(42 days)
The Nexus Detachable Coils are intended for the endovascular embolization of intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) be inoperable. The Nexus Detachable Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.
The Nexus coils are platinum alloy coils, enlaced with absorbable polymer fibers, and attached to a stainless steel guiding system with a radiopaque positioning coil. Nexus coils are designed for use with the NXT Detachment System specifically designed for coil detachment. The NXT Detachment System is sold separately.
The provided text describes a medical device, the Nexus Morpheus 3D CSR, and its premarket notification (510(k)) submission to the FDA. The submission focuses on establishing substantial equivalence to a predicate device, the Nexus Tetris 3D CSR, rather than proving the device meets acceptance criteria through a study demonstrating performance metrics in a clinical setting against a defined ground truth.
Therefore, many of the requested details related to a performance study (like sample size, data provenance, expert ground truth, MRMC study, standalone performance, training set details) are not applicable or not present in the provided document, as it describes a different type of regulatory submission. The verification and test summary focuses on bench testing to ensure the new device functions similarly to the predicate.
Here's an attempt to answer based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are the established engineering and functional benchmarks for the device, and "reported device performance" indicates whether these benchmarks were met.
| Bench Testing Acceptance Criteria | Reported Device Performance |
|---|---|
| Coil Deformation met established criteria | Met established criteria |
| Dimensional & Visual Analysis met established criteria | Met established criteria |
| Ease of Delivery/Coil Frictional Characteristics met established criteria | Met established criteria |
| In Vitro Aneurysm Fills and Reliability After Fatigue met established criteria | Met established criteria |
| Microfilament Pull-Out met established criteria | Met established criteria |
| Tensile Strength met established criteria | Met established criteria |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for these bench tests. The data provenance is internal testing performed by Micro Therapeutics, Inc. (DBA ev3 Neurovascular) on the device components. This is not clinical data, but rather engineering and material testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for clinical performance studies (e.g., expert consensus on medical images or pathology results) is not relevant for the bench testing described. The "ground truth" here would be engineering specifications and standards.
4. Adjudication method for the test set
Not applicable. This was bench testing against predefined engineering criteria, not a subjective assessment requiring adjudication.
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
No. This is a medical device (neurovascular embolization coil), not an AI diagnostic or assistance system. Therefore, an MRMC study related to AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device. "Standalone" performance in this context refers to the device's functional integrity during bench testing, not an algorithm's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the bench tests would have been the internal engineering specifications and standards that the device's performance was measured against. This is not clinical ground truth.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is a physical medical device, not a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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| 510(k) Summary | APR 20 2006 | |
|---|---|---|
| Trade Name: | Nexus Morpheus 3D CSR | |
| Generic Name: | Neurovascular Embolization Device | |
| Classification: | Class II, 21 CFR 882.5950 | |
| Submitted By: | Micro Therapeutics, Inc.DBA ev3 Neurovascular2 GoodyearIrvine, California 92618 | |
| Contact: | Florin Truuvert |
Predicate
Device:
| Number | Description | Predicate For | Clearance Date |
|---|---|---|---|
| K050543 | Nexus Detachable Coils,Tetris 3D | Nexus Detachable Coil,Morpheus 3D | April 27, 2005 |
Device Description
The Nexus coils are platinum alloy coils, enlaced with absorbable polymer fibers, and attached to a stainless steel guiding system with a radiopaque positioning coil. Nexus coils are designed for use with the NXT Detachment System specifically designed for coil detachment. The NXT Detachment System is sold separately.
Indication For Use
The Nexus Detachable Coils are intended for the endovascular embolization of intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) be inoperable. The Nexus Detachable Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.
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Verification and Test Summary Table
| Bench Testing | Result |
|---|---|
| Coil Deformation | Met established criteria |
| Dimensional & Visual Analysis | Met established criteria |
| Ease of Delivery/Coil Frictional Characteristics | Met established criteria |
| In Vitro Aneurysm Fills and Reliability After Fatigue | Met established criteria |
| Microfilament Pull-Out | Met established criteria |
| Tensile Strength | Met established criteria |
Summary of Substantial Equivalence
The data presented in this submission demonstrates the technological similarity and equivalency of the Nexus Morpheus 3D CSR coils compared with the predicate device Nexus Tetris 3D CSR.
The two devices,
- Have the same intended use, .
- Use the same operating principle, .
- Incorporate the same basic design, .
- Use similar construction and material, ●
- Are packaged and sterilized using same processes. .
In summary, the Nexus coils described in this submission are, in our opinion, substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES" around the perimeter. Inside the circle is a stylized image of a human figure with three lines emanating from the head, representing health, services, and people.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 0 2006
Micro Therapeutics, Inc. dba ev3 Neurovascular c/o Ms. Florin Truuvert Regulatory Affairs Manager 2 Goodyear Irvine, California 92618
Re: K060625
Trade/Device Name: Nexus Detachable Coil, Morpheus 3D CSR Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: March 21, 2006 Received: March 22, 2006
Dear Ms. Truuvert:
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 vour 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
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Page 2 - Ms. Florin Truuvert
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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
dl.mee
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: Nexus Detachable Coil, Morpheus 3D CSR
Indications For Use:
The Nexus Detachable Coils are intended for the endovascular embolization of intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition -- are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) be inoperable. The Nexus Detachable Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 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
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510(k) Number__* 06 08 x 5
§ 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).