(157 days)
Not Found
No
The summary describes a data management and monitoring system with signal analysis, but there is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML devices. The focus is on data acquisition, display, charting, and archiving.
No
The device is described as a central monitoring system that provides surveillance, charting, and data management functions; it does not claim to treat, prevent, or mitigate any disease or condition.
No
The device is a central monitoring system for data analysis, display, and archiving, and does not mention providing a diagnosis.
No
The device description explicitly states it consists of personal computers, data acquisition modules, and a system server, indicating it includes hardware components beyond just software.
Based on the provided information, the CALM system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for "central monitoring with signal analysis and display functions" and interfaces with "standard fetal and maternal monitors." It focuses on monitoring physiological signals and managing patient data.
- Device Description: The description reinforces this by mentioning "personal computers, data acquisition modules, and a system server" that interface with monitors for "fetal surveillance, charting, and archiving of patient data."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are specifically designed to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
The CALM system appears to be a patient monitoring and data management system used in a clinical setting, not a device that performs in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
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.
Product codes
85 HGM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
perinatal clinical environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).
0
JUL 31 1998
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ি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 ]
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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
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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
CALM | ADVANCED MEDICAL
SYSTEMS
BIRTHNET II |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Computer Assisted Labor
Monitoring (CALM) system is
designed for use to capture,
display, print and manage
physiological obstetrical and
fetal patient data. It is
intended to permit the real-
time monitoring of multiple
obstetrical and fetal patients
simultaneously and to
correlate pertinent patient
observations of physiological
parameters. It is also capable
of plotting recorded cervical
dilatation versus time, of the
monitored patient and
comparing it with a sample
population as a reference. | The BirthNet II perinatal
Patient Data Management
System is designed for use to
capture, display and manage
physiological obstetrical and
fetal patient data. It is
intended to permit the real-
time monitoring of multiple
obstetrical and fetal patients
simultaneously and to
correlate non-monitored
patient data with monitored
physiological parameters. It
plots recorded cervical
dilatation versus time for each
patient. |
| Data Collection | Collects Fetal Heart Rate
(FHR) and Uterine Activity
(UA) data from maternal
Monitors. It also collects data
input by the caregiver | Collects Fetal Heart Rate
(FHR) and Uterine Activity
(UA) data from maternal
Monitors. It also collects data
input by the caregiver. |
| Sample Rate | Samples FHR at a minimum
of 4 samples per second –
typical of data managed by
FHR monitors | Samples FHR at a minimum
of 4 samples per second –
typical of data managed by
FHR monitors |
| Central Display | Central display capability
provided at any required WS.
This includes Chalkboard and
All Tracings display as well as | Central display capability
provided at any required WS.
This includes Chalkboard and
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 |
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4-2
| FEATURE | LMS MEDICAL SYSTEMS
CALM | ADVANCED MEDICAL
SYSTEMS
BIRTHNET II |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Viewing | selected observations for all
patients
View FHR and UA data while
charting | as selected observations for
all patients.
View FHR and UA data while
charting |
| Additional patient viewing | With appropriate access
privileges, view another
patient's observations from
any patient's room. | View another patient's
observations from any
patient's room. |
| Chalkboard | Any workstation can be
configured to display "Ward
Status" chalkboard. | Any workstation can be
configured to display "Ward
Status" chalkboard. |
| Communications | Communications of data via
network to workstations. | Communications of data via
network to workstations |
| Communications to other
Hospital Information
System | Uses the ANSI standard
Health Level 7 (HL7) v2.3
protocol. | Uses HL7 protocol. |
| Labor Progress Curves | Displays the patient's curve of
Cervical Dilatation compared
to a reference population | Display the patient's Cervical
Dilatation curve that is
intended for comparison with
Friedman's curve * |
| Archiving | Optional -Uses Dual optical
disk as well as others | Optional - Uses Dual optical
disk |
| Annotation | Bedside annotation of
caregiver (i.e. doctors and
nurses) interventions | Bedside annotation of nursing
interventions |
| Admission, Transfer &
Discharge (ADT) | ADT capability provided for
patient visits. | ADT capability provided for
patient visits |
| Calculations | Calculates patient age, fetal
gestational age and estimated
date of delivery | Calculates patient age and
estimated date of delivery |
| Reports | Several patient reports
available. | Several patient reports
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)
| (Division Sign-Off) | (Division Sign-Off) | ||||
| (Division Sign-Off) | |||||
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |||||
| 510(k) NumberK980719 | 510(k) Number | K980719 | |||
| 510(k) Number | K980719 | ||||
| Prescription Use (Per 21 CFR 801.109) | OROver-The-Counter Use | OR | Over-The-Counter Use | ||
| OR | Over-The-Counter Use |
(Optional Format 1-2-96)