(150 days)
No
The summary describes a physical medical device (detachable coils) and its mechanical properties and testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, which is a therapeutic intervention.
No
The device is indicated for endovascular embolization, which is a therapeutic procedure used to block blood flow, not to diagnose a condition.
No
The device description explicitly details physical components made of platinum-tungsten alloy and stainless steel, and the performance studies involve testing of physical properties like tensile strength and detachment, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Target Detachable Coils are for endovascular embolization of intracranial aneurysms and other vascular abnormalities. This is a therapeutic procedure performed within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical implantable device (coils) and a delivery system, designed for placement within blood vessels. This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to physically block blood flow in specific areas, which is a therapeutic intervention.
N/A
Intended Use / Indications for Use
- Target Detachable 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 (comma separated list FDA assigned to the subject device)
HCG, KRD
Device Description
Stryker Neurovascular Target Detachable Coils are comprised of the following coil types: Target 360 Nano Target Helical Nano Target XL 360 Soft Target 360 Ultra Target Helical Ultra Target XL 360 Stand Target 360 Soft Target XL Helical Target 360 Standard Target 3D 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 the Stryker Neurovascular 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 Coils in the 360-shape, 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. The Stryker Neurovascular 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, neurovascular, 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 was conducted on the modified Target Detachable Coil including: Delivery Wire Tensile Strength, Proximal Contact Buckling, Proximal Contact Tensile Strength, Coil Detachment, Biocompatibility (MEM Elution Cytotoxicity, Hemolysis Direct/Extract Contact, USP Physicochemical USP , FTIR, Natural Rubber Latex, ELISA Inhibition Assay for Antigenic Protein ASTM D6499-12), Packaging, and Simulated Use (Detachment unit compatibility with coil, Introducer sheath friction acceptability, Removal of coil from the packaging hoop without damaging the device). All tests met the same criteria as the predicate device.
Additionally, MRI testing was performed for magnetically induced displacement (ASTM F2052), magnetically induced torque (ASTM F2213), magnetically induced heating effect (ASTM F2182), and MR induced image artifact (ASTM F2119). All MRI tests met the same criteria as the predicate device.
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.
K093142, K102672, K112385, K113412
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2016
Stryker Neurovascular Ms. Kate Taylor Sr. Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538
Re: K153658
Trade/Device Name: Target Detachable Coils Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: May 13, 2016 Received: May 16, 2016
Dear Ms. Taylor:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153658
Device Name Target Detachable Coils
Indications for Use (Describe)
- Target Detachable 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
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The word is black and the background is white. There is a registered trademark symbol to the right of the word.
Neurovascular
510(k) Summary
| Summary Date: | May 19, 2016 |
|---|---|
| Submitter Name and Address: Stryker Neurovascular | 47900 Bayside Parkway |
| Fremont, CA. 94538 | |
| Contact Person: | Kate Taylor |
| Sr. Regulatory Affairs Specialist | |
| Phone: 510 413-2175 | |
| Email: kate.taylor@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). | |
| Legally Marketed | |
| Predicate Devices: | Primary Predicate |
| K123377, Target Detachable Coils (cleared 30 November 2012) | |
| Reference Devices | |
| K093142 Target Detachable Coils (cleared 04 Feb 2010) | |
| K102672 Target Detachable Coils (cleared 15 October 2010) | |
| K112385 Target Detachable Coils (cleared 15 September 2011) | |
| K113412 Target Detachable Coils (cleared 13 December 2012) |
4
| Device Description: | Stryker Neurovascular Target Detachable Coils are comprised of the following coil types:
Target 360 Nano Target Helical Nano Target XL 360 Soft
Target 360 Ultra Target Helical Ultra Target XL 360 Stand
Target 360 Soft Target XL Helical
Target 360 Standard Target 3D
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 the Stryker Neurovascular 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 Coils in the 360-shape, 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.
The Stryker Neurovascular 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. |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to the Predicate Device: | Target Detachable Coils
The modifications described within this 510(k) include minor dimensional changes to the components in the Target Coil design, which when used with the updated InZone Detachment System, result in shorter detachment time. Additional changes include modifications to the Target Detachable Coils carton, packaging hoop and Directions for Use.
