(54 days)
Remel RPMI 1640 Agar w/ MOPS and 2% Glucose is a solid medium recommended for use with antibiotic gradient-based systems for quantitative determination of susceptibility to antifungal agents when testing Candida spp. directly from colonies grown on nonselective media.
RPMI-1640 was developed by Moore et al. at Roswell Park Memorial Institute. The formulation is based on the RPMI- 1630 series of media utilizing a bicarbonate buffering system and alterations in the amounts of amino acids and vitamins. RPMI-1640 medium has demonstrated wide applicability in cell culture and also as the reference method for antifungal broth microdilution recommended by Clinical Laboratory Standards Institute (CLSI). When properly supplemented with MOPS, glucose, and agar RPMI-1640 has demonstrated accuracy for use with gradient-based systems with results comparable to that obtained with the CLSI reference method for testing Candida spp. against antifungal agents. The gradient method is based on a combination of the concepts of both dilution and diffusion tests, but differs from conventional disk methods by the use of a preformed, stable antibiotic gradient strip. When the strip is applied to the inoculated agar plate, there is an immediate release of the antibiotic into the agar matrix. A continuous and exponential gradient of antibiotic concentration is created beneath the carrier. After incubation a symmetrical inhibition ellipse centered along the carrier is seen. The zone edge intersects the strip at the minimum inhibitory concentration (MIC) value given in ug/ml. For antifungal testing, due to trailing effect, MICs should be read at approximately 90% inhibition of growth, ignoring faint hazes and minute colonies for flucytosine and 80% inhibition for fluconazole and itraconazole.
The provided document describes a 510(k) premarket notification for a culture medium (Remel RPMI 1640 Agar w/ MOPS and 2% Glucose) used for antifungal susceptibility testing. It is a submission for a new in-vitro diagnostic device, not an AI/ML powered medical device. Therefore, much of the requested information (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) is not applicable or cannot be extracted from this type of document, as it pertains to AI/ML device evaluation.
However, I can extract information related to the device's intended use and comparison to a predicate device, which implicitly defines its acceptance criteria in the context of a 510(k) submission (i.e., substantial equivalence to the predicate).
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (culture medium), "acceptance criteria" are implied by demonstrating substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device performs similarly in its intended application. The document focuses on comparing the characteristics of the new device to its predicate.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Remel RPMI 1640 Agar w/ MOPS and 2% Glucose) |
|---|---|---|
| Intended Use | Quantitative determination of susceptibility to methicillin and oxacillin when testing staphylococci directly from colonies grown on nonselective media, using antibiotic gradient-based systems. (Predicate: Mueller Hinton Agar w/ 2% NaCl) | Quantitative determination of susceptibility to antifungal agents when testing Candida spp. directly from colonies grown on nonselective media, using antibiotic gradient-based systems. (Device: RPMI 1640 Agar w/ MOPS and 2% Glucose) |
| Incubation | 35° C (Predicate) | 35° C (Device) |
| Inoculation | Staphylococcus spp. (Predicate) | Candida spp. (Device) |
| Technology | To be used with predefined and preformed oxacillin gradient on a plastic strip. (Predicate) | To be used with predefined and preformed antifungal gradient on a plastic strip. Single antifungal agent per strip. (Device) |
| Interpretation | MIC is read at the end point where there is complete inhibition. (Predicate) | MICs should be read at approximately 90% inhibition of growth ignoring faint hazes and minute colonies for Flucytosine and 80% inhibition for Fluconazole and Itraconazole. (Device) |
| Key Performance | The 510(k) summary states, "When properly supplemented with MOPS, glucose, and agar RPMI-1640 has demonstrated accuracy for use with gradient-based systems with results comparable to that obtained with the CLSI reference method for testing Candida spp. against antifungal agents." | The 510(k) summary states, "When properly supplemented with MOPS, glucose, and agar RPMI-1640 has demonstrated accuracy for use with gradient-based systems with results comparable to that obtained with the CLSI reference method for testing Candida spp. against antifungal agents." |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" sample size in the context of AI/ML evaluation. It mentions "results comparable to that obtained with the CLSI reference method," implying that studies were conducted to compare the device's performance against a recognized standard using relevant microbial strains and antifungal agents. However, specific numbers of isolates, data origin (country), or whether the data was retrospective or prospective are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The "ground truth" for this type of device would typically be established by established microbiological methods (e.g., CLSI reference method) and not by expert human graders of images or features.
4. Adjudication method for the test set
This information is not applicable and not provided.
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
This is not an AI/ML powered device, so an MRMC study related to AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an AI/ML powered device, so standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for evaluating the performance of this culture medium would be the Minimum Inhibitory Concentration (MIC) values determined by a Clinical and Laboratory Standards Institute (CLSI) reference method. The submission explicitly states the device's results are "comparable to that obtained with the CLSI reference method."
8. The sample size for the training set
This is not an AI/ML powered device, so a "training set" in that context is not applicable.
9. How the ground truth for the training set was established
This is not an AI/ML powered device, so "ground truth for the training set" is not applicable.
