Micromate

GUDID 09010279000411

The intended use of the Micromate™ device is to function as a remote-operated positioning and guidance system during interventional procedures. Positioning is done in a remote-controlled manner; planning of the position/angulation is done based on 2D/3D patient data (CT, cone-beam CT, fluoroscopy) by external/internal planning software – for example using an image-guided navigation system or external/internal navigation system, or planning software coming with the used imaging device. Also, verification of the correct position and orientation of the tool prior to/during/after the intervention is done by means of these external devices. The Micromate™ system is then acting as a guideway during the manual insertion of the interventional tool – usually a needle type device, and the like - through a third-party needle guide, manufactured by Exact MM (K101689): P/N E2178 (Micromate Needle Guide Set, 8-11G), P/N E2183 (Micromate Needle Guide Set,10-14G) and P/N E2184 (Micromate Needle Guide Set, 15-21G). During operation, the device is covered with a sterile drape, which is part of the P/N2178, P/N E2183 and E2184. An additional third-party Control Unit Drape is available, also manufactured by Exact MM (K101689): P/N 11718EU (Micromate Control Unit Drape). Applications include, but are not limited to, interventions like biopsy procedures, tumor ablation, nerve blocking, electrode placement, etc.

iSYS Medizintechnik GmbH

Robotic surgical arm system

• Primary Device ID: 09010279000411
• NIH Device Record Key: 45362d1a-c8ed-4ef9-bba7-0d809cfdf3de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Micromate
• Version Model Number: iONE
• Company DUNS: 300207996
• Company Name: iSYS Medizintechnik GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09010279000411 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203720

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-14
• Device Publish Date: 2023-09-06

Devices Manufactured by iSYS Medizintechnik GmbH

• 09010279001050 - iFIX: 2024-08-07 iFIX Tray is a extremity support product, a part of iFIX Arm Rest. It is a long top surface capable of fitting the PearlFit Cush
• 09010279001289 - iFIX: 2024-08-07 The iFIX Canon Aquilioin Adapter is a non-sterile product which allows to attach a Slot Adapter 3.0/30 to a table T-Slot (for al
• 29010279001702 - iFIX: 2024-08-07 Designed for connection with operating tables, contains a side-rail adapter portion (to fit US side-rails) and a flat plastic po
• 29010279001719 - iFIX: 2024-08-07 Designed for connection with operating tables, contains a side-rail adapter portion (to fit JP side-rails) and a flat plastic po
• 09010279001548 - Micromate Navi+: 2024-03-05 The Micromate™ Navi+ system allows the percutaneous execution of a surgical intervention by providing instrument guidance acco
• 09010279000411 - Micromate: 2023-09-14The intended use of the Micromate™ device is to function as a remote-operated positioning and guidance system during interventional procedures. Positioning is done in a remote-controlled manner; planning of the position/angulation is done based on 2D/3D patient data (CT, cone-beam CT, fluoroscopy) by external/internal planning software – for example using an image-guided navigation system or external/internal navigation system, or planning software coming with the used imaging device. Also, verification of the correct position and orientation of the tool prior to/during/after the intervention is done by means of these external devices. The Micromate™ system is then acting as a guideway during the manual insertion of the interventional tool – usually a needle type device, and the like - through a third-party needle guide, manufactured by Exact MM (K101689): P/N E2178 (Micromate Needle Guide Set, 8-11G), P/N E2183 (Micromate Needle Guide Set,10-14G) and P/N E2184 (Micromate Needle Guide Set, 15-21G). During operation, the device is covered with a sterile drape, which is part of the P/N2178, P/N E2183 and E2184. An additional third-party Control Unit Drape is available, also manufactured by Exact MM (K101689): P/N 11718EU (Micromate Control Unit Drape). Applications include, but are not limited to, interventions like biopsy procedures, tumor ablation, nerve blocking, electrode placement, etc.
• 09010279000411 - Micromate: 2023-09-14 The intended use of the Micromate™ device is to function as a remote-operated positioning and guidance system during intervent
• 09010279001128 - iFIX: 2021-07-09 short-term patient stabilization
• 09010279001135 - iFIX: 2021-07-09 short-term patient stabilization