The modified Stryker Neurovascular Target Detachable Coils have the same intended use/indications for use as the predicate Target Detachable Coils.
The modifications to the Target Detachable Coils do not alter the intended use, indications for use, or the fundamental scientific technology of the predicate devices.
Risk assessment of the modifications in the form of design and use failure modes and effects analysis (design and use FMEAs) has been conducted in accordance with EN ISO 14971:2012. Stryker Neurovascular has determined the modifications to the predicate devices raise no new questions of safety or effectiveness. |
5
Verification Testing:
Verification testing of the modified Target Detachable Coil consisted of the following:
| Test | Test Method Summary/Purpose | Results |
|---|---|---|
| Delivery Wire | ||
| Tensile Strength | Determine the force at break at bond | |
| joints for delivery wire via tensile | ||
| testing. | Met the same criteria as | |
| the predicate device. | ||
| Proximal Contact | ||
| Buckling | Determine the maximum buckling | |
| force to kink the proximal contact. | Met the same criteria as | |
| the predicate device. | ||
| Proximal Contact | ||
| Tensile Strength | Determine the maximum tensile force | |
| to break the proximal contact joint. | Met the same criteria as | |
| the predicate device. | ||
| Coil Detachment | Measure coil detachment time in | |
| bovine serum using the InZone | ||
| Detachment System. | Met the same criteria as | |
| the predicate device. | ||
| Biocompatibility | • MEM Elution Cytotoxicity | |
| • Hemolysis Direct/Extract Contact | ||
| • USP Physicochemical USP | ||
| • FTIR | ||
| • Natural Rubber Latex | ||
| • ELISA Inhibition Assay for | ||
| Antigenic Protein ASTM D6499-12 | Met the same criteria as | |
| the predicate device. | ||
| Packaging | Assess the ability of the packaging | |
| system to protect the finished device. | Met the same criteria as | |
| the predicate device. | ||
| Simulated Use | • Detachment unit compatibility with | |
| coil | ||
| • Introducer sheath friction | ||
| acceptability | ||
| • Removal of coil from the packaging | ||
| hoop without damaging the device | Met the same criteria as | |
| the predicate device. |
Additional MRI testing was conducted in support of updates to the Directions for Use MRI Safety Information (Peripheral Use)
| Test | Test Method Summary/Purpose | Results |
|---|---|---|
| Magnetically | ||
| induced | ||
| displacement | ASTM F2052 | Met the same criteria as |
| the predicate device. | ||
| Magnetically | ||
| induced torque | ASTM F2213 | Met the same criteria as |
| the predicate device. | ||
| Magnetically | ||
| induced heating | ||
| effect | ASTM F2182 | Met the same criteria as |
| the predicate device. | ||
| MR induced | ||
| image artifact | ASTM F2119 | Met the same criteria as |
| the predicate device. |
Predicate Device Testing (from K102672)
MRI testing from a previous 510(k) was used in support of updates to the Directions for Use MRI Safety Information (Neurovascular Use)
| Test | Test Method Summary/Purpose | Results |
|---|---|---|
| Magnetically | ||
| induced | ||
| displacement | ASTM F2052 | Met the same criteria as |
| the predicate device. | ||
| Magnetically | ||
| induced torque | ASTM F2213 | Met the same criteria as |
| the predicate device. | ||
| Magnetically | ||
| induced heating | ||
| effect | ASTM F2182 | Met the same criteria as |
| the predicate device. | ||
| MR induced | ||
| image artifact | ASTM F2119 | Met the same criteria as |
| the predicate device. |
6
Accessories:
Intended Use / Indications for Use: Target Detachable Coils are not packaged with any accessories.
Intended Use
Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Indications for Use
Target Detachable 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
Because the subject modifications do not alter the intended use or indications for use of the predicate devices, or the fundamental scientific technology of the predicate devices; and because risk assessment of the modifications and successful verification testing raise no new questions of safety and effectiveness, Stryker Neurovascular has determined the modified Target Detachable Coils to be substantially equivalent to the predicate devices.