(33 days)
Sorin CONNECT is a modularly structured program package that is exclusively used with Sorin/Stöckert heart lung machines. The system allows detailed recording of perfusion data during cardiopulmonary bypass as well as the processing and evaluation of this data. The data may be recorded automatically or entered manually.
The Sorin CONNECT is aiming to capture, display and store numerical or other perfusion related information entered by the user or captured from Stocket/Sorin Heart Lung Machine and from any compatible external device via a serial cable connection to the HLM interface. The capture of the data is performed automatically from the HLM via a serial cable communication or via RFID while simultaneously allowing for simple, manual user inputs The Sorin CONNECT Data Management System includes a hardware unit (the Personal Computer, hereinafter referred to as Datapad II, and the RFID card/reader hereinafter identified as Heartlink) and the software only product. The Sorin CONNECT software can be embedded into Datapad II (Online version hereinafter identified as Connect recorder) or available also on a server computer (server version hereinafter identified as Connect Manager). The Datapad II with embedded Connect Recorder allows for collection of all data that occur during an operation in order to generate a complete case record; its database store data in trend, event, calculation and it is possible to display on the monitor tabular trends or to view measurement trend graphs, with different measurements combined in each graph, to help the perfusionist in identify changes in the patient's physiological condition. The Connect Manager is a central database application in which all case records are stored and processed; in this case it is possible to consolidate data from different Connect Recorders on one central server computer. The application stores and manages data for documentation, reporting, analysis and export after the clinical case has been done: data are stored in a specific database and it is possible to display on the server workstation tabular trends, measurement trend graphs as well as statistical analysis and document them on a printer. The two different Sorin CONNECT applications have access to their own, independent database and data transfer among the databases takes place using either an USB memory stick or a network (Ethernet) connection: - HLM32.DBS is the database on the server computer. This database contains all case records that are already closed. - ONLINE32.DBS is the database on each of the online computers. This database contains the current case record(s) data. The Sorin CONNECT, through actuators, software and control mechanisms, performs the data collection, storage and management as requested by the operator through the user interface. Operating modes include automatic collection of data and manual insertion of data via keyboard The supported medical devices for Sorin CONNECT are the Stöckert/Sorin Heartlung machines SC (K982014), S3 (950990), S5 (K071318) and C5 (K093882).
The provided text outlines the acceptance criteria and the study conducted for the Sorin CONNECT Data Management System to demonstrate its substantial equivalence to predicate devices, rather than a study proving the device meets specific performance criteria in a clinical setting.
The study described is primarily focused on non-clinical bench testing for safety and performance specifications, and a comparison of technological characteristics with predicate devices to establish substantial equivalence for regulatory purposes.
Here's an analysis based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table with specific, quantifiable acceptance criteria (e.g., accuracy, sensitivity, specificity) for device performance in the way one might expect for a diagnostic or therapeutic AI device. Instead, the "acceptance criteria" are implied by the standards and characteristics listed in the comparison table with predicate devices and the scope of the non-clinical tests.
| Parameter/Characteristic (Implied Acceptance Criteria) | Reported Performance/Comparison (Sorin CONNECT) |
|---|---|
| Intended Use Equivalence | Equivalent to TLink; limited to cardiac surgery intervention compared to IntelliVue. |
| Modular Division | Equivalent to both IntelliVue and TLink; all systems have an SW application for PC/server and an online application for data collection monitor (also a PC). |
| User Interface | Equivalent to both IntelliVue and TLink (touch screen, standard keyboard/mouse). |
| Data Source | Equivalent to IntelliVue (manual, automatic, RFID, calculations); difference with TLink is RFID vs. barcode scanner. |
| Data Management | Identical to both IntelliVue and TLink (operator can overrule and modify data). |
| Data Storage | Equivalent to both IntelliVue and TLink (relational database, PC embedded or central server). |
| Data Transfer/Backup | Equivalent to TLink (portable storage, network, WLAN); difference with IntelliVue which also uses telemetry. |
| Data Output | Equivalent to TLink (numerical, graphical, statistical); difference with IntelliVue which also outputs wave pulse. |
