NDOHD High Definition Imaging System (NDOHD)

K190420 · Altaravision, Inc. · LLZ · Apr 15, 2019 · Radiology

Device Facts

• Record ID: K190420
• Device Name: NDOHD High Definition Imaging System (NDOHD)
• Applicant: Altaravision, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Apr 15, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The NDŌHD system is intended for viewing, acquiring, recording, archiving and retrieving video and still images of endoscopic and fluoroscopic procedures.

Device Story

NDŌHD High Definition Imaging System (v2.1) is a PACS for endoscopic and fluoroscopic procedures; captures, displays, records, and archives video/still images. System comprises MacBook Pro hardware, CMOS camera, and proprietary software. Operates via C-mount camera connection; records .mp4 (H.264) video and .tiff images. Used by clinicians/physicians in clinical settings; provides high-definition visualization to assist in procedural documentation and review. Updated from predicate (K131873) to replace obsolete hardware, transition to Swift programming language, and support macOS 10.14+.

Clinical Evidence

No clinical data. Substantial equivalence supported by software verification, system validation, and electrical safety testing (IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2, IEC 62304).

Technological Characteristics

PACS system; MacBook Pro platform; CMOS camera sensor; C-mount coupler; USB-3.0 interface; SSD storage; macOS 10.14+; Swift-based software; H.264 video compression; .tiff image format. Standards: IEC 60601-1 (safety), IEC 60601-2-18 (endoscopic equipment), IEC 60601-1-2 (EMC), IEC 62304 (software lifecycle).

Indications for Use

Indicated for medical doctors or clinicians (e.g., speech pathologists) to view, acquire, record, archive, and retrieve video and still images of endoscopic and fluoroscopic procedures. Prescription use only. Not for use in environments requiring sterilization.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• NDŌHD High Definition Imaging System (K131873)

Submission Summary (Full Text)

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## 510(k) Summary

## Altaravision, Inc. K190420

This 510(k) Summary is in conformance with 21CFR 807.92

| Submitter: | Altaravision, Inc.<br>130 Salem Town Court<br>Apex, NC 27502<br>Phone: [phone] |
|------------------|--------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King, CEO<br>MethodSense, Inc.<br>Email: [e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| Company Contact: | Stuart Bradley<br>Chief Executive Officer |
| Date Prepared: | April 12, 2019 |

## Device Name and Classification

| Trade Name: | NDŌHD High Definition Imaging System (NDŌHD) |
|-----------------------|--------------------------------------------------------------|
| Common Name: | Picture Archiving Communications System (PACS) |
| Classification: | Class II |
| Regulation Number: | 892.2050- Picture Archiving and Communications System (PACS) |
| Classification Panel: | Radiology |
| Product Code: | LLZ |

Predicate Device:

| | Primary Predicate |
|---------------------------|--------------------------------------------------------------|
| Trade Name | NDŌHD High Definition Imaging System (NDŌHD) |
| Common Name | Picture Archiving Communications System (PACS) |
| 510(k) Submitter / Holder | Altaravision, Inc. |
| 510(k) Number | K131873 |
| Regulation Number | 892.2050- Picture Archiving and Communications System (PACS) |
| Classification Panel | Radiology |
| Product Code | LLZ |

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### Device Description and Intended Use

The NDOнd High Definition Imaging System (NDOнD) previously acquired FDA clearance in 2013 as a Class II picture archiving and communication system that provides capabilities related to the acquisition, transfer, display, storage, and digital processing of images and videos (K131873). The NDOнD High Definition Imaging System (NDOHD) previously acquired FDA clearance in 2013 as a Class II picture archiving and communication system (K131873). Altaravision replaced off the shelf hardware components due to the hardware becoming obsolete. Altaravision also updated the NDOHD software to enable use of the new hardware, improve the software user interface and conform to Apple's latest coding best practices.

The NDŌнь system is intended for viewing, acquiring, recording, archiving and retrieving video and still images of endoscopic and fluoroscopic procedures.

