Predicate Devices

Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a culture medium and an instrument that detects changes in oxygen concentration due to microbial growth. There is no mention of AI or ML in the device description, intended use, or performance studies. The detection mechanism is based on a sensor and fluorescence, not algorithmic learning.

Therapeutic

No
The device is a culture medium used for the qualitative culture and recovery of microorganisms from blood and sterile body fluids. It is intended for diagnostic purposes, not for treating diseases or conditions.

Diagnostic

Yes

Explanation: The device is a culture medium used with an instrument to detect the presence of microorganisms (mycobacteria, yeast, and fungi) in blood and sterile body fluids, which is a diagnostic function.

SaMD (Software as a Medical Device)

No

The device is a culture medium vial containing physical components (broth formulation, sensor) and is used in conjunction with a physical instrument (BD BACTEC fluorescent series instruments). It is not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states it's a "nonselective culture medium to be used as an adjunct to aerobic blood culture media for the qualitative culture and recovery of mycobacteria, yeast and fungi from blood." It also mentions use for "culture of sterile body fluids when yeast or fungi are suspected." This clearly indicates it's used to examine specimens derived from the human body to provide information for diagnostic purposes.
Device Description: The description details a culture medium designed to support the growth of specific microorganisms from patient samples (blood and sterile body fluids). The sensor and instrument interaction are part of the diagnostic process to detect the presence of these microorganisms.
Performance Studies: The document includes extensive performance studies (Precision/Reproducibility, Detection Limit, False Positive/Negative Rates, etc.) which are typical for IVD devices to demonstrate their analytical and clinical performance.
Predicate Device: The mention of predicate devices (BD BACTEC Myco/f Lytic Culture Vials) with K numbers indicates that this device is being compared to previously cleared IVD devices.

All these factors align with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for the diagnosis, treatment, or prevention of disease.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

BD BACTEC Myco/F Lytic culture medium when used with the BD BACTEC fluorescent series instruments is a nonselective culture medium to be used as an adjunct to aerobic blood culture media for the qualitative culture and recovery of mycobacteria, yeast and fungi from blood. This medium may also be used for the culture of sterile body fluids when yeast or fungi are suspected.

Additional information

The device aids in the diagnosis of disease caused by pathogenic microorganisms and is automated on the BD BACTEC fluorescent series instruments.

Product codes (comma separated list FDA assigned to the subject device)

MDB

Device Description

BD BACTEC Myco/F Lytic culture medium is a Middlebrook 7H9 and Brain Heart Infusion broth formulation for the recovery of mycobacteria from blood specimens, and yeast and fungi from blood and sterile body fluids. Specific modifications were made to enhance the growth and recovery of mycobacteria, yeast and fungi. These modifications include ferric ammonium citrate to provide an iron source for specific strains of mycobacteria and fungi, the addition of saponin as a blood lysing agent, and the addition of specific proteins and sugars to provide nutritional supplements. Each vial contains a sensor which can detect decreases in oxygen concentration in the vial resulting from microorganism metabolism and growth. The sensor is monitored by the BD BACTEC fluorescent series instrument for increasing fluorescence, which is due to the decrease in oxygen. A positive determination indicates the presumptive presence of viable microorganisms in the vial.

BD BACTEC Myco/F Lytic Culture Vials are supplied in a carton containing 50 vials. It is a nonsterile product.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

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Input Imaging Modality

Not Found

Anatomical Site

Blood, sterile body fluids

Indicated Patient Age Range

Adult

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

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)

Precision/Reproducibility:

Blood Volumes: Evaluated at 1mL, 3mL, 5mL blood volumes across three lots. Inoculum levels of 0-1, 1-10, and 10-100 CFU were used. No statistically significant differences in organism detection times or percent recovery.
Sterile Body Fluid Volumes: Evaluated at pleural, synovial, and cerebrospinal fluid types, four volumes (0.5mL, 1mL, 3mL, 5mL) across three lots. Inoculum levels of 0-1, 1-10, and 10-100 CFU were used. No statistically significant differences in organism detection times or percent recovery.

Microbial Detection Limit (MDL) in blood (0-1, 1-10 CFU/vial):

Sample Size: 412 paired vials (23 organisms x 3 lots x 3 blood vol x 2 inoculum levels x 1 instrument, with 2 pairs discarded).
Key Results: The plastic device performed equivalently or better than the predicate glass device for all organisms, with the exception of Blastomyces dermatitidis (ratio of positive yields 0.33), which showed inconsistent growth.

