(29 days)
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.
The Micrus Microcoil System consists of an embolic coil ("Microcoil") attached to a Device Positioning Unit ("DPU")
This document, K082739, is a 510(k) premarket notification for a medical device called the "Micrus Microcoil Delivery System." It aims to demonstrate substantial equivalence to previously cleared devices rather than prove the device meets specific acceptance criteria through a formal study with statistical endpoints. As such, the provided text does not contain the information required to populate most sections of your request.
Here's a breakdown based on the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not present in the provided document. The 510(k) submission focuses on demonstrating substantial equivalence through design, material, function, and intended use comparison, along with non-clinical testing. It does not detail specific performance metrics and acceptance criteria for patient outcomes or diagnostic accuracy that would be found in a clinical study for a new device.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not applicable/not present. No "test set" in the context of a clinical study for performance evaluation is described. The submission relies on "non-clinical testing" which typically refers to bench testing, engineering tests, and biocompatibility, not patient data for performance evaluation in the way you're asking.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable/not present. As there is no clinical test set described, there's no mention of experts establishing ground truth for such a set.
4. Adjudication Method for the Test Set:
This information is not applicable/not present. No clinical test set or adjudication process is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not applicable/not present. The document does not describe any MRMC study. The comparison is to predicate devices through design and function, not through a clinical performance comparison with human readers.
6. Standalone (Algorithm Only) Performance Study:
This information is not applicable/not present. This device is a physical medical device (microcoil delivery system), not an algorithm or AI-based diagnostic tool.
7. Type of Ground Truth Used:
This information is not applicable/not present in the context of a clinical performance study. For the substantial equivalence claim, the "ground truth" or basis of comparison is the safety and effectiveness of the predicate devices as established by their prior FDA clearance. The assessment is then whether the new device is "substantially equivalent" to these already cleared devices, meaning its design, materials, function, and intended use are similar enough that it raises no new questions of safety or effectiveness.
8. Sample Size for the Training Set:
This information is not applicable/not present. This is not a study involving a "training set" for an algorithm or a clinical trial with patient enrollment numbers.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/not present.
Summary of what the document does state regarding acceptance criteria and "proof":
The document states that the Micrus Microcoil Delivery System with a new "Device Positioning Unit" has shown substantial equivalence to FDA-cleared and marketed Micrus Microcoil Systems.
The "proof" for this substantial equivalence is based on:
- Comparison of intended use, design, material, method of construction, and dimensions to predicate devices.
- The assertion that "The modification has not altered the fundamental technology of the predicate devices."
- Non-clinical testing performed by Micrus Endovascular Corporation. (The specifics of this testing, its acceptance criteria, and results are not detailed in this summary document.)
Conclusion:
This 510(k) summary is designed to demonstrate that the modified device is substantially equivalent to existing, cleared devices. It does not contain the kind of detailed study information (acceptance criteria, sample sizes, expert ground truth, etc.) that would be found for a novel device undergoing a performance study or a clinical trial with predefined endpoints. The "acceptance criteria" here implicitly align with the FDA's requirements for substantial equivalence for a Class II device.
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Summary of Safety and Effectiveness
| Submitter Name andAddress: | Micrus Endovascular Corp.821 Fox LaneSan Jose, CA 95131 | OCT 17 2008 |
|---|---|---|
| Contact Name: | Patrick Lee, Manager of Regulatory AffairsPhone: 408-433-1428Fax: 408-433-1585Email: plee@micruscorp.com | |
| Preparation Date: | September 16, 2008 | |
| Device Name andClassification: | Micrus Microcoil Delivery SystemCommon Name: Micrus Microcoil SystemClassification Name: Device, Artificial EmbolizationProduct Code HCGRegulatory Class II | |
| Predicate Devices: | Micrus Microcoil System, 510(k) K080379Micrus Microcoil System, 510(k) K080437Micrus Microcoil System, 510(k) K073442Micrus Microcoil Delivery System, 510(k) K072173Micrus 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 forendovascular embolization of intracranial aneurysms, otherneurovascular abnormalities such as arteriovenous malformationsand arteriovenous fistulae, and are also intended for arterial andvenous 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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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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§ 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).