(105 days)
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No
The device description and performance studies focus on a growth medium and an instrument that detects CO2 levels, indicating microbial growth. There is no mention of AI or ML in the provided text.
No.
The device is described as a bacterial growth medium used for the detection and recovery of microorganisms from blood specimens, not for treating any condition.
Yes
Explanation: The device is used for the qualitative recovery and detection of aerobic microorganisms (bacteria and fungi) from blood specimens, indicating the presence of viable organisms and abnormal conditions, which classifies it as a diagnostic device.
No
The device description clearly states it is a "bacterial growth medium" in a "glass vial" and is used with "BACTEC NR (non-radiometric) blood culture series instruments," indicating it is a physical product with hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "qualitative procedure for the culture and recovery of aerobic microorganisms (mainly bacteria and fungi) from pediatric and other blood specimens." This describes a test performed in vitro (outside the body) on a biological sample (blood) to provide information about a patient's health status (presence of microorganisms).
- Device Description: The description details a "bacterial growth medium" used to detect microorganisms in blood samples. This is a classic example of an IVD component used in a diagnostic process.
- Anatomical Site: The device is used with "blood specimens," which are biological samples taken from the body for diagnostic testing.
- Performance Studies: The document describes clinical studies evaluating the performance of the device in detecting microorganisms in patient blood samples. This type of testing and evaluation is characteristic of IVDs.
The device is designed to be used in vitro to diagnose or provide information about a disease or condition by examining a sample from the human body. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
pediatric and other blood specimens
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
§ 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
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.
1
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 |
| Sodium | ||
| Polyanetholesulfonate(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 Specimen | ||
| Volume | ||
| (maximum ) | 5 mL | 5 mL |
| Recommended Specimen | ||
| Volume | ||
| (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 Headspace | |
| Sampling | Invasive Vial Headspace | |
| Sampling | ||
| Agitation | Orbital Rotator | Orbital Rotator |
| Vial Type | Type III Soda Lime Glass | |
| with Notched Base | Type III Soda Lime Glass | |
| with Notched Base |
- Ingredients list (% is w/v ): Soybean-Casein Digest Broth 2.75%, Hemin 0.0005%, Dextrose
2
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