IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP

K071299 · Digital Healthcare, Ltd. · NFJ · Aug 31, 2007 · Radiology

Device Facts

• Record ID: K071299
• Device Name: IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP
• Applicant: Digital Healthcare, Ltd.
• Product Code: NFJ · Radiology
• Decision Date: Aug 31, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The IP system is used by health professionals to capture, store, encode, encrypt, transmit, decrypt, decode, display, process, spatially calibrate, assess, grade and report on images and data that are captured on a range of approved medical devices that include but are not limited to : - A. Mydriatic Fundus Cameras - B. Non Mydriatic Fundus Cameras - C. Scanning Laser Ophthalmoscopes - D. Optical Coherence Tomography Instruments - E. Bio Microscopes (Slit Lamps) - F. Non Radiometric Ultrasound devices - G. Video image sources - H. TWAIN compliant imaging sources - I. Compliant data sources placed in network accessible folders and directories - Images of known format from digital cameras and scanners J. - K. Electronic information complying to accepted DICOM formats - L. Other devices connected in proprietary formats

Device Story

iP System is a digital imaging and informatics platform for ophthalmic data management. It ingests inputs from diverse sources: fundus cameras (mydriatic/non-mydriatic), scanning laser ophthalmoscopes, OCT, slit lamps, ultrasound, video sources, TWAIN-compliant devices, and DICOM-compliant data. The system performs capture, storage, encoding, encryption, transmission, decryption, decoding, display, processing, spatial calibration, assessment, grading, and reporting. Used in clinical settings by healthcare professionals; facilitates image review and clinical decision-making through centralized data management and reporting capabilities. Benefits include streamlined workflow and standardized image assessment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based ophthalmic image management system. Supports DICOM and TWAIN connectivity. Functions include image processing, spatial calibration, encryption, and reporting. Operates as a networked informatics platform for various ophthalmic imaging modalities.

Indications for Use

Indicated for use by health professionals to manage, process, and report on ophthalmic images and data captured from various medical imaging devices.

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).

Submission Summary (Full Text)

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| Sponsor/<br>Manufacturer | Digital Healthcare Inc<br>Address: 343 South White Street<br>Wake Forest<br>NC 27587<br>Phone: [phone]<br>Fax [phone]<br>e-mail [e-mail] | AUG 3 I 2007 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact | Mr Gerry Skews<br>Digital Healthcare Inc<br>Address 343 South White Street<br>Wake Forest<br>NC 27587<br>Phone: [phone]<br>Fax [phone]<br>e-mail [e-mail] | |
| Date Prepared | April 30th, 2007 | |
| Proposed Class | II | |
| Proprietary Name | <i>iP</i> ® Digital Image and Informatics Platform to include<br>OcuLab <i>iP</i> ® OptoMize <i>iP</i> ® Retasure <i>iP</i> ® | |
| Common Name | Clinical Imaging and Data Management Software | |
| Classification Name | HKI, NFF, NFG, NFJ | |

Image /page/0/Picture/5 description: The image shows two sets of characters in what appears to be a handwritten style. The first set, "第二次第一次," is written in traditional Chinese characters. Below this, there is a single character, "ﻬﺎ," which is written in Arabic script.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Digital Healthcare, Inc. c/o Gerry Skews 343 South White Street Wake Forest, NC 27587

AUG 3 1 2007

Re: K071299

Trade/Device Name: iP System Regulation Number: 21 CFR 892.2050 Regulation Name: Opthalmic Image Management System Regulatory Class: Class II Product Code: NFJ, NFF, NFG, HKI Dated: July 12, 2007 Received: July 16, 2007

Dear Mr. Skews:

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, Dr to 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, l'asting of devices, good manufacturing practice, labeling, and prohibitions against misbuanding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations after ting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, TDA 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 af 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the edectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

M. B. Egerston, mD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Digital Healthcare

510(k) Number (if known):

iP® Digital Imaging and Informatics Management System Device Name:

Indications for use: The IP system is used by health professionals to capture, store, encode, encrypt, transmit, decrypt, decode, display, process, spatially calibrate, assess, grade and report on images and data that are captured on a range of approved medical devices that include but are not limited to :

- A. Mydriatic Fundus Cameras
- B. Non Mydriatic Fundus Cameras
- C. Scanning Laser Ophthalmoscopes
- D. Optical Coherence Tomography Instruments
- E. Bio Microscopes (Slit Lamps)
- F. Non Radiometric Ultrasound devices
- G. Video image sources
- H. TWAIN compliant imaging sources
- I. Compliant data sources placed in network accessible folders and directories
- Images of known format from digital cameras and scanners J.
- K. Electronic information complying to accepted DICOM formats
- L. Other devices connected in proprietary formats

| Prescription Use | X |
|---------------------------|---|
| (21CFR 801.109 Subpart D) | |
| OR | |
| Over the counter use | |
| (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 (ODE)

Clay R. Butteme

(División Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K071299

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