(61 days)
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No
The device description and intended use are focused on a traditional agar diffusion test method using impregnated paper discs. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI or ML. The interpretation relies on standardized procedures and zone sizes determined by the drug manufacturer and FDA approval, not on adaptive or learned patterns.
No
This device is an in vitro diagnostic product used to test the susceptibility of bacteria to an antimicrobial agent, not to treat a patient.
Yes
The device (Antimicrobial Susceptibility Test Discs, specifically Ertapenem 10 µg BBL™ Sensi-Disc™) is used for "semi-quantitative in vitro susceptibility testing" to determine the "susceptibility of bacteria to Ertapenem." This process provides information that helps in the diagnosis and treatment of bacterial infections by guiding antibiotic selection.
No
The device is described as impregnated paper discs used for in vitro susceptibility testing, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the device is used for "semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures." The term "in vitro" is a key indicator of an IVD. It also specifies the purpose is to determine the susceptibility of bacteria to Ertapenem, which is a diagnostic function performed outside of the living body.
- Device Description: The description details the composition and function of the discs, which are used in a laboratory setting for testing.
- Context: The document discusses standardized procedures like the Bauer-Kirby method and mentions regulatory bodies like the FDA and WHO, which are relevant to the regulation of IVDs.
The entire context of the document points to a device used in a laboratory setting to perform diagnostic tests on biological samples (bacteria) outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Ertapenem 10 µg BBL™ Sensi-Disc™ is intended for use in determining the susceptibility to Ertapenem of a wide range of bacteria, as described in the "Indications for Use" section. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, Merck & Co., Inc. and received FDA approval under NDA Number 21-337.
Use of Ertapenem 10 µg, BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Ertapenem. Ertapenem has been shown to be active in vitro against most strains of microorganisms listed below, as described in the Merck & Co., Inc. package insert for this antimicrobic.
Active In Vitro and in clinical infections against:
Aerobic gram-positive microorganisms
- Staphylococcus aureus (methicillin-susceptible strains only)
- Streptococcus agalactiae
- Streptococcus pneumoniae (penicillin-susceptible strains only)
- Streptococcus pyogenes
Aerobic gram-negative microorganisms
- Escherichia coli
- Haemophilus influenzae (beta-lactamase negative strains only)
- Klebsiella pneumoniae
Active In Vitro Against:
Aerobic gram-positive microorganisms
- Streptococcus pneumoniae (penicillin-intermediate strains only)
Aerobic gram-negative microorganisms
- Citrobacter freundii
- Citrobacter koseri
- Enterobacter aerogenes
- Enterobacter cloacae
- Haemophilus influenzae (beta-lactamase positive strains)
- Haemophilus parainfluenzae
- Klebsiella oxytoca (excluding ESBL producing strains)
- Morganella morganii
- Proteus mirabilis
- Proteus vulgaris
- Serratia marcescens
Product codes
JTN
Device Description
Ertapenem 10 µg BBL™ Sensi-Disc™ is prepared by impregnating high quality paper with accurately determined amounts of Ertapenem supplied by the manufacturer, Merck & Co., Inc. Each Ertapenem disc is clearly marked on both sides with the agent and drug content. Ertapenem cartridges each contain 50 impregnated discs that are packed as either a single cartridge in a single box, or in a package containing ten cartridges. Ertapenem discs are used for semi-quantitative in vitro susceptibility evaluations by the agar diffusion test method.
Agar diffusion susceptibility methods employing dried filter paper discs impregnated with specific concentrations of antimicrobial agents were developed in the 1940s. In order to eliminate or minimize variability in the testing, Bauer et al. developed a standardized procedure in which Mueller Hinton Agar was selected as the test medium.
Various regulatory agencies and standards-writing organizations subsequently published standardized reference procedures based on the Bauer-Kirby method. Among the earliest and most widely accepted of these standardized procedures were those published by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO). The procedure was adopted as a consensus standard by the National Committee for Clinical Laboratory Standards (NCCLS) and is periodically updated.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Other BBL™ Sensi-Disc™
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.1620 Antimicrobial susceptibility test disc.
