(29 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of the embolization coils, with no mention of AI or ML for image analysis, decision support, or any other function.
Yes
The device is used to treat peripheral vascular anomalies by inducing thrombosis and reducing blood flow, which aligns with the definition of a therapeutic device.
No.
The device is used for therapeutic embolization (occlusion of blood vessels) in the peripheral vasculature, not for diagnosis.
No
The device description clearly states the Prestige Coil System consists of physical components (coils made of platinum/tungsten, delivery pusher) that are inserted into the body. This is a hardware medical device, not software-only.
Based on the provided information, the Prestige Coil System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Prestige Coil System Function: The Prestige Coil System is a medical device that is implanted directly into the patient's peripheral vasculature to physically block blood flow (embolization). This is an in vivo procedure, meaning it happens inside the body.
- Intended Use: The intended use clearly states "arterial and venous embolizations in the peripheral vasculature," which is a therapeutic intervention performed within the body.
Therefore, the Prestige Coil System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
KRD
Device Description
The Prestige Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize peripheral 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 anomalies to create blood stasis, reducing flow in the target vasculature, and inducing thrombosis. Upon positioning coils into the vasculature, the coils are thermally detached from the delivery pusher in serial manner until the target vasculature is occluded.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
angiographic visualization
Anatomical Site
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)
Non-clinical bench testing was performed to demonstrate substantial equivalence of the Prestige Coil System to the Predicate device. These tests included Visual and Dimensional Inspection, Simulated Use, Stretch-Resistance Thread Tensile Testing, and Usability Validation, all of which met established acceptance criteria. Evaluations leveraged from the predicate device (K200030) included biocompatibility, shelf life, packaging, gamma sterilization, corrosion, detachment zone tensile, and Magnetic Resonance Imaging Characterization. All these evaluations were deemed still valid for the subject device.
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.
Prestige 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
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(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 § 870.1(e).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.
April 8, 2022
Balt USA, LLC Michael Peters Manager, Regulatory Affairs 29 Parker Irvine, California 92618
Re: K220699
Trade/Device Name: Prestige Coil System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: March 8, 2022 Received: March 10, 2022
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 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
1
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 medical devices and radiation-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,
Finn Donaldson Acting Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220069
Device Name Prestige Coil System
Indications for Use (Describe)
The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K220069 510(k) Summary
| Applicant: | Balt USA, LLC |
|---|---|
| 29 Parker | |
| Irvine, CA 92618 | |
| Registration No.: 3014162263 | |
| Contact Person: | Michael Peters |
| Manager, Regulatory Affairs | |
| Telephone: (949) 788-1443 | |
| Email: michael.peters@baltgroup.com |
| Date Summary
| Prepared: | April 7, 2022 |
|---|---|
| Trade Name: | Prestige Coil System |
| Common Name: | Vascular embolization device |
| Review Panel: | Cardiovascular |
| Product Code: | KRD |
| Regulation Number: | 21 CFR 870.3300 |
| Regulation Name: | Device, Vascular, for Promoting Embolization |
| Device Classification: | Class II |
| Predicate Device: | Prestige Coil System, 510(k)#: K200030 |
| Originally cleared under trade name Optima Coil System |
Device Description:
The Prestige Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize peripheral 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 anomalies to create blood stasis, reducing flow in the target vasculature, and inducing thrombosis. Upon positioning coils into the vasculature, the coils are thermally detached from the delivery pusher in serial manner until the target vasculature is occluded.
Indications for Use:
The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature.
Intended Use:
The Prestige Coil System is intended for use in the peripheral vasculature to endovascularly obstruct or occlude blood flow in vascular abnormalities of the peripheral vessels.
4
Device Comparison:
| | Predicate Device
(K200030) | Prestige Coil System
(Subject Device, K220069) |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | Prestige Coil System is indicated for arterial and venous
embolizations in the peripheral vasculature.
*These Indications for Use for the Prestige Coil System
are a subset of those cleared for the Predicate. |
| 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. | The Prestige Coil System is intended for use in the
peripheral vasculature to endovascularly obstruct or
occlude blood flow in vascular abnormalities of the
peripheral vessels.
