(97 days)
The MicroPlex Coil System (MCS) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
HyperSoft® 3D in the MicroPlex Coil System (MCS) consist of an implant coil made of platinum alloy. The coils are designed in 3D spherical structure in various loop sizes and lengths. The coil is attached to V-Trak™ or V-Trak™ Advanced Delivery Pusher via polyolefin elastomer filament. The Delivery Pusher is a variable stiffness stainless steel hypotube with platinum and stainless steel coils at the distal end. The proximal end of the Delivery Pusher is inserted into a hand held battery powered V-Grip™ Detachment Controller. When the Detachment Controller is activated, the flow of electrical current heats the polyolefin elastomer filament. resulting in detachment of the implant segment.
The provided text describes a 510(k) submission for the MicroPlex Coil System (MCS) – HyperSoft® 3D, which is a neurovascular embolization device. The submission aims to demonstrate substantial equivalence to previously marketed predicate devices (K131948, K153594). The document focuses on performance data from bench testing and biocompatibility assessments rather than a clinical study involving human patients or complex AI algorithms. Therefore, many of the requested details, such as human reader improvement with AI assist, ground truth establishment for training data, and expert adjudication, are not applicable to this type of device submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally "All test samples passed testing" for bench tests and specific results for biocompatibility tests (e.g., "Non-toxic", "No sensitizer response").
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bench Testing | ||
| Visual Inspection | Meets device drawing specifications (PDM-ATP) | All test samples passed testing. |
| Dimensional Measurement | Meets specified secondary wire diameter | All test samples passed testing. |
| Advancement/Retraction Force | Maximum force required to advance and retract coil through microcatheter is within acceptable limits. | All test samples passed testing. |
| Simulated Use | Device performs as intended in a cerebrovascular benchtop model. | All test samples passed testing. |
| Spring Constant | Spring constant force (determination of maximum force to break monofilament) is within acceptable limits. | All test samples passed testing. |
| Biocompatibility (HyperSoft® 3D Implant & Delivery Pusher) | ||
| Cytotoxicity (MEM Elution Test, ISO Cell Culture Agar Overlay) | Non-toxic | Non-toxic |
| Sensitization (Guinea Pig Maximization Test) | No sensitizer response | No sensitizer response |
| Irritation (ISO Intracutaneous Reactivity Evaluation Test) | Non-irritant | Non-irritant |
| Hemocompatibility (Hemolysis) | Non-hemolytic | Non-hemolytic |
| Hemocompatibility (Prothrombin Time Assay - ISO) | No adverse effect on coagulation time | No adverse effect on coagulation time |
| Systemic Toxicity (IV injection, Rabbit Pyrogen Test) | Non-toxic, Non-pyrogenic | Non-toxic, Non-pyrogenic |
| Genetic Toxicology (Bacteria Reverse Mutation Assay) | Negative response for mutagenicity | Negative response for mutagenicity |
| Intramuscular Implantation (7-day, 13-week, 26-week) | Non-irritant | Non-irritant |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document states "All test samples passed testing" for bench tests, implying that the samples tested for each specific bench test (visual inspection, dimensional measurement, advancement/retraction force, simulated use, spring constant) constituted the test set for those attributes. However, the exact number of samples for each test is not specified in the provided text. For biocompatibility, the tests are performed on material samples rather than a "set" of clinical cases.
- Data Provenance: The data is generated from bench testing and biocompatibility studies conducted by the manufacturer, MicroVention, Inc., located in Tustin, California, USA. This is an in-vitro and ex-vivo type of data provenance, not human clinical data. The tests are prospective in the sense that they are specifically designed and performed to evaluate the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the study did not involve human interpretation of clinical data where a "ground truth" would be established by experts. The "ground truth" for the performance tests comes from engineering specifications, material science standards, and established biological safety protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies for resolving discrepancies in expert interpretations (e.g., of medical images). The presented studies are engineering and biological safety tests.
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
This information is not applicable. This submission is for a physical medical device (embolization coils), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or evaluation of AI's effect on human readers was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This submission is for a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for these studies is based on:
- Engineering Specifications: For visual inspection, dimensional measurement, advancement/retraction force, simulated use, and spring constant, the ground truth is adherence to the device's design specifications and functional requirements.
- International Standards (ISO): For biocompatibility tests, the ground truth is defined by the passing criteria outlined in the referenced ISO standards (e.g., ISO 10993-3, -4, -5, -6, -10, -11). These standards represent established scientific consensus on acceptable biological responses.
