(21 days)
No
The summary describes a physical medical device (detachable coils) and its intended use for embolization. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies listed are bench tests of the physical device's properties.
Yes
The device is described as being used for "endovascular embolization of intracranial aneurysms" and "embolization of other neuro vascular abnormalities," which are therapeutic procedures to treat medical conditions.
No
The document describes an embolization coil used for treatment, not for diagnosing conditions.
No
The device description clearly outlines physical components like platinum alloy coils, polymer fibers, a stainless steel guiding system, and a radiopaque positioning coil. It also mentions a separate detachment system. This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes an in vivo procedure – the endovascular embolization of intracranial aneurysms and other neuro vascular abnormalities within the patient's body.
- Device Description: The device is a physical implant (coils) and a delivery system, designed to be used inside the body.
- Lack of In Vitro Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) outside of the body to provide information for diagnostic purposes.
IVD devices are specifically designed to be used in vitro (outside the body) to test samples from a patient to diagnose, monitor, or screen for diseases or conditions. This device is used in vivo (inside the body) for treatment.
N/A
Intended Use / 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.
Product codes
HCG
Device Description
The Nexus Helix Super Soft CSR arc platinum alloy coils, enlaced with absorbable polymer fibers, and attached to a stainless steel guiding system with a radiopaque positioning coil. Nexus Helix Super Soft CSR coils are designed for use with the NXT Detachment System specifically designed for coil detachment. The NXT Detachment System is sold separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial (aneurysms)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
treating neurosurgical team
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
JUN 2 2 2005
Micro Therapeutics, Inc.
Special 510(k), Nexus Helix Super Soft CSR
| 510(k) Summary | |
|---|---|
| Trade Name: | 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
System | Nexus Detachable Coil, Helix
Super Soft CSR | April 27, 2005 |
Device Description
The Nexus Helix Super Soft CSR arc platinum alloy coils, enlaced with absorbable polymer fibers, and attached to a stainless steel guiding system with a radiopaque positioning coil. Nexus Helix Super Soft CSR 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
bs14252/v
Micro Therapeutics, Inc.
Special 510(k), Nexus Helix Super Soft CSR
Verification and Test Summary Table
| 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 |
Summary of Substantial Equivalence
The data presented in this submission demonstrates the technological similarity and The data prescificul in this submission actively 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 Helix Super Soft CSR coils described in this submission are, in our opinion, substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 2 2005
Ms. Florin Truuvert Regulatory Affairs Manager Micro Therapeutics Incorporated 2 Goodyear Irvine, California 92618
Re: K051425
Trade/Device Name: Nexus Detachable Coil, Helix Super Soft CSR Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: II Product Code: HCG Dated: May 31, 2005 Received: June 1, 2005
Dear Ms. Truuvert:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed four becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreated of the enactment date of the Medical Device Amendments, or to conimered prior to rial) 2011-07-11 in accordance with the provisions of the Federal Food, Drug, uc necs that hat to been require approval of a premarket approval application (PMA). and Cosmetic (110. (110.) that to device, subject to the general controls provisions of the Act. The r ou may, merelore, manes of the Act include requirements for annual registration, listing of general controls provisions 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 it may of subject to bash as Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA oun or found in the ovaouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease of acrised a determination that your device complies with other requirements of the Act that I Dr Hao intatutes and regulations administered by other Federal agencies. You must or any I cach statutes and sequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Fart 607); adoling (21 CFR Part 820); and if applicable, the electronic forth in the quant) 3500210 (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -- Ms. Florin Truuvert
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin maketing your advice of your device of your device to a legally
premarket notification. The FDA finding of substantial equivales of tyour premarket notification. The FDA Iniding of substantal of a levice 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
rs the regularies and 10 10 10 10 115 - Also, masses note the regulation en If you desire specific advice for your de need on our of . Also, please note the regulation entitled,
contact the Office of Compliance at (240) 276-0115 . Also, please note t contact the Office of Compliatics at (240) 270 - 1712097 Patt 807.97). You may obtain
"Misbranding by reference to premarket notification that attact from the Division of Sm "Misbranding by reference to premarket nouliicanon" (er on the Division of Small)
other general information on your responsibilities under the Act from the Division of Small other general information on your responsionals and its toll-free number (800) 638-2041 or Manufacturers, International and Colisunier Assistance at to too in industry/support/index.html.
Sincerely yours,
E. E. H.
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
4
051425
Indications for Use
510(k) Number (if known):
Nexus Detachable Coil, Helix Super Soft CSR Device Name:
Indications For Use:
The Nexus Detachable Coils are intended for the endovascular embolization of The Next's Delachable Cons are menous to morphology, their location, or the mitfactanial ancearyonis mat
patient's general medical condition -- are considered by the treating patient's general medical very high risk for management by traditional neurosurgical team to oc a) very ing increable. The Nexus Detachable Coils are also a operative techniques, or 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
ும் நீர்ந்-மரி) ion of General, Restorative and Neurological Devices 5147
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