The Solus Gold Embolization Device is a vascular plug device intended to obstruct or reduce the rate of blood flow in the peripheral vasculature. It is comprised of an implant assembly and a delivery system assembly. The delivery system assembly is comprised of a microcatheter and a delivery catheter. A rotating hemostatic valve (RHV) and a 3-way stopcock is provided on the hub of the delivery catheter for injecting fluid to facilitate expansion of the implant. The Solus Gold implant is available in 3 mm – 6 mm diameters. All implant sizes are provided with the same delivery system, and the physician selects the device size based on the treatment plan. The Solus Gold implant assembly consists of a gold implant body, a distal neck subassembly, and an implant mating component. The proximal end of the implant is joined to the delivery catheter through the implant , which is a platinum tubular segment secured to the inside of the gold implant body with adhesive. The distal neck subassembly is comprised of two stacked silicone valves and a platinum (Pt) marker band that are contained within a stainless-steel housing and bonded to the implant with adhesive. The distal neck subassembly of the implant is mounted to the microcatheter over a preparation tool, which is removed by the user after device preparation. The implant is pleated and folded, loaded onto the delivery catheter and microcatheter, and protected with a sheath. The device is provided sterile and is intended for single use only.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the Solus Gold Embolization Device:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary doesn't explicitly present acceptance criteria in a structured table with performance against each. However, we can infer the criteria and reported performance from the various performance data sections.

Acceptance Criteria (Inferred)	Reported Device Performance
Sterilization: Sterility Assurance Level (SAL)	Validated to provide a SAL of 10^-6 according to ANSI / AAMI /ISO 11135.
Packaging & Shelf-Life: Pouch Seal Strength	Demonstrated at T=0 and accelerated aging T=6 months.
Packaging & Shelf-Life: Packaging Integrity	Demonstrated at T=0 and accelerated aging T=6 months.
Packaging & Shelf-Life: Unique Device Identification Barcode Quality	Demonstrated at T=0 and accelerated aging T=6 months.
Packaging & Shelf-Life: Microbial Barrier	Demonstrated at T=0 and accelerated aging T=6 months.
Packaging & Shelf-Life: Product Integrity Following Transit	Demonstrated at T=0.
Packaging & Shelf-Life: Device Condition after Transit	Demonstrated at T=0.
Packaging & Shelf-Life: Device performs as intended throughout labeled shelf-life	Accelerated aged samples demonstrated the device performs as intended throughout its labeled shelf-life.
Biocompatibility: Meet ISO 10993-1 and FDA Guidance Standards	Biological risks addressed by appropriate testing, chemical characterization, literature review, or a combination. The device is categorized for long-term contact with circulating blood (implant) and limited contact with blood (delivery system).
Bench Performance (Implant): Tensile Strength	Performed (no specific values provided, but confirmed to meet product specifications).
Bench Performance (Implant): Expansion Rate/Characteristics	Performed (no specific values provided, but confirmed to meet product specifications).
Bench Performance (Implant): Maximum Pressure	Performed (no specific values provided, but confirmed to meet product specifications).
Bench Performance (Implant): Distal Neck Sub-assembly Flow	Performed (no specific values provided, but confirmed to meet product specifications).
Bench Performance (Implant): Dimensions	Performed (no specific values provided, but confirmed to meet product specifications).
Bench Performance (Implant): Corrosion Resistance	Performed (no specific values provided, but confirmed to meet product specifications).
Bench Performance (Implant): MR Compatibility	Performed (no specific values provided, but confirmed to meet product specifications).
Bench Performance (Delivery System): Microcatheter Distal Flexibility	Performed (no specific values provided, but confirmed to meet product specifications).
Bench Performance (Delivery System): Microcatheter/Delivery Catheter Liquid Leak/Burst	Performed (no specific values provided, but confirmed to meet product specifications).
Bench Performance (Delivery System): Catheter Air Leak	Performed (no specific values provided, but confirmed to meet product specifications).
Bench Performance (Delivery System): Catheter Kink Resistance	Performed (no specific values provided, but confirmed to meet product specifications).
Bench Performance (Delivery System): Catheter Torque Durability	Performed (no specific values provided, but confirmed to meet product specifications).
Bench Performance (Delivery System): Catheter Tensile Force	Performed (no specific values provided, but confirmed to meet product specifications).
Bench Performance (Delivery System): Inadvertent Implant Detachment	Performed (no specific values provided, but confirmed to meet product specifications).
Bench Performance (Delivery System): Luer Hub Compatibility	Performed (no specific values provided, but confirmed to meet product specifications).
Bench Performance (Delivery System): Coating Integrity	Performed (no specific values provided, but confirmed to meet product specifications).
Bench Performance (Delivery System): Catheter Corrosion Resistance	Performed (no specific values provided, but confirmed to meet product specifications).
Bench Performance (Complete Device): Simulated Use Testing	Performed (no specific values provided, but confirmed to meet product specifications).
Bench Performance (Complete Device): Microcatheter Retraction Tensile Force	Performed (no specific values provided, but confirmed to meet product specifications).
Bench Performance (Complete Device): Implant Detachment Tensile Force	Performed (no specific values provided, but confirmed to meet product specifications).
Bench Performance (Complete Device): Particulate	Performed (no specific values provided, but confirmed to meet product specifications).
Human Factors: Proper use of device, safe in intended environment, no new risks	Evaluated by 15 users. Demonstrated proper use, risks acceptable, no new risks identified.
Animal Study (Acute Embolization Effectiveness): Time to achieve complete target vessel occlusion	Mean time to complete (Grade 0 or 1) occlusion: 0.50 minute for Solus Gold (compared to 1.94 minutes for predicate).
Animal Study (Chronic Embolization Effectiveness/Durability): Complete target vessel occlusion at 90 days	14/14 occurrences for Solus Gold (compared to 2/14 for predicate).
Animal Study (Chronic Embolization Effectiveness/Durability): Morphometric percent vessel lumen occlusion at 90 days	Mean (maximal) percent vessel lumen occlusion: 100% for Solus Gold (compared to 79.6% for predicate).
Animal Study (Safety): No complications	No complications observed for the Solus Gold Embolization Device.

