BACTEC MYCO/F-SPUTA CULTURE VIALS

{0}------------------------------------------------ K972758 AUG - 8 1997 June 13, 1997 ## SUMMARY OF SAFETY AND EFFECTIVENESS ### SUBMITTED BY: Colleen A. Rohrbeck Becton Dickinson Microbiology Systems 250 Schilling Circle Cockeysville, MD 21030-0243 ### NAME OF DEVICE: Trade Name: Common Name: Microbial Growth Monitor BACTEC® MYCO/F-Sputa Culture Vials PREDICATE DEVICES: BACTEC® 460TB System Conventional Media ## INTENDED USE: MYCO/F-Sputa culture media BACTEC Supplement /F when used with the BACTEC Brand 9000MB fluorescent series instrument is a qualitative procedure for the in vitro culture and recovery of mycobacteria from digested decontaminated clinical specimens and sterile body fluids other than blood. {1}------------------------------------------------ # DEVICE COMPARISON: The BACTEC® MYCO/F-Sputa culture vials will be compared to the BACTEC 12B culture vials and conventional medium (Lowenstein-Jensen agar slants) for purposes of evaluating equivalence of mycobacterial growth detection methods in non-respiratory specimens. | | BACTEC MYCO/F-Sputa<br>Culture Vials | BACTEC 12 B<br>Culture Vials | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Qualitative culture and<br>recovery of mycobacteria from<br>clinical specimens | Qualitative culture and<br>recovery of mycobacteria<br>from clinical specimens | | Sample type | Sterile body fluids other than<br>blood and digested<br>decontaminated clinical<br>specimens | Clinical specimens,<br>sputum, gastric, urine,<br>tissue, mucopurulent<br>specimens, other body<br>fluids and other<br>respiratory secretions | | Sample volume | 0.5mL | 0.5 - 1.0 mL | | Growth medium | 7H9 Middlebrook broth base<br>with nutrient additives | Enriched 7H9<br>Middlebrook broth base | | Reactive Ingredient<br>Concentration | | | | Processed Water<br>7H9 Broth Base<br>Casein Hydrolysate<br>Supplement H*<br>Glycerol<br>Ammonium Sulfate<br>Ferric Ammonium Citrate<br>Polysorbate 80<br>Hemin<br>Bovine Serum Albumin<br>Catalase<br>14C-substrate | 40 ml<br>0.47% w/v<br>0.10% w/v<br>0.30% w/v<br>0.10% w/v<br>0.05% w/v<br>0.006% w/v<br>0.0025% w/v<br>0.0005% w/v<br>---<br>---<br>--- | 4 ml<br>4.7 g/L<br>1.0g/L<br>---<br>---<br>---<br>---<br>---<br>---<br>5.0g/L<br>48,000 units/L<br>1,000 $\mu$ Ci/L | | Table 1: | BACTEC MYCO/F-Sputa Culture Vials versus BACTEC 12B Culture Vial | |----------|------------------------------------------------------------------| |----------|------------------------------------------------------------------| {2}------------------------------------------------ | | BACTEC MYCO/F-Sputa<br>Culture Vials | BACTEC 12 B<br>Culture Vials | |----------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| | Antimicrobial Supplement | Polymyxin B, amphotericin B,<br>nalidixic acid, trimethoprim &<br>azlocillin (PANTA) | Polymyxin B,<br>amphotericin B, nalidixic<br>acid, trimethoprim &<br>azlocillin (PANTA) | | Growth Detection | Fluorescent detection of O₂<br>consumption by mycobacterial<br>growth | Radiometric detection of<br>CO₂ liberated by<br>mycobacterial growth | | Incubation temperature/<br>mixing | On-board incubation at 37°C<br>±1.5°C; internal instrument<br>agitation every 10 minutes | External incubation at<br>37°C ± 1.0°C. No<br>agitation in instrument | | Automated System Used<br>for Detection | BACTEC® 9000MB | BACTEC® 460TB | * L-asparagine {3}------------------------------------------------ Device Comparison (cont.) | | | | Table 2: | |--|--|--|----------| |--|--|--|----------| | | BACTEC MYCO/F-Sputa<br>Culture Media | CONVENTIONAL<br>MEDIUM¹ | |--------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| | Intended Use | Qualitative culture and<br>recovery of mycobacteria from<br>clinical