The InZone Detachment System is intended for use with all versions of Stryker Neurovascular detachable coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the InZone® Detachment System:

1. Table of Acceptance Criteria and Reported Device Performance

The submission is a Special 510(k) for firmware modifications to an already cleared device (K103008). Therefore, the "acceptance criteria" discussed are primarily related to verifying the impact of these changes and demonstrating substantial equivalence, rather than establishing initial performance benchmarks for a new device.

The document lists "Physical and Performance Characteristics" that describe the device, but these are not explicitly presented as "acceptance criteria" with quantitative targets and reported performance. Instead, the "Verification Testing" section outlines the types of tests performed to confirm the modifications did not negatively impact the device or raise new safety/effectiveness questions.

Characteristic / Acceptance Criterion (Implicit)	Reported Device Performance / Assessment
Firmware Functionality (General)	Software (firmware) test case model and bench top testing conducted.
Delivery Wire Detection	Assessed via software (firmware) test case model and bench top testing. (Goal: Reduce wire type detection time compared to predicate)
Maximum Detachment Time	Assessed via software (firmware) test case model and bench top testing.
Detachment Consistency	Assessed via software (firmware) test case model and bench top testing.
Detachment Attempts (Full Cycle vs. Less-than-Full Cycle)	Assessed via software (firmware) test case model and bench top testing. (Goal: Differentiate between these and increase first cycle detachment success for Target coils)
Labeling Changes	Assessed and verified.
Software Verification	Performed in accordance with Stryker Neurovascular Corporate SOP for Medical Device Software Development.
Risk Assessment	Conducted in accordance with ISO 14971:2009 using DFMEA. (Conclusion: No new questions of safety or effectiveness raised by modifications)
Impact on Sterility Assurance	Assessed, determined to have no impact.
Impact on Shelf Life	Assessed, determined to have no impact.
Impact on Packaging Validation	Assessed, determined to have no impact.
Substantial Equivalence	Device materials, design, and performance technology compared to predicate. Modifications do not alter intended use/indications or fundamental scientific technology. Verification testing (bench top and firmware test cases) and risk assessment concluded substantial equivalence to K103008, raising no new questions of safety and effectiveness. (Implicit acceptance: Device functions as intended for detachment without introducing new risks or compromising existing performance standards).

2. Sample Size for the Test Set and Data Provenance

The document provides no specific sample sizes for "test sets" in the traditional sense of clinical or even large-scale performance testing using patient data. The verification testing described is primarily bench-top and firmware test case modeling.

Sample Size: Not specified quantitatively. The text refers to "software (firmware) test case model" and "bench top testing." This typically implies a systematic set of tests covering various scenarios and parameters, but not a large statistical sample of physical units or clinical cases. For a firmware change, test cases would be numerous but not necessarily represent a "sample size" in the conventional sense.
Data Provenance: Not applicable as it's not a clinical study. The testing is internal to Stryker Neurovascular ("bench top") and software-based.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This is not a study involving human interpretation of data where ground truth would be established by experts. The "ground truth" for firmware and bench testing would be the expected functional behavior and performance defined by the design specifications.

4. Adjudication Method for the Test Set

Not applicable. There's no mention of an adjudication method as no expert-derived ground truth or human assessments were involved. The testing is objective and based on engineering verification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document does not describe any MRMC comparative effectiveness study. It's a technical submission for firmware modifications to a detachment system, not an imaging-based AI diagnostic device requiring human reader assessment studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Yes, in essence. The verification testing conducted (software/firmware test case model and bench top testing) assesses the device's performance in a standalone manner. The device, which automates a detachment process based on embedded firmware, acts as an "algorithm only" system in this context. The study did not involve human-in-the-loop performance modification.

7. The Type of Ground Truth Used

The ground truth used for this type of verification testing is based on:

Design Specifications: The intended behavior and performance parameters defined during the device's design and development.
Predicate Device Performance: The established and cleared performance of the original InZone Detachment System (K103008). The firmware modifications aim to improve specific aspects (e.g., wire detection time, detachment success for Target coils) while maintaining overall safety and effectiveness.
Industry Standards: Compliance with relevant standards like ISO 14971:2009 for risk management.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI algorithm in the context of data training. The "firmware" is a program with predefined logic and parameters, not something that "learns" from a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of firmware update.

