(47 days)
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No
The summary describes a traditional antimicrobial susceptibility test using agar diffusion discs, which is a manual, non-digital method and does not involve AI/ML. There are no mentions of AI, ML, image processing, or any computational analysis of data.
No
The device is described as an "Antimicrobial Susceptibility Test Disc" used for "semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms." This indicates a diagnostic or laboratory testing purpose, not a direct therapeutic application like treating or preventing a disease.
Yes
The device is used for "semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms," which provides information about the susceptibility of microorganisms to antimicrobials, aiding in the diagnosis and treatment of infections.
No
The 510(k) summary describes Antimicrobial Susceptibility Test Discs, which are physical components used in laboratory testing, not a software-only device.
Based on the provided information, the device described is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms." This describes a test performed in vitro (outside the body) on biological samples (micro-organisms) to determine their susceptibility to antimicrobial agents. This is a classic definition of an in vitro diagnostic test.
The lack of information in other sections (Device Description, Mentions image processing, etc.) does not negate the clear indication in the Intended Use that this is an IVD.
N/A
Intended Use / Indications for Use
Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. For Ertapenem these include: Staphylococcus aureus (methicillin susceptible isolates only), Streptococcus agalactiae, Streptococcus pneumoniae (penicillin susceptible isolates only), Streptococcus pyogenes, Escherichia coli, Haemophilus influenzae (Beta-lactamase negative isolates only), Klebsiella pneumoniae, Moraxella catarrhalis, and Proteus mirabilis.
Product codes
JTN
Device Description
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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
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Key Metrics
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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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§ 866.1620 Antimicrobial susceptibility test disc.
(a)
Identification. An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Andy Hollingsworth Regulatory Affairs Manager Oxoid Limited Wade Road, Basingstoke Hants RG24 8PW England
MAR 1 4 2007
Re: K070262
Trade/Device Name: Ertapenem Antimicrobial Susceptibility Test Disc Regulation Number: 21 CFR 866.1620 Regulation Name: Antimicrobial Susceptibility Test Disc Regulatory Class: Class II Product Code: JTN Dated: January 2, 2007 Received: January 26, 2007
Dear Mr. Hollingsworth:
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 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,
Sally, a story
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
510(k) Number (if known): K070262
Device Name: Ertapenem Antimicrobial Susceptibility Test Disc
Indications For Use:
Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. For Ertapenem these include: Staphylococcus aureus (methicillin susceptible isolates only), Streptococcus agalactiae, Streptococcus pneumoniae (penicillin susceptible isolates only), Streptococcus pyogenes, Escherichia coli, Haemophilus influenzae (Beta-lactamase negative isolates only), Klebsiella pneumoniae, Moraxella catarrhalis, and Proteus mirabilis.
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)
Ludde W. Rode
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K070212