BACTEC PEDS PLUS CLUTURE VIALS

K954924 · Becton Dickinson Diagnostic Instrument Systems · MDB · Feb 8, 1996 · Microbiology

Device Facts

• Record ID: K954924
• Device Name: BACTEC PEDS PLUS CLUTURE VIALS
• Applicant: Becton Dickinson Diagnostic Instrument Systems
• Product Code: MDB · Microbiology
• Decision Date: Feb 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2560
• Device Class: Class 1
• Attributes: Pediatric

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.

Device Story

BACTEC PEDS PLUS Culture Vials are glass vials containing enriched Soybean-Casein Digest Broth, resins, and CO2. Used with BACTEC NR series blood culture instruments. Input: blood specimen inoculated into vial. Principle: microorganisms metabolize substrates, producing CO2; instrument analyzes vial headspace gas via infrared (IR) sensor. Output: instrument indicates positive result if CO2 threshold is exceeded. Used in clinical laboratory settings by trained personnel. Benefits: enhanced recovery of microorganisms from small-volume pediatric samples via antimicrobial-neutralizing resins.

Clinical Evidence

Prospective clinical study at three tertiary pediatric hospitals (n=4,581 paired vials). Primary endpoints: organism recovery and time to detection. Results: 289 clinically significant organisms isolated; PEDS PLUS recovered 256 (88.6%) vs NR6A 214 (74.0%) (p<0.001). In patients on antimicrobial therapy, PEDS PLUS recovered 127 (89%) vs NR6A 98 (69%) (p<0.001). Time to detection was significantly faster for PEDS PLUS (p<0.001).

Technological Characteristics

Type III soda lime glass vial; 20 mL enriched Soybean-Casein Digest Broth; nonionic adsorbing resin (20.0% w/v); cationic exchange resin (1.2% w/v); 0.025% w/v SPS. Detection via infrared (IR) analyzer monitoring headspace CO2. Orbital rotator agitation. Compatible with BACTEC NR series instruments.

Indications for Use

Indicated for the culture and recovery of aerobic bacteria and fungi from pediatric and other blood specimens, typically <3 mL in volume.

Regulatory Classification

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.

Predicate Devices

• BACTEC® NR6A Culture Vials (K954924)

Submission Summary (Full Text)

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K954924

# 510(k) SUMMARY

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

CONTACT: Dennis Mertz, Manager Regulatory Affairs
TELEPHONE: [phone]
FAX: [phone]

PREPARED: October 17, 1995

TRADE NAME: BACTEC® PEDS PLUS™ Culture Vials

COMMON NAME: Blood Culture Medium

CLASSIFICATION NAME: Monitor, Microbial Growth

PREDICATE DEVICE: BACTEC® NR6A Culture Vials

INTENDED 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.

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.

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# SUBSTANTIAL EQUIVALENCE:

Table 1 summarizes the similarities and differences between BACTEC® PEDS PLUS™ Culture Vials and BACTEC® NR6A Culture Vials.

Table 1. Substantial Equivalence of BACTEC® PEDS PLUS™ Culture Vials to 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 0.06%, Sucrose 0.08%, Pyridoxal HCL (Vitamin B₆) 0.001%, Menadione 0.00005% w/v

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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&lt;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&lt;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&lt;0.001). Thus, the performance of BACTEC PEDS PLUS medium was as good as the BACTEC NR6A medium.

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