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.

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.

AI/ML Overview

The provided FDA 510(k) Clearance Letter for the Prestige Coil System (Prestige Packing Coil Line Extension) does not describe a study involving an AI/Machine Learning device, human readers, or image interpretation. Instead, it describes a vascular embolization device and its mechanical and physical performance testing.

Therefore, many of the requested points in your prompt are not applicable to this document, as they relate to studies of AI performance or human reader studies in diagnostic imaging, which is not the subject of this 510(k) clearance.

However, I can extract the relevant information from the provided text regarding the device's acceptance criteria and the performance testing conducted.

Here's the breakdown based on the provided document:

Device: Prestige Coil System (Prestige Packing Coil Line Extension)

Type: Vascular Embolization Device (mechanical medical device)
Purpose: Arterial and venous embolizations in the peripheral vasculature.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
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 (All tested samples met the established acceptance criteria.)
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 (All tested samples met the established acceptance criteria for device performance in a clinically relevant model.)

2. Sample size used for the test set and the data provenance

Sample Size: The document repeatedly mentions "test samples" but does not specify the exact number of samples used for each test (Visual Inspection, Dimensional Inspection, Resistance Check, and Simulated Use).
Data Provenance: Not applicable in the context of clinical data. This refers to bench testing involving physical device samples. No specific country of origin or retrospective/prospective data collection is mentioned as this relates to device manufacturing and testing, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. "Ground truth" in this context refers to the defined engineering specifications and performance characteristics of the device. These are established through design controls, manufacturing standards, and engineering principles, not through expert consensus on medical image interpretation. The "experts" would be engineers and quality control personnel involved in the device's design and testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. This is a concept related to consensus building among human readers (e.g., radiologists) for establishing ground truth in image-based studies. For physical device bench testing, the "adjudication" is based on objective measurements against pre-defined engineering specifications and Pass/Fail criteria. No multi-reader adjudication method applies here.

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. This document describes a vascular embolization device, not an AI/Machine Learning diagnostic device. Therefore, no MRMC study or AI assistance was involved.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a mechanical device, not an algorithm. Standalone performance refers to the device's inherent functional capabilities as demonstrated in the bench tests, which are independent of a human operator's actions beyond following the instructions for use during the test.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance testing is based on pre-established engineering specifications, design requirements, and manufacturing tolerances for the physical device. The device passes if its measured physical and functional characteristics meet these objective, pre-defined criteria. There is no biological "ground truth" (like pathology or outcomes data) in this specific submission, as it focuses on demonstrating the substantial equivalence of a modified mechanical device through bench testing.

8. The sample size for the training set

Not Applicable. This applies to AI/Machine Learning models, not physical medical devices undergoing bench testing. The device itself is not "trained."

9. How the ground truth for the training set was established

Not Applicable. As above, this applies to AI/Machine Learning models.

Summary

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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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 SystemDetachment 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

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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.

Regulation Number and Section

§ 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).