Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard image acquisition, archiving, and processing functionalities typical of a PACS system, with no mention of AI or ML algorithms for analysis, interpretation, or decision support.

Therapeutic

No.
The device is described as an imaging system for viewing, acquiring, archiving, and retrieving video and still images; it does not directly treat or diagnose a disease.

Diagnostic

No
The device is described as an imaging system for viewing, acquiring, archiving, and retrieving video and still images, and a picture archiving and communication system (PACS). Its function is to manage and display images, not to provide a medical diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system includes a computer and a camera, which are hardware components.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is for "viewing, acquiring, 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 (in vitro).
Device Description: The description focuses on the system's capabilities as a "picture archiving and communication system" for images and videos. It doesn't mention any components or functions related to analyzing biological specimens.
Input Imaging Modality: The input is "Video and still images of endoscopic and fluoroscopic procedures," which are imaging modalities, not biological samples.
Predicate Device: The predicate device is a "Digital Video Recording System," which is consistent with an imaging management system, not an IVD.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The NDOHD system's function is centered around managing medical images obtained from procedures, not analyzing biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

LLZ

Device Description

The NDOHD High Definition Imaging System (NDOHD) was initially commercialized in 2011 as a photographic accessory for endoscopes (FEM), Class I Exempt device. Altaravision has expanded the capabilities of the NDOHD system to include a computer and a camera, included a lossy image compression mechanism using standard irreversible compression technique, H.264, added a time code on the display of the image, created camera controls and added profiles for multiple camera settings and user preferences. Therefore, Altaravision has created a picture archiving and communication system that provides capabilities related to the acceptance, transfer, display, storage and digital processing of images and videos.

Mentions image processing

Yes

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 NDOHD system is not intended to be used in an environment that requires sterilization.

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 Validation and Electrical Safety Testing have been completed according to FDA Guidance documents 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
. IEC 60601-1: 1998+A1:1991+A2:1995+ Am.11+ Am.12 + Am.13:1996, Medical Electrical Equipment Part 1-2: General Requirements for Safety
. IEC 60601-1-1, Ed 2.0, Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical . electrical systems
. IEC 60601-2-18: 2009, Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
Laboratory data is not required. The NDOHD system utilizes standard irreversible compression techniques (H.264).

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

Not Found

Predicate Device(s)

K991738

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

0

510(k) Summary

Altaravision K131873

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

Submitter:

Altaravision, Inc. 130 Salem Towne Court Apex, NC 27502 t

Primary Contact:

Rita King MethodSense, Inc. Email: ritaking@methodsense.com Phone: 919-313-3961 Fax: 919-313-3979

Company Contact:

Stuart Bradley Chief Executive Officer

SEP 2 5 2013

Date Prepared: June 18, 2013

Device Name and Classification

Trade Name:	NDŎHD High Definition Imaging System (NDŎHD)
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

Trade Name:	Digital Video Recording System
Common Name:	System, Image Processing
510(k) Submitter / Holder:	Kay Elemetrics Corp.
510(k) Number:	K991738
Regulation Number:	892.2050 – Picture Archiving and Communications System
(PACS)
Classification Panel:	Radiology
Product Code:	LLZ

NDOHD High Definition Imaging System Traditional 510(k)

Confidential

1

Device Description and Intended Use

The NDOHD High Definition Imaging System (NDOHD) was initially commercialized in 2011 as a photographic accessory for endoscopes (FEM), Class I Exempt device. Altaravision has expanded the capabilities of the NDOHD system to include a computer and a camera, included a lossy image compression mechanism using standard irreversible compression technique, H.264, added a time code on the display of the image, created camera controls and added profiles for multiple camera settings and user preferences. Therefore, Altaravision has created a picture archiving and communication system that provides capabilities related to the acceptance, transfer, display, storage and digital processing of images and videos. Based on the new system functions and the use of the device, the NDOнo system is now considered a Class II device and requires a premarket approval.

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

Indications for Use

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.

Substantial Equivalence:

The NDOHD system is substantially similar to a predicate device currently on the market. This device is:

Digital Video Recording System (DVRS) K991738 .
Both devices use very similar technologies, overall design and operating principals.

