(82 days)
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 IOPS Viewpoint Catheters are sterile, single use 6 Fr catheters intended for use with the Intra-Operative Positioning System (IOPS), manufactured by Centerline Biomedical. They are designed to be inserted into the femoral artery, brachial artery, or axillary artery and navigate through vasculature in the descending aorta to access branch vessels near to, or involved in, the lesion during endovascular procedures. The IOPS Viewpoint Catheters are available in two tip shape configurations (Simple and Double). Each tip shape is available in two lengths (75cm and 125cm). All models are equipped with multiple tracking sensors allowing the loPS to detect and visualize the catheter tip position and shape, in real time, on a 3D rendent's vascular map. The catheters have a radiopaque marker near the distal tip and a luer locking hub on the proximal end.
The provided text describes a 510(k) premarket notification for the Intra-Operative Positioning System (IOPS®) Viewpoint Catheters. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's performance against specific acceptance criteria for an AI/algorithm-based diagnostic device.
Therefore, many of the requested details regarding acceptance criteria, study design for AI evaluation (e.g., sample sizes for training/test sets, expert ground truth establishment, MRMC studies, standalone performance), and ground truth methodologies are not available within this document. The document primarily reports on non-clinical testing to ensure the physical and functional aspects of the catheter meet safety and performance standards for a medical device.
Here's a breakdown based on the provided text, highlighting what is and isn't available:
Acceptance Criteria and Device Performance
The document does not present a table of specific acceptance criteria for an AI/algorithm's performance (e.g., sensitivity, specificity, accuracy targets). Instead, it lists various non-clinical tests performed on the catheter device itself to establish its safety and effectiveness. The "device performance" reported is the successful completion of these tests, indicating the catheter performs as intended.
Table of Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Testing of the Catheter):
| Acceptance Criteria Category (Test Performed) | Reported Device Performance/Conclusion |
|---|---|
| Evaluation per ISO 10555-1 (Peak tensile force, freedom from leakage, radio-detectability, hubs, visual inspection) | Achieved equivalency to predicate device in safety and effectiveness |
| Dimensional analysis | Successful |
| Simulated use in an abdominal aorta model | Successful |
| Sensor functionality, placement, and accuracy | Successful (for real-time tip position visualization on a 3D vascular map, as per the device's function) |
| Hub to connector cable bond | Successful |
| Particulate testing per USP <788> | Successful |
| Radiopacity per ASTM F640 | Successful |
| Accuracy testing with IOPS per ASTM F2554 | Successful (presumably for the catheter's tracking accuracy within the IOPS system) |
| IEC 60601 and Applied Part Testing | Successful |
| Hub compliance with ISO 80369 | Successful |
| Biocompatibility per ISO 10993 | Successful |
| Sterilization per ISO 11135 and ANSI/AAMI TIR 28 | Successful |
| EO/ECH residuals per ISO 10993-7 | Successful |
| Bacterial endotoxins per USP <85> | Successful |
| Simulated distribution per ISTA Procedure 3A and ASTM D4169 | Successful |
| Packaging integrity per ASTM F2096 and ASTM F88/F88M | Successful |
| Overall Conclusion | "The successful completion of non-clinical testing demonstrates that the IOPS Viewpoint Catheters perform as intended and are substantially equivalent to the predicate." |
Details Not Available in the Provided Text (Pertaining to AI/Algorithm Performance):
The document describes the IOPS Viewpoint Catheters, which are "sensor-equipped compatible catheters and guidewires" used with the "Intra-Operative Positioning System (IOPS)". The IOPS system itself "visualize[s] the catheter tip position and shape, in real time, on a 3D renders vascular map." This suggests that the "IOPS" has an underlying algorithm for positioning and navigation, but the provided text focuses on the catheters as the subject devices for the 510(k) submission. Therefore, information typical for an "AI/algorithm performance study" is absent.
- Sample size used for the test set and the data provenance: Not applicable/not provided for AI algorithm evaluation. The document mentions "simulated use in an abdominal aorta model" as a test for the catheter, but not as an AI test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable/not provided. The device is an "adjunct to fluoroscopy" for real-time tip positioning and navigation, not a diagnostic AI system assisting human readers in interpreting medical images.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not provided explicitly for the algorithm. The "Sensor functionality, placement, and accuracy" and "Accuracy testing with IOPS per ASTM F2554" of the catheter itself imply testing of the system's ability to track the catheter, but not a standalone AI diagnostic performance study.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/not provided for an AI algorithm. For the catheter, the ground truth for testing would be physical measurements and established engineering standards.
- The sample size for the training set: Not applicable/not provided.
- How the ground truth for the training set was established: Not applicable/not provided.
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July 24, 2024
Centerline Biomedical, Inc. Amanda Shade Sr. Regulatory Affairs Manager 10000 Cedar Ave Cleveland, Ohio 44106
Re: K241243
Trade/Device Name: Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK, DOY Dated: June 21, 2024 Received: June 24, 2024
Dear Amanda Shade:
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 (the 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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.
