CALM

{0}------------------------------------------------ K980719 JUL 31 1998 । িয়েছে Image /page/0/Picture/2 description: The image shows a logo for "LMS Medical Systems Limited". The logo features the letters "LMS" in a bold, blocky font, with the words "Medical Systems Limited" written underneath in a smaller font. Above the letters, there is a drawing of two figures, possibly cherubs or angels, in a classical style. The image is in black and white and appears to be a scan or photocopy. 5252 de Maisonneuve Blvd. W., Suite 314 ♦ Montréal, Québec ♦ Canada H4A 3S5 Phone: (514) 488-3461 ♦ Fax: (514) 488-1880 # APPENDIX 8 # CALM SYSTEM 510(K) SUMMARY [510k Summary.doc ] {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a logo for LMS Medical Systems Limited. The logo features an illustration of two figures tending to a baby. The text "LMS Medical Systems Limited" is written in a bold, sans-serif font below the illustration. 5252 de Maisonneuve Blvd. W., Suite 314 ♦ Montréal, Québec ♦ Canada H4A 3S5 Phone: (514) 488-3461 ♦ Fax: (514) 488-1880 2/4 ### 510(k) Summary as required by 807.92 ( c ) for CALM Prepared 20th February, 1998 - LMS Medical Systems, Ltd. Submitted by: 5252 de Maisonneuve Boulevard West Suite 314 Montreal, Quebec Canada. H4A 3S5 Tel: (514)-488-3461, Fax: (514)-488-1880 - Contact Person: Dr. Emily Hamilton, M.D. President #### Device Trade Name: CALM - Computer-based information management system for obstetrical Common name: care. Classification: Perinatal monitoring system and accessories. Predicate Device: Birthnet TM Perinatal Patient Data Management System manufactured by Advanced Medical Systems, Inc., Sherman Avenue, Hamden, CT. (K965008) Description of Device: CALM is an easy-to-use system consisting of personal computers, data acquisition modules, and a system server. Interfaced with standard fetal and maternal monitors, CALM helps an Obstetrics Labor and Delivery department with fetal surveillance, charting, and archiving of patient data. - Intended Use of Device: The CALM system is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring or labor progress, charting reporting, and data analysis, display and archiving functions. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a logo for LMS Medical Systems Limited. The logo features two figures that appear to be statues, possibly representing a classical or mythological theme. The text "LMS Medical Systems Limited" is written below the figures, with "LMS" in a larger, bolder font size than "Medical Systems Limited." ## 5252 de Maisonneuve Blvd. W., Suite 314 ♦ Montréal, Québec ♦ Canada H4A 3S5 Phone: (514) 488-3461 ♦ Fax: (514) 488-1880 34 ### Substantial Equivalence to Predicate Device: The Computer Assisted Labor Monitoring (CALM) system is substantially equivalent to the Birthnet™ Perinatal Patient Data Management System manufactured by Advanced Medical Systems Inc, 925 Sherman Avenue, Hamden, CT (K965008). The features between CALM and the predicate device, are identified in the comparison table below: | FEATURE | LMS MEDICAL SYSTEMS<br>CALM | ADVANCED MEDICAL<br>SYSTEMS<br>BIRTHNET II | |-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The Computer Assisted Labor<br>Monitoring (CALM) system is<br>designed for use to capture,<br>display, print and manage<br>physiological obstetrical and<br>fetal patient data. It is<br>intended to permit the real-<br>time monitoring of multiple<br>obstetrical and fetal patients<br>simultaneously and to<br>correlate pertinent patient<br>observations of physiological<br>parameters. It is also capable<br>of plotting recorded cervical<br>dilatation versus time, of the<br>monitored patient and<br>comparing it with a sample<br>population as a reference. | The BirthNet II perinatal<br>Patient Data Management<br>System is designed for use to<br>capture, display and manage<br>physiological obstetrical and<br>fetal patient data. It is<br>intended to permit the real-<br>time monitoring of multiple<br>obstetrical and fetal patients<br>simultaneously and to<br>correlate non-monitored<br>patient data with monitored<br>physiological parameters. It<br>plots recorded cervical<br>dilatation versus time for each<br>patient. | | Data Collection | Collects Fetal Heart Rate<br>(FHR) and Uterine Activity<br>(UA) data from maternal<br>Monitors. It also collects data<br>input by the caregiver | Collects Fetal Heart Rate<br>(FHR) and Uterine Activity<br>(UA) data from maternal<br>Monitors. It also collects data<br>input by the caregiver. | | Sample Rate | Samples FHR at a minimum<br>of 4 samples per second –<br>typical of data managed by<br>FHR monitors | Samples FHR at a minimum<br>of 4 samples per second –<br>typical of data managed by<br>FHR monitors | | Central Display | Central display capability<br>provided at any required WS.<br>This includes Chalkboard and<br>All Tracings display as well as | Central display capability<br>provided at any required WS.