(97 days)
Not Found
No
The summary describes a mechanical device for embolization and does not mention any AI or ML components or functions.
Yes.
The device is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, which is a therapeutic intervention.
No
The device is described as an implant system for endovascular embolization and vascular occlusion, which are therapeutic procedures, not diagnostic ones.
No
The device description clearly details physical components including platinum alloy coils, a stainless steel hypotube, and a battery-powered detachment controller, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the endovascular embolization and vascular occlusion of blood vessels within the neurovascular and peripheral vasculature. This is a therapeutic procedure performed in vivo (within the body).
- Device Description: The device description details an implantable coil and a delivery system used to place the coil within blood vessels. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples for diagnostic purposes. This device is used in vivo for therapeutic intervention.
N/A
Intended Use / Indications for Use
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.
Product codes
HCG, KRD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
General intravascular use, including the neuro and 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
Bench Testing:
Visual Inspection: Using a microscope, inspect HyperSoft® 3D per device drawing, PDM-ATP. Result: All test samples passed testing.
Dimensional Measurement: Using a microscope, inspect HyperSoft® 3D Coil's secondary wire diameter. Result: All test samples passed testing.
Advancement/Retraction Force: The test represents the maximum force required to advance and retract the coil through the microcatheter. Result: All test samples passed testing.
Simulated Use: The test simulate the use of HyperSoft® 3D coils in-vitro using a cerebrovascular benchtop model. Result: All test samples passed testing.
Spring Constant: The spring constant force (determination of maximum force to break monofilament) of the coil is measured. Result: All test samples passed testing.
Biocompatibility Summary – HyperSoft® 3D Implant:
Cytotoxity (MEM Elution Test, ISO 10993-5; 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 Evaluation Test, ISO 10993-10): Non-irritant.
Hemocompatibility (Hemolysis, ISO 10993-4; Prothrombin Time Assay - ISO, ISO 10993-4): Non-hemolytic, No adverse effect on coagulation time.
Systemic Toxicity (Systemic toxicity (IV injection), ISO 10993-11; Rabbit Pyrogen Test (material mediated), ISO 10993-11): Non-toxic, Non-pyrogenic.
Genetic Toxicology (Bacteria Reverse Mutation Assay (Ames Test), ISO 10993-3): Negative response for mutagenicity.
Intramuscular Implantation (7-day Muscle Implantation, ISO 10993-6; 13-week Intramuscular Implantation Test, ISO 10993-6; 26-week Intramuscular Implantation Test, ISO 10993-6): Non-irritant for all.
Biocompatibility Summary – V-Trak™ or V-Trak™ Advanced Delivery Pusher:
Cytotoxity (MEM Elution Test, ISO 10993-5; 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 Evaluation Test, ISO 10993-10): Non-irritant.
Hemocompatibility (Hemolysis, ISO 10993-4; Prothrombin Time Assay - ISO, ISO 10993-4): Non-hemolytic, No adverse effect on coagulation time.
Systemic Toxicity (Systemic toxicity (IV injection), ISO 10993-11; Rabbit Pyrogen Test (material mediated), ISO 10993-11): Non-toxic, Non-pyrogenic.
Key Metrics
Not Found
Predicate Device(s)
MicroPlex Coil System (MCS) - HyperSoft® 3D (K131948, K153594)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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) |
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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 Line
Extension (Subject
Device |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Intended Use | | |
| Intended Use
Statement | 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. | Same |
| Performance | | |
| Function | The coils are used for the endovascular
embolization of aneurysms, other
neurovascular abnormalities such as
arteriovenous malformations, arteriovenous
fistulae and arterial and venous embolizations
in the peripheral neurovasculature. | Same |
| Anatomical Location | General intravascular use, including the neuro
and peripheral vasculature. | Same |
| Implantable Embolization Coil | | |
| Coil Shape | 3D - Spherical | Same |
| Primary Coil Wire OD | 0.00125 inch | 0.00125 inch and 0.0015
inch |
| 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 Pusher
Filament | Polyolefin Elastomer | Same |
| Stretch resistant (SR) | Polyethylene Terephthalate (K131948) | Polyethylene
Terephthalate or
Polyolefin Elastomer
(Engage™) |
| Other Attributes | | |
| Detachment System | Detachment Controller; stand alone, hand
held battery operated unit detaches the coil
implant | 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 per | |
| device drawing, PDM-ATP. | All test samples passed testing. |
| Dimensional Measurement: Using a microscope, inspect | |
| HyperSoft® 3D Coil's secondary wire diameter. | All test samples passed testing. |
| Advancement/Retraction Force: The test represents the maximum | |
| force required to advance and retract the coil through the | |
| microcatheter. | 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 of | |
| maximum 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 Evaluation
| Test | 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 (Ames | ||||
| Test) | 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 Evaluation | ||
| Test | 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.