K Number

Device Name

SENSE-4BABY SYSTEM

Manufacturer

SENSE4BABY, INC.

Date Cleared

2013-11-22

(66 days)

Product Code

HGM HFM KNG

Regulation Number

884.2740

Intended Use

The Sense4Baby System Model B+ is indicated for monitoring of maternal and fetal physiologic parameters during the antepartum period. It is to be used by health care professionals in hospitals, clinics, physicians' offices, antepartum rooms, and in the patients' home on the order of a physician.

Device Description

The Sense4Baby Model B+ is a non-invasive, wireless, external monitoring system used to measure fetal heart rate, maternal heart rate, and uterine contractions during antepartum (nonstress) testing. The system transmits the measured data to a gateway device, and then a HIPAA-Compliant web based portal for storage and physician review.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K954351

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a system for measuring and transmitting physiological data, with no mention of AI/ML algorithms for analysis or interpretation.

Therapeutic

No
The device is indicated for monitoring and measurement of physiological parameters during the antepartum period, which is a diagnostic rather than therapeutic function.

Diagnostic

Yes
The device monitors physiologic parameters (fetal heart rate, maternal heart rate, and uterine contractions) and transmits data for physician review, which is a key characteristic of diagnostic devices.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "non-invasive, wireless, external monitoring system" that "measure[s] fetal heart rate, maternal heart rate, and uterine contractions." It also mentions "Hardware testing" and "Mechanical testing" in the performance studies, indicating the presence of physical hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Sense4Baby System Model B+ is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
Sense4Baby Function: The Sense4Baby System Model B+ is described as a non-invasive, wireless, external monitoring system that measures physiological parameters (fetal heart rate, maternal heart rate, and uterine contractions) directly from the body. It does not analyze samples taken from the body.

Therefore, the Sense4Baby System Model B+ falls under the category of a non-invasive physiological monitoring device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

HGM, KNG, HFM

Device Description

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

health care professionals in hospitals, clinics, physicians' offices, antepartum rooms, and in the patient's home on the order of a physician.

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)

Verification and validation activities established the performance, functionality, and reliability characteristics of the device with respect to the predicate. Testing involved sub-system, as well as system level tests. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results demonstrated substantial equivalence. Performance bench testing included:

. Simulated Use testing
. Hardware testing
. Predicate comparison testing
Software testing ●
Environmental testing (operating and storage) .
Mechanical testing (drop, cleaning, etc.) .
. Water ingress testing (to IEC 60529)
. Shipping testing (to ASTM D4169-09)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Phillips/HP Series 50XM Fetal Monitor 510(k) # K954351.

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

Sense 4 Baby. Inc.

510(k) Summary

Submitters Name:

NOV 222 2013

Jacques Ginestet Sense4Baby. Inc. 3344 N. Torrey Pines Court, Suite 100 La Jolla, CA 92037

Date of Summary:

This summary was prepared on July 1, 2013

Trade Name of the Device:

Sense 4 Babv Svstem, Model B+

Common Name:

Fetal Monitor

Regulatory Classification: Class II (Performance standards)

Device Panel	Classification	Product Code	Description
Obstetrical and
Gynecological
Monitoring Devices	$884.2740.	HGM	Perinatal monitoring system
and accessories

Predicate Device:

Phillips/HP Series 50XM Fetal Monitor 510(k) # K954351.

Device Description:

Indications for Use:

Technological Characteristics:

The fundamental scientific technology employed in the Sense4Baby, Inc. Model B+ Fetal/Maternal Monitor is substantially equivalent to that of the Phillips/HP Series 50XM Fetal monitor.

Sense4Baby System Model B+ Premarket Notification 510 (k) Vol 005 Page 1 of 3

Safety Testing (Bench):

The Sense4 Baby System Model B+ complies with applicable voluntary safety standards, in the areas of:

. Electrical Safety
. EMC
. Material safety
Risk Management .

Safety testing performed in conformance to these voluntary standards was conducted at accredited independent test facilities to demonstrate that the Sense4Baby System Model B+ is as safe and effective as the predicate device. The specific standards employed were:

IEC 60601-1:2005 + CORR.2 (2007) + Al(2012), Medical electrical equipment Part 1: . General requirements for safety.
. National deviations of IEC 60601-1: 2005, such as EN 60601-1, Ed. 3 (European Harmonized Standard), AAMI ES 60601-1, Ed. I (US National Standard), CSA - C22.2 No 60601-1:2008 (Canadian National Standard).
. IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests.
IEC 60601-2-37:2007 Medical Electrical Equipment Part 2-37: Particular requirements . for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
. ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.
ISO 10993-5:2009: Biological evaluation of medical devices. Part 5- Tests for in vitro . cytotoxicity.
ISO 10993-10:2010 Biological evaluation of medical devices, Part 10- Tests for irritation t and skin sensitization.
ASTM D4169:2009 Standard Practice for Performance Testing of Shipping Containers . and Systems.
IEC 60529:1989 + A 1(1999) Degrees of protection provided by enclosures (IP Code). .

The possibility of hazards arising from hardware and software errors was further minimized in compliance with ISO 14971:2007 and ISO 13485:2003

Performance Testing (Bench):

. Simulated Use testing
. Hardware testing
. Predicate comparison testing
Software testing ●
Environmental testing (operating and storage) .
Mechanical testing (drop, cleaning, etc.) .

Sense4Baby System Model B+ Premarket Notification 510 (k)

Sense 4 Baby, Inc.

. Water ingress testing (to IEC 60529)
. Shipping testing (to ASTM D4169-09)

Conclusion:

The performance and safety verification and validation test results demonstrate that the Sense4Baby System Model B+ is as safe and effective, and performs as well as the predicate device.

Sense4Baby System Model B+ Premarket Notification 510 (k) Vol 005 Page 3 of 3

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wavy lines representing the agency's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002

November 22, 2013

Sense4Baby, Inc. % Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street Buffalo, MN 55313

Re: K132918

Trade/Device Name: Sense4Baby System model B+ Regulation Number: 21 CFR§ 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM, KNG, HFM Dated: November 7, 2013 Received: November 8, 2013

Dear Mark Job,

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

Page 2 - Mark Job

.............................................................................................................................................................................. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Benjamin R. Fisher

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known): K132918

Device Name: Sense4Baby System Model B+

Indications for Use:

The Sense4Baby System Model B+ is indicated for monitoring of maternal and fetal physiologic parameters during the antepartum period.

It is to be used by health care professionals in hospitals, clinics, physicians' offices, antepartum rooms, and in the patient's home on the order of a physician."

Prescription Use: X (Part 21 CFR 801 Subpart D) Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin R. Fisher -S 2013.11.22 14:48:52 -05'00'

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