AccessGUDID - DEVICE: Micromate Navi+ (09010279001548)

GUDID

Device Identifier (DI) Information

Brand Name: Micromate Navi+
Version or Model: iONE
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: iSYS Medizintechnik GmbH

Primary DI Number: 09010279001548
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 300207996 *Terms of Use

Device Description: The Micromate™ Navi+ system allows the percutaneous execution of a surgical intervention by providing instrument guidance according to one or more pre-operative plans defined by an internal planning and navigation software (MicroNav). The alignment to the surgical plan is performed through a manual gross-positioning using a Positioning Arm, followed by automatic or joystick-controlled movement with image guidance, such as optical CT navigation (tracked by camera). After alignment, the advancement of surgical instruments and delivery of therapy is performed manually by the user, while the position is retained by the targeting platform of Micromate™ Navi+, relying on the displayed navigation information or real-time images from third party imaging device. The Micromate™ Navi+ device is a user-controlled electromechanical arm with a needle guide. It is intended to assist the user in the positioning of surgical instruments in the chest, abdomen and musculoskeletal structures when computed tomography (CT) optical navigation can be used for target trajectory planning and intra-operative tracking. The needle is then manually advanced by the user. Trajectory planning is made with software that is a part of the Micromate™ Navi+ device.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38723	Robotic surgical navigation system	An assembly of electromechanical devices used during orthopaedic computer assisted surgery (CAS) as a functional extension of the surgeon for precise procedural movement and placement (navigation) during the procedure (e.g., placement of a pedicle screw in spinal surgery). It is computer-based and typically consists of, e.g., an operator's console and a video camera used to track the instrumentation. The input to the computer is usually by means of an existing CT or MRI scan that is used as a template. The system tracks the instrumentation by reading the location points giving a three-dimensional (3-D) picture of the instrument's position/angulation. It can also be used as a training aid.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAK	System, X-Ray, Tomography, Computed

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230130	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 28410a32-052b-4401-a34e-ac7845a6d513
Public Version Date: March 05, 2024
Public Version Number: 1
DI Record Publish Date: February 26, 2024