(331 days)
Not Found
No
The device description and performance studies focus on the biological medium and the instrument's detection of oxygen changes due to microbial growth, not on AI/ML algorithms for analysis or interpretation.
No
The device is described as a qualitative test for the culture and recovery of mycobacteria in human blood specimens, indicating it is an in vitro diagnostic (IVD) device used for diagnosis, not for therapy or treatment.
Yes
The device is described as a "qualitative test for the culture and recovery of mycobacteria in human blood specimens from patients who are suspected of having septicemia," indicating its use in identifying infectious agents to aid in diagnosis.
No
The device description clearly states it is a culture medium (a physical substance) used with a specific instrument (hardware), indicating it is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "qualitative test for the culture and recovery of mycobacteria in human blood specimens from patients who are suspected of having septicemia." This describes a test performed in vitro (outside the body) on a human specimen (blood) to provide diagnostic information.
- Device Description: The description details a "blood culture medium" used with an instrument to monitor clinical blood specimens for the presence of microorganisms. This further reinforces its use in a laboratory setting for diagnostic purposes.
- Anatomical Site: The specimen is "Blood," which is a human biological sample.
- Performance Studies: The document describes clinical performance studies comparing the device to a predicate device for the recovery and detection of mycobacteria from blood specimens. This is typical for IVD devices undergoing regulatory review.
- Key Metrics: The document provides metrics like false positive rate and false negative rate, which are relevant to the performance evaluation of a diagnostic test.
- Predicate Device: The mention of a "Predicate Device(s)" (BACTEC 13A MYCOBACTERIA CULTURE MEDIUM) is a strong indicator that this device is being compared to an existing legally marketed IVD.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BACTEC ® MYCO/F LYTIC Culture vial when used with the BACTEC 9000MB System is a qualitative test for the culture and recovery of mycobacteria in human blood speciments from patients who are suspected of having septicemia. .
Product codes
MDB
Device Description
BACTEC MYCO/F LYTIC blood culture medium is a non-selective growth medium intended for the culture and recovery of mycobacteria and designed for blood volumes of one to five mL. BACTEC MYCO/F LYTIC culture medium is a Middlebrook 7H9 and Brain Heart Infiusion broth formulation with specific formulation modifications made to enhance the growth of mycobacteria. It is used specifically with the BACTEC 9000MB instrument in the monitoring of clinical blood specimens for the presence of microorganisms. This medium contains the same fluorescence senor as the BACTEC MYCO/F Sputa culture medium and detection is based on changes in oxygen concentration in the vial resulting from metabolism and growth of microorganisms. The sensor is monitored by the BACTEC 9000MB System for increasing fluorescence which is proportinal to the decrease in oxygen. A positive determination indicates the presumptive presence of viable microorganisms in the vial.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A study was conducted to evaluate the recovery and time to detection of a variety of mycobacteria species at different CFU levels with the BACTEC MYCOFF LYTIC Culture medium. The following isolates were detected as positive in the BACTEC 9000MB instrument using BACTEC MYCO/F Lytic medium: M. tuberculosis, M. kansasii, M. fortuitum, M. intracellulare, M. bovis, M. terrae, M. simiae, M gordonae, M. celatum, M. abscessus, M. maimoense. During internal studies, M. xenopi and M. szulgai exhibited unsetisfactory recovery with BACTEC MYCO/F LYTIC culture medium.
The BACTEC MYCO/F Lytic culture medium was evaluated with the BACTEC 9000MB instrument at two clinical sites considered large tertiary care teaching hospitals in geographically diverse areas. The site populations included patients suspected of a mycobacterial infection, immunocompromised patients and transplant patients. A total of 284 blood specimens were tested during the study.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Internal Performance: A study was conducted to evaluate the recovery and time to detection of a variety of mycobacteria species at different CFU levels with the BACTEC MYCOFF LYTIC Culture medium. The following isolates were detected as positive in the BACTEC 9000MB instrument using BACTEC MYCO/F Lytic medium: M. tuberculosis, M. kansasii, M. fortuitum, M. intracellulare, M. bovis, M. terrae, M. simiae, M gordonae, M. celatum, M. abscessus, M. maimoense.
