LIFESYS PACS

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 symbol that resembles a caduceus, which is a traditional symbol of medicine and healthcare. The symbol is composed of three abstract, curved lines that suggest the wings of a bird or the serpents of a caduceus. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 5, 2017 Lifetrack Medical Systems, Inc. % Mr. Keith Barritt Attorney Fish & Richardson 1425 K Street NW WASHINGTON DC 20005 Re: K161341 Trade/Device Name: Lifesys™ PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 21, 2017 Received: March 22, 2017 Dear Mr. Barritt: 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 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Michael D'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K161341 Device Name LifeSys™ PACS #### Indications for Use (Describe) LifeSys™ PACS is a Picture Archive and Communications software product used to receive pertinent radiology patient information and DICOM images and allow easy generation of a Radiology Report for distribution over a network. LifeSys™ PACS software is intended for use as a primary diagnostic and analysis tool for diagnostic images. LifeSys™ PACS is for hospitals, imaging centers, radiology professional services providers and any user who requires and is granted access to patient image, demographic and report information. The LifeSys™ PACS viewer displays images from CT, computed radiography, MRI, nuclear medicine, PET, ultrasound, x-ray angiography, and x-ray fluoroscopy. | 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) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### Section 5: 510(k) Summary Date Prepared: February 21, 2017 Submitter: Lifetrack Medical Systems, Inc. 1007 One World Place, 32nd Street, BGC Taguig City, Metro Manila, 1634, Philippines Contact Person: Eric Schulze, MD, PhD Chief Executive Officer O: +632 802 9980 F: +632 802 9980 Official Correspondent: Eric Schulze, MD, PhD Chief Executive Officer O: +632 802 9980 F: +632 802 9980 eric.schulze@lifetrackmed.com Trade Name: LifeSys™ PACS Classification Name: System, Image Processing, Radiological Picture, archive and communications system (PACS) Common Name: Product Code: LLZ # Predicate Device: Device Classification Name: System, Image Processing, Radiological 510(k) Number: K120995 Device Name: eRAD PACS and eRAD RIS/PACS Original Applicant: eRAD, Inc., 9 Pilgrim Road, Greenville, SC 29607 Product Code: LLZ Decision Date:December 3, 2012 Decision: Substantial equivalent (SE) Type: Traditional # Device Description: LifeSys™ PACS is a PACS software product that provides medical imaging departments of all types (Hospitals, Imaging Centers, and Clinics) with the capability to archive patient imaging studies and generate reports on said studies. LifeSys™ PACS is a single piece of software which includes the following functional modules: LifePACS™, which includes a Worklist, Tech Page, Image acquisition, receipt and archive, Report Editor, and tools for integration; and LifeView™, which includes a DICOM image viewer, rapid loading for fast and efficient reading and reporting and multiple monitor support. # Indications for Use: LifeSys™ PACS is a Picture Archive and Communications software product used to receive pertinent radiology patient information and DICOM images and allow easy generation of a Radiology Report for distribution over a network. {4}------------------------------------------------ LifeSys™ PACS software is intended for use as a primary diagnostic and analysis tool for diagnostic images. LifeSys™ PACS is for hospitals, imaging centers, radiologists, radiology professional services providers and any user who requires and is granted access to patient image, demographic and report information. The LifeSys™ PACS viewer displays images from CT, computed radiography, MRI, nuclear medicine. PET. ultrasound. x-rav angiography. and x-ray fluoroscopy. # Technological Characteristics: LifeSys™ PACS is a device that does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed. The LifeSys™ PACS device labeling contains instructions for use and any warnings or cautions to provide for the safe and effective use of the device. Users of the device are responsible to imonsure that display quality, environmental lighting and other possible distractions are consistent with a clinical environment. The hardware components specified are all "off the shelf" computer components. It is our conclusion that there is no software or hardware component in the LifeSys™ PACS device whose failure or latent design flaw would be expected to result in death or injury to a patient. The "level of concern" on the LifeSys™ PACS device is "moderate". # Substantial Equivalence: The new device (LifeSys™ PACS) and predicate device (eRAD PACS and eRAD RIS/PACS) are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The new device does not raise any new potential safety risks and is equivalent in performance to the predicate device. The two devices are substantially equivalent in the areas of design, architecture, general function, application, and intended use. # Non-Clinical Testing: Thorough non-clinical system verification and validation testing was conducted in accordance with applicable international standards and internal design requirement to verify that LifeSys™ PACS software product meets user needs and indications for use. The Verification & Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed in each operational mode. LifeSys™ PACS software passed all in-house testing criteria. {5}------------------------------------------------ # Conclusion The 510(k) Pre-Market Notification for LifeSys™ PACS contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. The subject device and predicate device are substantially equivalent in the areas of technical characteristics, general function, application, intended use, and does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices. LifeSys™ PACS is substantially equivalent with respect to safety and effectiveness to the predicate device.