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 mediation-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,
Aneesh S. Deoras -S
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices
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Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters)
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 descending aorta. 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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| 510(k) #: K241243 | 510(k) Summary | Prepared on: 2024-06-21 |
|---|---|---|
| Contact Details 21 CFR 807.92(a)(1) | ||
| Applicant Name | Centerline Biomedical, Inc. | |
| Applicant Address | 10000 Cedar Ave Cleveland OH 44106 United States | |
| Applicant Contact Telephone | 216-206-7364 | |
| Applicant Contact | Amanda Shade | |
| Applicant Contact Email | amanda@centerlinebiomedical.com | |
| Device Name 21 CFR 807.92(a)(2) | ||
| Device Trade Name | Intra-Operative Positioning System (IOPS®) Viewpoint (Simple CurveCatheters);Intra-Operative Positioning System (IOPS®) Viewpoint (Double CurveCatheters) | |
| Common Name | Programmable diagnostic computer | |
| Classification Name | Computer, Diagnostic, Programmable | |
| Regulation Number | 870.1425 | |
| Product Code(s) | DQK, DQY | |
| Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K190106 | IOPS Simple Curve Catheter and IOPS Reverse Curve Catheter | DQK |
| K230309 | IOPS Simple Curve Catheter and IOPS Reverse Curve Catheter | DQK |
| Device Description Summary 21 CFR 807.92(a)(4) | ||
| The IOPS Viewpoint Catheters are sterile, single use 6 Fr catheters intended for use with the Intra-Operative Positioning System (IOPS),manufactured by Centerline Biomedical. They are designed to be inserted into the femoral artery, brachial artery, or axillary artery andnavigate through vasculature in the descending aorta to access branch vessels near to, or involved in, the lesion during endovascularprocedures.The IOPS Viewpoint Catheters are available in two tip shape configurations (Simple and Double). Each tip shape is available in two |
lengths (75cm and 125cm). All models are equipped with multiple tracking sensors allowing the loPS to detect and visualize the catheter tip position and shape, in real time, on a 3D rendent's vascular map. The catheters have a radiopaque marker near the distal tip and a luer locking hub on the proximal end.
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 position using sensor-equipped compatible catheters and guidewires used in endovascular in the descending aorta. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
Indications for Use Comparison
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
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The indications for use of the IOPS Viewpoint Catheters have not changed from the predicate devices.
Technological Comparison
21 CFR 807.92(a)(6)
The subject and predicate devices are intended for use with the Intra-Operative Positioning System. The principles of operation of IOPS Viewpoint Catheters remain unchanged from the predicate devices are compatible with 0.035" (OPS quidewire. The following technological differences exist between the subject and predicate devices:
-The subject devices have a smaller OD (6 Fr) in comparison to the predicate devices (8 Fr).
-The subject devices have different working length (75cm) and overall length options (85cm and 135cm) in comparison to the predicate devices (100cm working length and 105cm overall length).
-The subject devices have different distal tip shapes, angles, and forming process in comparison to the predicate devices.
-The subject devices have longer signal cable and smaller size EM Sensors in comparison to the predicate devices.
-The subject devices include a radiopaque marker near the distal tip.
-The subject devices have some different materials used in the construction of catheters.
-The subject devices are packaged in a tray system and Tyvek pouch while the predicate in a mounting card and Tyvek pouch.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Non-Clinical Testing:
The following tests were conducted on the IOPS Viewpoint Catheters to establish equivalency to the predicate device in safety and effectiveness:
· Evaluation per ISO 10555-1 for peak tensile force, freedom from leakage, radio-detectability, hubs, and visual inspection of surface/ distal tip
- · Dimensional analysis
- · Simulated use in an abdominal aorta model
- · Sensor functionality, placement, and accuracy
- · Hub to connector cable bond
- · Particulate testing per USP <788>
- · Radiopacity per ASTM F640
- · Accuracy testing with IOPS per ASTM F2554
- · IEC 60601 and Applied Part Testing
- · Hub compliance with ISO 80369
- · Biocompatibility per ISO 10993
- · Sterilization per ISO 11135 and ANSI/AAMI TIR 28
- · EO/ECH residuals per ISO 10993-7
- · Bacterial endotoxins per USP < 85>
- · Simulated distribution per ISTA Procedure 3A and ASTM D4169
- · Packaging integrity per ASTM F2096 and ASTM F88/F88M
Conclusion:
The subject devices have similar technological characteristics and the same indications/intended use as the predicate devices. The differences in technological characteristics do not raise new or different questions of safety or effectiveness. The successful completion of non-clinical testing demonstrates that the IOPS Viewpoint Catheters perform as intended and are substantially equivalent to the predicate.
§ 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).