(81 days)
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.
The Micrus Microcoil System cach consist of an embolic coil ("Microcoil") attached to a Device Positioning Unit (DPU) (single usc, sterile).
This 510(k) premarket notification for the Micrus Microcoil Delivery System does not contain a study that establishes performance against acceptance criteria in the manner typically seen for AI/ML devices or novel technologies with specific performance metrics. This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The provided document does not specify quantitative acceptance criteria or report device performance against such criteria. The basis for clearance is "substantial equivalence" to predicate devices, implying that the device performs similarly to devices already on the market.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. There is no mention of a "test set" or specific study data, as the submission relies on substantial equivalence.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth establishment is not relevant in a substantial equivalence filing for this type of medical device where performance is based on similarity to existing products, rather than novel diagnostic or interventional outcomes requiring expert-driven validation.
4. Adjudication Method
Not applicable. There is no mention of a study involving adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is not mentioned. This type of study is typically used for diagnostic devices involving human interpretation of data, often comparing AI-assisted performance to unassisted performance. This device is an interventional tool, not a diagnostic one.
6. Standalone Performance Study
No. A standalone performance study for the algorithm (without human-in-the-loop) is not applicable or mentioned, as the device itself is a physical medical instrument, not software.
7. Type of Ground Truth Used
Not applicable. The concept of "ground truth" as it applies to diagnostic or prognostic AI/ML algorithms is not relevant here. The "truth" in this context is that the device functions as intended and is safe and effective similarly to its predicates.
8. Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not an AI/ML device that learns from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of the Document's Approach:
The core of this 510(k) submission for the Micrus Microcoil Delivery System is the argument of substantial equivalence to predicate devices. This means the manufacturer is asserting that:
- Intended Use: The device shares the same intended use as legally marketed predicate devices (endovascular embolization of intracranial aneurysms, neurovascular abnormalities, and peripheral arterial/venous embolizations).
- Design and Specifications: The design, specifications, and materials are comparable to the predicate devices.
- Safety and Effectiveness: Because of the similarities in intended use, technology, and materials, the device is considered as safe and effective as the predicate devices.
The clearance letter from the FDA confirms this determination: "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... to legally marketed predicate devices."
Therefore, the "study that proves the device meets the acceptance criteria" in this case is the comparison to predicate devices and the FDA's agreement that this comparison demonstrates substantial equivalence, rather than a clinical trial with specific performance metrics against pre-defined acceptance criteria.
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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 Corporation821 Fox LaneSan Jose, California 95131Phone: (408) 433-1400Est. 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.
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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.
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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
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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
§ 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).