(147 days)
Not Found
Not Found
No
The description explicitly states that the user determines the MIC by visually looking for growth, indicating manual interpretation rather than automated analysis using AI/ML. The device appears to be an imaging and magnification tool for manual reading.
No
The device is described as an instrument that takes a digital image of a susceptibility plate and magnifies it for visual inspection, aiding in the determination of MIC results. It is an alternate manual reading method and does not directly treat or diagnose a disease or condition.
Yes
The device is described as an "instrument that takes a digital image of a Sensititre® susceptibility plate" and allows a user to "determine the MIC by visually looking for the presence or absence of growth in the wells." This process of determining Minimal Inhibitory Concentration (MIC) from a susceptibility plate is a diagnostic method used to identify the lowest concentration of an antimicrobial that will inhibit the visible growth of a microorganism, which is crucial for guiding treatment.
No
The device description explicitly states that the "Sensititre Vizion" is an "instrument" that "takes a digital image" and "captures an image," indicating the presence of hardware components beyond just software.
Based on the provided information, the Sensititre Vizion is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for use with the Sensititre® MIC or BP Susceptibility Test System and is an alternate manual reading method for Sensititre® susceptibility plates. These plates are used to determine the susceptibility of microorganisms to antimicrobial agents, which is a diagnostic process performed in vitro (outside the body).
- Device Description: The description details how the device assists in the visual reading of these susceptibility plates, which are used in diagnostic testing.
- Function: The device's function is to aid in the interpretation of results from an in vitro diagnostic test (the Sensititre® susceptibility plate).
While the device itself doesn't directly perform the biological test, it is an essential component of the overall Sensititre® Susceptibility Test System, which is an IVD system. The Vizion's purpose is to facilitate the accurate reading and interpretation of the results generated by the IVD test.
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 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.
Product codes
JWY
Device Description
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital image of a Sensititre® susceptibility plate.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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 and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it. The caduceus is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
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 (800) 638-2041 or (240) 276-3150 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
2
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 | |
|---|---|
| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) | |
| Division Sign-Off |
Office of In Vitro Diagnostic Device Evaluation and Salety
510(k) K081526