Optima Coil System

K223386 · Balt USA, LLC · HCG · Dec 6, 2022 · Neurology

Device Facts

• Record ID: K223386
• Device Name: Optima Coil System
• Applicant: Balt USA, LLC
• Product Code: HCG · Neurology
• Decision Date: Dec 6, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Optima Coil System consists of platinum/tungsten embolization coils attached to a delivery pusher; used for endovascular embolization of intracranial aneurysms and other vascular abnormalities. Device inserted into vasculature under angiographic visualization; coils placed into aneurysm to create blood stasis, reduce flow, and induce thrombosis. Detachment from pusher achieved via thermal detachment controller. Used in neurovascular and peripheral vasculature by physicians. System available in various shapes, lengths, and sizes; provides permanent obstruction of blood flow to vascular malformations.

Clinical Evidence

Bench testing only. Testing included visual and dimensional inspection, simulated use in a clinically relevant model, and stretch resistance (tensile strength) testing. All tests passed.

Technological Characteristics

Implant: 92/8 Platinum/Tungsten alloy coil. Delivery system: stainless steel hypotube, PET jacket, polyimide-coated silver lead wires. Detachment: thermal via controller. Dimensions: 3-65 cm length, 1-14 mm secondary diameter. Sterilization: Gamma irradiation (SAL 10^-6). Single-use. Materials include Dymax 1128A-M-VT adhesive and Epoxy 353 ND.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms, arteriovenous malformations, and arteriovenous fistulae; vascular occlusion of blood vessels within the neurovascular system; and arterial and venous embolizations in the peripheral vasculature.

Regulatory Classification

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.

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 § 882.1(e).

Predicate Devices

• Optima Coil System (K200030)

Submission Summary (Full Text)

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December 6, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K223386

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: November 4, 2022 Received: November 7, 2022

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 (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

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Naira Muradyan -S

Naira Muradyan, Ph.D. 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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## Indications for Use

510(k) Number (if known) K223386

Device Name Optima Coil System

#### Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

| <label>Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label>Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
|--------------------------------------------------------------|--------------------------------------------------------------|
| <div style="display:inline-block; margin-right:5px;">☑</div> | <div style="display:inline-block; margin-right:5px;">☐</div> |

X Prescription Use (Part 21 CFR 801 Subpart D)

] Over-The-Counter Use (21 CFR 801 Subpart C)

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### 510(k) Summarv K223386

| Applicant: | Balt USA, LLC<br>29 Parker<br>Irvine, CA 92618<br>Registration No.: 3014162263 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person: | Kavita Chandrashekar<br>Senior Regulatory Affairs Specialist<br>Telephone: [phone]<br>Email : [e-mail] |
| Secondary Contact | Brandon Shepard<br>Director, Regulatory Affairs<br>Telephone: [phone]<br>Email : [e-mail] |

| Date Summary Prepared: | December 02, 2022 |
|------------------------|-------------------------------------------------------------------------------------|
| 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;<br>Device, Vascular, for Promoting Embolization |
| Device Classification: | Class II |
| Predicate Device: | Optima Coil System, 510(k): K200030 |

