(326 days)
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No
The device is a standard agar medium used in a manual laboratory procedure (Bauer-Kirby method) for antimicrobial susceptibility testing. The process involves visual measurement of inhibition zones and comparison to predefined standards, with no mention of automated analysis or computational methods that would suggest AI/ML.
No
The device is a laboratory medium used for in vitro susceptibility testing of bacteria, not for treating or diagnosing patients.
Yes
Explanation: The device is used for in vitro antimicrobial disk diffusion susceptibility testing to determine if an organism is susceptible, intermediate, or resistant to an antimicrobial agent, which provides information for diagnosis and treatment.
No
The device is a physical agar medium used for bacterial susceptibility testing, not a software program.
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 product is "intended for in vitro antimicrobial disk diffusion susceptibility testing". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Device Description: The description further elaborates on the use of the agar medium for testing isolated colonies of bacteria, which is a diagnostic procedure performed outside of a living organism.
- Performance Studies: The description of the performance studies details testing conducted on bacterial strains to evaluate the performance of the agar in determining antimicrobial susceptibility. This type of testing is a core function of IVDs used in clinical microbiology laboratories.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K960420) indicates that this device is being compared to a previously cleared device, which is a process specific to medical devices, including IVDs, regulated by bodies like the FDA. The name of the predicate device, "Mueller Hinton Agar with 5% Sheep Blood," is also a type of culture medium commonly used in IVD testing.
The entire context of the document describes a product used to perform a diagnostic test (determining bacterial susceptibility to antimicrobials) outside of the human body, which aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Mueller Hinton Agar is a standard basal medium intended for in vitro antimicrobial disk diffusion susceptibility testing of isolated colonies of common, rapidly growing bacteria by the Bauer-Kirby method as standardized by the Clinical and Laboratory Standards Institute (CLSI). This product has not been evaluated for gradient diffusion testing.
Product codes
JTZ
Device Description
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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
Mueller Hinton Agar was evaluated in a multi-site reproducibility study. Antimicrobial disk diffusion susceptibility testing was conducted, according to the CLSI Performance Standards for Antimicrobial Disk Susceptibility Tests: Approved Standard, M02-A11. Vol. 32, No. 1 at three sites, on three separate days. Six bacterial strains representing Gram negative and Gram positive rapidly growing (non-fastidious) CLSI recommended quality control organisms from American Type Culture Collection (ATCC) were included in the study (Escherichia coli ATCC 25922, Staphylococcus aureus ATCC 25923, Pseudomonas aeruginosa ATCC 27853. Enterococcus faecalis ATCC 29212. Enterococcus faecalis ATCC 51299, and Escherichia coli ATCC 35218). Antimicrobials representing the major drug classes relevant to each organism were included in the study. Testing was conducted in duplicate using two different lots of Mueller Hinton Agar, and antimicrobial disks from two different manufacturers, resulting in a total of 72 results for most organism-antimicrobial combinations. Antimicrobial disks from only one manufacturer were available at the time of testing for Ceftaroline, High Level Gentamicin, High Level Streptomycin, resulting in a total of 36 results for each of these antimicrobials.
The performance of Mueller Hinton Agar was evaluated relative to the acceptable range as indicated in the antimicrobial specific FDA drug label, or CLSI Standards M100-S24 or M02-A11. Acceptable performance for each organism-antimicrobial combination was determined as test results falling within the acceptable range ≥95% of the time.
Escherichia coli ATCC 25922 was tested against 14 antimicrobials. A total of three results were out of expected range. The percent of results within expected range was 99.7% (969/972).
Staphylococcus aureus ATCC 25923 was tested against 10 antimicrobials. A total of four results were out of expected range. The percent of results within expected range was 99.4% (644/648).
Pseudomonas aeruginosa ATCC 27853 was tested against seven antimicrobials. One result was out of expected range. The percent of results within expected range was 99.8% (467/468).
Enterococcus faecalis ATCC 29212 was tested against one antimicrobial. The percent of results within expected range was 100%(72/72).
Enterococcus faecalis ATCC 51299 was tested against three antimicrobials. The percent of results within expected range was 100% (144/144).
Escherichia coli ATCC 35218 was tested against five antimicrobials. The percent of results within expected range was 100% (360/360).
