(98 days)
InTray GC is used, like conventional Thayer-Martin media plates, to grow Neisseria gonomhoeae and similar organisms.
The InTray GC contains a Modified Thayer-Martin (MTM) medium within a sealed inner well. It has a two inch diameter well and 5-6ml of media. The inner seal that covers this well also covers another sealed cavity containing a CO2 generating tablet. There is also an outer adhesive label seal with a window that does not fog up under 100% relative humidity. The user opens and reseals this outer label. In practice, when the user opens the outer seal, he may then remove and discard the inner seal exposing the surface of the medium and the sealed cavity. The next step is to inoculate the surface of the medium with the patient sample. Next, puncture the seal over the cavity with any convenient sharp point. Finally, reseal the outer label over the InTray. High humidity within the InTray causes the tablet to generate CO2. Incubate the InTray and observe the growth of organisms through the window without opening the InTray and therefore without disturbing the atmosphere. Observation can be by eye, hand lens or microscope. This packaging has been used since 1994 for other BioMed media products.
The provided text describes a 510(k) premarket approval for the BioMed Diagnostics Incorporated's InTray GC for the isolation of pathogenic Neisseria. The submission details both laboratory and clinical studies to demonstrate its performance.
Here's an analysis of the acceptance criteria and study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The text does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for sensitivity, specificity, or colony counts. However, the study aims to demonstrate that InTray GC performs comparably to or better than existing commercial media. The implicit acceptance criteria appear to be:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Laboratory Study: | |
| Ability to recover N. gonorrhoeae | - For two N. gonorrhoeae strains, recovered colony counts were comparable to fresh commercially prepared media. - For the other two N. gonorrhoeae strains, colony counts were about half compared to fresh commercial media. - In no case was there failure to recover the organism. |
| Suppression of competing organisms (e.g., N. sicca, E. coli, S. epidermidis, P. mirabilis, C. albicans) | - After one year at room temperature, the InTray GC was superior to fresh commercial media in suppressing growth of these organisms. |
| Shelf life | - Demonstrated performance after "one year at room temperature." (Superior in suppressing contaminants after one year at room temperature. Implied adequate for N. gonorrhoeae recovery after one year as well, as tested.) |
| Clinical Study: | |
| Agreement with commercially prepared media for N. gonorrhoeae detection | - Results positive for N. gonorrhoeae were identical to those for commercially prepared media: 18 positive, 210 negative. |
| Reduction of contaminants (clinical samples) | - The principal contaminant was C. albicans. - 17 positive for the InTray GC (for C. albicans) - 30 positive with the comparison MTM medium (for C. albicans). - This indicates superiority of InTray GC in suppressing C. albicans in a clinical setting. |
| Safety (no adverse indications) | - There were no adverse indications in these tests. |
2. Sample Size Used for the Test Set and Data Provenance
-
Laboratory Study:
- Test Set Organisms: Pure cultures of four strains of N. gonorrhoeae (including NCCLS standard strain and an AHU auxotype) and several competing organisms (N. sicca, E. coli, S. epidermidis, P. mirabilis, C. albicans).
- Sample Size: Not explicitly stated as a number of distinct samples for each culture, but described as tests performed using "pure cultures at 10^2 cfu for each of four strains of N. gonorrhoeae and at 10^5 cfu for competing organisms." It also mentions "two one-year studies." This implies multiple tests over time for each organism.
- Data Provenance: The N. gonorrhoeae strains were drawn from a "world-wide data base." The study was performed "in the laboratory."
- Retrospective/Prospective: The laboratory studies sound prospective in design, carefully controlled experiments designed to test the media's performance over one year.
-
Clinical Study:
- Test Set Sample Size: 228 female patients.
- Data Provenance: Clinical study using cervical swabs. The country of origin is not specified, but typically for 510(k) submissions, clinical data is often from the US or a region with comparable medical standards.
- Retrospective/Prospective: This was a prospective clinical study, comparing the InTray GC to commercially prepared media.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide details about experts for establishing ground truth in the traditional sense of consensus or adjudication for image-based or diagnostic interpretation.
- For the laboratory study, the "ground truth" for organism identification and colony counts would have been established by standard microbiological methods, likely performed by trained microbiologists.
- For the clinical study, the "ground truth" for N. gonorrhoeae positivity and the presence of C. albicans would have been established by the comparison to "commercially prepared media," which serves as the reference standard in this context. It's implied that clinical laboratory personnel would have read these results, but their qualifications are not specified.
4. Adjudication Method for the Test Set
Not applicable. This device is a culture medium, and the "ground truth" is determined by the growth or non-growth of specific organisms, not by interpretive reads that would require adjudication among experts. The comparison is directly to a reference method (commercial media).