2. Sample Sizes Used for the Test Set and Data Provenance

Sterilization Validation: Not specified, but validated to ISO 11135.
Packaging & Shelf-Life Validation: Samples tested at T=0 and accelerated aging T=6 months. Specific numerical sample sizes are not provided.
Biocompatibility: No specific sample size as it involves testing, chemical characterization, and literature review.
Bench Performance Testing: Not specified, but "bench testing" was performed.
Human Factors Assessment: 15 intended users evaluated the device. The data provenance is a simulated clinical setting.
Pre-Clinical Animal Performance Testing: Seven (7) canine subjects underwent treatment procedures. Data provenance is a prospective animal study model (canine), conducted under Good Laboratory Practice (GLP) controls, specifically 21 CFR §58, and complied with relevant guidance documents. The study was conducted by Artio Medical, Inc., likely in the US given the FDA submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Human Factors Assessment: No "experts" established ground truth in the traditional sense. The ground truth (device usability and safety) was assessed through observation of 15 intended users during simulated use and their knowledge assessments.
Pre-Clinical Animal Performance Testing: The ground truth for acute and chronic embolization effectiveness, as well as safety, was established by the study investigators through:
- Angiography (Day 0 and Day 28 ± 3 days)
- Histology (morphometric percent vessel lumen occlusion on Day 90)
- Observation for complications.
  The specific qualifications of these investigators are not detailed beyond operating under GLP controls and adhering to specific guidance documents for animal studies for cardiovascular devices.

4. Adjudication Method for the Test Set

Human Factors Assessment: Adjudication method isn't explicitly stated but appears to be based on direct observation of user performance and knowledge assessments, with results compiled and analyzed by the study observers/team.
Pre-Clinical Animal Performance Testing: Adjudication for angiographic and histological measurements is not explicitly described (e.g., blinded reads by multiple independent experts). However, the study being conducted under GLP controls implies a structured approach to data collection and reporting.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done.
This device is a physical medical device (embolization device), not an Artificial Intelligence (AI) software/algorithm. Therefore, the concept of human readers improving with AI assistance is not applicable. The comparison was between the subject device and a predicate physical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Human Factors Assessment: The ground truth was primarily user performance observation and knowledge assessments related to device usability and safety in a simulated environment.
Pre-Clinical Animal Performance Testing: The ground truth was based on:
- Angiographic assessments (time to occlusion, degree of occlusion).
- Histology (morphometric percent vessel lumen occlusion).
- Clinical observation of the animals for safety and complications.
  This can be categorized as a type of outcomes data (short-term and chronic biological/physiological outcomes) from an animal model.

