(30 days)
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
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.
This document, K161429, concerns the 510(k) premarket notification for Stryker Neurovascular Target Detachable Coils, specifically the new Target XXL 360 Detachable Coils. The submission aims to demonstrate substantial equivalence to previously cleared Target Detachable Coils.
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes "Verification Testing" to demonstrate substantial equivalence. The acceptance criteria for the new Target XXL 360 Detachable Coils are explicitly stated as meeting the same criteria as the predicate device for each test. The reported device performance is that the new coils Met the same criteria as the predicate device.
| Test | Test Method Summary/Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensions | Coil Secondary Diameter and 2D Loop Secondary Diameter are measured. | Met the same criteria as the predicate device. | 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. | 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. | 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. | 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. | Met the same criteria as the predicate device. |
| Biocompatibility | • MEM Elution Cytotoxicity/Part 5• Hemolysis Direct/Extract Contact/Part 4• USP Physicochemical USP <661>• FTIR/Part 18• Natural Rubber Latex | Met the same criteria as the predicate device. | 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. | 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. | Met the same criteria as the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the test set for any of the verification tests. It also does not provide information on the data provenance, such as country of origin or whether the data was retrospective or prospective. The tests described are laboratory-based engineering and material testing, not clinical studies involving human patients or data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided in the document. The "ground truth" in this context refers to the defined engineering and material properties acceptable within the product specifications, not to clinical diagnoses or interpretations by medical experts. The tests are designed to measure physical and chemical properties against established internal specifications, which likely involve engineering standards and regulatory requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided in the document. Adjudication methods are typically used in clinical studies involving observer variability in assessments (e.g., image interpretation). The verification tests performed are objective, measurable physical and chemical tests, not requiring human adjudication.
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
An MRMC comparative effectiveness study was not conducted. This document describes the clearance of a medical device (detachable coils) based on substantial equivalence through engineering and material testing, not an AI or imaging diagnostic device. Therefore, questions regarding human reader improvement with or without AI assistance are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
A standalone performance study for an algorithm was not conducted. This document pertains to the clearance of a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the verification tests performed is based on defined engineering specifications, material properties, and regulatory standards for similar predicate devices. The acceptance criteria are "the same criteria as the predicate device," indicating that the "truth" is established by the performance and specifications of previously cleared, substantially equivalent devices. This is not derived from expert consensus, pathology, or outcomes data in the clinical sense, but from established physical and performance benchmarks for the device type.
8. The sample size for the training set
This information is not applicable and not provided. As this is not an AI/machine learning device, there is no "training set." The coils are physical devices validated through engineering tests.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As there is no "training set" in the context of this device clearance, the method of establishing its ground truth is irrelevant.
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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.
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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
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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 Neurovascular47900 Bayside ParkwayFremont, CA. 94538 |
| Contact Person: | Kate TaylorStaff Regulatory Affairs SpecialistPhone: 510 413-2175Email: 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 neurovascularembolization 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 MarketedPredicate Devices: | Primary PredicateK153658 Target Detachable Coils (cleared 19 May 2016)Reference PredicatesK123377 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 |
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| Device Description:(continued) | All Target Coils are stretch resistant coils. Target Coils incorporate a lengthof multi-strand material through the center of the coil designed to help resiststretching. Target Coils are designed for use with the Stryker NeurovascularInZone® Detachment System (sold separately). |
|---|---|
| Each Target Coil type consists of a platinum-tungsten alloy coil attached toa stainless steel delivery wire. For Target Coils in the 360-shape, the distalend of the main coil is formed such that there is a smaller distal loop at theend of the main coil to facilitate placement of the coil. The diameter of thedistal loop is 75% that of the rest of the main coil loops. | |
| The Stryker Neurovascular InZone Detachment System is intended for usewith all Stryker Neurovascular Detachable Coils in the embolization ofintracranial aneurysms and other vascular malformations of the neuro andperipheral vasculature. | |
| Comparison to thePredicate Device: | Target Detachable CoilsThis 510(k) requests clearance of 8 new Target Detachable Coil UPNs –Target XXL 360 Detachable Coils. The change which differentiates theTarget XXL 360 Coils from the rest of the Target Detachable Coil productfamily is a new, larger primary coil OD (0.017 inches), as compared tocurrent range of Target Coils primary coil ODs (0.010 - 0.014 inches).The larger primary coil OD of the Target XXL 360 Detachable Coilsnecessitates minor dimensional increase to the ID of the introducer sheath,which is a component of the packaging hoop and facilitates introductioninto the microcatheter. The new introducer sheath is made of the same highdensity polyethylene material as the current introducer sheath, but uses adifferent pigment to color the sheath to provide differentiation from otherTarget Coils. The larger primary OD requires that the Target XXL Coil beused with the larger of the microcatheters recommended for all other TargetCoils: maximum internal diameter 0.48 mm [0.019 in].The new UPNs utilize the same design and materials of existing TargetCoils, and the same manufacturing, packaging and sterilization processes.The modified Stryker Neurovascular Target Detachable Coils have the sameintended use/indications for use as the predicate TargetDetachable Coils.The modifications to the Target Detachable Coils do not alter the intendeduse, indications for use, or the fundamental scientific technology of thepredicate devices.Risk assessment of the modifications in the form of design and use failuremodes and effects analysis (design and use FMEAs) has been conducted inaccordance with EN ISO 14971:2012. Stryker Neurovascular hasdetermined the modifications to the predicate devices raise no newquestions of safety or effectiveness. |
| Verification testing has demonstrated the modified Target Detachable Coilsare substantially equivalent to the predicate Target Detachable Coils. |
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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 2DLoop Secondary Diameter aremeasured. | Met the same criteria asthe predicate device. |
| Visual | Visual confirmation that the entire coilis contained within the introducersheath. | Met the same criteria asthe predicate device. |
| Durability | The coil is visually inspected fordamage and Main Junction TensileStrength is tested after simulateddeployment/retraction in a tortuousmodel. | Met the same criteria asthe predicate device. |
| Particulates | Particulate release due to delivery ofthe coil is measured. | Met the same criteria asthe predicate device. |
| Friction | Frictional force through an introducersheath and a compatiblemicrocatheter is measured. | Met the same criteria asthe predicate device. |
| Biocompatibility | • MEM Elution Cytotoxicity/Part 5• Hemolysis Direct/ExtractContact/Part 4• USP Physicochemical USP <661>• FTIR/Part 18• Natural Rubber Latex | Met the same criteria asthe predicate device. |
| Packaging | Assess the ability of the packagingsystem to protect the finished device. | Met the same criteria asthe predicate device. |
| Simulated Use | • Coil conformability• Coil durability during repositioning• Microcatheter compatibility• Coil friction during delivery throughthe microcatheter• Introducer sheath frictionacceptability• Removal of coil from the packaginghoop without damaging the device | Met the same criteria asthe 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. |
§ 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).