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
Not applicable. This is not an AI-assisted diagnostic device, nor is it an imaging device requiring human reader interpretation in the context of an MRMC study. It's a culture medium.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a culture medium, not an algorithm. Its performance is inherent to the medium itself.
7. The Type of Ground Truth Used
- Laboratory Study: Microbiological culture standards (known pure cultures at specific CFUs), and comparison to fresh commercial MTM and chocolate media.
- Clinical Study: Comparison to "commercially prepared media" (presumably reference MTM or other standard culture methods for N. gonorrhoeae). The results were compared for agreement on positive and negative cases.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a distinct training set. The "training" for such a product would be its development and formulation, not data feeding to an algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm.
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510(k) Summary
BioMed Diagnostics Incorporated has gought premarket approval for its proprietary InTrayTM GC packaging of MTM media for isolation of pathogenic Neisseria, (83JTY).
Classification Name:
Culture Medium, for isolation of pathogenic Neisseria, (83JTY) .
Common/Usual Name: Gonorrhoea isolation medium.
Trade/Proprietary Name: InTrayTM GC
The InTray GC contains a Modified Thayer-Martin (MTM) medium within a sealed inner well. It has a two inch
diameter well and 5-6ml of media. The inner seal that covers this well also covers another sealed cavity containing a CO2 generating tablet. There is also an outer adhesive label seal with a window that does not fog up under 100% relative humidity. The user opens and reseals this outer label. In practice, when the user opens the outer seal, he may then remove and discard the inner seal exposing the surface of the medium and the sealed cavity. The next step is to inoculate the surface of the medium with the patient sample. Next, puncture the seal over the cavity with any convenient sharp point. Finally, reseal the outer label over the InTray. High humidity within the InTray causes the tablet to generate · CO2. Incubate the InTray and observe the growth of organisms through the window without opening the InTray and therefore without disturbing the atmosphere. Observation can be by eye, hand lens or microscope. This packaging has been used since 1994 for other BioMed media products.
Two one year studies were performed comparing the performance of room temperature stored InTray GC against fresh commercial MTM and chocolate media. Tests were performed in the laboratory using pure cultures at 102 cfu for each of four strains of N. gonorrhoeae and at 105 cfu for competing organisms. The four strains of N. gonorrhoeae included the NCCLS standard strain and three others drawn from a world wide data base. One of them was an AHU auxotype known to be difficult to grow. For two of the strains, recovered colony counts were comparable to fresh commercially prepared media. For the other two, colony counts were about half compared to fresh commercial media. In no case was there failure to recover the organism.
1430 Koll Circle, Suite 101, San Jose, CA 95112 • Tel (408) 451-0400 • Fax (408) 451-0409
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The potential contaminants that were tested include N. sicca, E. coli, S. epidermidis, P. mirabilis and C. albicans. After one year at room temperature, the InTray GC was superior to fresh commercial media in suppressing growth of these organisms.
A clinical study was performed with 228 female patients using cervical swabs. Results positive for N. gonorrhoeae were identical to those for commercially prepared media, 18 positive, 210 negative. The principal contaminant was C. albicans with 17 positive for the InTray GC and 30 positive with the comparison MTM medium. There were no adverse indications in these tests.
In conclusion, the laboratory tests established the presumption of effectiveness and safety which was borne out by the clinical testing. The evidence indicates that InTray GC is superior for shelf life, ease of observation and suppression of C. albicans.
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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 is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures. The symbol is composed of three wavy lines.
DEC 1 6 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Robert D. Hall President BioMed Diagnostics, Inc. 1430 Koll Circle, Suite 101 San Jose, California 95112
Re: K993033 Trade Name: InTray™ GC Regulatory Class: II Product Code: JTY Dated: September 3, 1999 Received: November 23, 1999
Dear Mr. Hall:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K993033
Device Name: InTray™ GC
Indications For Use:
InTray GC is used, like conventional Thayer-Martin media plates, to grow Neisseria gonomhoeae and similar organisms.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Dubocs
n of Clinical Laboratory Devices K44303 510(k) Number
Prescription Use_Y (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 866.2410 Culture medium for pathogenic
Neisseria spp.(a)
Identification. A culture medium for pathogenicNeisseria spp. is a device that consists primarily of liquid or solid biological materials used to cultivate and identify pathogenicNeisseria spp. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusNeisseria, such as epidemic cerebrospinal meningitis, other meningococcal disease, and gonorrhea, and also provides epidemiological information on these microorganisms.(b)
Classification. Class II (performance standards).