8. The sample size for the training set
This information is not applicable. This is a submission for a physical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. No training set was used.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 31, 2016
MicroVention, Inc. Ms. Sapna Singh, MS. RAC Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, California 92780
Re: K161452
Trade/Device Name: MicroPlex Coil System (MCS) Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: August 1, 2016 Received: August 2, 2016
Dear Ms. Singh:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J.Hoffmann -A
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K161452
Device Name MicroPlex Coil System (MCS)
Indications for Use (Describe)
The MicroPlex Coil System (MCS) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) SUMMARY
This 510(k) summary for the MicroPlex Coil System (MCS) – HyperSoft® 3D is submitted in accordance with the requirements of 21 CFR 807.87(h) and 807.92 and following the recommendations outlined in FDA Guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], dated 28 July, 2014.
SUBMITTER [807.92(a)(1)]
MicroVention, Inc. 1311 Valencia Avenue Tustin, California U.S.A.
| Telephone: | (714) 247-8162 |
|---|---|
| Fax: | (714) 247-8014 |
| Contact Person: | Sapna Singh |
|---|---|
| Email: | sapna.singh@microvention.com |
| Date Prepared: | May 25, 2016 |
DEVICE [807.92(a)(2)]
| Name of Device: | MicroPlex Coil System (MCS) |
|---|---|
| Common or Usual Name: | MicroPlex Platinum Coils |
| Classification Name: | Neurovascular Embolization Device |
| Product Code: | HCG, KRD |
| Regulatory Class: | Class II |
| Submission Type: | Special 510(K) |
| Regulation Number: | 21 CFR 882.5950 |
| Reviewing Product Branch: | Division of Neurological and Physical Medicine Devices(Office of Device Evaluation, CDRH) |
PREDICATE DEVICE [807.92(a)(3)]
MicroPlex Coil System (MCS) - HyperSoft® 3D (K131948, K153594)
DEVICE DESCRIPTION [807.92(a)(4)]
HyperSoft® 3D in the MicroPlex Coil System (MCS) consist of an implant coil made of platinum alloy.
{4}------------------------------------------------
The coils are designed in 3D spherical structure in various loop sizes and lengths. The coil is attached to V-Trak™ or V-Trak™ Advanced Delivery Pusher via polyolefin elastomer filament. The Delivery Pusher is a variable stiffness stainless steel hypotube with platinum and stainless steel coils at the distal end. The proximal end of the Delivery Pusher is inserted into a hand held battery powered V-Grip™ Detachment Controller. When the Detachment Controller is activated, the flow of electrical current heats the polyolefin elastomer filament. resulting in detachment of the implant segment.
INDICATIONS FOR USE [807.92(a)(5)]
The MicroPlex Coil System (MCS) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS [807.92(a)(6)]
The Table I compares the technological characteristics of the existing HyperSoft® 3D coils (K131948, K153594) with the additional models presented in this 510(k) submission. The devices.
- Have the same intended use ●
- Use the same operating principle ●
- Incorporate the same basic coil design ●
- Use same construction and material
- Are packaged and sterilized using same material and processes .
The line extension of the HyperSoft® 3D coils (includes addition of sizes from 1mm to 6 mm secondary wind diameter with lengths from 6 cm to 20 cm) and change in the Stretch Resistance Member Material from Polyethylene Terephthalate (PET) to PET or Polyolefin Elastomer (Engage™) does not change the indications for use of the coils and is not a change to the fundamental scientific technology.
The performance data below shows the device will perform as well as the previously marketed device.
{5}------------------------------------------------
| Existing HyperSoft® 3D (Predicate Device,(K131948, K153594) | HyperSoft® 3D LineExtension (SubjectDevice | |
|---|---|---|
| Intended Use | ||
| Intended UseStatement | The MicroPlex Coil System (MCS) areintended for the endovascular embolization ofintracranial aneurysms and otherneurovascular abnormalities such asarteriovenous malformations andarteriovenous fistulae. The MCS are alsointended for vascular occlusion of bloodvessels within the neurovascular system topermanently obstruct blood flow to ananeurysm or other vascular malformation andfor arterial and venous embolizations in theperipheral vasculature. | Same |
| Performance | ||
| Function | The coils are used for the endovascularembolization of aneurysms, otherneurovascular abnormalities such asarteriovenous malformations, arteriovenousfistulae and arterial and venous embolizationsin the peripheral neurovasculature. | Same |
| Anatomical Location | General intravascular use, including the neuroand peripheral vasculature. | Same |
| Implantable Embolization Coil | ||
| Coil Shape | 3D - Spherical | Same |
| Primary Coil Wire OD | 0.00125 inch | 0.00125 inch and 0.0015inch |
| Coil Implant Diameter | 1 - 5 mm | 1 - 6 mm |
| Coil Restrained Length | 2 - 15 cm | 6 - 20 cm |
| Coil Gap | Closed | Closed |
| Delivery pusher length | 195 cm | Same |
| Material | ||
| Main Coil Wire | Platinum/Tungsten Alloy (Pt/W: 92/8) | Same |
| Coil-to-Pusher Coupler | Platinum/Iridium (Pt/Ir: 90/10) | Same |
| Adhesive | Ultraviolet Curing Adhesive | Same |
| Implant to PusherFilament | Polyolefin Elastomer | Same |
| Stretch resistant (SR) | Polyethylene Terephthalate (K131948) | PolyethyleneTerephthalate orPolyolefin Elastomer(Engage™) |
| Other Attributes | ||
| Detachment System | Detachment Controller; stand alone, handheld battery operated unit detaches the coilimplant | Same |
| Catheter compatibility | Compatible with 10-system microcatheters(minimum ID of 0.0165") | Same |
| MRI compatibility | Yes | Same |
| Method of Supply | Sterile and single use (e-beam) | Same |
| Package Configuration | Placed in Introducer Sheath, Dispenser Coil,Pouch, and Shipping Carton | Same |
Table I: Predicate Device vs Subject Device Comparison Table
{6}------------------------------------------------
PERFORMANCE DATA [807.92(b)]
Results of the verification and validation testing (Table II) indicate that the product meets established performance requirements, and is substantially equivalent for its intended use.
