(385 days)
VITEK® 2 AST-Gram Negative Meropenem 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 Meropenem in is a quantitative test. Meropenem 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
Klebsiella pneumoniae
Proteus mirabilis
Pseudomonas aeruginosa
In vitro data are available, but clinical significance is unknown:
Citrobacter freundii
Citrobacter koseri
Enterobacter cloacae
Hafnia alvei
Klebsiella oxytoca
Morganella morganii
Serratia marcescens
The VITEK® 2 Gram Negative Susceptibility Card Meropenem also reports susceptibility for the following additional organisms as listed on the FDA Susceptibility Test Interpretive Criteria website:
Acinetobacter spp.
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.
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(0). 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 cvcle, 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 Meropenem (≤0.25 - ≥16 µg/mL) has the following concentrations in the card: 0.5, 1. 2. 4 and 8 ug/mL (equivalent standard method concentration by efficacy in us/mL).
Here's an analysis of the provided text regarding the acceptance criteria and study for the VITEK® 2 AST-Gram Negative Meropenem:
Acceptance Criteria and Reported Device Performance
For Antimicrobial Susceptibility Test (AST) Systems, the FDA Class II Special Controls Guidance Document typically defines acceptance criteria based on statistical agreement between the investigational device and a reference method. The key metrics are:
- Essential Agreement (EA): The percentage of results where the MIC result of the device is within +/- one doubling dilution of the reference method.
- Category Agreement (CA): The percentage of results where the device and the reference method produce the same interpretive category (e.g., Susceptible, Intermediate, Resistant).
- Very Major Errors (VME): The frequency with which the device incorrectly reports a susceptible isolate as resistant compared to the reference method (false resistance).
- Major Errors (ME): The frequency with which the device incorrectly reports a resistant isolate as susceptible compared to the reference method (false susceptibility).
- Minor Errors (mE): The frequency with which the device incorrectly reports an intermediate isolate as susceptible or resistant, or a susceptible/resistant isolate as intermediate.
The reported performance of the VITEK® 2 AST-Gram Negative Meropenem is presented in Table 2:
| Metric | Acceptance Criteria (from FDA Guidance - typical) | Reported Device Performance |
|---|---|---|
| Overall Performance | ||
| % Essential Agreement (EA) | Greater than or equal to 90% | 95.0% (1016/1070) |
| % Category Agreement (CA) | Greater than or equal to 90% | 95.0% (1016/1070) |
| Very Major Errors (VME) | Less than or equal to 1.5% | 0.0% (0/346) |
| Major Errors (ME) | Less than or equal to 3.0% | 0.6% (4/680) |
| Minor Errors (mE) | Less than or equal to 10.0% | 4.7% (50/1070) |
| Enterobacterales | ||
| % Essential Agreement (EA) | Greater than or equal to 90% | 94.4% (537/569) |
| % Category Agreement (CA) | Greater than or equal to 90% | 97.0% (552/569) |
| Very Major Errors (VME) | Less than or equal to 1.5% | 0.0% (0/65) |
| Major Errors (ME) | Less than or equal to 3.0% | 0.8% (4/491) |
| Minor Errors (mE) | Less than or equal to 10.0% | 2.3% (13/569) |
| P. aeruginosa | ||
| % Essential Agreement (EA) | Greater than or equal to 90% | 94.7% (267/282) |
| % Category Agreement (CA) | Greater than or equal to 90% | 89.7% (253/282) |
| Very Major Errors (VME) | Less than or equal to 1.5% | 0.0% (0/121) |
| Major Errors (ME) | Less than or equal to 3.0% | 0.0% (0/137) |
| Minor Errors (mE) | Less than or equal to 10.0% | 10.3% (29/282) |
| Acinetobacter spp. | ||
| % Essential Agreement (EA) | Greater than or equal to 90% | 96.8% (212/219) |
| % Category Agreement (CA) | Greater than or equal to 90% | 96.3% (211/219) |
| Very Major Errors (VME) | Less than or equal to 1.5% | 0.0% (0/160) |
| Major Errors (ME) | Less than or equal to 3.0% | 0.0% (0/52) |
| Minor Errors (mE) | Less than or equal to 10.0% | 3.7% (8/219) |
(Note: The acceptance criteria are "typical" for FDA guidance on AST systems. While the document mentions guidance, it doesn't explicitly state the exact numerical acceptance criteria within the provided text. The numbers above are common thresholds found in such guidances.)
2. Sample size used for the test set and the data provenance:
- Overall Test Set Sample Size: 1070 isolates. This is the denominator for the "Overall Performance" categories.
