(25 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of the embolization coils and delivery system. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as "intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities" and creates "blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm," which are direct therapeutic actions.
No
The device description and intended use clearly state that the Optima Coil System is used for endovascular embolization and vascular occlusion, which are therapeutic procedures to treat conditions, not diagnose them. It is a series of specialized coils inserted to create blood stasis and thrombose anomalies, indicating a treatment function.
No
The device description explicitly states the device is comprised of physical components (specialized coils made of platinum/tungsten, a delivery pusher) and is inserted into the vasculature. This is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Optima Coil System is an implantable device used for the physical embolization (blocking) of blood vessels and aneurysms within the body. It is inserted directly into the vasculature.
- Lack of Sample Testing: The description does not mention any testing of samples taken from the body. The device's function is to physically obstruct blood flow, not to analyze biological samples.
Therefore, the Optima Coil System falls under the category of an implantable medical device used for therapeutic intervention, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HCG, KRD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
angiographic visualization
Anatomical Site
intracranial, neurovascular system, peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Tested parameters: Visual and dimensional inspection, Simulated Use, Detachment, Detachment Zone tensile testing, Stretch-resistance thread tensile testing, Usability. All tests passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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
1
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) | |
|---|---|
| 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) | Modified
Optima
Embolization
Coil System
(Subject
Device) | Effect on
substantial
equivalence |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-----------------------------------------|
| APPLICANT: | Balt USA, LLC
29 Parker
Irvine, CA, 92653 USA | | General | | |
| CONTACT PERSON: | Michael Peters, International Regulatory Affairs Specialist
michael.peters@balt-usa.com
+1.949.788.1443 | 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 | None |
| TRADE NAME: | Optima Coil System | Anatomical Site | Neurovasculature
Peripheral Vasculature | Same | None |
| COMMON NAME: | Neurovascular embolization device | Delivery to site | Via delivery wire through
microcatheter | Same | None |
| CLASSIFICATION
NAME: | Device, Neurovascular Embolization
Device, Vascular Embolization | Principle of
Operation | Facilitates endovascular embolization
of intracranial aneurysms and other
vascular abnormalities | Same | None |
| DEVICE
CLASSIFICATION: | Class II, 21 CFR 882.5950 (HCG)
Class II, 21 CFR 870.3300 (KRD) | System Components | Coil (implant)
Delivery System
Detachment Controller | Same | None |
| PRODUCT CODE: | HCG, KRD | Method of supply
(coil/delivery system) | Sterile, single use | Same | None |
| PREDICATE
DEVICE: | Optima Coil System (K172390) | Coil (Implant) | | | |
| PURPOSE OF
SUBMISSION: | The purpose of this Special 510(k) submission is to obtain market
clearance for a modified device. | Main Coil Material | Platinum/Tungsten alloy | Same | None |
| 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. | Primary Coil Wind
Diameter | 0.010"-0.014" | Same | None |
| 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 | Coil Secondary
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
(K172390)
(Predicate Device) | Modified
Optima
Embolization
Coil System
(Subject
Device) | Effect on
substantial
equivalence |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Secondary Shapes | Complex/Helical | Same | None |
| Coil Types | Framing, Filling, Finishing | Same | None |
| Coil length | 1cm - 65cm | Same | None |
| Stretch
resistance/attachment
thread | Polyolefin Engage Thread | Same | None |
| Coupler/Markerband | Platinum/Iridium alloy | Same | None |
| No. of sizes offered | 119 | 209 | Additional
models as part
of line
extension, all
new sizes fall
within existing
ranges |
| Primary wind (Coil
OD) x Filar (Wire
Diameter)
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 previous
combinations,
with addition of
the 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" | Additional
combinations as
part of line
extension; all
additions met
specified criteria
and were
validated not to
impact
substantial
equivalence |
| 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) | Modified
Optima
Embolization
Coil System
(Subject
Device) | Effect on
substantial
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 | ||
| 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
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 |
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).