(145 days)
BD BACTEC™ Lytic/10 Anaerobic/F culture vials (prereduced enriched Soybean-Casein Digest broth with CO2) are for anaerobic blood cultures. Principal use is with the BACTEC fluorescent series instruments for the qualitative culture and recovery of anaerobic microorganisms from blood.
The sample to be tested is inoculated into one or more vials which are inserted into the BACTEC fluorescent series instrument for incubation and periodic reading. Each vial contains a chemical sensor which can detect increases in CO2 produced by the growth of microorganisms. The sensor is monitored by the instrument every ten minutes for an increase in its fluorescence, which is proportional to the amount of CO2 present. A positive reading indicates the presumptive presence of viable microorganisms in the vial. Detection is limited to microorganisms that will grow in a particular type of medium.
The provided document describes the BD BACTEC Lytic/10 Anaerobic/F (plastic) blood culture medium. The study aims to demonstrate substantial equivalence to its predicate device, the BD BACTEC Lytic/10 Anaerobic/F (glass) medium, by showing equivalent performance in various analytical aspects.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implicit from Equivalence Claim) | Reported Device Performance (BD BACTEC Lytic/10 Anaerobic/F (plastic)) |
|---|---|---|---|
| Recovery | Percent Recovery (10-100 CFU/bottle) | Equivalent to predicate (100% recovery) | 100% recovery for 342 paired sets |
| Percent Recovery (0-1 and 1-10 CFU/bottle) | Equivalent to predicate | Not explicitly stated as a strict acceptance metric, but comparison made | |
| Time to Detection (TTD) | Median TTD difference | Equivalent to predicate | 10 minutes faster (plastic vial) |
| 95% TTD difference range | Equivalent to predicate | Between -1.68 hours (faster for glass) and 3 hours (faster for plastic) | |
| False Positive Rate | Absence of false positives | 0% (or comparable to predicate) | No false positive bottles observed (0%) |
| False Negative Rate | Absence of false negatives (instrument negative, subculture positive) | 0% (or comparable to predicate) | No false negative results observed (0%) |
| Instrument Compatibility | Percent Recovery across instruments | 100% recovery in both devices across instruments | 100% recovery in both devices across BACTEC FX, 9240, 9050 |
| Lot-to-Lot Consistency | Percent Recovery across lots | 100% recovery | 100% (95% CI: 98.9%, 100%) recovery across 3 lots with 100% agreement between any two lots |
2. Sample size used for the test set and the data provenance
- Time to Detection (TTD):
- 10-100 CFU/bottle: 342 paired sets.
- 0-1 and 1-10 CFU/bottle: 191 paired sets (positive in both devices).
- Percent Recovery:
- 10-100 CFU/bottle: 342 paired sets.
- Subset of organisms (Finegoldia magna, Peptoniphilus asaccharolyticus): Sample size not explicitly stated for this subset, but demonstrated 100% recovery.
- False Positive Rate: 240 paired sets (80 bottles from each of 3 lots).
- False Negative Rate: 121 paired sets.
- BACTEC Instrument Compatibility: 114 paired sets.
- Comparison Across Lots: 342 paired sets (114 paired sets x 3 lots).
The data provenance is not explicitly stated regarding country of origin; however, the study appears to be an analytical study conducted in a laboratory setting. The data is prospective in nature, as it involves the inoculation and testing of the new device alongside the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This study does not involve human readers or experts establishing ground truth in the traditional sense of image interpretation or clinical diagnosis. The "ground truth" for this device, a blood culture medium, is determined by the objective growth and detection of microorganisms, followed by subculture analysis (for false negatives). Therefore, there were no experts mentioned.
4. Adjudication method for the test set
Not applicable. The study design does not involve adjudication by experts as it is an analytical study for microbial growth detection. The "ground truth" is established through laboratory protocols (e.g., terminal subculture to confirm growth in negative bottles).
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 an analytical study of a medical device (blood culture medium), not an AI-based diagnostic tool. There are no human readers or AI involved in interpreting results in this context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is a standalone system in terms of its ability to detect microbial growth within the BACTEC instrument. The instrument's algorithm (growth and detection algorithms) processes the sensor data. The study primarily evaluated the performance of this "algorithm-only" or instrumental detection.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used is primarily microbiological culture and detection, specifically:
- Positive growth validation: Visual confirmation of growth, and possibly subculture for confirmation of specific organisms and CFU counts used for inoculation.