Microbial Detection Limit (MDL) in Sterile Body Fluid (SBF) (0-1, 1-10 CFU/vial):

Sample Size: 264 paired vials (variable organisms x 3 lots x 4 SBF volumes x 2 inoculum levels x 1 instrument).
Key Results: The plastic device performed equivalently or better than the predicate glass device for all organisms, with the exception of Blastomyces dermatitidis (ratio of positive yields 0.86), which showed inconsistent growth.

Delayed Entry in blood for Mycobacteria:

Study Type: Internal seeded study.
Key Results: 100% recovery of 8 mycobacterium strains with delayed entry up to 96 hours at 20-25°C.

Instrument Time to Detection (TTD) study in blood:

Study Type: Combined Percent Recovery and Microbial Detection Limit studies.
Sample Size: Not explicitly stated as a single number, but based on the combined studies data.
Key Results: The plastic device performed equivalently to or better than the predicate vial for all conditions, with the exception of Dimorphic Fungi at an inoculum concentration of 0-1 CFU/vial at 1 mL blood volume and Mycobacteria at 1-10 CFU/vial and 1mL blood volume.

Instrument Time to Detection (TTD) study in SBF:

Study Type: Combined Percent Recovery and Microbial Detection Limit studies.
Sample Size: Not explicitly stated as a single number, but based on the combined studies data.
Key Results: The plastic device performed equivalently to or better than the predicate vial for all conditions, with the exception of Dimorphic Fungi under some test conditions.

Percent Recovery (Detection) Study in Blood (10-100 CFU/Vial):

Sample Size: 207 paired sets.
Key Results: 99.52% recovery for plastic vials vs 100% for glass vials. One negative result for plastic vial with Blastomyces dermatitidis.

Percent Recovery (Detection) Study in SBF (10-100 CFU/Vial):

Sample Size: 132 paired sets.
Key Results: 100% recovery for plastic vials vs 99.24% for glass vials. One negative result for glass vial with Candida auris.

False Positive Rate (Instrument-positive, subculture-negative) in Blood:

Sample Size: 143 paired sets.
Key Results: False positive rate for plastic vial for all fresh blood volume combined was 0.70%, lower than 25.87% for predicate vials (glass).

False Positive Rates (Instrument-positive, subculture-negative) in Sterile Body Fluid:

Sample Size: 425/424 paired vials (after contamination exclusions).
Key Results: False positive rate for all sterile body fluids combined was 0.47% in the test vial (plastic) and 0.71% in the predicate vial (glass).

False Negative Rates (Instrument-negative, subculture-positive) in Blood:

Sample Size: 619 paired sets.
Key Results: False negative rates for predicate (glass) vial and plastic vial were 0.48% (3/619) and 0.65% (4/619), respectively. Not statistically significant.

False Negative Rates (Instrument-negative, subculture positive) in Sterile Body Fluid:

Sample Size: 396 paired sets.
Key Results: False negative rates for predicate (glass) vial and plastic vial were 1.01% (4/396) and 1.52% (6/396), respectively. Not statistically significant.

BD BACTEC Instrument Compatibility Study (Blood and SBF):

Study Type: Evaluated three lots of plastic and glass vials using four BACTEC fluorescent instruments (FX, FX-40, 9240, and 9050). Six organisms were evaluated for blood, four for SBF.
Key Results: The study demonstrated that the four instruments performed equivalently, and they are compatible with the BD BACTEC Myco/F Lytic culture medium in plastic vials.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

False Positive Rate in Blood:

Plastic: 0.70%
Glass (Predicate): 25.87%

False Positive Rate in Sterile Body Fluid:

Plastic: 0.47%
Glass (Predicate): 0.71%

False Negative Rate in Blood:

Plastic: 0.65% (4/619)
Glass (Predicate): 0.48% (3/619)

False Negative Rate in Sterile Body Fluid:

Plastic: 1.52% (6/396)
Glass (Predicate): 1.01% (4/396)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K970333, K970512

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY

I Background Information:

A 510(k) Number

K222559

B Applicant

Becton, Dickinson and Company

C Proprietary and Established Names

BD BACTEC Myco/F Lytic Culture Vials

D Regulatory Information

| Product
Code(s) | Classification | Regulation
Section | Panel |
|--------------------|-------------------|--------------------------------------------------|-------------------|
| MDB | Class I, reserved | 21 CFR 866.2560 -
Microbial Growth
Monitor | MI - Microbiology |

II Submission/Device Overview:

Purpose for Submission: র

To obtain a substantial equivalence determination for a premarket notification for the BD BACTEC™ Myco F/Lytic Culture Vials (plastic).

