K Number

Device Name

Manufacturer

BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS

Date Cleared

1996-11-21

(392 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Qualitative culture and recovery of yeasts and fungi from blood

Device Description

BACTEC Fungal Medium is a growth medium providing an aerobic environment for the detection of yeast and fungi. It has been designed for blood volumes of four to 10 mL, and is used specifically with BACTEC non-radiometric (NR) series instruments in the monitoring of clinical blood specimens for the presence of yeasts and fungi. BACTEC Fungal medium has a higher weight/volume concentration of dextrose and sucrose then the predicate device to enhance the recovery and CO2 production of yeast. Saponin was added to the BACTEC Fungal Medium as a lysing agent, and ferric ammonium citrate was added as a source of iron to stimulate recovery of fungi other than yeast. Resin was removed from this medium. Principles for detection of CO2 produced by microorganisms metabolizing blood culture medium nutrients are identical to the predicate device.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the BACTEC® Fungal Medium, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly derived from the comparative study against predicate devices (BACTEC® PLUS 26 Culture Vials and ISOLATOR™ Microbial Tubes/ISOSTAT® Microbial System). The goal is to demonstrate that the BACTEC® Fungal Medium performs "as good or better than" or "equivalent to" these predicate devices for the recovery of yeasts and fungi from blood, particularly in terms of recovery rates and speed of detection.

Acceptance Criteria Category	Specific Criteria (Implicitly Derived)	Reported Device Performance (BACTEC® Fungal Medium)
Recovery of Fungi	Vs. BACTEC® PLUS 26: Statistically significantly better recovery of all fungi combined and of Torulopsis glabrata. Vs. IS System: Equivalent recovery of fungi, with the exception of Histoplasma capsulatum. (i.e., performance should not be significantly worse for most fungi).	Vs. BACTEC® PLUS 26: - 68 fungi isolates total. - 31 (45.6%) recovered in both media. - 11 (16.2%) recovered in BACTEC® PLUS 26 only. - 26 (38.2%) recovered in BACTEC® Fungal Medium only. - *Recovery of all fungi combined and of Torulopsis glabrata* was statistically significantly better (p < 0.025) in BACTEC® Fungal Medium. Vs. IS System:** - 93 fungi isolates total. - 42 (45.2%) recovered in both media. - 34 (36.6%) recovered in IS System only. - 17 (18.3%) recovered in BACTEC® Fungal Medium only. - Excluding H. capsulatum (which was better in IS System), 17 fungi were isolated only in BACTEC® Fungal Medium and nine fungi were isolated only in the IS System; this difference is not statistically significant.
Speed of Detection (Fungi)	Vs. BACTEC® PLUS 26: No statistically significant difference in speed of detection for any or all fungi combined. Vs. IS System: No statistically significant difference in speed of detection for all fungi combined; potentially earlier detection for specific fungi (T. glabrata).	Vs. BACTEC® PLUS 26: - No statistically significant difference in the speed of detection of any of the fungi in the two media, nor of all fungi combined. Vs. IS System: - T. glabrata was detected significantly earlier in BACTEC® Fungal Medium (p < 0.05). - The difference in speed of detection of all fungi in each of the two media was not significantly significant.
Recovery of Bacteria	(Implicitly, not the primary focus of the fungal medium, but generally should not be significantly worse if present in clinical specimens).	Vs. BACTEC® PLUS 26: 161 bacteria isolates recovered (implicit understanding that the primary focus of the new medium is fungal recovery, not improved bacterial recovery compared to a general culture medium). Vs. IS System: 125 bacteria isolates recovered.

Study Details

Sample sizes used for the test set and the data provenance:
- BACTEC® Fungal Medium vs. BACTEC® PLUS 26:
  - Sample Size: 4886 adequately filled paired vials.
  - Data Provenance: Clinical study conducted at four university-affiliated hospitals. This indicates a prospective collection of real-world clinical samples. The country of origin is not explicitly stated but is implied to be the US given the submission to the FDA.
- BACTEC® Fungal Medium vs. ISOLATOR™ Microbial Tubes/ISOSTAT® Microbial System:
  - Sample Size: 4907 adequately filled paired vials and tubes.
  - Data Provenance: Clinical study conducted at four university-affiliated hospitals. This indicates a prospective collection of real-world clinical samples. The country of origin is not explicitly stated but is implied to be the US.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the summary. The "ground truth" for recovery is based on the actual growth and identification of microorganisms from the culture media, which would typically be performed by trained laboratory personnel (microbiologists/medical technologists). The summary does not specify the number or qualifications of these individuals.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not explicitly stated. For microbiology studies, "adjudication" in the traditional sense of multiple readers reviewing images isn't directly applicable. Instead, the results are likely determined by standard laboratory protocols for organism identification and confirmation.
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:
- No, this was not an MRMC comparative effectiveness study involving human readers and AI assistance. This study evaluates the performance of different microbial culture media, an in vitro diagnostic device, not an AI-powered diagnostic imaging system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense, this was a "standalone" evaluation of the media. The BACTEC instrument automatically detects CO2 production. The study evaluates the medium's ability to support growth detectable by the instrument, without human intervention in the primary detection phase, although humans perform subsequent identification of the isolates.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established by microbiological culture and identification of isolates recovered from the blood samples. This is considered the gold standard for detecting and identifying microorganisms in blood cultures. "Clinically significant isolates" implies a determination by a clinician or microbiologist that the isolated organism is relevant to the patient's condition.
The sample size for the training set:
- This information is not explicitly provided. The study describes "clinical performance" testing, which typically refers to the final validation set for regulatory submission. Details of earlier development or optimization ("training") sample sizes for the medium formulation are not usually included in a 510(k) summary. The formulation of the medium itself is a scientific development process, not an AI training process.
How the ground truth for the training set was established:
- As with the training set, details on how ground truth was established during the development or "training" phase of the medium formulation are not in this summary. However, it would similarly have involved microbiological culture and identification methods to assess the growth characteristics of various target microorganisms in different medium formulations.