Clinical Performance: The BACTEC MYCO/F Lytic culture medium was evaluated with the BACTEC 9000MB instrument at two clinical sites. A total of 284 blood specimens were tested. The BACTEC MYCO/F Lytic culture medium was compared to the BACTEC 13A culture medium for the recovery and detection of mycobacteria from blood specimens. The total number of pathogenic mycobacterial isolates recovered in the study was 39. Of these positives, five (13%) were recovered in the BACTEC MYCO/F Lytic culture medium only and two (5%) were recovered by BACTEC 13A culture medium only. A total of 28 BACTEC MYCO/F LYTIC vials were over filled with specimen (between 6 to 20 mL) during the clinical evaluation and were not included in this study. Of these 28 BACTEC MYCO/F LYTIC vials, 16 (57%) were identified as false positive.
Of the 284 blood specimens tested in the clinical study, one BACTEC MYCO/F LYTIC vial (0.4%) was determined to be false positive (instrument-positive, smear and/or subculture-negative). Of the 38 instrument positive MYCO/F LYTIC vials, 1 (2.6%) was determined to be false positive. The false negative rate (instrument-negative, smear and/or subculture-positive) was determined to be 0% based on terminal subcultures of 50% of negative vials. The contamination rate during this evaluation was determination to be 0.9%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
False positive rate: 0.4%
False negative rate: 0%
Contamination rate: 0.9%
Predicate Device(s)
Not Found
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
1410512
JAN - 8 1998
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
BECTON DICKINSON MICROBIOLOGY SYSTEMS SUBMITTED BY: 7 LOVETON CIRCLE SPARKS, MD 21152
Dennis R. Mertz, Manager of Regulatory Affairs CONTACT:
(410) 316-4099 TELEPHONE:
FAX: (410) 316-4499
December 23, 1997 PREPARED:
BACTEC MYCO/F LYTIC BLOOD CULTURE MEDIUM DEVICE NAME:
DEVICE
CLASSIFICATION: Monitor, Microbial Growth, Class I
PREDICATE
BACTEC 13A MYCOBACTERIA CULTURE MEDIUM DEVICE:
- BACTEC MYCO/F LYTIC when used with the BACTEC 9000MB INTENDED USE: instrument is a non-selelctive culture medium for the qualitative culture and recovery of mycobacteria from blood specimens.
DEVICE DESCRIPTION:
BACTEC MYCO/F LYTIC blood culture medium is a non-selective growth medium intended for the culture and recovery of mycobacteria and designed for blood volumes of one to five mL. BACTEC MYCO/F LYTIC culture medium is a Middlebrook 7H9 and Brain Heart Infiusion broth formulation with specific formulation modifications made to enhance the growth of mycobacteria. It is used specifically with the BACTEC 9000MB instrument in the monitoring of clinical blood specimens for the presence of microorganisms. This medium contains the same fluorescence senor as the BACTEC MYCO/F Sputa culture medium and detection is based on changes in oxygen concentration in the vial resulting from metabolism and growth of microorganisms. The sensor is monitored by the BACTEC 9000MB System for increasing fluorescence which is proportinal to the decrease in oxygen. A positive determination indicates the presumptive presence of viable microorganisms in the vial.
SUBSTANTIAL EQUIVALENCE:
Table 1 summarizes the similarities and differences between the BACTEC MYCO/F LYTIC Culture medium and the BACTEC 13A Mycobacteria culture medium.
1
INTERNAL PERFORMANCE:
A study was conducted to evaluate the recovery and time to detection of a variety of mycobacteria species at different CFU levels with the BACTEC MYCOFF LYTIC Culture medium. The following isolates were detected as positive in the BACTEC 9000MB instrument using BACTEC MYCO/F Lytic medium: M. tuberculosis, M. kansasii, M. fortuitum, M. intracellulare, M. bovis, M. terrae, M. simiae, M gordonae, M. celatum, M. abscessus, M. maimoense. During internal studies, M. xenopi and M. szulgai exhibited unsetisfactory recovery with BACTEC MYCO/F LYTIC culture medium. TABLE 2 describes the results of this study.