### Indications for Use

The NDŌнь system is intended for viewing, acquiring, recording, archiving and retrieving video and still images of endoscopic and fluoroscopic procedures. The professionals or practitioners using this system would be medical doctors or clinicians such as speech pathologists. The device is a prescription device. The NDOHD system is not intended to be used in an environment that requires sterilization.

### Risk Analysis Method

Risk Management activities were completed following ISO 14971:2007 and ISO 14971:2012 and Altaravision's current Risk Management Procedure, SOP 1070, in order to assess the impact of the modification on the device and its components. A Risk Management Plan was created to identify the risk management team, the risk acceptability criteria, and the plan for completion of a risk assessment and risk management report. Hazards for the new system were identified systematically using the device safety characteristics, and reviewing known hazards and hazard categories. Hazards related to the use of off the shelf software were also incorporated in the Risk Assessment. Risk was then evaluated using the established risk acceptability criteria and taking into account current controls of the system. Risks were then further evaluated after additional controls were taken into account. From here, residual risk was evaluated, and it was determined if a risk benefit analysis was necessary. All risks were found to be acceptable, and no risk benefit analysis was necessary. After the completion of the Risk Assessment, the overall risk and residual risk of the NDOнь 2.1 system has been found to be acceptable by executive management.

### Substantial Equivalence

The table below provides a detailed comparison of the NDŌнɒ High Definition Imaging System to the predicate device.

