(29 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, Target Helical Nano, Target 360 Ultra, Target Helical Ultra, Target 360 Soft, Target 3D, Target 360 Standard, Target XXL 360, Target XL 360 Soft, Target XL 360 Standard, Target XL Helical, Target Tetra. All Target Coils are stretch resistant coils. Target Coils incorporate a length of monofilament stretch resistant fiber or in the case of the Target Tetra, 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.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sampling sizes, ground truth establishment, or clinical study results for the Target Detachable Coils.
The document appears to be a 510(k) premarket notification for the consolidation of instructions for use and patient information leaflets, along with other minor changes, for existing Target Detachable Coils. It asserts that the modifications do not alter the intended use, indications for use, or fundamental scientific technology of the predicate devices. Therefore, a comparative clinical study is not detailed here.
The document states:
- "This 510(k) requests clearance for the consolidation of three separate Target Instructions for Use (IFUs) into a single shared IFU and consolidates two separate Target Patient Information Leaflet (PIL) with Patient Information Card (PIC), making it a single PIL with PIC for all Target Detachable Coils, in addition to other changes made since the last 510(k) clearance resulting in a cumulative assessment that a new 510(k) is required."
- "The subject devices 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 do not alter the intended use, indications for use, or the fundamental scientific technology of the Predicate Devices."
- "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 the risk assessment of the modifications raise no new questions of safety and effectiveness, Stryker Neurovascular has determined the modified Target Detachable Coils to be substantially equivalent to the predicate device."
Therefore, the requested information regarding acceptance criteria and a study proving device performance is not present in the provided text.
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Image /page/0/Picture/0 description: The image shows the date August 29, 2024. The month is written out in full, followed by the day and year. The text is in a simple, sans-serif font and is easy to read. The date is likely used to indicate an event or deadline.
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Lorraine Mazzeo Staff Regulatory Affairs Specialst 47900 Bayside Parkway Fremont, California 94538
Re: K242243
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: July 30, 2024 Received: July 31, 2024
Dear Lorraine Mazzeo:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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K242243 - Lorraine Mazzeo
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sara S. Thompson -S
Sara S. Thompson, D.V.M. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Stryker Neurovascular Premarket Notification, Special 510(k) Target Detachable Coils
| Date Prepared: | July 30, 2024 |
|---|---|
| Submitter: | Stryker Neurovascular47900 Bayside ParkwayFremont, CA 94538Facility Registration #300853977 |
| Contact: | Lorraine MazzeoStaff Regulatory Affairs SpecialistTel (510) 413-2676E-mail: lorraine.mazzeo@stryker.com |
Device Trade Name: Target Detachable Coils
Classification Name: Target Detachable Coils are 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 Device:
Predicate Devices
K153658 (Cleared 19-May-2016)
K161429 (Cleared 22-June-2016)
K222533 (Cleared 14-Dec-2022)
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DEVICE DESCRIPTION
Stryker Neurovascular Target Detachable Coils are comprised of the following coil types:
| Target 360 Nano | Target Helical Nano |
|---|---|
| Target 360 Ultra | Target Helical Ultra |
| Target 360 Soft | Target 3D |
| Target 360 Standard | Target XXL 360 |
Target XL 360 Soft Target XL 360 Standard Target XL Helical Target Tetra
Please note that all Target Detachable Coils referenced in this submission are considered the subject device.
All Target Coils are stretch resistant coils. Target Coils incorporate a length of monofilament stretch resistant fiber or in the case of the Target Tetra, 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.
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 for the consolidation of three separate Target Instructions for Use (IFUs) into a single shared IFU and consolidates two separate Target Patient Information Leaflet (PIL) with Patient Information Card (PIC), making it a single PIL with PIC for all Target Detachable Coils, in addition to other changes made since the last 510(k) clearance resulting in a cumulative assessment that a new 510(k) is required. The subject devices 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 do not alter the intended use, indications for use, or the fundamental scientific technology of the Predicate Devices. A comparison of the Subject Device with the Predicate Devices is summarized in Table 1 below.
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Stryker Neurovascular Premarket Notification, Special 510(k) Target Detachable Coils
| Characteristic | Predicate DevicesK153658/K161429/K222533 | Subject Device |
|---|---|---|
| Manufacturer | Stryker | Same |
| Trade Name | Target Detachable Coils | Same |
| Device Type | Vascular Embolization Device; Neurovascular Embolization Device | Same |
| Classification | 870.3300, Class 2 | Same |
| Regulation (21 CFR) | 882.5950, Class 2 | Same |
| Product Code: | KRD, HCG | Same |
| IntendedUse/Indication forUse | Target Detachable Coils are intended to endovascularly obstruct orocclude blood flow in vascular abnormalities of the neurovascularand peripheral vessels.Target Detachable Coils are indicated for endovascular embolizationof:•Intracranial aneurysms•Other neurovascular abnormalities such as arteriovenousmalformations and arteriovenous fistulae•Arterial and venous embolizations in the peripheral vasculature | Same |
| How Supplied | Single Use/Sterile | Same |
| Method ofSterilization | Ethylene Oxide (EtO) Gas | Same |
| Coil Material | Platinum/Tungsten alloy | Same |
| Delivery WireMaterial | Stainless steel | Same |
| Features | ||
| Secondary Coil OuterDiameter | 1 mm – 24 mm | Same |
| Coil Length | 1 cm - 50 cm | Same |
| Coil SecondaryShape Types | Helical, 360, 3D, Tetrahedral | Same |
| Power SupplyCompatibility | InZone® Detachment System | Same |
| PackagingConfiguration andMaterials | Pouch:Tyvek/Film pouchCarton:Chipboard cartonDispenser coil (Hoop):HDPE tubing and clips | Same |
Table 1. Substantial Equivalence Comparison
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ACCESSORIES
Target Detachable Coils are not packaged with any accessories.
INTENDED USE / INDICATION FOR USE:
Intended Use:
Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Indication 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 ●
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 the risk assessment of the modifications raise no new questions of safety and effectiveness, Stryker Neurovascular has determined the modified Target Detachable Coils to be substantially equivalent to the predicate device.
§ 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).