(29 days)
The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature.
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.
The provided text is a 510(k) summary for the Prestige Coil System, a vascular embolization device, which explicitly states that it is not an AI/ML powered device. Therefore, it does not involve any of the AI/ML related concepts you asked about, such as training sets, test sets, ground truth establishment, MRMC comparative effectiveness studies, or AI performance metrics.
However, I can still extract the acceptance criteria and information about the studies performed for this non-AI medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Performance |
|---|---|---|
| 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 |
| 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 |
2. Sample size used for the test set and the data provenance
As this is a non-AI/ML device, the concept of a "test set" in the context of AI does not directly apply. The studies mentioned are bench tests and non-clinical device assessments. Specific sample sizes for each test are not provided in this summary. The data provenance is from non-clinical bench testing performed by the manufacturer (Balt USA, LLC) to demonstrate substantial equivalence to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is not an AI/ML device and does not involve establishing ground truth through expert review for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not an AI/ML device and does not involve adjudication of expert assessments for a test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable, as this is not an AI/ML device and does not involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is not an AI/ML device and does not have an algorithm to be evaluated in standalone mode.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as this is not an AI/ML device. The "ground truth" for the device's performance in these non-clinical tests is based on pre-defined acceptance criteria derived from device specifications and recognized standards (e.g., ISO 10993-1).
8. The sample size for the training set
Not applicable, as this is not an AI/ML device and therefore no training set was used.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device and therefore no training set was used or ground truth established for it.
{0}------------------------------------------------
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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 SummaryPrepared: | 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)#: K200030Originally 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 endovascularembolization of intracranial aneurysms and other neurovascularabnormalities such as arteriovenous malformations andarteriovenous fistulae. The Optima Coil System is also intended forvascular occlusion of blood vessels within the neurovascular systemto permanently obstruct blood flow to an aneurysm or other vascularmalformation and for arterial and venous embolizations in theperipheral vasculature. | Prestige Coil System is indicated for arterial and venousembolizations in the peripheral vasculature.*These Indications for Use for the Prestige Coil Systemare a subset of those cleared for the Predicate. |
| Intended Use | The Optima Coil System is intended for use in the peripheral andneuro-vasculature to endovascularly obstruct or occlude blood flowin vascular abnormalities of the neurovascular and peripheralvessels. | The Prestige Coil System is intended for use in theperipheral vasculature to endovascularly obstruct orocclude blood flow in vascular abnormalities of theperipheral vessels.*This Intended Use for the Prestige Coil System is asubset of that cleared for the Predicate. |
| Anatomical Site | NeurovasculaturePeripheral Vasculature | Peripheral Vasculature*The target anatomy for the Prestige Coil System is asubset of the cleared anatomy for the Predicate. |
| Delivery to site | Via delivery wire through microcatheter | Same as K200030 |
| System Components | Coil (implant)Delivery SystemDetachment 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 onDistalmost End (Complex only) | 1.5 x 70% | 1.5 x 70%3 x 70%3 x 100% | ||
| Primary Wind (Coil OD) xFilar (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) CoilD. 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 |
{7}------------------------------------------------
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 andDimensionalInspection | The samples shall meet established acceptance criteria for visualphysical damage and secondary diameter and length. | Pass |
| Simulated Use | The samples shall be prepared in accordance with the instructionsfor use and meet established acceptance criteria for deviceperformance in a clinically relevant model. | Pass |
| Stretch-ResistanceThread TensileTesting | The samples shall meet established acceptance criteria for tensilestrength. | Pass |
| Usability Validation | The devices shall be prepared in accordance with their respectiveinstructions for use and meet established acceptance criteria fordevice performance in a clinically relevant model. The labelingshall 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.
§ 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).