The EMBOLD™ Soft Detachable Coil System and EMBOLD™ Packing 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 Description

The EMBOLD™ Soft Detachable Coil System and EMBOLD™ Packing Detachable Coil System consists of a delivery wire, removable introducer sheath, and permanent implantable non-fibered embolic coil. The EMBOLD™ Soft coil can be delivered to challenging peripheral anatomy, and the EMBOLD™ Packing coil is highly conformable to enable dense packing. The device is compatible with 0.027-inch microcatheters. In addition, the device features a 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™ Soft and EMBOLD™ Packing 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

Here's an analysis of the provided FDA 510(k) summary for the EMBOLD™ Soft Detachable Coil System and EMBOLD™ Packing Detachable Coil System, focusing on the requested information regarding acceptance criteria and the supporting study:

The provided document is a 510(k) summary, which is a regulatory submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device. It does not describe acceptance criteria for a diagnostic algorithm or a study proving that a device meets such criteria in terms of accuracy or clinical performance (e.g., sensitivity, specificity). Instead, it focuses on the performance of a medical device (embolic coils) in terms of its physical and functional characteristics.

Therefore, many of the requested fields cannot be directly answered from this document, as they pertain to clinical performance studies for diagnostic or AI-driven devices, which is not the subject of this 510(k).

However, I can extract the relevant information regarding the performance data and equivalence testing for this specific type of device.

Acceptance Criteria and Device Performance (as interpreted for a physical medical device)

1. Table of Acceptance Criteria and Reported Device Performance

For an embolic coil system, "acceptance criteria" and "reported device performance" are geared towards physical and functional specifications to ensure safety and effectiveness, rather than diagnostic accuracy metrics.

Acceptance Criteria Category (based on regulatory guidance)	Specific Test/Evaluation	Acceptance Criteria (implied/general)	Reported Device Performance (Summary from K230706)
Biocompatibility	ISO 10993 testing	Meets biocompatibility standards	Performed in accordance with ISO 10993. Results provide reasonable assurance.
Material & Design	Bench testing	Comparable to predicate device	Substantially equivalent in materials, design, fundamental technology.
Mechanical Properties	Bench testing	Functional as intended (e.g., detachment mechanism, deliverability)	Detachment mechanism is the same as predicate. Coils can be delivered through 0.027-inch microcatheters.
Sterilization	EO gas sterilization validation	Sterile, per established methods	Provided sterile, using 100% ethylene oxide (EO) gas sterilization.
Intended Use Equivalence	Comparison of IFU	Same as predicate device	Intended Use/Indications for Use are the same as the predicate device.
Safety & Effectiveness	Bench, animal, biocompatibility testing	Comparable safety and effectiveness to predicate	No new safety or performance issues raised. Considered as safe and effective as the predicate.

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

Test Set Sample Size: Not explicitly stated as a "test set" in the context of clinical images or patient data. For physical device testing (bench, animal), specific numbers of coils, devices, or animals tested are not provided in this summary.
Data Provenance: Not applicable in the context of image data. The testing is for the physical device itself.

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

Number of Experts & Qualifications: Not applicable. This is not a study assessing diagnostic performance against a "ground truth" established by experts.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable for this type of device and study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. This is a physical device, not an AI-driven diagnostic tool where human reader performance would be a factor.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: For this type of device, the "ground truth" for performance is generally defined by engineering specifications, validated test methods (e.g., ISO standards), and a comparison to the established performance of a predicate device. It's not a clinical "ground truth" like pathology or outcomes data in the usual sense for a diagnostic device.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

Ground Truth Establishment for Training Set: Not applicable. There is no training set for this device.

Summary of Device and its Assessment - As per the K230706 Document:

The EMBOLD™ Soft Detachable Coil System and EMBOLD™ Packing Detachable Coil System are physical vascular embolization devices. The FDA clearance (K230706) is based on demonstrating substantial equivalence to a previously cleared predicate device (EMBOLD™ Fibered Detachable Coil System, K213398).

The evidence provided to the FDA for this substantial equivalence included:

Bench Testing: To assess mechanical properties, design, and material characteristics.
Animal Testing: Likely to evaluate in-vivo performance, deliverability, and deployment.
Biocompatibility Testing: In accordance with ISO 10993 standards to ensure the materials are safe for human contact.

The conclusion of the submission states that the proposed device is "as safe and effective as the predicate" because:

It has the same intended use.
It incorporates "substantially equivalent device materials and design, fundamental technology, manufacturing processes, sterilization process."
Differences in technological characteristics (packing coil shape, non-fibered coil) do not raise new questions of safety and effectiveness, supported by the results of the aforementioned testing.

Summary

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July 6, 2023

Boston Scientific Corporation Laure Judge Regulatory Affairs Specialist 300 Boston Scientific Way Marlborough Boston, Massachusetts 01752

Re: K230706

Trade/Device Name: EMBOLD Soft Detachable Coil System and EMBOLD Packing Detachable Coil System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD

Dear Laura Judge:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 27, 2023. Specifically, FDA is updating this SE Letter due to a typo in the trade name as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Misti Malone, OHT2: Office of Cardiovascular Devices, 301-796-2520, Misti.Malone@fda.hhs.gov.