Summary

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K954923

510(k) SUMMARY

NOV 21 1996

SUBMITTED BY:	BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS7 LOVETON CIRCLESPARKS, MD 21152
CONTACT:	Dennis Mertz, Manager Regulatory Affairs
TELEPHONE:	(410) 316-4099
FAX:	(410) 316-4499
PREPARED:	October 25, 1995
DEVICE NAME:	BACTEC® Fungal Medium
PREDICATE DEVICE:	BACTEC® PLUS 26 Culture Vials
INTENDED USE:	Qualitative culture and recovery of yeasts and fungi from blood

DEVICE DESCRIPTION:

SUBSTANTIAL EQUIVALENCE:

Table 1 summarizes the similarities and differences between BACTEC® Fungal Medium and BACTEC® PLUS 26 Culture Vials.

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	to BACTEC® PLUS 26 Culture Vials
	BACTEC® Fungal Medium	BACTEC® PLUS 26
Intended use	Qualitative culture and recovery of yeasts and fungi	Qualitative culture and recovery of aerobicmicroorganisms (mainly bacteria andfungi)
Sample type	Blood	Blood
Sample volume	4 - 10 mL	5 - 10 mL
Blood to broth ratio	1 to 2.5	1 to 2.5
Growth medium	Enriched brain heart infusion broth with CO₂	Enriched soybean-casein digest broth with CO₂
Lysing Agent	Saponin (0.24% w/v)	None
Reactive ingredientconcentrations
• Processed water	25 mL	25 mL
• Brain heartinfusion broth	1.0% w/v	2.75% w/v
• Soybean-caseindigest broth	0.035% w/v	0.25% w/v
• Yeast extract	0.035% w/v	0.06% w/v
• Dextrose	0.1% w/v	0.084% w/v
• Sucrose	0.6% w/v
• m-Inositol	0.05% w/v	0.0005% w/v
• Hemin	---	0.00005% w/v
• Menadione	---	---
• Ferricammoniumcitrate	0.0001% w/v	0.001% w/v
• Pyridoxal HCl	---	---
• Saponin	0.24% w/v	---
• Anti-foamingagent	0.01% w/v	---
• SPS	0.05% w/v	0.05% w/v
• Chloramphenicol	0.005% w/v	---
• Tobramycin	0.001% w/v	---
• Nonionicadsorbing resin	---	16.0% w/v
• Cationicexchange resin	---	1.0% w/v
Resins	None	Yes (see above)
Instrument	BACTEC® NR instruments	BACTEC® NR instruments
Growth detection	Infrared spectrophotometricmeasurement of CO₂ produced bymicroorganisms metabolizingculture medium nutrients	Infrared spectrophotometricmeasurement of CO₂ produced bymicroorganisms metabolizingculture medium nutrients
Incubationtemperature	35°C ± 1.5°C	35°C ± 1.5°C
Agitation	Orbital agitation for the first 24hours recommended	Orbital agitation for the first 24hours recommended
Vial glass	Type III, soda lime	Type III, soda lime
Closure	Rubber	Rubber

Table 1. Substantial Equivalence of BACTEC® Fungal Medium

Substantial Equivalence or use of Active Viele C® PI US 26 Culture Vials D

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CLINICAL PERFORMANCE:

A multi-center clinical study comparing BACTEC® Fungal Medium, BACTEC® PLUS 26 blood culture medium, and the ISOLATOR™ Microbial Tubes/ISOSTAT® Microbial System (IS System) was conducted at four university-affiliated hospitals. There were a total of 4886 adequately filled paired vials in the comparison of BACTEC® Fungal Medium to BACTEC® PLUS 26 blood culture medium, and 4907 adequately filled paired vials and tubes in the comparison of BACTEC® Fungal Medium to the IS System. Of the 229 clinically significant isolates recovered in the comparison of BACTEC® Fungal Medium to BACTEC® PLUS 26 blood culture medium, 161 were bacteria and 68 were fungi. Of the 68 fungi, 31 isolates (45.6%) were recovered in both media, 11 (16.2%) were recovered in BACTEC® PLUS 26 blood culture medium only, and 26 (38.2%) were recovered in BACTEC® Fungal Medium only. Recovery of all fungi combined and of Torulopsis glabrata was statistically significantly better (p < 0.025) in BACTEC® Fungal Medium. There was no statistically significant difference in the speed of detection of any of the fungi in the two media, nor of all fungi combined.

Of the 218 clinically significant isolates recovered in the comparison of BACTEC® Fungal Medium to the IS System. 125 were bacteria and 93 were fungi. 42 isolates (45.2%) were recovered in both media, 34 (36.6%) were recovered in the IS System only, and 17 (18.3%) were recovered in BACTEC® Fungal Medium only. Of the 34 isolates recovered only in the IS System, 25 were Histoplasma capsulatum; recovery of H. capsulatum was statistically significantly better (p < 0.001) in the IS System. Excluding the H. capsulatum isolates, 17 fungi were isolated only in BACTEC® Fungal Medium and nine fungi were isolated only in the IS System; this difference is not statistically significant. T. glabrata was detected significantly earlier in BACTEC® Fungal Medium (p < 0.05). The difference in speed of detection of all fungi in each of the two media was not significantly significant. Thus, the performance of BACTEC® Fungal Medium in detecting growth of fungi in blood was as good or better than that of BACTEC® PLUS 26 blood culture medium, and, with the exception of H. capsulatum, equivalent to that of the IS System.

Regulation Number and Section

§ 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.