(22 days)
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WalkAway® S7 System
No
The summary focuses on antimicrobial susceptibility testing panels and revisions to limitations, with no mention of AI or ML technologies.
No.
This device is designed to determine antimicrobial susceptibility and is used for diagnostic purposes by identifying suitable antimicrobial agents, not for directly treating a condition.
Yes
The device determines quantitative and/or qualitative antimicrobial agent susceptibility, which is a diagnostic function to guide treatment decisions.
No
The device is a MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panel, which is a physical panel used for antimicrobial susceptibility testing. It is read on a hardware system (WalkAway® S7 System or equivalent). The submission is a revision to a limitation on this physical panel.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic Gram-Negative bacilli". This is a classic description of an in vitro diagnostic test, as it involves analyzing biological samples (bacterial colonies) outside of the body to provide information for diagnosis or treatment decisions (determining susceptibility to antibiotics).
- Device Name: The name "MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panel" itself suggests a laboratory-based test panel used for diagnostic purposes.
- Reading on a System: The mention of being read on the "WalkAway® S7 System or equivalent" further indicates a laboratory instrument used for processing and analyzing diagnostic tests.
The description clearly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for clinical purposes.
N/A
Intended Use / Indications for Use
MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic Gram-Negative bacilli (Enterobacteriaceae, glucose non-fermenters, and non-Enterobacteriaceae glucose fermenters. After inoculation, panels are read on the WalkAway® S7 System or equivalent (upgraded WalkAway® 40 or WalkAway® 96) according to the Package Insert.
This particular submission is to revise the limitation for the antimicrobial agent Ampicillin and Proteus mirablis on the MicroScan® Synergies plus™ Gram-Negative MICICombo Panels.
The Gram-Negative organisms which may be used for Ampicillin susceptibility testing in this panel are:
Escherichia coli Proteus mirabilis Salmonella spp.
The MicroScan Synergies plus" Gram-Negative with Ampicillin is not intended for use with:
Citrobacter spp. Enterobacter spp. Klebsiella spp. Providencia spp Proteus vulgaris Shigella spp
Product codes
LON
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.”
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The eagle is facing to the right. The logo is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 3 1 2004
Mr. Robert Eusebio Manager Regulatory Affairs Dade MicroScan, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691
Re: K033482
Trade/Device Name: MicroScan® Synergies Plus Gram Negative MIC/Combo Panels with Ampicillin (0.25 - 128 µg/ml)
Regulation Number: 21 CFR 866.1645
Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System
Regulatory Class: II Product Code: LON Dated: July 30, 2004 Received: August 3, 2004
Dear Mr. Eusebio:
This letter corrects our substantially equivalent letter of November 26, 2003, regarding the trade name which was changed to MicroScan® Synergies Plus to better reflect the intended use of the device.
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 (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 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.
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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.
This letter will allow you to continue 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-3084. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Leddie K. Poole for
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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Indications for Use Statement
510(k) Number (if known): K033482
Device Name: MicroScan® Synergies plus" Gram-Negative MIC/Combo Panels with Ampicillin (0.25 -128 ug/ml
Indications For Use:
MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic Gram-Negative bacilli (Enterobacteriaceae, glucose non-fermenters, and non-Enterobacteriaceae glucose fermenters. After inoculation, panels are read on the WalkAway® S7 System or equivalent (upgraded WalkAway® 40 or WalkAway® 96) according to the Package Insert.
This particular submission is to revise the limitation for the antimicrobial agent Ampicillin and Proteus mirablis on the MicroScan® Synergies plus™ Gram-Negative MICICombo Panels.
The Gram-Negative organisms which may be used for Ampicillin susceptibility testing in this panel are:
Escherichia coli Proteus mirabilis Salmonella spp.
The MicroScan Synergies plus" Gram-Negative with Ampicillin is not intended for use with:
Citrobacter spp. Enterobacter spp. Klebsiella spp. Providencia spp Proteus vulgaris Shigella spp
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 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)
Freddie L. Poole
Division Sign-Off
Page 1 of __ 1
ffice of In Vitro Diagnostic Device Evaluation and Safety
510(k) Kb33482