(365 days)
BACTEC 13A MYCOBACTERIA CULTURE MEDIUM, BACTEC NR FUNGAL CULTURE MEDIUM, AND ISOLATOR™ SYSTEM
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No
The device description and performance studies focus on the culture medium and the instrument's ability to detect oxygen changes, not on AI/ML for analysis or interpretation. There are no mentions of AI, DNN, or ML, nor descriptions of training or test sets for such algorithms.
No.
The device is intended for the detection and recovery of mycobacteria, yeast, and fungi from blood and sterile body fluids, which is a diagnostic purpose, not a therapeutic one.
Yes
Explanation: The BACTEC® MYCO/F Lytic culture vials are used as an "adjunct to routine blood culture for patients suspected of having mycobacteria, yeast and fungi septicemia," and for the "culture of sterile body fluids when yeast or fungi are suspected." This indicates its role in identifying the presence of specific microorganisms, which is a key function of a diagnostic device.
No
The device description clearly states it is a culture medium (a physical substance) and a vial containing a sensor, which are hardware components. While it interacts with instrumentation, the device itself is not solely software.
Based on the provided information, the BACTEC® MYCO/F Lytic culture vials are an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used "as an adjunct to routine blood culture for patients suspected of having mycobacteria, yeast and fungi septicemia." This indicates it's used to diagnose or aid in the diagnosis of these conditions.
- Device Description: The description details a culture medium and a sensor that detects changes in the vial resulting from microorganism growth. This process is performed in vitro (outside the body) to identify the presence of microorganisms.
- Anatomical Site: The specimens used are "Blood, other sterile body fluids," which are collected from the patient and tested in vitro.
- Performance Studies: The document describes performance studies evaluating the device's ability to recover and detect microorganisms from these specimens, which is a standard practice for IVDs.
The device is designed to be used in vitro to examine specimens from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
MYCO/F LYTIC culture medium when used with the BACTEC 9000 Blood Culture Series of instruments is a non-selective culture medium to be used as an adjunct to aerobic blood culture media for the recovery of mycobacteria, yeast and fungi. This media may also be used for the culture of sterile body fluids when yeast or fungi are suspected.
The BACTEC® MYCO/F Lytic culture vials when used with the 9000 Blood Culture series of instrumentation are intended as an adjunct to routine blood culture for patients suspected of having mycobacteria, yeast and fungi septicemia. Extended incubation times (7 days for yeast, 30 days for fungi, and 42 days for mycobacteria) will permit recovery of mycobacteria and fungi when more rapidly growing organisms are not present. This medium may also be used for the culture of sterile body fluids when yeast or fungi are suspected.
Product codes (comma separated list FDA assigned to the subject device)
MDB
Device Description
BACTEC MYCO/F LYTIC Culture medium is a Middlebrook 7H9 and Brain Heart Infusion broth formulation for the recovery of mycobacteria from blood specimens and fungi from blood and sterile body fluids. The range of specimen volume which can be cultured is one to five mL. with optimum recovery obtained at three to five mL. Specific modifications were made to enhance the growth and recovery of mycobacteria, veast, and fungi. These modifications include ferric ammonium citrate to provide an iron source for specific strains of mycobacteria and fungi, the addition of saponin as a blood lysing agent and the addition of specific proteins and sugars to provide nutritional supplements. Each vial contains a sensor which can detect decreases in oxygen concentration in the vial resulting from microorganism and growth. The sensor is monitored by the BACTEC 9000 Blood Culture Systems for increasing fluorescence which is proportional to the decrease in oxygen. A positive determination indicates the presumptive presence of viable microorganisms in the vial.
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
Blood, sterile body fluids
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Internal Performance:
A study was conducted to evaluate the recovery and time to detection (TTD) of a variety of yeast and fungi species at different CFU levels and specimen volumes between BACTEC NR FUNGAL Culture medium and BACTEC MYCO/F LYTIC Culture medium.
A study was conducted to evaluate the recovery and time to detection of a variety of mycobacteria at different CFU levels and specimen volumes with BACTEC MYCO/F LYTIC Culture medium.
Clinical Performance:
The BACTEC MYCO/F Lytic medium was evaluated with the BACTEC 9240 instrument at two clinical sites considered large tertiary care teaching hospitals in geographically diverse areas. The site populations included patients infected with HIV. immunocompromised patients. transplant patients, and patients suspected of a mycobacterial infection. The BACTEC MYCO/F Lytic medium was compared to the BACTEC 13A medium for the recovery and detection of mycobacteria from blood. A total of 1,100 blood culture specimens were tested during the evaluation.
The BACTEC MYCO/F LYTIC medium was evaluated with the BACTEC 9240 instrument at four clinical sites considered large tertiary care teaching hospitals. The site populations included patients infected with HIV, immunocompromised patients, transplant patients, and patients suspected of a fungal infection. The BACTEC MYCO/F LYTIC medium was compared to the ISOLATOR™ System (Wampole Laboratories, Cranbrook, NJ) for the recovery and detection of yeast and fungi from blood. MYCO/F LYTIC vials were inoculated with 1-5 mL of blood and ISOLATOR tubes were inoculated with 3-10 mL of blood. The ISOLATOR sediment was plated to Chocolate Agar, Brain Heart Infusion Agar with 5% sheep blood, and Sabaraud Dextrose Agar. A total of 748 specimens were tested during the evaluation.
