(22 days)
To determine bacterial antimicrobial agent susceptibility
The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument.
This particular submission is for the addition of instrument read capability of the antimicrobial Clindamycin, at concentrations of 0.015 to 2 mcg/ml on the MicroScan MICroSTREP plus® Panel and the removal of the "Do not report" for S. pneumoniae.
The organisms which may be used for Clindamycin susceptibility testing on this panel are:
Streptococci Streptococcus pneumoniae
The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 – 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read according to the Package Insert.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument.
The provided text describes a 510(k) premarket notification for a medical device called the MicroScan MICroSTREP plus® Panel, specifically focusing on its ability to determine bacterial susceptibility to Clindamycin. The submission aims to add instrument-read capability for Clindamycin and remove a "Do not report" limitation for Streptococcus pneumoniae.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Essential Agreement (EA) | Overall EA ≥ 95.7% for Clindamycin compared with the Expected Result, including S. pneumoniae. | Achieved: "The MICroSTREP plus® Panel demonstrated acceptable performance with an overall Essential Agreement of ≥95.7% for Clindamycin compared with the Expected Result including S. pneumoniae." |
| Instrument Reproducibility | Acceptable reproducibility and precision with Clindamycin and the WalkAway® instrument. | Achieved: "Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Clindamycin and the WalkAway® instrument." |
| Quality Control (QC) | Acceptable results for Clindamycin. | Achieved: "Quality Control testing demonstrated acceptable results for Clindamycin." |
| Substantial Equivalence | Demonstrated substantially equivalent performance with streptococcal isolates when compared with an expected result generated on a CLSI frozen Reference Panel, as defined in FDA guidance document. | Achieved: "The proposed instrument read method for the MicroScan MICroSTREP plus® Panel demonstrated substantially equivalent performance with streptococcal isolates when compared with an expected result generated on a CLSI frozen Reference Panel, as defined in the FDA document 'Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA', dated February 5, 2003." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample size for the external evaluations, but it mentions a test set consisting of:
- CDC Challenge strains: Used to confirm the acceptability of the instrument read method.
- Fresh and stock isolates: Used from the original external design validation of the manual method to support removing the "Do not report" limitation for S. pneumoniae.
The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective in a sense that it uses "fresh and stock isolates" from a previous validation, but also likely includes prospective data for the specific instrument-read capability evaluation. Given the context of FDA submission, the data likely originates from studies conducted or overseen in the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish the ground truth. It refers to an "Expected Result generated on a CLSI frozen Reference Panel" and "Expected Results determined before the evaluation." This implies that the ground truth was established by recognized reference methods and possibly validated expert consensus according to CLSI guidelines, but the specific individuals are not mentioned.
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). The comparison is made against an "Expected Result," which implies a pre-established ground truth rather than a process of adjudicating discrepancies among multiple expert readers for the purpose of the study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study's focus is on comparing the device's performance (instrument-read method vs. expected reference result) rather than evaluating how human readers' performance changes with or without AI assistance. This is a standalone device validation, not a human-in-the-loop clinical efficacy study in that specific MRMC sense.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone study was done. The entire evaluation focuses on the MicroScan® WalkAway instrument's ability (the "algorithm/instrument only") to read the MICroSTREP plus® Panel accurately for Clindamycin. The phrase "proposed instrument read method" and the comparison to an "Expected Result" highlights this standalone performance assessment. While the panels can be "read manually," the study specifically validates the instrument-read capability.
7. The Type of Ground Truth Used
The ground truth used is primarily based on an "Expected Result generated on a CLSI frozen Reference Panel" and "Expected Results determined before the evaluation." This implies a highly standardized and validated laboratory reference method, likely aligned with Clinical and Laboratory Standards Institute (CLSI) guidelines, which is considered a gold standard for antimicrobial susceptibility testing.
8. The Sample Size for the Training Set
The document does not explicitly state the sample size for a "training set." This type of device (an AST panel read by an instrument) is typically validated against reference methods for its performance rather than trained like a machine learning algorithm. The "CDC Challenge strains" and "fresh and stock isolates" serve as the test data for validation, not a training set in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
As there is no explicit mention of a 'training set' in the context of a machine learning model, the question of establishing its ground truth is not directly applicable. The "Expected Result" from the CLSI frozen Reference Panel and other pre-determined expected results serve as the benchmark for evaluation, not as ground truth for training an algorithm in a supervised learning paradigm. The instrument's reading mechanism is likely based on optical detection and pre-programmed algorithms designed to interpret growth patterns, rather than being "trained" on a large dataset in the modern AI sense.
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(06277)
OCT 1 U 2006
510(k) Summary Information:
| Device Manufacturer: | Dade Behring Inc. |
|---|---|
| Contact name: | Maureen Mende, Regulatory Affairs Group Manager |
| Phone/Fax: | 916-374-3174/916-374-3144 |
| Date prepared: | August 28, 2006 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan MICroSTREP plus® Panel |
| Intended Use: | To determine bacterial susceptibility to Clindamycin |
| Indication for Use: | For determining antimicrobic susceptibility with aerobic |
| streptococci including Streptococcus pneumoniae | |
| Predicate device: | MicroScan® MICroSTREP plus® Panel |
510(k) Summary:
The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 – 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read according to the Package Insert.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument.
The proposed instrument read method for the MicroScan MICroSTREP plus® Panel demonstrated substantially equivalent performance with streptococcal isolates when compared with an expected result generated on a CLSI frozen Reference Panel, as defined in the FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated February 5, 2003.
This Premarket Notification (510[k]) presents data in support of reading the MICroSTREP plus® Panel with Clindamycin on the MicroScan® WalkAway instrument.
The external evaluations conducted with CDC Challenge strains were designed to confirm the acceptability of the proposed instrument read method for the MICroSTREP plus® Panel by comparing its performance with Expected Results determined before the evaluation.
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In addition, data on fresh and stock isolates is presented from the original external design validation of the manual method to support removing the "Do not report" limitation for S. pneumoniae with Clindamycin.
The MICroSTREP plus® Panel demonstrated acceptable performance with an overall Essential Agreement of ≥95.7% for Clindamycin compared with the Expected Result including S. pneumoniae.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Clindamycin and the WalkAway® instrument.
Quality Control testing demonstrated acceptable results for Clindamycin.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Maureen Mende Regulatory Affairs Group Manager Dade Behring, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691-9972
Re: K062777
Trade/Device Name: MicroScan MICroSTREP plus® Panel Clindamycin (0.015 to 2 mcg/ml) Regulation Number: 21 CFR § 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: LRG, LTT Dated: August 28, 2006 Received: September 18, 2006
Dear Ms. Mende:
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.
OCT 1 0 2006
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)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours.
Sally, attorn
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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Indication for Use Statement
510(k) No .:
(To be assigned by FDA)
062777
MicroScan MICroSTREP plus® Panel Clindamycin (0.015 to 2 mcg/ml)
Intended Use
Indications for Use:
Device Name:
To determine bacterial antimicrobial agent susceptibility
The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument.
This particular submission is for the addition of instrument read capability of the antimicrobial Clindamycin, at concentrations of 0.015 to 2 mcg/ml on the MicroScan MICroSTREP plus® Panel and the removal of the "Do not report" for S. pneumoniae.
The organisms which may be used for Clindamycin susceptibility testing on this panel are:
Streptococci Streptococcus pneumoniae
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
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Office of In Vitro Diagnostic Device Evaluation and Salery
510(k) K062777
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§ 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).