(99 days)
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.
The TLink™ DMS consists of the TLink™ software and hardware accessories including computers meeting minimum requirements, data entry devices (barcode laser scanner, touch screen stylus, keyboard), mounting trays and brackets, and serial converters. The system can interface with a variety of external medical devices including, but not limited to, heart-lung machines, blood parameter monitoring systems, centrifugal systems, blood gas devices, patient monitors and anesthesia monitors. Case data can be entered manually by the user or collected automatically from independent medical devices. Screen layouts are customizable to meet hospital and user requirements for patient/case records. Physiological data can be graphed at user defined time intervals for event recording. Certain calculations routinely performed by the clinician during surgery can be performed by the TLink™ DMS, e.g., Body Surface Area (based on patient height and weight data) and Fluid Balance (based on fluid input and output data). Case templates and administrative information are developed on a central computer and transferred to the satellite computer(s) connected to the external medical device(s) in the procedure rooms. Case records are then transferred back to the central computer or hospital information system for central storage and post-case analysis/reporting. All transfers between satellite and central computers are via network and/or removable media. A variety of post-procedure reports are available including case report, clinical activity, case checklist, quality assurance, audit summary report, and audit detail report.
Here's a breakdown of the acceptance criteria and study information for the TLink™ Data Management System (DMS) based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| System & Software Design Verification Testing | Documented evidence that design outputs for TLink™ DMS V. 2.0 meet existing design inputs of prior software release versions and new design inputs, covering all software-related system requirements and additional hardware. | Pass - Test results demonstrate that the design outputs meet the design input requirements (pre-defined acceptance criteria). |
| System & Software Design Validation Testing | Validation that TLink™ DMS V. 2.0 meets user needs and intended use under simulated use conditions by addressing packaging, labeling, and miscellaneous installation and set-up. | Pass - Test results demonstrate that intended use and user needs are fulfilled. |
Note: The provided documentation is a summary for a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance metrics like sensitivity/specificity for a diagnostic AI system. The acceptance criteria here are functional and validation-based, typical for a software system that manages and displays data.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify a "test set" in the context of clinical data for algorithmic performance. The tests described are System & Software Design Verification Testing and System & Software Design Validation Testing. These are engineering and usability tests, not clinical performance studies involving patient data.
- Sample Size for Test Set: Not applicable in the context of clinical data. The tests refer to the comprehensive evaluation of the software and hardware system.
- Data Provenance: Not applicable. The tests are focused on the system's design and functionality, not analysis of patient data from specific origins.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. As noted above, the tests are functional and validation-based, not reliant on expert-established ground truth from clinical cases.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication (e.g., of expert interpretations) is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. This device is a data management system, not a diagnostic AI system intended to improve human reader performance in interpreting medical images or data.
6. Standalone (Algorithm Only) Performance
Yes, the studies described (System & Software Design Verification Testing and System & Software Design Validation Testing) are essentially "standalone" in the sense that they evaluate the device's functionality and adherence to design specifications and user needs. There is no human-in-the-loop performance described for these specific tests, as the device itself is designed to collect, display, store, and manage data, not to interpret it in a diagnostic manner that would typically involve a "human-in-the-loop" interaction for algorithmic decision-making.
7. Type of Ground Truth Used
The "ground truth" for the verification and validation tests described would be the design inputs and user requirements themselves. For example:
- Design Verification: The ground truth is whether the system's outputs match the specified design requirements.
- Design Validation: The ground truth is whether the system effectively meets the intended user needs under simulated use conditions.
This is not clinical ground truth (like pathology, expert consensus on imaging, or patient outcomes data) because the device's function is data management, not diagnostic interpretation.
8. Sample Size for the Training Set
Not applicable. The TLink™ DMS is a clinical information management system, not an AI or machine learning model that requires a training set of data. Its functionality is based on programmed logic and user configuration.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for such a set.
