(30 days)
No
The document describes a physical medical device (detachable coils) and its delivery system. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML.
Yes
The device is intended to obstruct or occlude blood flow in vascular abnormalities, such as aneurysms and malformations, which is a therapeutic intervention.
No
The device, Target Detachable Coils, is described as being used for endovascular embolization to obstruct or occlude blood flow in vascular abnormalities, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states that the device is comprised of physical components made of platinum-tungsten alloy and stainless steel, and is used with a physical detachment system. This indicates it is a hardware device, not software-only.
Based on the provided information, 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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use clearly state that the Target Detachable Coils are implanted devices used to physically obstruct or occlude blood flow within blood vessels. They are used in vivo (within the living body) for therapeutic purposes (embolization).
- Lack of IVD Characteristics: There is no mention of testing biological samples, analyzing biomarkers, or providing diagnostic information based on laboratory analysis.
Therefore, the Target Detachable Coils are a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
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
HCG, KRD
Device Description
Stryker Neurovascular Target Detachable Coils are comprised of the following coil types: Target 360 Nano. 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
neurovascular and peripheral vessels, 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
Verification testing of the modified Target Detachable Coil consisted of the following:
Measurements of Coil Secondary Diameter and 2D Loop Secondary Diameter were taken and "Met the same criteria as the predicate device." Visual confirmation that the entire coil is contained within the introducer sheath was performed and "Met the same criteria as the predicate device." Durability testing involved visually inspecting the coil for damage and testing Main Junction Tensile Strength after simulated deployment/retraction in a tortuous model, and "Met the same criteria as the predicate device." Particulate release due to delivery of the coil was measured and "Met the same criteria as the predicate device." Frictional force through an introducer sheath and a compatible microcatheter was measured and "Met the same criteria as the predicate device." Biocompatibility testing included MEM Elution Cytotoxicity/Part 5, Hemolysis Direct/Extract Contact/Part 4, USP Physicochemical USP , FTIR/Part 18, and Natural Rubber Latex, all of which "Met the same criteria as the predicate device." Packaging assessment involved checking the ability of the packaging system to protect the finished device and "Met the same criteria as the predicate device." Simulated use testing evaluated coil conformability, coil durability during repositioning, microcatheter compatibility, coil friction during delivery through the microcatheter, introducer sheath friction acceptability, and removal of coil from the packaging hoop without damaging the device, with all aspects meeting "the same criteria as the predicate device."
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K123377, K093142, K102672, K112385, K113412
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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 22, 2016
Stryker Neurovascular Ms. Kate Taylor Staff Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538
Re: K161429
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 20, 2016 Received: May 23, 2016
Dear Ms. Kate 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) K161429
Device Name Target Detachable Coils
Indications for Use (Describe)
Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
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)
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Neurovascular
510(k) Summary
| Summary Date: | May 20, 2016 |
|---|---|
| Submitter Name and Address: | Stryker Neurovascular |
| 47900 Bayside Parkway | |
| Fremont, CA. 94538 | |
| Contact Person: | Kate Taylor |
| Staff 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
K153658 Target Detachable Coils (cleared 19 May 2016)
Reference Predicates
K123377 Target Detachable Coils (cleared 30 November 2012) |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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) |
| Device Description: | Stryker Neurovascular Target Detachable Coils are comprised of the following coil types:
Target 360 Nano |
4
| Device Description:
(continued) | 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
This 510(k) requests clearance of 8 new Target Detachable Coil UPNs –
Target XXL 360 Detachable Coils. The change which differentiates the
Target XXL 360 Coils from the rest of the Target Detachable Coil product
family is a new, larger primary coil OD (0.017 inches), as compared to
current range of Target Coils primary coil ODs (0.010 - 0.014 inches).
The larger primary coil OD of the Target XXL 360 Detachable Coils
necessitates minor dimensional increase to the ID of the introducer sheath,
which is a component of the packaging hoop and facilitates introduction
into the microcatheter. The new introducer sheath is made of the same high
density polyethylene material as the current introducer sheath, but uses a
different pigment to color the sheath to provide differentiation from other
Target Coils. The larger primary OD requires that the Target XXL Coil be
used with the larger of the microcatheters recommended for all other Target
Coils: maximum internal diameter 0.48 mm [0.019 in].
The new UPNs utilize the same design and materials of existing Target
Coils, and the same manufacturing, packaging and sterilization processes.
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. |
| | Verification testing has demonstrated the modified Target Detachable Coils
are substantially equivalent to the predicate Target Detachable Coils. |
5
Verification Testing:
Accessories:
Verification testing of the modified Target Detachable Coil consisted of the following:
| Test | Test Method Summary/Purpose | Results |
|---|---|---|
| Dimensions | Coil Secondary Diameter and 2D | |
| Loop Secondary Diameter are | ||
| measured. | Met the same criteria as | |
| the predicate device. | ||
| Visual | Visual confirmation that the entire coil | |
| is contained within the introducer | ||
| sheath. | Met the same criteria as | |
| the predicate device. | ||
| Durability | The coil is visually inspected for | |
| damage and Main Junction Tensile | ||
| Strength is tested after simulated | ||
| deployment/retraction in a tortuous | ||
| model. | Met the same criteria as | |
| the predicate device. | ||
| Particulates | Particulate release due to delivery of | |
| the coil is measured. | Met the same criteria as | |
| the predicate device. | ||
| Friction | Frictional force through an introducer | |
| sheath and a compatible | ||
| microcatheter is measured. | Met the same criteria as | |
| the predicate device. | ||
| Biocompatibility | • MEM Elution Cytotoxicity/Part 5 | |
| • Hemolysis Direct/Extract | ||
| Contact/Part 4 | ||
| • USP Physicochemical USP | ||
| • FTIR/Part 18 | ||
| • Natural Rubber Latex | 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 | • Coil conformability | |
| • Coil durability during repositioning | ||
| • Microcatheter compatibility | ||
| • Coil friction during delivery through | ||
| the microcatheter | ||
| • Introducer sheath friction | ||
| acceptability | ||
| • Removal of coil from the packaging | ||
| hoop without damaging the device | Met the same criteria as | |
| the predicate device. |
Target Detachable Coils are not packaged with any accessories.
| Intended Use /
| Indications for Use | Intended Use/Indications for use |
|---|---|
| Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. |
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 |
| Conclusion: | 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. |