(103 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.
Stryker Neurovascular's 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.
Here's an analysis of the provided text regarding the InZone Detachment System, focusing on acceptance criteria and the supporting study:
The provided document (K212455) is a 510(k) summary for modifications to the InZone Detachment System. It does not describe a study involving human readers or AI. Instead, it focuses on bench testing and software verification to demonstrate substantial equivalence to a predicate device after firmware modifications. The device is a medical instrument used for detaching coils in neurovascular procedures, not an AI or imaging diagnostic tool. Therefore, many of the requested points related to AI, ground truth establishment, expert consensus, and MRMC studies are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
The document implicitly treats the successful completion of the listed verification tests as meeting acceptance criteria, demonstrating the modified device functions as intended and is substantially equivalent to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Firmware Functionality: | 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) detachment cycle time b) maximum detachment time c) detachment consistency d) detection consistency e) max voltage output f) max current output g) low battery detection h) fault detection at power up i) over voltage and over current detection j) data storage and retrieval capability k) delivery wire compatibility and detection l) button activation m) audio and visual signals • Software verification in accordance with EN 62304 and Stryker Neurovascular Design and Development Planning SOP. (The document states these tests were successfully completed, indicating the performance met the criteria.) |
| Risk Management: | • Risk assessment in accordance with ISO 14971 and Stryker Neurovascular Risk Management Planning SOP. • Design failure modes and effects analysis (DFMEA) was conducted. (Result: "Stryker Neurovascular has determined the modifications to the predicate device raise no new questions of safety or effectiveness.") |
| Impact on Other Device Aspects: | • Assessment of the modifications for impact upon: Electrical Safety (no impact) Electromagnetic Compatibility (no impact) Sterility Assurance (no impact) Shelf Life (no impact) Packaging Verification (no impact) Packaging Shelf Life (no impact) |
| Substantial Equivalence: | • "Verification testing of the modified InZone Detachment System has demonstrated the device to be substantially equivalent to the predicate InZone Detachment System cleared under K160096." |
| Minimum Number of Detachments: | • The device should be capable of a "Minimum of 20 detachments." (Although not explicitly stated as a test result, this is a listed characteristic, implying it was verified.) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of patient data or clinical images. The testing described is primarily bench-top testing of the device's firmware and physical characteristics. Therefore, there is no mention of country of origin or whether data was retrospective or prospective in the clinical sense. The "test cases" for software and bench-top testing would refer to specific scenarios and conditions the device was put through. The number of iterations or specific samples for each bench test (e.g., how many coils were detached for detachment consistency) is not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts
Not applicable. This device is an instrument, not an AI diagnostic tool requiring expert interpretation of medical data for ground truth. Ground truth for the device's functionality would be established by engineering specifications, proper electrical readings, and functional verification, typically performed by engineers and technicians.
4. Adjudication Method for the Test Set
Not applicable. There is no clinical test set requiring adjudication in the context of expert review. The device's performance is objectively measured against engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI diagnostic device, and no MRMC study was performed. The device is a tool used by interventionalists, and the study focuses on its functional performance, not its impact on human reader effectiveness for diagnosis.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the device itself (the "algorithm" being its firmware). The "Verification Testing" detailed in the table above is a standalone assessment of the device's performance. It evaluates the device's ability to perform its functions (detachment, detection, safety features) without human intervention beyond initiating the process.
7. The Type of Ground Truth Used
The ground truth used for the verification testing (standalone performance) is based on engineering specifications and expected functional outcomes. For example:
- Detachment cycle time: Should fall within a defined range.
- Max voltage/current output: Must not exceed specified limits.
- Low battery detection: Must accurately signal when battery is low.
- Fault detection: Must correctly identify and signal specified faults.
- Delivery wire compatibility and detection: Must correctly identify and interface with different coil types.
These ground truths are derived from existing design requirements, safety standards (e.g., ISO 14971, EN 62304), and the established performance of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI system that undergoes "training" with data in the conventional machine learning sense. Its firmware is programmed based on design specifications and engineering principles.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of machine learning. The "ground truth" for the device's design and programming comes from established medical device standards, functional requirements for electrolytic detachment, and the performance characteristics of the previously cleared predicate device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
November 16, 2021
Stryker Neurovascular Breskella Halteh Senior Manager, RAQA Compliance 47900 Bayside Parkway Fremont, California 94538
Re: K212455
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: August 27, 2021 Received: August 30, 2021
Dear Breskella Halteh:
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, 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) K212455
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the Stryker logo in black font. The logo is a stylized version of the company name, with the letters connected to each other. A registered trademark symbol is located to the right of the letter 'r' in 'Stryker'. The logo is simple and modern, and it is easily recognizable.
