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/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 thermally detached from the delivery pusher in serial manner until the aneurysm is occluded.

AI/ML Overview

The provided document describes the Optima Coil System, a neurovascular embolization device. The submission is a Special 510(k) to obtain market clearance for a modified device, primarily involving the addition of new sizes (coil OD, length) and combinations of primary wind and filar diameters. The document asserts that the modified device is substantially equivalent to the predicate device (Optima Coil System K172390).

Here's an analysis of the acceptance criteria and supporting study information:

1. A table of acceptance criteria and the reported device performance

Testing Type	Acceptance Criteria	Reported Device Performance
Visual and dimensional inspection	All samples must show no sign of visual physical damage and meet specified secondary diameter and length requirements.	Pass
Simulated Use	All samples must achieve a performance rating of 3 or greater for introduction, tracking, deployment, and repositioning.	Pass
Detachment	All samples must detach by the third attempt.	Pass
Detachment Zone tensile testing	All samples must meet a specified minimum tensile strength.	Pass
Stretch-resistance thread tensile testing	All samples must meet a specified minimum tensile strength.	Pass
Usability	All samples must meet established clinical performance metrics in the benchtop model.	Pass

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample size used for each test set. It repeatedly mentions "All samples," suggesting that a representative number of devices were tested for each criterion.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, based on the context of a 510(k) submission for a medical device and the types of tests conducted (bench testing, simulated use), it is safe to infer that this is prospective bench testing data conducted by the manufacturer (Balt USA, LLC) as part of their design verification and validation process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the document describes a 510(k) submission for a physical medical device (embolization coils) and the performance data presented is from bench testing. The "ground truth" here is defined by engineering specifications and objective measurements (e.g., visual inspection, dimensional requirements, tensile strength, detachment attempts, performance rating for simulated use). Human expert evaluation for establishing ground truth in the way it's typically understood for AI/diagnostic studies (e.g., radiologists interpreting images) is not relevant for this type of device and testing.

4. Adjudication method for the test set

This section is not applicable for the same reasons as point 3. Bench testing of a physical medical device does not typically involve adjudication among human experts to establish ground truth. The acceptance criteria are objective measurements and pass/fail results based on predefined engineering limits.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. The device described is a neurovascular embolization coil system, not an AI-powered diagnostic or assistive tool. Therefore, a multi-reader multi-case comparative effectiveness study involving human readers with and without AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. The device is a physical medical implant (embolization coils) and a delivery system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the test results in this document is established by engineering specifications and quantifiable physical properties. This includes:

Dimensional requirements: For secondary diameter and length.
Visual inspection criteria: For physical damage.
Performance ratings: For introduction, tracking, deployment, and repositioning in simulated use. These ratings would be based on predefined operational standards and potentially expert observation during the simulated procedure.
Objective detachment criteria: Detachment within a specified number of attempts.
Minimum tensile strength values: For detachment zone and stretch-resistance thread.
Established clinical performance metrics: For usability in the benchtop model, likely reflecting real-world performance expectations.

8. The sample size for the training set

This section is not applicable. The device is a physical medical product, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

This section is not applicable for the same reason as point 8.

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 1, 2020

Balt USA, LLC Michael Peters International Regulatory Affairs Specialist 29 Parker Irvine, California 92618

Re: K200030

Trade/Device Name: Optima Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: January 3, 2020 Received: January 7, 2020

Dear Michael Peters:

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

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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 (OS) 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 mediation-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,

Xiaolin Zheng, Ph.D., M.S. 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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Indications for Use

510(k) Number (if known) K200030

Device Name Optima 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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OPTIMA EMBOLIZATION COIL SYSTEM 510(K) SUMMARY OF SUBSTANTIAL EQUIVALENCE

This 510(k) summary for the Optima Coil System is submitted in accordance with the requirements of 21 CFR 807.87(h) and 807.92 and following the recommendation outlined in FDA Guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)], dated 28 July, 2014.

DATE PREPARED:	January 3, 2020		Optima Embolization Coil System(K172390)(Predicate Device)	ModifiedOptimaEmbolizationCoil System(SubjectDevice)	Effect onsubstantialequivalence
APPLICANT:	Balt USA, LLC29 ParkerIrvine, CA, 92653 USA		General
CONTACT PERSON:	Michael Peters, International Regulatory Affairs Specialistmichael.peters@balt-usa.com+1.949.788.1443	Intended Use	The Optima Coil System is intendedfor use in the peripheral and neuro-vasculature to endovascularly obstructor occlude blood flow in vascularabnormalities of the neurovascular andperipheral vessels.	Same	None
TRADE NAME:	Optima Coil System	Anatomical Site	NeurovasculaturePeripheral Vasculature	Same	None
COMMON NAME:	Neurovascular embolization device	Delivery to site	Via delivery wire throughmicrocatheter	Same	None
CLASSIFICATIONNAME:	Device, Neurovascular EmbolizationDevice, Vascular Embolization	Principle ofOperation	Facilitates endovascular embolizationof intracranial aneurysms and othervascular abnormalities	Same	None
DEVICECLASSIFICATION:	Class II, 21 CFR 882.5950 (HCG)Class II, 21 CFR 870.3300 (KRD)	System Components	Coil (implant)Delivery SystemDetachment Controller	Same	None
PRODUCT CODE:	HCG, KRD	Method of supply(coil/delivery system)	Sterile, single use	Same	None
PREDICATEDEVICE:	Optima Coil System (K172390)	Coil (Implant)
PURPOSE OFSUBMISSION:	The purpose of this Special 510(k) submission is to obtain marketclearance for a modified device.	Main Coil Material	Platinum/Tungsten alloy	Same	None
INDICATIONS FORUSE:	The Optima Coil System is intended for the endovascularembolization of intracranial aneurysms and other neurovascularabnormalities such as arteriovenous malformations andarteriovenous fistulae. The Optima Coil System is also intended forvascular occlusion of blood vessels within the neurovascular systemto permanently obstruct blood flow to an aneurysm or othervascular malformation and for arterial and venous embolizations inthe peripheral vasculature.	Primary Coil WindDiameter	0.010"-0.014"	Same	None
DEVICEDESCRIPTION:	The Optima Coil System is a series of specialized coils that areinserted into the vasculature under angiographic visualization toembolize intracranial aneurysms and other vascular anomalies. Thesystem consists of an embolization coil implant comprised ofplatinum/tungsten, affixed to a delivery pusher to facilitate insertion	Coil SecondaryDiameter	1mm-24mm	Same	None
Coil Wire Diameter	0.00125"-0.0035"	Same	None

