Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters)

K241243 · Centerline Biomedical, Inc. · DQK · Jul 24, 2024 · Cardiovascular

Device Facts

• Record ID: K241243
• Device Name: Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters)
• Applicant: Centerline Biomedical, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Jul 24, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

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.

Device Story

IOPS Viewpoint Catheters are sterile, single-use 6 Fr catheters used with the Intra-Operative Positioning System (IOPS). Inserted into femoral, brachial, or axillary arteries; navigated through descending aorta vasculature to access branch vessels. Catheters contain multiple electromagnetic (EM) tracking sensors and a radiopaque marker. System transforms sensor input into real-time 3D visualization of catheter tip position and shape overlaid on a pre-acquired 3D vascular map. Used in endovascular procedures by clinicians as an adjunct to fluoroscopy. Provides real-time navigation guidance; does not perform diagnosis. Benefits include improved visualization and navigation during endovascular interventions.

Clinical Evidence

Bench testing only. Testing included ISO 10555-1 mechanical evaluation (tensile force, leakage), dimensional analysis, simulated use in abdominal aorta models, sensor accuracy per ASTM F2554, radiopacity per ASTM F640, biocompatibility per ISO 10993, sterilization validation per ISO 11135, and packaging integrity testing.

Technological Characteristics

6 Fr sterile, single-use catheters with EM tracking sensors and radiopaque markers. Materials comply with ISO 10993. Sterilization via EO (ISO 11135). Connectivity via integrated signal cable to IOPS console. Standards: ISO 10555-1 (catheters), ASTM F640 (radiopacity), ASTM F2554 (accuracy), ISO 80369 (hubs), IEC 60601 (electrical safety).

Indications for Use

Indicated for patients undergoing endovascular interventions in the descending aorta. Used as an adjunct to fluoroscopy for real-time navigation and tip positioning of sensor-equipped catheters and guidewires. Not for diagnostic use.

Regulatory Classification

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.

Predicate Devices

• IOPS Simple Curve Catheter and IOPS Reverse Curve Catheter (K190106)
• IOPS Simple Curve Catheter and IOPS Reverse Curve Catheter (K230309)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

K241243

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 | [e-mail] | |
| Device Name 21 CFR 807.92(a)(2) | | |
| Device Trade Name | Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve<br>Catheters);<br>Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve<br>Catheters) | |
| 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),<br>manufactured by Centerline Biomedical. They are designed to be inserted into the femoral artery, brachial artery, or axillary artery and<br>navigate through vasculature in the descending aorta to access branch vessels near to, or involved in, the lesion during endovascular<br>procedures.<br>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.