(62 days)
The MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive staphylococci and enterococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35°C +/- 1°C, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the AST portions can be read visually, according to the Package Insert.
This particular submission is for the addition of the antimicrobial agent Trimethoprim/Sulfamethoxazole, at concentrations of 0.5/9.5 to 8/152 ug/ml, to the test panel.
The gram-positive organisms which may be used for Trimethoprim/Sulfamethoxazole susceptibility testing in this panel are:
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus species - Coagulase Negative
Staphylococcus saprophyticus
MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels, utilizing both the MicroScan® Rapid Fluorogenic Identification and Dried Overnight Antimicrobial Susceptbility Testing (AST) technologies, are designed for use in determining quantitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive staphylococci and enterococci.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. 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 Synergies plus" Pos Broth, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® SI System, or equivalent, for 4.5 - 18 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.
Here's an analysis of the provided text regarding the acceptance criteria and study for the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Trimethoprim/Sulfamethoxazole:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Trimethoprim/Sulfamethoxazole) |
|---|---|
| Overall Essential Agreement with frozen Reference panel | >98% |
| Instrument Reproducibility | Acceptable |
| Quality Control | Acceptable |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a numerical value. The document mentions "fresh and stock Efficacy isolates and stock Challenge strains" were used for external evaluation. It does not provide the total number of isolates or challenge strains.
- Data Provenance: Retrospective, as indicated by the use of "stock Efficacy isolates and stock Challenge strains." The country of origin is not specified but implicitly within the US given the FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not specified. The ground truth (Expected Results) for Challenge strains was "determined prior to the evaluation," implying expert consensus or established references.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The comparison is made against a "CLSI frozen Reference Panel" for the main evaluation and "Expected Results" for challenge strains. This suggests a direct comparison against established standards rather than an adjudication process between multiple readers of the device's results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging or subjective interpretation devices. For a highly automated system like an AST panel, the comparison is typically against a reference method rather than human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, the study evaluates the performance of the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel itself without human interpretation as the primary outcome. The device automatically determines the Minimum Inhibitory Concentration (MIC) for the test organism, and this is then compared to a reference method. While human interaction is involved in setting up the test and reading results, the "performance" described (Essential Agreement, Reproducibility, QC) refers to the device's output.
7. The Type of Ground Truth Used
- Ground Truth Type:
- External Evaluation: "CLSI frozen Reference Panel" for performance comparison, which represents a recognized gold standard for antimicrobial susceptibility testing.
- Challenge Strains: "Expected Results" which were "determined prior to the evaluation," likely based on expert consensus, established reference methods, or known characteristics of the challenge strains.
8. The Sample Size for the Training Set
- Sample Size: Not applicable/not provided. This device is not described as using a machine learning algorithm that requires a "training set" in the traditional sense. It's a chemical and instrumentation-based system that follows established protocols.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable as there is no "training set" for this type of device. The system relies on precise dilutions, reagent reactions, and growth inhibition principles, rather than learning from data.
{0}------------------------------------------------
K05-1350
JUL 25 2005
Page 1 of ___
510(k) Summary
510(k) Submission Information:
| Device Manufacturer: | Dade Behring Inc. |
|---|---|
| Contact name: | Robert Eusebio, Regulatory Affairs Manager |
| Fax: | 916-374-3144 |
| Date prepared: | April 25, 2005 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | New antimicrobial - Trimethoprim/Sulfamethoxazole |
| Predicate device: | MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels and MicroScan® |
| Dried Gram-Positive Panels |
510(k) Summarv:
MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels, utilizing both the MicroScan® Rapid Fluorogenic Identification and Dried Overnight Antimicrobial Susceptbility Testing (AST) technologies, are designed for use in determining quantitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive staphylococci and enterococci.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. 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 Synergies plus" Pos Broth, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® SI System, or equivalent, for 4.5 - 18 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.
The proposed MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel demonstrated substantially equivalent performance when compared with 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. The Premarket Notification (510/k]) presents data in support of the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel with Trimethoprim/Sulfamethoxazole.
The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed Synergies plus " Gram-Positive Panel by comparing its performance with a frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation. The Synergies plus" Gram-Positive Panel demonstrated acceptable performance with an overall Essential Agreement of >98% for Trimethoprim/Sulfamethoxazole when compared with the frozen Reference panel.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision for Trimethoprim/Sulfamethoxazole, with Turbidity inoculum preparation method and the WalkAway® System or equivalent.
Quality Control testing demonstrated acceptable results for Trimethoprim/Sulfamethoxazole.
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
JUL 25 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Robert Eusebio Regulatory Affairs Manager Dade Behring 1584 Enterprise Boulevard West Sacramento, CA 95691-9972
Re: K051350
Trade/Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels Trimethoprim/Sulfamethoxazole (0.5/9.5-8/152 µg/ml) Regulation Number: 21 CFR 866.1645, 866.1640 Regulation Name: Fully automated short-term incubation cycle antimicrobial susceptibility system. Regulatory Class: Class II Product Code: LON, JWY, LRG, LTT Dated: May 19, 2005 Received: June 1, 2005
Dear Mr. Eusebio:
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).
{2}------------------------------------------------
Page 2 -
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,
Sale, a Hory
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
{3}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Trimethoprim/Sulfamethoxazole (0.5/9.5-8/152 µg/ml)
Indications For Use: The MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive staphylococci and enterococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35°C +/- 1°C, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the AST portions can be read visually, according to the Package Insert.
This particular submission is for the addition of the antimicrobial agent Trimethoprim/Sulfamethoxazole, at concentrations of 0.5/9.5 to 8/152 ug/ml, to the test panel.
The gram-positive organisms which may be used for Trimethoprim/Sulfamethoxazole susceptibility testing in this panel are:
Staphylococcus aureus Staphylococcus epidermidis Staphylococcus species - Coagulase Negative Staphylococcus saprophyticus
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)
Concurrent Six Sich Significan In Vitto Diagno Devices (OIVD)
T S 510k a.doc 5/20/2005
Office of In Vitro Diagnostic Device Evaluation and Safety
ko 51350 510(k).
ix
§ 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.”