(210 days)
Not Found
Not Found
Yes
The document explicitly mentions an "expert system feature," which is a type of AI technology.
No
The device is used to read and manage susceptibility test data, providing information for clinicians, bacteriologists, and epidemiologists, but it does not directly treat or diagnose any medical condition.
Yes
The device reads susceptibility test data and compiles reports for clinicians, bacteriologists, and epidemiologists to use, which is a diagnostic function.
No
The device description explicitly states that SIRSCAN consists of two components, one of which is the "SIRSCAN automated zone reader device" which is described as a "video-camera image analysis computer-based system". This indicates the presence of hardware (video-camera) in addition to the software components.
Based on the provided information, the SIRSCAN device is an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The primary intended use is to read and interpret susceptibility test data from Kirby-Bauer disk-diffusion test plates. This test is performed on biological samples (bacterial cultures) in vitro (outside the body) to determine the susceptibility of microorganisms to antimicrobial agents. The results are used by clinicians and bacteriologists to guide patient treatment.
- Device Description: The device is specifically designed to automate the reading and management of data from these in vitro susceptibility tests. It processes images of the test plates and manages the resulting data.
- Context: The device is used in a laboratory setting by bacteriologists, which is a typical environment for IVD devices.
The fact that it uses image analysis and an "expert system feature" to process and interpret data from in vitro tests strongly aligns with the definition of an IVD device.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device. The entire 'Control Plan Authorized (PCCP) and relevant text' section is marked as 'Not Found'.
Intended Use / Indications for Use
The SIRSCAN automated zone reader device is a video-camera image analysis computer-based system to read susceptibility test data from NCCLS M2-A6 Kirby-Bauer disk-diffusion test plates for the following organisms: enterobacteriacae; staphylococci, (except coagulase negative staphylococci with weak growth); and non-fermenting gram negative bacilli (except strains with weak growth). Other susceptibility tests on solid medium are read with the electronic caliper, and the results of susceptibility tests in other media can be keved in manually.
The SIRSCAN data management system compiles data from the NCCLS agar disk diffusion test. It prints, files and produces integrated results reports, reqularly or on request, to be used by clinicians, bacteriologists and epidemiologists. Its expert system feature offers consistency checks for validation of tests and results.
In addition, the SIRSCAN data management system: interprets zones; calculates MICs; provides quality control and epidemiology and infection control; identifies and eliminates duplicates: compares patient histories: classifies and monitors resistance phenotypes; monitors multi-resistant organisms; detects and monitors nosocomial infections; and prepares epidemiological statistics.
SIRSCAN can be connected to any laboratory management system, as well as to some micro-dilution systems (e.g., Vitek™, Microscan™).
Product codes (comma separated list FDA assigned to the subject device)
KZK
Device Description
SIRSCAN is an automatic reader of petri dishes that is used to manage overall susceptibility tests. The SIRSCAN is an automated susceptibility reader and interpretation system. It consists of two components:
(1) The SIRSCAN automated zone reader device is a video-camera image analysis computer-based system to read susceptibility test data from NCCLS M2-A6 Kirby-Bauer disk-diffusion test plates for the following organisms: enterobacteriacae; staphylococci, (except coagulase negative staphylococci with weak growth); and non-fermenting gram negative bacilli (except strains with weak growth). Other susceptibility tests on solid medium are read with the electronic caliper, and the results of susceptibility tests in other media can be keyed in manually.
(2) The SIRSCAN data management system compiles data from the NCCLS agar disk diffusion test. It prints, files and produces integrated results reports, regularly or on request, to be used by clinicians, bacteriologists and epidemiologists. Its expert system feature offers consistency checks for validation of tests and results.
In addition, the SIRSCAN data management system: interprets zones; calculates MICs; provides quality control and epidemiology and infection control; identifies and eliminates duplicates; compares patient histories; classifies and monitors resistance phenotypes; monitors multi-resistant organisms; detects and monitors nosocomial infections; and prepares epidemiological statistics.
SIRSCAN can be connected to any laboratory management system, and to some micro-dilution systems (e.g., VitekTM, MicroscanTM).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
Medeiros, A. And Crellin, J., Evaluation of the SIRSCAN Automated Zone Reader in a Clinical Microbiology Laboratory, Brown University (1998). See Appendix C.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
§ 866.2850 Automated zone reader.
(a)
Identification. An automated zone reader is a mechanical device intended for medical purposes to measure zone diameters of microbial growth inhibition (or exhibition), such as those observed on the surface of certain culture media used in disc-agar diffusion antimicrobial susceptibility tests. The device aids in decisionmaking respecting the treatment of disease.(b)
Classification. Class I (general controls).