One thousand four hundred eighty-eight (1,488) blood cultures obtained from patients suspected of mycobacterial, yeast or fungal infections were evaluated in the BACTEC MYCO/F LYTIC culture vial with the BACTEC 9240 Blood Culture System.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Internal Performance:
Study Type: Performance evaluation comparing BACTEC MYCO/F LYTIC Culture medium with BACTEC NR FUNGAL Culture medium and BACTEC 13A Mycobacteria culture medium.
Sample Size: Not explicitly stated in terms of number of vials, but defined by CFU levels and specimen volumes (0 mL, 1 mL, 5 mL blood for fungi; 1 mL, 3 mL, 5 mL blood for mycobacteria).
Key Results:
- Recovery of Histoplasma capsulatum and Malesezzia furfur with BACTEC MYCO/F LYTIC culture medium demonstrated improved recovery compared to the BACTEC NR FUNGAL Culture medium.
- Pencillium purpurescens and Blastomvees dermatitidis were not detectable in the BACTEC MYCO/F LYTIC culture medium for some conditions.
- Hansenula anomala, Exophiala jeamselmei, Actinomvces bovis, Rhodotorula rubra, and Mucor ramosissimus exhibited inconsistent results at low inoculum levels (
§ 866.2560 Microbial growth monitor.
(a)
Identification. A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended in a liquid medium by measuring changes in light scattering properties, optical density, electrical impedance, or by making direct bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I. With the exception of automated blood culturing system devices that are used in testing for bacteria, fungi, and other microorganisms in blood and other normally sterile body fluids, this device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
0
JAN 28 1998
510/k) SUMMARY OF SAFETY AND EFFECTIVENESS
SUBMITTED BY: BECTON DICKINSON MICROBIOLOGY SYSTEMS 7 LOVETON CIRCLE SPARKS, MD 21152
CONTACT: Dennis R. Mertz, Manager of Regulatory Affairs
TELEPHONE: (410) 316-4099
FAX: (410) 316-4499
January 20, 1998 PREPARED:
DEVICE NAME: BACTEC MYCO/F LYTIC BLOOD CULTURE MEDIUM
DEVICE
CLASSIFICATION: Monitor, Microbial Growth, Class I
PREDICATE
BACTEC 13A MYCOBACTERIA CULTURE MEDIUM. BACTEC NR DEVICE: FUNGAL CULTURE MEDIUM, AND ISOLATOR™ SYSTEM
INTENDED USE:
MYCO/F LYTIC culture medium when used with the BACTEC 9000 Blood Culture Series of instruments is a non-selective culture medium to be used as an adjunct to aerobic blood culture media for the recovery of mycobacteria, yeast and fungi. This media may also be used for the culture of sterile body fluids when veast or fungi are suspected.
DEVICE DESCRIPTION:
BACTEC MYCO/F LYTIC Culture medium is a Middlebrook 7H9 and Brain Heart Infusion broth formulation for the recovery of mycobacteria from blood specimens and fungi from blood and sterile body fluids. The range of specimen volume which can be cultured is one to five mL. with optimum recovery obtained at three to five mL. Specific modifications were made to enhance the growth and recovery of mycobacteria, veast, and fungi. These modifications include ferric ammonium citrate to provide an iron source for specific strains of mycobacteria and fungi, the addition of saponin as a blood lysing agent and the addition of specific proteins and sugars to provide nutritional supplements. Each vial contains a sensor which can detect decreases in oxygen concentration in the vial resulting from microorganism and growth. The sensor is monitored by the BACTEC 9000 Blood Culture Systems for increasing fluorescence which is proportional to the decrease in oxygen. A positive determination indicates the presumptive presence of viable microorganisms in the vial.
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SUBSTANTIAL EQUIVALENCE:
Table 1 summarizes the similarities and differences between the BACTEC MYCO/F LYTIC culture medium and BACTEC 13A Mycobacteria culture medium and BACTEC NR FUNGAL culture medium. Internal and clinical studies demonstrated equivalent performance with all predicate devices.
