(55 days)
Not Found
Not Found
No
The 510(k) summary describes a susceptibility testing system and focuses on the removal of a limitation regarding vancomycin resistance detection. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description is purely about the performance characteristics of the susceptibility plates.
No
The device is an in vitro diagnostic product used for clinical susceptibility testing, which helps in identifying resistance to antibiotics. It does not treat or cure a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the product "is an in vitro diagnostic product for clinical susceptibility testing."
No
The device description is not provided, but the intended use clearly describes an "in vitro diagnostic product" and "susceptibility plates," which are physical components, not software. The 510(k) is for a change to the technical insert of this physical system.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive and gram negative organisms."
This statement clearly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive and gram negative organisms.
This 510(k) is for the removal of limitation number 22 in the Sensititre technical insert. The limitation to be removed is:
"The ability of the Sensititre system to detect resistance to vancomycin for Staphylococcus aureus is unknown because there are not an adequate number of strains available for testing. An alternate procedure such as broth microdilution or agar dilution with a full 24 hour incubation should be used to confirm results. CDC has reported (26) that BHI agar supplemented with 6ug/mL vancomycin is useful in detecting staphylococci with reduced susceptibilities to vancomycin and that this method is also reliable with the first three recognized VRSA isolated reported to CDC."
Then the following statement would be added to the technical insert:
Sensititre 18-24 hour MIC susceptibility plates is capable of detecting vancomycin resistance in the VRSA S. aureus strains available at the time of comparative testing. The ability of the Sensititre 18-24 hour MIC susceptibility plates to detect vancomycin resistance in other S. aureus strains is unknown due to the limited number of resistant strains available for comparative testing.
Product codes
JWY, LRG
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Cynthia C. Knapp Director Lab Services TREK Diagnostic Systems, Inc. 982 Keynote Circle, Suite 6 Cleveland, OH 44131
MAY 16 2006
K060783 Re:
Trade/Device Name: Susceptibility Test Panel for Vancomycin VRSA 1-128µg/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY, LRG Dated: March 20, 2006 Received: March 24, 2006
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).
1
Page 2 -
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 information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sales a Hon
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
510(k) Number (if known):
Device Name: Susceptibility Test Plate for Vancomycin VRSA Range 1-128ug/ml
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility Indications For Use: System is an in vitro diagnostic product for clinical susceptibility testing of gram positive and gram negative organisms.
This 510(k) is for the removal of limitation number 22 in the Sensititre technical insert. The limitation to be removed is:
"The ability of the Sensititre system to detect resistance to vancomycin for Staphylococcus aureus is unknown because there are not an adequate number of strains available for testing. An alternate procedure such as broth microdilution or agar dilution with a full 24 hour incubation should be used to confirm results. CDC has reported (26) that BHI agar supplemented with 6ug/mL vancomycin is useful in detecting staphylococci with reduced susceptibilities to vancomycin and that this method is also reliable with the first three recognized VRSA isolated reported to CDC."
Then the following statement would be added to the technical insert:
Sensititre 18-24 hour MIC susceptibility plates is capable of detecting vancomycin resistance in the VRSA S. aureus strains available at the time of comparative testing. The ability of the Sensititre 18-24 hour MIC susceptibility plates to detect vancomycin resistance in other S. aureus strains is unknown due to the limited number of resistant strains available for comparative testing.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Freddie M. Poole
Division Sign-Off
Division Sign-Off
Office of In With Diegnostic Device Evaluation art الحكومات تاقل
510(k) K060.783
Page 1 of ー