A qualitative procedure for the culture and recovery of aerobic microorganisms (mainly bacteria and fungi) from pediatric and other blood specimens which are generally less than 3 mL in volume.

Device Description

BACTEC PEDS PLUS medium is a bacterial growth medium providing an aerobic environment for the detection of bacteria and fungi. It has been designed for the recovery of microorganisms from pediatric and other blood specimens which are generally less than 3 mL in volume and is used specifically with the BACTEC NR ( non-radiometric )blood culture series instruments. Each glass vial of medium contains 20 mL of enriched Soybean-Casein Digest Broth with resins and CO2. If microorganisms are present in the test sample inoculated into the BACTEC vial, CO2 will be produced and liberated into the atmosphere when the organisms metabolize the substrates present in the vial. The instrument analyzes the vial head space gas for CO2 and, If a threshold level is exceeded, indicates that the vial is positive, i.e., that the test sample contains viable organisms.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the BACTEC® PEDS PLUS™ Culture Vials, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance (BACTEC PEDS PLUS)
Detects clinically significant organisms	Overall Recovery: 256 organisms detected (181 from both + 75 from PEDS PLUS only) out of 289 total clinically significant organisms (88.6%).
Better or equivalent recovery of organisms compared to predicate device (BACTEC NR6A)	Significantly better (p<0.001) with 75 organisms detected only in PEDS PLUS vs. 33 in NR6A.
Shorter or equivalent time to detection compared to predicate device	Significantly better (p<0.001) with 39 organisms detected earlier in PEDS PLUS vs. 13 in NR6A.
Improved recovery from patients receiving antimicrobial therapy	Significantly better (p<0.001) with 45 organisms detected only in PEDS PLUS vs. 16 in NR6A.
Qualitative procedure for culture and recovery of aerobic microorganisms (bacteria and fungi)	Qualitatively detects CO2 produced by microorganisms, indicating presence of viable organisms.
Suitable for pediatric and other blood specimens generally < 3 mL	Designed for this purpose as per intended use.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: 4,581 paired vials (meaning 4,581 BACTEC PEDS PLUS vials and 4,581 BACTEC NR6A vials were tested, for a total of 9,162 vials).
- Data Provenance: Prospective, clinical studies conducted at three tertiary care pediatric hospitals. The country of origin is not specified, but given the submission is to the FDA, it's likely 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 text. The ground truth appears to be based on the isolation and identification of "clinically significant organisms," which implies laboratory culture and identification methods, rather than expert interpretation of results.
Adjudication method for the test set:
- This information is not provided in the text.
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 study and does not involve AI. It is a comparison of two culture media.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The "device" in this context is primarily the BACTEC PEDS PLUS medium and its performance in detecting growth, measured by the BACTEC NR series instruments. The detection process itself (sensing CO2) is automated by the instrument, and the results (positive/negative, time to detection) are generated without direct human interpretation of a visual image, for example. The "algorithm" here is the instrument's CO2 detection threshold.
The type of ground truth used:
- The ground truth was established by the isolation and identification of "clinically significant organisms" from the blood cultures. This implies standard microbiological culture and identification techniques, which is a form of laboratory-confirmed outcome/clinical outcome.
The sample size for the training set:
- Not applicable. This study is a clinical comparison of two culture media, not an AI model requiring a training set.
How the ground truth for the training set was established:
- Not applicable. This study is a clinical comparison of two culture media, not an AI model requiring a ground truth for a training set.

Summary

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K954924

510(k) SUMMARY

BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS SUBMITTED BY: 7 LOVETON CIRCLE SPARKS, MD 21152

Dennis Mertz, Manager Regulatory Affairs CONTACT: (410) 316-4099 TELEPHONE: (410) 316-4499 FAX:

October 17, 1995 PREPARED:

BACTEC® PEDS PLUS™ Culture Vials TRADE NAME:

COMMON NAME: Blood Culture Medium
CLASSIFICATION Monitor, Microbial Growth NAME:

PREDICATE

DEVICE:

