Sense4Baby System Model B+ (MSA)

K143114 · Airstrip Technologies, Inc. · LQK · Mar 10, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K143114
• Device Name: Sense4Baby System Model B+ (MSA)
• Applicant: Airstrip Technologies, Inc.
• Product Code: LQK · Obstetrics/Gynecology
• Decision Date: Mar 10, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2730
• Device Class: Class 2

Intended Use

The Sense4Baby System Model B+ is indicated for conventional antepartum fetal monitoring applications in pregnancies greater than or equal to 24 weeks gestation. It may be used for antenatal monitoring (e.g., non-stress testing and/or uterine activity monitoring) in a health care setting or home. It is to be used by health care professionals and patients on the order of a physician. Before the Sense4Baby System Model B+ is prescribed for home use, the user (patient) must be instructed/trained in proper use of the equipment. Home uterine activity monitoring has not been shown to prevent the onset of preterm labor nor will it prevent the occurrence of preterm birth.

Device Story

Non-invasive, wireless, external monitoring system; measures fetal heart rate (FHR), maternal heart rate, and uterine contractions during antepartum testing. Inputs: pulsed Doppler ultrasound (1 MHz) via piezo-electric crystals for FHR; relative pressure sensor (tocodynamometer) for uterine activity. Data transmitted to gateway device, then to HIPAA-compliant web portal for storage and physician review. Used in clinical settings or home; operated by health care professionals or patients (following training). Output: graphical overlay of FHR and uterine activity on screen or paper. Benefits: enables remote antenatal monitoring, facilitating physician review of fetal/maternal status outside traditional clinical settings.

Clinical Evidence

Bench testing only. Verification and validation included simulated use, hardware, software, environmental, mechanical, water ingress (IEC 60529), and shipping (ASTM D4169-09) testing. Formative and summative usability studies conducted to evaluate lay user operation in home environments; results demonstrated a success rate statistically equivalent to health care provider environments.

Technological Characteristics

Pulsed Doppler ultrasound (1 MHz) for FHR; relative pressure sensor (tocodynamometer) for uterine activity. Wireless (Bluetooth) connection for toco sensor. Rechargeable batteries. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1/5/10. Biocompatible materials. Non-sterile. Dimensions: 25mm x 95mm x 75mm; weight <0.2 kg.

Indications for Use

Indicated for conventional antepartum fetal monitoring in pregnancies >= 24 weeks gestation. Used for antenatal monitoring (non-stress testing, uterine activity) in health care settings or homes. Prescribed by physicians for use by health care professionals and patients.

Regulatory Classification

Identification

A home uterine activity monitor (HUAM) is an electronic system for at home antepartum measurement of uterine contractions. The HUAM system comprises a tocotransducer and an at-home recorder. This device is intended for use in women with a previous preterm delivery to aid in the detection of preterm labor.

Special Controls

*Classification.* Class II (special controls); guidance document (Class II Special Controls Guidance for Home Uterine Activity Monitors).

Predicate Devices

• Huntliegh Healthcare Limited Fetal Assist (K020390)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 10, 2015

Airstrip Technologies, Inc. % Curtis Egan Sr. Ouality, Regulatory & Design Engineer Certified Compliance Solutions Inc. 11665 Avena Place, Suite 203 San Diego, California 92128

Re: K143114

> Trade/Device Name: Sense4baby System Model B+ (MSA) Regulation Number: 21 CFR 884.2730 Regulation Name: Home Uterine Activity Monitor Regulatory Class: Class II Product Code: LOK, MOH, HGM Dated: December 1, 2014 Received: December 10, 2014

Dear Curtis Egan,

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. 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

{1}------------------------------------------------

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Herbert P. Lerner -S

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

Enclosure

{2}------------------------------------------------

### Indications for Use

510(k) Number (if known) K143114

Device Name Sense4Baby System, Model B+ (MSA)

#### Indications for Use (Describe)

The Sense4Baby System Model B+ is indicated for conventional antepartum fetal monitoring applications in pregnancies greater than or equal to 24 weeks gestation. It may be used for antenatal monitoring (e.g., non-stress testing and/or uterine activity monitoring) in a health care setting or home.

It is to be used by health care professionals and patients on the order of a physician.

Before the Sense4Baby System Model B+ is prescribed for home use, the user (patient) must be instructed/trained in proper use of the equipment.