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| Item | Subject Device | Predicate Device | Comparison |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NDŌHD High Definition<br>Imaging System, version 2.1 | NDŌHD High Definition Imaging<br>System (K131873) | |
| Intended Use | The NDŌHD system is intended<br>for viewing, acquiring, recording,<br>archiving and retrieving video<br>and still images of endoscopic<br>and fluoroscopic procedures. | The NDŌHD system is intended<br>for viewing, acquiring, recording,<br>archiving and retrieving video and<br>still images of endoscopic and<br>fluoroscopic procedures. | NDŌHD High Definition Imaging<br>System Version 2.1 is identical to<br>NDŌHD High Definition Imaging<br>System (NDŌHD ). |
| Indications for<br>Use | The NDŌHD system is intended<br>for viewing, acquiring, recording,<br>archiving and retrieving video<br>and still images of endoscopic<br>and fluoroscopic procedures.<br>The professionals or<br>practitioners using this system<br>would be medical doctors or<br>clinicians such as speech<br>pathologists. The device is a<br>prescription device. The NDŌHD<br>system is not intended to be<br>used in an environment that<br>requires sterilization. | The NDŌHD system is intended<br>for viewing, acquiring, recording,<br>archiving and retrieving video and<br>still images of endoscopic and<br>fluoroscopic procedures. The<br>professionals or practitioners<br>using this system would be<br>medical doctors or clinicians such<br>as speech pathologists. The<br>device is a prescription device.<br>The NDŌHD system is not<br>intended to be used in an<br>environment that requires<br>sterilization. | NDŌHD High Definition Imaging<br>System Version 2.1 is identical to<br>NDŌHD High Definition Imaging<br>System (NDŌHD ). |
| Target Population | Medical doctors or clinicians<br>such as speech pathologists | Medical doctors or clinicians such<br>as speech pathologists | NDŌHD High Definition Imaging<br>System Version 2.1 is identical to<br>NDŌHD High Definition Imaging<br>System (NDŌHD ). |
| Computer | MacBook Pro 13-inch and 15-<br>inch | MacBook Pro 15-inch | NDŌHD High Definition Imaging<br>System Version 2.1 is equivalent to<br>NDŌHD High Definition Imaging<br>System (NDŌHD ). |
| Item | Subject Device | Predicate Device | Comparison |
| | NDŌHD High Definition<br>Imaging System, version 2.1 | NDŌHD High Definition Imaging<br>System (K131873) | |
| Display | Built-in computer display – 13-<br>inch and 15-inch | Built-in computer display – 15-<br>inch | NDŌHD High Definition Imaging<br>System Version 2.1 is equivalent to<br>NDŌHD High Definition Imaging<br>System (NDŌHD ). |
| Storage Medium | Non removable solid state drive<br>(SSD) | Non removable hard drive | NDŌHD High Definition Imaging<br>System Version 2.1 is equivalent to<br>NDŌHD High Definition Imaging<br>System (NDŌHD ). |
| Operating System | macOS 10.14 + | macOS 10.8 + | NDŌHD High Definition Imaging<br>System Version 2.1 is equivalent to<br>NDŌHD High Definition Imaging<br>System (NDŌHD ), with the only<br>difference being the version of the<br>operating system. This difference<br>does not affect the intended use or<br>safety and effectiveness of the<br>device. |
| Camera Coupler | C-Mount | C-Mount | NDŌHD High Definition Imaging<br>System Version 2.1 is identical to<br>NDŌHD High Definition Imaging<br>System (NDŌHD ). |
| Camera –<br>Computer Cable | USB-3.0 USB C to USB Micro-B | Firewire | NDŌHD High Definition Imaging<br>System Version 2.1 uses a different<br>cable than the NDŌHD High<br>Definition Imaging System. This |
| Item | Subject Device | Predicate Device | Comparison |
| | NDŌHD High Definition<br>Imaging System, version 2.1 | NDŌHD High Definition Imaging<br>System (K131873) | |
| | | | difference does not affect the<br>intended use or safety and<br>effectiveness of the device. |
| Video Output<br>Format | .mp4 H.264 Video | .mov H.264 Video | The video output format of the<br>NDŌHD High Definition Imaging<br>System Version 2.1 is different from<br>the video output format used with the<br>NDŌHD High Definition Imaging<br>System. The difference in video<br>format does not affect the intended<br>use or safety and effectiveness of the<br>device. |
| Still Image Output<br>Format | .tiff Image | .tiff Image | NDŌHD High Definition Imaging<br>System Version 2.1 is identical to<br>NDŌHD High Definition Imaging<br>System. |
| Camera Sensor<br>Type | CMOS | CCD Progressive | The camera sensor type of the<br>NDŌHD High Definition Imaging<br>System Version 2.1 is different from<br>the one used with the NDŌHD High<br>Definition Imaging System. This<br>difference does not affect the<br>intended use or safety and<br>effectiveness of the device. |
| Camera Frame<br>Rate | 203 fps (frames per second) | 31 fps (frames per second) | The camera frame rate of the NDŌHD<br>High Definition Imaging System |
| Item | Subject Device | Predicate Device | Comparison |
| | NDŌHD High Definition<br>Imaging System, version 2.1 | NDŌHD High Definition Imaging<br>System (K131873) | |
| | | | Version 2.1 is different from the one<br>used with the NDŌHD High Definition<br>Imaging System. This difference<br>does not affect the intended use or<br>safety and effectiveness of the<br>device. |
| Pixel Size | 4.8 μm x 4.8 µm | 4.65 μm x 4.65 μm | NDŌHD High Definition Imaging<br>System Version 2.1 is equivalent to<br>NDŌHD High Definition Imaging<br>System. |
| Camera Bit Depth | 10 bits | 8 - 14 bits | NDŌHD High Definition Imaging<br>System Version 2.1 is equivalent to<br>NDŌHD High Definition Imaging<br>System. |
| Camera<br>Resolution (H x V) | 1280 px x 1024 px | 1032 px x 776 px | The camera resolution used in the<br>NDŌHD High Definition Imaging<br>System Version 2.1 is different from<br>the one used with the NDŌHD High<br>Definition Imaging System. This<br>difference does not affect the<br>intended use or safety and<br>effectiveness of the device. |
| Power<br>Consumption | 3 W (Typical) | < 4 W | NDŌHD High Definition Imaging<br>System Version 2.1 is equivalent to<br>NDŌHD High Definition Imaging<br>System. |
| Item | Subject Device | Predicate Device | Comparison |
| | NDŌHD High Definition<br>Imaging System, version 2.1 | NDŌHD High Definition Imaging<br>System (K131873) | |
| Lossy Image<br>Compression | Yes, H.264 compression | Yes, H.264 compression | NDŌHD High Definition Imaging<br>System Version 2.1 is identical to<br>High Definition Imaging System. |
| Power Source | Computer built in battery<br>operated | Computer built in battery<br>operated | NDŌHD High Definition Imaging<br>System Version 2.1 is identical to<br>power source of the NDŌHD High<br>Definition Imaging System. |
| Software | NDŌHD Software is used to<br>control the recording, playback,<br>storage, retrieval, and live view<br>of high definition video (.mp4),<br>audio and images (.tiff) data. | NDŌHD Software is used to<br>control the recording, playback,<br>storage, retrieval, and live view of<br>high definition video (.mov), audio<br>and images (.tiff) data. | NDŌHD High Definition Imaging<br>System Version 2.1 is equivalent to<br>NDŌHD High Definition Imaging<br>System. |
| Programming<br>Language | Swift | Objective C | The programming language of the<br>NDŌHD High Definition Imaging<br>System Version 2.1 is different from<br>the programming language of the<br>NDŌHD High Definition Imaging<br>System. This difference does not<br>affect the intended use or safety and<br>effectiveness of the device. |