BACTEC® NR6A Culture Vials

A qualitative procedure for the culture and recovery of aerobic INTENDED USE: microorganisms (mainly bacteria and fungi) from pediatric and other blood specimens which are generally less than 3 mL in volume.
BACTEC PEDS PLUS medium is a bacterial growth medium DESCRIPTION: providing an aerobic environment for the detection of bacteria and fungi. It has been designed for the recovery of microorganisms from pediatric and other blood specimens which are generally less than 3 mL in volume and is used specifically with the BACTEC NR ( non-radiometric )blood culture series instruments. Each glass vial of medium contains 20 mL of enriched Soybean-Casein Digest Broth with resins and CO2. If microorganisms are present in the test sample inoculated into the BACTEC vial, CO2 will be produced and liberated into the atmosphere when the organisms metabolize the substrates present in the vial. The instrument analyzes the vial head space gas for CO2 and, If a threshold level is exceeded, indicates that the vial is positive, i.e., that the test sample contains viable organisms.

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SUBSTANTIAL EQUIVALENCE:

Table 1 summarizes the similarities and differences between BACTEC® PEDS PLUS™
Press and and CARDS AREA Culture Viels Table 1 summanized CRCTEC® NR6A Culture Vials.

Table 1. Substantial Equivalence of BACTEC® PEDS PLUS™ Culture Vials to a

lliant Collection Be SETEC NECA Culture Viole BACTEC® NR6A Culture Vials

	BACTEC NR 6	BACTEC PEDS PLUS
Basic Medium Formulation	* See below	* See below
SodiumPolyanetholesulfonate(SPS)	0.035% w/v	0.025% w/v
Antifoaming Agent	0.01% w/v	None
Yeast Extract	None	0.25% w/v
Nonionic Adsorbing Resin	None	20.0% w/v
Cationic Exchange Resin	None	1.2% w/v
Processed Water	30 mL	20 mL
Optimum Blood-to-Broth Ratio	1:6	1:6.7
Recommended SpecimenVolume(maximum )	5 mL	5 mL
Recommended SpecimenVolume(optimum range)	3 - 5 mL	1 - 3 mL
Instrument	BACTEC NR Series	BACTEC NR Series
Metabolite Detected	CO2	CO2
CO2 Detector	I.R. Analyzer	I.R. Analyzer
CO2 Monitoring	Invasive Vial HeadspaceSampling	Invasive Vial HeadspaceSampling
Agitation	Orbital Rotator	Orbital Rotator
Vial Type	Type III Soda Lime Glasswith Notched Base	Type III Soda Lime Glasswith Notched Base

Ingredients list (% is w/v ): Soybean-Casein Digest Broth 2.75%, Hemin 0.0005%, Dextrose

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CLINICAL PERFORMANCE:

Clinical studies were conducted comparing BACTEC® PEDS PLUS™ Culture Vials and BACTEC® NR6A Culture Vials at three tertiary care pediatric hospitals. A total of 4,581 paired vials were evaluated. From those sets a total of 289 clinically significant organisms were isolated from 452 positives. Of the 289 clinically significant organisms isolated. 181(63%) were from both media, 75 (26%) from the BACTEC PEDS PLUS medium and 33 (11%) from the BACTEC NR6A medium. The difference in recovery between the two media was statistically significant (X2 = 16.3, p<0.001). In regards to time to detection, 129 (71%) organisms were detected from both media at the same time, 39 (22%) were detected earlier in the BACTEC PEDS PLUS medium and 13 (7%) were detected earlier in BACTEC NR6A medium. The time to detection between the two media was statistically significant for the BACTEC PEDS PLUS medium (X2 = 13.0, p<0.001). Additionally, of the 143 patients receiving therapy, 82 (58%) organisms were recovered from both media, 45 (31%) organisms were recovered from the BACTEC PEDS PLUS medium only which contains antimicrobial resins and 16 (11%) from the BACTEC NR6A medium only. The BACTEC PEDS PLUS medium detected significantly more organisms than the BACTEC NR6A (X2 = 13.8, p<0.001). Thus, the performance of BACTEC PEDS PLUS medium was as good as the BACTEC NR6A medium.

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.