Summary of the Study Proving Acceptance Criteria:
The document indicates that the device's performance was evaluated by comparing its results to those obtained with the CLSI reference method for antifungal susceptibility testing of Candida spp. against antifungal agents. This comparison demonstrated "accuracy for use with gradient-based systems with results comparable" to the CLSI reference method. While specific study details (like sample size numbers, statistical methods, or full data tables) are not provided in this 510(k) summary, the statement about comparability to the CLSI reference method is the core evidence presented to establish substantial equivalence and thus, acceptance. The "acceptance criteria" were met by demonstrating that the new culture medium provides reliable and comparable MIC results when used with antibiotic gradient-based systems for Candida spp. as per established microbiological standards.
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510(k) SUMMARY
| Contact Information: | Andre HsiungTechnical Projects ManagerRemel Inc.Thermo Fisher Scientific12076 Santa Fe DriveLenexa, KS 66215Phone: (913) 895-4264Fax: (913) 895-4264email: andre.hsiung@thermofisher.com | |
|---|---|---|
| Date Prepared: | July 14, 2007 | NOV 2 6 2007 |
| Device Trade Name: | RPMI 1640 Agar w/ MOPS and 2% Glucose | |
| Predicate Device: | Mueller Hinton Agar w/ 2% NaCl | |
| Device Classification: | 21 CFR 866.1700; Culture medium for antimicrobialsusceptibility tests | |
| Intended Use: | Remel RPMI 1640 Agar w/ MOPS and 2% Glucose is a solidmedium recommended for use with antibiotic gradient-basedsystems for quantitative determination of susceptibility toantifungal agents when testing Candida spp. directly fromcolonies grown on nonselective media. | |
| Device Description: | RPMI-1640 was developed by Moore et al. at Roswell ParkMemorial Institute. The formulation is based on the RPMI-1630 series of media utilizing a bicarbonate buffering systemand alterations in the amounts of amino acids and vitamins.RPMI-1640 medium has demonstrated wide applicability incell culture and also as the reference method for antifungalbroth microdilution recommended by Clinical LaboratoryStandards Institute (CLSI). When properly supplementedwith MOPS, glucose, and agar RPMI-1640 hasdemonstrated accuracy for use with gradient-based systemswith results comparable to that obtained with the CLSIreference method for testing Candida spp. against antifungalagents.The gradient method is based on a combination of theconcepts of both dilution and diffusion tests, but differs fromconventional disk methods by the use of a preformed, stableantibiotic gradient strip. When the strip is applied to theinoculated agar plate, there is an immediate release of the | |
| Characteristic | Device | Predicate |
| Intended Use | Remel's RPMI 1640 Agar w/ MOPS and 2%Glucose is a solid medium recommended for usewith antibiotic gradient-based systems forquantitative determination of susceptibility toantifungal agents when testing Candida spp.directly from colonies grown on nonselectivemedia. | Remel's Mueller Hinton Agar w/ 2% NaCl isa solid medium recommended for use withantibiotic gradient-based systems forquantitativedetermination of susceptibility to methicillinand oxacillin when testing staphylococcidirectly from colonies grown on nonselectivemedia. |
| Incubation | 35° C | 35° C |
| Inoculation | Candida spp. | Staphylococcus spp. |
| Technology | To be used with predefined and preformedantifungal gradient on a plastic strip. Singleantifungal agent per strip. | To be used with predefined and preformedoxacillin gradient on a plastic strip |
| Interpretation | MICs should be read at approximately 90%inhibition of growth ignoring faint hazes andminute colonies for Flucytosine and 80% inhibitionfor Fluconazole and Itraconazole. | MIC is read at the end point where there iscomplete inhibition |
, ,
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antibiotic into the agar matrix. A continuous and exponential gradient of antibiotic concentration is created beneath the carrier. After incubation a symmetrical inhibition ellipse centered along the carrier is seen. The zone edge intersects the strip at the minimum inhibitory concentration (MIC) value given in ug/ml. For antifungal testing, due to trailing effect, MICs should be read at approximately 90% inhibition of growth, ignoring faint hazes and minute colonies for flucytosine and 80% inhibition for fluconazole and itraconazole.
Device Comparison:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administratio 2098 Gaither Road Rockville MD 20850
NOV 2 6 2007
Mr. Andre Hsiung Technical Project Manager Remel Inc. Thermo Fisher Scientific 12076 Santa Fe Drive Lenexa, KS 66215
Re: K072827
Trade/Device Name: RPMI 1640Agar w/ MOPS and 2% Glucose Regulation Number: 21 CFR 866.1700 Regulation Name: Culture medium for antimicrobial susceptibility test Regulatory Class: Class II Product Code: MJE Dated: October 1, 2007 Received: October 3, 2007
Dear Mr. Hsiung:
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).
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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 advice for your device on our labeling regulation (21 CFR Part 801), 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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally attaym
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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Indications for Use
510(k) Number (if known): K072827
Device Name: RPMI 1640 Agar w/ MOPS and 2% Glucose
Indications For Use: Remel RPMI 1640 Agar w/ MOPS and 2% Glucose is a plated medium recommended for use with antibiotic gradient-based systems for quantitative determination of susceptibility to antifungal agents when testing Candida spp. directly from colonies grown on nonselective media.
× Prescription Use (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 CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Eudette Poole
Division Sign-Off
Division Sign-Off
Page 1 of
Office of In Vitro Diagnostic Device Evaluation and Safety
07282 510(k).
§ 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).