### 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.

#### 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.

#### 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 I Device Comparison | | | | |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Category | Optima Coil System (predicate device K200030) | Modified Optima Coil<br>System (subject device<br>K223386) | | |
| Intended Use | The Optima Coil System is intended for use in the<br>peripheral and neuro-vasculature to endovascularly<br>obstruct or occlude blood flow in vascular abnormalities<br>of the neurovascular and peripheral vessels. | Same | | |
| Indications for Use | The Optima Coil System is intended for the endovascular<br>embolization of intracranial aneurysms and other<br>neurovascular abnormalities such as arteriovenous<br>malformations and arteriovenous fistulae. The Optima<br>Coil System is also intended for vascular occlusion of<br>blood vessels within the neurovascular system to<br>permanently obstruct blood flow to an aneurysm or other<br>vascular malformation and for arterial and venous<br>embolizations in the peripheral vasculature. | Same | | |
| Risk Class | Class II | Same | | |
| Product Code | HCG, KRD | Same | | |
| Common Name | Neurovascular Embolization Device | Same | | |
| Anatomical Location | Neuro Vasculature and Peripheral Vasculature | Same | | |
| Visualization | Visible under radiographic imaging | Same | | |
| Method of Supply | Sterile; single-use | Same | | |
| Coil Delivery Mechanism | Pusher assembly | Same | | |
| System Components | Coil (implant)<br>Delivery System<br>Detachment Controller | Same | | |
| Main Coil Material | 92/8 Platinum/Tungsten (Pt/W) Alloy | Same | | |
| Coil Length | 1 cm - 65 cm | 3 cm - 65 cm | | |
| Coil Secondary Diameter | 1 mm – 24 mm | 1 mm – 14 mm | | |
| Coil Wire Diameter | 0.00125" - 0.0035" | Same | | |
| Primary Coil Wind Diameter | 0.010" - 0.014" | 0.012" - 0.014" | | |
| Category | Optima Coil System (predicate device K200030) | | Modified Optima Coil System<br>(subject device K223386) | |
| No. & Size of Helical Loops<br>on Distalmost End<br>(Complex only) | 1.5 loops of 70% nominal diameter | | 3 loops of 70% nominal secondary diameter<br>3 loops of 100% nominal secondary diameter (with gaps of 0.0015") | |
| Primary Wind and Filar<br>Combinations | Complex | Helical | Complex | Helical |
| | .010" x .00125"<br>.011" x .0015"<br>.010" x .0015"<br>.011" x .00175"<br>.012" x .002"<br>.013" x .00225"<br>.014" x .003"<br>.014" x .0035"<br>.012" x .00125"<br>.014" x .0015"<br>.014" x .00175"<br>.014" x .002" | .012" x .002"<br>.011" x .0015"<br>.010" x .00125"<br>.012" x .00125"<br>.014" x .0015"<br>.014" x .00175"<br>.014" x .002" | .012" x .00125"<br>.014" x .0015"<br>.014" x .0020"<br>.014" x .0025"<br>.014" x .00275"<br>(gap)<br>.014" x .0030"<br>.014" x .0030"<br>(gap) | There are no new dimensions that are subject to this submission. |
| No. of sizes offered | 209 | | 239 (30 additional models as part of this line extension, all new sizes fall within existing ranges) | |
| Detachment | Thermal via Detachment Controller | | Same | |
| Pouch | Tyvek® | | Same | |
| Shelf Life | 5 Years | | Same | |
| Sterilization Method,<br>Sterility Assurance Level<br>(SAL) | Gamma irradiation, 10-6 | | Same | |
| Delivery System (pusher) | | | | |
| Construction/Design | Body coil laser welded to hypotube | | Same | |
| Body coil | 4-part coil:<br>A. Heater Coil (92/8 Pt/W)<br>B. Distal Coil (SSTL) | | Same | |

#### Table 1 Device Co .

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| | C. Radio-opaque (RO, 92/8 Pt/W) Coil | |
|-----------------------|--------------------------------------|------|
| | D. Proximal Coil (SSTL) | |
| Hypotube | SSTL Hypotube | Same |
| Connector | Gold plated, SSTL hypotube | Same |
| Adhesive | Dymax 1128A-M-VT | Same |
| Jacket | PET | Same |
| Fluoro safe markers | Pad Printed PET Shrink tube | Same |
| Epoxy | Epoxy 353 ND | Same |
| Lead wires | Polyimide coated silver lead wires | Same |
| Detachment Controller | | |
| Coil detachment | Thermal via detachment controller | Same |

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

- Addition of new sizes of the coil implant. ●
- Addition of new combinations of coil OD, filar diameter, secondary shape diameter and ● lengths.

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 Coil System to the predicate device:

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

#### Conclusion:

There is no change to the intended use, materials, principles of operation or performance requirements of the modified Optima Coil System in comparison to the predicate device (K200030). The successful completion of non-clinical bench testing demonstrates that the modified Optima Coil System is substantially equivalent to the predicate device.