TLINK DATA MANAGEMENT SYSTEM (DMS)

{0}------------------------------------------------ K113214 FEB - 7 2012 ## Section 5: 510(k) Summary This section includes a summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92. | Submitter Information | | |------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | Terumo Cardiovascular Systems Corporation | | Address | 6200 Jackson Road<br>Ann Arbor MI, 48103 | | Phone number | Tel: (734) 663-4145 | | Fax number | Fax: (734) 741-6069 | | E-mail | Rebecca.andersen@terumomedical.com | | Establishment<br>Registration Number | 1828100 | | Name of contact person | Rebecca Andersen, PhD | | Date prepared | October 28, 2011 | | Device Information | | | Trade or proprietary<br>name | TLink™ Data Management System (DMS) | | Common or usual name | Clinical information management system | | Classification name | Monitor, Physiological, Patient (Without Arrhythmia<br>Detection or Alarms) | | Classification panel | 74 Cardiovascular | | Regulation | 870.2450 | | Product Code(s) | Medical Cathode-ray tube display<br>DXJ | | Legally marketed<br>device(s) to which<br>equivalence is claimed | K012349, MetaVision Clinical Information System | | Reason for 510(k) | Traditional 510(k) for new device | | Device Information | | | Device description | The TLink™ DMS consists of the TLink™ software and<br>hardware accessories including computers meeting<br>minimum requirements, data entry devices (barcode laser<br>scanner, touch screen stylus, keyboard), mounting trays and<br>brackets, and serial converters. The system can interface<br>with a variety of external medical devices including, but not<br>limited to, heart-lung machines, blood parameter monitoring<br>systems, centrifugal systems, blood gas devices, patient<br>monitors and anesthesia monitors. Case data can be<br>entered manually by the user or collected automatically from<br>independent medical devices. Screen layouts are<br>customizable to meet hospital and user requirements for<br>patient/case records. Physiological data can be graphed at<br>user defined time intervals for event recording. Certain<br>calculations routinely performed by the clinician during<br>surgery can be performed by the TLink™ DMS, e.g., Body<br>Surface Area (based on patient height and weight data) and<br>Fluid Balance (based on fluid input and output data). Case<br>templates and administrative information are developed on a<br>central computer and transferred to the satellite computer(s)<br>connected to the external medical device(s) in the procedure<br>rooms. Case records are then transferred back to the<br>central computer or hospital information system for central<br>storage and post-case analysis/reporting. All transfers<br>between satellite and central computers are via network<br>and/or removable media. A variety of post-procedure<br>reports are available including case report, clinical activity,<br>case checklist, quality assurance, audit summary report, and<br>audit detail report. | | Indication for use | The TLink™ DMS is an electronic clinical record keeping<br>and reporting system indicated for use in collecting,<br>displaying, storing and managing data from external<br>medical devices. The system facilitates the creation of<br>electronic patient records and enables post-procedural<br>case reviews. Data and records can be viewed on local<br>workstations or transferred to a central computer or hospital<br>network for storage and post-case analysis/reporting. | January 20, 2012 Image /page/0/Picture/6 description: The image shows the logo for Terumo. The logo consists of a circle with the letter T inside of it, followed by the word "TERUMO" in all capital letters. There is a small registered trademark symbol to the right of the word "TERUMO". {1}------------------------------------------------ ______________________________________________________________________________________________________________________________________________________________________________ ### Section 5: 510(k) Summary {2}------------------------------------------------ #### Section 5: 510(k) Summary ## Substantial Equivalence - Summary of the technological characteristics of the TLink™ DMS compared to the predicate device - MetaVision | Characteristic | TLink™ DMS | MetaVision - K012349 | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for Use | The TLink™ DMS is an electronic<br>clinical record keeping and<br>reporting system indicated for use<br>in collecting, displaying, storing<br>and managing data from external<br>medical devices. The system<br>facilitates the creation of electronic<br>patient records and enables post-<br>procedural case reviews. Data<br>and records can be viewed on<br>local workstations or transferred to<br>a central computer or hospital<br>network for storage and post-case<br>analysis/reporting. | For use in data collection,<br>display, management, and<br>storage in the intensive care unit.<br>The system is used in<br>conjunction with independent<br>patient bedside devices and<br>systems, connected via a<br>network. The way the system is<br>used for generating patient<br>records, computation of drug and<br>fluid dosage and research tasks<br>is determined by the health care<br>providers, in terms of their<br>environment and requirements.