*This Intended Use for the Prestige Coil System is a
subset of that cleared for the Predicate. |
| Anatomical Site | Neurovasculature
Peripheral Vasculature | Peripheral Vasculature
*The target anatomy for the Prestige Coil System is a
subset of the cleared anatomy for the Predicate. |
| Delivery to site | Via delivery wire through microcatheter | Same as K200030 |
| System Components | Coil (implant)
Delivery System
Detachment Controller | Same as K200030 |
| Method of Supply | Sterile, single use | Same as K200030 |
| | Coil (Implant) | |
| Main Coil Material | Platinum/Tungsten | Same as K200030 |
| Primary Coil Wind Diameter | 0.010"-0.014" | Same as K200030 |
| Coil Wire Diameter | 0.00125"-0.0035" | Same as K200030 |
| Coil Length | 1-65cm | Same as K200030 |
| Coil Secondary Diameter | 1-24mm | Same as K200030 |
| Number of Sizes Offered | 209 | 267 |
| Secondary Shapes | Complex, Helical | Same as K200030 |
| Coil Types | Framing, Filling, Finishing | Same as K200030 |
5
| | Predicate Device
(K200030) | | Prestige Coil System
(Subject Device, K220069) | |
|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| No. & Size of Helical Loops on
Distalmost End (Complex only) | 1.5 x 70% | | 1.5 x 70%
3 x 70%
3 x 100% | |
| 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"
.012" x .00125"
.014" x .0015"
.014" x .00175"
.014" x .002" | Helical
.012" x .002"
.011" x .0015"
.010" x .00125"
.012" x .00125"
.014" x .0015"
.014" x .00175"
.014" x .002" | 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"
.012" x .00125"
.014" x .0015"
.014" x .00175"
.014" x .002"
.014" x .00275"
.014" x .0025" | Helical
.012" x .002"
.011" x .0015"
.010" x .00125"
.012" x .00125"
.014" x .0015"
.014" x .00175"
.014" x .002" |
| Stretch-resistance thread /
attachment thread | Polyolefin Engage Thread | | Same as K200030 | |
| Coupler/Markerband | Platinum/Iridium Alloy | | Same as K200030 | |
| | Delivery System (Pusher) | | | |
| Construction/Design | Body coil laser welded to hypotube | | Same as K200030 | |
| 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
D. Proximal Coil (SSTL) | | Same as K200030 | |
| Hypotube | SSTL Hypotube | | Same as K200030 | |
| Connector | Gold plated, SSTL Hypotube | | Same as K200030 | |
| Adhesive | Dymax 1128A-M-VT | | Same as K200030 | |
| Jacket | PET | | Same as K200030 | |
| Fluorosafe Markers | Pad Printed PET Shrink Tube | | Same as K200030 | |
| Epoxy | Epoxy 353 ND | | Same as K200030 | |
| Lead Wires | Polyimide coated silver lead wires | | Same as K200030 | |
6
K220069
Page 4 of 5
| | Predicate Device
(K200030) | Prestige Coil System
(Subject Device, K220069) |
|------------|-----------------------------------|---------------------------------------------------|
| Other | | |
| Detachment | Thermal via Detachment Controller | Same as K200030 |
| Pouch | Tyvek® | Same as K200030 |
| Shelf Life | 5 Years | Same as K200030 |
| Method | Gamma Irradiation | Same as K200030 |
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Evaluations Leveraged from Predicate Device
The following non-clinical device assessments were performed in support of the Predicate Device's submission and clearance and have been evaluated as still valid based on the proposed changes to the Subject Prestige Coil System.
| Test | Acceptance Criteria | Results |
|---|---|---|
| Biocompatibility | The samples shall be biocompatible for their intended use based on the requirements of ISO 10993-1. | Pass |
| Shelf Life | The samples shall meet established acceptance criteria based on device specifications after simulated aging and transportation/distribution simulation. | Pass |
| Packaging | The samples shall meet established acceptance criteria for packaging performance. | Pass |
| Gamma Sterilization | The samples shall meet established acceptance criteria for sterility. | Pass |
| Corrosion | The samples shall meet established acceptance criteria for corrosion. | Pass |
| Detachment Zone Tensile | The samples shall meet established acceptance criteria for tensile strength. | Pass |
In addition to the above, the Magnetic Resonance Imaging Characterization undergone by the Predicate device has also been evaluated as still applicable to the Subject device and has not been reperformed.
Performance Data - Bench:
The following non-clinical bench testing was performed to demonstrate substantial equivalence of the Prestige Coil System to the Predicate device:
| Test | Acceptance Criteria | Results |
|---|---|---|
| Visual and | ||
| Dimensional | ||
| Inspection | The samples shall meet established acceptance criteria for visual | |
| physical damage and secondary diameter and length. | Pass | |
| Simulated Use | The samples shall be prepared in accordance with the instructions | |
| for use and meet established acceptance criteria for device | ||
| performance in a clinically relevant model. | Pass | |
| Stretch-Resistance | ||
| Thread Tensile | ||
| Testing | The samples shall meet established acceptance criteria for tensile | |
| strength. | Pass | |
| Usability Validation | The devices shall be prepared in accordance with their respective | |
| instructions for use and meet established acceptance criteria for | ||
| device performance in a clinically relevant model. The labeling | ||
| shall be clear and understandable by the intended user. | Pass |
Conclusion:
There is no change to the risk profile, principles of operations or performance requirements of the Prestige Coil System in comparison to the Predicate Device (K200030). The successful completion of non-clinical bench testing demonstrates that the Prestige Coil System is substantially equivalent to the Predicate Device.