The primary differences in the technology between the NDOHD System and the DVRS are described in the table below:

Item	Subject Device	Predicate Device	Comparison
	NDOHD High Definition
Imaging System (NDOHD)	Digital Video
Recording System
(DVRS)
Intended Use	The NDOHD system is
intended for viewing,
acquiring, recording,
archiving and retrieving video
and still images of
endoscopic and fluoroscopic	The intended use of
the DVRS is for
viewing, acquiring,
recording, archiving
and retrieving video
images of	Same as
predicate
Item	Subject Device	Predicate Device	Comparison
	NDOHD High Definition
Imaging System (NDOHD)	Digital Video
Recording System
(DVRS)
	procedures.	endoscopic and
fluoroscopic
procedures
Indications for
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.	The intended use of
the DVRS is for
viewing, acquiring,
recording, archiving
and retrieving video
images of
endoscopic and
fluoroscopic
procedures. The
images may be
monochrome or
color. The
professionals or
practitioners using
this system would be
medical doctors or
clinicians such as
speech pathologists.
The device is a -
prescription device.	Same as
predicate
Target Population	Medical doctors or clinicians
such as speech pathologists	Medical doctors or
clinicians such as
speech pathologists	Same as
predicate
Display	Built-in computer display	NEC MultiSync
E900+	Similar to
predicate
Storage Medium	Non removable hard drive	Removable 2Gb hard
drive	Similar to
predicate
Video Output
Format	.mov H.264 Video and .tiff still
images	MJPEG and AVI	Similar to
predicate.
Predicate uses
Windows
specific
formats, while
the NDOHD
system is
using an OS
agnostic
format.
Camera CCD
(charge
discharge)	1032x762 CCD. 1/3" sensor,
31 FPS (Frames per second)
progressive scan, 800Mb/s,
bit depth: 8-14 bit.	Optional	The use of a
camera is
optional for the
predicate
Item	Subject Device	Predicate Device	Comparison
NDOHD High Definition
Imaging System (NDOHD)	Digital Video
Recording System
(DVRS)
Lossy Image
Compression	Yes, H.264 compression	Yes	Similar to
predicate. The
exact
compression
type of the
predicate is
unknown
Energy	Computer built in battery
operated	UPS battery operated	Similar to
predicate. Both
systems use
battery during
operation. The
NDOHD system
provides safety
controls to
prevent
operators from
using the
device while
plugged into an
AC power
outlet.
Software	NDOHD Software used to
control the recording,
playback, storage, retrieval,
and live view of high definition
video (.mov), audio and
images (.tiff) data.	DVRS Software used
to control the
recording, playback,
storage and retrieval
of digital video
(MJPEG images) and
audio data.	Similar to
predicate. The
NDOHD
Software
provides a live
view of the
procedure in
progress.
NDOHD
Software is
developed
using
Macintosh-
compatible
technology.
DVRS is
developed
using
Microsoft-
compatible
technology.

Detailed Comparison of the Subject and Predicate Devices

2

:

、・・

:

·

NDOHD High Definition Imaging System Traditional 510(k)

.

Confidential

.

3

・・・

.

4

Testing

Software Validation and Electrical Safety Testing have been completed according to FDA Guidance documents 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
. IEC 60601-1: 1998+A1:1991+A2:1995+ Am.11+ Am.12 + Am.13:1996, Medical Electrical Equipment Part 1-2: General Requirements for Safety
. IEC 60601-1-1, Ed 2.0, Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical . electrical systems
. IEC 60601-2-18: 2009, Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

Laboratory data is not required. The NDOHD system utilizes standard irreversible compression techniques (H.264).

Substantial Equivalence Conclusions

In conclusion, the intended use for the NDOHD system is the same as that of the predicate device, the technological characteristics demonstrate that the NDOnp system is equivalent to the predicate device, and the testing shows that the NDOHD system is substantially equivalent to the predicate device and assures that the NDÔно system is as safe and effective as the predicate devices. ·

Conclusion

The 510(k) Pre-market Notification for the NDOHD system contains adequate information and data to determine that the NDÔHD system is as safe and effective as the legally marketed predicate devices.

5

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 25, 2013

Altaravision Incorporated % Ms. Rita King CEO PO Box 110352 Durham, North Carolina 27709

Re: K131873

Trade/Device Name: NDOHD High Definition Imaging System (NDOHD) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: June 18, 2013 Received: June 27, 2013

Dear Ms. 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

6

Page 2 - Ms. Rita King

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/McdicalDevices/ResourcesforYou/Industry/default.htm. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

Long H. ...... Chen -A

For

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

7

Page 1 of 1

Indications for Use Statement

510(k) Number (if known): K131873

Device Name: NDOHD High Definition Imaging System (NDOHD)

Indications for Use

The NDÔно 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 NDOнь system is not intended to be used in an environment that requires sterilization.

Prescription Use Yes	AND/OR	Over-The-Counter Use No
(Part 21 CFR 801 Subpart D)		(Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation

Neil R Ogder 2013.09.25 10:04:3 3-04'00'

(Division Sign-Off) for MXM

Division of Surgical Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

NDOHD High Definition Imaging System Traditional 510(k) Page 5-1 of 5-1