specimens | Qualitative culture and<br>recovery of mycobacteria<br>from clinical specimens | | Sample type | Sterile body fluids other than<br>blood and digested<br>decontaminated clinical<br>specimens | Primary specimens type -<br>respiratory; other body<br>fluids (including blood)<br>acceptable | | Sample volume | 0.5mL | 0.1 - 0.5 mL | | Growth medium | 7H9 Middlebrook broth base<br>with nutrient additives | Lowenstein-Jensen<br>medium; Egg enriched<br>agar base with nutrient<br>additives | | Reactive Ingredient<br>Concentration | | | | Processed Water | 40 ml | 8 ml | | 7H9 Broth Base | 0.47% w/v | --- | | Casein Hydrolysate | 0.10% w/v | --- | | Supplement H* | 0.30% w/v | 0.22% w/v | | Glycerol | 0.10% w/v | 0.74% v/v | | Ammonium Sulfate | 0.05% w/v | --- | | Ferric Ammonium Citrate | 0.006% w/v | --- | | Polysorbate 80 | 0.0025% w/v | --- | | Hemin | 0.0005% w/v | --- | | Monopotassium Phosphate | --- | 0.15% w/v | | Magnesium Sulfate | --- | 0.014% w/v | | Sodium Citrate | --- | 0.037% w/v | | Potato Flour | --- | 1.86% w/v | | Whole Egg | --- | 62% v/v | | Malachite Green | --- | 0.024% w/v | | Antimicrobial Supplement | Polymyxin B, amphotericin B,<br>nalidixic acid, trimethoprim &<br>azlocillin (PANTA) | None | : {4}------------------------------------------------ | | BACTEC MYCO/F-Sputa<br>Culture Media | CONVENTIONAL<br>MEDIUM1 | |----------------------------------------|-----------------------------------------------------------------------------------------------|------------------------------------------------------| | Growth Detection | Fluorescent detection of O2<br>consumption by mycobacterial<br>growth | Macroscopic observance<br>of growth of media surface | | Incubation temperature<br>mixing | On-board incubation at 37°C<br>$\pm$ 1.5°C; internal instrument<br>agitation every 10 minutes | 35°C to 38°C2<br>Manual manipulation of<br>media | | Automated System Used<br>for Detection | BACTEC® 9000MB | None Required | 1- CONVENTIONAL MEDIA - Lowenstein-Jensen agar slants 2- CDC recommendations * L-asparagine # TIME TO DETECTION: Table 3 shows the overall average times to detection of positive mycobacterial cultures for the BACTEC® MYCO/F-Sputa culture vials, BACTEC 12B culture vials, and conventional media. | Table 3: | Overall Average Times to Detection for Non-Respiratory Specimens | |----------|------------------------------------------------------------------| |----------|------------------------------------------------------------------| | ISOLATE GROUP | BACTEC 9000MB | BACTEC 460TB | CONVENTIONAL LJ | |-------------------------------|---------------|--------------|-----------------| | ALL MYCOBACTERIAL<br>ISOLATES | 12.2 days | 13.3 days | 24.3 days | | MTB COMPLEX | 18.4 days | 17.2 days | 22.1 days | | M AVIUM COMPLEX | 7.9 days | 10.2 days | 28.3 days | Paired t-tests were performed to compare time to detection in the BACTEC MYCO/F-Sputa culture vials to each of the reference systems, BACTEC 460TB and conventional media (Lowenstein-Jensen), for digested decontaminated clinical specimens and sterile body fluids other than blood. Both tests were performed at the 5% significance level. No significant difference in time to detection was seen between the BACTEC MYCO/F-Sputa culture vials and the BACTEC 460TB system. A statistically significant difference in time to detection was seen between the BACTEC MYCO/F-Sputa culture vials and conventional media. {5}------------------------------------------------ # RECOVERY PERFORMANCE: In a separate study at a large tertiary care teaching hospital. 