(83 days)
Not Found
No
The summary describes a navigation system using electromagnetic tracking and pre-acquired CT data for real-time positioning. There is no mention of AI, ML, deep learning, or any related concepts in the device description, intended use, or performance studies. The technology described is based on established navigation principles.
No
The device is described as a surgical navigation system that assists with real-time tip positioning and navigation during endovascular interventions as an adjunct to fluoroscopy. It does not treat or cure a disease, but rather provides guidance.
No
The text explicitly states: "The IOPS does not make a diagnosis." and "The system is for use as an adjunct to fluoroscopy and does not make a diagnosis."
No
The device description explicitly states that the IOPS consists of "surgical navigation technology and a number of associated accessories," and lists physical accessories such as guidewires, catheters, and a fiducial tracking pad. It also mentions electromagnetic tracking technology, which implies hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- IOPS Function: The IOPS system is used during a medical procedure (endovascular interventions) to assist with the real-time positioning and navigation of instruments (catheters and guidewires) within the patient's body. It uses previously acquired scan data (CT scans) and electromagnetic tracking to guide the physician.
- Lack of Specimen Analysis: The IOPS does not analyze any specimens taken from the patient's body. Its function is entirely focused on guiding instruments within the living patient.
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The IOPS does not make a diagnosis." While not a definitive indicator of not being an IVD, it reinforces that the device's purpose is not diagnostic in the traditional sense of analyzing biological samples.
In summary, the IOPS is a surgical navigation system used in vivo (within the living body) to assist with procedures, not an in vitro diagnostic device that analyzes biological samples.
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 peripheral, aortic side branch vasculature. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
Product codes
DQK, DQY, DQX
Device Description
The Intra-Operative Positioning System (IOPS) consists of a surgical navigation technology and a number of associated accessories. The navigation technology is a non-contact reusable multi-patient use device. The associated accessories are single use devices provided sterile (EtO).
The IOPS displays the position and orientation of sensor equipped catheters, guidewires, and tracking pad 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 displayed on a monitor. The system is for use as an adjunct to fluoroscopy and does not make a diagnosis.
The associated accessories include:
- Guidewire
- Catheters
- Fiducial Tracking Pad
- Guidewire Handle
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan data
Anatomical Site
peripheral, aortic side branch vasculature
Indicated Patient Age Range
Adults Only
Intended User / Care Setting
Not Found
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)
Bench Testing
Software verification was conducted to establish equivalency to the predicate device in safety and effectiveness. There are no hardware changes to IOPS and its associated accessories and therefore Electrical, Mechanical and Thermal Safety Testing is not needed.
Design Validation, including usability testing, was performed to support the inclusion of all peripheral, aortic and aortic side branch vasculature vessels in the indications for use statement and to establish equivalency to the predicate device in safety and effectiveness. These studies included physician targeting of three regions for cannulation: branches of the aortic arch, distal branches of the descending aorta, and branches of the peripheral vasculature. In addition, technicians were given test case scenarios and asked to place the tracking pad in each of the three proposed expanded indications regions.
Animal Testing
No animal testing was completed as a part of this submission.
Clinical Testing
No clinical testing was completed as a part of this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K190106, K230309, K241243, K242133
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" below it.
March 6, 2025
Centerline Biomedical, Inc. Kevin Reed Director, Quality & Regulatory 4535 Renaissance Pkwy Cleveland, Ohio 44128
Re: K243842
Trade/Device Name: Intra-Operative Positioning System (IOPS®) Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, DQY, DQX Dated: December 13, 2024 Received: December 13, 2024
Dear Kevin Reed:
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 (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 available 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
2
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,
MARCO CANNELLA -S
for
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
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 peripheral, aortic side branch vasculature. 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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4
SUBMITTER
Centerline Biomedical, Inc. 4535 Renaissance Pkwy Cleveland, OH 44128
Phone: 330-577-5033 Email: kevin.reed@centerlinebiomedical.com
Contact Person: Kevin Reed Date Prepared: 21 FEB 2023
DEVICE
| Trade Name: | Intro-Operative Positioning System (IOPS®) |
|---|---|
| Common Name: | Programmable diagnostic computer |
| Classification Name: | Computer, diagnostic, programmable |
| Regulatory Class: | II |
| Product Codes: | DQK, DQY, DQX |
| Regulation Number: | 870.1425 |
PREDICATE DEVICE
The legally marketed device to which equivalence is being claimed [807.92(a)(3)] is as follows:
| 510(k) Number | Name | Product Code |
|---|---|---|
| K190106 | Intra-Operative Positioning System (IOPS) | DQK |
| K230309 | Intra-Operative Positioning System (IOPS®) | DQK |
| K241243 | Intra-Operative Positioning System (IOPS®) Viewpoint | DQK |
| K242133 | Intra-Operative Positioning System (IOPS®) | DQK |
Primary predicate is listed first. The predicates have not been the subject of any design-related recalls.
DEVICE DESCRIPTION
The Intra-Operative Positioning System (IOPS) consists of a surgical navigation technology and a number of associated accessories. The navigation technology is a non-contact reusable multi-patient use device. The associated accessories are single use devices provided sterile (EtO).