CLINICAL PERFORMANCE:
The BACTEC MYCO/F Lytic culture medium was evaluated with the BACTEC 9000MB instrument at two clinical sites considered large tertiary care teaching hospitals in geographically diverse areas. The site populations included patients suspected of a mycobacterial infection, immunocompromised patients and transplant patients. The BACTEC MYCO/F Lytic culture medium was compared to the BACTEC 13A culture medium for the recovery and detection of mycobacteria from blood specimens. A total of 284 blood specimens were tested during the study. The total number of pathogenic mycobacterial isolates recovered in the study was 39 ( See TABLE 1). Of these positives, five (13%) were recovered in the BACTEC MYCO/F Lytic culture medium only and two (5%) were recovered by BACTEC 13A culture medium only. A total of 28 BACTEC MYCO/F LYTIC vials were over filled with specimen (between 6 to 20 mL) during the clinical evaluation and were not included in this study since they were above the maximum fill volume. Of these 28 BACTEC MYCO/F LYTIC vials, 16 (57%) were identified as false positive.
Of the 284 blood specimens tested in the clinical study, one BACTEC MYCO/F LYTIC vial (0.4%) was determined to be false positive (instrument-positive, smear and/or subculture-negative). Of the 38 instrument positive MYCO/F LYTIC vials, 1 (2.6%) was determined to be false positive. The false negative rate (instrument-negative, smear and/or subculture-positive) was determined to be 0% based on terminal subcultures of 50% of negative vials. The contamination rate during this evaluation was determination to be 0.9%.
| Organism | Total
Isolates | Myco/F Lytic
Medium Only | 13A Medium
Only | Both |
|------------------------------|-------------------|-----------------------------|--------------------|------|
| All Pathogenic Mycobacteria: | | | | |
| Mycobacterium avium | 30 | 3 | 1 | 26 |
| Mycobacterium tuberculosis | 6 | 0 | 0 | 6 |
| Mycobacterium kansasii | 3 | 2 | 1 | 0 |
| Total | 39 | 5 | 2 | 32 |
TABLE 1: SUMMARY OF MYCO/F LYTIC CULTURE MEDIUM ISOLATE RECOVERY DURING CLINICAL TRIALS
2
| | BACTEC MYCO/F
LYTIC | BACTEC 13A |
|------------------------------------------|------------------------------------------------------------------------|-----------------------------------------------------|
| Intended Use | Qualitative culture and
recovery of myoobacteria | Qualitative culture and
recovery of mycobacteria |
| Sample Type | Blood, unprocessed and
other sterile body fluids | Blood, unprocessed |
| Sample Volume | 1 - 5 mL | 1 - 5 mL |
| Blood to Broth Ratio | 1 to 8 | 1 to 6 |
| Growth Medium | Modified Middlebrook 7H9
and enriched brain heart
infusion broth | Modified Middlebrook 7H9
broth |
| Reactive ingredients:
• Process water | 40mL | 30mL |
| • Brain heart infusion | 0.5%w/v | --- |
| • Soybean-Casein Digest | 0.10%w/v | --- |
| • 7H9 Broth Base | 0.12%w/v | 0.47%w/v |
| • Inositol | 0.05%w/v | --- |
| • Casein Hydrolysate | 0.10%w/v | 0.10%w/v |
| • Ferric Ammonium Citrate | 0.006%w/v | --- |
| • Glycerol | 0.10%w/v | --- |
| • Sodium Polysulfonate(SPS) | 0.025%w/v | 0.025%w/v |
| • Tween 80(Polysorbate) | 0.0025%w/v | 0.02%w/v |
| • Saponin | 0.24%w/v | --- |
| • L-Asparagine¹ | 0.10%w/v | --- |
| • Catalase | --- | 1440 units |
| • Antifoam Agent | 0.01%w/v | --- |
| • Hemin | --- | --- |
| • ¹⁴C Substrate | --- | 5µCi |
| • Potassium Phosphate | 0.024%w/v | --- |
| • Pyridoxal HCL | 0.0001%w/v | --- |
| • Ammonium Sulfate | --- | --- |
| Supplement | None | BACTEC Enrichment |
| Instrument | BACTEC 9000MB | BACTEC 460TB |
| Growth Detection | O₂ metabolism | Palmitate Decarboxylation |
| Incubation T°/mixing | 37°C ± 1.5°C; internal
instrument agitation every
10 minutes | 37° C ± 1.5°C; no agitation
by instrument |
| Type of Monitoring | Non-invasive, fluorescent
detection | Invasive vial headspace
sampling |
Table 1. Substantial Equivalence of BACTEC MYCO/F LYTIC Culture Medium to
PACTEC 12 A
150
.
发出了我们的意见的
3
Table 2
Detection of Mycobacteria in the Myco/F Lytic Medium.
