SENSITITRE AIM (TM) by TREK DIAGNOSTIC SYSTEMS, LTD.

The Sensititre® AIM™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® AIMTM is an instrument used to inoculate Sensititre® MIC or BP Susceptibility plates.

The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious gram negative organisms.

Device Description

The Sensititre AIM™ is a microprocessor controlled instrument that delivers inoculum in 50ul multiples to the Sensititre 96 well micro-titre plate. The user prepares the inoculum suspension in accordance with the package insert. A Sensititre disposable dosehead is affixed to the glass tube containing the final inoculum density which is placed into the AIM's pump assembly. The inoculum is then dispensed into the microtitre plates.

AI/ML Overview

This appears to be a 510(k) clearance letter for the Sensititre AIM™ device, which is an instrument used to inoculate Sensititre MIC or BP Susceptibility plates for antimicrobial susceptibility testing. The provided document itself does not contain the detailed study information, acceptance criteria, or performance data that would be typically found in a clinical study report or a summary of safety and effectiveness.

The letter explicitly states: "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..."

This means the FDA granted clearance based on the device being substantially equivalent to a predicate device, rather than requiring extensive new clinical trial data that would be presented in the format you're requesting. The detailed performance data would have been submitted by the manufacturer as part of their 510(k) submission, but it's not included in this public-facing clearance letter.

Therefore, I cannot extract the following information from the provided text:

A table of acceptance criteria and the reported device performance: This information is not present.
Sample sizes used for the test set and the data provenance: This information is not present.
Number of experts used to establish the ground truth for the test set and their qualifications: This information is not present.
Adjudication method for the test set: This information is not present.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This information is not present.
If a standalone (algorithm only) performance study was done: This information is not present. The Sensititre AIM™ is an instrument for inoculation, not an algorithm in the sense of AI/ML.
The type of ground truth used: This information is not present.
The sample size for the training set: This information is not present.
How the ground truth for the training set was established: This information is not present.

What the document does tell us:

Device Name: Sensititre® AIM™
Intended Use: The Sensititre® AIM™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. It is an instrument used to inoculate Sensititre® MIC or BP Susceptibility plates. The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious gram-negative organisms.
Device Function: It is a microprocessor-controlled instrument that delivers inoculum in 50ul multiples to the Sensititre 96 well micro-titre plate. The user prepares the inoculum suspension, affixes a disposable dosehead to the glass tube containing the final inoculum density, and places it into the AIM's pump assembly for dispensing into microtitre plates.
Regulatory Pathway: 510(k) substantial equivalence. This means the device was found to be as safe and effective as a legally marketed predicate device. The performance data justifying this equivalence would have been submitted to the FDA in the original 510(k) application.
Product Code: LIE, JWY, LRG
Regulation Number/Name: 21 CFR 866.1640, Antimicrobial Susceptibility Test Powder (Note: This regulation name seems to refer to the reagents, not directly to the instrument itself, highlighting that the AIM is part of a larger system.)

To obtain the detailed acceptance criteria and study data for the Sensititre AIM™, one would typically need to review the original 510(k) submission summary (often called the 510(k) Summary or 510(k) Statement) which is usually publicly accessible on the FDA website for cleared devices, or directly from the manufacturer.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle, there is a stylized image of an eagle or bird with its wings spread, facing to the right.

Food and Drug Administration 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

APR 2 7 2011

Re: K110331

Trade/Device Name: Sensititre AIM™ Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: LIE, JWY, LRG Dated: January 27, 2011 Received: February 9, 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 vour 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 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 (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,

Jaly axhm

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 Sensititre® AIM™

510(k) Number: K ||033 /

Device Name: The Sensititre® AIM™

Indications for Use:

The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious gram negative organisms.

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

This 510(k) is for the addition of: "AIMTM"

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR Over-The-Counter Use

(Part 21 CFR 80) 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)

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Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) <110 33/

Regulation Number and Section

§ 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).