NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR
K051560 · Micro Therapeutics, Inc. · HCG · Jun 28, 2005 · Neurology
Device Facts
Record ID
K051560
Device Name
NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR
Applicant
Micro Therapeutics, Inc.
Product Code
HCG · Neurology
Decision Date
Jun 28, 2005
Decision
SESE
Submission Type
Special
Regulation
21 CFR 882.5950
Device Class
Class 2
Attributes
Therapeutic
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.
Device Story
Platinum alloy coils enlaced with absorbable polymer fibers; attached to stainless steel guiding system with radiopaque positioning coil. Used for endovascular embolization of intracranial aneurysms and neurovascular abnormalities. Operated by neurosurgical teams in clinical settings. Designed for use with NXT Detachment System (sold separately) for coil detachment. Provides mechanical occlusion of vascular structures; benefits patients by treating lesions deemed high-risk or inoperable via traditional surgery.
Clinical Evidence
Bench testing only. Testing included coil deformation, dimensional/visual analysis, coating integrity, force transfer, delivery/frictional characteristics, fiber endurance, fatigue/detachment reliability, fiber pull-out, tensile strength, particulate generation, PGLA tensile testing, and packaging integrity. All tests met established criteria.
Technological Characteristics
Platinum alloy coils with absorbable polymer fibers; stainless steel guiding system; radiopaque positioning coil. Dimensions vary by model (Multi-Diameter/Helix). Standalone device used with separate detachment system. Sterilized via validated processes.
Indications for Use
Indicated for endovascular embolization of intracranial aneurysms in patients considered high-risk for traditional surgery or inoperable, and for embolization of neurovascular abnormalities including arteriovenous malformations and arteriovenous fistulae.
Regulatory Classification
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.
Special Controls
*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).
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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 Coil<br>System | Nexus Detachable Coil, Helix<br>Super 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.
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| 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)
signature
vision Sign-Off of Conners & Storative
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Cal Namber
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Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
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Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
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Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
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Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
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Click the citation bubbles to jump to the relevant highlight in the source document.
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At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
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A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
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The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