8. The Sample Size for the Training Set

Not applicable. This summary does not describe any machine learning or AI components that would require a "training set." The data presented is for device verification and validation of a physical medical device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no described training set for an AI/ML algorithm, this question is irrelevant to the provided document.

Summary

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March 21, 2022

Artio Medical, Inc. Erdie Peralta Vice-President, Clinical And Regulatory Affairs 127 Independence Drive Menlo Park, California 94025

Re: K213200

Trade/Device Name: Solus Gold Embolization Device Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: February 14, 2022 Received: February 15, 2022

Dear Erdie Peralta:

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

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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 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 (OS) 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 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).

Sincerely,

Misti 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

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Indications for Use

510(k) Number (if known) K213200

Device Name Solus Gold Embolization Device

Indications for Use (Describe)

The Solus Gold Embolization Device is indicated to obstruct or reduce the rate of blood flow 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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510(k) SUMMARY

K213200 510(k) Number:

I. SUBMITTER INFORMATION

Submitter:	Artio Medical, Inc.127 Independence DriveMenlo Park, CA 94025
Contact:	Erdie DePeraltaVice President, Clinical and Regulatory AffairsPhone: (978) 408-0949Email: edeperalta@artiomedical.com

March 18, 2021 Date Summary Prepared:

II. SUBJECT DEVICE INFORMATION

Device Trade Name:	Solus Gold™ Embolization Device
Common Name:	Device, Vascular, For Promoting Embolization
Classification Name:	Vascular Embolization Device
Regulation Number:	21 CFR §870.3300
Regulatory Class:	II
Product Code:	KRD
Submission Type:	Traditional 510(k)

III. PREDICATE DEVICE INFORMATION:

Predicate Device: Reverse Medical Micro Vascular Plug System (K141313)

IV. DEVICE DESCRIPTION:

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V. INDICATIONS FOR USE

The Solus Gold Embolization Device is indicated to obstruct or rete of blood flow in the peripheral vasculature.

VI. COMPARISON OF INTENDED USE, INDICATIONS FOR USE, AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Attribute	Subject DeviceSolus Gold™ Embolization Device	Predicate DeviceReverse Medical Micro Vascular Plug System(K141313, K150108)
Product Code	KRD	Same as subject device
Regulation No.	21 CFR §870.3300	Same as subject device
Regulation Name	Vascular embolization device	Same as subject device
Intended Use	To obstruct or reduce the rate of blood flow inthe peripheral vasculature	Same as subject device
Indications forUse	The Solus Gold Embolization Device is indicated toobstruct or reduce the rate of blood flow in theperipheral vasculature.	The Reverse Medical Micro Vascular Plug Systemis indicated to obstruct or reduce the rate ofblood flow in the peripheral vasculature.
Anatomical Site	Peripheral vasculature	Same as subject device
Target VesselDiameter	1.5 - 5.0 mm	1.5 – 7.0 mm
Implant Diameter xImplant Length(Expanded orUnconstrained)	3 mm x 6.7 mm, 3.5 mm x 7.6 mm,4 mm x 8.4 mm, 4.5 mm x 9.3 mm,5 mm x 10.2 mm, 5.5 mm x 11.1 mm,6 mm x 11.9 mm	MVP-3: 5.3 mm x 12 mmMVP-5: 6.5 mm x 12 mmMVP-7: 9.2 mm x 16 mm
Implant Materials	Gold, platinum/iridium, stainless steel,silicone, adhesive	Nitinol, platinum, ePTFE
Delivery SystemMaterials ofConstruction	PTFE, PEBA, polyurethane, nylon, nitinol, stainless-steel, platinum/iridium, liquid crystal polymer(LCP), adhesive, polyolefin, hydrophilic coating	Stainless steel, solder, polypropylene,urethane, cyanoacrylate
Implant Description	Ovoid gold implant body with proximal neckimplant mating component and distal necksubassembly, expanded by injection of saline or amixture of saline and contrast	Ovoid nitinol frame with an ePTFE cover overthe proximal portion, self-expanding
Implant Radiopacity	Entire gold implant body and proximal and distalplatinum/iridium marker bands	Proximal and distal marker bands only
Delivery method	Implant comes attached to the delivery catheterand microcatheter, is delivered over a .014"guidewire to the intended treatment site,expanded, and detached from the deliverycatheter and microcatheter.	Implant comes attached to a delivery wire, ispushed through a commercially availablecatheter to the intended treatment site,expanded, and detached from delivery wire.
CatheterCompatibility	Compatible with commercially available catheters:All implant sizes: > 0.070" ID catheter (6 Fr)	Compatible with commercially availablecatheters:MVP-3Q: 0.021" - 0.027" ID catheterMVP-5Q: 0.027" ID catheterMVP-7Q: 0.041" ID catheter
MicrocatheterMaximum Length	154 cm	150 cm
Delivery SystemMaximum Length	Delivery catheter length: 136 cm	Delivery wire length: 160 – 180 cm
How Transferred toCatheter	Attached to delivery system, inserted intovasculature over a guidewire and through acompatible commercially available catheter	Attached to delivery wire, inserted intovasculature through a compatible,commercially available catheter
Attribute	Subject DeviceSolus GoldTM Embolization Device	Predicate DeviceReverse Medical Micro Vascular Plug System(K141313, K150108)
Detachment	Mechanical	Same as subject device
How Provided	Sterile, single-use	Same as subject device
SterilizationMethod	Ethylene oxide	Same as subject device