Home uterine activity monitoring has not been shown to prevent the onset of preterm labor nor will it prevent the occurrence of preterm birth.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------|---------------------------------------------|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

### 1. 510(k) Summary

| Submitter: | Airstrip Technologies, Inc. |
|----------------------|-----------------------------------|
| Address: | 565 Pearl St suite 209 |
| | La Jolla, CA 92037 |
| Phone number: | [phone] |
| Fax number: | [phone] |
| Contact person: | Curtis M. Egan |
| Phone number: | [phone] |
| Fax number: | [phone] |
| Date prepared: | October 21, 2014 |
| Trade name: | Sense4Baby System, Model B+ (MSA) |
| Common Name: | Fetal Monitor |
| Classification Name: | Home Uterine Activity Monitor |
| Product Code: | LQK, MOH, HGM |
| Regulation: | 21 CFR 884.2730 |

Substantial equivalence claimed to: Huntliegh Healthcare Limited Fetal Assist, K020390

#### 1.1. Description:

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

{4}------------------------------------------------

## Sense4Babv System B+ 510(k) Submission

### 1.2. Indications for Use:

The Sense4Baby System Model B+ is indicated for conventional antepartum fetal monitoring applications in pregnancies greater than or equal to 24 weeks gestation. It may be used for antenatal monitoring (e.g., non-stress testing and/or uterine activity monitoring) in a health care setting or home.

It is to be used by health care professionals and patients on the order of a physician.

Before the Sense4Baby System Model B+ is prescribed for home use, the user (patient) must be instructed/trained in proper use of the equipment.

Home uterine activity monitoring has not been shown to prevent the onset of preterm labor nor will it prevent the occurrence of preterm birth.

### 1.3. Technological Characteristics

Sense4Baby, Inc. Model B+ (MSA) is substantially equivalent to the predicate device the Huntliegh Healthcare Limited Fetal Assist (K020390).

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

- · Electrical Safety
- · Electro-Magnetic Compatibility (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+(MSA) is as safe and effective as the predicate device. The specific standards employed were:

- IEC 60601-1:2005 + CORR.2 (2007) + A1 (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. 1 (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 and skin sensitization.
- · ASTM D4169:2009 Standard Practice for Performance Testing of Shipping Containers and Systems.
- · IEC 60529:1989 + A1 (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

| Sense4Baby System Model B+ |
|-------------------------------|
| Premarket Notification 510(k) |

{5}------------------------------------------------

# Sense4Baby System B+ 510(k) Submission

| General Device | Sense4Baby | Huntliegh Healthcare Limited |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | System B+ (MSA) | Fetal Assist (K020390) |
| Indication for Use | The Sense4Baby System Model B+ is<br>indicated for conventional antepartum<br>fetal monitoring applications in<br>pregnancies greater than or equal to 24<br>weeks gestation. It may be used for<br>antenatal monitoring (e.g., non-stress<br>testing and/or uterine activity<br>monitoring) in a health care setting or<br>home.<br>It is to be used by health care<br>professionals and patients on the order<br>of a physician.<br>Before the Sense4Baby<br>-<br>System Model B+ is<br>prescribed for home use, the<br>user (patient) must be<br>instructed/trained in proper<br>use of the equipment.<br>Home uterine activity<br>monitoring has not been<br>shown to prevent the onset<br>of preterm labor nor will it<br>prevent the occurrence of<br>preterm birth. | The FETAL ASSIST is suitable for use in all conventional antepartum<br>fetal monitoring application from a gestation age of approximately 26<br>weeks. It is particularly intended for use in the following specific areas:<br>Antenatal monitoring in the hospital, doctors office, health clinic,<br>home or community.<br>External Labor monitoring.<br>Waterbith monitoring using optional waterproof transducers.<br>Home Uterine Activity Monitoring (HUAM) in conjunction with<br>standard high-risk care, for the daily at-home measurement of uterine<br>activity for women with history of preterm birth.<br>Domiciliary Non Stress Testing Applications.<br>NB: before being used in domiciliary HUAM and/or Non Stress Testing<br>applications the mother would be instructed in the use of the equipment.<br>The FETAL ASSIST is a prescription device. |
| Product Code | LQK, MOH, HGM | LQK, MOH |
| Classification | 884.2730, 884.2740 | 884.2730 |
| Indication | Antenatal monitoring | Antenatal monitoring |
| Target Patient | Gravid patient | Gravid patient |
| Anatomical Site | Maternal Abdomen | Maternal Abdomen |
| Use/Reuse | Reusable | Reusable |
| Sterility | Non-sterile | Non-sterile |
| Fetal Heart Rate | Sense4Baby<br>System B+ (MSA) | Huntliegh Healthcare Limited<br>Fetal Assist (K020390) |
| | | |
| Technology | Pulsed Doppler Ultrasound | Doppler Ultrasound |
| Sensors | Piezo-electric crystals | Piezo-ceramic transmitter crystals |
| Ultrasound frequency | 1 MHz | 1.5 Mhz |
| Ultrasound burst rep rate | 3125 Hz | 3200 Hz |
| Signal Processing | Analog to digital conversion | Analog to digital conversion |
| FHR sensor power source | Rechargeable battery | Rechargeable battery |
| FHR audio signal | Speakers (phone) | Speaker |
| Fetal Motion Indicator | Yes (3 levels) | Yes |
| Signal Quality Indicator | Yes (3 levels) | Yes |
| External Uterine Pressure | Sense4Baby<br>System B+ (MSA) | Huntliegh Healthcare Limited<br>Fetal Assist (K020390) |
| Technology | Relative pressure sensor<br>(tocodynamometer) | Relative pressure sensor (tocodynamometer) |
| Sensor | Differential pressure sensor | Differential pressure sensor |
| Signal Processing | Analog to digital conversion | Analog to digital conversion |
| Toco sensor power source | Rechargeable battery | Rechargeable battery |
| Connection of toco sensor | Wireless (Bluetooth) | Cable |
| Physical | Sense4Baby<br>System B+ | Huntliegh Healthcare Limited<br>Fetal Assist (K020390) |
| Size | 25mm(H) x 95mm(W) x 75MM(D) | 2" (50mm) x 10" (250mm) x 6 (150mm) |
| Weight | <0.2 kg | 3.5 lb (1.6Kg) (including battery) |
| Safety | Sense4Baby<br>System B+ (MSA) | Huntliegh Healthcare Limited<br>Fetal Assist (K020390) |
| Hardware | IEC 60601 compliant | EN60601-1: 1990 compliant |
| Ultrasound | IEC 60601-2-37 compliant | -- |
| EMC | IEC 60601-1-2 compliant | EN60601-1-2 : 1993 compliant |
| Applied Parts Type | BF | -- |
| Biocompatible materials | Yes | -- |

