(29 days)
Not Found
No
The summary describes a physical medical device (microcoil delivery system) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended for "endovascular embolization" of various vascular abnormalities, which is a therapeutic intervention aimed at treating a medical condition.
No
The intended use describes embolization of aneurysms and vascular abnormalities, which is a treatment (therapeutic) procedure, not a diagnostic one.
No
The device description explicitly states it consists of a physical embolic coil and a Device Positioning Unit, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "endovascular embolization of intracranial aneurysms, other neurovascular abnormalities... and are also intended for arterial and venous embolizations in the peripheral vasculature." This describes a 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, which are used to physically block blood flow within vessels. This is a therapeutic device, not a diagnostic one.
- 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. This device does not perform any such analysis of specimens.
Therefore, based on the provided information, the Micrus Microcoil Delivery System is a therapeutic medical device used for embolization procedures, 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, 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")
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, arterial and venous embolizations in the 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
Non-clinical testing performed by Micrus Endovascular Corporation.
Key Metrics
Not Found
Predicate Device(s)
K080379, K080437, K073442, K072173, K070707
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 | OCT 17 2008 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Name: | Patrick Lee, Manager of Regulatory Affairs
Phone: 408-433-1428
Fax: 408-433-1585
Email: plee@micruscorp.com | |
| Preparation Date: | September 16, 2008 | |
| 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, 510(k) K080379
Micrus Microcoil System, 510(k) K080437
Micrus Microcoil System, 510(k) K073442
Micrus Microcoil Delivery System, 510(k) K072173
Micrus Microcoil Delivery System, 510(k) K070707 | |
| Device Description: | The Micrus Microcoil System consists of an embolic coil
("Microcoil") attached to a Device Positioning Unit ("DPU") | |
| Device Intended 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. | |
Comparison to Predicate Devices:
The Micrus Microcoil Systems with a new "Device Positioning Unit" have shown substantial equivalence to FDA-cleared and marketed Micrus Microcoil Systems in terms of intended use, design, material, method of construction, and dimensions. The modification has not altered the fundamental technology of the predicate devices.
Conclusion:
Based upon the design, material, function, intended use comparison with currently marketed devices and the non-clinical testing performed by Micrus Endovascular Corporation, it is concluded that the Micrus Microcoil System with new device positioning unit is substantially equivalent to the predicate devices in safety and effectiveness.
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Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's three main goals. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion 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
OCT 1 7 2008
Re: K082739
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: September 16, 2008 Received: September 18, 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 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 M. Milliman
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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Micrus Microcoil Delivery System 510(k) Premarket Notification
K08J739
| Indications for Use | |
|---|---|
| 510(k) Number (if known): | K082739 |
| 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)
Neil RP Ogle farmer
(Division Sign-O Division of General, Restorative, and Neurological Devices
510(k) Number K082739
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