(81 days)
No
The summary describes a mechanical device (microcoil delivery system) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for embolization of intracranial aneurysms and other neurovascular abnormalities, which is a therapeutic intervention aimed at treating medical conditions.
No
Explanation: The device is intended for endovascular embolization, which is an interventional/therapeutic procedure, not a diagnostic one. It delivers an embolic coil to treat abnormalities, rather than diagnose them.
No
The device description clearly states it consists of an embolic coil and a Device Positioning Unit (DPU), which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for endovascular embolization within the body (intracranial, neurovascular, arterial, venous, peripheral vasculature). This is a therapeutic procedure performed in vivo.
- Device Description: The device consists of an embolic coil and a delivery system, which are physical components used for a medical intervention within the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a therapeutic device used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
The 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 each consist 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, peripheral vasculature (arterial and venous)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
KO 73442
Micrus Microcoil Delivery System 510(k) Premarket Notification
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5.0 510(k) Summary
Micrus Endovascular Corporation Micrus® Microcoil Delivery System
FES 26 - 2
This 510(k) Summary for the Microcoil Delivery System is submitted in accordance with the requirements of 21 C.F.R. § 807.92.
GENERAL INFORMATION
| Manufacturer: | Micrus Endovascular Corporation
821 Fox Lane
San Jose, California 95131
Phone: (408) 433-1400
Est. Registration No. 2954740 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Julia Gross |
| Contact Person: | Julia Gross |
|---|---|
| Director, Regulatory & Clinical Affairs | |
| Phone: | (408) 433-1408 |
| Fax: | (408) 433-1585 |
| jgross@micruscorp.com |
December 6, 2007 Date Prepared:
DEVICE CLASSIFICATION
| Classification: | Class II |
|---|---|
| Trade Name: | Micrus® Microcoil Delivery System |
| Generic/Common Name: | Neurovascular embolization device (21 CFR § 882.5950) |
| Vascular embolization device (21 CFR § 870.3300) |
PREDICATE DEVICES
Micrus® Microcoil Delivery System (reference: K070707) Micrus® Microcoil Delivery System (reference: K031578) Boston Scientific / Target Therapeutics, Guglielmi Detachable Coil (reference: K962503) Cordis Neurovascular, Trufill DCS Detachable Coil (reference: K071962)
INTENDED USE
The 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.
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Micrus Microcoil Delivery System 510(k) Premarket Notification
e73442
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DEVICE DESCRIPTION
The Micrus Microcoil System cach consist of an embolic coil ("Microcoil") attached to a Device Positioning Unit (DPU) (single usc, sterile).
SUBSTANTIAL EQUIVALENCE
The previously cleared Microcoil Delivery System is substantially cquivalent to the Boston Scientific / Target Therapeutics Gugliclmi Detachable Coil and the Cordis Neurovascular Trufill DCS Detachable Coil systems in terms of intended use, design, specifications, and materials. These systems are all intended for use in the embolization of aneurysms. The predicate devices have additional indications in their labeling; specifically, embolization in the peripheral vasculature. The Microcoil Delivery System uses the same methods and materials in construction, packaging, and sterilization as its predicates. The modification to the intended use statement has not altered the fundamental technology of the Micrus devices.
CONCLUSION
As described in this 510(k) Summary, Micrus Endovascular Corporation considers the Micrus® Microcoil Delivery System to be substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circle around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2008
Micrus Endovascular Corporation % Ms. Julia Gross Director, Regulatory and Clinical Affairs 821 Fox Lane San Jose, California 95131
Re: K073442
Trade/Device Name: Micrus Microcoil Delivery Systems Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: December 6, 2007 Received: December 7, 2007
Dear Ms. Gross:
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.
3
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.
Mark N Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Micrus Microcoil Delivery System 510(k) Premarket Notification
Indications for Use 4.0
510(k) Number (if known): _
Micrus Microcoil Delivery Systems Device Name:
Indications For Use:
The 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)
Marle M. Millan
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K073442
Micrus Endovascular Corporation