| Fundamental Scientific Technology | Equivalent to IntelliVue and TLink (Microsoft .NET framework, WLAN module). |
| Availability | Identical to IntelliVue and TLink (standalone SW embedded in PC or LAN). |
| Materials (Hardware/Firmware) | Equivalent to IntelliVue and TLink (PC, Microsoft Windows XP/Windows). |
| Sterilization/Shelf Life | Identical to IntelliVue and TLink (not sterile). |
| Biocompatibility | Identical to IntelliVue and TLink (no blood contacting parts). |
| EMC (Emissions) | Identical to IntelliVue (Group 1 Class A per CISPR 11); TLink data not available. |
| Electromagnetic Compatibility & Electrical Safety | Identical to IntelliVue (UL 60601-1, IEC 60601-1-2 testing); TLink data not available. |
| Compliance with Performance Specifications | Performance testing conducted to verify and stress PC server/client specifications and simulate various real deployment scenarios. Confirmed performance of software with compatible devices. |
| Electrical Testing | Compliant (details not specified). |
| Electromagnetic Compatibility Testing | Compliant (details not specified, but references IEC 60601-1-2). |
| Software Compliance | Compliant with IEC 62304 and FDA Guidance for Off-the-Shelf software. |
| Cybersecurity | Compliant with FDA Guidance for networked medical devices. |
| Usability | Compliant with IEC 62366. |
| Health Information Technology | Compliant with ANSI HL 7 V2.5-2003. |
| Risk Management | Compliant with ISO 14971. |
| Wireless Technology | Compliant with FDA guidance for radio frequency wireless technology. |
2. Sample Size for the Test Set and Data Provenance:
The document mentions "performance testing... simulating various scenarios of real customer deployment in the hospital" but does not specify a numerical sample size for this testing. It implies a simulated environment rather than actual patient data. There is no information regarding country of origin or whether the data was retrospective or prospective, as it appears to be a systems/software validation rather than a clinical data study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a data management system, not a diagnostic device requiring expert interpretation of medical images or measurements to establish a "ground truth" for a test set. The validation is against technical specifications and predicate device characteristics.
4. Adjudication Method for the Test Set:
Not applicable. As described above, there's no clinical "ground truth" or expert review process detailed for this type of software system validation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret cases, and the AI's impact on their performance is evaluated. The Sorin CONNECT is a data management system, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, a form of "standalone" evaluation was performed in the sense that the software's performance was tested against its specifications and predicate device characteristics in simulated environments, independent of active human clinical decision-making during the test. The "performance testing" described directly assesses the system's functionality.
7. Type of Ground Truth Used:
The "ground truth" for this device's validation is adherence to:
- Predicate Device Characteristics: The comparison table explicitly uses the characteristics of the IntelliVue Clinical Information Portfolio and TLink Data Management System as a benchmark for substantial equivalence.
- Technical Standards and Regulations: Compliance with various international and national standards (e.g., IEC 62304 for software, ISO 14971 for risk management, FDA guidances for cybersecurity and off-the-shelf software, electrical safety, EMC).
- Internal Performance Specifications: The testing aimed to "verify and stress the PC server and client specifications" and confirm performance.
8. Sample Size for the Training Set:
Not applicable. The Sorin CONNECT Data Management System described is not an AI/ML device that requires a training set in the conventional sense for learning patterns from data. It's a software system for data capture, display, and storage.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
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| Sorin CONNECT Data Management System Traditional 510(k) | |||
|---|---|---|---|
| Sorin Group Deutschland GmbH | June 7, 2013 | ||
| K131816 | |||
| P 1/7 | |||
| 510(k) SUMMARY | JUL 2 3 2013 | ||
| SUBMITTER: | Sorin Group Deutschland GmbH | ||
| 25, Lindberghstrasse | |||
| D-80939 Munich, Germany | |||
| CONTACT PERSON: | Renate Göbert | ||
| Phone: + 49 (0)89 323-153 | |||
| Fax: + 49 (0)89 32301333 | |||
| DATE PREPARED: | June 7, 2013 | ||
| DEVICETRADE NAME: | Sorin CONNECT | ||
| COMMON NAME: | Data Management System | ||
| CLASSIFICATION NAME: | Display, Cathode-ray Tube, Medical | ||
| PREDICATE DEVICE: | IntelliVue Clinical Information Portfolio | K100272 | |
| TLink Data Mangement System | K113214 |
DEVICE DESCRIPTION:
The Sorin CONNECT is aiming to capture, display and store numerical or other perfusion related information entered by the user or captured from Stocket/Sorin Heart Lung Machine and from any compatible external device via a serial cable connection to the HLM interface.
