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

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 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

Sensititre Vizion is an imaging instrument for antimicrobial susceptibility testing; captures digital images of 96-well micro-titre susceptibility plates; projects images onto a touch screen monitor for magnification. Used in clinical laboratory settings by laboratory personnel. Device serves as an alternate manual reading method; user visually inspects magnified well images to determine presence or absence of bacterial growth to establish Minimum Inhibitory Concentration (MIC) results. Output facilitates clinical decision-making regarding antimicrobial therapy; benefits patient by providing standardized, magnified visualization of susceptibility test results.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Instrumental imaging system; consists of digital camera, touch screen monitor, and dedicated software. Operates as an alternate manual reading method for 96-well micro-titre plates. Connectivity/interoperability details not specified. Software-based image projection and magnification.

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

• Sensititre 18-24 hour MIC or Breakpoint Susceptibility System (K081520)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Cynthia C. Knapp Director Lab Services Trek Diagnostic System, Inc. 982 Keynote Circle Suite 6 Cleveland, OH 44131

OCT 2 4 2008

Re: K081520 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 21, 2008 Received: October 22, 2008

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 either class II (Special Controls) or class III (PMA), 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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 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 Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Sally attaynta

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 (k081520):

## 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 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.

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

## This 510(k) is for the addition of: "Vizion®"

The Vizion® captures an image of a Sensititre 96 well micro-titre susceptibility plate and projects it onto a touch screen monitor. The user determines the MIC by visually looking for the presence or absence of growth in the wells.

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

Prescription Use X

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)

| | Leslie L. Poole |
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| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) | |
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Office of In Vitro Diagnostic Device Evaluation and Salety

510(k) K081526