CALM CURVE, VERSION 01.00

{0}------------------------------------------------ DEC 2 2 2005 # 510(k) Summary for CALM Curve - K052715 Revised - 22 November 2005 ### Submitted by LMS Medical Systems, Ltd. 5252 de Maisonneuve Boulevard West Suite 314 Montreal, Quebec Canada H4A 3S5 FDA facility registration number: 9615396 Telephone: (514) 488-3461 Fax: (514) 488-1880 Contact Person: Pamela J. Haswell Director, QA/RA #### Device Information Trade Name: CALM Curve Common Name: Computer-based labor progress monitoring system for obstetrical care. Device Class. Perinatal monitoring systems and accessories were reviewed by the Device Oldoo. Formatornient and are classified in Class II per 21 CFR 884.2740. ### Predicate Device Information The predicate device for CALM Curve is the Labor Progress Monitoring module (LPM me producte devilos for Sriem Sarvet CALM (Computer Assisted Labor Monitoring) software K980719, clearance date 31 July 1998 #### Labeling and Intended Use A draft User Guide for CALM Curve is provided as Appendix 5. The User Guide has been updated to reflect the modifications described in this submission. A draft promotional piece for CALM Curve is provided as Appendix 6. #### Intended Use CALM Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is > 35 weeks. This intended use is the same as for the Labor Progress module of CALM. The Indications for Use statement is provided as Appendix 2. {1}------------------------------------------------ #### Device Description CALM Curve is a computerized method to assess progress during labor. Its algorithms calculate the patient's progress based on user-entered values for parity, dilatation, effacement, station, contraction frequency, and epidural use. Results of these calculations are displayed graphically and as percentile values derived from comparison to a database of women with similar characteristics who delivered vaginally. CALM Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is > 35 weeks. CALM Curve can function in a networked environment, as a standalone workstation, or as a web-based application. When connected to a fetal monitor, CALM Curve can use the monitor's uterine activity signal in lieu of user-entered values to calculate contraction counts. A more detailed description of the architecture of the proposed changes is provided as Appendix 3. ### Summary of Design Control Activities - Risk Analysis The risk analysis method used to assess the impact of the modifications was a Failure Mode and Effects Analysis (FMEA). The results of that analysis are provided as Appendix 4. # Summary of Design Control Activities -- Verification and Validation The risk analysis method used to assess the impact of the modifications was a Failure Mode and Effects Analysis (FMEA). The results of that analysis are provided as Appendix 5. #### Comparison to the Predicate Device There are only three differences between CALM Curve and the LPM module of the CALM software: - The LPM module runs as a module within the CALM software suite. CALM Curve can t also be used as a stand-alone product. - The LPM module derives its cumulative contraction count from fetal monitor uterine . activity signals. CALM Curve can also accept manually-entered contraction frequency data. In obstetrical practice, clinicians routinely estimate contraction frequency without the aid of a fetal monitor. The entry of manual contraction data has the added advantage of allowing the clinician to update contraction information even when the patient is not connected to a fetal monitor, as when the patient is up and walking. - As a part of the CALM software suite, the LPM module runs as a full client/server . application. CALM Curve can also be run as a web-based product. {2}------------------------------------------------ # Statement of Substantial Equivalence to the Predicate Device CALM Curve is substantially equivalent to the LPM module of LMS's CALM software CALM Curve is substantially equivalorit to the LPM module are compared in the table below. | Feature | LPM Module of CALM | CALM Curve | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | As a system with signal analysis and<br>display functions ... [for] monitoring of<br>labor progress, data analysis and display<br>functions.* | CALM Curve is intended for use as a<br>data analysis system to assess labor<br>progress in singleton, cephalic<br>presentation pregnancies when the<br>gestational age is ≥ 35 weeks | | Patient population | Singleton birth<br>>35 weeks gestational age<br>Cephalic presentation | Singleton birth<br>>35 weeks gestational age<br>Cephalic presentation | | Access to the system | Client/server application | Client/server application, stand-alone PC<br>OR as a web-based product | | Software application | As a module within the CALM system | As a module within the CALM system OR<br>as a stand-alone application | | Algorithm | See K980719 | Same algorithm | | Algorithm variables | Parity, dilatation, effacement, station,<br>epidural use, contraction count | Parity, dilatation, effacement, station,<br>epidural use, contraction count | | Contraction count | Calculated from maternal/fetal monitor<br>uterine activity signal. | Calculated from maternal/fetal monitor<br>uterine activity signal OR from data<br>entered by the user. | | Exam data | Entered by the user | Entered by the user | | Graphical display | Patient's labor progress curve and<br>station | Patient's labor progress curve and<br>station | | Percentile display | Patient's value (in tabular display) | Patient's value (in tabular display) | | | Curve of mean and outer limits (3rd / 97th,<br>5th / 95th, or 10th / 90th) of the reference<br>population added to graphical display | Curve of mean and outer limits (3rd / 97th<br>5th / 95th, or 10th / 90th) of the reference<br>population added to graphical display | | Selection of reference<br>population | Based on parity and previous delivery<br>type (vaginal or c/section) | Based on parity and previous delivery<br>type (vaginal or c/section) | *NOTE: This statement is taken from the intended use statement for the cleared CALM software system, which is intended for use "as a central monitoring system with signal analysis and display System, which is morned a to 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". ### Declarations, Certifications, and Statements The following declarations, certifications, and statements are provided as Appendix 4. - Declaration of Conformity with Design Controls * - 510(k) Statement for the CALM Curve . - Certification of Truthfulness and Accuracy of the CALM Curve described in this ● submission. {3}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 2 2 2005 Ms. Pamela Haswell Director, QA/RA LMS Medical Systems, Inc. 5252 de Maisonneuve West, Suite 314 Montreal, Quebec H4A 3S5 CANADA Re: K052715 Trade/Device Name: CALM Curve Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: November 22, 2005 Received: November 23, 2005 Dear Ms. Haswell: 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 the enorologics to regioned date of the Medical Device Amendments, or to devices that have been reasy 20, 11 v, accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a prematket approval application (PMA). You may, therefore, market the do inot require to the general controls provisions of the Act. The general controls provisions of the Act do reo, sacjos to an got and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket 11 your al), it may be subject to such additional controls. Existing major regulations affecting your Applorar, the 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. 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 I Drival statutes and regulations administered by other Federal agencies. You must comply with all the r carrates are are any ing (21 CFR Part 801); good nanufacturing 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. {4}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin hanketing your ence of your device of your device to a legally premarket notheation. The PDA miding of Sassannal reports 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), please If you desire specific advice for your derites on our of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification the Also, please note the regulation entitled, "Theoration on your responsibilities under the Act from the 807.97). You may outlar outcr general informations and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Nancy C. Hogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ #### Indications for Use Form 2.1 Applicant: LMS Medical Systems, Inc. 510(k) Number: K052715 - **10** % - **15** % Device Name: CALM Curve # Indications for Use: CALM Curve is intended for use as a data analysis system to assess labor progress in CALM Curve is intended for use as a duta analyers eyests the new is ≥ 35 weeks. (Per 21 CFR 801.109) X _ Prescription Use Over the Counter (Per 21 CFR 801 109) David A. Ingram (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number _