(28 days)
Not Found
No
The documentation does not mention the use of AI, DNN, or ML, and focuses on the physical characteristics and function of embolic coils for vascular embolization.
Yes
The device is described as permanently placed in peripheral vessels "to create blood stasis, reducing flow into the anomaly, and thrombosing the target site," which are therapeutic actions to treat vascular abnormalities.
No
Explanation: The device is an embolic coil system used to obstruct or occlude blood flow, making it a therapeutic device, not a diagnostic one.
No
The device description clearly states "The Prestige Coil System is a product family of embolic coils with associated delivery system components." This indicates the device includes physical hardware components (coils and delivery systems) and is not solely software.
No
The device is an implantable embolic coil system used to obstruct blood flow within peripheral blood vessels, which is an intervention performed on the patient's body, not an in vitro diagnostic test performed on samples outside the body.
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 product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral vascular abnormalities. The devices are to be permanently placed in the peripheral vessels to create blood stasis, reducing flow into the anomaly, and thrombosing the target site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature / peripheral vessels
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 Prestige Coil System (Prestige Packing Coil 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.
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).
FDA 510(k) Clearance Letter for Prestige Coil System
Page 1
May 30, 2025
Balt USA, LLC
Kavita Chandrashekar
Senior Regulatory Affairs Specialist
29 Parker
Irvine, California 92618
Re: K251383
Trade/Device Name: Prestige Coil System (Prestige Packing Line Extension)
Regulation Number: 21 CFR 870.3300
Regulation Name: Vascular Embolization Device
Regulatory Class: Class II
Product Code: KRD
Dated: May 2, 2025
Received: May 2, 2025
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.
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K251383 - Kavita Chandrashekar Page 2
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" (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 QS 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 (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-reporting-combination-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 Rule"). 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-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K251383 - Kavita Chandrashekar Page 3
assistance/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,
SEVAN R. OUNGOULIAN -S Digitally signed by SEVAN R. OUNGOULIAN -S
Date: 2025.05.30 16:31:42 -04'00'
For:
Misti L. Malone, PhD
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K251383
Device Name
Prestige Coil System (Prestige Packing Coil Line Extension)
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)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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:
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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
510(k) Summary
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: 05/28/2025
Trade Name: Prestige Coil System (Prestige Packing Coil Line Extension)
Common Name: Vascular embolization device
Review Panel: Cardiovascular
Product Code: KRD
Regulation Number: 21 CFR 870.3300 – Vascular Embolization Device (KRD)
Regulation Name: Device, Vascular, for Promoting Embolization
Device Classification: Class II
Predicate Device: Prestige Coil System, 510(k): K220699
Device Description:
The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral vascular abnormalities. The devices are to be permanently placed in the peripheral vessels to create blood stasis, reducing flow into the anomaly, and thrombosing the target site.
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.
K251383
Page 1 of 4
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K251383
Page 2 of 4
Comparison of Technological Characteristics:
Table 1: Device Comparison
| Category | Prestige Coil System (predicate device K220699) | Modified Prestige Coil System (Prestige Packing Coil Line Extension, subject device) |
|---|---|---|
| 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. | Same |
| Indications for Use | The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature. | Same |
| Risk Class | Class II | Same |
| Regulation Name | Device, Vascular for promoting Embolization | Same |
| Generic Name | Vascular Embolization Device | Same |
| Anatomical Location | 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 |
| Shelf-Life | 5 years | Same |
| Coil (Implant features) | ||
| Main Coil Material | 92/8 Platinum/Tungsten (Pt/W) Alloy | Same |
| Coil Length | 1 cm – 65 cm | 10 cm – 65 cm |
| Primary Coil Wind Diameter | 0.010" – 0.014" | 0.014" |
| Coil Secondary Shape Diameter | 1 mm – 24 mm | 2 mm |
| Coil Wire Diameter | 0.00125" – .003" | .0015" – .002" |
| Secondary Shapes | Complex, Helical | Helical |
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K251383
Page 3 of 4
| Category | Prestige Coil System (predicate device K220699) | Modified Prestige Coil System (Prestige Packing Coil Line Extension, subject device) |
|---|---|---|
| Coupler | 90/10 Platinum/Iridium (Pt/I) alloy Markerband | Same |
| Primary Wind & Filar Combinations | .010" x .00125" - .014" x .0035" | No new combinations |
| Delivery System | ||
| Construction / Design | Body coil laser welded to hypotube | 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 |
| Bonding Adhesive | Dymax 1128A-M-VT | Same |
| Jacket | Polyethylene Terephthalate | Same |
| Solder | Gold solder | Same |
| Detachment Controller | ||
| Detachment Controller | Ultra Detachment Controller (thermal) | Same |
Page 8
K251383
Page 4 of 4
The modified Prestige Coil System (Prestige Packing Coil Line Extension) and the predicate Prestige Coil System differ in the following:
- Implementation of an updated implant design that will grab and anchor into the previously packed coil. This update will also reduce resistance and improve the navigability of the coil system through tortuous or narrow vessels.
- Implementation of a more robust pusher that will improve the navigability of the coil system through tortuous or narrow vessels by increasing the overall strength and stiffness of the device. This update will also improve the visibility of the pusher during deployment.
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 Prestige Coil System (Prestige Packing Coil 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 Prestige Coil System (Prestige Packing Coil Line Extension) in comparison to the predicate device (K220699). The successful completion of non-clinical bench testing and user validation demonstrates that the modified Prestige Coil System (Prestige Packing Coil Line Extension) is substantially equivalent to the predicate device.