The levels of thymine and thymidine in Mueller Hinton Agar were evaluated by testing Enterococcus faecalis ATCC 29212 with trimethoprim/sulfamethoxazole. The results of the testing of this organism-antimicrobial combination were within range, indicating adequate levels of thymine and thymidine.
The levels of the cations calcium and magnesium in Mueller Hinton Agar were evaluated by testing Pseudomonas aeruginosa ATCC 27853 with the aminoglycosides gentamicin and tobramycin. The results of the testing of these antimicrobials were within range, indicating adequate levels of calcium and magnesium.
Key Metrics
For Escherichia coli ATCC 25922, the percent of results within expected range was 99.7% (969/972).
For Staphylococcus aureus ATCC 25923, the percent of results within expected range was 99.4% (644/648).
For Pseudomonas aeruginosa ATCC 27853, the percent of results within expected range was 99.8% (467/468).
For Enterococcus faecalis ATCC 29212, the percent of results within expected range was 100%(72/72).
For Enterococcus faecalis ATCC 51299, the percent of results within expected range was 100% (144/144).
For Escherichia coli ATCC 35218, the percent of results within expected range was 100% (360/360).
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.1700 Culture medium for antimicrobial susceptibility tests.
(a)
Identification. A culture medium for antimicrobial susceptibility tests is a device intended for medical purposes that consists of any medium capable of supporting the growth of many of the bacterial pathogens that are subject to antimicrobial susceptibility tests. The medium should be free of components known to be antagonistic to the common agents for which susceptibility tests are performed in the treatment of disease.(b)
Classification. Class II (performance standards).
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JUN 3 0 2014
Mueller Hinton Agar
Traditional 510(k) Submission
Edge Biologicals, Inc.
510 (k) SUMMARY
This summary of 510(k) safety and effectiveness is submitted in accordance with the requirements of 21 CRF 807.92
| 510(k) Number: | K132491 |
|---|---|
| Submitter: | Edge Biologicals, Inc. |
| 598 N 2nd Street | |
| Memphis, Tennessee 38105 | |
| Contact Person: | Ted Pearson |
| Telephone: 901-523-0034 | |
| Fax: 901-527-3343 | |
| E-mail: pearson@edgebiological.com | |
| Date Prepared: | May 30, 2014 |
| Trade Name: | Mueller Hinton Agar |
| Common Name: | Mueller Hinton Agar |
| Device Class: | II |
| Classification Name: | 21 CFR 866.1700 |
| Culture Medium for Antimicrobial Susceptibility Tests | |
| Product Code - JTZ | |
| Predicate Device: | Mueller Hinton Agar with 5% Sheep Blood |
| Becton Dickinson (K960420) |
510(k) Summary:
Mueller Hinton Agar is a standard basal medium intended for in vitro antimicrobial disk diffusion susceptibility testing of isolated colonies of common, rapidly growing bacteria
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by the Bauer-Kirby method standardized by the Clinical and Laboratory Standards Institute (CLSI). This product has not been evaluated for gradient diffusion testing.
The Bauer-Kirby procedure is based on the diffusion through an agar gel of antimicrobial substances which are impregnated on sterile paper disks. This method employs disks with a sinqle concentration of antimicrobial agent and zone sizes are correlated with minimum inhibitory concentrations. In the test procedure, a standardized suspension of the organism is swabbed over the entire surface of the agar medium. Sterile paper disks impregnated with specified amounts of antibiotic or other antimicrobial agents are then placed on the surface of the inoculated agar medium. The agar medium is incubated at 35+ 2°C for 16-18 hours. The organism will grow as a solid "lawn". The antimicrobial will diffuse outward (in a circle). If the antimicrobial agent has activity against the organism, a circular zone of growth inhibition will result. The zone of inhibition around the paper disk is measured. A determination as to whether the organism is susceptible, intermediate or resistant to the antimicrobial agent is determined by comparing the size of the zone of inhibition to the zone diameter interpretive criteria in the CLSI M100 Standard.
