(29 days)
Not Found
No
The summary describes a handheld, battery-powered device for detaching coils. There is no mention of AI, ML, image processing, or any data processing that would suggest the use of such technologies. The performance studies focus on basic device functionality and software verification, not AI/ML model performance.
Yes
The device is used in the embolization of intracranial aneurysms and other vascular malformations, which is a therapeutic intervention.
No
The device is described as an "embolization" system for "detachable coils," indicating its role in treating vascular malformations, not diagnosing them. Its function is to deploy coils for therapeutic purposes rather than to acquire, process, or analyze medical data for diagnostic ends.
No
The device description explicitly states it is a "sterile, handheld, single-patient use device" consisting of an enclosure, button, LED lamps, funnel, cable connection port, and batteries, indicating it is a physical hardware device. While it contains software (firmware), it is not solely software.
Based on the provided information, the Stryker Neurovascular InZone Detachment System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the embolization of intracranial aneurysms and other vascular malformations within the body (in vivo). IVDs are used to examine specimens from the body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a handheld system used to detach coils during a surgical procedure. It interacts directly with the medical device (coils) and the patient's vasculature, not with a biological sample outside the body.
- Anatomical Site: The anatomical sites mentioned are within the neuro and peripheral vasculature, indicating an in-vivo application.
Therefore, the InZone Detachment System is a medical device used in a surgical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 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.
Product codes (comma separated list FDA assigned to the subject device)
HCG, KRD
Device Description
The Stryker Neurovascular InZone Detachment System is a sterile, handheld, single-patient use device designed for use with Stryker Neurovascular Detachable Coils. The device consists of an enclosure with a detachment button, five LED indicator lamps, a funnel inset at its distal end, and a cable connection port. The device comes pre-loaded with two AAAA (1.5 VDC) batteries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial aneurysms and other vascular malformations of the neuro and 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 of the modified InZone Detachment System consisted of the following:
-
Software (firmware) test case model as well as bench top testing to assess a) delivery wire detection; b) maximum detachment time; c) detachment consistency; d) detachment attempts that run the full cycle and those that complete in less than full cycle, and e) changes to labeling.
-
Software verification in accordance with Stryker Neurovascular Corporate SOP for Medical Device Software Development.
-
Risk assessment in accordance with ISO 14971:2009
-
Assessment of the modifications for impact upon:
Sterility Assurance (no impact) Shelf Life (no impact) Packaging Validation (no impact)
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
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(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 § 870.1(e).
0
InZone® Detachment System
Image /page/0/Picture/2 description: The image shows the logo for Stryker Neurovascular. The word "Stryker" is in a bold, sans-serif font on the top line. Below that, the word "Neurovascular" is in a smaller, bold, sans-serif font. The logo is black and white.
510(k) Summary of Safety and Effectiveness
| Summary Date | March 2012 |
|---|---|
| Submitter Name and | |
| Address | Stryker Neurovascular |
| 47900 Bayside Parkway | |
| Fremont, CA 94538 | |
| Contact Person: | Mara Chou |
| Sr. Regulatory Affairs Specialist | |
| Phone: 510 413 2595 | |
| Fax: 510 413 2588 | |
| Email: mara.chou@stryker.com | |
| Trade Name: | InZone Detachment System |
| Common Name: | Power Supply |
| Classification Name: | The 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. |
Stryker Neurovascular detachable coils are Class II devices
(special controls) classed as neurovascular embolization
devices under 21 CFR 882.5950 (HCG) and vascular
embolization devices under 21 CFR 870.3300 (KRD).
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: | |
| | Device
Reference (Clearance Date) |
APR 1 7 2012
Page 1 of 7
InZone Detachment System
K103008 (10 Dec 2010)
1
Device Description:
The Stryker Neurovascular InZone Detachment System is a sterile, handheld, single-patient use device designed for use with Stryker Neurovascular Detachable Coils. The device consists of an enclosure with a detachment button, five LED indicator lamps, a funnel inset at its distal end, and a cable connection port. The device comes pre-loaded with two AAAA (1.5 VDC) batteries.
How the Device Functions
Use of Stryker Neurovascular Detachable Coils involves a minimally invasive procedure to access the treatment area (intracranial aneurysm or other neuro or peripheral abnormality) from within a blood vessel (endovascular therapy). Treatment involves insertion of a Stryker Neurovascular two tip-marker microcatheter into a patient's femoral artery and then navigation of the microcatheter through the vascular system, into the neuro or peripheral vasculature, and then to the site of the lesion.
Detachable coils are used in conjunction with:
- · Stryker Neurovascular microcatheters
- · a Stryker Neurovascular InZone Detachment System
- · a Stryker Neurovascular IZDS Connecting Cable, and
· a Patient Return Electrode (an off-the-shelf 20 or 22 gauge stainless-steel hypodermic needle)
Microcatheters, InZone Detachment System and IZDS Connecting Cable are all sold separately.
During a procedure, a physician will assess the target lesion to determine the type, size and number of coils to use. After prepping the patient and preparing the coil according to the instructions for use, the coil is delivered through the microcatheter to the lesion. The delivery wire enables the physician to deploy, position, or reposition the coil until proper placement. Prior to detachment of the coil, the entire device (i.e., coil and delivery wire) may be withdrawn completely, if necessary (e.g., if the physician desires to use a different size or shape coil).