The capture of the data is performed automatically from the HLM via a serial cable communication or via RFID while simultaneously allowing for simple, manual user inputs
The Sorin CONNECT Data Management System includes a hardware unit (the Personal Computer, hereinafter referred to as Datapad II, and the RFID card/reader hereinafter identified as Heartlink) and the software only product. The Sorin CONNECT software can be embedded into Datapad II (Online version hereinafter identified as
{1}------------------------------------------------
| Sorin Group Deutschland GmbH | June |
|---|---|
| ------------------------------ | ------ |
7, 2013
P 2/7
Connect recorder) or available also on a server computer (server version hereinafter identified as Connect Manager).
The Datapad II with embedded Connect Recorder allows for collection of all data that occur during an operation in order to generate a complete case record; its database store data in trend, event, calculation and it is possible to display on the monitor tabular trends or to view measurement trend graphs, with different measurements combined in each graph, to help the perfusionist in identify changes in the patient's physiological condition.
The Connect Manager is a central database application in which all case records are stored and processed; in this case it is possible to consolidate data from different Connect Recorders on one central server computer. The application stores and manages data for documentation, reporting, analysis and export after the clinical case has been done: data are stored in a specific database and it is possible to display on the server workstation tabular trends, measurement trend graphs as well as statistical analysis and document them on a printer.
The two different Sorin CONNECT applications have access to their own, independent database and data transfer among the databases takes place using either an USB memory stick or a network (Ethernet) connection:
-
HLM32.DBS is the database on the server computer. This database contains all case records that are already closed.
-
ONLINE32.DBS is the database on each of the online computers. This database contains the current case record(s) data.
The Sorin CONNECT, through actuators, software and control mechanisms, performs the data collection, storage and management as requested by the operator through the user interface. Operating modes include automatic collection of data and manual insertion of data via keyboard
The supported medical devices for Sorin CONNECT are the Stöckert/Sorin Heartlung machines SC (K982014), S3 (950990), S5 (K071318) and C5 (K093882).
INDICATIONS FOR USE:
Sorin CONNECT is a modularly structured program package that is exclusively used with Sorin/Stöckert heart lunq machines. The system allows detailed recording of perfusion data during cardiopulmonary bypass as well as the processing and evaluation of this data. The data may be recorded automatically or entered manually.
{2}------------------------------------------------
K131816 P 3/7
TECHNOLOGICAL CHARACTERISTICS:
Sorin makes the claim of substantial equivalence to cited predicates based on intended use, indications for use, technological characteristics, and operational characteristics.
Sorin CONNECT and the predicates are software only products intended to be installed on a PC or on a server. They have a client server architecture and are compliant with the up to date Micrsosoft® Operating System and databases.
The related software supports a standard hospital LAN interface and Sorin device interface for connection to the compatible measuring devices.
Sorin Group Deutschland GmbH believes that the Sorin CONNECT is substantially equivalent to the IntelliVue family of Patient Data Management solutions, to TLink DMS and to other currently marketed data management devices, that any differences are minor, and raise no new issues of safety and effectiveness.
The summary of equivalences regarding general features and performance characteristics of the Sorin CONNECT and the predicate devices is presented below
| Parameters | Sorin CONNECT | INTELLIVUE | TLink DMS | Equivalence |
|---|---|---|---|---|
| Intendeduse | Sorin CONNECT is amodularly structuredprogram package thatis used together withSorin heart lungmachines.The system allowsdetailed recording ofsystemic perfusiondata during cardio-surgical interventions;as well as theprocessing andevaluation of thesedata afterwards.The recording of thedata is performedautomatically or viaRFID whilesimultaneouslyallowing for simple,manual user inputs. | The INTELLIVUE isintended for use in thedata collection, storage,and management withindependent bedsidedevices and ancillarysystems that areconnected either directlyor through networks.This device is indicatefor use by the healthcare providers wheneverthere is a need forgeneration of a patientrecord and computationdrug usage | The TLink DMS is anelectronic clinicalrecord keeping andreporting systemindicated for use incollecting, displaying,storing andmanaging data fromexternal medicaldevices. The systemfacilitates thecreation of electronicpatient records andenables post-procedural casereviews. Data andrecords can beviewed in localworkstations ortransferred to acentral computer orhospital network forstorage and post-case analysis/reporting | Equivalent toTLink as bothsystem aretailored for use inboth OR andafterwards byperfusionistsEquivalent toINTELLIVUE butlimited to datamanagement ofcardiac surgeryintervention(IntelliVue can beused also forbedside datamanagement)and not intendedfor the scope ofcomputation drugusage but onlyfor generation ofpatient record |
