The BD Phoenix™ Automated Microbiology System is intended for the rapid identification and in vitro antimicrobial susceptibility testing of isolates from pure culture of most aerobic and facultative anaerobic Gram-negative and Gram-positive bacteria of human origin.

The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and Non-Enterobacteriaceae and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus and Enterococcus.

This premarket notification is for the antimicrobial agent amoxicillin-clavulanate at concentrations of 0.25/0.12-32/16 ug/mL to Gram-positive ID/AST or AST only Phoenix panels. Amoxicillin-clavulanate has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobial agent.

Active In Vitro and in Clinical Infections Against:
Staphylococcus aureus (beta-lactamase and non-beta-lactamase producing)

Active In Vitro Against:
Enterococcus faccalis
Staphylococccus epidermidis (beta-lactamase and non-beta-lactamase producing)
Staphylococcus saprophyticus (beta-lactamase and non-beta-lactamase producing)

Device Description

The BD Phoenix Automated Microbiology System (Phoenix System) is an automated system for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically relevant bacterial isolates. The system includes the following components:

BD Phoenix instrument and software.
BD Phoenix panels containing biochemicals for organism ID testing and antimicrobial agents . or AST determinations.
BD Phoenix ID Broth used for performing ID tests and preparing AST Broth inoculum.
BD Phoenix AST Broth used for performing AST tests only.
BD Phoenix AST Indicator solution added to the AST Broth to aid in bacterial growth . determination.

The Phoenix panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells containing dried reagents. Organisms for susceptibility testing must be a pure culture and preliminarily identified as a Gram-negative or Gram-positive isolate. Phoenix panels are inoculated with a specified organism density and placed into the instrument.

The Phoenix AST method is a broth based microdilution test. The Phoenix System utilizes a redox indicator for the detection of organism growth in the presence of an antimicrobial agent. Measurements of changes to the indicator as well as bacterial turbidity are used in the determination of bacterial growth. Each AST panel configuration contains several antimicrobial agents with a wide range of two-fold doubling dilution concentrations.

The instrument houses the panels where they are continuously incubated at a nominal temperature of 35°C. The instrument takes readings of the panels every 20 minutes. The readings are interpreted to give an identification of the isolate, minimum inhibitory concentration (MIC) values and category interpretations, S, I, R or N (susceptible, intermediate, resistant or not susceptible).

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the BD Phoenix™ Automated Microbiology System for Amoxicillin-clavulanate, structured according to your requested information.

1. A table of acceptance criteria and the reported device performance

Performance Metric	Acceptance Criteria (Implicit from FDA Guidance)	Reported Device Performance
Essential Agreement (EA)	Generally > 90%	94.1%
Category Agreement (CA)	Generally > 90%	96.7%
Reproducibility	Generally > 90%	Intra-site: > 90% Inter-site: > 95%

Note: The acceptance criteria are "generally >90%" for these types of devices based on the referenced FDA Draft guidance document, "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000. Specific numerical thresholds are not explicitly stated as "acceptance criteria" in the document, but rather performance demonstrated to be "substantially equivalent."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: 871 isolates (combined clinical, stock, and challenge isolates).
Data Provenance:
- Country of Origin: United States ("multiple geographically diverse sites across the United States").
- Retrospective/Prospective: Not explicitly stated, but the mention of "clinical, stock and challenge isolates" being tested and clinical isolates being compared to a reference method suggests a blend. "Clinical isolates" would likely be prospective or recently collected if they were concurrently tested with the reference method. "Stock and challenge isolates" are typically existing, well-characterized collections.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not mention the use of human experts to establish ground truth for the test set.
Instead, the ground truth for clinical isolates was established by comparison to a CLSI reference broth microdilution method.
For challenge isolates, it was compared to "expected results," which typically refers to established and validated results for those specific strains.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

There was no mention of an adjudication method involving human experts for the test set.
The comparison was directly between the BD Phoenix System's results and the reference method or expected results.