Summary

{0}------------------------------------------------

InZone® Detachment System

K120816

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 andAddress	Stryker Neurovascular47900 Bayside ParkwayFremont, CA 94538
Contact Person:	Mara ChouSr. Regulatory Affairs SpecialistPhone: 510 413 2595Fax: 510 413 2588Email: mara.chou@stryker.com
Trade Name:	InZone Detachment System
Common Name:	Power Supply
Classification Name:	The InZone Detachment System is intended for use with allStryker Neurovascular Detachable Coils in the embolization ofintracranial aneurysms and other vascular malformations ofthe neuro and peripheral vasculature.Stryker Neurovascular detachable coils are Class II devices(special controls) classed as neurovascular embolizationdevices under 21 CFR 882.5950 (HCG) and vascularembolization 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 andNeurovascular Embolization Devices (issued 29 Dec 2004).
Legally MarketedPredicate Devices:
	DeviceReference (Clearance Date)

APR 1 7 2012

Page 1 of 7

InZone Detachment System

K103008 (10 Dec 2010)

{1}------------------------------------------------

Device Description:

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, usedwithin 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 deliverywire turns unit off. Unit turns off after 2 minutes if unitdetects no activity
Safety Features:	At start up: Memory integrity (checksum assessment);calibration validity
	During detachment: Over-current / over-voltage (at least10x/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 ReturnElectrode (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 Matrix2Detachable 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 whenpowered 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 :<full cycle
Running	Current Flow Indicator (LED) on (green)
Low Battery	Low Battery Indicator (LED) flashes (amber)
Grounding	Grounding Indicator (LED) on (amber) until complete circuit isdetected; when complete circuit is detected, LED goes off andSystem Ready Indicator (LED) will turn on (green) accompanied bysingle beep
To start detachment	Press Detachment Button
Resume current afterdetachment	Press Detachment Button
Error	All 5 LEDs illuminate

Packaging:

Each InZone Detachment System is packaged in a PETG tray. A Tyvek lid is heat-sealed onto the tray. The tray with lid is then placed into a fiberboard carton along with Directions for Use.

{5}------------------------------------------------

Verification Testing:

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)

neuro and peripheral vasculature.

Accessories:

Indications for Use / Intended 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

There are no accessories to the InZone Detachment System.

Comparison to Predicate Device:

This Special 510(k) is for modifications to device firmware to a) reduce wire type detection time; b) increase first cycle detachment success for Target coils; c) remove suboptimal indication to the user; d) differentiate between detachment attempts that run the full cycle and those that complete in less than full cycle and e) labeling changes.

The modified InZone Detachment System has the same intended use and indications for use as the current legally marketed predicate device cleared under premarket notification K103008 (cleared 10 Dec 2010).

{6}------------------------------------------------

Comparison to Predicate Device (cont.):

Although the InZone Detachment System incorporates modifications to device firmware and device labeling, the modifications do not alter the fundamental scientific technology of the predicate device.

Risk assessment of the modifications, in the form of design failure modes and effects analysis (DFMEA), has been conducted in accordance with ISO 14971:2009. Stryker Neurovascular has determined the modifications to the predicate device raise no new questions of safety or effectiveness.

Verification testing of the modified InZone Detachment System has demonstrated the device to be substantially equivalent to the predicate InZone Detachment System cleared under K103008.

Conclusion:

In terms of substantial equivalence, Stryker Neurovascular has compared device materials, design and performance technology to the predicate device. Since the subject modifications do not alter the intended use/ indications for use of the predicate device or the fundamental scientific technology of the predicate device; and because risk assessment of the modifications and successful verification testing using both bench top and firmware test case model raise no new questions of safety and effectiveness, Stryker Neurovascular has determined that the modified InZone Detachment System to be substantially equivalent to the current legally marketed predicate device cleared in K103008.

{7}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

APR 1 7 2012

Stryker Neurovascular c/o Ms. Mara Chou Sr. Regulatory Affairs Specialist 47900 Bayside Parkway Fremont. CA 94538

Re: K120816

Trade/Device Name: InZone® Detachment System
Regulation Number: 21 CFR 882.5950
. Regulation Name: Neurovascular Embolization Device
Regulatory Class: Class II

Product Code: HCG, KRD

Dated: March 16, 2012
Received: March 19, 2012

Dear Ms. Chou:

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.

{8}------------------------------------------------

Page 2 - Ms. Mara Chou

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 device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

R.A. Remick

Malvina B. Eydelman. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{9}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number : حارا 2 0 8 1 جل

Device Name:

InZone® Detachment System

Indications for Use:

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

Page _/ of _/

Regulation Number and Section

§ 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).