Sincerely,

Misti L. Malone -S

Misti Malone, PhD Assistant Director 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

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June 27, 2023

Boston Scientific Corporation Laura Judge Regulatory Affairs Specialist 300 Boston Scientific Wav Marlborough Boston, Massachusetts 01752

Re: K230706

Trade/Device Name: EMBOLD™ Soft Detachable Coil System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: May 26, 2023 Received: May 26, 2023

Dear Laura Judge:

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

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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 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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Misti E. Malone -S

Enclosure

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Indications for Use

510(k) Number (if known) K230706

Device Name

EMBOLD™ Soft Detachable Coil System and EMBOLD™ Packing Detachable Coil System

Indications for Use (Describe)

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

l. SUBMITTER INFORMATION

Submitter Name: Boston Scientific Corporation

Submitter Address: 300 Boston Scientific Way Marlborough, Boston, MA 01752, USA

Telephone: 353 (86) 177 7184 Email: Laura.Judge@bsci.com

Contact person name: Laura Judge Date Prepared: March 14, 2023

= DEVICE INFORMATION

Device Name: The EMBOLD™ Soft Detachable Coil System and EMBOLD™ Packing Detachable Coil System.

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

III. PREDICATE DEVICE IDENTIFICATION

EMBOLD™ Fibered Detachable Coil System (K213398, Cleared April 12, 2022) Predicate device referenced above has not been subject to a design-related recall.

Reference Devices:

IDC™ Interlocking Detachable Coil (K141378, Cleared 08 October 2014)
Interlock™ -35 Fibered IDC Occlusion System (K133208, Cleared 14 November 2013
Penumbra's Occlusion Device (POD®) Packing Coil (K170852, Cleared 19 July 2017).

Reference devices listed above have not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

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

V. INDICATIONS FOR USE

Predicate and subject devices intended uses are the same.

Subject Device	Subject Device	Predicate Device
EMBOLD™ SOFT Detachable	EMBOLD™ PACKING Detachable	EMBOLD™ FIBERED Detachable Coil
Coil System Intended Use and	Coil Intended Use and Indications	Intended Use and Indications for Use
Indications for Use	for Use
Intended Use/Indications for UseThe EMBOLD Soft Detachable CoilSystem is indicated to obstruct orreduce rate of blood flow in theperipheral vasculature. This device isnot intended for coronary orneurovascular use.	Intended Use/Indications for UseThe EMBOLD Packing Detachable CoilSystem is indicated to obstruct or reducerate of blood flow in the peripheralvasculature. This device is not intended forcoronary or neurovascular use.	Intended Use/Indications UseThe EMBOLD™ Fibered Detachable Coil system isintended to obstruct or reduce rate of blood flowin the peripheral vasculature. This device is notintended for coronary or neurovascular use.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The EMBOLD™ Soft Detachable Coil System and EMBOLD™ Packing Detachable Coil System incorporate substantially equivalent device materials and design, materials and design, fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate device, EMBOLD™ Fibered Detachable Coil system, K213398.

Similar to the predicate Embold™ Fibered Detachable Coil System, the subject device consists of a delivery wire with an implantable platinum/tungsten coil attached at the distal end with platinum/iridium alloy coupler arms contained within an introducer sheath which also allow smooth delivery of the coil system through 0.021 inch to 0.027-inch microcatheters. EMBOLD Soft and EMBOLD Packing have the same mechanical, user-activated, detachment mechanism as the predicate device. The subject device features a non-fibered, coil implant with a stretch-resistant feature.

The following technological differences exist between the subject and predicate devices:

Packing Coil Shape
. Non-Fibered Coil

Differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness. The results of bench testing provide reasonable assurance of substantial equivalence of the EMBOLD Soft Detachable Coil System and EMBOLD Packing Detachable Coil System with the predicate device (K213398).

VII. PERFORMANCE DATA

The EMBOLD™ Soft Detachable Coil system and EMBOLD™ Packing Detachable Coil System were subjected

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K230706 Page 3 of 3

to testing according to the requirements of Guidance for Industry and FDA Staff-Class II Special Controls Document: Vascular and Neurovascular Embolization Devices (December 29, 2004). Bench, animal and biocompatibility testing in accordance with ISO 10993 were performed to support a determination of substantial equivalence. 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 performance issues were raised during the testing; this device is substantially equivalent to the predicate device.

VIII. CONCLUSIONS

Based on the intended use, technological characteristics, and the safety and performance data provided, the Embold™ Soft Detachable Coil System and Embold™ Packing Detachable Coil System is considered appropriate for the intended use and substantially equivalent to the predicate device's technological and material differences do not raise new questions of safety or effectiveness, and the subject devices are as safe and effective as the predicate Embold ™ Fibered Detachable Coil System (K213398).

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).