0
APPENDIX H
510(k) SUMMARY i2a Corporation SIRSCAN
This 510(k) summary of safety and effectiveness for SIRSCAN is submitted in accordance with the requirements of SMDA and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
| Applicant: | i2a Corporation (Intelligence Artificielle Applications) |
|---|---|
| Address: | Parc de la Méditerranée |
| BP 42 | |
| 34470 PEROLS Cedex | |
| FRANCE | |
| Contact Person: | Mr. Jean-Philippe Duverge, Managing Director |
| Telephone: | 011-33-467-504-800 |
| Preparation Date: | June 1998 |
| Device Trade Name: | SIRSCAN™ |
| Common Name: | Automatic Zone Reader |
| Classification Name: | Automated Zone Reader (see 21 C.F.R. § 866.2850) |
| Product Code: KZK | |
| Device Description: | SIRSCAN is an automatic reader of petri dishes that is used |
| to manage overall susceptibility tests. The SIRSCAN is an | |
| automated susceptibility reader and interpretation system. It | |
| consists of two components: | |
| (1) The SIRSCAN automated zone reader device is a | |
| video-camera image analysis computer-based system to | |
| read susceptibility test data from NCCLS M2-A6 Kirby- | |
| Bauer disk-diffusion test plates for the following organisms: | |
| enterobacteriacae; staphylococci, (except coagulase | |
| negative staphylococci with weak growth); and non- | |
| fermenting gram negative bacilli (except strains with weak | |
| growth). Other susceptibility tests on solid medium are read | |
| with the electronic caliper, and the results of susceptibility | |
| tests in other media can be keyed in manually. |
1
| | (2) The SIRSCAN data management system compiles data
from the NCCLS agar disk diffusion test. It prints, files and
produces integrated results reports, regularly or on request,
to be used by clinicians, bacteriologists and epidemiologists.
Its expert system feature offers consistency checks for
validation of tests and results. |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | In addition, the SIRSCAN data management system:
interprets zones; calculates MICs; provides quality
control and epidemiology and infection control;
identifies and eliminates duplicates; compares patient
histories; classifies and monitors resistance
phenotypes; monitors multi-resistant organisms;
detects and monitors nosocomial infections; and
prepares epidemiological statistics. |
| | SIRSCAN can be connected to any laboratory management
system, and to some micro-dilution systems (e.g., VitekTM,
MicroscanTM). |
| Intended Use: | SIRSCAN is intended for the management of overall |
| | susceptibility tests for the following organisms: |
| | Enterobacteriacae, staphylococci (expert coagulase negative |
| | staphylococci with weak growth), and non-fermenting gram |
| | negative bacilli (except strains with weak growth). |
| Performance Data: | Medeiros, A. And Crellin, J., Evaluation of the SIRSCAN
Automated Zone Reader in a Clinical Microbiology
Laboratory, Brown University (1998). See Appendix C. |
| CONCLUSIONS: | Based on the foregoing and other information in this |
| | application, i2a Corporation believes that the performance |
| | data provide reasonable assurance of the safety and |
| | effectiveness of SIRSCAN for its proposed indications for |
| | use. Further, SIRSCAN is substantially equivalent to the |
| | claimed predicates under conditions of intended use. |
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human figures, represented by flowing lines, suggesting unity and cooperation.
NOV 23 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Intelligence Artificielle Applications (i2a) Corp. Mr. Marc J. Scheineson, Esq. c/o Reed Smith Shaw & McClay 1301 K Street, N.W. Suite 1100 - East Tower Washington, D.C. 20005-3317
K991473 Re: Trade Name: SIRSCANTM Regulatory Class: II Product Code: KZK Dated: September 27, 1999 Received: September 28, 1999
Dear Mr. Scheineson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 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, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
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
4
APPENDIX C
LABELING/INDICATIONS FOR USE
Application Number (if known): _______________________________________________________________________________________________________________________________________________
Device Name: SIRSCAN
Indications For Use:
The SIRSCAN automated zone reader device is a video-camera image analysis computer-based system to read susceptibility test data from NCCLS M2-A6 Kirby-Bauer disk-diffusion test plates for the following organisms: enterobacteriacae; staphylococci, (except coagulase negative staphylococci with weak growth); and non-fermenting gram negative bacilli (except strains with weak growth). Other susceptibility tests on solid medium are read with the electronic caliper, and the results of susceptibility tests in other media can be keved in manually.
The SIRSCAN data management system compiles data from the NCCLS agar disk diffusion test. It prints, files and produces integrated results reports, reqularly or on request, to be used by clinicians, bacteriologists and epidemiologists. Its expert system feature offers consistency checks for validation of tests and results.
In addition, the SIRSCAN data management system: interprets zones; calculates MICs; provides quality control and epidemiology and infection control; identifies and eliminates duplicates: compares patient histories: classifies and monitors resistance phenotypes; monitors multi-resistant organisms; detects and monitors nosocomial infections; and prepares epidemiological statistics.
SIRSCAN can be connected to any laboratory management system, as well as to some micro-dilution systems (e.g., Vitek™, Microscan™).
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
(Per 21 C.F.R. 801.109)
Over-the-Counter Use
Woody Dubois
ision of Clinical Laboratory Devices 510(k) Number_1(991473