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.

AI/ML Overview

The Sense4Baby System Model B+ is a perinatal monitoring system. The provided text details its safety and performance testing to demonstrate substantial equivalence to a predicate device, the Phillips/HP Series 50XM Fetal Monitor.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify numerical acceptance criteria for specific performance metrics (e.g., accuracy of fetal heart rate detection). Instead, the acceptance criteria for performance are generally stated as achieving "substantial equivalence" to the predicate device. The reported performance is a declaration that these criteria have been met through various tests.

Acceptance Criteria (General)	Reported Device Performance
Substantial equivalence to predicate device in performance, functionality, and reliability.	"Verification and validation activities established the performance, functionality, and reliability characteristics of the device with respect to the predicate." "Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results demonstrated substantial equivalence."
Compliance with applicable voluntary safety standards.	"The Sense4 Baby System Model B+ complies with applicable voluntary safety standards..." "Safety testing performed... demonstrated that the Sense4Baby System Model B+ is as safe and effective as the predicate device."
Minimization of hazards from hardware and software errors.	"The possibility of hazards arising from hardware and software errors was further minimized in compliance with ISO 14971:2007 and ISO 13485:2003."

2. Sample Size for Test Set and Data Provenance

The provided text does not contain information about a specific clinical test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The performance testing described is primarily "bench testing" and "simulated use testing," rather than a clinical study with patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since a clinical test set with patient data is not described in the provided sections, there is no information regarding experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

As no clinical test set with human assessment is described, no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is described in the provided text. The submission focuses on demonstrating substantial equivalence through bench and simulated use testing against a predicate device, not on comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The provided text describes "Software testing" as part of the performance bench testing. However, it does not provide details of a standalone performance study with specific metrics (e.g., sensitivity, specificity, accuracy) for the algorithm itself, without human intervention. The focus is on overall system performance meeting predicate specifications.

7. Type of Ground Truth Used

For the described "Performance Testing (Bench)" and "Simulated Use testing," the "ground truth" implicitly refers to the established specifications and functionalities of the predicate device. The goal was to demonstrate that the Sense4Baby system's performance, functionality, and reliability matched or were equivalent to these predicate specifications.

8. Sample Size for the Training Set

The provided text does not contain any information about a training set or its sample size. This submission focuses on hardware and software verification and validation, not on the development or training of an AI/machine learning algorithm with a distinct training dataset.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned, there is no information on how its ground truth would have been established.

Summary

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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 andGynecologicalMonitoring Devices	$884.2740.	HGM	Perinatal monitoring systemand 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

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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):

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.) .

Sense4Baby System Model B+ Premarket Notification 510 (k)

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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

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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.

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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

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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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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).