(29 days)
The Micrus MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
The Micrus Microcoil Delivery System consists of (1) An embolic coil ("Microcoil") attached to a Device Positioning Unit (DPU) (single use, sterile). (2) An Connecting Cable ("CCB") (3) A Detachment Control Box ("DCB")
The provided documentation is a 510(k) summary for the Micrus Microcoil Delivery System and related FDA correspondence. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics typically found in AI/ML device submissions.
Therefore, many of the requested categories (e.g., sample sizes for training/test sets, expert qualifications, MRMC studies, standalone performance, ground truth establishment) are not applicable to this type of submission.
Here's a breakdown of the information that can be extracted and a clear indication of what is not available from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate devices in terms of intended use, design, material, method of construction, and dimensions. | The modification (new Detachment Control Box - DCB) has not altered the fundamental technology of the sponsor's predicate device. Based on design, materials, function, intended use comparison with currently marketed device, and non-clinical testing, the new DCB is deemed substantially equivalent to predicate devices in safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable/Not provided. This submission relies on "non-clinical testing" and comparison to a predicate device, not a clinical study with a test set in the context of AI/ML.
- Data Provenance: Not applicable/Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. The ground truth concept as typically applied to AI/ML devices for diagnostic accuracy is not relevant here. The "ground truth" for this submission is the established safety and effectiveness of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study Done?: No. This type of study is not relevant for this device submission which focuses on substantial equivalence of a physical medical device.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML algorithm. The submission is for a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth Type: For this submission, the 'ground truth' is implicitly the established safety and effectiveness profile of the legally marketed predicate devices (Micrus Microcoil Delivery System, 510(k) K002056 and K031578). The new device is shown to be substantially equivalent to these.
8. The sample size for the training set
- Not applicable/Not provided. This is not an AI/ML device trained on data.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
{0}------------------------------------------------
ー1 2007
Summary of Safety and Effectiveness
| Submitter Name and Address: | Micrus Endovascular Corp.821 Fox LaneSan Jose, CA 95131 |
|---|---|
| Contact Name: | Patrick Lee, Regulatory Affairs SpecialistPhone: 408-433-1428Fax: 408-433-1585Email: plee@micruscorp.com |
| Preparation Date: | May 1, 2007 |
| Device Name andClassification: | Micrus Microcoil Delivery SystemCommon Name: Micrus Microcoil SystemClassification Name: Device, Artificial EmbolizationProduct Code HCGRegulatory Class II |
| Predicate Devices: | Micrus Microcoil Delivery System, 510(k) K002056Micrus Microcoil Delivery System, 510(k) K031578 |
| Device Description: | The Micrus Microcoil Delivery System consists of(1) An embolic coil ("Microcoil") attached to a DevicePositioning Unit (DPU) (single use, sterile).(2) An Connecting Cable ("CCB")(3) A Detachment Control Box ("DCB") |
| Device Intended Use | The Micrus MicroCoil Delivery System is intended forendovascular embolization of intracranial aneurysms. |
Comparison to Predicate Devices:
The Microcoil Delivery Systems with the new Detachment Control Box ("DCB") have shown substantial equivalence to the FDA-cleared and marketed Micrus Microcoil Delivery System 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 device and the non-clinical testing performed by Micrus Endovascular Corporation, it is concluded that the new DCB of the Micrus Microcoil Delivery System is substantially equivalent to the predicate devices in safety and effectiveness.
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES · USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 1 2007
Micrus Endovascular Corporation % Mr. Patrick Lee Regulatory Affairs Specialist 821 Fox Lane San Jose. California 95131
Re: K071246
Trade/Device Name: Micrus Microcoil Delivery System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization Regulatory Class: II Product Code: HCG Dated: May 1, 2007 Received: May 3, 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.
{2}------------------------------------------------
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 the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
KO71246 510(k) Number (if known): ___
Device Name: Micrus Microcoil Delivery System
Indications For Use:
The Micrus Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
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)
Mark A. Millikan
(Division Sign-Cd) Division of General, Restorative, and Neurological Devices
510(k) Number_
§ 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).