B Measurand:

Aerobic microorganisms (mycobacteria, yeast, and fungi) from blood Aerobic microorganisms (yeast, and fungi) from sterile body fluids

C Type of Test:

Liquid culture medium for recovery of microorganisms from blood and sterile body fluids using fluorescent technology to detect decreases in O2 resulting from the metabolism and growth of microorganisms.

III Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov

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B Indication(s) for Use:

BD BACTEC Myco/F Lytic culture medium when used with the BD BACTEC fluorescent series instruments is a nonselective culture medium to be used as an adjunct to aerobic blood culture media for the qualitative culture and recovery of mycobacteria, yeast and fungi from blood. This medium may also be used for the culture of sterile body fluids when veast or fungi are suspected.

Additional information

The device aids in the diagnosis of disease caused by pathogenic microorganisms and is automated on the BD BACTEC fluorescent series instruments.

C Special Conditions for Use Statement(s): Rx - For Prescription Use Only

D Special Instrument Requirements:

BACTEC fluorescent series instruments BACTEC FX, BACTEC FX40, BACTEC 9240 and BACTEC 9050 were evaluated using software versions listed below:

Instrument	Software Version
BACTEC FX	6.40A or 6.40W*
BACTEC 9240	4.95A
BACTEC 9050	2.01A2
BACTEC FX40	3.40A
STATE A CETT " A " TET" 1 " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "

*6.40W is the Window-based version of 6.40A

IV Device/System Characteristics:

A Device Description:

BD BACTEC Myco/F Lytic culture medium is a Middlebrook 7H9 and Brain Heart Infusion broth formulation for the recovery of mycobacteria from blood specimens, and yeast and fungi from blood and sterile body fluids. Specific modifications were made to enhance the growth and recovery of mycobacteria, yeast and fungi. These modifications include ferric ammonium citrate to provide an iron source for specific strains of mycobacteria and fungi, the addition of saponin as a blood lysing agent, and the addition of specific proteins and sugars to provide nutritional supplements. Each vial contains a sensor which can detect decreases in oxygen concentration in the vial resulting from microorganism metabolism and growth. The sensor is monitored by the BD BACTEC fluorescent series instrument for increasing fluorescence, which is due to the decrease in oxygen. A positive determination indicates the presumptive presence of viable microorganisms in the vial.

BD BACTEC Myco/F Lytic Culture Vials are supplied in a carton containing 50 vials. It is a nonsterile product.

Principle of Operation: B

The BD BACTEC Myco/F Lytic Culture Vial is designed for the rapid detection of mycobacteria in blood, and yeast and fungi in blood and sterile body fluids. Specimens are inoculated into the BD BACTEC Myco/F Lytic vial either with a syringe or direct draw with a needle and tubing. The vial is placed into the BD BACTEC fluorescent series instrument and is continuously

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agitated and incubated at 35°C for maximum recovery. The default testing protocol is 42 days. The recommended testing protocols for the following organisms are: 7 days for yeast, 30 days for filamentous fungi, and 42 days for mycobacteria and dimorphic fungi. Each vial contains a sensor which can detect decreases in oxygen concentration in the vial resulting from microorganism metabolism and growth. The sensor is monitored by the BD BACTEC fluorescent series instrument every ten minutes. Analysis of the rate of oxygen decrease as measured by increasing fluorescence enables the BD BACTEC fluorescent series instrument to determine if the vial is instrument positive determination indicates the presumptive presence of viable microorganisms in the vial. Detection is limited to microorganisms that will grow in the medium at 35 ℃. The medium is not selective and will support the growth of other aerobic organisms including bacteria which may interfere, if present, with the recovery of slower growing mycobacteria, yeast and fungi. Culture vials which remain negative after the completion of protocol, and which show no visible sign of positivity are removed from the instrument and sterilized prior to discarding. This qualitative culture functions as an aid to diagnosis and is automated on the BD BACTEC fluorescent series instrument.