Neurovascular
510(k) Summary
| Summary Date | November 15, 2021 |
|---|---|
| Submitter Name andAddress | Stryker Neurovascular47900 Bayside ParkwayFremont, CA 94538 |
| Contact Person: | Breskella HaltehSenior Manager, RAQA ComplianceStryker NeurovascularPhone: 650 814 3781 (mobile)Email: breskella.halteh@stryker.com |
| Trade Name: | InZone® Detachment System |
| Common Name: | Power Supply |
| 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. |
| Classification Name: | 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 Device: | InZone Detachment System cleared under K160096 on 19 Feb2016. |
{4}------------------------------------------------
Device Description:
Stryker Neurovascular's 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
- Stryker Neurovascular's InZone Detachment System
- Stryker Neurovascular's 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.
{5}------------------------------------------------
Table 1 - Compatibility between Stryker Neurovascular's InZone® Detachment System and Stryker Neurovascular Detachable Coils
| Types of Coils that can be used | |
|---|---|
| InZone Detachment System(M00345100950) | GDC Detachable Coils1Target Detachable Coils2 |
1 Requires use of Stryker Neurovascular's IZDS Connecting Cable, p/n M00345110250 (sold separately) with the InZone Detachment System. 2 No cable required for coil detachment.
When using the InZone Detachment System to detach GDC 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).
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.
{6}------------------------------------------------
Scientific Concept (cont.)
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 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 Characteristics
| 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 Coils: 1mAWhen detaching Target Detachable Coils: 2.4 mA |
| Power Switch: | Inserting coil delivery wire turns unit on. Removingdelivery wire turns unit off. During use, if after 2minutes unit detects no activity, unit will enter SLEEPMODE; pressing and releasing the DETACHMENTBUTTON will bring the system back to its previous state. |
| Safety Features: | At start up: Memory integrity (checksum assessment);calibration validityDuring detachment: Over-current / over-voltage (atleast 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 ReturnElectrode (PRE): | When detaching GDC Coils:Black cable with minigrabber attached to PREWhen detaching Target Detachable Coils:Not applicable: return is integral to the device |
{7}------------------------------------------------
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 GDCDetachable 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 poweredup |
| Current Voltage | Current Flow Indicator (LED) on (green) |
| Cycle Complete | Cycle Complete Indicator (LED) on (solid green), 3 short beeps:For Target Coils: InZone software has assessed that detachment haslikely occurred.For GDC Coils: InZone has assessed a full cycle is complete in less than 75seconds. |
| Cycle Complete | Cycle Complete Indicator (LED) on (blinking green), 1 long beep:For Target Coils: InZone software has assessed that detachment haslikely not occurredFor GDC Coils: InZone has assessed a full cycle is complete in 75 seconds. |
| Running | Current Flow Indicator (LED) on (solid green) |
| Low Battery | Low Battery Indicator (LED) on (blinking amber) |
| Grounding | Grounding Indicator (LED) on (blinking amber) until complete circuit isdetected; when complete circuit is detected, LED will remain on (solidamber) and System Ready Indicator (LED) will turn on (solid green)accompanied by a single beep. |
| To start detachment | Press Detachment Button. |
| To initiate another detachment cycle | If CYCLE COMPLETE LED is lit, pressing and releasing the DetachmentButton will initiate another cycle. |
| Error | All LEDs illuminate except CYCLE COMPLETE LED. |
{8}------------------------------------------------
| Packaging: | Each InZone® Detachment System is packaged in a PETG tray. ATyvek lid is heat-sealed onto the tray. The tray with lid is thenplaced into a fiberboard carton along with Directions for Use. |
|---|---|
| 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 timeb) maximum detachment timec) detachment consistencyd) detection consistencye) max voltage outputf) max current outputg) low battery detectionh) fault detection at power upi) over voltage and over current detectionj) data storage and retrieval capabilityk) delivery wire compatibility and detectionl) button activationm) audio and visual signals | |
| 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: | |
| Electrical Safety (no impact)Electromagnetic Compatibility (no impact)Sterility Assurance (no impact)Shelf Life (no impact)Packaging Verification (no impact)Packaging Shelf Life (no impact) | |
| Accessories: | There are no accessories to the InZone Detachment System. |
{9}------------------------------------------------
| Comparison to Predicate Device: | This 510(k) is for modifications to InZone Detachment System firmware to decrease detachment time when used with Target Coils and to update product labeling. |
|---|---|
| The modified InZone® Detachment System has the same intended use / indications for use as the current legally marketed predicate device cleared under premarket notification K160096. | |
| Although the InZone Detachment System incorporates modifications to device firmware and device labeling and packaging, 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 14971:2019. 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 K160096. | |
| Conclusion: | Stryker Neurovascular has compared device materials, design, and performance 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 raise no new questions of safety and effectiveness, Stryker Neurovascular believes the modified InZone Detachment System to be substantially equivalent to the current legally marketed predicate device cleared in K160096. |
§ 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).