<br>This includes Chalkboard and<br>All Tracings display as well | {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a logo for LMS Medical Systems Limited. The logo features an image of two figures that appear to be statues. The text "LMS Medical Systems Limited" is written in bold font below the image. 「不要不可能」意味了!!! 出版社会的 不同意见是是是是有着了了了 | 5252 de Maisonneuve Blvd. W., Suite 314 ♦ Montréal, Québec ♦ Canada H4A 3S5 | |-----------------------------------------------------------------------------| | Phone: (514) 488-3461 ♦ Fax: (514) 488-1880 | પ/4 4-2 | FEATURE | LMS MEDICAL SYSTEMS<br>CALM | ADVANCED MEDICAL<br>SYSTEMS<br>BIRTHNET II | |-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | Viewing | selected observations for all<br>patients<br>View FHR and UA data while<br>charting | as selected observations for<br>all patients.<br>View FHR and UA data while<br>charting | | Additional patient viewing | With appropriate access<br>privileges, view another<br>patient's observations from<br>any patient's room. | View another patient's<br>observations from any<br>patient's room. | | Chalkboard | Any workstation can be<br>configured to display "Ward<br>Status" chalkboard. | Any workstation can be<br>configured to display "Ward<br>Status" chalkboard. | | Communications | Communications of data via<br>network to workstations. | Communications of data via<br>network to workstations | | Communications to other<br>Hospital Information<br>System | Uses the ANSI standard<br>Health Level 7 (HL7) v2.3<br>protocol. | Uses HL7 protocol. | | Labor Progress Curves | Displays the patient's curve of<br>Cervical Dilatation compared<br>to a reference population | Display the patient's Cervical<br>Dilatation curve that is<br>intended for comparison with<br>Friedman's curve * | | Archiving | Optional -Uses Dual optical<br>disk as well as others | Optional - Uses Dual optical<br>disk | | Annotation | Bedside annotation of<br>caregiver (i.e. doctors and<br>nurses) interventions | Bedside annotation of nursing<br>interventions | | Admission, Transfer &<br>Discharge (ADT) | ADT capability provided for<br>patient visits. | ADT capability provided for<br>patient visits | | Calculations | Calculates patient age, fetal<br>gestational age and estimated<br>date of delivery | Calculates patient age and<br>estimated date of delivery | | Reports | Several patient reports<br>available. | Several patient reports<br>available. | | Remote Access | Via Modem | Via Modem | * Friedman's curve is the most commonly used Clinical standard {4}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 3 | 1998 Dr. Emily Hamilton President LMS Medical Systems Ltd. 5252 de Maisonneuve West, Suite 314 Montreal, Quebec CANADA H4A 3S5 Re: K980719 CALM System (Computer Assisted Labor Monitoring) Dated: June 4, 1998 Received: June 10, 1998 Regulatory Class: II 21 CFR 884.2740/Procode: 85 HGM Dear Dr. Hamilton: 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 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 (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 Quality System Regulation (OS) for Medical Devices: General regulation (2) 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 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. 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 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmadsmam.html". Sincerely your Sincerely yours, Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal. Ear. Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ (510k) Number (if known): Device Name: CALM (for Computer Assisted Labor Monitoring) Indications For Use: The CALM system is intended for use as a central monitoring system with signal analysis and display functions and remotre repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions. #### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | | <table style="border: 0px; width: 100%;"><tr><td></td><td><table style="border: 0px; width: 100%;"><tr><td></td><td></td></tr></table></td></tr></table> | | <table style="border: 0px; width: 100%;"><tr><td></td><td></td></tr></table> | | | |---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|------------------------------------------------------------------------------|----------------------|--| | | <table style="border: 0px; width: 100%;"><tr><td></td><td></td></tr></table> | | | | | | | | | | | | | | <table><tr><td>(Division Sign-Off)</td><td></td></tr></table> | (Division Sign-Off) | | | | | (Division Sign-Off) | | | | | | | | Division of Reproductive, Abdominal, ENT, and Radiological Devices | | | | | | | <table><tr><td>510(k) Number</td><td>K980719</td></tr></table> | 510(k) Number | K980719 | | | | 510(k) Number | K980719 | | | | | | Prescription Use (Per 21 CFR 801.109) | <div> <table style="border: 0px; width: 100%;"><tr><td></td><td>OR</td><td>Over-The-Counter Use</td><td></td></tr></table> </div> | | OR | Over-The-Counter Use | | | | OR | Over-The-Counter Use | | | | (Optional Format 1-2-96)