- Negative validation: Absence of growth in the instrument, and crucially, terminal subculture to confirm no viable organisms were present (to rule out false negatives).
8. The sample size for the training set
Not applicable. This is an analytical study comparing a new device to a predicate device. There is no explicit "training set" in the context of machine learning or AI algorithm development because the device functions based on chemical/biological reactions and instrument-specific algorithms, not a learned model from a dataset.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned in the context of this device evaluation.
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MAY 1 3 2013
510(k) SUMMARY
BECTON, DICKINSON AND COMPANY SUBMITTED BY: 7 LOVETON CIRCLE SPARKS, MD 21152 Phone: 410-316-4905 Fax: 410-316-4499 CONTACT NAME: Paul Swift, RAC Regulatory Affairs Project Manager DATE PREPARED: April 25, 2013 DEVICE TRADE NAME: BD BACTEC Lytic/10 Anaerobic/F (plastic) DEVICE COMMON NAME: Anaerobic blood culture medium DEVICE CLASSIFICATION: 21 CFR $866.2560, Class I PREDICATE DEVICE: BD BACTEC Lytic/10 Anaerobic/F medium (K954925)
INTENDED USE:
BD BACTEC™ Lytic/10 Anaerobic/F culture vials (prereduced enriched Soybean-Casein Digest broth with CO2) are for anaerobic blood cultures. Principal use is with the BACTEC fluorescent series instruments for the qualitative culture and recovery of anaerobic microorganisms from blood.
DEVICE DESCRIPTION:
The sample to be tested is inoculated into one or more vials which are inserted into the BACTEC fluorescent series instrument for incubation and periodic reading. Each vial contains a chemical sensor which can detect increases in CO2 produced by the growth of microorganisms. The sensor is monitored by the instrument every ten minutes for an increase in its fluorescence, which is proportional to the amount of CO2 present. A positive reading indicates the presumptive presence of viable microorganisms in the vial. Detection is limited to microorganisms that will grow in a particular type of medium.
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DEVICE COMPARISON:
The BD BACTEC Lytic/10 Anaerobic/F (plastic) medium differs from the BD BACTEC Lytic/10 Anaerobic/F (glass) medium in the following ways:
- The medium in the new device is contained in a plastic bottle; whereas, the . medium in the predicate device is contained in a glass bottle.
- . The new device's sensor has been adjusted to obtain equivalent performance to that of the predicate device
- The new bottle weighs less than the predicate device. .
- The new device measures 5.0 inches high compared to the predicate device height . of 5.6 inches.
The BD BACTEC Lytic/10 Anaerobic/F (plastic) medium is similar to the BD BACTEC Lytic/10 Anaerobic/F (glass) medium in the following ways:
- Both the new and predicate devices are used for the qualitative anaerobic culture . and recovery of microorganisms from human blood.
- Both devices are intended to be used with the BD BACTEC fluorescent-series of . blood culture instruments.
- The BD BACTEC fluorescent-series of blood culture instruments apply the same . incubation and agitation parameters to both devices.
- The BD BACTEC fluorescent-series of blood culture instruments apply the same . growth and detection algorithms to both devices.
- . Both devices are incubated at 35° C (± 1.5° C) for a period of up to 120 hours.
- . Both devices incorporate a sensor that detects increases in CO2 within the bottle as a result of organism growth.
- Both devices require a sample volume of 3 10 mL of blood. .
- Both devices utilize 40 mL of enriched soybean casein digest broth as the growth . medium.
- Both devices have a maximum blood to broth ratio of 1:5. .
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SUMMARY OF PERFORMANCE DATA
Analytical Studies:
Instrument Time to Detection (TTD)
The data included 342 paired sets at the 10-100 CFU per bottle inoculum level and were evaluated in both the new and the predicate devices with 100% recovery. The observed median TTD difference between the paired sets was 10 minutes faster for the BD BACTEC Lytic/10 Anaerobic/F medium contained in a plastic vial. Ninety-five percent of the TTD differences between the paired sets were between -1.68 hours faster for the glass vial and 3 hours faster for the plastic vial.
There were 191 paired sets at the 0-1 and 1-10 CFU per bottle inoculum levels that were positive in both the new and predicate devices.
