(53 days)
Not Found
No
The description focuses on a microdilution technique and automated monitoring of bacterial growth, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
This device is an in vitro diagnostic (IVD) device used to determine the susceptibility of microorganisms to antimicrobial agents, which is a laboratory aid and not a direct therapeutic intervention.
Yes
The device is designed for "antimicrobial susceptibility testing" which aids in the "determination of in vitro susceptibility to antimicrobial agents" and is an "in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents," all of which are diagnostic functions.
No
The device description clearly outlines a physical card with wells containing premeasured antibiotic and culture media, which is then processed by a VITEK® 2 or VITEK® 2 Compact System (hardware). While software is involved in monitoring growth and generating reports, the core of the device is a physical component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "designed for antimicrobial susceptibility testing of Gram Negative bacilli" and is "intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." The term "in vitro" is a key indicator of an IVD.
- Device Description: The description details a test performed on a sample (bacterial isolate) outside of the body, using a specific card with premeasured reagents to determine susceptibility. This aligns with the definition of an in vitro test.
- Intended User / Care Setting: The device is intended for use in "clinical laboratories," which are typical settings for performing IVD tests.
- Performance Studies: The description of performance studies involves comparing the device's results to a "CLSI broth microdilution reference method," which is a standard method for in vitro susceptibility testing.
All of these points strongly indicate that the VITEK® 2 AST-Gram Negative Polymyxin B is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK® 2 AST-Gram Negative Polymyxin B is designed for antimicrobial susceptibility testing of Gram Negative bacilli and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Negative Polymyxin B is a quantitative test. Polymyxin B has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.
Active in vitro and in clinical infections: Pseudomonas aeruginosa
The VITEK® 2 Gram-Negative Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed.
Product codes
LON, LTW, LTT
Device Description
The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique reported by MacLowry and Marsh (1) and Gerlach (2). The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique (3).
Each VITEK® 2 AST card contains 64 wells. A control well which only contains microbiological culture media is resident on all cards. The remaining wells contain premeasured portions of a specific antibiotic combined with culture media. The bacterial or yeast isolate to be tested is diluted to a standardized concentration with 0.45 - 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling, sealing and loading operation. The VITEK® 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.
VITEK® 2 AST-GN Polymyxin B has the following concentrations in the card: 0.125, 0.5, 2 and 8 ug/mL (equivalent standard method concentration by efficacy in ug/mL).
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
clinical laboratories
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
An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of VITEK® 2 AST-GN Polymyxin B by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hours.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK® 2 AST-GN Polymyxin B demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (Issued August 28, 2009). The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
VITEK® 2 AST-GN Polymyxin B demonstrated acceptable performance of 93.9% overall Essential Agreement and 96.6% overall Category Agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results.
Predicate Device(s)
VITEK® 2 AST-GN Delafloxacin (K183524)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
February 14, 2020
BioMerieux, Inc. Esther Hernandez Regulatory Affairs Specialist 595 Anglum Road Hazelwood, Missouri 63042
Re: K193567
Trade/Device Name: VITEK 2 AST- Gram Negative Polymyxin B (=16 ug/mL) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: Class II Product Code: LON, LTW, LTT Dated: December 20, 2019 Received: December 23, 2019
Dear Esther Hernandez:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with a blue top half and a yellow-green bottom half. The word "BIOMÉRIEUX" is written in white letters in the center of the blue half of the circle.
510(k) SUMMARY
VITEK® 2 AST-GN Polymyxin B
A. 510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Esther Hernandez |
| Regulatory Affairs Specialist | |
| Phone Number: | 314-731-8841 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | December 19, 2019 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST- Gram Negative Polymyxin B (≤ |
| 0.25 - ≥ 16 µg/mL) | |
| Classification Name: | 21 CFR 866.1645 |
| Fully Automated Short-Term Incubation Cycle | |
| Antimicrobial Susceptibility System | |
| Product Code LON | |
| Common Name: | VITEK® 2 AST-GN Polymyxin B |
| Predicate Device: | VITEK® 2 AST-GN Delafloxacin (K183524) |
D. Device Description:
B.
C.
The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique reported by MacLowry and Marsh (1) and Gerlach (2). The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique (3).
Each VITEK® 2 AST card contains 64 wells. A control well which only contains microbiological culture media is resident on all cards. The remaining wells contain
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Image /page/3/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with a blue top half and a green and yellow gradient bottom half. The word "BIOMÉRIEUX" is written in white letters in the blue portion of the circle.
premeasured portions of a specific antibiotic combined with culture media. The bacterial or yeast isolate to be tested is diluted to a standardized concentration with 0.45 - 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling, sealing and loading operation. The VITEK® 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.
VITEK® 2 AST-GN Polymyxin B has the following concentrations in the card: 0.125, 0.5, 2 and 8 ug/mL (equivalent standard method concentration by efficacy in ug/mL).