| Modulesdivision | Connect(centralapplication - basedon bothand/or PC-)Connect recorder(online application -PC based-) | IntelliVueapplication(centraldatabase application -based on both serverand/or PC-)IntelliVuemonitors(online application - PCbased-) | XDSTLinkmanagement system(centraldatabaseapplication -based onboth server and/orPC-)TLinkmanagement system(On line applicationbased on a touchscreen PC) | Data Equivalent tobothINTELLIVUE andTLink : all systemhave a SWapplication whichcan be loaded ona PC or on aserver and anonline applicationloaded on themonitor wheredata arecollected ( which.is actually a PCas well) |
| Parameters | Sorin CONNECT | INTELLIVUE | TLink DMS | Equivalence |
| Userinterface | Touch screenwithout additionalinput devices(Connect Recorder)Standard keyboardand mouse ofcommercial PC(Connect Manager) | Touch screen; additionalinput devices like mouse,remote control ortrackball can be used(IntelliVue monitors)Standard keyboard andmouse of commercial PC(XDS application) | Touch screencomputerStandard keyboardand mouse ofcommercial PC(TLink DMS) | Equivalent tobothINTELLIVUE andTLink |
| Data source | Manually,Automaticallycaptured bycompatiblemeasuring devices,RFID card reader,calculations | Manually, Automaticallycaptured by compatiblemeasuring devices, RFIDcard reader, calculations | Manually,Automaticallycaptured bycompatible measuringdevices, bar codescanner, calculations | Equivalent toINTELLIVUE.Only differencewith TLink is that; it is not using aRFID card readerbut a bar codereader |
| Datamanagement | The operator can atany moment overrulethe data entry in anymode and manuallyenter or modify eachsingle parameter andsave the modifieddata | The operator can at anymoment overrule thedata entry in any modeand manually enter ormodify each singleparameter and save themodified data | The operator can atany moment overrulethe data entry in anymode and manuallyenter or modify eachsingle parameter andsave the modifieddata | identical to bothINTELLIVUE andTLink |
| Datastorage | Relational databasePC embedded(Connect recorder)Relational databasePC and/or centraldatabase serverembedded (Connectmanager) | Relational database PCembedded (IntelliVuemonitors)Relational database PCand/or central databaseserver embedded (XDSapplication) | Relational databasePC embedded (TLinkDMS embedded intothe touch screencomputer)Relational databasePC and/or centraldatabase serverembedded (TLINKDMS | Equivalent tobothINTELLIVUE andTLink |
| Parameters | Sorin CONNECT | INTELLIVUE | TLink DMS | Equivalence |
| Datatransfer/backup | Data can betransferred to/from:connect managerconnect recorder via:- portable storagemedium- network connection- WLAN connection | Data can be transferredto/from: IntelliVuemonitors to XDSapplication:- portable storagemedium- network connection- WLAN connection- Telemetry | Data can betransferred via:- portable storagemedium- network connection- WLAN connection | Equivalent toTLink.Only differencewith INTELLIVUEis that ; it allowstransfer of dataalso usingtelemetry ( notpossible inConnect andTlink) |
| Data Output | Numerical, graphical,statistical, | Numerical, graphical,waves, statistical, | Numerical, graphical,statistical, | Equivalent toTLink.Only differencewith INTELLIVUEis that ; it allowsdata output alsoin form of wavepulse (notpossible inConnect andTlink) |
| Fundamentalscientifictechnology | Microsoft.NETframework together withWLAN module | Microsoft.NET frameworktogether with WLAN module | Microsoft.NETframework together withWLAN module | Equivalent toINTELLIVUE andTLink |
| Availability | Availability as astandalone SWembedded into a PC orinto a LAN Network | Availability as a standaloneSW embedded into a PC orinto a LAN Network | Availability as astandalone SWembedded into a PC orinto a LAN Network | Identical toINTELLIVUE andTLink |
| Materials | Hardware: PCFirmware: MicrosoftWindows XP | Hardware: PCFirmware: MicrosoftWindows XP | Hardware: PCFirmware: MicrosoftWindows ( version Notavailable) | Equivalent toINTELLIVUE andTLink |
| Sterilization/Shelf Life | Not sterile | Not sterile | Not sterile | Identical toINTELLIVUE andTLINK |
| Biocompatibility | No blood contactingparts | No blood contacting parts | No blood contactingparts | Identical toINTELLIVUE andTLINK |
| EMC(emissions) | Group 1 Class A (CISPR 11) | Group 1 Class A (CISPR 11) | Data not available | Identical toINTELLIVUE |
| Parameters | Sorin CONNECT | INTELLIVUE | TLink DMS | Equivalence |
| Electromagneticcompatibilityand electricalsafety | UL 60601-1 (IEC60601-1, A1, A2) andIEC 60601-1-2 testing | UL 60601-1 (IEC 60601-1,A1, A2) and IEC 60601-1-2testing | Data not available | Identical toINTELLIVUE |
{3}------------------------------------------------
Sorin Group Deutschland GmbH
June 7, 2013
{4}------------------------------------------------
Sorin Group Deutschland GmbH
June 7, 2013
{5}------------------------------------------------
Sorin Group Deutschland GmbH
June 7, 2013
IN VITRO TEST RESULTS:
Testing supplied in the 510(k) premarket notification for the Sorin CONNECT includes electrical testing, electromagnetic compatibility testing, and performance testing that demonstrate compliance with performance specifications.
