SIRSCAN

K991473 · Intelligence Artificielle Applications · KZK · Nov 23, 1999 · Microbiology

Device Facts

• Record ID: K991473
• Device Name: SIRSCAN
• Applicant: Intelligence Artificielle Applications
• Product Code: KZK · Microbiology
• Decision Date: Nov 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2850
• Device Class: Class 1

Indications for 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).

Device Story

SIRSCAN is an automated zone reader and data management system for microbiology laboratories. It utilizes a video camera to capture images of NCCLS M2-A6 Kirby-Bauer disk-diffusion plates; image analysis software measures inhibition zones. For non-disk-diffusion tests, an electronic caliper is used for manual measurement; data from other media can be keyed in manually. The system integrates results, calculates MICs, and provides an expert system for consistency checks. It compiles reports for clinicians, bacteriologists, and epidemiologists; identifies duplicates; monitors resistance phenotypes and nosocomial infections; and generates epidemiological statistics. The device connects to laboratory management systems and micro-dilution systems (e.g., Vitek, Microscan). By automating reading and data management, it assists in clinical decision-making regarding antibiotic susceptibility and infection control.

Clinical Evidence

Clinical evaluation performed by Medeiros and Crellin at Brown University (1998). Study evaluated the SIRSCAN Automated Zone Reader in a clinical microbiology laboratory setting. No specific sensitivity/specificity metrics provided in the summary text.

Technological Characteristics

Video-camera based image analysis system; electronic caliper for manual measurements; computer-based data management system. Connectivity via interface to laboratory management systems and micro-dilution systems. Expert system software for consistency checks and data validation.

Indications for Use

Indicated for management of susceptibility test data for Enterobacteriacae, staphylococci (excluding coagulase-negative with weak growth), and non-fermenting gram-negative bacilli (excluding strains with weak growth) using NCCLS M2-A6 Kirby-Bauer disk-diffusion plates. Intended for use by clinicians, bacteriologists, and epidemiologists.

Regulatory Classification

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.

Reference Devices

• Vitek (micro-dilution system)
• Microscan (micro-dilution system)

Submission Summary (Full Text)

{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<br>BP 42<br>34470 PEROLS Cedex<br>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)<br>Product Code: KZK |
| Device Description: | SIRSCAN is an automatic reader of petri dishes that is used<br>to manage overall susceptibility tests. The SIRSCAN is an<br>automated susceptibility reader and interpretation system. It<br>consists of two components: |
| | (1) The SIRSCAN automated zone reader device is a<br>video-camera image analysis computer-based system to<br>read susceptibility test data from NCCLS M2-A6 Kirby-<br>Bauer disk-diffusion test plates for the following organisms:<br>enterobacteriacae; staphylococci, (except coagulase<br>negative staphylococci with weak growth); and non-<br>fermenting gram negative bacilli (except strains with weak<br>growth). Other susceptibility tests on solid medium are read<br>with the electronic caliper, and the results of susceptibility<br>tests in other media can be keyed in manually. |

{1}------------------------------------------------

| | (2) The SIRSCAN data management system compiles data<br>from the NCCLS agar disk diffusion test. It prints, files and<br>produces integrated results reports, regularly or on request,<br>to be used by clinicians, bacteriologists and epidemiologists.<br>Its expert system feature offers consistency checks for<br>validation of tests and results. |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | In addition, the SIRSCAN data management system:<br>interprets zones; calculates MICs; provides quality<br>control and epidemiology and infection control;<br>identifies and eliminates duplicates; compares patient<br>histories; classifies and monitors resistance<br>phenotypes; monitors multi-resistant organisms;<br>detects and monitors nosocomial infections; and<br>prepares epidemiological statistics. |
| | SIRSCAN can be connected to any laboratory management<br>system, and to some micro-dilution systems (e.g., VitekTM,<br>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<br>Automated Zone Reader in a Clinical Microbiology<br>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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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