Summary of Substantial Equivalence Testing:
Mueller Hinton Agar was evaluated in a multi-site reproducibility study. Antimicrobial disk diffusion susceptibility testing was conducted, according to the CLSI Performance Standards for Antimicrobial Disk Susceptibility Tests: Approved Standard, M02-A11. Vol. 32, No. 1 at three sites, on three separate days. Six bacterial strains representing Gram negative and Gram positive rapidly growing (non-fastidious) CLSI recommended quality control organisms from American Type Culture Collection (ATCC) were included in the study (Escherichia coli ATCC 25922, Staphylococcus aureus ATCC 25923, Pseudomonas aeruginosa ATCC 27853. Enterococcus faecalis ATCC 29212. Enterococcus faecalis ATCC 51299, and Escherichia coli ATCC 35218). Antimicrobials representing the major drug classes relevant to each organism were included in the study. Testing was conducted in duplicate using two different lots of Mueller Hinton Agar, and antimicrobial disks from two different manufacturers, resulting in a total of 72 results for most orqanism-antimicrobial combinations. Antimicrobial disks from only one manufacturer were available at the time of testing for Ceftaroline, High Level Gentamicin, High Level Streptomycin, resulting in a total of 36 results for each of these antimicrobials.
The performance of Mueller Hinton Agar was evaluated relative to the acceptable range as indicated in the antimicrobial specific FDA drug label, or CLSI Standards M100-S24 or M02-A11. Acceptable performance for each organism-antimicrobial combination was determined as test results falling within the acceptable range ≥95% of the time.
Escherichia coli ATCC 25922 was tested against 14 antimicrobials. A total of three results were out of expected range. The percent of results within expected range was 99.7% (969/972).
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Staphylococcus aureus ATCC 25923 was tested against 10 antimicrobials. A total of four results were out of expected range. The percent of results within expected range was 99.4% (644/648).
Pseudomonas aeruginosa ATCC 27853 was tested against seven antimicrobials. One result was out of expected range. The percent of results within expected range was 99.8% (467/468).
Enterococcus faecalis ATCC 29212 was tested aqainst one antimicrobial. The percent of results within expected range was 100%(72/72).
Enterococcus faecalis ATCC 51299 was tested against three antimicrobials. The percent of results within expected range was 100% (144/144).
Escherichia coli ATCC 35218 was tested against five antimicrobials. The percent of results within expected range was 100% (360/360).
The levels of thymine and thymidine in Mueller Hinton Agar were evaluated by testing Enterococcus faecalis ATCC 29212 with trimethoprim/sulfamethoxazole. Excess amounts of thymine and thymidine can reverse the inhibitory effect of sulfonamides and trimethoprim, resulting in smaller, less distinct zones of inhibition or no zones at all. The results of the testing of this organism-antimicrobial combination were within range, indicating adequate levels of thymine and thymidine.
The levels of the cations calcium and magnesium in Mueller Hinton Agar were evaluated by testing Pseudomonas aeruginosa ATCC 27853 with the aminoglycosides gentamicin and tobramycin. Excess cation content results in reduced zone sizes, whereas low cation content results in unacceptably large zone sizes. The results of the testing of these antimicrobials were within range, indicating adequate levels of calcium and magnesium.
The results of the study for each organism-antimicrobial combination, were within acceptable range ≥95% of the time. This demonstrates that Mueller Hinton Agar is substantially equivalent to similar medium already in commercial distribution.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
EDGE BIOLOGICALS, INCORPORATED TED PEARSON QUALITY ASSURANCE DIRECTOR 589 N 2ND STREET MEMPHIS TN 38105
June 30, 2014
Re: K132491
Trade/Device Name: Mueller Hinton Agar Regulation Number: 21 CFR 866.1700 Regulation Name: Culture medium for antimicrobial susceptibility tests Regulatory Class: II Product Code: JTZ Dated: June 12, 2014 Received: June 13, 2014
Dear Mr. Pearson:
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. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Mr. Pearson
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Uwe Scherf -S for
Sally A. Hojvat Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K132491
Device Name: Mueller Hinton Agar
Indications for Use:
Mueller Hinton Agar is a standard basal medium intended for in vitro antimicrobial disk diffusion susceptibility testing of isolated colonies of common, rapidly growing bacteria by the Bauer-Kirby method as standardized by the Clinical and Laboratory Standards Institute (CLSI). This product has not been evaluated for gradient diffusion testing.
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)
Concurrence of Center for Devices and Radiological Health (CDRH)
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