Who is the manufacturer of EMBOLD Fibered Detachable Coil System?

Boston Scientific Corporation filed the 510(k) submission for EMBOLD Fibered Detachable Coil System (K213398).

What is the FDA product code for EMBOLD Fibered Detachable Coil System?

KRD. It is classified under 21 CFR 870.3300 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for EMBOLD Fibered Detachable Coil System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like EMBOLD Fibered Detachable Coil System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EMBOLD Fibered Detachable Coil System

K213398 · Boston Scientific Corporation · KRD · Apr 12, 2022 · Cardiovascular

Device Facts

Record ID	K213398
Device Name	EMBOLD Fibered Detachable Coil System
Applicant	Boston Scientific Corporation
Product Code	KRD · Cardiovascular
Decision Date	Apr 12, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.3300
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

EMBOLD Fibered Detachable Coil System consists of delivery wire, introducer sheath, and permanent implantable fibered embolic coil; compatible with 0.021-0.027 inch microcatheters. Device used in hospital setting by physicians for peripheral vascular embolization. User advances coil through microcatheter to target site; coil can be fully advanced, retracted, and repositioned prior to deployment. Mechanical detachment mechanism uses inner pull wire connected to coupler arms; user activates detachment by retracting pull wire once coil is outside microcatheter. Permanent coil remains in vessel to obstruct blood flow; synthetic fibers promote thrombosis. Benefits include controlled placement and effective vessel occlusion. Device provided sterile via ethylene oxide.

Clinical Evidence

Bench testing and acute GLP animal study performed. Bench testing included biocompatibility and mechanical performance verification. Animal study confirmed safety and effectiveness in vivo. No clinical data provided.

Technological Characteristics

Materials: Platinum/tungsten alloy coil, metal alloy coupler, synthetic fibers. Mechanical detachment via pull wire. Compatible with 0.021-0.027 inch microcatheters. Sterilization: 100% ethylene oxide. MR Conditional. Single-use.

Indications for Use

Indicated for obstruction or reduction of blood flow in peripheral vasculature. Not for coronary or neurovascular use.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

Interlock™ Fibered IDC™ Occlusion System (K132578)

Related Devices

K230706 — EMBOLD Soft Detachable Coil System · Boston Scientific Corporation · Jun 27, 2023
K992121 — EMBOLIZATION COIL SYSTEM · Cook, Inc. · Dec 20, 1999
K132578 — INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM · Boston Scientific Corp · Sep 13, 2013
K993455 — FLIPPER DETACHABLE EMBOLIZATION COIL · Cook, Inc. · Jan 11, 2000
K123712 — RETRACTA DETACHABLE EMBOLIZATION COIL · Cook Incorporated · Jan 3, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | <div> <svg height="15" width="15"> <rect fill="none" height="15" stroke="black" stroke-width="1" width="15" x="0" y="0"></rect> <line stroke="black" stroke-width="2" x1="2" x2="13" y1="2" y2="13"></line> <line stroke="black" stroke-width="2" x1="13" x2="2" y1="2" y2="13"></line> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <svg height="15" width="15"> <rect fill="none" height="15" stroke="black" stroke-width="1" width="15" x="0" y="0"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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 Secondary Wind 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 | {4}------------------------------------------------ ### Table 2: Additional Device Information | Common or Usual name | Regulatory Number | Regulatory Name | Product Code | Product Code Name | Regulatory Class | |------------------------------------|-------------------------|------------------------------------|--------------|-------------------------------------------------------|---------------------| | Vascular embolic coil system | 21 CFR Part 870.3300 | Vascular Embolization Device | KRD | Device, Vascular, For Promoting Embolization | 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 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. 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 {5}------------------------------------------------ | 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 Device EMBOLD™ Fibered Detachable Coil System | Predicate Device Interlock™ Fibered IDC ™ Occlusion System (K132578) | Comparison | |--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------| | Coil Primary Wind OD (inches) | 0.015 | 0.012 | SIMILAR Minimal dimensional differences support additional microcatheter | | Microcatheter Compatibility (inches) | 0.021 (0.53mm) to 0.027 (0.6mm) | 0.0021 (0.53mm) | compatibility. | | Coil Lengths (cm) | 4-60 | 4-60 | SAME | | Secondary Coil OD (mm) | 2-32 | 2-22 | SIMILAR Additional OD treats same anatomy as predicate. | | Coil Shapes | 2mm: Helical 3-32mm: 2D | 2-22mm: 2D | SIMILAR Helical loops same as 2D, with no smaller loops. | | Delivery Wire Length | 177cm effective length | 175cm effective length | SIMILAR Subject device delivered through same standard microcatheter lengths as predicate. | | Coil Detachment Mechanism | Mechanical, user activated, interlocking coupler arms detach when outside of microcatheter and when user manually retracts inner pull wire from coupler arms | Mechanical, user activated, interlocking coupler arms detach when pushed out of microcatheter | SIMILAR Same mechanical detachment with coupler arm separation, with additional feature. | | Introducer Sheath | 1 length Reinforced tapered tip Separate lock component | 2 lengths Tapered tip Integrated lock | SIMILAR Same function as predicate with modifications to align with EMBOLD Fibered | {6}------------------------------------------------ | Characteristic | Subject Device EMBOLDTM Fibered Detachable Coil System | Predicate Device InterlockTM Fibered IDCTM Occlusion System (K132578) | Comparison | |---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | MRI Compatibility | MR Conditional | MR Conditional | SAME | | Sterilization Method | EO | EO | SAME | | SAL | 10-6 | 10-6 | SAME | | Coil Materials | Platinum /Tungsten alloy coil Metal alloy coil coupler arm Synthetic fibers | Platinum /Tungsten alloy coil Metal alloy coil coupler arm Synthetic fibers | SAME | | Delivery Wire Materials | Metal and polymer materials Metal alloy delivery wire coupler arm | Metal and polymer materials Metal alloy delivery wire coupler arm | SIMILAR Basic delivery function is the same as the predicate with material differences to facilitate detachment and microcatheter compatibility. | | Packaging Materials and Configuration | Package holds one EMBOLD Fibered device. No RHV is included. Sterile package contained in shelf carton. An eIFU exists for the EMBOLD Fibered product. No physical IFU included with package. | Package holds one Interlock Fibered IDC device. RHV is included inside sterile barrier. Sterile package and paper IFU contained in shelf carton. | SIMILAR The RHV is no longer provided with the device as available through ancillary devices or hospital. The IFU is available outside the package 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).