K Number

Device Name

NDOHD High Definition Imaging System (NDOHD)

Manufacturer

Altaravision Inc.

Date Cleared

2019-04-15

(53 days)

Product Code

LLZ

Regulation Number

892.2050

Intended Use

The NDOHD 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.

Device Description

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). 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K131873

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a system for image acquisition, storage, and basic digital processing, with no mention of AI, ML, or related concepts like deep learning or automated analysis based on learned patterns. The updates are focused on hardware replacement and software interface improvements.

Therapeutic

No.
The device is described as a system for viewing, acquiring, recording, archiving, and retrieving medical images and videos, indicating it is an imaging and data management system, not a device that directly treats or prevents a disease or condition.

Diagnostic

No
The device is described as an imaging system for viewing, acquiring, recording, archiving, and retrieving video and still images of endoscopic and fluoroscopic procedures. While it processes images and videos, its purpose is for management and display of existing images rather than making a diagnosis itself.

SaMD (Software as a Medical Device)

The device description explicitly states that Altaravision replaced "off the shelf hardware components" and updated the software to enable use of the "new hardware," indicating the device includes hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "viewing, acquiring, recording, archiving and retrieving video and still images of endoscopic and fluoroscopic procedures." This describes a system for managing medical images, not for performing tests on biological samples to diagnose disease or other conditions.
Device Description: The device is described as a "picture archiving and communication system" that handles the acquisition, transfer, display, storage, and digital processing of images and videos. This aligns with image management systems, not IVDs.
Lack of IVD Characteristics: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.), reagents, or for performing analytical tests.

Therefore, the NDOHD system, as described, falls under the category of medical imaging and information management systems, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The NDŌHD 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.

Product codes (comma separated list FDA assigned to the subject device)

LLZ

Device Description

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.

Mentions image processing

digital processing of images

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

endoscopic and fluoroscopic procedures

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

medical doctors or clinicians such as speech pathologists. The device is a prescription device.

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)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K131873

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).

Summary

510(k) Summary

Altaravision, Inc. K190420

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

| Submitter: | Altaravision, Inc.
130 Salem Town Court
Apex, NC 27502
Phone: 919-342-5778 |
|------------------|--------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King, CEO
MethodSense, Inc.
Email: ritaking@methodsense.com
Phone: 919-313-3961
Fax: 919-313-3979 |
| Company Contact: | Stuart Bradley
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

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.

Item	Subject Device	Predicate Device	Comparison
	NDŌHD High Definition
Imaging System, version 2.1	NDŌHD High Definition Imaging
System (K131873)
Intended Use	The NDŌHD system is intended
for viewing, acquiring, recording,
archiving and retrieving video
and still images of endoscopic
and fluoroscopic procedures.	The NDŌHD system is intended
for viewing, acquiring, recording,
archiving and retrieving video and
still images of endoscopic and
fluoroscopic procedures.	NDŌHD High Definition Imaging
System Version 2.1 is identical to
NDŌHD High Definition Imaging
System (NDŌHD ).
Indications for
Use	The NDŌHD 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 NDŌHD
system is not intended to be
used in an environment that
requires sterilization.	The NDŌHD 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 NDŌHD system is not
intended to be used in an
environment that requires
sterilization.	NDŌHD High Definition Imaging
System Version 2.1 is identical to
NDŌHD High Definition Imaging
System (NDŌHD ).
Target Population	Medical doctors or clinicians
such as speech pathologists	Medical doctors or clinicians such
as speech pathologists	NDŌHD High Definition Imaging
System Version 2.1 is identical to
NDŌHD High Definition Imaging
System (NDŌHD ).
Computer	MacBook Pro 13-inch and 15-
inch	MacBook Pro 15-inch	NDŌHD High Definition Imaging
System Version 2.1 is equivalent to
NDŌHD High Definition Imaging
System (NDŌHD ).
Item	Subject Device	Predicate Device	Comparison
	NDŌHD High Definition
Imaging System, version 2.1	NDŌHD High Definition Imaging
System (K131873)
Display	Built-in computer display – 13-
inch and 15-inch	Built-in computer display – 15-
inch	NDŌHD High Definition Imaging
System Version 2.1 is equivalent to
NDŌHD High Definition Imaging
System (NDŌHD ).
Storage Medium	Non removable solid state drive
(SSD)	Non removable hard drive	NDŌHD High Definition Imaging
System Version 2.1 is equivalent to
NDŌHD High Definition Imaging
System (NDŌHD ).
Operating System	macOS 10.14 +	macOS 10.8 +	NDŌHD High Definition Imaging
System Version 2.1 is equivalent to
NDŌHD High Definition Imaging
System (NDŌHD ), with the only
difference being the version of the
operating system. This difference
does not affect the intended use or
safety and effectiveness of the
device.
Camera Coupler	C-Mount	C-Mount	NDŌHD High Definition Imaging
System Version 2.1 is identical to
NDŌHD High Definition Imaging
System (NDŌHD ).
Camera –
Computer Cable	USB-3.0 USB C to USB Micro-B	Firewire	NDŌHD High Definition Imaging
System Version 2.1 uses a different
cable than the NDŌHD High
Definition Imaging System. This
Item	Subject Device	Predicate Device	Comparison
	NDŌHD High Definition
Imaging System, version 2.1	NDŌHD High Definition Imaging
System (K131873)
			difference does not affect the
intended use or safety and
effectiveness of the device.
Video Output
Format	.mp4 H.264 Video	.mov H.264 Video	The video output format of the
NDŌHD High Definition Imaging
System Version 2.1 is different from
the video output format used with the
NDŌHD High Definition Imaging
System. The difference in video
format does not affect the intended
use or safety and effectiveness of the
device.
Still Image Output
Format	.tiff Image	.tiff Image	NDŌHD High Definition Imaging
System Version 2.1 is identical to
NDŌHD High Definition Imaging
System.
Camera Sensor
Type	CMOS	CCD Progressive	The camera sensor type of the
NDŌHD High Definition Imaging
System Version 2.1 is different from
the one used with the NDŌHD High
Definition Imaging System. This
difference does not affect the
intended use or safety and
effectiveness of the device.
Camera Frame
Rate	203 fps (frames per second)	31 fps (frames per second)	The camera frame rate of the NDŌHD
High Definition Imaging System
Item	Subject Device	Predicate Device	Comparison
	NDŌHD High Definition
Imaging System, version 2.1	NDŌHD High Definition Imaging
System (K131873)
			Version 2.1 is different from the one
used with the NDŌHD High Definition
Imaging System. This difference
does not affect the intended use or
safety and effectiveness of the
device.
Pixel Size	4.8 μm x 4.8 µm	4.65 μm x 4.65 μm	NDŌHD High Definition Imaging
System Version 2.1 is equivalent to
NDŌHD High Definition Imaging
System.
Camera Bit Depth	10 bits	8 - 14 bits	NDŌHD High Definition Imaging
System Version 2.1 is equivalent to
NDŌHD High Definition Imaging
System.
Camera
Resolution (H x V)	1280 px x 1024 px	1032 px x 776 px	The camera resolution used in the
NDŌHD High Definition Imaging
System Version 2.1 is different from
the one used with the NDŌHD High
Definition Imaging System. This
difference does not affect the
intended use or safety and
effectiveness of the device.
Power
Consumption	3 W (Typical)	Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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