IOPS™ Software Application SW-1

GUDID 00843152104000

The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires used in endovascular interventions in the descending aorta. After the patient is placed on the OR table, a cone beam CT (CBCT) is acquired using fluoroscopy with a flat panel detector (FPD). The scan is uploaded to the hospital’s PACS. The CBCT is registered to the initial CT using the IOPS software and the 3D renderings. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.

CENTERLINE BIOMEDICAL, INC.

Electromagnetic surgical navigation device tracking system

• Primary Device ID: 00843152104000
• NIH Device Record Key: c920598c-1db2-4083-a513-ff6203ce9b1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IOPS™ Software Application
• Version Model Number: SW-1
• Catalog Number: SW-1
• Company DUNS: 080088507
• Company Name: CENTERLINE BIOMEDICAL, INC.
• 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: false
• 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	00843152104000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190106

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-08-10
• Device Publish Date: 2020-09-18

Devices Manufactured by CENTERLINE BIOMEDICAL, INC.

• 10843152103000 - IOPS™: 2023-09-18 IOPS™ Tracking Pad 1
• 10843152101020 - IOPS™: 2021-12-22 IOPS™ Catheter Simple Curve 1
• 10843152101037 - IOPS™: 2021-12-22 IOPS™ Catheter Reverse Curve 1
• 00843152100002 - IOPS Mobile Cart: 2021-08-10 The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling f
• 00843152104000 - IOPS™ Software Application: 2021-08-10The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires used in endovascular interventions in the descending aorta. After the patient is placed on the OR table, a cone beam CT (CBCT) is acquired using fluoroscopy with a flat panel detector (FPD). The scan is uploaded to the hospital’s PACS. The CBCT is registered to the initial CT using the IOPS software and the 3D renderings. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
• 00843152104000 - IOPS™ Software Application: 2021-08-10 The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling f
• 10843152102010 - IOPS™: 2020-10-29 IOPS™ Guidewire 2 Handle for connection of guidewire sensor to system