(316 days)
CALM Patterns is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at ≥36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
WARNING: Evaluation of FHR during labor and patient management decisions should not be based solely on CALM Patterns annotations.
CALM Patterns is a computerized method to detect, label and measure features in the fetal monitor recording. CALM Patterns uses fetal monitor data imported through an interface with an external source as described in a previous submission (K980719) or with a third-party clinical information system. CALM Patterns can function in a networked environment or as a standalone workstation.
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for the CALM Patterns device, discussing its substantial equivalence to a predicate device (OB TraceVue).
Therefore, I cannot provide the requested information. The document focuses on comparing the features of CALM Patterns to OB TraceVue for substantial equivalence, rather than presenting a performance study with acceptance criteria.
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FEB - 8 2005
K040788
Page 1 of 2
510(k) Summary for CALM Patterns
Prepared 03 February 2005
| Submitted by: | LMS Medical Systems, Ltd.5252 de Maisonneuve Boulevard WestSuite 314Montreal, QuebecCanada H4A 3S5 |
|---|---|
| Telephone: | (514) 488-3461 |
| Fax: | (514) 488-1880 |
| Contact Person: | Pamela J. HaswellDirector, QA/RA |
| Device Trade Name: | CALM Patterns |
| Common Name: | Computer-based information management system for obstetrical care. |
| Classification: | Perinatal monitoring system and accessories |
| Predicate Device: | OB TraceVueHewlett-Packard(K 970456) |
| Description of the Device: | CALM Patterns is a computerized method to detect, label and measurefeatures in the fetal monitor recording. CALM Patterns uses fetalmonitor data imported through an interface with an external source asdescribed in a previous submission (K980719) or with a third-partyclinical information system. CALM Patterns can function in a networkedenvironment or as a standalone workstation. |
| Intended Use of the Device: | CALM Patterns is intended for use as an adjunct to qualified clinicaldecision-making during antepartum or intrapartum obstetrical monitoringat ≥36 weeks gestation to obtain annotation of the FHR for baseline.accelerations and decelerations.WARNING: Evaluation of FHR during labor and patient managementdecisions should not be based solely on CALM Patterns annotations. |
| Substantial Equivalenceto Predicate Device: | CALM Patterns is substantially equivalent to the Hewlett-PackardOB TraceVue (currently manufactured by Philips Medical Systems). Thefeatures of CALM Patterns and the predicate device are compared inthe table on the following page. |
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Page 2 of 2
| Feature | LMS - CALM Patterns | Hewlett-Packard - OB TraceVue* |
|---|---|---|
| Intended Use | To provide a standardized approachto FHR analysis through the use ofcomputerized algorithms. | To provide a standardized approachto FHR analysis through the use ofcomputerized algorithms. |
| Terminology consistent withNIHCD | Yes | Similar |
| Data Collection | Collects FHR and uterine activity datafrom maternal/fetal monitors. | Collects FHR and uterine activity datafrom maternal/fetal monitors. |
| Sample Rate | Samples FHR at a minimum of foursamples per second. | Samples FHR at a minimum of foursamples per second. |
| Annotation of the tracing | Provides for electronic annotation bythe caregiver. | Provides for electronic annotation bythe caregiver. |
| Labeling accelerations on thetracing | Yes | No |
| Labeling decelerations on thetracing | Yes | No. Posts a message and a timerange to describe collections offeature(s). |
| Analysis provided andsummarized in 15 minuteincrements | Yes | No |
| Displays compressed view oftracing. | Yes | No |
| Handling of disagreementsbetween algorithm detectedpatterns and clinician opinion | User can add, modify or delete afeature annotation | Users asked to acknowledgeagreement or disagreement withcollections of patterns |
| Printing functions | Yes | Yes |
| Patient admission dischargetransfer status | Yes | Yes |
- OB TraceVue is currently manufactured by Philips Medical Systems.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 8 2005
Ms. Pamela Haswell Director, Ouality Assurance and Regulatory Affairs LMS Medical Systems 5252, de Maisonneuve O. Bureau 314 Montreal, Quebec CANADA H4A 3S5
Re: K040788
Trade/Device Name: CALM Patterns Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: 85 HGM Dated: November 8, 2004 Received: November 9, 2004
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 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be 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 Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing 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.
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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one 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" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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/dsma/dsmamain.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K04078
page
Indications for Use Form
Applicant: LMS Medical Systems, Ltd.
510(k) Number: K040788
Device Name: CALM Patterns
Indications for Use:
CALM Patterns is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at ≥36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
WARNING: Evaluation of FHR during labor and patient management decisions should not be based solely on CALM Patterns annotations.
(Per 21 CFR 801.109)
X _ Prescription Use
Over the Counter
Nancy C Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number.
§ 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).