(34 days)
Not Found
No
The description focuses on automated biochemical and growth-based methods for identification and susceptibility testing, with no mention of AI or ML algorithms for data interpretation or prediction.
No.
The device is used for in vitro diagnostic testing (identification and antimicrobial susceptibility testing of bacterial isolates), not for direct treatment or diagnosis of disease in a living patient.
Yes
The device is intended for the rapid identification and antimicrobial susceptibility testing of bacterial isolates, providing information on whether the bacteria are sensitive, intermediate, or resistant to various antimicrobial agents. This information is crucial for diagnosing infections and guiding treatment decisions.
No
The device description explicitly lists hardware components such as the "BD Phoenix instrument" and "BD Phoenix panels," in addition to the software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system is intended for "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." and "in vitro quantitative determination of antimicrobial susceptibility". The term "in vitro" is a key indicator of an IVD.
- Device Description: The description details a system that analyzes biological samples (bacterial isolates from pure culture) outside of the human body using reagents and instruments to provide diagnostic information (identification and susceptibility to antimicrobial agents).
- Performance Studies: The performance studies described (Site Reproducibility and Clinical Studies) are typical evaluations conducted for IVD devices to demonstrate their accuracy and reliability in a laboratory setting.
- Predicate Device(s): The listed predicate devices (VITEK® System and previous BD Phoenix™ systems) are also known IVD devices used for similar purposes.
Therefore, based on the provided information, the BD Phoenix™ Automated Microbiology System is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BD Phoenix™ Automated Microbiology System is intended for in vitro quantiative 11th DD I hooma's antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most decemination of animiero im ultative anaerobic bacteria isolates from pure culture for Oram-hegative acrono and Non-Enteriaceae and most Gram-positive bacteria isolates from pure Enterococcionains to the genera Staphylococcus and Enterococcus.
This premarket notification is for the addition of the antimicrobial agent cefoxitin at concentrations of I ins premation is formeditor is for the addines only Phoenix panels. It will also be used as a test to 1-32 pg mill to Grain Fount Fraphylococcus aureus in these panels. Cefoxitin has been shown to product in vitro against most strains of microorganisms listed below, as described in the FDAapproved package insert for this antimicrobial agent.
Active In Vitro and in Clinical Infections Against:
Staphylococcus aureus® (including penicillinase-producing strains) Staphylococcus epidermidisª
a Staphylococci resistant to methicillin/oxacillin should be considered resistant to cefoxitin.
Product codes (comma separated list FDA assigned to the subject device)
LON
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 contaming drive roughts: 0 Gram-negative or Gram-positive isolate. For cach isolate, an inoculation equivalent to a 0.5 McFarland standard is prepared in Phoenix ID broth.
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, or R (sensitive, intermediate, or resistant).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Substantial Equivalence Studies
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.
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 pancl 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.
Key Results: 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.
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.
Assessment: The performance of the Phoenix System was assessed by calculating the Essential Agreement (EA) and Category Agreement (CA), and comparing these 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, and resistant).
Accuracy: Table 1 summarizes the performance for the isolates tested in this study. The table is not properly formatted and does not specifically provide values for accuracy.
Reproducibility: Testing performed at multiple clinical sites demonstrated >95% reproducibility or greater within ± 1 dilution.
Conclusion: The data collected from the substantial equivalence studies demonstrate that testing on the BD Phocnix™ 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA), Category Agreement (CA)
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.
VITEK® System (PMA No. N50510), K020321, K020323, K020322
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
§ 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.”
0
510(k) SUMMARY
| SUBMITTED BY: | Becton, Dickinson and Company
7 Loveton Circle
Sparks, MD 21152
Phone: 410-316-4287
Fax: 410-316-4499 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT NAME: | Monica E. Giguere
Regulatory Affairs Specialist |
| DATE PREPARED: | November 16, 2005 |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System -
Cefoxitin 1-32 µg/mL |
| DEVICE COMMON NAME: | Antimicrobial susceptibility test system-short incubation |
| DEVICE CLASSIFICATION: | Fully Automated Short-Term Incubation Cycle Antimicrobial
Susceptibility Device, 21 CFR 866.1645 |
| PREDICATE DEVICES: | VITEK® System (PMA No. N50510) and BD Phoenix™
Automated Microbiology System with Gatifloxacin (K020321
May 23, 2002), Ofloxacin (K020323, April 14, 2002), and
Levofloxacin (K020322, March 27, 2002). |
| INTENDED USE: | 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. |
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.
1
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 contaming drive roughts: 0 Gram-negative or Gram-positive isolate. For cach isolate, an inoculation equivalent to a 0.5 McFarland standard is prepared in Phoenix ID broth.
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, or R (sensitive, intermediate, or resistant).
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 pancl 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.