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VII. PERFORMANCE DATA

Sterilization Validation:

Sterilization conditions were validated according to ANSI / AAMI /ISO 11135, Sterilization of health care products — Ethylene oxide — Requirements for development, validation and routine control of a sterilization process for medical devices to provide a Sterility Assurance Level (SAL) of 10-6.

Packaging & Shelf-Life Validation:

Packaging Validation for the Solus Gold Embolization Device included: Pouch Seal Strength, Packaging Integrity, Unique Device Identification Barcode Quality, and Microbial Barrier testing was conducted at both the T=0 timepoint and the accelerated aging timepoint at T=6 months. Product Integrity Following Transit and Device Condition after Transit was done at T=0. Additionally, the performance testing results of the accelerated aged samples demonstrated that the device performs as intended throughout its labeled shelf-life.

Biocompatibility:

The biological evaluation for the Solus Gold Embolization Device was conducted in accordance with the FDA recognized consensus standard (ANSI/AAMI/ISO 10993-1) "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" and FDA's applicable guidance document, "Use of International Standard ISO 10993" issued September 2020. The implant of the Solus Gold Embolization Device is categorized as "Long Term Contact with Circulating Blood." The non-implantable delivery system, including the microcatheter and delivery catheter, is categorized as "Externally Communicating Device in Limited Contact with Blood." Pursuant to ISO 10993-1 and the 2020 FDA Guidance, biological risks were addressed by: appropriate testing, a chemical characterization assessment, a literature review or a combination of these approaches.

Bench Performance Testing:

Pursuant to the Class II Special Controls Guidance Document: Vascular Embolization Devices (issued December 29, 2004), bench testing of the Solus Gold Embolization Device was performed. Bench testing of the Solus Gold Embolization implant included: 1) implant tensile; 3) implant tensile; 3) implant expansion; 4) implant maximum pressure; 5) distal neck sub-assembly flow; 6) implant dimensions; 7) corrosion resistance; and 8) MR compatibility. Delivery catheter and microcatheter verification testing included: 1) microcatheter distal flexibility; 2) microcatheter liquid leak under pressure and delivery catheter liquid leak and burst; 3) catheter air leak under vacuum; 4) catheter kink resistance; 5) catheter torque durability; 6) catheter tensile force; 7) inadvertent implant detachment; 8) luer hub compatibility; 10) coating integrity; and 11) catheter corrosion resistance. Additionally, verification testing of the complete Solus Gold Embolization Device included: 1) simulated use testing; 2) microcatheter retraction tensile force; 3) implant detachment tensile force; and 4) particulate. These bench performance studies confirm that the device performed as intended per the

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product specifications and also demonstrated that the Solus Gold Embolization Device is substantially equivalent to the MVP predicate device.

