(25 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and physical characteristics of the coils and detachment system, with no mention of AI or ML.
Yes.
The device is used for the treatment and embolization of intracranial aneurysms and other neuro and peripheral vascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae, which are medical conditions.
No
The device is a therapeutic embolization coil used for treating various vascular abnormalities, not for diagnosing them. Its intended use is to treat, not to detect or identify.
No
The device description clearly states it is comprised of physical components (platinum-tungsten alloy coil, stainless steel delivery wire) and is used with a physical detachment system. It is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the treatment of intracranial aneurysms and other vascular abnormalities through endovascular embolization. This is a therapeutic procedure performed within the body.
- Device Description: The description details a physical implant (coils) and a delivery system used to place the implant. This is consistent with a medical device used for treatment, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), reagents, or diagnostic purposes.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic implant used to treat a condition directly.
N/A
Intended Use / Indications for Use
Target Detachable Coils are intended for use in the treatment of intracranial aneurysms and other neuro and peripheral vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
Target Coils are indicated for endovascular embolization of:
- Intracranial aneurysms
- Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
- Arterial and venous embolizations in the peripheral vasculature
Product codes
HCG, KRD
Device Description
Stryker Neurovascular's Target Detachable Coils are comprised of four coil types: Target Coil 360 STANDARD, Target Coil 360 SOFT, Target Coil 360 ULTRA and Target Coil HELICAL ULTRA. All Target Coils are stretch resistant coils. Target Coils incorporate a length of multi-strand material through the center of the coil designed to help resist stretching. Target Coils are designed for use with Stryker Neurovascular's InZoneTM Detachment System (sold separately).
Each Target Coil type consists of a platinum-tungsten alloy coil attached to a stainless steel delivery wire. For Target Coil 360 STANDARD, Target Coil 360 SOFT and Target Coil 360 ULTRA coils the distal end of the main coil is formed such that there is a smaller distal loop at the end of the main coil to facilitate placement of the coil. The diameter of the distal loop is 75% that of the rest of the main coil loops.
Stryker Neurovascular's InZone Detachment System is intended for use with all Stryker Neurovascular Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.
The modifications described within this Special 510(k) have resulted in 12 new smaller coil sizes to be added to the currently approved Target Helical ULTRA and Target 360 ULTRA coil subtypes. These 12 new UPNs use the same processes as the current Target Detachable Coil products with the only difference being the use of a smaller Platinum (Pt) coil wire diameter of 0.00125in.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial (aneurysms), neurovascular (abnormalities), peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Verification testing of the modified Target Detachable Coil consisted of the following:
Testing and Assessments performed for modifications that are the subject of this submission
- Functional Testing to assess mechanical properties impacted by the use of a smaller Platinum (Pt) coil wire diameter of 0.00125in:
- Main Junction Tensile Test a)
- b) Durability Challenge Test
- c) Coil / Catheter Compatibility
-
- Assessment of coil migration of smaller coil sizes via Use and Design FMEAs
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
Image /page/0/Picture/0 description: The image shows the logo for Stryker Neurovascular. The word "Stryker" is in a bold, sans-serif font on the top line. Below that, the word "Neurovascular" is in a smaller, bold, sans-serif font. The logo is black and white.
v ·
KII3412
DEC 1 3 2011
| 510(k) Summary Of Safety And Effectiveness | |
|---|---|
| Summary Date | December 12, 2011 |
| Submitter Name and | |
| Address | Stryker Neurovascular |
| 47900 Bayside Parkway | |
| Fremont, CA. 94538 | |
| Contact Person: | Rhoda M. Santos |
| Sr. Regulatory Affairs Specialist | |
| Phone: 510 413-2269 | |
| Fax: 510 413-2588 | |
| Email: rhoda.santos@stryker.com | |
| Trade Name: | Target® Detachable Coils |
| Common Name: | Occlusion Coil, Vascular Occlusion Coil, Neurovascular Occlusion |
| Coil | |
| Classification Name: | Target Detachable Coils are classed as vascular and neurovascular |
| embolization devices under 21 CFR 870.3300 (KRD) and 21 CFR | |
| 882.5950 (HCG), respectively, and are Class II devices (special | |
| controls). | |
| The special control for the devices is FDA's guidance document, | |
| Class II Special Controls Guidance Document: Vascular and | |
| Neurovascular Embolization Devices (issued 29 Dec 2004). |
1
K113412
Legally Marketed Predicate Devices:
| Reference (Clearance Date) | Device |
|---|---|
| K093142 (4 February 2010) | Target Detachable Coil and InZone® |
| Detachment System | |
| K102672 (15 October 2010) | Target Detachable Coil |
| K112385 (15 September 2011) | Target Detachable Coil |
Device Description:
Stryker Neurovascular's Target Detachable Coils are comprised of four coil types: Target Coil 360 STANDARD, Target Coil 360 SOFT, Target Coil 360 ULTRA and Target Coil HELICAL ULTRA. All Target Coils are stretch resistant coils. Target Coils incorporate a length of multi-strand material through the center of the coil designed to help resist stretching. Target Coils are designed for use with Stryker Neurovascular's InZone™ Detachment System (sold separately).
Each Target Coil type consists of a platinum-tungsten alloy coil attached to a stainless steel delivery wire. For Target Coil 360 STANDARD, Target Coil 360 SOFT and Target Coil 360 ULTRA coils the distal end of the main coil is formed such that there is a smaller distal loop at the end of the main coil to facilitate placement of the coil. The diameter of the distal loop is 75% that of the rest of the main coil loops.
Stryker Neurovascular's InZone Detachment System is intended for use with all Stryker Neurovascular Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.
The modifications described within this Special 510(k) have resulted in 12 new smaller coil sizes to be added to the currently approved Target Helical ULTRA and Target 360 ULTRA coil subtypes. These 12 new UPNs use the same processes as the current Target Detachable Coil products with the only difference being the use of a smaller Platinum (Pt) coil wire diameter of 0.00125in.
Verification Testing:
Verification testing of the modified Target Detachable Coil consisted of the following:
Testing and Assessments performed for modifications that are the subject of this submission
- Functional Testing to assess mechanical properties impacted by the use of a smaller Platinum (Pt) coil wire diameter of 0.00125in:
2