(56 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™ Detachable Coil are platinum alloy coils, enlaced with absorbable polymer fibers, and attached to a stainless steel guiding system with a radiopaque positioning coil. Nexus™ Detachable Coils are designed for use with the NXT Detachment System, specifically designed for coil detachment. The NXT Detachment System is sold separately.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Nexus Detachable Coil System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Testing) | Reported Device Performance |
|---|---|
| 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 |
2. Sample Size Used for the Test Set and Data Provenance
The document only mentions "Bench Testing" and states that a variety of tests were conducted. It does not specify the sample size used for individual tests, nor does it provide information on data provenance (e.g., country of origin, retrospective/prospective). These appear to be laboratory-based engineering tests, not clinical studies involving human or animal subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided. Since the testing described is primarily bench testing for mechanical and material properties, it's unlikely that "experts" in the sense of medical professionals were establishing ground truth for these specific tests. Instead, the "ground truth" would be established by engineering specifications and industry standards.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the bench testing, an adjudication method typically used in clinical studies (like 2+1) is not applicable. The results would likely be determined by meeting predefined engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through bench testing and comparison to predicate devices, not on comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance assessment was not done. The Nexus Detachable Coil System is a physical medical device, not an AI or software algorithm.
7. The Type of Ground Truth Used
The ground truth for the "acceptance criteria" presented appears to be based on established engineering specifications, material standards, and performance benchmarks derived from the predicate devices. The document states "Met established criteria" for each test, implying that there were pre-defined quantitative or qualitative criteria for success.
8. The Sample Size for the Training Set
This concept is not applicable to this submission. The Nexus Detachable Coil System is a physical device, not an AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable to this submission, as there is no "training set" for this physical medical device.
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K050543 pg. 1 of 2
APR 2 7 2305
Nexus Detachable Coil System
| 510(k) Summary | |
|---|---|
| Trade Name: | Nexus Detachable Coil System |
| Generic Name: | Neurovascular Embolization Device |
| Classification: | Class II, 21 CFR 882.5950 |
| Submitted By: | Micro Therapeutics, Inc.2 GoodyearIrvine, California 92618 |
| Contact: | Florin Truuvert |
Predicate Device:
| Number | Description | Predicate For | Clearance Date |
|---|---|---|---|
| K041649 | Sapphire NXT DetachableCoil System | Nexus Detachable Coil System | July 16, 2004 |
| K012985 | Boston Scientific Target,Matrix Detachable Coils | Nexus Detachable Coil System | Sept 06, 2001 |
Device Description
The Nexus™ Detachable Coil are platinum alloy coils, enlaced with absorbable polymer fibers, and attached to a stainless steel guiding system with a radiopaque positioning coil. Nexus™ Detachable 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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K05 0543 pg. 2 of 2
Micro Therapeutics, Inc.
Nexus Detachable Coil System
| 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 equivalency of the Nexus Detachable Coils compared with the predicate device Sapphire NXT 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/2 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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
APR 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Florin Truuvert Regulatory Affairs Manager Micro Therapeutics, Inc. 2 Goodyear Irvine, California 92618
Re: K050543
Trade/Device Name: Nexus Detachable Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: II Product Code: HCG Dated: March 1, 2005 Received: March 2, 2005
Dear 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 – Florin Truuvert
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and w you've organism of substantial equivalence of your device to a legally prematic nounceation "re 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 If you done specific aarroliance 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 other general 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.
Sincerety yours,
Signature
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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12050543
Indications for Use
510(k) Number (if known):
Nexus Detachable Coil System Device Name:
Indications For Use:
The Nexus Detachable Coils are intended for the endovascular embolization of I he Nexus Decaonable Octib at - because of their morphology, their location, or the nitiaoramal anouryouse condition - are considered by the treating patient 3 goneral inso be a) very high risk for management by traditional neurosurgical team to oo a) very magaable. The Nexus Detachable Coils are also 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
. Restorative
Page 1 of 1_
50543
008
§ 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).