(114 days)
Not Found
No
The summary describes a physical medical device (detachable coils) and its mechanical properties and performance. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to obstruct or occlude blood flow in vascular abnormalities, which is a therapeutic intervention for medical conditions like aneurysms and arteriovenous malformations.
No
The device is intended for endovascularly obstructing or occluding blood flow to treat vascular abnormalities, which is a therapeutic rather than diagnostic function.
No
The device description explicitly states that the device is comprised of physical components made of platinum-tungsten alloy and stainless steel, and is designed for use with a separate physical detachment system. It is a physical medical 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Target Detachable Coils are physical devices intended to be inserted into blood vessels to obstruct or occlude blood flow. This is an in vivo procedure (performed within the living body), not an in vitro test (performed outside the body).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the Target Detachable Coils are a medical device used for therapeutic intervention within the body, 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 (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 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 (Subject Device)
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 with the Tetrahedral shape, the distal end of the main coil is formed such that the diameter of the distal loop is approximately 75% that of the overall secondary outer diameter (OD) size.
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
Fluoroscopy
Anatomical Site
Neurovascular and peripheral vessels
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)
Performance bench testing has demonstrated that the Target Tetra Detachable Coils are substantially equivalent to the predicate devices and do not raise new questions of safety or effectiveness.
Performance bench testing of the Target Tetra Detachable Coils consisted of the following tests listed in Table 2:
- Tipball Attachment: Use tensile tester to tensile test the tipball. Place tipball in flow test setup. Visually inspect tipball to ensure it is attached to the main coil after being subjected to pre-loading and flow test conditions. Met acceptance criteria.
- Durability: The coil is visually inspected for damage and main junction tensile strength is tested after simulated deployment/retraction in a tortuous model. Met acceptance criteria.
- Particulates: Particulate release due to delivery of the coil is measured. Particulate characterization was acceptable.
- Friction: Frictional force through an introducer sheath and a compatible microcatheter is measured. Met acceptance criteria.
- Packaging: Assess the ability of the packaging system to protect the finished device. Met acceptance criteria.
- Simulated Use: Microcatheter Compatibility, Main Coil Softness (Coil Conformability), Sheath Friction, Aneurysm Frame and Fill, Coil Framing Ability, Coil Stretch Resistance [SR], Coil Durability During Repositioning, Main Junction Interaction with Microcatheter during Alignment, Intended Use Environment, Labeling Requirements, Device Visibility under Fluoroscopy. Design validation testing met acceptance criteria.
No animal study was conducted.
No clinical study was conducted.
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.
Not Found
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).
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December 14, 2022
Image /page/0/Picture/1 description: The image shows 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.
Stryker Neurovascular Jonathan Bemben Staff Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538
Re: K222533
Trade/Device Name: Target Tetra Detachable Coils Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: November 10, 2022 Received: November 14, 2022
Dear Jonathan Bemben:
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. 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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
Naira Muradyan -S
Naira Muradyan, Ph.D. 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
Enclosure
2
Indications for Use
510(k) Number (if known) K222533
Device Name Target Tetra™ Detachable Coils
Indications for Use (Describe)
Target Detachable Coils are intended to endovascularly obstuct 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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Image /page/3/Picture/0 description: The image shows the Stryker Neurovascular logo. The word "Stryker" is in a bold, sans-serif font, with the "S" being the largest letter. Below "Stryker" is the word "Neurovascular" in a smaller, sans-serif font. There is a registered trademark symbol to the right of the word "Stryker".
| Submitter: | Stryker Neurovascular
47900 Bayside Parkway
Fremont, CA 94538
Facility Registration #300853977 |
|------------|---------------------------------------------------------------------------------------------------------|
| Contact: | Jonathan Bemben
Tel (651) 202-8121
E-mail: Jonathan.Bemben@Stryker.com |
Date Prepared: December 14, 2022
Device Trade Name: Target Tetra™ 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 Devices:
| Predicate Devices | |
|---|---|
| K153658 (Cleared 19-May-2016) | Target Detachable Coils |
| K161429 (Cleared 22-June-2016) |
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Image /page/4/Picture/0 description: The image shows the logo for Stryker Neurovascular. The word "Stryker" is in a bold, sans-serif font, with the "S" being the largest letter. Below "Stryker" is the word "Neurovascular" in a smaller, sans-serif font. The logo is black and white, and there is a registered trademark symbol next to the "r" in "Stryker."
