(21 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 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Nexus Helix Super Soft CSR device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bench Testing | Implicit criteria: Demonstrate equivalence to the predicate device and meet established safety/performance standards for neurovascular embolization devices. Specific quantitative criteria are not detailed in the provided document, but the device must demonstrate comparable performance to the predicate and established norms for safety and efficacy.** | Met established criteria for all listed categories: |
| Coil Deformation | (Implicit: Maintain intended shape and structural integrity under anticipated forces.) | Met established criteria |
| Dimensional & Visual Analysis | (Implicit: Conform to specified dimensions and be free from visual defects.) | Met established criteria |
| Coating Integrity | (Implicit: Maintain a robust and intact coating.) | Met established criteria |
| Force Transfer | (Implicit: Efficiently transfer force for deployment and withdrawal.) | Met established criteria |
| Ease of Delivery/Coil Frictional Characteristics | (Implicit: Demonstrate smooth and controlled delivery with acceptable frictional properties.) | Met established criteria |
| Fiber Endurance Testing | (Implicit: Fibers, if present, must withstand expected stresses over time.) | Met established criteria |
| Reliability After Fatigue & Premature Detachment | (Implicit: Maintain integrity and prevent premature detachment after simulated fatigue.) | Met established criteria |
| Fiber Pull-Out | (Implicit: Fibers must remain securely attached to the coil structure.) | Met established criteria |
| Tensile Strength | (Implicit: Possess adequate tensile strength for handling and deployment.) | Met established criteria |
| Particulate Generation – Adjusted Particles / 1 mL | (Implicit: Generate minimal and acceptable levels of particulates to prevent adverse events.) | Met established criteria |
| PGLA Tensile Testing | (Implicit: If PGLA is used, its tensile properties must meet standards.) | Met established criteria |
| Packaging Integrity | (Implicit: Packaging must maintain sterility and protect the device.) | Met established criteria |
| Overall Substantial Equivalence to Predicate Device | Same intended use, same operating principle, same basic design, similar construction and material, packaged and sterilized using same processes. | The data presented demonstrates technological similarity and is actively compared with the predicate device Nexus Detachable Coils, leading to an opinion of substantial equivalence. |
Study Details:
The provided document describes a Special 510(k) submission for the Nexus Helix Super Soft CSR device. This type of submission relies on the concept of substantial equivalence to a previously cleared predicate device (K050543, Nexus Detachable Coil System). Therefore, the "study" is primarily a bench testing and comparative analysis rather than a full-scale clinical trial.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the sample size used for each bench test. It merely states that the tests "Met established criteria."
- Data Provenance: The data provenance is from Micro Therapeutics, Inc., the manufacturer. It is retrospective in the sense that the testing was conducted by the manufacturer for the purpose of the 510(k) submission, likely in a controlled laboratory setting. No country of origin for the data is explicitly mentioned beyond the company's address in Irvine, California, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Experts and Qualifications: This information is not provided in the document. For bench testing, "ground truth" is typically established by engineering specifications, validated test methods, and industry standards, rather than expert consensus in the clinical sense. The "established criteria" would have been determined by the manufacturer based on these engineering and regulatory requirements.
4. Adjudication Method for the Test Set
- Adjudication Method: This information is not applicable/provided. Bench testing results are typically objectively measured against pre-defined engineering criteria, not adjudicated by a panel in the way clinical study outcomes might be.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This document describes the clearance of a physical medical device (neurovascular embolization coils) through a 510(k) pathway, which primarily relies on bench testing and comparison to an existing predicate device. It is not an AI-assisted diagnostic or imaging device, so MRMC studies involving human readers and AI assistance are irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a physical embolization coil, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
- Ground Truth Type: The "ground truth" for the bench tests is the pre-established engineering specifications, performance standards, and safety requirements for neurovascular embolization devices, as well as the performance characteristics of the predicate device. These are derived from a combination of scientific principles, regulatory guidelines, and industry best practices.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/machine learning model that requires a "training set." The development of the device would involve engineering design and iterative testing, but not in the context of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set Establishment: Not applicable. As explained above, there is no "training set" in the context of this device and submission type.
{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 | ClearanceDate |
|---|---|---|---|
| K050543 | Nexus Detachable CoilSystem | Nexus Detachable Coil, HelixSuper 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
Page 1 of 1
§ 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).