(23 days)
No
The summary describes a physical medical device (embolic coil and delivery system) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for "endovascular embolization of intracranial aneurysms," which is a medical treatment.
No
The device is described as an "embolic coil" system intended for "endovascular embolization of intracranial aneurysms," which is a treatment modality, not a diagnostic one.
No
The device description explicitly mentions physical components like an embolic coil, Device Positioning Unit (DPU), introducer sheath, and re-sheathing tool, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "endovascular embolization of intracranial aneurysms." This is a therapeutic procedure performed within the body (in vivo) to treat a medical condition.
- Device Description: The device consists of an embolic coil and a delivery system. These are physical devices used to perform a medical intervention.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body (in vitro) to provide information for diagnosis, monitoring, or screening. The description of the Micrus MicroCoil Delivery System does not involve the analysis of any biological specimens.
Therefore, the Micrus MicroCoil Delivery System is a medical device used for a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Micrus MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
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). An "introducer sheath" covers the microcoil and DPU and is attached to a re-sheathing tool
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Micrus Microcoil System Cashmere, 510(k) K063653, Micrus Microcoil Delivery System, 510(k) K062036, Micrus Modified Microcoil System, 510(k) K053160, Micrus Microcoil Delivery System, 510(k) K033813, Micrus Microcoil Delivery System, 510(k) K032872
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
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-6 2007
Summary of Safety and Effectiveness
| Submitter Name and
Address: | Micrus Endovascular Corp.
821 Fox Lane
San Jose, CA 95131 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Patrick Lee, Regulatory Affairs Specialist
Phone: 408-433-1428
Fax: 408-433-1515
Email: plee@micruscorp.com |
| Preparation Date: | March 12, 2007 |
| Device Name and
Classification: | Micrus Microcoil Delivery System
Common Name: Micrus Microcoil System
Classification Name: Device, Artificial Embolization
Product Code HCG
Regulatory Class II |
| Predicate Devices: | Micrus Microcoil System Cashmere, 510(k) K063653
Micrus Microcoil Delivery System, 510(k) K062036
Micrus Modified Microcoil System, 510(k) K053160
Micrus Microcoil Delivery System, 510(k) K033813
Micrus Microcoil Delivery System, 510(k) K032872 |
| Device Description: | The Micrus MicroCoil System consists of an embolic coil
("MicroCoil") attached to a Device Positioning Unit (DPU)
(single use, sterile). An "introducer sheath" covers the
microcoil and DPU and is attached to a re-sheathing tool |
| Device Intended Use | The Micrus MicroCoil Delivery System is intended for
endovascular embolization of intracranial aneurysms. |
Comparison to Predicate Devices:
The Micrus Microcoil Systems with the new "introducer sheath and re-sheathing tool" have shown substantial equivalence to the FDA-cleared and marketed Micrus Microcoil Systems in terms of intended use, design, material and method of construction, and dimensions. 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 Microcoil System with a new sheath and resheathing tool is substantially equivalent to the predicate devices in safety and effectiveness.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Micrus Endovascular Corporation % Mr. Patrick Lee Regulatory Affairs Specialist 821 Fox Lane San Jose, California 95131
APR - 6 2007
Re: K070707
Trade/Device Name: Micrus Microcoil Delivery System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: March 12, 2007 Received: March 14, 2007
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | |||
|---|---|---|---|
| Device Name: | Micrus Microcoil Delivery System | ||
| Indications For Use: | |||
| of intracranial aneurysms. | The Micrus MicroCoil Delivery System is intended for endovascular embolization | ||
| Prescription Use | |||
| (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 | L07072
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