. •
| strain | cfu/bottle | BACTEC 9000MB | |||
|---|---|---|---|---|---|
| 1 mL blood | 3 mL blood | 5 mL blood | |||
| M. tuberculosis | 582 | 0, 0 | 20.7 | 18.7 | 17.3 |
| Replicate | 25.0 | neg | neg | ||
| Average | 22.9 | 18.7 | 17.3 | ||
| M. avium | 2638 | 49, 45 | 7.8 | 8.1 | 8.1 |
| Replicate | 8.1 | 8.1 | 8.1 | ||
| Average | 8.0 | 8.1 | 8.1 | ||
| M. Intracellulare | 2792 | 80, 44 | 25.8 | 16.7 | 10.5 |
| Replicate | 24.3 | 22.5 | 15.0 | ||
| Average | 25.0 | 19.6 | 12.8 | ||
| M. fortuitum | 3072 | 5, 0 | 9.1 | 5.6 | 5.0 |
| Replicate | 6.8 | 6.0 | 5.2 | ||
| Average | 8.0 | 5.8 | 5.1 | ||
| M. bovis | 2003 | 12, 13 | 24.4 | 20.0 | 20.0 |
| Replicate | 24.7 | 21.0 | 20.4 | ||
| Average | 24.5 | 20.5 | 20.2 | ||
| M. kansasii | 2205 | 7,3 | 12.3 | 14.3 | 14.3 |
| Replicate | 13.0 | 13.3 | neg | ||
| Average | 12.7 | 13.8 | 14.3 | ||
| M. terrae | 3001 | 0, 0 | 15.3 | 11.6 | 16.6 |
| Replicate | 17.0 | 32.4 | neg | ||
| Average | 16.2 | 22.0 | 16.6 | ||
| M. azulgai | 2353 | 1,2 | 15.7 | neg | neg |
| Replicate | neg | 22.7 | neg | ||
| Average | 15.7 | 22.7 | neg | ||
| M. simiae | 2304 | 68,58 | 7.2 | 7.4 | 7.7 |
| Replicate | 7.2 | 7.5 | 7.4 | ||
| Average | 7.2 | 7.5 | 7.6 | ||
| M. gordonae | 2454 | 2,5 | 26.4 | 28.7 | neg |
| Replicate | 24.0 | 32.0 | neg | ||
| Average | 25.2 | 30.4 | neg | ||
| M. celatum | 3661 | 53, 31 | 18.3 | 12.0 | 12.3 |
| Replicate | 18.3 | 15.0 | 12.3 | ||
| Average | 18.3 | 13.5 | 12.3 | ||
| M. abscessus | 3370 | 1,0 | 4.9 | 4.4 | 3.9 |
| Replicate | 9.3 | 4.3 | neg | ||
| Average | 7.1 | 4.4 | 3.9 | ||
| M. malmoense | 3472 | 16, 20 | 30.0 | 21.5 | 10.8 |
| Replicate | 32.0 | 21.1 | 18.6 | ||
| Average | 31.0 | 21.3 | 14.7 | ||
| M. haemophilum | 5121 | 1, 1 | 36.1 | 23.0 | 18.4 |
| Replicate | 39.3 | 23.4 | 24.4 | ||
| Average | 37.7 | 23.2 | 21.4 | ||
| M. xenopi | 3062 | 0, 0 | neg | neg | neg |
| Replicate | neg | neg | neg | ||
| Average | neg | neg | neg |
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN - 8 1998
Mr. Dennis R. Mertz Manager, Regulatory Affairs Becton Dickinson Microbiology Systems 7 Loveton Circle Sparks, Maryland 21152-0999
Re: K970512 Trade Name: BACTEC Myco/F Lytic Culture Vials Regulatory Class: I Product Code: MDB Dated: October 20, 1997 Received: October 21, 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 (QS) 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.
5
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 vour 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
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510(k) Number (if known): __ K970512
Device Name: Myco/F Lytic Culture Vials
Indications For Use:
The BACTEC ® MYCO/F LYTIC Culture vial when used with the BACTEC 9000MB System is a qualitative test for the culture and recovery of mycobacteria in human blood speciments from patients who are suspected of having septicemia. .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
John Titchurst MD 1/6/98
(Division Sign-Off) Intelian Chilian Chical I aboratory Devices Division of Clinical Laboratory Devices K970512 510(k) Number ..
Presoription Use (Par 21 OFF 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-86)