NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD)

{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<br>(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<br>(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<br>Imaging System (NDOHD) | Digital Video<br>Recording System<br>(DVRS) | | | Intended Use | The NDOHD system is<br>intended for viewing,<br>acquiring, recording,<br>archiving and retrieving video<br>and still images of<br>endoscopic and fluoroscopic | The intended use of<br>the DVRS is for<br>viewing, acquiring,<br>recording, archiving<br>and retrieving video<br>images of | Same as<br>predicate | | Item | Subject Device | Predicate Device | Comparison | | | NDOHD High Definition<br>Imaging System (NDOHD) | Digital Video<br>Recording System<br>(DVRS) | | | | procedures. | endoscopic and<br>fluoroscopic<br>procedures | | | Indications for<br>Use | The NDOHD system is<br>intended for viewing,<br>acquiring, recording,<br>archiving and retrieving video<br>and still images of<br>endoscopic and fluoroscopic<br>procedures. The<br>professionals or practitioners<br>using this system would be<br>medical doctors or clinicians<br>such as speech pathologists.<br>The device is a prescription<br>device. The NDOHD system is<br>not intended to be used in an<br>environment that requires<br>sterilization. | The intended use of<br>the DVRS is for<br>viewing, acquiring,<br>recording, archiving<br>and retrieving video<br>images of<br>endoscopic and<br>fluoroscopic<br>procedures. The<br>images may be<br>monochrome or<br>color. The<br>professionals or<br>practitioners using<br>this system would be<br>medical doctors or<br>clinicians such as<br>speech pathologists.<br>The device is a -<br>prescription device. | Same as<br>predicate | | Target Population | Medical doctors or clinicians<br>such as speech pathologists | Medical doctors or<br>clinicians such as<br>speech pathologists | Same as<br>predicate | | Display | Built-in computer display | NEC MultiSync<br>E900+ | Similar to<br>predicate | | Storage Medium | Non removable hard drive | Removable 2Gb hard<br>drive | Similar to<br>predicate | | Video Output<br>Format | .mov H.264 Video and .tiff still<br>images | MJPEG and AVI | Similar to<br>predicate.<br>Predicate uses<br>Windows<br>specific<br>formats, while<br>the NDOHD<br>system is<br>using an OS<br>agnostic<br>format. | | Camera CCD<br>(charge<br>discharge) | 1032x762 CCD. 1/3" sensor,<br>31 FPS (Frames per second)<br>progressive scan, 800Mb/s,<br>bit depth: 8-14 bit. | Optional | The use of a<br>camera is<br>optional for the<br>predicate | | Item | Subject Device | Predicate Device | Comparison | | NDOHD High Definition<br>Imaging System (NDOHD) | Digital Video<br>Recording System<br>(DVRS) | | | | Lossy Image<br>Compression | Yes, H.264 compression | Yes | Similar to<br>predicate. The<br>exact<br>compression<br>type of the<br>predicate is<br>unknown | | Energy | Computer built in battery<br>operated | UPS battery operated | Similar to<br>predicate. Both<br>systems use<br>battery during<br>operation. The<br>NDOHD system<br>provides safety<br>controls to<br>prevent<br>operators from<br>using the<br>device while<br>plugged into an<br>AC power<br>outlet. | | Software | NDOHD Software used to<br>control the recording,<br>playback, storage, retrieval,<br>and live view of high definition<br>video (.mov), audio and<br>images (.tiff) data. | DVRS Software used<br>to control the<br>recording, playback,<br>storage and retrieval<br>of digital video<br>(MJPEG images) and<br>audio data. | Similar to<br>predicate. The<br>NDOHD<br>Software<br>provides a live<br>view of the<br>procedure in<br>progress.<br>NDOHD<br>Software is<br>developed<br>using<br>Macintosh-<br>compatible<br>technology.<br>DVRS is<br>developed<br>using<br>Microsoft-<br>compatible<br>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