Optima Coil System
Device Facts
| Record ID | K200030 |
|---|---|
| Device Name | Optima Coil System |
| Applicant | Balt USA, LLC |
| Product Code | HCG · Neurology |
| Decision Date | Feb 1, 2020 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 882.5950 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
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 and thrombosis. Thermal detachment mechanism, controlled by external unit, releases coils from pusher in serial manner until occlusion achieved. Used in clinical settings by physicians; provides permanent obstruction of blood flow to aneurysms/malformations. Benefits include reduced flow into aneurysm and effective thrombosis, minimizing rupture risk.
Clinical Evidence
Bench testing only. Testing included visual/dimensional inspection, simulated use (introduction, tracking, deployment, repositioning), detachment performance, and tensile strength testing for detachment zones and stretch-resistance threads. All samples met pre-determined acceptance criteria.
Technological Characteristics
Implant: Platinum/Tungsten alloy coil. Delivery system: Stainless steel hypotube, PET jacket, polyimide-coated silver lead wires. Detachment: Thermal via external controller. Sizes: 0.010"-0.014" primary wind diameter; 1mm-24mm secondary diameter. Sterile, single-use. No software/algorithm.
Indications for Use
Indicated for patients requiring endovascular embolization of intracranial aneurysms, arteriovenous malformations, arteriovenous fistulae, and other neurovascular or peripheral vascular abnormalities requiring blood flow obstruction.
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 (K172390)
Submission Summary (Full Text)
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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)
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) | |
|--------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> 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<br>(K172390)<br>(Predicate Device) | Modified<br>Optima<br>Embolization<br>Coil System<br>(Subject<br>Device) | Effect on<br>substantial<br>equivalence |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-----------------------------------------|
| APPLICANT: | Balt USA, LLC<br>29 Parker<br>Irvine, CA, 92653 USA | | General | | |
| CONTACT PERSON: | Michael Peters, International Regulatory Affairs Specialist<br>michael.peters@balt-usa.com<br>+1.949.788.1443 | Intended Use | The Optima Coil System is intended<br>for use in the peripheral and neuro-<br>vasculature to endovascularly obstruct<br>or occlude blood flow in vascular<br>abnormalities of the neurovascular and<br>peripheral vessels. | Same | None |
| TRADE NAME: | Optima Coil System | Anatomical Site | Neurovasculature<br>Peripheral Vasculature | Same | None |
| COMMON NAME: | Neurovascular embolization device | Delivery to site | Via delivery wire through<br>microcatheter | Same | None |
| CLASSIFICATION<br>NAME: | Device, Neurovascular Embolization<br>Device, Vascular Embolization | Principle of<br>Operation | Facilitates endovascular embolization<br>of intracranial aneurysms and other<br>vascular abnormalities | Same | None |
| DEVICE<br>CLASSIFICATION: | Class II, 21 CFR 882.5950 (HCG)<br>Class II, 21 CFR 870.3300 (KRD) | System Components | Coil (implant)<br>Delivery System<br>Detachment Controller | Same | None |
| PRODUCT CODE: | HCG, KRD | Method of supply<br>(coil/delivery system) | Sterile, single use | Same | None |
| PREDICATE<br>DEVICE: | Optima Coil System (K172390) | Coil (Implant) | | | |
| PURPOSE OF<br>SUBMISSION: | The purpose of this Special 510(k) submission is to obtain market<br>clearance for a modified device. | Main Coil Material | Platinum/Tungsten alloy | Same | None |
| INDICATIONS FOR<br>USE: | The Optima Coil System is intended for the endovascular<br>embolization of intracranial aneurysms and other neurovascular<br>abnormalities such as arteriovenous malformations and<br>arteriovenous fistulae. The Optima Coil System is also intended for<br>vascular occlusion of blood vessels within the neurovascular system<br>to permanently obstruct blood flow to an aneurysm or other<br>vascular malformation and for arterial and venous embolizations in<br>the peripheral vasculature. | Primary Coil Wind<br>Diameter | 0.010"-0.014" | Same | None |
| DEVICE<br>DESCRIPTION: | The Optima Coil System is a series of specialized coils that are<br>inserted into the vasculature under angiographic visualization to<br>embolize intracranial aneurysms and other vascular anomalies. The<br>system consists of an embolization coil implant comprised of<br>platinum/tungsten, affixed to a delivery pusher to facilitate insertion | Coil Secondary<br>Diameter | 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<br>(K172390)<br>(Predicate Device) | Modified<br>Optima<br>Embolization<br>Coil System<br>(Subject<br>Device) | Effect on<br>substantial<br>equivalence |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Secondary Shapes | Complex/Helical | Same | None |
| Coil Types | Framing, Filling, Finishing | Same | None |
| Coil length | 1cm - 65cm | Same | None |
| Stretch<br>resistance/attachment<br>thread | Polyolefin Engage Thread | Same | None |
| Coupler/Markerband | Platinum/Iridium alloy | Same | None |
| No. of sizes offered | 119 | 209 | Additional<br>models as part<br>of line<br>extension, all<br>new sizes fall<br>within existing<br>ranges |
| Primary wind (Coil<br>OD) x Filar (Wire<br>Diameter)<br>combinations | Complex:<br>.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>Helical:<br>.012" x .002"<br>.011" x .0015"<br>.010" x .00125" | All previous<br>combinations,<br>with addition of<br>the following:<br>Complex:<br>.012" x .00125"<br>.014" x .0015"<br>.014" x .00175"<br>.014" x .002"<br>Helical:<br>.012" x .00125"<br>.014" x .0015"<br>.014" x .00175"<br>.014" x .002" | Additional<br>combinations as<br>part of line<br>extension; all<br>additions met<br>specified criteria<br>and were<br>validated not to<br>impact<br>substantial<br>equivalence |
| Delivery System (pusher) | | | |
| Construction/Design | Body coil laser welded to hypotube | Same | None |
| Body coil | 4-part coil:<br>A. Heater Coil (92/8 Pt/W)<br>B. Distal Coil (SSTL)<br>C. Radio-opaque (RO, 92/8 Pt/W) Coil | Same | None |
| | Optima Embolization Coil System<br>(K172390)<br>(Predicate Device) | Modified<br>Optima<br>Embolization<br>Coil System<br>(Subject<br>Device) | Effect on<br>substantial<br>equivalence |
| 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 dimensional<br>inspection | 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 performance<br>rating of 3 or greater for introduction,<br>tracking, deployment, and repositioning. | Pass |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------|
| Detachment | All samples must detach by the third<br>attempt. | Pass |
| Detachment Zone tensile<br>testing | All samples must meet a specified<br>minimum tensile strength. | Pass |
| Stretch-resistance thread<br>tensile testing | All samples must meet a specified<br>minimum tensile strength. | Pass |
| Usability | All samples must meet established clinical<br>performance metrics in the benchtop<br>model. | 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).
