(153 days)
Not Found
No
The description focuses on electromagnetic tracking, 3D rendering from CT data, and real-time navigation overlay, which are standard techniques in image-guided surgery and do not inherently involve AI/ML. The document explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The device is intended for navigation and positioning during endovascular interventions and does not directly provide therapy. It is described as an "adjunct to fluoroscopy" for real-time tip positioning and navigation, helping clinicians guide catheters and guidewires, but it does not treat or cure any condition itself.
No
The "Intended Use / Indications for Use" section explicitly states, "The IOPS does not make a diagnosis." The device is intended for real-time tip positioning and navigation during endovascular interventions, using 3D modeling from previously acquired scan data, and as an adjunct to fluoroscopy.
No
The device description explicitly lists multiple hardware components including a mobile cart, monitor, computer, keyboard, pointing device, UPS, cables, tracking system (SCU, SIU, field generator, mounting brackets), sensor embedded catheter, guidewire, and tracking pad. The performance studies also include testing for electrical safety, biocompatibility, sterilization, packaging, and mechanical evaluation of hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the IOPS is for the evaluation of vascular anatomy and real time tip positioning and navigation during endovascular interventions. It is an adjunct to fluoroscopy. Crucially, it explicitly states: "The IOPS does not make a diagnosis." IVDs are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
- Device Description: The device description details a system that uses electromagnetic tracking to display the position of sensors on a 3D rendering of the patient's vascular system derived from CT data. This is a navigation and visualization tool used during a medical procedure, not a test performed on a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, tissue, etc.), performing chemical or biological tests, or providing diagnostic information based on such analysis.
The IOPS is a medical device used for surgical planning, navigation, and guidance during an interventional procedure. It falls under the category of image-guided surgery systems or navigation systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured via 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 system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
Product codes
DQK
Device Description
The IOPS system displays the position and orientation of sensor equipped guidewires and catheters utilizing electromagnetic tracking technology. The system enables mapping of the patient's vascular system utilizing previously acquired CT scan data. IOPS registers the location and orientation of the sensors in real time superimposing navigation of the catheters and guidewires to the patient's vascular map.
The patient's vascular map is generated using a contrast enhanced, high resolution CT scan. The IOPS creates a 3D rendering of that structure. A bone segmented 3D rendering may optionally be created to provide anatomical, skeletal points visible in relation to the vascular rendering.
The main principles of action for the IOPS are similar to those used in Global Positioning System (GPS) tracking. The navigation components generate a time-varying magnetic field in which the position and orientation of sensor embedded catheters and guidewires are read. The computing unit visually displays the location of the sensor on the patient's vascular map.
The system is intended for use by trained clinicians for patients undergoing endovascular interventional procedures of the descending aorta, such as stent grafting. The system promotes more efficient use of operating room time and minimizes the need for fluoroscopy. The clinician uses the IOPS catheters and guidewires to navigate through the aorta to access branch vessels near to, or involved in, the lesion. The catheters and guidewires are not for angiographic or diagnostic use.
IOPS is composed of a mobile cart which houses a monitor, computer, keyboard, pointing device, uninterruptable power supply (UPS), and cables. IOPS includes a tracking system composed of a system control unit (SCU), system interface unit (SIU), field generator, mounting brackets, and cables. These components are reusable and not patient contacting. The IOPS is integrated with software to generate the mapping and overlay of the live sensors. The IOPS works with a sensor embedded catheter, guidewire, and tracking pad which are provided sterile and not intended for re-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan data
Anatomical Site
vascular system, descending aorta
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained clinicians for patients undergoing endovascular interventional procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted to demonstrate the performance and accuracy of the IOPS and to verify that it does not raise any new safety and effectiveness concerns. Test results indicate that the IOPS is substantially equivalent to the predicate device and does not raise any new safety or effectiveness concerns. All testing was performed on production equivalent devices.
