CARDNAV

K120282 · Paieon, Inc. · OWB · Dec 10, 2012 · Radiology

Device Facts

• Record ID: K120282
• Device Name: CARDNAV
• Applicant: Paieon, Inc.
• Product Code: OWB · Radiology
• Decision Date: Dec 10, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Software as a Medical Device, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K120282 · Dec 10, 2012	CARDNAV	Paieon, Inc.	Retrospective clinical data	Retrospective clinical data was utilized as part of the performance evaluation to demonstrate that the CardNav software performs as intended and is safe for its intended use.	Retrospective clinical data; Performance evaluation

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Retrospective analysis	—	Not applicable for this study	Device performance and safety

Indications for Use

CardNav, an image acquisition and processing modular software package, is indicated for use as follows: Assist in projection selection using 3D modeling based on 2D images. Perform quantitative analysis on coronary veins based on fluoroscopy images. Assists in device positioning by providing real time localization on predefined roadmaps and live fluoroscopy. Perform motion analysis on coronary veins based on fluoroscopy images. To be used in cardiac procedures and off-line for post-procedural analysis.

Device Story

CardNav is a modular software add-on for conventional X-ray angiography systems. It processes 2D fluoroscopy images to assist clinicians during cardiac procedures involving coronary venous device placement. The device performs 3D modeling from 2D images for projection selection, provides real-time localization on roadmaps for device positioning, and conducts quantitative and motion analysis of coronary veins. Used by clinicians in cardiac procedure settings and for offline post-procedural review. The software enhances diagnostic and therapeutic staging without altering standard angiography workflows. Benefits include improved procedural planning, accurate device placement, and quantitative assessment of venous anatomy and motion.

Clinical Evidence

Evidence includes in-house software verification, on-site system evaluation, bench testing using phantoms, retrospective clinical data, and an animal study. The animal study compared device results against a sonomicrometry measurement method. Results demonstrated that the device performs as intended and is safe for its intended use.

Technological Characteristics

Modular software package designed as an add-on to conventional X-ray angiography systems. Features include 3D modeling from 2D images, quantitative analysis, real-time localization, and motion analysis. Operates on standard fluoroscopy input. No specific hardware materials or energy sources listed as the device is software-only.

Indications for Use

Indicated for patients undergoing device placement in the coronary venous system. Used in cardiac procedures and post-procedural analysis.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• IC-PRO System (version 3.5, model B) (K110256)
• 4D LV-Analysis software (K110746)
• syngo Vector Velocity Imaging application (K072090)
• Cardiac Motion Quantification Plugin (CMQ) (K103815)

Submission Summary (Full Text)

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K|20282

## DEC 1 0 2012

Image /page/0/Picture/2 description: The image shows the word "Paieon" in a stylized font. Below the word "Paieon" is the phrase "Realizing Cardiac Imaging". The text is black and the background is white. The image appears to be a logo or title for a company or organization related to cardiac imaging.

510(k) SUMMARY

## 510(k) SUMMARY- CardNav

| Submitter Name: | Paieon Inc. |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 747 Third Ave., 4th floor New York, NY 10017-2803 |
| Contact Person: | Shimon Vaknin |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Date Prepared: | October 31, 2012 |
| Device Trade Name: | CardNav |
| Device Common<br>Name: | Cardiovascular Angiography Analysis System |
| Classification Name: | Image-intensified fluoroscopic x-ray system (product code<br>OWB) |
| Predicate Devices: | 1. The IC-PRO System (version 3.5, model B) cleared under<br>K110256;<br>2. The 4D LV-Analysis software cleared under K110746;<br>3. The syngo Vector Velocity Imaging application cleared<br>with the Diagnostic Ultrasound System with Accessories<br>under K072090;<br>4. The Cardiac Motion Quantification Plugin (CMQ) which is<br>a part of the QLAB software included with the Q-Station<br>cleared under K103815. |
| Device Description: | CardNav (version 1.0) is an image acquisition and processing<br>modular software package designed as an add-on to<br>conventional X-ray angiography systems. It enhances the<br>output of cardiovascular angiography by providing software<br>modules that assist in diagnosis, procedure planning and<br>therapeutic staging. This data is obtained without altering the<br>basic angiography procedure. |

The CardNav software is to be used with patients undergoing device placement in the coronary venous system.

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510(k) SUMMARY

CardNav, an image acquisition and processing modular Intended Use: software package, is indicated for use as follows: Assist in projection selection using 3D modeling based on . 2D images. Perform quantitative analysis on coronary veins based on fluoroscopy images. Assists in device positioning by providing real time localization on predefined roadmaps and live fluoroscopy. Perform motion analysis on coronary veins based on 트 fluoroscopy images. . To be used in cardiac procedures and off-line for postprocedural analysis. None Performance Standards: Testing included in-house software verification testing, on-site Performance Data: system evaluation, bench testing using phantoms and retrospective clinical data, and animal study comparing device results with a sonomicrometry measurement method. The results of the testing indicate that CardNav 1.0 performs as intended and is safe for its intended use. The intended uses of CardNav (version 1.0) are substantially Substantial equivalent to a combination of the intended use of the predicate Equivalence: devises. All CardNav 1.0 technological characteristics, except motion analysis are the same as the cleared IC-PRO (version 3.5, model B) system; the motion analysis is technologically different from the predicate devices in terms of imaging modality and different output, but similar in terms of temporal resolution. Performance data was provided and showed that the device is safe and effective. The testing reported in this 510(K) establishes that the Conclusion: CardNav (version 1.0) is substantially equivalent to its predicate device and it is safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 10, 2012

Paion, Inc. % Mr. Shimon Vaknin Official Correspondent Paieon Medical, Ltd. 23 Hamilacha St., P.O.B 11355 Rosh Haayin, 48091 ISRAEL

Re: K120282 Trade/Device Name: CardNay Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB AND LLZ Dated: November 30, 2012 Received: December 3, 2012

Dear Mr. Vaknin:

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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2-Mr. Vaknin

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

## Janine M. Morris -S

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K120282

Device Name: CardNav 1.0

Indications For Use:

CardNav, an image acquisition and processing modular software package, is indicated for use as follows:

- 트 Assist in projection selection using 3D modeling based on 2D images.
- Perform quantitative analysis on coronary veins based on fluoroscopy images.
- 트 Assists in device positioning by providing real time localization on predefined roadmaps and live fluoroscopy.
- 트 Perform motion analysis on coronary veins based on fluoroscopy images.
- 트 To be used in cardiac procedures and off-line for post-procedural analysis.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Janine M. Morris -S 2012.12.10 12:43:52 -05'00'

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