(62 days)
Not Found
No
The document describes a hand-held, battery-operated device for detaching coils. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The predicate device is also a detachment controller, suggesting a similar, non-AI/ML technology.
Yes
The V-Grip Plus is described as an accessory to the MicroPlex Coil System and HydroCoil Embolization System, which are intended for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities to permanently obstruct blood flow. This direct involvement in treating a medical condition makes it a therapeutic device.
No
The V-Grip Plus Detachment Controller is used to detach embolization coils after they have been delivered to the treatment site. Its purpose is to facilitate the therapeutic embolization procedure, not to diagnose a condition.
No
The device description explicitly states it is a "hand held, battery operated device" and mentions "Electrical output verification," "Functional testing," "Electrical safety testing," and "Electromagnetic compatibility testing" in the performance studies, indicating it is a hardware device with embedded software.
Based on the provided information, the V-Grip Plus Detachment Controller is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- V-Grip Plus Function: The V-Grip Plus is a device used to detach coils within the patient's body during an endovascular procedure. It is an accessory to the coils themselves, which are implanted devices.
- Intended Use: The intended use clearly describes its role in detaching coils used for embolization of vascular abnormalities within the neurovascular and peripheral vasculature. This is an in vivo (within the living body) procedure, not an in vitro (in glass/outside the body) test.
The device description and intended use clearly indicate that the V-Grip Plus is a surgical accessory used during an interventional procedure on a living patient.
N/A
Intended Use / Indications for Use
The V-Grip Plus Detachment Controller is used to detach the MicroVention MicroPlex Coil System and the HydroCoil Embolization System. As an accessory to the coils, the indications for use for the Detachment Controller remain the same as the coils and is as follows:
The MicroPlex Coil System and Hydrocoil Embolization System are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, The MCS and HES 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 (comma separated list FDA assigned to the subject device)
HCG
Device Description
The V-Grip Plus Detachment Controller is a hand held, battery operated device designed specifically to detach the MicroVention MicroPlex and HydroCoil family of coils. When the coil is delivered to the treatment site, the proximal end of the delivery pusher (of coil) is inserted into the Detachment Controller. When the Detachment Controller is activated, coil detachment occurs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, neurovascular system, 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)
Bench Testing:
- Electrical output verification: Met established criteria
- Functional testing: Met established criteria
- Detachment testing: Met established criteria
- Software validation: Met established criteria
- Electrical safety testing: Met established criteria
- Electromagnetic compatibility testing: Met established criteria
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K090001
1/2
510(k) Summary
.
MAR - 5 2009
| Trade Name: | V-Grip Plus Detachment Controller |
|---|---|
| Generic Name: | Neurovascular Embolization Device, accessory |
| Classification: | Class II, 21 CFR 882.5950 |
| Submitted By: | MicroVention, Inc |
| 75 Columbia | |
| Aliso Viejo, California U.S.A. | |
| Contact: | Naomi Gong |
Predicate Device:
| Number | Description | Clearance Date |
|---|---|---|
| K050954 | MicroPlex Coil and HydroCoil | |
| Embolization System (V-Grip | ||
| Detachment Controller) | June 28, 2005 |
Device Description
The V-Grip Plus Detachment Controller is a hand held, battery operated device designed specifically to detach the MicroVention MicroPlex and HydroCoil family of coils. When the coil is delivered to the treatment site, the proximal end of the delivery pusher (of coil) is inserted into the Detachment Controller. When the Detachment Controller is activated, coil detachment occurs.
1
Indication For Use
The V-Grip Plus Detachment Controller is used to detach the MicroVention MicroPlex Coil System and the HydroCoil Embolization System. As an accessory to the coils, the indications for use for the Detachment Controller remain the same as the coils and is as follows:
The MicroPlex Coil System and Hydrocoil Embolization System are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, The MCS and HES 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.
| Bench Testing | Result |
|---|---|
| Electrical output verification | Met established criteria |
| Functional testing | Met established criteria |
| Detachment testing | Met established criteria |
| Software validation | Met established criteria |
| Electrical safety testing | Met established criteria |
| Electromagnetic compatibility testing | Met established criteria |
Verification and Test Summary Table
Summary of Substantial Equivalence
The data presented in this submission demonstrates the similarity and equivalency of the V-Grip Plus Detachment Controller when compared with the predicate device MicroVention V-Grip Detachment Controller (K050954).
The devices,
- . Have the same intended use,
- Use the same operating principle, .
- . Incorporate the same basic design,
- Use similar construction and material,
- � Are packaged and sterilized using same material and processes.
In summary, the V-Grip Plus Detachment Controller described in this submission is, in our opinion, substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, clutching a caduceus, a symbol associated with medicine and healthcare.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MicroVention, Inc. % Ms. Naomi Gong . Regulatory Affairs Project Manager 75 Columbia, Suite A Aliso Viejo, California 92656
MAR - 5 2009
Re: K090001
Trade/Device Name: V-Grip Plus Detachment Controller Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: February 5, 2009 Received: February 6, 2009
Dear Ms. Gong:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Naomi Gong
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
L.K. m.D. for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
V-Grip Plus Detachment Controller Device Name:
Indications For Use:
The V-Grip Plus is used to detach the MicroVention MicroPlex Coil System and the HydroCoil Embolization System. As an accessory to the coils, the indications for use for the Detachment Controller remain the same as the coils and is as follows:
The MicroPlex Coil System and Hydrocoil Embolization System are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS and HES are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct hlood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kuone kumu
(Division Sign-Off)
3/4/2009
Division of Gener . . Restorative, and Neurological Devices
510(k) Number K090001