthetic fibers	Platinum /Tungsten alloy coilMetal alloy coil coupler armSynthetic fibers	SAME
Delivery WireMaterials	Metal and polymer materialsMetal alloy delivery wirecoupler arm	Metal and polymer materialsMetal alloy delivery wirecoupler arm	SIMILARBasic delivery function isthe same as thepredicate with materialdifferences to facilitatedetachment andmicrocathetercompatibility.
PackagingMaterials andConfiguration	Package holds one EMBOLDFibered device. No RHV isincluded. Sterile packagecontained in shelf carton.An eIFU exists for theEMBOLD Fibered product.No physical IFU includedwith package.	Package holds one InterlockFibered IDC device. RHV isincluded inside sterilebarrier. Sterile package andpaper IFU contained in shelfcarton.	SIMILARThe RHV is no longerprovided with the deviceas available throughancillary devices orhospital. The IFU isavailable outside thepackage configuration.

VII. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING

A full suite of biocompatibility testing, bench testing, and an acute GLP animal study were performed to support a determination of substantial equivalence between the EMBOLD™ Fibered Detachable Coil System and the predicate Interlock™ Fibered IDC™ Occlusion System (K132578). The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or effectiveness issues were raised during the device testing.

VIII. CONCLUSION

Based on the intended use, technological characteristics, and the safety and performance data provided, the EMBOLD™ Fibered Detachable Coil System is considered appropriate for the intended use and substantially equivalent to the predicate device technological and material differences do not raise new questions of safety or effectiveness, and the subject devices are substantially equivalent to the predicate Interlock™ Fibered IDC™ Occlusion System (K132578).

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).