- IEC 60601-1 and IEC 60601-1-2 Electrical Safety and Electromagnetic Compatibility ● Testing
- Biocompatibility testing for guidewires and catheters (Externally Communicating Device, Circulating blood contact. A - limited
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
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June 24, 2019
Centerline Biomedical, Inc. % Lauren Smith Senior Quality and Regulatory Engineer JALEX Medical 30311 Clemens Rd Suite 5D Westlake, Ohio 44145
Re: K190106
Trade/Device Name: Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter : Angled Tip Guidewire : Tracking Pad : Guidewire Handle Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: June 21, 2019 Received: June 24, 2019
Dear Lauren Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190106
Device Name Intra-Operative Positioning System (IOPS)
Indications for Use (Describe)
The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured via 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 system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/1 description: The image shows the logo for Centerline Biomedical. The logo consists of a blue circular design with the letter C in the center, and the words "Centerline" and "Biomedical" are written in gray next to the design. Below the logo, the text "510(k) Submission Intra-Operative Positioning System" is written in black.
VIII. 510(k) Summary
| Submitted By: | Centerline Biomedical, Inc. |
|---|---|
| 10000 Cedar Ave | |
| Cleveland, Ohio 44106 | |
| Date: | 6/7/2019 |
| Contact Person: | Lauren Smith, Senior Quality/Regulatory Engineer |
| Contact Telephone: | 440.541.0060 |
| Contact Fax: | 440.933.7839 |
| Device Trade Name: | Intra-Operative Positioning System (IOPS) |
| Device Classification Name: | Programmable diagnostic computer (21 CFR 870.1425) |
| Device Classification: | Class II |
| Reviewing Panel: | Cardiovascular |
| Product Code: | DQK |
| Primary Predicate Device: | St. Jude Medical, MediGuide Technology (K162643) |
| Secondary Predicate Devices: | MediGuide Enabled Livewire Steerable Electrophysiology |
| Catheter (K151622) | |
| CPS Excel MediGuide Enabled Guidewire (K120298) |
Device Description:
The IOPS system displays the position and orientation of sensor equipped guidewires and catheters utilizing electromagnetic tracking technology. The system enables mapping of the patient's vascular system utilizing previously acquired CT scan data. IOPS registers the location and orientation of the sensors in real time superimposing navigation of the catheters and guidewires to the patient's vascular map.
The patient's vascular map is generated using a contrast enhanced, high resolution CT scan. The IOPS creates a 3D rendering of that structure. A bone segmented 3D rendering may optionally be created to provide anatomical, skeletal points visible in relation to the vascular rendering.
The main principles of action for the IOPS are similar to those used in Global Positioning System (GPS) tracking. The navigation components generate a time-varying magnetic field in which the position and orientation of sensor embedded catheters and guidewires are read. The computing unit visually displays the location of the sensor on the patient's vascular map.
The system is intended for use by trained clinicians for patients undergoing endovascular interventional procedures of the descending aorta, such as stent grafting. The system promotes more efficient use of operating room time and minimizes the need for fluoroscopy. The clinician uses the IOPS catheters and guidewires to navigate through the aorta to access branch vessels
4
Image /page/4/Picture/1 description: The image shows the logo for Centerline Biomedical. The logo consists of a circular symbol with concentric circles in blue and gray, along with the text "Centerline" above "Biomedical" in gray. Below the logo, the text "510(k) Submission Intra-Operative Positioning System" is displayed.
near to, or involved in, the lesion. The catheters and guidewires are not for angiographic or diagnostic use.
IOPS is composed of a mobile cart which houses a monitor, computer, keyboard, pointing device, uninterruptable power supply (UPS), and cables. IOPS includes a tracking system composed of a system control unit (SCU), system interface unit (SIU), field generator, mounting brackets, and cables. These components are reusable and not patient contacting. The IOPS is integrated with software to generate the mapping and overlay of the live sensors. The IOPS works with a sensor embedded catheter, guidewire, and tracking pad which are provided sterile and not intended for re-use.