2
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 the Essential Agreement (EA) and Category Agreement (CA), and comparing these 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, and resistant).
Table 1 summarizes the performance for the isolates tested in this study.
Performance of BD Phoenix System for Gram-Positive Organisms by Drug Table 1:
| The Real Charles of Children Comments of the Cases and Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call
Antimicrobia | oncentration | 1
Property | A montal control condi a T answ and parties
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 10
1
September 1972 bir 1970 at posses on posses and | CALL AN WALL PLANT COLLECTION COLLEGION
DAY AND RESEARCE F THE CONSTITUTION OF THE POSTED OF THE |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| I
Concession Commender Comments of Children of
1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
efoxitin | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
. | | VITA | Company | nr |
Conclusions Drawn from Substantial Equivalence Studies
The data collected from the substantial equivalence studies demonstrate that testing on the BD Phocnix™ 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), Ofloxacin (K020323, April 14, 2002), and Levofloxacin (K020322, March 27, 2002).
3
の 2007年の1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年に10000000000000000000000000000000000000000000000000000000000000
SUMMARY INFORMATION FOR CEFOXITIN Available Range 1-32 µg/mL
Performance
Accuracy
| close and the contract and the comments of the mark of the security of
Antimicrobial | Concentration
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the commen
(n
CA | A
(). | Actively of the county of cars of the program
n
. Fr | 10/0 t |
|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|------------------------------------------------------------|---------|
| would be and the work of the county and a second of the county of
cloxilin | र
' ue/mL
ા | 104 | Vir | 104 | OL
ﺮ |
Reproducibility
Testing performed at multiple clinical sites demonstrated >95% reproducibility or greater within ± 1 dilution.
Breakpoints - CLSI and FDA
| and have a would be a was a support
Company of Children Company of Children Company of
A
Company of Children and Carder of The
Acres of the Party of Canadian Company of Concession of Concession of Children
Production In and In armer of
Irganism
CARD THE CALL CALL CONSULT OF CLAIM OF CHAIN CARDED THE | A COLORIO CONTROLLER COLLECTION COLLEGION COLLEGION CONTROLLERS CONTRACTOR COLLEGION
publication and the less of the Research paramation and | A. BUY OF CHERRENT AND A LEARNER OF CHARACT TO AND A BOOK
NAME OF CHARACT A | A LEBEL AND LE
NAME A LIE LEASE CONSULE OF CHARACT CONSULER COLLECTION CONSULTER
ﺑ
A |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
טוויזיאמעומעומעניצערע
CH2CIPC
A M - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A -
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Separate of the count of the pro-
----------------------------------- | | ----- |
Recommended Quality Control Organisms - CLSI and FDA
| Quality Control Strain | MIC Range | Source |
|---|---|---|
| Staphylococcus aureus ATCC 29213 | 1 - 4 $ μ $ g/mL | CLSI |
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 2 2005
Ms. Monica E. Giguere Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
Re: K053241
Trade/Device Name: BD Phoenix™ Automated Microbiology System Cefoxitin (1-32 µg/mL) - Gram Positive ID/AST or AST Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Devices Regulatory Class: Class II Product Code: LON Dated: November 16, 2005 Received: November 18, 2005
Dear Ms. Giguere:
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 r hat 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).
5
Page 2 -
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)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html
Sincerely yours,
Sally, a Hon
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
6
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
| Device Name: | BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent cefoxitin |
|---|---|
| (1-32 µg/mL) - Gram positive ID/AST or AST only Phoenix panels. |
Indications for Use:
The BD Phoenix™ Automated Microbiology System is intended for in vitro quantiative 11th DD I hooma's antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most decemination of animiero im ultative anaerobic bacteria isolates from pure culture for Oram-hegative acrono and Non-Enteriaceae and most Gram-positive bacteria isolates from pure Enterococcionains to the genera Staphylococcus and Enterococcus.
This premarket notification is for the addition of the antimicrobial agent cefoxitin at concentrations of I ins premation is formeditor is for the addines only Phoenix panels. It will also be used as a test to 1-32 pg mill to Grain Fount Fraphylococcus aureus in these panels. Cefoxitin has been shown to product in vitro against most strains of microorganisms listed below, as described in the FDAapproved package insert for this antimicrobial agent.
Active In Vitro and in Clinical Infections Against:
Staphylococcus aureus® (including penicillinase-producing strains) Staphylococcus epidermidisª
a Staphylococci resistant to methicillin/oxacillin should be considered resistant to cefoxitin.
Prescription Use X
AND/OR
Over-The-Counter Use
(Per 21 CFR 801 Subpart D)
(Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Luddi Lu Polo
Division Sign-Off
Office of In ' = " "Lagnostic Device Evaluation an
BD Diagnostic Systems Becton, Dickinson and Company
Page 1
5100(k) K053241