- Specific Organism Group Sample Sizes:
- Enterobacterales: 569 isolates
- P. aeruginosa: 282 isolates
- Acinetobacter spp.: 219 isolates
- Data Provenance: The study involved an "external evaluation" conducted with "fresh and stock clinical isolates, as well as a set of challenge strains." The document does not specify the country of origin, but clinical isolates and challenge strains are generally used to ensure a broad representation of resistance mechanisms and phenotypes. The use of "fresh and stock clinical isolates" suggests a retrospective component (stock) and a prospective component (fresh).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts to establish ground truth.
4. Adjudication method for the test set:
- The document does not mention an adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an automated antimicrobial susceptibility testing system, not an AI-assisted diagnostic tool that human readers would interpret. Its performance is compared to a reference laboratory method.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance study was done. The VITEK® 2 system is essentially an "algorithm only" device that automatically processes samples and provides MIC values and interpretive categories. Its performance was directly compared to the CLSI broth microdilution reference method, without human interpretation influencing the device's output.
7. The type of ground truth used:
- The ground truth was established by the CLSI broth microdilution reference method, which is the gold standard for antimicrobial susceptibility testing.
8. The sample size for the training set:
- The document does not explicitly mention a "training set" or its size in the context of machine learning, as this is a device based on microdilution technology. If the system uses internal algorithms that were "trained" or developed, the details of that process (including sample sizes) are not provided in this regulatory summary. The listed clinical isolates and challenge strains would primarily fall under the "test set" for performance evaluation against the reference method.
9. How the ground truth for the training set was established:
- As a training set is not explicitly mentioned in the context of machine learning or AI, the method of establishing ground truth for such a set is not described. The ground truth for the performance evaluation set was established by the CLSI broth microdilution reference method.
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July 9, 2021
bioMérieux, Inc. Debra Broyles Sr. Regulatory Affairs Specialist 595 Anglum Road Hazelwood, Missouri 63042
Re: K201675
Trade/Device Name: VITEK 2 AST-Gram Negative Meropenem (≤ 0.25 - ≥ 16 µg/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: June 18, 2020 Received: June 19, 2020
Dear Debra Broyles:
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
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- 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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Indications for Use
510(k) Number (if known)
Device Name
Indications for Use (Describe)
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
B.
C.
VITEK® 2 AST-Gram Negative Meropenem (≤0.25 - ≥16 µg/mL)
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum RoadHazelwood, MO 63042 |
| Contact Person: | Debra BroylesSenior Regulatory Affairs Specialist |
| Phone Number: | 314-731-8805 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | December 8, 2020 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST-Gram Negative Meropenem (≤0.25 - ≥16$µg/mL$ ) |
| Classification Name: | 21 CFR 866.1645Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility SystemProduct Code(s): LON, LTW, LTT |
| Common Name: | VITEK® 2 AST-GN Meropenem (≤0.25 - ≥16 $µg/mL$ ) |
| Predicate Device: | VITEK® 2 AST-GN Eravacycline (≤ 0.12 - ≥ 4$µg/mL$ ) (K191766) |
D. 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(0). The VITEK @ 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique(3).
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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 cvcle, 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 Meropenem (≤0.25 - ≥16 µg/mL) has the following concentrations in the card: 0.5, 1. 2. 4 and 8 ug/mL (equivalent standard method concentration by efficacy in us/mL).
E. Substantial Equivalence Information:
The similarities and differences of the VITEK® 2 AST-GN Meropenem (≤0.25 - ≥16 µg/mL) when compared to the predicate device, VITEK® 2 AST-GN Eravacycline ( ≤ 0.12 –> 4 ug/mL), are described in the Table 1 below.