The IOPS displays the position and orientation of sensor equipped catheters, guidewires, and tracking pad 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 displayed on a monitor. The system is for use as an adjunct to fluoroscopy and does not make a diagnosis.
The associated accessories include:
- Guidewire
- Catheters
- Fiducial Tracking Pad
- · Guidewire Handle
5
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 peripheral, aortic side branch vasculature. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Indications for Use statement for the IOPS and its associated accessories is not identical to the predicate device; however, the differences do not alter the intended use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use for the evaluation of vascular anatomy as captured via 3D modeling from previously acquired scan data and for real time tip positioning and navigation using sensor equipped compatible catheters and guidewires.
All technological characteristics of the IOPS and its associated accessories are the same as the predicate devices except for IOPS software version.
Table 1 lists the differences between the subject device and the predicate device.
| Table 1: Summary Comparison | |||
|---|---|---|---|
| Subject Device | Predicate Device | ||
| (K190106, K230309, | |||
| K2414243, K242133)* | Discussion | ||
| Trade Name | Intra-Operative Positioning | ||
| System (IOPS) | Intra-Operative Positioning | ||
| System (IOPS) | Same | ||
| Model | |||
| Name/Number | Mobile Cart | ||
| MC-1 | Mobile Cart | ||
| MC-1 | Same | ||
| Product Code | DQK | DQK | Same |
| Class | II | II | Same |
| Classification | |||
| Identification | 870.1425 | 870.1425 | Same |
| Device | |||
| Description | The IOPS 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 IOPS 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. | Same | ||
| Device | |||
| Accessories | • IOPS Guidewire (ATW-2) | ||
| • IOPS Viewpoint Simple | |||
| Curve Catheters | • IOPS Guidewire (ATW-2) | ||
| • IOPS Viewpoint Simple | |||
| Curve Catheters | Similar | ||
| (C00751; C01251) | |||
| IOPS Viewpoint Double | |||
| Curve Catheters | |||
| (C00752; C01252) IOPS Fiducial Tracking | |||
| Pad (T02111) IOPS Guidewire Handle | |||
| (H01035) | (C00751; C01251) | ||
| IOPS Viewpoint Double | |||
| Curve Catheters | |||
| (C00752; C01252) IOPS Fiducial Tracking | |||
| Pad (T02111;TP-1) IOPS Guidewire Handle | |||
| (H01035) | subject device in this | ||
| submission is not intended to | |||
| be used with the first | |||
| generation IOPS Tracking Pad | |||
| (TP-1). | |||
| 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 | |||
| peripheral, aortic and aortic | |||
| side branch vasculature. The | |||
| system is indicated for use as | |||
| an adjunct to fluoroscopy. | |||
| The IOPS does not make a | |||
| diagnosis. | 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. | The Indications for Use | ||
| statement for the IOPS and | |||
| its associated accessories is | |||
| not identical to the predicate | |||
| device; however, the | |||
| differences do not alter the | |||
| intended use of the device | |||
| nor do they affect the safety | |||
| and effectiveness of the | |||
| device relative to the | |||
| predicate. Both the subject | |||
| and predicate devices have | |||
| the same intended use for | |||
| the evaluation of vascular | |||
| anatomy as captured via 3D | |||
| modeling from previously | |||
| acquired scan data and for | |||
| real time tip positioning and | |||
| navigation using sensor | |||
| equipped compatible | |||
| catheters and guidewires. | |||
| The subject device has been | |||
| evaluated through design | |||
| validation. | |||
| Intended Use | |||
| Population | Adults Only | Adults Only | Same |
| Software Version | 1.5.81 | 1.0.5056 | The difference in the |
| software version does not | |||
| raise new questions of safety | |||
| or effectiveness. The subject | |||
| device has been evaluated | |||
| through software verification | |||
| testing |
Table 1: Summary Comparison
6
- The predicate device was originally cleared in K190106 and cleared with updated labeling (changed Applied Part designations from Type BF to Defibrillation-Proof Type BF) in K230309. IOPS Viewpoint Catheters were cleared in K241243. IOPS Fiducial Tracking Pad and Guidewire Handle were cleared in K242133.
PERFORMANCE DATA
Bench Testing
Software verification was conducted to establish equivalency to the predicate device in safety and effectiveness. There are no hardware changes to IOPS and its associated accessories and therefore Electrical, Mechanical and Thermal Safety Testing is not needed.
Design Validation, including usability testing, was performed to support the inclusion of all peripheral,
7
aortic and aortic side branch vasculature vessels in the indications for use statement and to establish equivalency to the predicate device in safety and effectiveness. These studies included physician targeting of three regions for cannulation: branches of the aortic arch, distal branches of the descending aorta, and branches of the peripheral vasculature. In addition, technicians were given test case scenarios and asked to place the tracking pad in each of the three proposed expanded indications regions.
Animal Testing
No animal testing was completed as a part of this submission.
Clinical Testing
No clinical testing was completed as a part of this submission.
CONCLUSIONS
The change in the indications for use does not raise new or different questions of safety or effectiveness. The successful completion of non-clinical testing demonstrates that IOPS performs as intended and is substantially equivalent to the predicate device.