(28 days)
Not Found
No
The description focuses on the physical characteristics and mechanical function of the embolization coils and delivery system. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used to embolize intracranial aneurysms and other neurovascular abnormalities by permanently obstructing blood flow, which is a therapeutic intervention.
No
Explanation: The Optima Coil System is described as a treatment device intended for embolization and vascular occlusion, not for identifying or diagnosing medical conditions. It is used to obstruct blood flow to an aneurysm or other vascular malformation.
No
The device description clearly states the device is a series of specialized coils made of platinum and tungsten, which are physical implants, not software.
Based on the provided information, the Optima Coil System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the endovascular embolization of intracranial aneurysms and other vascular abnormalities. This is a therapeutic procedure performed directly on the patient's vasculature.
- Device Description: The device is a physical implant (coils) delivered into the body to obstruct blood flow.
- Lack of In Vitro Testing: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. The Optima Coil System does not perform any such testing.
The Optima Coil System is a medical device used for a therapeutic intervention within the body, not for diagnostic testing of samples outside the body.
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
Radiographic imaging
Anatomical Site
Neuro Vasculature & 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 (OptiBlock Line Extension) 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, secondary diameter and length, and resistance.
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
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): K223386
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
September 27, 2024
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 & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Balt USA, LLC Kavita Chandrashekar Senior Regulatory Affairs Specialist 29 Parker Irvine, California 92618
Re: K242582
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: August 29, 2024 Received: August 30, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Sara S. Thompson -S
Sara Thompson, D.V.M. 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
3
Indications for Use
510(k) Number (if known) K242582
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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| 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: | 09/25/2024 |
|---|---|
| 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): K223386 |
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:
| Category | Optima Coil System (predicate device
K223386) | Modified Optima Coil System
(OptiBlock Line Extension,
subject device K242582) |
|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |
| Regulation Name | Neurovascular Embolization Device | Same |
| Generic Name | Neurovascular Embolization Device | Same |
| Anatomical Location | Neuro Vasculature & 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 |
| Sterilization Method, SAL | Gamma irradiation, 10-6 | Same |
| Category | Optima Coil System (predicate device K223386) | Modified Optima Coil System (OptiBlock Line Extension, subject device K242582) |
| Shelf-Life | 5 years | Same |
| Coil (Implant features) | | |
| Main Coil Material | 92/8 Platinum/Tungsten (Pt/W) Alloy | Same |
| Coil Length | 3 cm – 65 cm | Same |
| Primary Coil Wind Diameter | 0.012"-0.014" | 0.010" - 0.014" |
| Coil Secondary Shape Diameter | 1mm-14mm | Same |
| Coil Wire Diameter | 0.00125" - .0030" | Same |
| Secondary Shapes | Complex, Helical | Same |
| Stretch-resistance Thread | .0022" Polyolefin Engage thread (Annealed)
.0018" Polyolefin Engage thread (Annealed) | Same |
| Coupler | 90/10 Platinum/Iridium (Pt/I) alloy Markerband | Same |
| Primary Wind & Filar Combinations | .012" x .00125"
.014" x .0015"
0.014 x .00275" (gap) + 0.014 x 0.002"
0.014 x .00275" (gap) + 0.014 x 0.0025"
0.014" x .003" (gap) + 0.014" x .003" | .012" x .00125"
.014" x .0015"
.010" x .00125"
.014" x .00275" (gap) + .014" x .002"
.014" x .00275" (gap) + .014" x .0025"
0.014 x 0.003" (gap) + 0.014 x 0.003" |
| No. & Size of Distal Helical Loops
(Complex Implant) | 3 loops of 100% nominal diameter (with gaps of 0.0015") | Same |
| Category | Optima Coil System (predicate device
K223386) | Modified Optima Coil System
(OptiBlock Line Extension, subject
device K242582) |
| Body Coil Components | 4-part coil:
- Heater coil (92/8 Platinum/Tungsten)
- Distal Coil (Stainless Steel)
- Radio-opaque (RO) Coil (92/8
Platinum/Tungsten) - Proximal Coil (Stainless Steel) | Same |
| Hypotube | Stainless Steel Hypotube | Same |
| Connector (to Detachment Controller) | Gold plated, stainless steel hypotube | Same |
| Fluorosafe Markers | Pad printed PET Shrink tube | Same |
| Epoxy | Epoxy 353ND | Same |
| Lead Wires | Polyimide coated silver lead wires | Same |
| Pusher Working Length | 185 cm | Same |
| Delivery Wire Diameter | 0.0125" Stainless Steel Coil
0.0125" Platinum/Tungsten Coil
0.0135" Stainless Steel hypotube | Same |
| PET Jacket | .016" ID x .00025" Wall PET | Same |
| Solder | Gold solder | Same |
| Bonding Adhesive | Dymax 1128A-M-VT | Same |
| Attachment Zone Length | 0.045" | Same |
| Detachment Equipment | | |
| Detachment Equipment Components | Xcel Detachment Controller | Same |
| User Interface | Handheld | Same |
| Power Source | Battery, n=3 12V, size A23 | Same |
| Detachment Mechanism | Thermal via detachment controller | Same |
| Controller Sterilization | Ethylene oxide gas | Same |
| Method of supply | Sterile; single use | Same |
6
7
8
The modified Optima Coil System (OptiBlock Line Extension) and the predicate Optima Coil System differ in the following:
- Addition of coil models with new combinations of diameter and length.
- Reduction of the coil's helical proximal loops by 1mm or 2mm in diameter, for coil models ● with nominal loop diameters of 3-5mm and 6-14mm, respectively.
- Implementation of 0.0015-inch gaps added to the primary wind of distal helical loops for ● secondary diameters ranging from 3 mm to 3.5 mm.
- Implementation of a smaller .010" Primary wind OD. ●
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 (OptiBlock Line Extension) 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, secondary diameter and length, | ||
| and resistance. | 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 |
Conclusion:
There is no change to the intended use, materials, principles of operation or performance requirements of the modified Optima Coil System (OptiBlock Line Extension) in comparison to the predicate device (K223386). The successful completion of non-clinical bench testing demonstrates that the modified Optima Coil System (OptiBlock Line Extension) is substantially equivalent to the predicate device.