Intended Use:
The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured via 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. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
| | Subject Device
Centerline Biomedical
IOPS | Predicate Device
MediGuide Technology
System | Comparison |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | DQK | DQK | Same |
| Intended
Use/Indications
for Use | The IOPS (Intra-
Operative Positioning
System) is intended for
the evaluation of
vascular anatomy as
captured via 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. The
system is indicated for
use as an adjunct to | The MediGuide™
Technology System is
intended for the evaluation
of vascular and cardiac
anatomy. It is intended to
enable real time tip
positioning and navigation
of a MediGuide
Enabled™/Sensor
Enabled™ (equipped with a
magnetic sensor) invasive
device used in vascular or
cardiac interventions in the
Cath Lab environment, on
both live fluoroscopy or
recorded background. | The IOPS is only
intended for the
evaluation of
vascular anatomy
for vascular
interventions
only. Both
sensors enable
real time tip
positioning and
navigation of
magnetic sensor
equipped devices. |
| | fluoroscopy. The IOPS
does not make a
diagnosis. | | |
| Device
Description | The IOPS system
displays the position
and orientation of
sensor equipped
guidewires and
catheters utilizing
electromagnetic
tracking technology.
The system enables
mapping of the
patient's vascular
system utilizing
previously acquired CT
scan data. IOPS
registers the location
and orientation of the
sensors in real time
superimposing
navigation of the
catheters and
guidewires to the
patient's vascular map. | MediGuide Technology
enables navigation of
devices on pre-recorded X-ray images allowing the
physician to reduce the
duration of live X-ray
during a procedure.
MediGuide Technology
applies 3D visualization
and precise navigation to
pre-recorded 2D X-ray
images and can be used by
the physician to perform
complex electrophysiology
procedures and CRT
implants. MediGuide
Technology is analogous to
a global positioning system
(GPS) in that it uses a low
powered electromagnetic
field to locate device-based
sensors in three-
dimensional space. The
system uses this location
information to overlay
MediGuide™
Enabled/Sensor Enabled™
devices on the
corresponding pre-recorded
X-ray image, which allows
the physician to reduce the
duration of live X-ray
during a procedure.
MediGuide creates a real-
time clinical environment
by compensating for patient
motion, respiration and
heart rate variability. | IOPS enables
navigation of
devices on a 3D
rendering of the
vasculature. Both
systems
compensate for
patient motion. |
| Class | Class II | Class II | Same |
| Classification
Identification | 21 CFR 870.1425
Programmable
Diagnostic computer | 21 CFR 870.1425
Programmable Diagnostic
computer | Same |
| System
dedicated
tracking devices | 2 Catheters
1 Guidewire | Variety of catheters,
guidewire, connector
accessories | Both systems
include magnetic
sensor equipped
catheters and
guidewires |
Substantial Equivalence:
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Image /page/5/Picture/1 description: The image shows the logo for Centerline Biomedical. The logo consists of a blue target-like symbol on the left, with the words "Centerline" and "Biomedical" in gray on the right. A horizontal line extends from the target symbol to separate the two words.
510(k) Submission Intra-Operative Positioning System
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Image /page/6/Picture/1 description: The image shows the logo for Centerline Biomedical. The logo consists of a blue target-like symbol on the left, with the words "Centerline Biomedical" in gray on the right. A horizontal line separates the two words.
n Intra-Operative Positioning System
Non-Clinical Testing:
Performance testing was conducted to demonstrate the performance and accuracy of the IOPS and to verify that it does not raise any new safety and effectiveness concerns. Test results indicate that the IOPS is substantially equivalent to the predicate device and does not raise any new safety or effectiveness concerns. All testing was performed on production equivalent devices.
- IEC 60601-1 and IEC 60601-1-2 Electrical Safety and Electromagnetic Compatibility ● Testing
- Biocompatibility testing for guidewires and catheters (Externally Communicating Device, Circulating blood contact. A - limited