(15 days)
Not Found
No
The description focuses on the physical characteristics and intended use of platinum alloy coils for embolization, with no mention of AI or ML technology.
Yes
The device is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, which is a therapeutic intervention.
No
Explanation: The device description and intended use clearly state that the Nexus Detachable Coils are used for "endovascular embolization," which is a treatment procedure, not a diagnostic one. They are used to treat conditions like intracranial aneurysms and arteriovenous malformations.
No
The device description explicitly states the device is a platinum alloy coil with polymer fibers and a stainless steel guiding system, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Nexus Detachable Coils Function: The description clearly states that the Nexus Detachable Coils are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities. This is a therapeutic procedure performed inside the body to block blood flow to a specific area.
The device description and intended use are entirely focused on a surgical/interventional procedure, not on analyzing samples taken from the body.
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 (comma separated list FDA assigned to the subject device)
HCG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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 | ||
| System | Nexus Detachable Coil, Helix | ||
| 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.
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.
2
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.
3
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
4
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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