INTERNAL PERFORMANCE
A study was conducted to evaluate the recovery and time to detection (TTD) of a variety of yeast and fungi species at different CFU levels and specimen volumes between BACTEC NR FUNGAL Culture medium and BACTEC MYCO/F LYTIC Culture medium. TABLE 2 shows the results of this study. The recovery of Histoplasma capsulatum and Malesezzia furfur with BACTEC MYCO/F LYTIC culture medium demonstrated improved recovery compared to the BACTEC NR FUNGAL Culture medium. Pencillium purpurescens and Blastomvees dermatitidis were not detectable in the BACTEC MYCO/F LYTIC culture medium. Hansenula anomala, Exophiala jeamselmei, Actinomvces bovis, Rhodotorula rubra, and Mucor ramosissimus exhibited inconsistent results at low inoculum levels (M. tuberculosis | 582 | 0, 0 | 16.8 | 16.8 | 14.2 |
| Replicate | | | neg | 16.8 | neg |
| Average | | | 16.8 | 16.8 | 14.2 |
| M. avium | 2638 | 49, 45 | 8.1 | 8.1 | 8.1 |
| Replicate | | | 8.1 | 7.8 | 8.1 |
| Average | | | 8.1 | 8.0 | 8.1 |
| M. intracellulare | 2792 | 80, 44 | 21.5 | 10.8 | 10.1 |
| Replicate | | | neg | 10.5 | 9.8 |
| Average | | | 21.5 | 10.7 | 10.0 |
| M. fortuitum | 3072 | 5, 0 | 5.5 | 4.4 | 4.3 |
| Replicate | | | 5.8 | 4.4 | 3.9 |
| Average | | | 5.7 | 4.4 | 4.1 |
| M. bovis | 2003 | 12, 13 | 19.8 | 20.5 | 19.1 |
| Replicate | | | 20.8 | 19.5 | 19.5 |
| Average | | | 20.3 | 20.0 | 19.3 |
| M. kansasii | 2205 | 7, 3 | 13.1 | 12.5 | 15.8 |
| Replicate | | | 12.1 | 13.5 | 14.1 |
| Average | | | 12.6 | 13.0 | 15.0 |
| M. terrae | 3001 | 0, 0 | 13.8 | 18.5 | 9.5 |
| Replicate | | | 12.5 | neg | 12.7 |
| Average | | | 13.2 | 18.5 | 11.1 |
| M. szulgai | 2353 | 1, 2 | 25.5 | 22.8 | 19.1 |
| Replicate | | | 22.5 | neg | neg |
| Average | | | 24.0 | 22.8 | 19.1 |
| M. simiae | 2304 | 68, 58 | 7.0 | 7.4 | 7.4 |
| Replicate | | | 6.9 | 7.4 | 7.3 |
| Average | | | 7.0 | 7.4 | 7.4 |
| M. gordonae | 2454 | 2, 5 | 28.2 | 31.2 | neg |
| Replicate | | | 30.8 | 28.8 | 29.5 |
| Average | | | 29.5 | 30.0 | 29.5 |
| M. celatum | 3661 | 53, 31 | 13.1 | 10.8 | 10.8 |
| Replicate | | | 13.1 | 10.5 | 10.8 |
| Average | | | 13.1 | 10.7 | 10.8 |
| M. abscessus | 3370 | 1, 0 | 4.1 | neg | neg |
| Replicate | | | 4.3 | 4.0 | 3.6 |
| Average | | | 4.2 | 4.0 | 3.6 |
| M. malmoense | 3472 | 16, 20 | 24.8 | 10.8 | 10.4 |
| Replicate | | | 25.3 | 10.4 | 10.4 |
| Average | | | 25.1 | 10.6 | 10.4 |
| M. haemophilum | 5121 | 1, 1 | neg | 23.2 | 19.8 |
| Replicate | | | 35.9 | 23.5 | 17.2 |
| Average | | | 35.9 | 23.4 | 18.5 |
| M. xenopi | 3052 | 0, 0 | neg | 42.9 | 40.2 |
| Replicate | | | neg | 34.5 | 40.9 |
| Average | | | neg | 38.7 | 40.6 |
| C. neoformans | 13690 | 13, 31 | 2.8 | 2.5 | 2.8 |
| Replicate | | | 2.7 | 2.7 | 2.9 |
| Average | | | 2.8 | 2.6 | 2.9 |
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Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized eagle or bird-like symbol with three distinct segments forming its body and wings. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 8 1998
Mr. Dennis R. Mertz Manager, Regulatory Affairs Becton Dickinson Microbiology Systems 7 Loveton Circle Sparks, Maryland 21152-0999
Re: K970333
Trade Name: BACTEC® Myco/F Lytic Culture Vials Regulatory Class: I Product Code: MDB Dated: October 24, 1997 Received: October 27, 1997
Dear Mr. Mertz:
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 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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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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Page 2
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 Autman
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
10
INDICATIONS STATEMENT
510(k) Number K970333
Device Name: BACTEC® MYCO/F LYTIC Culture Vials
Indication for Use:
Per 21 CFR 801.109
The BACTEC® MYCO/F Lytic culture vials when used with the 9000 Blood Culture series of instrumentation are intended as an adjunct to routine blood culture for patients suspected of having mycobacteria, yeast and fungi septicemia. Extended incubation times (7 days for yeast, 30 days for fungi, and 42 days for mycobacteria) will permit recovery of mycobacteria and fungi when more rapidly growing organisms are not present. This medium may also be used for the culture of sterile body fluids when yeast or fungi are suspected.
(Please do not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | V.Am Tichurt MD Interim Ch. of, Microbiol Pr |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | __________________________ |
| Prescription Use | ✓ | OR | Over-The-Counter Use | __________________________ |
|---|---|---|---|---|
| ------------------ | -------------------------------------- | ---- | ---------------------- | ---------------------------- |