(15 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 510(k) submission for the Nexus Multi-Diameter CSR and Helix Super Soft CSR neurovascular embolization devices. This document focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than reporting on a study involving human or animal subjects that would result in performance metrics like sensitivity, specificity, or reader improvement. Therefore, many of the requested elements for a study on device performance and acceptance criteria (e.g., sample size for test/training set, number of experts, adjudication method, MRMC studies, standalone performance, ground truth types) are not applicable or cannot be extracted from this specific document.
The acceptance criteria are generally "Met established criteria" for various bench tests. The "study" that proves the device meets these criteria is the bench testing itself, as summarized in the Verification and Test Summary Table.
Here's the information that can be extracted and a note on what cannot be provided based on the input text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Coil Deformation (Established Criteria) | Met established criteria |
| Dimensional & Visual Analysis (Established Criteria) | Met established criteria |
| Coating Integrity (Established Criteria) | Met established criteria |
| Force Transfer (Established Criteria) | Met established criteria |
| Ease of Delivery/Coil Frictional Characteristics (Established Criteria) | Met established criteria |
| Fiber Endurance Testing (Established Criteria) | Met established criteria |
| Reliability After Fatigue & Premature Detachment (Established Criteria) | Met established criteria |
| Fiber Pull-Out (Established Criteria) | Met established criteria |
| Tensile Strength (Established Criteria) | Met established criteria |
| Particulate Generation - Adjusted Particles / 1 mL (Established Criteria) | Met established criteria |
| PGLA Tensile Testing (Established Criteria) | Met established criteria |
| Packaging Integrity (Established Criteria) | Met established criteria |
2. Sample sized 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 specified in the provided text. The text only mentions "Bench Testing" with various categories of tests, but does not provide details on the number of coils or samples tested for each category.
- Data Provenance: Not applicable. The data comes from internal bench testing conducted by the manufacturer, Micro Therapeutics, Inc., located in Irvine, California, USA. This is an engineering/materials-based evaluation, not a clinical study involving patient data.
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. Ground truth in this context refers to engineering specifications and performance benchmarks, not clinical expert consensus. The "ground truth" for the acceptance criteria would be the pre-defined engineering and performance specifications set by Micro Therapeutics, Inc.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically relevant for clinical studies where expert consensus is needed to resolve discrepancies in diagnoses or interpretations. Bench testing involves objective measurements against established criteria.
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 document does not mention any MRMC study. The device is a physical medical implant (coil), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's evaluation is based on pre-defined engineering specifications and performance standards for physical characteristics, material integrity, and functional attributes relevant to the device's intended use. This is a technical/engineering ground truth for bench testing.
8. The sample size for the training set
Not applicable. This document describes a 510(k) submission for a physical medical device, relying on bench testing to demonstrate substantial equivalence. There is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned or implied in this submission, the method for establishing its ground truth is irrelevant.
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K051560\u2044₂
Micro Therapeutics, Inc.
Special 510(k), Multi Diameter CSR, Helix Super Son
JUN 2 8 2005
| 510(k) Summary | |||
|---|---|---|---|
| Trade Name: | Nexus Multi-Diameter CSR and Nexus Helix Super Soft CSR | ||
| Generic Name: | Neurovascular Embolization Device | ||
| Classification: | Class II, 21 CFR 882.5950 | ||
| Submitted By: | Micro Therapeutics, Inc. | ||
| 2 Goodyear | |||
| Irvine, California 92618 | |||
| Contact: | Florin Truuvert |
Predicate Device:
| Number | Description | Predicate For | Clearance Date |
|---|---|---|---|
| K050543 | Nexus Detachable CoilSystem | Nexus Detachable Coil, HelixSuper Soft CSR | 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.
{1}------------------------------------------------
| Bench Testing | Result |
|---|---|
| Coil Deformation | Met established criteria |
| Dimensional & Visual Analysis | Met established criteria |
| Coating Integrity | Met established criteria |
| Force Transfer | Met established criteria |
| Ease of Delivery/Coil Frictional Characteristics | Met established criteria |
| Fiber endurance Testing | Met established criteria |
| Reliability After Fatigue & Premature Detachment | Met established criteria |
| Fiber Pull-Out | Met established criteria |
| Tensile Strength | Met established criteria |
| Particulate Generation - Adjusted Particles / 1 mL | Met established criteria |
| PGLA Tensile Testing | Met established criteria |
| Packaging Integrity | Met established criteria |
Verification and Test Summary Table
Summary of Substantial Equivalence
The data presented in this submission demonstrates the technological similarity and equivalency of the Nexus Multi-Diameter CSR and Helix Super Soft CSR coils compared with the predicate device Nexus Detachable Coils.
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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or birds in flight, stacked vertically. The logo is rendered in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 8 2005
Ms. Florin Truuvert Regulatory Affairs Manager Micro Therapeutics Incorporated 2 Goodyear Irvine, California 92618
Re: K051560
Trade/Device Name: Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSR
Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: II Product Code: HCG Dated: June 10, 2005 Received: June 14, 2005
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 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 - Ms. Florin Truuvert
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/industry/support/index.html.
Sincerely yours,
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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05/560
Indications for Use
510(k) Number (if known):
Device Name: Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft 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)
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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).