| Item | Device:VITEK® 2 AST-GramNegative Meropenem( $\leq$ 0.25 - $\geq$ 16 µg/mL) | Predicate:VITEK® 2 AST-GNEravacycline( $\leq$ 0.12 - $\geq$ 4 µg/mL)(K191766) |
|---|---|---|
| Similarities | ||
| Intended Use | VITEK® 2 AST-Gram NegativeMeropenem is designed forantimicrobial susceptibilitytesting of Gram negative bacilliand is intended for use with theVITEK® 2 and VITEK® 2Compact Systems as a laboratoryaid in the determination of invitro susceptibility toantimicrobial agents. VITEK® 2AST-Gram Negative Meropenemin is a quantitative test.Meropenem has been shown to beactive against most strains of themicroorganisms listed below,according to the FDA label forthis antimicrobial. | VITEK® 2 AST-Gram NegativeEravacycline is designed forantimicrobial susceptibility testingof Gram negative bacilli and isintended for use with the VITEK®2 and VITEK® 2 Compact Systemsas a laboratory aid in thedetermination of in vitrosusceptibility to antimicrobialagents. VITEK® 2 AST-GramNegative Eravacycline is aquantitative test. Eravacycline hasbeen shown to be active againstmost strains of the microorganismslisted below, according to the FDAlabel for this antimicrobial. |
| Item | Device:VITEK® 2 AST-GramNegative Meropenem( $≤0.25 - ≥16$ µg/mL) | Predicate:VITEK® 2 AST-GNEravacycline( $≤ 0.12 - ≥ 4$ µg/mL)(K191766) |
| Similarities | ||
| Active in vitro and in clinical infections:Escherichia coliKlebsiella pneumoniaeProteus mirabilisPseudomonas aeruginosaIn vitro data are available, but clinical significance is unknown:Citrobacter freundiiCitrobacter koseriEnterobacter cloacaeHafnia alveiKlebsiella oxytocaMorganella morganiiSerratia marcescensThe VITEK® 2 Gram Negative Susceptibility Card Meropenem also reports susceptibility for the following additional organisms as listed on the FDA Susceptibility Test Interpretive Criteria website:Acinetobacter sppThe 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. | Active in vitro and in clinical infections:Citrobacter freundiiEnterobacter cloacaeEscherichia coliKlebsiella oxytocaKlebsiella pneumoniaeIn vitro data are available, but clinical significance is unknown:Citrobacter koseriKlebsiella (Enterobacter) aerogenesThe 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. | |
| Item | Device:VITEK® 2 AST-GramNegative Meropenem( $\leq$ 0.25 - $\geq$ 16 µg/mL) | Predicate:VITEK® 2 AST-GNEravacycline( $\leq$ 0.12 - $\geq$ 4 µg/mL)(K191766) |
| Similarities | ||
| Test Methodology | Automated quantitativeantimicrobial susceptibility testfor use with the VITEK® 2 andVITEK® 2 Compact Systems todetermine the in vitrosusceptibility of microorganisms | Same |
| Inoculum | Saline suspension of organism | Same |
| Test Card | Gram Negative (AST-GN)Susceptibility Card | Same |
| Instrument | VITEK® 2 and VITEK® 2Compact Systems | Same |
| Differences | ||
| Antimicrobial Agent | Meropenem | Eravacycline |
| Concentrations | 0.5, 2, 6, 12 | 0.25, 1, 2, 4 |
Table 1: Substantial Equivalence
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F. Intended Use:
VITEK® 2 AST-Gram Negative Meropenem 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 Meropenem in is a quantitative test. Meropenem 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 Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa
In vitro data are available, but clinical significance is unknown:
Citrobacter freundii Citrobacter koseri
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Enterobacter cloacae Hafnia alvei Klebsiella oxytoca Morganella morganii Serratia marcescens
The VITEK® 2 Gram Negative Susceptibility Card Meropenem also reports susceptibility for the following additional organisms as listed on the FDA Susceptibility Test Interpretive Criteria website:
Acinetobacter spp.
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.
G. Performance Overview and Conclusion:
VITEK® 2 AST-GN Meropenem 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 Meropenem. 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 Meropenem by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
The VITEK® 2 AST-GN Meropenem demonstrated acceptable performance as presented in Table 2 below:
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| Table 2: VITEK® 2 AST-GN Meropenem Performance | ||||||||
|---|---|---|---|---|---|---|---|---|
| %EA | VME | ME | mE | %CA | VME | ME | mE | |
| OverallPerformance (withthe referencemethod) | (1016/1070)95.0 | N/A | N/A | N/A | (1016/1070)95.0 | (0/346)0.0 | (4/680)0.6 | (50/1070)4.7 |
| Enterobacterales | (537/569)94.4 | N/A | N/A | N/A | (552/569)97.0 | (0/65)0.0 | (4/491)0.8 | (13/569)2.3 |
| P. aeruginosa | (267/282)94.7 | N/A | N/A | N/A | (253/282)89.7 | (0/121)0.0 | (0/137)0.0 | (29/282)10.3 |
| Acinetobacter spp. | (212/219)96.8 | N/A | N/A | N/A | (211/219)96.3 | (0/160)0.0 | (0/52)0.0 | (8/219)3.7 |
Reproducibility and Quality Control demonstrated acceptable results.
H. 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.
§ 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.”