Micromate

Primary DI
09010279000411
Brand
Micromate
Company
iSYS Medizintechnik GmbH
Model
iONE
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.
Published
2023-09-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203720000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203720000MICROMATEIsys Medizintechnik GmbH2021-06-22JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09010279000411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09010279000411090102790004119010279000411

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical arm systemAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
300207996
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09010279001548Micromate Navi+iONE2024-02-26
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09010279001715iFIXiFIX Side Rail Adapter JP42642-JP2024-07-30
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09010279001142iFIXHead Kit MRI GE587812021-07-01
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09010279001135iFIXHead Kit CT587802021-07-01
09010279001159iFIXThorax Kit CT Canon587872021-07-01
09010279001166iFIXThorax Kit CT Siemens587882021-07-01
09010279001173iFIXKit CT Micromate BP587862021-07-01
09010279001180iFIXThorax Kit CT GE587892021-07-01
09010279001197iFIXThorax Kit MRI Philips587912021-07-01
09010279001203iFIXThorax Kit MRI Siemens587922021-07-01
09010279001210iFIXThorax Kit MRI GE587932021-07-01
09010279001227iFIXArm Stabilization Kit587962021-07-01
09010279001234iFIXSpine Surgery Kit587982021-07-01
09010279001241iFIXHead Kit MRI589322021-07-01

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