(24 days)
No
The summary describes a physical medical device (microcoil delivery system) and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as an "embolic coil" system intended for "endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature," which are therapeutic procedures to treat medical conditions.
No
The device is an embolic coil system used for "endovascular embolization," which is a treatment procedure, not a diagnostic one. It's intended to block blood flow, not to identify or characterize medical conditions.
No
The device description explicitly states it consists of a physical embolic coil and a Device Positioning Unit (DPU), which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Micrus Microcoil Delivery System is an implantable medical device used for the physical embolization (blocking) of blood vessels. It is used within the body, not to test samples taken from the body.
- Intended Use: The intended use clearly describes a therapeutic procedure (embolization) performed directly on the patient's vasculature.
Therefore, based on the provided information, the Micrus Microcoil Delivery System is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Micrus Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature.
Product codes
HCG
Device Description
The Micrus Microcoil System consists of an embolic coil ("Microcoil") attached to a Device Positioning Unit (DPU) (single use, sterile)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial, arterial and venous (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)
Non-clinical testing was performed. It concluded that the DELTAPLUSH Microcoil System is substantially equivalent to the predicate device in safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
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Summary of Safety and Effectiveness
Submitter Name and Address:
Micrus Endovascular Corp. 821 Fox Lane San Jose, CA 95131
Email: plee@micruscorp.com
Phone: 408-433-1428 Fax: 408-433-1585
Patrick Lee
JAN - 2 2009
Contact Name:
Preparation Date: Device Name and Classification:
Predicate Devices:
December 8, 2008 Micrus Microcoil System Common Name: Occlusion Coil Trade Name: Micrus Microcoil System, DELTAPLUSH "DELTAPLUSH 10 Stretch-Resistant" (model "DPL") and "DELTAPLUSH 10 Cerecyte." (model
"CPL")
Classification Name: Device, Neurovascular Embolization Regulatory Class II
Micrus Microcoil Systems, Deltapaq
510(k) no. K080437 and K080379 Device Description: The Micrus Microcoil System consists of an embolic coil
Device Intended Use
use, sterile) The Micrus Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature.
("Microcoil") attached to a Device Positioning Unit (DPU) (single
Comparison to Predicate Devices:
The Microcoil System, DELTAPLUSH, has shown substantial equivalence to the Micrus Microcoil System, Deltapaq, in terms of intended use, design, material of construction, implant dimensions including wire dimensions, coil dimensions, coil pitch, and coil stiffness. The DELTAPLUSH microcoils use the same method and material of . construction, packaging, and sterilization method as its predicate. The modification has not altered the fundamental technology of the sponsor's predicate device
Conclusion:
Based upon the design, materials, function, intended use, comparison with currently marketed devices and the non-clinical testing performed by Micrus Endovascular Corporation, it is concluded that the DELTAPLUSH Microcoil System is substantially equivalent to the predicate device in safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, clutching a staff entwined with a serpent. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Micrus Endovascular Corporation % Mr. Patrick Lee Manger Regulatory Affairs 821 Fox Lane San Jose, California 95131.
JAN - 2 2009
Re: K083646
Trade/Device Name: Microcoil System DELTA PLUSH Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: December 8, 2008 Received: December 9, 2008
Dear Mr. Lee:
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 (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.
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Page 2 - Mr. Patrick Lee
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 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.
Mark H. Mullens
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K0856466
Indications for Use
510(k) Number (if known):
Device Name:
Micrus Microcoil Delivery System
Indications For Use:
The Micrus Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number 108364
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