(29 days)
Not Found
No
The description focuses on the physical components and mechanical function of the device (coils for embolization) and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for embolization and occlusion of aneurysms and vascular abnormalities to obstruct blood flow, which is a direct therapeutic intervention.
No
The device is an embolization coil system used for therapeutic occlusion of blood vessels, not for diagnosing conditions.
No
The device description clearly states the Optima Coil System is comprised of physical components (platinum and tungsten coils, delivery pusher) and is intended for physical insertion into the vasculature. It is a hardware-based 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 examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The Optima Coil System is described as a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. This is an in vivo procedure, meaning it is performed inside the body.
- Intended Use: The intended use clearly describes the device being used for endovascular embolization and vascular occlusion within the body.
Therefore, the Optima Coil System is a therapeutic medical device used for interventional procedures, 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Visible under radiographic imaging
Anatomical Site
Neuro Vasculature and 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)
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: Visual Inspection, Dimensional Inspection, and Resistance Check
Acceptance Criteria: The test samples shall meet established test acceptance criteria for visual physical damage and secondary diameter and length.
Results: Pass
Test: Simulated Use
Acceptance Criteria: 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.
Results: Pass
Test: Stretch Resistance
Acceptance Criteria: The samples shall meet established test acceptance criteria for tensile strength.
Results: Pass
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.
Optima Coil System, 510(k): K200030
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).
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ☑ | ☐ |
X Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summarv K223386
| 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: | 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; |
| 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.
4
Comparison of Technological Characteristics:
| Table I Device Comparison | ||||
|---|---|---|---|---|
| Category | Optima Coil System (predicate device K200030) | Modified Optima Coil | ||
| System (subject device | ||||
| K223386) | ||||
| 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 | ||
| 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) | |||
| Delivery System | ||||
| 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 | ||
| (subject device K223386) | ||||
| No. & Size of Helical Loops | ||||
| on Distalmost End | ||||
| (Complex only) | 1.5 loops of 70% nominal diameter | 3 loops of 70% nominal secondary diameter | ||
| 3 loops of 100% nominal secondary diameter (with gaps of 0.0015") | ||||
| Primary Wind and Filar | ||||
| Combinations | Complex | Helical | Complex | Helical |
| .010" x .00125" | ||||
| .011" x .0015" | ||||
| .010" x .0015" | ||||
| .011" x .00175" | ||||
| .012" x .002" | ||||
| .013" x .00225" | ||||
| .014" x .003" | ||||
| .014" x .0035" | ||||
| .012" x .00125" | ||||
| .014" x .0015" | ||||
| .014" x .00175" | ||||
| .014" x .002" | .012" x .002" | |||
| .011" x .0015" | ||||
| .010" x .00125" | ||||
| .012" x .00125" | ||||
| .014" x .0015" | ||||
| .014" x .00175" | ||||
| .014" x .002" | .012" x .00125" | |||
| .014" x .0015" | ||||
| .014" x .0020" | ||||
| .014" x .0025" | ||||
| .014" x .00275" | ||||
| (gap) | ||||
| .014" x .0030" | ||||
| .014" x .0030" | ||||
| (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, | ||||
| Sterility Assurance Level | ||||
| (SAL) | Gamma irradiation, 10-6 | Same | ||
| Delivery System (pusher) | ||||
| Construction/Design | Body coil laser welded to hypotube | Same | ||
| Body coil | 4-part coil: | |||
| A. Heater Coil (92/8 Pt/W) | ||||
| B. Distal Coil (SSTL) | Same |
Table 1 Device Co .
5
6
| 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 |
7
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 | ||
| Inspection, and Resistance Check | The test samples shall meet established test | |
| acceptance criteria for visual physical | ||
| damage and secondary diameter and length. | 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 | |
| Stretch Resistance | The samples shall meet established test | |
| 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.