K Number
K112276
Device Name
VIZION
Date Cleared
2011-11-16

(99 days)

Product Code
Regulation Number
866.1640
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
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 Vizione captures an image of a Sensitite 96 well micro-titre susceptibility plate and projects it onto a touch screen monitor.
More Information

Not Found

Not Found

No
The description explicitly states that the user manually determines the MIC by visually looking for color change, and the device is described as an "alternate manual reading method." There is no mention of automated analysis or interpretation of the image using AI/ML.

No.
The device is used to take and magnify digital images of susceptibility plates for manual reading of results, not for treating or preventing disease.

Yes

The device aids in determining susceptibility to antimicrobial agents (MIC), which is a crucial step in diagnosing and guiding treatment for various infections by identifying the most effective medication. The process of visually determining the MIC value directly contributes to diagnostic decision-making.

No

The device description explicitly states it is an "instrument" that "takes a digital image" and "projects it onto a touch screen monitor," indicating the presence of hardware components beyond just software.

Based on the provided text, the Sensititre® Vizion® is not an IVD (In Vitro Diagnostic) device itself.

Here's why:

  • It's an instrument used with an IVD system: The text explicitly states the Sensititre® Vizion® is "intended for use with the Sensititre® MIC or BP Susceptibility Test System" and "for reading Sensititre YeastOne Plates." The Sensititre® MIC/BP System and YeastOne Plates are the IVD components that perform the actual diagnostic test (susceptibility testing).
  • It's a reading aid: The Vizion®'s function is to "take a digital image," "magnify it," and "project it onto a touch screen monitor." It acts as an alternate manual reading method, assisting the user in interpreting the results of the IVD test. The user still determines the MIC by visually looking for the color change.

In essence, the Sensititre® Vizion® is a tool that facilitates the reading of results from an IVD test, but it does not perform the diagnostic test itself.

N/A

Intended Use / 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.

Product codes

JWY

Device Description

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 Vizione captures an image of a Sensitite 96 well micro-titre susceptibility plate and projects it onto a touch screen monitor.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Digital image

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 866.1640 Antimicrobial susceptibility test powder.

(a)
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.(b)
Classification. Class II (performance standards).

0

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

1

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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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

2

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.