Micromate
Basic Information
- Brand Name
- Micromate
- Primary DI
- 09010279000411
- Version / Model
- iONE
- Company Name
- iSYS Medizintechnik GmbH
- Labeler DUNS
- 300207996
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-06
- Public Version
- 1
- Public Version Date
- 2023-09-14
- Public Version Status
- New
- Public Device Record Key
- 45362d1a-c8ed-4ef9-bba7-0d809cfdf3de
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | Radiology | 892.1750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38678 | Robotic surgical arm system | An assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09010279000411 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203720 | 000 |