(a)
Identification. An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).
0
MAY 1 5 2002
510(k) Submission
Ertapenem 10 µg Sensi-Disc
Date: March 13, 2002
SUBMITTED BY:
510(k) SUMMARY
Becton Dickinson and Company 7 Loveton Circle Sparks, MD 21152 410-316-4778 Phone: 410-316-4499 Fax:
Michelle B. Bandy, Regulatory Affairs Specialist CONTACT NAME:
March 13, 2002 DATE PREPARED:
Ertapenem 10 µg, BBL™ Sensi-Disc™ Antimicrobial DEVICE TRADE NAME: Susceptibility Test Discs
Antimicrobial Susceptibility Test Discs DEVICE COMMON NAME:
21 CFR§866.1620, Class II (Product Code JTN), DEVICE CLASSIFICATION: Susceptibility Test Discs, Antimicrobial
Other BBL™ Sensi-Disc™ PREDICATE DEVICE: (eg, Ciprofloxacin 5 µg, BBL™ Sensi-Disc™)
INTENDED USE:
Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Ertapenem 10 µg BBL™ Sensi-Disc™ is intended for use in determining the susceptibility to Ertapenem of a wide range of bacteria, as described in the "Indications for Use" section. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, Merck & Co., Inc. and received FDA approval under NDA Number 21-337.
1
Ertapenem 10 ug Sensi-Disc
510(k) SUMMARY
INDICATIONS FOR USE:
Use of Ertapenem 10 µg, BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility OSe of Enaponion 10 pg, there is a need to determine the susceptibility of bacteria to testing is maloutou more has been shown to be active in vitro against most strains of microorganisms listed below, as described in the Merck & Co., Inc. package insert for this antimicrobic.
Active In Vitro and in clinical infections against:
Aerobic gram-positive microorganisms Staphylococcus aureus (methicillin-susceptible strains only) Streptococcus agalactiae Streptococcus pneumoniae (penicillin-susceptible strains only) Streptococcus pyogenes
Aerobic gram-negative microorganisms
Escherichia coli Haemophilus influenzae (beta-lactamase negative strains only) Klebsiella pneumoniae
Active In Vitro Against:
Aerobic gram-positive microorganisms Streptococcus pneumoniae (penicillin-intermediate strains only)
Aerobic gram-negative microorganisms
Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Haemophilus influenzae (beta-lactamase positive strains) Haemophilus parainfluenzae Klebsiella oxytoca (excluding ESBL producing strains) Morqanella morganii Proteus mirabilis Proteus vulgaris Serratia marcescens
2
DEVICE DESCRIPTION:
Ertapenem 10 µg BBL™ Sensi-Disc™ is prepared by impregnating high quality paper with accurately determined amounts of Ertapenem supplied by the manufacturer, Merck & Co., Inc. Each Ertapenem disc is clearly marked on both sides with the agent and drug content. Ertapenem cartridges each contain 50 impregnated discs that are packed as either a single cartridge in a single box, or in a package containing ten cartridges. Ertapenem discs are used for semi-quantitative in vitro susceptibility evaluations by the agar diffusion test method.
Agar diffusion susceptibility methods employing dried filter paper discs impregnated with specific concentrations of antimicrobial agents were developed in the 1940s. In order to eliminate or minimize variability in the testing, Bauer et al. developed a standardized procedure in which Mueller Hinton Agar was selected as the test medium.
Various regulatory agencies and standards-writing organizations subsequently published standardized reference procedures based on the Bauer-Kirby method. Among the earliest and most widely accepted of these standardized procedures were those published by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO). The procedure was adopted as a consensus standard by the National Committee for Clinical Laboratory Standards (NCCLS) and is periodically updated.
