(83 days)
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No
The document describes a microprocessor-controlled instrument for inoculating plates, with no mention of AI, ML, image processing, or any related concepts.
No
The device is described as an instrument used in a susceptibility testing system for in vitro diagnostic purposes, specifically to inoculate test plates. It does not directly treat or diagnose patients.
No
The Sensititre® AIM™ is described as an instrument used to inoculate Sensititre® MIC or BP Susceptibility plates. While it supports a system that is an "in vitro diagnostic product," the AIM™ itself is a preparation instrument rather than a device that performs a diagnostic test.
No
The device description clearly states it is a "microprocessor controlled instrument" and describes physical components like a pump assembly and dosehead, indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided text, the Sensititre® AIM™ itself is not an IVD.
Here's why:
- Intended Use: The Intended Use states that the Sensititre® AIM™ is an instrument used to inoculate Sensititre® MIC or BP Susceptibility plates. It is a tool used in the process.
- Device Description: The description details how the instrument physically dispenses inoculum. It does not perform any diagnostic testing or analysis itself.
- Relationship to the IVD: The text explicitly states that the "Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product". The AIM™ is a component or accessory used with this IVD system.
Therefore, the Sensititre® AIM™ is an instrument that facilitates the use of an IVD product, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
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.
Product codes
LIE, JWY, LRG
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
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
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,
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
2
INDICATIONS FOR USE STATEMENT Sensititre® AIM™
510(k) Number: K ||033 /
Device Name: The Sensititre® AIM™
Indications for Use:
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.
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"
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.
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)
Ludaliu u. Poob
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)