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 (Subject Device)
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 with the Tetrahedral shape, the distal end of the main coil is formed such that the diameter of the distal loop is approximately 75% that of the overall secondary outer diameter (OD) size.
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.
INTENDED USE / INDICATION 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
COMPARISON TO THE PREDICATE DEVICE: TARGET DETACHABLE COILS
The change which differentiates the Target Tetra Detachable Coils from the rest of the Target Detachable Coil product family is a new secondary shape, a modified stretch resistant fiber configuration and a modified link design as compared to the current range of Target Detachable Coils.
The Target Tetra Detachable Coils share the same intended use, indications for use, and fundamental scientific technology as the predicate devices. A comparison of the subject device with the predicate devices is summarized in Table 1 below.
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Image /page/5/Picture/0 description: The image shows the Stryker Neurovascular logo. The word "stryker" is in a bold, sans-serif font, with a registered trademark symbol to the right of the "r". Below "stryker" is the word "Neurovascular" in a smaller, bold, sans-serif font.
Stryker Neurovascular Premarket Notification, Traditional 510(k) K222533 Target Tetra Detachable Coils
| Characteristic | Target Detachable Coils (predicate
devices K153658 and K161429) | Target Tetra
Detachable Coils
(subject device
K222533) |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Stryker | Same |
| Trade Name | Target Detachable Coils | Target Tetra™
Detachable Coils |
| Device Type | Vascular Embolization Device; Neurovascular Embolization Device | Same |
| Classification
Regulation (21 CFR) | 870.3300, Class 2
882.5950, Class 2 | Same |
| Product Code: | KRD, HCG | Same |
| Intended
Use/Indication 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 | Same |
| How Supplied | Single Use/Sterile | Same |
| Method of
Sterilization | Ethylene Oxide (EtO) Gas | Same |
| Coil Material | ● Platinum/Tungsten alloy | Same |
| Delivery Wire
Material | ● Stainless steel | Same |
| Features | | |
| Primary Wire Outer
Diameter | 0.00125 in - 0.003 in
(0.032 mm - 0.076 mm) | Target Tetra fits within the
range of currently offered
Target Detachable Coils
and utilizes a Primary Wire
Outer Diameter of 0.00125
in |
| Primary Coil Wind
Outer Diameter | 0.010 in – 0.017 in
(0.254 mm – 0.432 mm) | Target Tetra fits within the
range of currently offered
Target Detachable Coils
and utilizes a Primary Coil
Wind Outer Diameter of
0.010 in |
| Secondary Coil Outer
Diameter | 1 mm – 24 mm | Target Tetra fits within
the range of currently
offered Target Detachable
Coils and utilizes a range
of Secondary Coil Outer
Diameters of 1.5 mm –
4.5 mm |
Table 1. Substantial Equivalence Comparison
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Image /page/6/Picture/0 description: The image shows the logo for Stryker Neurovascular. The word "Stryker" is in a bold, sans-serif font, with the "S" being slightly larger than the other letters. The word "Neurovascular" is in a smaller, sans-serif font and is located below the word "Stryker". There is a registered trademark symbol to the right of the "r" in Stryker.
Stryker Neurovascular Premarket Notification, Traditional 510(k) K222533 Target Tetra Detachable Coils
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Image /page/7/Picture/0 description: The image contains the logo for Stryker Neurovascular. The word "Stryker" is in a bold, sans-serif font on the top line, with a registered trademark symbol to the right of the "r". Below that, the word "Neurovascular" is in a smaller, sans-serif font.
Stryker Neurovascular
Premarket Notification, Traditional 510(k) K222533 Target Tetra Detachable Coils
| Characteristic | Target Detachable Coils (predicate devices K153658 and K161429) | Target Tetra Detachable Coils (subject device K222533) |
|---|---|---|
| Coil Length | 1 cm – 50 cm | Target Tetra fits within the range of currently offered Target Detachable Coils and utilizes a Coil Length range of 2.0 cm – 10.0 cm |
| Coil Secondary Shape Types | Helical, 360, 3D | Tetrahedral |
| Power Supply Compatibility | InZone® Detachment System | Same |
| Packaging Configuration and Materials | Pouch: Tyvek/Film pouch | |
| Carton: Chipboard carton | ||
| Dispenser coil (Hoop): HDPE tubing and clips | Same |
RISK ASSESSMENT
Risk assessment has been conducted for the subject device in accordance with EN ISO 14971:2019. Stryker Neurovascular has determined that no new questions of safety or effectiveness are raised when compared to the predicate devices. This line extension does not result in any new failure modes nor were there any changes to existing failure modes.