5. 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, an MRMC comparative effectiveness study was not done. This study assesses the performance of an automated system (BD Phoenix) against a reference laboratory method, not the improvement of human readers with or without AI assistance. The BD Phoenix is a standalone automated susceptibility test system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, a standalone study was done. The entire study presented is a standalone performance assessment of the BD Phoenix™ Automated Microbiology System (device/algorithm only) compared to the CLSI reference broth microdilution method without human intervention during the interpretation phase by the device. The device itself interprets the readings to determine MIC values and category interpretations.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Clinical Isolates: The ground truth was established by the CLSI reference broth microdilution method. The CLSI (Clinical and Laboratory Standards Institute) method is a standardized, well-accepted laboratory procedure considered the gold standard for antimicrobial susceptibility testing.
Challenge Isolates: The ground truth was based on "expected results" for these characterized strains.

8. The sample size for the training set

The document does not provide information on the sample size for the training set. The 510(k) summary focuses on the validation of the device's performance, not its development or training data.

9. How the ground truth for the training set was established

The document does not provide information on how the ground truth for the training set was established, as it does not discuss the training phase of the device.

Summary

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K061673
CONFIDENTIAL AND PROPRIETARY

510(k) SUMMARY

SUBMITTED BY:	JUL 2 8 2006Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4161Fax: 410-316-4499
CONTACT NAME:	Vicki L. Kennedy,Regulatory Affairs Specialist
DATE PREPARED:	June 13, 2006
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System -Amoxicillin-clavulanate 0.25/0.12-32/16 ug/mL
DEVICE COMMON NAME:	Antimicrobial susceptibility test system-short incubation
DEVICE CLASSIFICATION:	Fully Automated Short-Term Incubation Cycle AntimicrobialSusceptibility Device, 21 CFR 866.1645
PREDICATE DEVICES:	VITEK® System (PMA No. N50510) and BD Phoenix™Automated Microbiology System with Gatifloxacin (K020321,May 23, 2002 and K060324, May 25, 2006), Ofloxacin(K020323, April 14, 2002), and Levofloxacin (K020322, March27, 2002).
INTENDED USE:	The BD Phoenix™ Automated Microbiology System isintended for the rapid identification and in vitro antimicrobialsusceptibility testing of isolates from pure culture of mostaerobic and facultative anaerobic Gram-negative and Gram-positive bacteria of human origin.

DEVICE DESCRIPTION:

BD Phoenix instrument and software. ●
BD Phoenix panels containing biochemicals for organism ID testing and antimicrobial agents . or AST determinations.
BD Phoenix ID Broth used for performing ID tests and preparing AST Broth inoculum. .
BD Phoenix AST Broth used for performing AST tests only. .
BD Phoenix AST Indicator solution added to the AST Broth to aid in bacterial growth . determination.

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DEVICE COMPARISON:

The BD Phoenix™ Automated Microbiology System demonstrated substantially equivalent performance when compared with the CLSI reference broth microdilution method. This premarket notification provides data supporting the use of the BD Phoenix™ Automated Microbiology System Gram positive ID/AST or AST only Phoenix panels with this antimicrobial agent.

SUMMARY OF SUBSTANTIAL EQUIVALENCE TESTING:

The BD Phoenix™ Automated Microbiology System has demonstrated substantially equivalent performance when compared to the CLSI reference broth microdilution method (AST panels prepared according to NCCLS M7). The system has been evaluated as defined in the FDA Draft guidance document, "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000.

Site Reproducibility

Intra- and inter-site reproducibility of this antimicrobial agent in the BD Phoenix System was evaluated at three sites using a panel of Gram-positive isolates. Each site tested the isolates in triplicate on three different days using one lot of Gram Positive Phoenix panels containing this antimicrobial agent and associated reagents.

The results of the study demonstrate for the this antimicrobial agent there was an overall intra-site reproducibility of greater than 90% and an overall inter-site reproducibility greater than 95% for the Gram-positive isolates tested.