The radiopaqueness of the platinum-tungsten coil, in conjunction with radiopaque markers on the coil's delivery wire and on the microcatheter, enable the physician to properly position the device within the lesion and to always know the location of the coil relative to the distal tip of the microcatheter.
After being placed at the site of the lesion, the coil is detached from its delivery wire through an electrolytic process using the InZone Detachment System (Table 1).
2
Table 1 -
Compatibility between Stryker Neurovascular's InZone Detachment System and Detachable Coils
| Types of Coils that can be used | |
|---|---|
| InZone Detachment System | |
| (M00345100950) | GDC Detachable Coils1 |
| Matrix2 Detachable Coils1 | |
| Target Detachable Coils2 |
4 For coil detachment, requires use of IZDS Connecting Cable (M00345110250) with the InZone Detachment System.
2 No cable required for coil detachment.
When using the InZone Detachment System to detach GDC and Matrix Detachable Coils:
An IZDS Connecting Cable is used in conjunction with an off-the-shelf patient return electrode. The IZDS Connecting Cable (Model / UPN M00345110250) is a 180 cm ground cable (black) for use with the InZone Detachment System. There are no accessories provided with the IZDS Connecting Cable.
The proximal end of the coil's delivery wire is inserted into the InZone Detachment System (anode connection), and the IZDS Connecting Cable completes the circuit between the InZone Detachment System ground port and the patient return electrode (cathode connection).
The InZone Detachment System and IZDS Connecting Cable are sold separately.
When using the InZone Detachment System to detach Target Detachable Coils:
No cable is required as the device's composite metal and polymer wire incorporates an anode and cathode into the wire thus eliminating the need to use a connecting cable and patient return electrode when detaching a Target Detachable Coil.
The proximal end of the coil's delivery wire is inserted into the InZone Detachment System (anode connection); the device's delivery wire hypotube provides the current return path (cathode connection).
3
Scientific Concept
In the use of Stryker Neurovascular Detachable Coils, detachment of the coil from its delivery wire is accomplished by means of an electrolytic process wherein the body's electrolytes serve as the electrolytic carrier between positive and negative electrodes. Since body fluids are relatively ionic, these fluids serve as good conductors for the minimal electric current generated by the InZone Detachment System. Detachable Coils are designed so that electrolytic dissolution occurs in a defined area called the detachment zone.
Operation of the InZone Detachment System in the detachment of coils is governed by the InZone device's firmware first detecting the type of delivery wire which is inserted into the unit's funnel.
When used with GDC or Matrix Detachable Coils, the InZone Detachment System operates at a maximum 12VDC and a maximum current of 1.0 mA.
For Target Detachable Coils, when the InZone Detachment System detects that a Target Detachable Coil delivery wire has been inserted into the unit's funnel, the device's firmware engages circuitry which operates the device at a maximum 28VDC and 1.8 mA.
| Physical and Performance Characteristics | 1 |
|---|---|
| ------------------------------------------ | --- |
| Description: | Sterile, hand-held, internally powered, disposable unit, used
within sterile field |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Size: | 14.0 x 5.8 x 2.8 cm (5.5 x 2.3 x 1.1 inch) |
| Weight: | 80 g (2.8 oz) |
| Power: | 3V |
| Power Source: | Two 1.5 V (AAAA) DC batteries (in series) |
| CPU Operating Voltage: | 3.3 V DC |
| Max Current: | When detaching GDC and Matrix2 Coils: 1mA |
| | When detaching Target Detachable Coils: 1.8 mA |
| Power Switch: | Inserting coil delivery wire turns unit on. Removing delivery
wire turns unit off. Unit turns off after 2 minutes if unit
detects no activity |
| Safety Features: | At start up: Memory integrity (checksum assessment);
calibration validity |
| | During detachment: Over-current / over-voltage (at least
10x/sec) |
| | Software consistently running (at least 100x/sec) |
| Delivery Wire Interface: | InZone slides over proximal 6.5 cm of coil delivery wire |
| Attachment to Patient Return
Electrode (PRE): | When detaching GDC and Matrix2 Coils: |
| | Black cable with minigrabber attached to PRE |
| | When detaching Target Detachable Coils: |
| | Not applicable: return is integral to the device. |
Page 4 of 7
4
Physical and Performance Characteristics (cont.)
| Cable Socket Type: | 1.5 mm recessed male on black safety-sheathed (touch-
proof) socket (only for use when detaching GDC and Matrix2
Detachable Coils) |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization Method: | Ethylene Oxide Gas |
| Sterile Barrier: | PETG tray with Tyvek® lid |
| Packaging: | Carton with Directions for Use |
| User Serviceable Parts: | No user serviceable parts |
| User Required Maintenance: | No user required maintenance |
| Calibration: | Done at factory |
| Number of Detachments: | Minimum of 20 detachments |
| User Interface / Displays: | |
| Display | Comment/Action |
| Power | System Ready Indicator (LED) on and single audible tone when
powered up |
| Current Voltage | Current Flow Indicator (LED) on (green) |
| Cycle Complete | Cycle Complete Indicator (LED) on (blinking green), 1 long beep:
full cycle |
| Cycle Complete | Cycle Complete Indicator (LED) on (green), 3 short beeps :
OR Prescription Use X (Part 21 CFR 801 Subpart D).
Over The Counter Use (21 CFR 801 Subpart C)
(Please do not write Below This Line - Continue on another Page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
KRISTEN BOWSHER
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number_K1308 16
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