PERFORMANCE DATA - BIOCOMPATIBILITY TESTING
The subject device was evaluated for biocompatibility using EN ISO 10993-1:2020 and FDA guidance documents. All materials of the subject device have an established history of safe use from the predicate devices and there are no novel materials or processes used. Confirmatory chemical characterization testing was performed on the subject device using Fourier-transform infrared spectroscopy (FTIR) and physicochemical evaluation to determine substantial equivalence to the predicate devices. From the evaluation performed, the previously conducted biocompatibility testing for the predicate devices is deemed applicable for the subject device.
PERFORMANCE DATA - BENCH TESTING
Performance bench testing has demonstrated that the Target Tetra Detachable Coils are substantially equivalent to the predicate devices and do not raise new questions of safety or effectiveness.
Performance bench testing of the Target Tetra Detachable Coils consisted of the following tests listed in Table 2.
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Image /page/8/Picture/0 description: The image shows the Stryker Neurovascular logo. The word "Stryker" is in a bold, sans-serif font, with a registered trademark symbol to the right of the "r". Below "Stryker" is the word "Neurovascular" in a smaller, sans-serif font.
| Test | Test Method Summary/Purpose | Conclusions |
|---|---|---|
| Tipball Attachment | Use tensile tester to tensile test the | |
| tipball. Place tipball in flow test setup. | ||
| Visually inspect tipball to ensure it is | ||
| attached to the main coil after being | ||
| subjected to pre-loading and flow test | ||
| conditions. | Met acceptance criteria | |
| Durability | The coil is visually inspected for | |
| damage and main junction tensile | ||
| strength is tested after simulated | ||
| deployment/retraction in a tortuous | ||
| model. | Met acceptance criteria | |
| Particulates | Particulate release due to delivery of the | |
| coil is measured. | Particulate characterization was acceptable | |
| Friction | Frictional force through an introducer | |
| sheath and a compatible microcatheter | ||
| is measured. | Met acceptance criteria | |
| Packaging | Assess the ability of the packaging | |
| system to protect the finished device. | Met acceptance criteria | |
| Simulated Use | Microcatheter CompatibilityMain Coil Softness (Coil | |
| Conformability)Sheath FrictionAneurysm Frame and FillCoil Framing AbilityCoil Stretch Resistance [SR]Coil Durability During | ||
| RepositioningMain Junction Interaction with | ||
| Microcatheter during AlignmentIntended Use EnvironmentLabeling RequirementsDevice Visibility under | ||
| Fluoroscopy | Design validation testing met acceptance | |
| criteria |
Table 2. Performance Bench Testing
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Image /page/9/Picture/0 description: The image shows the logo for Stryker Neurovascular. The word "Stryker" is in a bold, sans-serif font, and the word "Neurovascular" is in a smaller, sans-serif font below it. The logo is black and white. There is a registered trademark symbol to the right of the word "Stryker".
PERFORMANCE DATA - ANIMAL STUDY
No animal study was conducted because bench testing was determined sufficient to support substantial equivalence to the predicate device.
PERFORMANCE DATA - CLINICAL STUDY
No clinical study was conducted because bench testing was determined sufficient to support substantial equivalence to the predicate device.
ACCESSORIES
Target Tetra Detachable Coils are not packaged with any accessories.
CONCLUSION
The Target Tetra Detachable Coils share the same intended use, indications for use, and fundamental scientific technology as the predicate devices, Target Detachable Coils. Additionally, risk assessment of the modifications raises no new questions of safety and effectiveness and successful verification and validation testing demonstrated that the device functions as intended. Therefore, Stryker Neurovascular has determined the Target Tetra Detachable Coils to be substantially equivalent to the predicate devices.