Human Factors Assessment:

The Solus Gold Embolization Device was evaluated by fifteen (15) intended users in a simulated clinical setting. This testing was conducted pursuant to the applicable requirements of FDA's Guidance Document titled "Applying Human Factors and Usability Engineering to Medical Devices (issued February 3, 2016)." For this evaluation, the users were trained by Artio personnel. After a decay period of at least 1 hour post training, users were provided with a Solus Gold Embolization Device and the proposed instructions for use. Critical tasks were assessed through observation during simulated use and through user knowledge assessments about the device's labeling and procedure steps that were not amendable to simulated use testing. Additionally, the test subjects completed a survey. The human factors assessment demonstrated that the device labeling and training provided to the intended users allowed for the proper use of the Solus Gold Embolization Device in its intended use environment. Further, this assessment confirmed that all identified risks were considered acceptable and that no new risks were identified.

Pre-Clinical Animal Performance Testing

The Solus Gold Embolization Device and the MVP predicate device were evaluated in a chronic 90-day canine animal study model. Specifically, safety, effectiveness, in vivo performance and handling were conducted to assess device performance with the design requirements and product specification. Additionally, in vivo thrombosis testing (thrombogenicity) was conducted as part of the GLP animal study. The study was conducted under Good Laboratory Practice (GLP) controls pursuant to 21 CFR §58. The study complied with the requirements of Vascular and Neurovascular Embolization Devices - Class II Special Controls Guidance Document for Industry and FDA Staff (Dec. 2004), EN ISO 10993-4:2017 Biological Evaluation of Medical Devices Part 4: Selection of Test for Interactions with Blood and FDA General Considerations for Animal Studies for Cardiovascular Devices – Guidance for Industry and FDA Staff (July 2010). A total of seven (7) canine underwent treatment procedures with the Solus Gold Embolization Device and/or the MVP predicate device (Day 0). One Solus Gold Embolization Device (2.5 mm to 6.0 mm with 0.5 mm increments) or the MVP predicate device (MVP-3Q, MVP-5Q, MVP-7Q devices) was placed per treated artery (internal thoracic artery, renal artery, external iliac artery, and splenic artery. Follow-up angiography occurred on Day 28 ± 3 days after the treatment procedure. Terminal procedures took place on Day 90 ± 7 days. Acute embolization effectiveness was assessed by the time to achieve complete (Grade 0 or Grade 1) target vessel segment occlusion by angiography on Day 0. Chronic embolization effectiveness (durability) was assessed by target vessel segment occlusion by angiography (Grade 0 – 4) and morphometric percent vessel lumen occlusion by histology on Day 90.

The mean time to achieve complete (Grade 0 or Grade 1) target vessel segment occlusion by angiography on Day 0 was .50 minute for the Solus Gold Embolization Device and 1.94 minutes for the MVP predicate device. Complete (Grade 0 or Grade 1) target vessel segment occlusion was observed at 90 days were 14/14 for the Solus Gold Embolization Device and 2/14 for the MVP predicate device. Mean (maximal) percent vessel lumen occlusion by histology at 90 days was 100% for the Solus Gold Embolization Device and 79.6 % for the MVP predicate device. No complications were observed for either the Solus Gold Embolization Device or the MVP predicate device.

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VIII. CONCLUSION

Information in this 510(k) submission demonstrate that the Solus Gold Embolization Device is substantially equivalent to the MVP predicate device. Substantial equivalence is based on comparative bench and animal testing, a comparison of the component materials and comparison of the technological characteristics of the Solus Gold Embolization Device and the MVP predicate device. The Solus Gold Embolization Device is substantially equivalent in its intended use, indications for use, and performance to the MVP predicate device. The differences between the Solus Gold Embolization Device and the MVP predicate device do not raise any new or different questions related to the device safety or effectiveness. Therefore, the Solus Gold Embolization Device is substantially equivalent to the MVP 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).