DEVICE PRINCIPLE:
Discs containing a wide variety of antimicrobial agents are applied to the surface of Mueller Hinton Agar plates for Haemophilus Test Medium Agar for Haemophilus influenzae or Mueller Hinton Agar with 5% Sheep Blood for Streptococcus species] inoculated with pure cultures of clinical isolates. Following incubation, the plates are examined and the zones of inhibition surrounding the discs are measured and compared with established zone size ranges for individual antimicrobial agents in order to determine the agent(s) most suitable for use in antimicrobial therapy. The categorical interpretation [susceptible (S), intermediate (I), or resistant (R)] for the organism being tested with the antimicrobial agent is made by comparing zone diameters to those found in the respective organism tables of NCCLS Document M2-A7 ("Performance Standards for Antimicrobial Disk Susceptibility Tests - Seventh Edition, Approved Standard", 1/00) and of NCCLS Document M100-S12 ("Performance Standards for Antimicrobial Susceptibility Testing", Twelfth Informational Supplement, 1/02).
3
DEVICE COMPARISON:
The BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Discs - Ertapenem 10 µg is similar to the BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Discs - Ciprofloxacin 5 uq in that:
- Both methods are for antimicrobial susceptibility testing using paper discs ● impregnated with an antimicrobial agent.
- Both methods have the same intended use. .
- Both methods provide the user with antimicrobic minimum inhibitory concentration . (MIC) results based on measurements of zone diameters.
- Both methods require the user to determine categorical interpretations (S///R) using . the measured zone diameters against NCCLS Approved Standards M2 and M100.
- Both methods use pure cultures of bacterial isolates. .
The BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Discs - Ertapenem 10 µg differs from the BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Discs - Ciprofloxacin 5 uq in that:
- BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Discs Ertapenem 10 µg is a . susceptibility test that uses discs impregnated with the antimicrobic Ertapenem at a concentration of 10 ug while the BBL"" Sensi-Disc" Antimicrobial Susceptibility Test Discs - Ciprofloxacin 5 ug is a susceptibility test that uses discs impregnated with the antimicrobic Ciprofloxacin at a concentration of 5 ug.
- BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disc Ertapenem 10 µg is a . susceptibility test used to test a different battery of microorganisms than the BBL™ Sensi-Disc" Antimicrobial Susceptibility Test Disc - Ciprofloxacin 5 ug.
SUBSTANTIAL EQUIVALENCE TESTING DATA:
See the INVANZ™ (Ertapenem for injection) Merck & Co., Inc. drug package insert, "Susceptibility Tests: Diffusion Techniques".
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or bird-like figure, with three curved lines forming the body and wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 5 2002
Ms. Michelle B. Bandy Regulatory Affairs Specialist BD Diagnostic Systems 7 Loveton Circle Sparks, MD 21152
K020842 Re:
Trade/Device Name: BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Discs, Ertapenem 10ug Regulation Number: 21 CFR 866.1620 Regulation Name: Susceptibility Test Discs Regulatory Class: Class II Product Code: JTN Dated: March 13, 2002 Received: March 15, 2002
Dear Ms. Bandy:
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 for associated in 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket I his lotter in all the your ding of substantial equivalence of your device to a legally marketed nothloadon. The FD I Intelligention for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (301) 591 1500. Traditional (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mionitation on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or Manufactor Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known): ___
Device Name: BBL™ Sensi-Disc" Antimicrobial Susceptibility Test Discs, Ertapenem 10ug
Indications for Use:
Use of Ertapenem 10 µg, BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated Use of Ertapenen 10 pg, DDC "Ochor Bloo" to " in " a chapenem. Ertapenem. Ertapenem in the March & Co when there is a need to determine the odsoophisms is active as described in the Merck & Co., Inc. package insert for this antimicrobic.
Active In Vitro and in clinical infections against:
Aerobic gram-positive microorganisms Staphylococcus aureus (methicillin-susceptible strains only) Streptococcus agalactiae Streptococcus pneumoniae (penicillin-susceptible strains only)
Streptococcus pyogenes
Aerobic gram-negative microorganisms
Escherichia coli Haemophilus influenzae (beta-lactamase negative strains only) Klebsiella pneumoniae
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Luddu h. Poole
(DNision Sign-Off) Division of Clinical Laboratory Devices
510(k) Number K020840
Prescription Use
(Per 21 CFR 801.109)
✓
OR
Over-The-Counter Use (Optional Format 1-2-96)