SENSITITRE VIZION

K081520 · Trek Diagnostic Systems, Inc. · JWY · Oct 24, 2008 · Microbiology

Device Facts

• Record ID: K081520
• Device Name: SENSITITRE VIZION
• Applicant: Trek Diagnostic Systems, Inc.
• Product Code: JWY · Microbiology
• Decision Date: Oct 24, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Indications for Use

The Sensititre Vizion is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The "Sensititre" Vizion" is an instrument that takes a digital image of a Sensititre® susceptibility plate and magnifies it through the use of a dedicated software and a monitor. The Sensititre® Vizion® is an alternate manual reading method for the Sensititre® MIC plates for non-fastidious Gram positive, Gram negative and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae and Streptococci other than S. pneumoniae.

Device Story

Vizion plate viewer is an accessory to the Sensititre MIC and Breakpoint Susceptibility system; used for reading microbial susceptibility test panels. Device captures panel images via video camera and displays them on a touch screen for user-selected MIC result entry. Workflow involves manual panel insertion into a drawer; results are recorded via PC running Swin software. Replaces the SensiTouch mirror/LCD display system. Operates in clinical laboratory settings; used by laboratory technicians. Provides visual aid for manual interpretation of bacterial growth; facilitates data management and reporting via connected PC. Benefits include improved lighting control and modernized hardware components (USB interface, upgraded circuit boards) compared to the predicate.

Clinical Evidence

Performance validated via in-house testing and three external clinical sites comparing Vizion to the SensiTouch predicate. A specific study addressed potential endpoint read differences by having three blinded individuals read the same plates under varying light settings; results were satisfactory. Verification and validation activities confirmed that predetermined acceptance criteria were met.

Technological Characteristics

System utilizes a video camera for image capture and a touch screen interface. Connectivity upgraded from RS232 to USB. Circuit boards upgraded to current manufacturing standards. System maintains compatibility with existing Swin software and Windows-based PCs. Complies with CSA and CE standards.

Indications for Use

Indicated for use as an alternate manual reading method for Sensititre MIC plates to determine antimicrobial susceptibility for non-fastidious Gram-positive, Gram-negative, and fastidious organisms (Haemophilus influenzae, Streptococci pneumoniae, and Streptococci other than S. pneumoniae).

Regulatory Classification

Identification

An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

Predicate Devices

• Sensitouch Plate Viewer (N50531)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K081520

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) Sensitouch Plate Viewer, N50531

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

No changes were made to the Indication/Intended Use.

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for the addition of the Vizion plate viewer to the Sensititre MIC and Breakpoint Susceptibility system. The fundamental Scientific Technology of the device did not change.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and

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| Table1. Feature Comparison of Vizion with the SensiTouch instrument | | | | |
| --- | --- | --- | --- | --- |
| FEATURE | SENSITOUCH | VIZION | EQUIVALENT | COMMENTS |
| CORE SYSTEM: | | | | |
| TECHNOLOGY | The panel image is displayed on a mirror with an LCD overlay over the panel image | The panel image is displayed on a touch screen directly from a video camera | Yes | Equivalence shown by in house performance testing and preliminary clinical data. |
| RESULTS ENTRY | MIC results selected by the user | MIC results selected by the user | Yes | User selects the result |
| INSTRUMENT DESIGN: | | | | |
| PANEL ENTRY | The panel is entered into the instrument via a manually operated drawer | The panel is entered into the instrument via a manually operated drawer | Yes | Entry exactly the same on both instruments. |
| LIGHTING | The Sensitouch has set light settings | The Vizion has variable light settings controlled by the user | Yes | The light adjustment allows much better control for the user |
| WORKFLOW | Panel results are selected by the user and recorded via a touch pad connected to a PC with Swin software. | Panel results are selected by the user and recorded via a touch screen connected to a PC, with Swin software. | Yes | Workflow is the same as the Sensitouch |
| CIRCUIT BOARDS | Near Obsolescence | Upgraded and to meet all current regulations | Changed to meet current manufacturing requirements | PC boards upgraded to state-of-the-art-technology. |
| INTERFACE TO PC | RS232 cable connection | USB connection | Changed to use current technology | RS232 is becoming obsolete. |
| | | | | |
| USER INTERFACE PC | | | | |
| OPERATING SYSTEM | WINDOWS | WINDOWS | No change | Same software used for both |

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| HARDWARE SPECIFICATION | WINDOWS compatible PC | WINDOWS compatible PC | No change | instruments Same software used for both instruments |
| --- | --- | --- | --- | --- |
| DATA MANAGEMENT | Done at the PC including all reporting | Done at the PC including all reporting | No change | Same software used for both instruments |
| OTHER SYSTEM FEATURES | | | | |
| AGENCY COMPLIANCE | CSA (Including USA), CE | CSA (Including USA), CE | No change | |

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis;

The manufacturer submitted a Risk Analysis method based on potential hazards that could occur with use of the device. Recommended mitigations were identified for each hazard followed by statements of residual risk after implementation of mitigations.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The verification and validation activities were submitted and, in general, are satisfactory. The sponsor submitted MIC results comparing the performance of the Vizion to the Sensitouch plate viewer from in-house testing as well as three external sites to demonstrate that the modification did not impact the performance of the device. The sponsor stated that Risk # 19 (Endpoint Read Differences) studies were not completed for the verification and validation activities of the Vizion reader. Because this information is critical to determine if there is a significant risk associated with adding a new reader, the sponsor was asked to perform a study with 3 individuals reading the same plates but blinded to the light settings used by the other individuals. The sponsor performed the study in-house and the results were satisfactory. We performed an interactive exchange to agree upon the content of the Vizion User Manual. In addition the SWIN software used by the reader was reviewed.

c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and

ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

The declaration of conformity with design controls was submitted and is satisfactory.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for

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# Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.