| Table II: Design Verification and Validation Test Summary | ||
|---|---|---|
| ----------------------------------------------------------- | -- | -- |
| Bench Testing | Result |
|---|---|
| Visual Inspection: Using a microscope, inspect HyperSoft® 3D perdevice drawing, PDM-ATP. | All test samples passed testing. |
| Dimensional Measurement: Using a microscope, inspectHyperSoft® 3D Coil's secondary wire diameter. | All test samples passed testing. |
| Advancement/Retraction Force: The test represents the maximumforce required to advance and retract the coil through themicrocatheter. | All test samples passed testing. |
| Simulated Use: The test simulate the use of HyperSoft® 3D coils in-vitro using a cerebrovascular benchtop model. | All test samples passed testing. |
| Spring Constant: The spring constant force (determination ofmaximum force to break monofilament) of the coil is measured. | All test samples passed testing. |
Biocompatibility Summary – HyperSoft® 3D Implant
| Biocompatibility | Test Standard | Results |
|---|---|---|
| Cytotoxity | ||
| MEM Elution Test | ISO 10993-5 | Non-toxic |
| ISO Cell Culture Agar Overlay | ISO 10993-5 | Non-toxic |
| Sensitization | ||
| Sensitization-Guinea Pig Maximization Test | ISO 10993-10 | No sensitizer response |
| Irritation |
{7}------------------------------------------------
| ISO Intracutaneous Reactivity EvaluationTest | ISO 10993-10 | Non-irritant | ||
|---|---|---|---|---|
| Hemocompatibility | ||||
| Hemolysis | ISO 10993-4 | Non-hemolytic | ||
| Prothrombin Time Assay - ISO | ISO 10993-4 | No adverse effect on coagulation time | ||
| Systemic Toxicity | ||||
| Systemic toxicity(IV injection) | ISO 10993-11 | Non-toxic | ||
| Rabbit Pyrogen Test (material mediated) | ISO 10993-11 | Non-pyrogenic | ||
| Genetic Toxicology | ||||
| Bacteria Reverse Mutation Assay (AmesTest) | ISO 10993-3 | Negative response for mutagenicity | ||
| Intramuscular Implantation | ||||
| 7-day Muscle Implantation | ISO 10993-6 | Non-irritant | ||
| 13-week Intramuscular Implantation Test | ISO 10993-6 | Non-irritant | ||
| 26-week Intramuscular Implantation Test | ISO 10993-6 | Non-irritant |
Biocompatibility Summary – V-Trak™ or V-Trak™ Advanced Delivery Pusher
| Biocompatibility | Test Standard | Results |
|---|---|---|
| Cytotoxity | ||
| MEM Elution Test | ISO 10993-5 | Non-toxic |
| ISO Cell Culture Agar Overlay | ISO 10993-5 | Non-toxic |
| Sensitization | ||
| Sensitization-Guinea Pig Maximization Test | ISO 10993-10 | No sensitizer response |
| Irritation | ||
| ISO Intracutaneous Reactivity EvaluationTest | ISO 10993-10 | Non-irritant |
| Hemocompatibility | ||
| Hemolysis | ISO 10993-4 | Non-hemolytic |
| Prothrombin Time Assay - ISO | ISO 10993-4 | No adverse effect on coagulation time |
| Systemic Toxicity | ||
| Systemic toxicity(IV injection) | ISO 10993-11 | Non-toxic |
| Rabbit Pyrogen Test (material mediated) | ISO 10993-11 | Non-pyrogenic |
{8}------------------------------------------------
CONCLUSIONS
Based on the 510(k) summary and information provided herein, we conclude the subject device, HyperSoft® 3D in the MCS, is substantially equivalent in its intended use, design, material, performance, and the underlying fundamental scientific technology used, to the predicate HyperSoft® 3D, K131948, K153594.
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(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 § 882.1(e).