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## Testing

Software verification, system validation, and electrical safety testing have been completed according to FDA Guidance and Industry Standards as follows:

- . General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 11, 2002
- . Guidance for the Submission of Premarket Notifications for Medical Image Management Devices, July 27, 2000
- . Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices. September 9, 1999
- IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 +A1:2012. Medical . Electrical Equipment Part 1: General Requirements for Safety
- . CAN/CSA C22.2 No. 60601-1:14
- IEC 60601-2-18:2009. Medical electrical equipment Part 2-18: Particular requirements ● for the basic safety and essential performance of endoscopic equipment
- . IEC 60601-1-2:2014 4th Edition, Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
- . IEC 62304: 2006, Medical device software - Software life cycle processes

## Substantial Equivalence Conclusions

In conclusion, the intended use for NDOHD High Definition Imaging System, version 2.1 is the same as that of the NDOHD High Definition Imaging System (K131873). The technological characteristics demonstrate that the NDOHD High Definition Imaging System, version 2.1 is equivalent to the NDÕнɒ High Definition Imaging System, and the testing shows that the NDOഫ High Definition Imaging System, version 2.1 is substantially equivalent to the NDO็นo High Definition Imaging System (K131873) and assures that the NDOнD High Definition Imaging System, version 2.1 is as safe and effective as the NDOHD High Definition Imaging System (K131873).

## Conclusion

The 510(k) Pre-market Notification for the NDOnD High Definition Imaging System contains adequate information and data to determine that the Altaravision, Inc. NDÔнь High Definition Imaging System is as safe and effective as the legally marketed predicate device(s).

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Altaravision Inc. % Ms. Rita King CEO MethodSense, Inc. 1 Copley Parkway, Suite 410 Morrisville, North Carolina 27560

April 15, 2019

Re: K190420

Trade/Device Name: NDOHD High Definition Imaging System (NDOHD) Regulation Number: 21 CFR 892.20507 Regulation Name: Picture Archiving and Communications System. Regulatory Class: Class II Product Code: LLZ Dated: March 15, 2019 Received: March 19, 2019

Dear Rita King:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K190420

Device Name NDOHD High Definition Imaging System (NDOHD)

#### Indications for Use (Describe)

The NDOHD system is intended for viewing, acquiring, archiving and retrieving video and still images of endoscopic and fluoroscopic procedures. The professionals or practitioners using this system would be medical doctors or clinicians such as speech pathologists. The device is a prescription device. The NDOHD system is not intended to be used in an environment that requires sterilization.

Type of Use (Select one or both, as applicable)

| [X] Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------|
| [] Over-The-Counter Use (21 CFR 801 Subpart C) |

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