(316 days)
K 970456
No
The summary describes a "computerized method to detect, label and measure features" but does not mention AI, ML, or any related concepts. The description is consistent with traditional algorithmic processing.
No.
The device is described as a "computerized method to detect, label and measure features in the fetal monitor recording" and is intended "as an adjunct to qualified clinical decision-making," indicating it provides information rather than directly treating or preventing a disease or condition.
Yes
The device is intended for use as an adjunct to qualified clinical decision-making during obstetrical monitoring to obtain annotation of the FHR for baseline, accelerations and decelerations. This process of obtaining annotations for clinical decision-making aligns with the definition of a diagnostic device.
Yes
The device description explicitly states "CALM Patterns is a computerized method" and describes its function as processing imported data. There is no mention of hardware components included with the device itself, only interfaces to external data sources.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- CALM Patterns Function: CALM Patterns analyzes fetal heart rate (FHR) data obtained through external monitoring (likely using a fetal monitor). This data is not a sample taken from the body for analysis in a lab setting. It's a physiological measurement.
- Intended Use: The intended use is to annotate FHR patterns during obstetrical monitoring, which is a clinical assessment of the fetus's well-being, not a diagnostic test performed on a biological sample.
- Device Description: The description mentions importing data from a fetal monitor or clinical information system, further indicating it processes external physiological data, not biological samples.
Therefore, CALM Patterns falls under the category of a medical device used for monitoring and analysis of physiological signals, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
85 HGM
Device Description
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.
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
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K 970456
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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 West
Suite 314
Montreal, Quebec
Canada H4A 3S5 |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | (514) 488-3461 |
| Fax: | (514) 488-1880 |
| Contact Person: | Pamela J. Haswell
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
Hewlett-Packard
(K 970456) |
| Description of the Device: | 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. |
| Intended Use of the Device: | 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. |
| Substantial Equivalence
to Predicate Device: | CALM Patterns is substantially equivalent to the Hewlett-Packard
OB TraceVue (currently manufactured by Philips Medical Systems). The
features of CALM Patterns and the predicate device are compared in
the table on the following page. |
1
Page 2 of 2
| Feature | LMS - CALM Patterns | Hewlett-Packard - OB TraceVue* |
|---|---|---|
| Intended Use | To provide a standardized approach | |
| to FHR analysis through the use of | ||
| computerized algorithms. | To provide a standardized approach | |
| to FHR analysis through the use of | ||
| computerized algorithms. | ||
| Terminology consistent with | ||
| NIHCD | Yes | Similar |
| Data Collection | Collects FHR and uterine activity data | |
| from maternal/fetal monitors. | Collects FHR and uterine activity data | |
| from maternal/fetal monitors. | ||
| Sample Rate | Samples FHR at a minimum of four | |
| samples per second. | Samples FHR at a minimum of four | |
| samples per second. | ||
| Annotation of the tracing | Provides for electronic annotation by | |
| the caregiver. | Provides for electronic annotation by | |
| the caregiver. | ||
| Labeling accelerations on the | ||
| tracing | Yes | No |
| Labeling decelerations on the | ||
| tracing | Yes | No. Posts a message and a time |
| range to describe collections of | ||
| feature(s). | ||
| Analysis provided and | ||
| summarized in 15 minute | ||
| increments | Yes | No |
| Displays compressed view of | ||
| tracing. | Yes | No |
| Handling of disagreements | ||
| between algorithm detected | ||
| patterns and clinician opinion | User can add, modify or delete a | |
| feature annotation | Users asked to acknowledge | |
| agreement or disagreement with | ||
| collections of patterns | ||
| Printing functions | Yes | Yes |
| Patient admission discharge | ||
| transfer status | Yes | Yes |
- OB TraceVue is currently manufactured by Philips Medical Systems.
2
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.
3
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
4
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.