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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 RoadAnn Arbor MI, 48103 |
| Phone number | Tel: (734) 663-4145 |
| Fax number | Fax: (734) 741-6069 |
| Rebecca.andersen@terumomedical.com | |
| EstablishmentRegistration Number | 1828100 |
| Name of contact person | Rebecca Andersen, PhD |
| Date prepared | October 28, 2011 |
| Device Information | |
| Trade or proprietaryname | TLink™ Data Management System (DMS) |
| Common or usual name | Clinical information management system |
| Classification name | Monitor, Physiological, Patient (Without ArrhythmiaDetection or Alarms) |
| Classification panel | 74 Cardiovascular |
| Regulation | 870.2450 |
| Product Code(s) | Medical Cathode-ray tube displayDXJ |
| Legally marketeddevice(s) to whichequivalence 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 andhardware accessories including computers meetingminimum requirements, data entry devices (barcode laserscanner, touch screen stylus, keyboard), mounting trays andbrackets, and serial converters. The system can interfacewith a variety of external medical devices including, but notlimited to, heart-lung machines, blood parameter monitoringsystems, centrifugal systems, blood gas devices, patientmonitors and anesthesia monitors. Case data can beentered manually by the user or collected automatically fromindependent medical devices. Screen layouts arecustomizable to meet hospital and user requirements forpatient/case records. Physiological data can be graphed atuser defined time intervals for event recording. Certaincalculations routinely performed by the clinician duringsurgery can be performed by the TLink™ DMS, e.g., BodySurface Area (based on patient height and weight data) andFluid Balance (based on fluid input and output data). Casetemplates and administrative information are developed on acentral computer and transferred to the satellite computer(s)connected to the external medical device(s) in the procedurerooms. Case records are then transferred back to thecentral computer or hospital information system for centralstorage and post-case analysis/reporting. All transfersbetween satellite and central computers are via networkand/or removable media. A variety of post-procedurereports are available including case report, clinical activity,case checklist, quality assurance, audit summary report, andaudit detail report. |
| Indication for use | The TLink™ DMS is an electronic clinical record keepingand reporting system indicated for use in collecting,displaying, storing and managing data from externalmedical devices. The system facilitates the creation ofelectronic patient records and enables post-proceduralcase reviews. Data and records can be viewed on localworkstations or transferred to a central computer or hospitalnetwork for storage and post-case analysis/reporting. |
January 20, 2012
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Section 5: 510(k) Summary
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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 electronicclinical record keeping andreporting system indicated for usein collecting, displaying, storingand managing data from externalmedical devices. The systemfacilitates the creation of electronicpatient records and enables post-procedural case reviews. Dataand records can be viewed onlocal workstations or transferred toa central computer or hospitalnetwork for storage and post-caseanalysis/reporting. | For use in data collection,display, management, andstorage in the intensive care unit.The system is used inconjunction with independentpatient bedside devices andsystems, connected via anetwork. The way the system isused for generating patientrecords, computation of drug andfluid dosage and research tasksis determined by the health careproviders, in terms of theirenvironment and requirements.The MetaVision application isresident on a workstation thatprovides for data input andpatient data display - to healthcare professionals. Typically, aMetaVision system comprisesseveral workstations connectedvia a network system to one ormore servers. Data is stored andmanaged by servers. TheMetaVision system network cancommunicate with a number ofremotely located patient careunits. |
| SystemComponents | • System software• Touch screen computer (localto monitoring devices)• Barcode laser scanner andholder• Touch screen stylus | • System software• Local workstations connectedvia hospital network• Bar code scanner forscanning drug vial bar codes |
| Characteristic | TLink™ DMS | MetaVision-K012349 |
| Functionality | • Hardware for mounting touch screen computer (trays, brackets)• 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• 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• 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• Generate reports including diagnoses, clinical data, procedures and outcomes. Reports used for post-procedure analysis, quality assurance and billing purposes |
January 20, 2012
TERUMO
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Section 5: 510(k) Summary
1
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Section 5: 510(k) Summary
Summary of Performance Tests Conducted for Determination of Substantial Equivalence
| Characteristic | Report | Results Summary |
|---|---|---|
| System & SoftwareDesign VerificationTesting | Provides documented evidence that thedesign outputs for TLink™ DMS V. 2.0continue to meet the existing design inputs ofprior software release versions and meet thenew design inputs as well. This protocolcovers all of the software-related systemrequirements and includes the additionalhardware components. | Pass - Test resultsdemonstrate that thedesign outputs meetthe design inputrequirements (pre-defined acceptancecriteria). |
| System & SoftwareDesign ValidationTesting | Validates that TLink™ DMS V. 2.0 meets theuser needs and intended use undersimulated use conditions by addressing thefollowing three areas:Packaging, Labeling andMiscellaneous Installation and Set-up Simulated Use | Pass - Test resultsdemonstrate thatintended use anduser needs arefulfilled. |
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.
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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.
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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
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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
§ 870.2450 Medical cathode-ray tube display.
(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).