The purpose of the performance testing was to ensure the performance of the device by verifying and stressing the PC server and client specifications and simulating various scenarios of real customer deployment in the hospital, The conducted performance tests have confirmed performances of the Sorin CONNECT software together with the compatible measuring devices and the local infrastructures under conditions simulating real environment of use.
The results of the study showed the device characteristics between Sorin CONNECT and IntelliVue were comparable.
The list of tests performed to fulfill compliance with the nonclinical tests is presented below with the relevant standard followed
{6}------------------------------------------------
Sorin CONNECT Data Management System Traditional 510(k)
| Sorin Group Deutschland GmbH | ||
|---|---|---|
| A market and the comments of the comments of the comments of |
K131816 P 7/7
| TEST | STANDARD |
|---|---|
| Vibration test | ASTM D999, version 6, Aug 1st, 2008 |
| Drop test | ASTM D5276 version 9, March 1st, 2009 |
| Software | IEC 62304 version 1, May1st, 2006 |
| Off the shelf Software | FDA Guidance for the compliance on Off-the-Shelfsoftware used in medical devices, September 9, 1999 |
| Cybersecurity | FDA Guidance for networked Medical devices containingOff-the-Shelf software January 14, 2005 |
| Usability | IEC 62366: 2007 |
| Health information technology | ANSI HL 7 V2.5-2003 |
| Electromagnetic compatibility | IEC 60601-1-2, version 3, March 1st, 2007 |
| Electrical safety | IEC 60601-1:2005, 3rd ed. |
| Risk management | ISO14971, version 3, July 1st, 2009 |
| Wireless technology | FDA guidance for radio frequency Wireless technology inmedical devices, Jan 3, 2007 |
·
CONCLUSIONS:
The results of in vitro studies demonstrate that the Sorin CONNECT is substantially equivalent to the predicate device in terms of safety and effectiveness.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 23, 2013
Sorin Group Deutschland GmbH c/o Mr. Olaf Tiechert Responsible Third Party Official TUV SUD America, Inc. 1775 Old Highway 8 NW New Brighton, MN 55112
Re: K131816
Trade/Device Name: Sorin "CONNECT Data Management System" Regulatory Number: 21 CFR 870.2450 Regulation Name: Display, Cathode-Ray tube, Medical Regulatory Class: Il (two) Product Code: 74 DXJ Dated: July 2, 2013 Received: July 11, 2013
Dear Mr. Tiechert:
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
{8}------------------------------------------------
Page 2 - Mr. Olaf Tiechert
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Owen P. Faris -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{9}------------------------------------------------
Sorin CONNECT Data Management System Traditional 510(k)
Sorin Group Deutschland GmbH
June 7, 2013
Indications for Use
Device Name: Sorin CONNECT Data Management System
Indications for Use:
Sorin CONNECT is a modularly structured program package that is exclusively used with Sorin/Stöckert heart lung machines. The system allows detailed recording of perfusion data during cardiopulmonary bypass as well as the processing and evaluation of this data. The data may be recorded automatically or entered manually.
Prescription Use X (Part 21 CFR 801 Subpart D) C)
| Over-the-Counter Use | |
|---|---|
| ---------------------------------------------------------------------------- |
(
AND/OR (21 CFR 807 Subpart
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Digitally signed by
Owen P. Faris -S
Date: 2013.07.23
12:49:36-04'00'
"
§ 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).