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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 thermally detached from the delivery pusher in serial manner until the aneurysm is occluded.

TECHNOLOGICAL CHARACTERISTICS

The subject device has the same technological characteristics as the predicate device.

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	Optima Embolization Coil System(K172390)(Predicate Device)	ModifiedOptimaEmbolizationCoil System(SubjectDevice)	Effect onsubstantialequivalence
Secondary Shapes	Complex/Helical	Same	None
Coil Types	Framing, Filling, Finishing	Same	None
Coil length	1cm - 65cm	Same	None
Stretchresistance/attachmentthread	Polyolefin Engage Thread	Same	None
Coupler/Markerband	Platinum/Iridium alloy	Same	None
No. of sizes offered	119	209	Additionalmodels as partof lineextension, allnew sizes fallwithin existingranges
Primary wind (CoilOD) x Filar (WireDiameter)combinations	Complex:.010" x .00125".011" x .0015".010" x .0015".011" x .00175".012" x .002".013" x .00225".014" x .003".014" x .0035"Helical:.012" x .002".011" x .0015".010" x .00125"	All previouscombinations,with addition ofthe following:Complex:.012" x .00125".014" x .0015".014" x .00175".014" x .002"Helical:.012" x .00125".014" x .0015".014" x .00175".014" x .002"	Additionalcombinations aspart of lineextension; alladditions metspecified criteriaand werevalidated not toimpactsubstantialequivalence
Delivery System (pusher)
Construction/Design	Body coil laser welded to hypotube	Same	None
Body coil	4-part coil:A. Heater Coil (92/8 Pt/W)B. Distal Coil (SSTL)C. Radio-opaque (RO, 92/8 Pt/W) Coil	Same	None
	Optima Embolization Coil System(K172390)(Predicate Device)	ModifiedOptimaEmbolizationCoil System(SubjectDevice)	Effect onsubstantialequivalence
Hypotube	SSTL hypotube	Same	None
Connector	Gold plated, SSTL hypotube	Same	None
Adhesive	Dymax 1128A-M-VT	Same	None
Jacket	PET	Same	None
Fluoro safe markers	Pad Printed PET Shrink tube	Same	None
Epoxy	Epoxy 353 ND	Same	None
Lead wires	Polyimide coated silver lead wires	Same	None
Detachment Controller
Coil detachment	Thermal via detachment controller	Same	None

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The modified Optima Embolization Coil System and predicate Optima Coil System devices differ in the following:

Addition of new sizes (coil OD, length) .
Note: Some are grouped into new subfamilies for marketing purposes

PERFORMANCE DATA [807.92(b)]

All necessary verification and validation testing has been performed for the Optima Embolization Coil System to assure substantial equivalence to the predicate device and demonstrate the device performs as intended. Comparative laboratory bench testing was performed on test units representative of finished devices to ensure that the device performance is maintained for the entirety of the proposed shelf life, and that it satisfies the pre-determined design input requirements per the Design V&V Plan:

Testing Type	Acceptance Criteria	Testing Result
Visual and dimensionalinspection	All samples must show no sign of visual physical damage and meet specified secondary diameter and length requirements.	Pass

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Simulated Use	All samples must achieve a performancerating of 3 or greater for introduction,tracking, deployment, and repositioning.	Pass
Detachment	All samples must detach by the thirdattempt.	Pass
Detachment Zone tensiletesting	All samples must meet a specifiedminimum tensile strength.	Pass
Stretch-resistance threadtensile testing	All samples must meet a specifiedminimum tensile strength.	Pass
Usability	All samples must meet established clinicalperformance metrics in the benchtopmodel.	Pass

The modified Optima Coil System met all specified criteria to be established as substantially equivalent to the legally marketed Predicate Optima Coil System (K1723290).

BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

Upon reviewing the performance data and comparing intended use, design, materials, principles of operation and overall technological characteristics, the modified Optima Coil System is determined to be substantially equivalent to the current, legally marketed Optima Coil System (K172390).

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).