(313 days)
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No
The summary describes a software update for an existing identification system that adds new species to its database. There is no mention of AI, ML, or any related technologies in the description or performance studies. The focus is on the accuracy of identification based on the updated database and software.
No.
The device is intended for the automated identification of bacteria, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The device description states it is "intended for use... for the automated identification of clinically significant streptococci, staphylococci, and a selected group of Gram positive bacilli." Identification of microbes from clinical samples for diagnosis and treatment falls under the definition of a diagnostic device. The performance studies also detail "correct genus call" and "correctly identified to the species level," further reinforcing its diagnostic purpose.
No
The device description explicitly mentions a "VITEK® Gram Positive Identification Card," which is a physical component, indicating it is not a software-only device. The summary also discusses performance studies related to the "GPI Card," further confirming the presence of hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "automated identification of clinically significant streptococci, staphylococci, and a selected group of Gram positive bacilli" in conjunction with the Vitek® System. This involves testing biological samples (likely bacterial cultures) in vitro (outside the body) to provide diagnostic information.
- Device Description: The description mentions a "VITEK® Gram Positive Identification Card" which is a component used in the Vitek® System for this identification process. This card likely contains reagents or wells for biochemical or other tests performed on the bacterial samples.
- Performance Studies: The performance studies describe testing on "enterococcal isolates" and "non-enterococcal isolates," which are biological samples. The goal of these studies is to validate the accuracy of the device in identifying these organisms, which is a core function of an IVD.
The information provided clearly indicates that this device is used to perform tests on biological samples in vitro to aid in the diagnosis or identification of microorganisms, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VITEK® Gram Positive Identification Card containing new claims for the identification of Enterococcus casseliflavus Enterococcus gallinarum Enterococcus hirae is intended for use in conjunction with the Vitek® System for the automated identification of clinically significant streptococci, staphylococci, and a selected group of Gram positive bacilli.
Product codes
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Device Description
Safety and effectiveness issues for the new software which contains the three additional species claims for Enterococcus for the bioMérieux Vitek GPI include the following considerations:
- . The study was designed to validate the addition of six new species of enterococcus to the bioMérieux Vitek, Inc. GPI software. After clinical testing was performed it was determined that the addition of Enterococcus malodoratus. Enterococcus raffinosus and Enterococcus mundtii did not improve the software. Not only was the testing on these organisms irreproducible, the react file lines affected the accuracy of the Enterococcus faecium call. Enterococcus malodoratus is not a clinical isolate and the other two species have little clinical utility, therefore it was determined to limit the FDA submission data to Enterococcus casseliflavis, Enterococcus gallinarum and Enterococcus hirae.
- Performance characteristics: Performance of the GPI Card remains the same utilizing the . new software compared to the current software as documented by clinical testing. The addition of three new enterococcal species does not affect the performance of the GPI card.
- . Reproducibility: The new software reproducibly identifies specified gram-positive organisms.
- The Correlation Studies on enterococcal isolates gave a correct genus call 96.7% of the . time after repeat and supplemental testing. Of these, 91.1% also correctly identified to the species level. Mis-identifications occurred at 3.3%.
- . Performance of the GPI Card for non-enterococcal isolates remains the same utilizing the new software compared to the current software. The addition of three new enterococcal species does not affect the performance of the GPI Card as documented by clinical testing. In the Equivalency Study, the overall agreement of identification between the new software and the current software occurred at 99.8%.
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
- Performance characteristics: Performance of the GPI Card remains the same utilizing the . new software compared to the current software as documented by clinical testing. The addition of three new enterococcal species does not affect the performance of the GPI card.
- . Reproducibility: The new software reproducibly identifies specified gram-positive organisms.
- The Correlation Studies on enterococcal isolates gave a correct genus call 96.7% of the . time after repeat and supplemental testing. Of these, 91.1% also correctly identified to the species level. Mis-identifications occurred at 3.3%.
- . Performance of the GPI Card for non-enterococcal isolates remains the same utilizing the new software compared to the current software. The addition of three new enterococcal species does not affect the performance of the GPI Card as documented by clinical testing. In the Equivalency Study, the overall agreement of identification between the new software and the current software occurred at 99.8%.
Key Metrics
- The Correlation Studies on enterococcal isolates gave a correct genus call 96.7% of the . time after repeat and supplemental testing. Of these, 91.1% also correctly identified to the species level. Mis-identifications occurred at 3.3%.
- In the Equivalency Study, the overall agreement of identification between the new software and the current software occurred at 99.8%.
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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§ 866.2660 Microorganism differentiation and identification device.
(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
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Image /page/0/Picture/0 description: The image shows the logo for bioMérieux. The logo consists of a stylized globe made up of curved lines, positioned above the company name. The company name "bioMérieux" is written in a sans-serif font, with the "M" in "Mérieux" capitalized.
AR 12 1996
K9h2007-
Summary of Safety and Effectiveness Information for the Enterococcus spp. claims added to the Vitek® GPI Card
The VITEK® Gram Positive Identification Card containing new claims for the identification of Enterococcus casseliflavus Enterococcus gallinarum Enterococcus hirae
is intended for use in conjunction with the Vitek® System for the automated identification of clinically significant streptococci, staphylococci, and a selected group of Gram positive bacilli.
Safety and effectiveness issues for the new software which contains the three additional species claims for Enterococcus for the bioMérieux Vitek GPI include the following considerations:
- . The study was designed to validate the addition of six new species of enterococcus to the bioMérieux Vitek, Inc. GPI software. After clinical testing was performed it was determined that the addition of Enterococcus malodoratus. Enterococcus raffinosus and Enterococcus mundtii did not improve the software. Not only was the testing on these organisms irreproducible, the react file lines affected the accuracy of the Enterococcus faecium call. Enterococcus malodoratus is not a clinical isolate and the other two species have little clinical utility, therefore it was determined to limit the FDA submission data to Enterococcus casseliflavis, Enterococcus gallinarum and Enterococcus hirae.
- Performance characteristics: Performance of the GPI Card remains the same utilizing the . new software compared to the current software as documented by clinical testing. The addition of three new enterococcal species does not affect the performance of the GPI card.
- . Reproducibility: The new software reproducibly identifies specified gram-positive organisms.
- The Correlation Studies on enterococcal isolates gave a correct genus call 96.7% of the . time after repeat and supplemental testing. Of these, 91.1% also correctly identified to the species level. Mis-identifications occurred at 3.3%.
- . Performance of the GPI Card for non-enterococcal isolates remains the same utilizing the new software compared to the current software. The addition of three new enterococcal species does not affect the performance of the GPI Card as documented by clinical testing. In the Equivalency Study, the overall agreement of identification between the new software and the current software occurred at 99.8%.
bioMérieux Vitek, Inc.
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Image /page/1/Picture/0 description: The image shows the logo for bioMerieux. The logo consists of a stylized globe above the company name. The globe is made up of curved lines, and the company name is written in a lowercase sans-serif font.
Summary of Safety and Effectiveness Information for the Enterococcus spp. claims added to the Vitek® GPI Card
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- Validation of software design: The software Certification Statement attests to our . adherence to design, validation and testing procedures, and that release of this software takes place only when these written criteria are met.
When used within the context of the package insert, the new software containing the new Enterococcus species will perform as claimed. Additional information may be found in the package insert and technical bulletin.