(173 days)
Not Found
No
The summary describes a physical medical device (vascular plug) and its mechanical and biological performance. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature, which is a therapeutic intervention for a medical condition.
No
The device is an embolization device used to obstruct or reduce blood flow, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components including an implant assembly (gold implant body, silicone valves, platinum marker band, stainless-steel housing) and a delivery system assembly (microcatheter, delivery catheter, RHV, 3-way stopcock). The performance studies also detail bench testing of these physical components.
Based on the provided information, the Solus Gold Embolization Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "obstruct or reduce the rate of blood flow in the peripheral vasculature." This is a therapeutic intervention performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is a vascular plug designed to be implanted in blood vessels. This is consistent with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition or provide information about a patient's health status.
Therefore, the Solus Gold Embolization Device is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Solus Gold Embolization Device is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.
Product codes
KRD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
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 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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mean time to achieve complete (Grade 0 or Grade 1) target vessel segment occlusion by angiography on Day 0: 0.50 minute for Solus Gold Embolization Device, 1.94 minutes for MVP predicate device.
Complete (Grade 0 or Grade 1) target vessel segment occlusion at 90 days: 14/14 for Solus Gold Embolization Device, 2/14 for MVP predicate device.
Mean (maximal) percent vessel lumen occlusion by histology at 90 days: 100% for Solus Gold Embolization Device, 79.6 % for MVP predicate device.
Predicate Device(s)
Reverse Medical Micro Vascular Plug System (K141313)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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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3
510(k) SUMMARY
K213200 510(k) Number:
I. SUBMITTER INFORMATION
| Submitter: | Artio Medical, Inc.
127 Independence Drive
Menlo Park, CA 94025 |
|------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Erdie DePeralta
Vice President, Clinical and Regulatory Affairs
Phone: (978) 408-0949
Email: 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:
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.
4
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 Device
Solus Gold™ Embolization Device | Predicate Device
Reverse 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 in
the peripheral vasculature | Same as subject device |
| Indications for
Use | The Solus Gold Embolization Device is indicated to
obstruct or reduce the rate of blood flow in the
peripheral vasculature. | The Reverse Medical Micro Vascular Plug System
is indicated to obstruct or reduce the rate of
blood flow in the peripheral vasculature. |
| Anatomical Site | Peripheral vasculature | Same as subject device |
| Target Vessel
Diameter | 1.5 - 5.0 mm | 1.5 – 7.0 mm |
| Implant Diameter x
Implant Length
(Expanded or
Unconstrained) | 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 mm
MVP-5: 6.5 mm x 12 mm
MVP-7: 9.2 mm x 16 mm |
| Implant Materials | Gold, platinum/iridium, stainless steel,
silicone, adhesive | Nitinol, platinum, ePTFE |
| Delivery System
Materials of
Construction | 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 neck
implant mating component and distal neck
subassembly, expanded by injection of saline or a
mixture of saline and contrast | Ovoid nitinol frame with an ePTFE cover over
the proximal portion, self-expanding |
| Implant Radiopacity | Entire gold implant body and proximal and distal
platinum/iridium marker bands | Proximal and distal marker bands only |
| Delivery method | Implant comes attached to the delivery catheter
and microcatheter, is delivered over a .014"
guidewire to the intended treatment site,
expanded, and detached from the delivery
catheter and microcatheter. | Implant comes attached to a delivery wire, is
pushed through a commercially available
catheter to the intended treatment site,
expanded, and detached from delivery wire. |
| Catheter
Compatibility | Compatible with commercially available catheters:
All implant sizes: > 0.070" ID catheter (6 Fr) | Compatible with commercially available
catheters:
MVP-3Q: 0.021" - 0.027" ID catheter
MVP-5Q: 0.027" ID catheter
MVP-7Q: 0.041" ID catheter |
| Microcatheter
Maximum Length | 154 cm | 150 cm |
| Delivery System
Maximum Length | Delivery catheter length: 136 cm | Delivery wire length: 160 – 180 cm |
| How Transferred to
Catheter | Attached to delivery system, inserted into
vasculature over a guidewire and through a
compatible commercially available catheter | Attached to delivery wire, inserted into
vasculature through a compatible,
commercially available catheter |
| Attribute | Subject Device
Solus GoldTM Embolization Device | Predicate Device
Reverse Medical Micro Vascular Plug System
(K141313, K150108) |
| Detachment | Mechanical | Same as subject device |
| How Provided | Sterile, single-use | Same as subject device |
| Sterilization
Method | Ethylene oxide | Same as subject device |
5
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
6
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.