(31 days)
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.
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.
This document, K160096, is a 510(k) premarket notification for the Stryker Neurovascular InZone Detachment System. It concerns modifications to existing firmware and hardware. However, a table of acceptance criteria and reported device performance derived from a study that specifically tested against such criteria is not present in the provided text. The document refers to "Verification Testing," which describes the tests performed and the areas assessed, but it doesn't provide a direct comparison table for acceptance criteria against performance metrics for a specific clinical or diagnostic AI/ML product.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
- If a standalone (algorithm only) performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The provided document is a 510(k) summary for a medical device (a detachment system for coils used in embolization of intracranial aneurysms), not an AI/ML-based diagnostic device. The "Verification Testing" mentioned in section {8} details general engineering and software tests (e.g., detachment cycle time, maximum detachment time, detachment consistency, max voltage/current output, battery detection, fault detection, etc.), and risk assessment, rather than performance metrics related to diagnostic accuracy, sensitivity, or specificity that would typically be associated with AI/ML products and their acceptance criteria in a clinical setting.
The device is a physical system that performs an electrolytic detachment process, and the testing described is engineering verification to ensure the system functions as intended and safely, not a study to evaluate algorithmic performance against a ground truth in a diagnostic context.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 19, 2016
Stryker Neurovascular Ms. Kate Taylor Sr. Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538-6515
Re: K160096
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: January 15, 2016 Received: January 20, 2016
Dear Ms. 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,
Michael J. Hoffmann -A
for 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) K160096
Device Name InZone Detachment System
Indications for Use (Describe)
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.
| 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 of Safety and Effectiveness
| Summary Date | January 15, 2016 |
|---|---|
| Submitter Name andAddress | Stryker Neurovascular47900 Bayside ParkwayFremont, CA 94538 |
| Contact Person: | Kate TaylorSr. Regulatory Affairs SpecialistPhone: 510 413 2595Fax: 510 413 2175Email: kate.taylor@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: |
| Reference (Clearance Date) | Device |
|---|---|
| K120816 (17 APR 2012) | InZone Detachment System |
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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).
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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 |
1 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 Matrix2 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).
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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 Matrix2 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 2.4 mA.
| Physical and Performance CharacteristicsDescription: | 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: 1mAWhen detaching Target Detachable Coils: 2.4 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 validityDuring 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 PREWhen detaching Target Detachable Coils:Not applicable: return is integral to the device. |
Physical and Performance Characteristics
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510(k) Summary of Safety and Effectiveness (cont.)
| 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 MatrixDetachable 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:InZone software has assessed that detachment has likelyoccurred |
| Cycle Complete Indicator (LED) on (green), 3 short beeps:InZone software has assessed that detachment has not occurred | |
| 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) accompaniedby single 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.
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510(k) Summary of Safety and Effectiveness (cont.)
| Verification Testing: | Verification testing of the modified InZone Detachment Systemconsisted of the following: |
|---|---|
| 1) Software (firmware) test case model as well as bench toptesting to assess a) detachment cycle time; b) maximumdetachment time; c) detachment consistency; d) max voltageoutput; e) max current output; f) battery compartment; g) lowbattery detection; h) fault detection at power up; i) over voltageand over current detection; j) data storage and retrievalcapability; k) table drop survival; l) patient leakage current; m)delivery wire compatibility and detection; n) electrostaticdischarge; o) radiated immunity and emissions; p) device mass;q)device mass; r) button activation; s) audio and visual signals;t) labeling changes. | |
| 2) Software verification in accordance with EN 62304 andStryker Neurovascular Design and Development Planning SOP | |
| 3) Risk assessment in accordance with ISO 14971 and StrykerNeurovascular Risk Management Planning SOP | |
| 4) Assessment of the modifications for impact upon: | |
| Sterility Assurance (no impact)Shelf Life (no impact)Packaging Verification (no impact) | |
| Accessories: | There are no accessories to the InZone Detachment System. |
| Indications for Use /Intended Use: | The InZone Detachment System is intended for use with allversions of Stryker Neurovascular Detachable Coils in theembolization of intracranial aneurysms and other vascularmalformations of the neuro and peripheral vasculature. |
| Comparison toPredicate Device: | This Special 510(k) is for modifications to device firmware andhardware to decrease detachment time when used withTarget Coils and update the product labeling. |
| The modified InZone Detachment System has the sameintended use and indications for use as the current legallymarketed predicate device cleared under premarket notificationK120816 (cleared 17 Apr 2012). |
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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 K120816.
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 K120816.
§ 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).