(98 days)
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No
The device description and performance studies focus on a traditional culture medium and its packaging, with no mention of AI or ML for analysis or interpretation.
No
The device is used to grow Neisseria gonorrhoeae and similar organisms for diagnostic purposes, not to treat a condition.
Yes
The device is used to grow Neisseria gonomhoeae from patient samples, which subsequently allows for the observation of organism growth. This process aids in the identification of the causative agent of an infection, thus making it a diagnostic device.
No
The device description clearly details a physical product containing media, a sealed well, a CO2 generating tablet, and an outer seal with a window. This is a hardware-based medical device for culturing bacteria.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "grow Neisseria gonomhoeae and similar organisms." This is a diagnostic purpose, as growing and identifying these organisms is a key step in diagnosing infections.
- Device Description: The device contains a culture medium (Modified Thayer-Martin) and is designed to be inoculated with a "patient sample" (cervical swabs). This is a typical setup for in vitro diagnostic tests that involve culturing microorganisms from patient specimens.
- Performance Studies: The document describes both laboratory studies using pure cultures and a clinical study using patient samples (cervical swabs) to evaluate the device's performance in detecting N. gonorrhoeae. These types of studies are conducted to demonstrate the diagnostic accuracy of an IVD.
- Clinical Study Results: The clinical study results compare the device's performance to commercially prepared media in identifying positive and negative cases of N. gonorrhoeae from patient samples. This directly relates to the diagnostic capability of the device.
The device is used in vitro (outside the body) to analyze a patient sample for the presence of specific microorganisms, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
InTray GC is used, like conventional Thayer-Martin media plates, to grow Neisseria gonomhoeae and similar organisms.
Product codes (comma separated list FDA assigned to the subject device)
JTY
Device Description
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.
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
cervical swabs
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 10^2 cfu for each of four strains of N. gonorrhoeae and at 10^5 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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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)