VIZION

K112276 · Trek Diagnostic Systems · JWY · Nov 16, 2011 · Microbiology

Device Facts

• Record ID: K112276
• Device Name: VIZION
• Applicant: Trek Diagnostic Systems
• Product Code: JWY · Microbiology
• Decision Date: Nov 16, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended 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 Sensitities 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 nonfastidious Gram positive, Gram negative and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae and Streptococci other than S. pneumoniae and Candida spp. NOTE: Please refer to the Sensititre® 18-24 hour MIC or Breakpoint Susceptibility System package insert and the YeastOne package insert for additional instructions, limitations, and references. This 510(k) is for the addition of: "Vizion® for reading Sensititre YeastOne Plates" The Vizione captures an image of a Sensitite 96 well micro-titre susceptibility plate and projects it onto a touch screen monitor. The user determines the MIC by visually looking for the color change as indicated in the YeastOne technical insert. The "Vizion" can be used as an alternate method where the user manually reads the MIC result on the Sensititre System.

Device Story

Sensititre Vizion is an imaging instrument for antimicrobial susceptibility testing. It captures digital images of 96-well micro-titre susceptibility plates; projects images onto a touch-screen monitor for magnification. Used in clinical laboratories by technicians/microbiologists. Device serves as an alternate manual reading method; user visually inspects projected image for color changes (e.g., YeastOne plates) to determine MIC results. Facilitates manual interpretation of susceptibility tests; improves visualization of growth/color endpoints compared to manual plate inspection. Does not automate result calculation; relies on user judgment.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and performance validation of the imaging system's ability to accurately display plate results for the added organism/plate types compared to standard manual reading methods.

Technological Characteristics

Digital imaging system consisting of a camera, touch-screen monitor, and dedicated software. Operates as a manual reading aid for 96-well micro-titre plates. Standalone instrument. No specific materials or energy standards cited.

Indications for Use

Indicated for use as an alternate manual reading method for Sensititre MIC/BP susceptibility plates for nonfastidious Gram-positive, Gram-negative, and fastidious organisms (H. influenzae, S. pneumoniae, Streptococci spp., and Candida spp.) to determine Minimum Inhibitory Concentration (MIC).

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

• Sensititre Vizion (K072635)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird with its wings spread, with three human profiles incorporated into the design of the bird's body.

10903 New Hampshire Avenue Silver Spring, MD 20993

TREK Diagnostic Systems c/o Cynthia C. Knapp Director of U.S. Regulatory and Global Affairs 982 Keynote Circle, Suite 6 Cleveland, OH 44131

NOV 1 6 2011

Re: K112276

Trade/Device Name: The Sensititre ® Vizion® Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: October 12, 2011 Received: October 24, 2011

Dear Ms. Knapp:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed

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Page 2 - Cynthia C. Knapp

predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Vayada

Sally A. Hojvat, M.Sc., Ph.D. Director. Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT Vizion®

510(k) Number

Device Name: The "Sensititre® Vizion®

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 Sensitities 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 nonfastidious Gram positive, Gram negative and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae and Streptococci other than S. pneumoniae and Candida spp.

NOTE: Please refer to the Sensititre® 18-24 hour MIC or Breakpoint Susceptibility System package insert and the YeastOne package insert for additional instructions, limitations, and references.

This 510(k) is for the addition of: "Vizion® for reading Sensititre YeastOne Plates" The Vizione captures an image of a Sensitite 96 well micro-titre susceptibility plate and projects it onto a touch screen monitor. The user determines the MIC by visually looking for the color change as indicated in the YeastOne technical insert.

The "Vizion" can be used as an alternate method where the user manually reads the MIC result on the Sensititre System.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Office of In Vitro Diagnostic Device Evaluation and Safet

510(4) K 112276.