E. Substantial Equivalence Information
The similarities and differences of the VITEK 2 AST-GN Polymyxin B when compared to the predicate device, VITEK 2 AST-GN Delafloxacin (K183524), are described in the following table.
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Image /page/4/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with a blue top half and a yellow-green gradient bottom half. The word "BIOMÉRIEUX" is written in white, sans-serif font in the center of the blue half of the circle.
| Item | Device:
VITEK® 2 AST-GN Polymyxin B | Predicate:
VITEK® 2 AST-G N
Delafloxacin (K183524) |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | VITEK® 2 AST-Gram Negative
Polymyxin B is designed for
antimicrobial susceptibility testing of
Gram negative bacilli and is intended
for use with the VITEK® 2 and VITEK®
2 Compact Systems as a laboratory
aid in the determination of in vitro
susceptibility to antimicrobial agents.
VITEK® 2 AST-Gram Negative
Polymyxin B is a quantitative test.
Polymyxin B has been shown to be
active against most strains of the
microorganisms listed below,
according to the FDA label for this
antimicrobial.
Active in vitro and in clinical
infections:
Pseudomonas
aeruginosa
The VITEK® 2 Gram-Negative
Susceptibility Card is intended for use
with the VITEK® 2 Systems in
clinical laboratories as an in vitro test
to determine the susceptibility of
clinically significant Gram-
negative bacilli to antimicrobial
agents when used as instructed. | VITEK® 2 AST-Gram Negative
Delafloxacin is designed for
antimicrobial susceptibility testing of
Gram negative bacilli and is intended
for use with the VITEK®2 and
VITEK® 2 Compact Systems as a
laboratory aid in the determination of
in vitro susceptibility to antimicrobial
agents. VITEK® 2 AST-Gram
Negative Delafloxacin is a quantitative
test.
Delafloxacin has been shown to be
active against most strains of the
microorganisms listed below, according
to the FDA label for this antimicrobial.
Active in vitro and in clinical infections:
Escherichia coli
Enterobacter cloacae
Klebsiella pneumoniae
Pseudomonas
aeruginosa
The VITEK® 2 Gram-negative
Susceptibility Card is intended for use
with the VITEK® 2 Systems in clinical
laboratories as an in vitro test to determine
the susceptibility of clinically significant
Gram-negative bacilli to
antimicrobial agents when used as
instructed. |
| Test
Methodology | Automated quantitative antimicrobial
susceptibility test for use with the
VITEK® 2 and VITEK® 2 Compact
Systems to determine the in vitro
susceptibility of Gram negative bacilli | Same |
| Inoculum | Saline suspension of organism | Same |
| | | |
| Test Card | VITEK® 2 Gram Negative Susceptibility
Test Card | Same |
| Instrument | VITEK® 2 and VITEK® 2
Compact Systems | Same |
| Analysis
Algorithms | Growth Pattern Analysis | Same |
| Differences | | |
| Antimicrobial
Agent | Polymyxin B | Delafloxacin |
| Antimicrobial
Concentration | 0.125, 0.5, 2, 8 | 0.06, 0.25, 0.5, 2 |
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Image /page/5/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with a blue upper half and a yellow-green lower half. The word "BIOMÉRIEUX" is written in white letters in the blue half of the circle.
F. Intended Use:
VITEK® 2 AST-Gram Negative Polymyxin B is designed for antimicrobial susceptibility testing of Gram Negative bacilli and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Negative Polymyxin B is a quantitative test. Polymyxin B has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.
Active in vitro and in clinical infections: Pseudomonas aeruginosa
The VITEK® 2 Gram-Negative Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed.
F. Performance Overview and Conclusion:
6
VITEK® 2 AST-GN Polymyxin B demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (Issued August 28, 2009).
The Premarket Notification (510[k]) presents data in support of VITEK® 2 AST- GN Polymyxin B. An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of VITEK® 2 AST-GN Polymyxin B by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hours. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
VITEK® 2 AST-GN Polymyxin B demonstrated acceptable performance of 93.9% overall Essential Agreement and 96.6% overall Category Agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results.
References:
-
- MacLowry, J.D. and Marsh, H.H., Semi-automatic Microtechnique for Serial Dilution Antibiotic Sensitivity Testing in the Clinical laboratory, Journal of Laboratory Clinical Medicine, 72:685-687, 1968.
-
- Gerlach, E.H., Microdilution 1: A Comparative Study, p. 63-76. Current Techniques for Antibiotic Susceptibility Testing. A. Balows (ed.), Charles C. Thomas, Springfield, IL, 1974.
-
- Barry, A.L., The Antimicrobic Susceptibility Test, Principles and Practices, Lea and Febiger, Philadelphia, PA, 1976.