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Clinical Studies

Clinical, stock and challenge isolates were tested across multiple geographically diverse sites across the United States to demonstrate the performance of the Phoenix antimicrobial susceptibility test with the Gram Positive Phoenix Panel format containing this antimicrobial agent. Phoenix System results for Challenge set isolates were compared to the expected results. Phoenix System results for clinical isolates were compared to the results obtained from the CLSI reference broth microdilution method.

The performance of the Phoenix System was assessed by calculating Essential Agreement (EA) and Category Agreement (CA) to expected/reference results for all isolates tested. Essential Agreement (EA) occurs when the BD Phoenix™ Automated Microbiology System agrees exactly or within + one two-fold dilution to the reference result. Category Agreement (CA) occurs when the BD Phoenix™ Automated Microbiology System agrees with the reference method with respect to the FDA categorical interpretive criteria (susceptible, intermediate, resistant or not susceptible).

Table 1 summarizes the performance for the isolates tested in this study.

Table 1: Performance of BD Phoenix System for Gram-Positive Organisms by Drug

Antimicrobial	Concentration	EA (n)	EA (%)	CA (n)	CA (%)
Amoxicillin-clavulanate	0.25/0.12-32/16 $\mu$ g/mL	871	94.1	871	96.7

Conclusions Drawn from Substantial Equivalence Studies

The data collected from the substantial equivalence studies demonstrate that testing on the BD Phoenix™ Automated Microbiology System with this antimicrobial agent is substantially equivalent as outlined in the FDA draft guidance document, "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000. Technological characteristics of this system are substantially equivalent to those used in the VITEK® system, which received approval by the FDA under PMA number N50510 and BD Phoenix™ Automated Microbiology System with Gatifloxacin (K020321, May 23, 2002 and K060324, May 25, 2006), Ofloxacin (K020323, April 14, 2002), and Levofloxacin (K020322, March 27, 2002).

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SUMMARY INFORMATION FOR AMOXICILLIN-CLAVULANATE Available Range 0.25/0.12-32/16 µg/mL

Performance

Accuracy

Antimicrobial	Concentration	EA (n)	EA (%)	CA (n)	CA (%)
Amoxicillin-clavulanate	0.25/0.12-32/16 µg/mL*	871	94.1	871	96.7

Performance excludes methicillin-resistant staphylococci

Reproducibility

Testing performed at multiple clinical sites demonstrated 95% reproducibility or greater within ± 1 dilution.

Breakpoints - CLSI

Organism	S	I	R
Staphylococcus spp.	$\leq4/2$	--	$\geq8/4$
Enterococcus spp.	$\leq8/4$	--	$\geq16/8$

Recommended Quality Control Organisms

Quality Control Strain	MIC Range	Source
Staphylococcus aureus ATCC 29213	0.12/0.06 - 0.5/0.25 $ µg/mL $	CLSI
Enterococcus faecalis ATCC 29212	0.25/0.12 – 1.0/0.5 $ µg/mL $	CLSI

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure, composed of three curved lines or strokes.

Public Health Service

JUL 2 8 2006

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Vicki L. Kennedy Regulatory Affairs Specialist Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152

K061673 Re: Trade/Device Name: BD Phoenix™ Automated Microbiology System - Amoxicillinclavulanate 0.25/0.12-32/16 ug/mL Regulation Number: 21 CFR § 866.1645 Regulation Name: Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: II Product Code: LON Dated: June 13, 2006 Received: June 14, 2006

Dear Ms. Kennedy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sally, anthony

Sally A. Hojvat. M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number: ¥ 0616 13

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent amoxicillin-clavulanate (0.25/0.12-32/16 µg/mL) - Gram-positive ID/AST or AST only Phoenix Panels.

Indications for Use:

Active In Vitro and in Clinical Infections Against:

Staphylococcus aureus (beta-lactamase and non-beta-lactamase producing)

Active In Vitro Against:

Enterococcus faccalis Staphylococccus epidermidis (beta-lactamase and non-beta-lactamase producing) Staphylococcus saprophyticus (beta-lactamase and non-beta-lactamase producing)

Prescription Use (Per 21 CFR 801.109) Over-the-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Luddi tu. Paola

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K221673

Regulation Number and Section

§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.

(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”