CALM PATTERNS, VERSION 01.00.00

K040788 · Lms Medical Systems , Ltd. · HGM · Feb 8, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K040788
• Device Name: CALM PATTERNS, VERSION 01.00.00
• Applicant: Lms Medical Systems , Ltd.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Feb 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

CALM Patterns is a computerized information management system for obstetrical care; functions as a standalone workstation or in a networked environment. Inputs include fetal heart rate (FHR) and uterine activity data imported from maternal/fetal monitors via external interface. Device uses computerized algorithms to detect, label, and measure FHR features (baseline, accelerations, decelerations). Outputs include electronic annotations of the fetal monitor tracing and 15-minute summary analyses. Clinicians review annotations and can add, modify, or delete features to resolve disagreements with algorithm output. Intended to assist clinicians in monitoring; not for sole reliance in patient management decisions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and functional comparison to the predicate device.

Technological Characteristics

Computerized information management system; interfaces with external maternal/fetal monitors. Samples FHR at minimum 4 samples/second. Software-based algorithm for pattern detection. Supports networked or standalone deployment. Printing and patient admission/discharge/transfer functions included.

Indications for Use

Indicated for pregnant patients ≥36 weeks gestation undergoing antepartum or intrapartum obstetrical monitoring. Used as an adjunct to clinical decision-making for FHR annotation.

Regulatory Classification

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.

Predicate Devices

• OB TraceVue (K970456)

Submission Summary (Full Text)

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FEB - 8 2005

K040788
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## 510(k) Summary for CALM Patterns

Prepared 03 February 2005

| Submitted by: | LMS Medical Systems, Ltd.<br>5252 de Maisonneuve Boulevard West<br>Suite 314<br>Montreal, Quebec<br>Canada H4A 3S5 |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Pamela J. Haswell<br>Director, 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 TraceVue<br>Hewlett-Packard<br>(K 970456) |
| Description of the Device: | CALM Patterns is a computerized method to detect, label and measure<br>features in the fetal monitor recording. CALM Patterns uses fetal<br>monitor data imported through an interface with an external source as<br>described in a previous submission (K980719) or with a third-party<br>clinical information system. CALM Patterns can function in a networked<br>environment or as a standalone workstation. |
| Intended Use of the Device: | CALM Patterns is intended for use as an adjunct to qualified clinical<br>decision-making during antepartum or intrapartum obstetrical monitoring<br>at ≥36 weeks gestation to obtain annotation of the FHR for baseline.<br>accelerations and decelerations.<br><br>WARNING: Evaluation of FHR during labor and patient management<br>decisions should not be based solely on CALM Patterns annotations. |
| Substantial Equivalence<br>to Predicate Device: | CALM Patterns is substantially equivalent to the Hewlett-Packard<br>OB TraceVue (currently manufactured by Philips Medical Systems). The<br>features of CALM Patterns and the predicate device are compared in<br>the table on the following page. |

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K040788

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| Feature | LMS - CALM Patterns | Hewlett-Packard - OB TraceVue* |
|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Intended Use | To provide a standardized approach<br>to FHR analysis through the use of<br>computerized algorithms. | To provide a standardized approach<br>to FHR analysis through the use of<br>computerized algorithms. |
| Terminology consistent with<br>NIHCD | Yes | Similar |
| Data Collection | Collects FHR and uterine activity data<br>from maternal/fetal monitors. | Collects FHR and uterine activity data<br>from maternal/fetal monitors. |
| Sample Rate | Samples FHR at a minimum of four<br>samples per second. | Samples FHR at a minimum of four<br>samples per second. |
| Annotation of the tracing | Provides for electronic annotation by<br>the caregiver. | Provides for electronic annotation by<br>the caregiver. |
| Labeling accelerations on the<br>tracing | Yes | No |
| Labeling decelerations on the<br>tracing | Yes | No. Posts a message and a time<br>range to describe collections of<br>feature(s). |
| Analysis provided and<br>summarized in 15 minute<br>increments | Yes | No |
| Displays compressed view of<br>tracing. | Yes | No |
| Handling of disagreements<br>between algorithm detected<br>patterns and clinician opinion | User can add, modify or delete a<br>feature annotation | Users asked to acknowledge<br>agreement or disagreement with<br>collections of patterns |
| Printing functions | Yes | Yes |
| Patient admission discharge<br>transfer status | Yes | Yes |

* OB TraceVue is currently manufactured by Philips Medical Systems.

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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 [phone] or [phone] 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.