V Substantial Equivalence Information:

Predicate Device Name(s): A

BD BACTEC Myco/f Lytic Culture Vials

Predicate 510(k) Number(s): B K970333, K970512

C Comparison with Predicates

| Device & Predicate
Device(s): | Dev
ice: | Predicate
: K970333,
K970512 |
|--------------------------------------------------|------------------------------------------------------------------------|----------------------------------------|
| | K22
255
9 | |
| Device Trade Name | BD BACTEC Myco/F Lytic Culture Vial
(plastic) | BD BACTEC Myco/F Lytic Culture
Vial |
| General Device
Characteristic
Similarities | | |
| Regulation | 21 CFR § 866.2560 | Same |
| Product Code | MDB | Same |
| Classification | Class I | Same |
| Detection used | BD BACTEC™ Fluorescent instrument
series | Same |
| Sample Source | Blood Culture, Sterile Body fluids | Same |
| Volume | 1 mL - 5.0 mL | Same |
| Protocol Length | 42 days for
Mycobacteria 7
days for Yeast
30 days for Fungi | Same |
| Target population | Adult | Same |
| General Device
Characteristic
Differences | | |
| | BD BACTEC™ Myco/F Lytic culture
medium when used with the BD BACTEC | |

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| Intended Use/Indications
for Use | fluorescent series instruments is a
nonselective culture medium to be used as
an adjunct to aerobic blood culture media
for the qualitative culture and recovery of
mycobacteria, yeast and fungi from blood.
This medium may also be used for the
culture of sterile body fluids when yeast or
fungi are suspected.
Additional information
The device aids in the diagnosis of disease
caused by pathogenic microorganisms and
is
automated on the BD BACTEC™
fluorescent
series instruments. | BD BACTEC™ Myco/F Lytic culture
medium when used with the BD BACTEC
fluorescent series instruments is a
nonselective culture medium to be used as an
adjunct to aerobic blood culture media for
the recovery of mycobacteria, yeast and
fungi from blood. This medium may also be
used for the culture of sterile body fluids
when yeast or fungi are suspected. |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Vial Material | Plastic | Glass |
| Vial Weight | 21.5 grams | 102.05 grams |
| Vial Height | 5.0 inches | 5.6 inches |
| Delayed Vial Entry
Studies | Included | Not Included |

VI Standards/Guidance Documents Referenced:

CLSI. Principles and Procedures for Blood Cultures. 2nd ed. CLSI guideline M47. Clinical and Laboratory Standards Institute; 2022.

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:

Blood Volumes

The BACTEC Myco/F Lytic (plastic) vial was evaluated at three different blood volumes (1mL, 3mL, 5mL) across three lots in Time-To- Detection (TTD) and Percent Recovery studies. Different lots of key raw materials were used to manufacture each lot of culture media. Inoculum levels of 0-1, 1-10, and 10-100 CFU were used in the analysis. Results of the reproducibility study demonstrated no statistically significant differences in organism detection times or percent recovery with blood specimens between the three different lots of BACTEC Myco/F Lytic (plastic) vials.

Sterile Body Fluid Volumes

The BACTEC Myco/F Lytic (plastic) vial was evaluated at three different sterile body fluid types (pleural, synovial, and cerebrospinal), four different volumes (0.5mL, 1mL, 3mL, 5mL) across three lots in Time-To- Detection (TTD) and Percent Recovery studies. Different lots of key raw materials were used to manufacture each lot of culture media. Inoculum levels of 0-1, 1-10, and 10-100 CFU were used in the analysis. Results of the reproducibility study demonstrated no statistically significant differences in organism

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detection times or percent recovery with sterile body fluid specimens between the three different lots of BACTEC Myco/F Lytic (plastic) vials.

1. Linearity:
  Not applicable
1. Analytical Specificity/Interference:
  Not applicable
1. Assay Reportable Range:
  Not applicable
1. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

Quality Control

An internal validation study across three lots with a target inoculum level of 10-100 CFU per vial was conducted using organisms listed below:

Table 1: Quality Control Organism and TTD Range

| QC Organism
ATCC® Strain | Time-To-Detection (TTD)
(Days) |
|-----------------------------------------------|-----------------------------------|
| Candida glabrata ATCC 15545 |