<br>The MetaVision application is<br>resident on a workstation that<br>provides for data input and<br>patient data display - to health<br>care professionals. Typically, a<br>MetaVision system comprises<br>several workstations connected<br>via a network system to one or<br>more servers. Data is stored and<br>managed by servers. The<br>MetaVision system network can<br>communicate with a number of<br>remotely located patient care<br>units. | | System<br>Components | • System software<br>• Touch screen computer (local<br>to monitoring devices)<br>• Barcode laser scanner and<br>holder<br>• Touch screen stylus | • System software<br>• Local workstations connected<br>via hospital network<br>• Bar code scanner for<br>scanning drug vial bar codes | | Characteristic | TLink™ DMS | MetaVision-K012349 | | Functionality | • Hardware for mounting touch screen computer (trays, brackets)<br>• Capture device data during procedure and display data in electronic record format customized by the user. Case data can be displayed graphically over time. Clinical events can be marked for subsequent analysis<br>• Generate reports including diagnoses, clinical data, procedures and outcomes. Reports used for post-procedure analysis and quality assurance | • Import data from hospital information systems for pre-op evaluations and patient preparation, such as patient medications, lab reports and imaging studies<br>• Capture device data during procedure and display data in electronic record format customized by the user. Case data can be displayed graphically over time. Clinical events can be marked for subsequent analysis<br>• Generate reports including diagnoses, clinical data, procedures and outcomes. Reports used for post-procedure analysis, quality assurance and billing purposes | January 20, 2012 TERUMO {3}------------------------------------------------ ## Section 5: 510(k) Summary 1 {4}------------------------------------------------ #### Section 5: 510(k) Summary ## Summary of Performance Tests Conducted for Determination of Substantial Equivalence | Characteristic | Report | Results Summary | |-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------| | System & Software<br>Design Verification<br>Testing | Provides documented evidence that the<br>design outputs for TLink™ DMS V. 2.0<br>continue to meet the existing design inputs of<br>prior software release versions and meet the<br>new design inputs as well. This protocol<br>covers all of the software-related system<br>requirements and includes the additional<br>hardware components. | Pass - Test results<br>demonstrate that the<br>design outputs meet<br>the design input<br>requirements (pre-<br>defined acceptance<br>criteria). | | System & Software<br>Design Validation<br>Testing | Validates that TLink™ DMS V. 2.0 meets the<br>user needs and intended use under<br>simulated use conditions by addressing the<br>following three areas:<br>Packaging, Labeling and<br>Miscellaneous Installation and Set-up Simulated Use | Pass - Test results<br>demonstrate that<br>intended use and<br>user needs are<br>fulfilled. | # Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The TLink™ DMS is substantially equivalent to the MetaVision Clinical Data Management System because it has the same intended use and substantially equivalent performance specifications. Image /page/4/Picture/8 description: The image shows the logo for Terumo Corporation. The logo consists of a circle with the letter 'T' inside, followed by the word 'TERUMO' in capital letters. There is a small circle above and to the right of the 'O' in 'TERUMO'. The logo is simple and recognizable. {5}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 FEB - 7 -2012 Terumo Cardiovascular Systems c/o Dr. Rebecca Andersen 6200 Jackson Rd Ann Arbor, MI 48103 Re: K113214 Trade/Device Name: TLink Data Management System Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-ray tube display Regulatory Class: Class II Product Code: DXJ Dated: January 17, 2012 Received: January 19, 2012 Dear Dr. Andersen: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becare ined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encrease) to tog-sey - the Medical Device Amendments, or to conninered pror conner of the in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic 71ct () the ) that the device, subject to the general controls provisions of the Act. The I ou may, merciors, manovate a ect include requirements for annual registration, listing of general connects provisions practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addiciation: Flease noter If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is blacklined (boo acon ) = ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = finay be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may found in the Oode of I caeral cogniteming your device in the Federal Register. {6}------------------------------------------------ Page 2 - Dr. Rebecca Andersen Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I Drimination that your device complies with other requirements of the Act that 1 DA has intact a and regulations administered by other Federal agencies. You must or any I city 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 CI K 1 at 607); adeling (21 CFR 803); good manufacturing practice requirements as set de vice-related adverse events) (21 CF 1000), government 820); and if applicable, the electronic form in the quants of ovisions (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 rr you active you fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm. Sincerely yours, Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ Terumo Cardiovascular Systems Corporation TLink™ DMS 510(k) #### Section 4: Indications for Use 510(k) Number: K113214 #### TLink™ Data Management System (DMS) Device Name: Indications for Use: The TLink™ DMS is an electronic clinical record keeping and reporting system indicated for use in collecting, displaying, storing and managing data from external medical devices. The system facilitates the creation of electronic patient records and enables post-procedural case reviews. Data and records can be viewed on local workstations or transferred to a central computer or hospital network for storage and post-case analysis/reporting. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 21 CFR 807 Subpart C) #### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Division Sign-Off 510(k) Number K113214 Section 4 - Page 1 of 1