The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

Device Description

The Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum and tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths, and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are detached from the delivery pusher in a serial manner until the aneurysm is occluded.

AI/ML Overview

N/A

Summary

FDA 510(k) Clearance Letter - Optima Coil System

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September 26, 2025

Balt USA, LLC
Kavita Chandrashekar
Senior Regulatory Affairs Specialist
29 Parker
Irvine, California 92618

Re: K252700
Trade/Device Name: Optima Coil System (Optima Packing Coil System)
Regulation Number: 21 CFR 882.5950
Regulation Name: Vascular Embolization Device
Regulatory Class: Class II
Product Code: HCG, KRD
Dated: August 26, 2025
Received: August 27, 2025

Dear Kavita Chandrashekar:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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K252700 - Kavita Chandrashekar Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

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K252700 - Kavita Chandrashekar Page 3

Sincerely,

Heather L. Dean -S

for Sara Thompson, DVM
Assistant Director
DHT5A: Division of Neurosurgical,
Neurointerventional, and
Neurodiagnostic Devices
OHT5: Office of Neurological and
Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K252700

Device Name: Optima Coil System (OptiBlock Line Extension)

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)

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
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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."

Page 5

510(k) Summary K252700

Applicant: Balt USA, LLC
29 Parker
Irvine, CA 92618
Registration No.: 3014162263

Primary Contact Person: Kavita Chandrashekar
Senior Regulatory Affairs Specialist
Telephone: (858) 405-1276
Email: kavita.chandrashekar@baltgroup.com

Secondary Contact: Brandon Shepard
Director, Regulatory Affairs
Telephone: (949) 788-1443
Email: brandon.shepard@baltgroup.com

Date Summary Prepared: 09/25/2025

Trade Name: Optima Coil System

Common Name: Neurovascular embolization device; Vascular embolization device

Review Panel: Neurology; Cardiovascular

Product Code: HCG, KRD

Regulation Number: 21 CFR 882.5950 (HCG), 21 CFR 870.3300 (KRD)

Regulation Name: Device, Neurovascular Embolization; Device, Vascular, for Promoting Embolization

Device Classification: Class II

Predicate Device: Optima Coil System, 510(k): K242582

Device Description:

Indications for Use:

Intended Use:

The Optima Coil System is intended for use in the peripheral and neuro-vasculature to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

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Comparison of Technological Characteristics:

Table 1 Device Comparison

Category	Optima Coil System (predicate device K242582)	Modified Optima Coil System (Optima Packing Line Extension, subject device K252700)
Intended Use	The Optima Coil System is intended for use in the peripheral and neuro-vasculature to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.	Same
Indications for Use	The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.	Same
Risk Class	Class II	Same
Regulation Name	Neurovascular Embolization Device	Same
Generic Name	Neurovascular Embolization Device	Same
Anatomical Location	Neuro Vasculature & Peripheral Vasculature	Same
Visualization	Visible under radiographic imaging	Same
Method of Supply	Sterile; single-use	Same
Coil Delivery Mechanism	Pusher assembly	Same

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System Components	Coil (implant) Delivery System Detachment Controller	Same
Sterilization Method, SAL	Gamma irradiation, 10⁻⁶	Same

Category	Optima Coil System (predicate device K242582)	Modified Optima Coil System (Optima Packing Line Extension, subject device K252700)
Shelf-Life	5 years	Same

Coil (Implant features)

Delivery System

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Detachment Equipment

| Detachment Equipment Components | XCEL | Same |

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The modified Optima Packing Coil System and the predicate OptiBlock Coil System differ in the following:

Implementation of an updated implant design of a combination of secondary shapes with features designed to reduce resistance and improve the navigability of the coil system through tortuous or narrow vessels, as well as grab and anchor into the vessel wall or into a previously packed coil.

The differences between the subject and predicate devices do not raise new questions of safety and effectiveness.

Performance Data – Bench:

The following non-clinical bench testing was performed to evaluate the device changes and to demonstrate substantial equivalence of the modified Optima Packing Coil System to the predicate device:

Test	Acceptance Criteria	Results
Visual Inspection, Dimensional Inspection, and Resistance Check	The test samples shall meet established test acceptance criteria for visual physical damage, secondary diameter and length, and resistance.	Pass
Simulated Use	The test samples shall be prepared in accordance with the instructions for use and meet established test acceptance criteria for device performance in a clinically relevant model.	Pass

Conclusion:

There is no change to the intended use, materials, principles of operation or performance requirements of the modified Optima Coil System (Optima Packing Line Extension) in comparison to the predicate device (K242582). The successful completion of non-clinical bench testing demonstrates that the modified Optima Coil System (Optima Packing Line Extension) is substantially equivalent to the predicate device.

Regulation Number and Section

§ 882.5950 Neurovascular embolization device.

(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(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 § 882.1(e).