Percent Recoverv
A total of 342 paired sets were evaluated at the 10-100 CFU per bottle inoculum level in the Percent Recovery comparison. All 342 paired sets were positive in both the new and predicate devices (100%). The analysis at the 10-100 CFU per bottle inoculum level supports substantial equivalence.
A subset of organisms, including Finegoldia magna (formerly Peptostreptococcus magnus) and Peptoniphilus asaccharolyticus (formerly Peptostreptococcus asaccharolyticus) were evaluated on the BD BACTEC FX instrument at 10 to 100 CFU per vial and demonstrated 100% recovery in both the BD BACTEC Lytic/10 Anaerobic/F medium contained in a plastic vial and the BD BACTEC Lytic/10 Anaerobic/F medium contained in a glass vial.
False Positive Rate
A total of 240 paired sets were used to execute this study. The 240 paired sets were comprised of 80 bottles from each of 3 lots. The paired sets were inoculated with fresh human blood at varving levels (2, 4, 6, 8, 10 mL) and entered into the BACTEC blood culture instrument. It was expected that each bottle would be instrument-negative following the complete protocol (120 hours). There were no false positive bottles of the new device observed during this evaluation.
False Negative Rate
A total of 121 paired sets were evaluated for the determination of the False Negative Rate of the new device. Bottles that were instrument negative at 120 hours but terminal subculture positive would be classified as false negative. Instrument negative bottles were terminally subcultured onto an appropriate medium and incubated under appropriate environmental conditions for up to five days. There were no false negative results with either the new or predicate device under this classification.
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Twenty-seven bottles did not detect in the new device only at the 0 to 1 CFU per bottle inoculum level and two bottles did not detect at the 1 to 10 CFU per bottle inoculum level. One of twelve replicates of Porphyromonas asaccharolytica (ATCC 25260, 4 CFU per bottle) failed to detect in the BD BACTEC Lytic/10 Anaerobic/F medium contained in a plastic vial. Instrument signal analysis demonstrated no evidence of growth in the replicate and a terminal subculture vielded no growth; indicating that there were likely no viable organisms inoculated into the vial.
Forty-four bottles did not detect in the predicate device only at the 0 to 1 CFU per bottle inoculum level and four bottles did not detect at the 1 to 10 CFU per bottle inoculum level.
BACTEC Instrument Compatibility
A total of 114 paired sets (new and predicate devices) were tested in each the BACTEC FX, BACTEC 9240 and BACTEC 9050 fluorescent-series blood culture instruments at the 10 to 100 CFU per bottle inoculum level. A recovery comparison of the new device versus the predicate device demonstrated that all 114 paired sets were positive in both the new and the predicate devices in each of the BACTEC fluorescent series blood culture instruments.
Comparison Across Lots
In the Percent Recovery study, the new device was evaluated across lots. Three hundred forty two paired sets (114 paired sets x 3 lots) at the 10 to 100 CFU per vial inoculum level vielded 100% (95% CI: 98.9%, 100%) recovery was compared between three pairs of lots. Recovery agreed 100% (95% CI: 96.8%, 100%) of the time between any two lots in each sampling of the 114 paired sets.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wavy lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Becton, Dickinson and Company c/o Paul Swift 7 Loveton Circle Sparks, MD. 21152
May 13, 2013
Re: K123903
Trade/Device Name: BD BACTEC Lytic/10 Anaerobic/F (plastic) Regulation Number: 21 CFR §866.2560 Regulation Name: Microbial growth monitor Regulatory Class: I Product Code: MDB Dated: April 25, 2013 Received: April 26, 2013
Dear Mr. Swift:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Mr. Swift
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Uwe Scherf - S for
Sally A. Hojvat, M.Sc., Ph.D Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE
510(k) Number (if known):
Device Name: BD BACTEC Lytic/10 Anaerobic/F Blood Culture Medium (plastic)
Indication For Use:
BD BACTECTM Lytic/10 Anaerobic/F culture vials (prereduced enriched Soybean-Casein Digest broth with CO2) are for anaerobic blood cultures. Principal use is with the BACTEC fluorescent series instruments for the qualitative culture and recovery of anaerobic microorganisms from blood.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Raquel A. Preat - 5.jjjj
2013.05.10 114:24:59:04'00'
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k),K123903
BD Diagnostic Systems Becton, Dickinson and company Page iv
§ 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.