803 non-respiratory specimens were tested with the BACTEC MYCO/F-Sputa culture medium, BACTEC 12B culture medium, and conventional medium (Lowenstein-Jensen). The total number of pathogenic mycobacteria positive isolates recovered in the study was 38. Of these positive isolates, the BACTEC 9000MB system recovered 29 (76.3%), 30 (78.9%) were recovered in the BACTEC 460TB system, and 24 (63.2%) were recovered by conventional medium (Lowenstein-Jensen). The BACTEC 9000MB system and solid media combined recovered 89.5% of the total pathogenic isolates. Total positive specimens (pathogenic and non-pathogenic mycobacteria) were distributed among the following sources: gastric (5.1%), sterile body fluids other than blood (17.9%), stool (10.3%), superficial skin/wound drainage (5.1%), tissue (53.8%), and urine (7.7%). The following isolates were detected as positive in the BACTEC 9000MB system using MYCO/F-Sputa during this clinical trial: M. tuberculosis, M. avium complex, M. chelonae, M. fortuitum, and M. bovis. A McNemar's paired comparison (modified chi-square test) was conducted to determine the significance of differences in total recovery between BACTEC MYCO/F-Sputa culture vials and the BACTEC 460TB system, as well as between the BACTEC MYCO/F-Sputa culture vials and conventional (Lowenstein Jensen) media. Both tests were performed at the 5% significance level. No statistical difference in recovery was seen between the BACTEC MYCO/F-Sputa culture vials and the BACTEC 460TB system. No statistical difference in recovery was seen between the BACTEC MYCO/F-Sputa culture vials and conventional media. Therefore, recovery of mycobacteria from digested decontaminated clinical specimens and sterile body fluids other than blood was not found to be different in the BACTEC MYCO/F-Sputa culture vials when compared to either the BACTEC 460TB system or conventional media. The overall false positive rate (instrument-positive, smear and/or subculture negative) was 5.0%. Due to the variety of specimens collected and tested. the false positive rate varied significantly from the rate previously reported for respiratory specimens. The breakthrough contamination rate for normally sterile specimens (i.e. tissue and sterile body fluids other than blood) ranged from 4.7% - 18.9%; non-sterile specimens (i.e. gastric, stool, urine, superficial skin/wound drainage) ranged from 8.2% - 73.9%. The overall breakthrough contamination rate was 14.9%. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Colleen Rohrbeck Regulatory Affairs Associate Becton Dickinson Microbiology Systems 250 Schilling Circle Cockeysville, Maryland 21030-0243 ······ AUG - 8 1997 Re : K972758 Trade Name: BACTEC® MYCO/F-Sputa Culture Vials Requlatory Class: I Product Code: MDB Dated: June 13, 1997 Received: June 16, 1997 Dear Ms. Rohrbeck: 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. Flease 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. {7}------------------------------------------------ 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 requlation (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 {8}------------------------------------------------ #### INDICATIONS STATEMENT K940268 K972758 510(k) Number (if known): Device Name: -- BACTEC® MYCO/F - Sputa Culture Vials ----- Indications for Use: MYCO/F-Sputa culture media with the addition of BACTEC Supplement/F when used with the BACTEC Brand 9000MB fluorescent series instrument is a qualitative test for the in-vitro culture and recovery of mycobacteria from digested decontaminated clinical specimens and sterile body fluids other than blood from patients suspected of pulmonary or disseminated mycobacterial infection. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Re Ps (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number 510(k) Number K972758 Prescription Use (Per 21 CFR 801.109) OR Over-the-Counter-Use A;\indicat.stm