Sense4Baby System Model B+ Premarket Notification 510(k)

Confidential

Page 3 of 7 Volume 026, Document 002

{6}------------------------------------------------

# Sense4Baby System B+ 510(k) Submission

{7}------------------------------------------------

### 1.4. Substantial Equivalence Discussion

The S4B System B+ (MSA) is substantially equivalent to the Huntliegh Healthcare Limited Fetal Assist (K020390) Systems based on indications for use and comparison of the functional capabilities. All of the devices are intended to provide fetal heart rate monitoring. Features common to all systems include:

- Doppler Ultrasound Technology
- Analog to digital signal conversion
- . Rechargeable Batteries
- . Relative Pressure Sensors

### Huntliegh Healthcare Limited Fetal Assist (K020390)

The S4B System B+ (MSA) is substantially equivalent to the Huntliegh Healthcare Limited Fetal Assist System (K020390). This is based on the comparison of the indications for use and comparison of the functional capabilities. All of the devices are intended to provide fetal heart rate monitoring.

| DEVICE | | Comparison |
|----------------|------------------------------------------------------|--------------|
| Model B+ (MSA) | The Model B+ (MSA) uses Pulsed Doppler | Equivalent |
| | ultrasound technology to determine the fetal heart | to Predicate |
| | rate, and obtain indications of fetal motion. | |
| Fetal Assist | The Fetal Assist uses the Doppler principle for non- | |
| | invasive monitoring of Fetal Heart Rate and Fetal | |
| | movement. | |

For this primary function, the Model B+ (MSA) utilizes scientific technology / operating principles which are identical or equivalent to the Fetal Assist. These are detailed below:

| Device | Technology | Comparison |
|------------------------|-------------------------------------------------------------|--------------|
| Model B+ (MSA) | The fetal heart rate is commonly measured using | Equivalent |
| | Doppler ultrasound devices and uterine contractions are | to Predicate |
| | commonly measured with a strain gauge based | |
| | tocodynamometer. | |
| | The Sense4Baby System Model B+ uses Piezo-electric | |
| | crystals to generate the ultrasound signals and | |
| | conventional technologies to measure the fetal heart rate | |
| | and uterine contraction patterns. The result is a graphical | |
| | overlay of both measurements that can be viewed either | |
| | on a screen or on paper. | |
| Fetal Assist (K020390) | The Fetal Assist ultrasound transducer contains a | |
| | transmitter and receiver. In use, the transducer sends out | |
| | a pulsed ultrasonic signal, generated by the piezo- | |
| | ceramic transmitter crystals. | |

The minor differences between the S4B System B+ (MSA and the Huntliegh Healthcare Limited Fetal Assist System (K020390) do not raise new questions of safety or effectiveness. These differences will be discussed in turn below:

{8}------------------------------------------------

### Sense4Babv System B+ 510(k) Submission

### Ultrasound Frequency:

The Model B+(MSA), use a frequency of 1 MHz, while the Fetal Assist (K020390) uses a frequency of 1.5 MHz. While these frequencies are similar, the lower the ultrasound frequency the better the depth pf penetration of ultrasound. The Model B+ (MSA) has a slightly deeper penetration than the Fetal Assist (K020390).

### Ultrasound Burst Rate:

The Model B+ (MSA), use a burst rate of 3125Hz, while the Fetal Assist (K020390) uses a burst rate of 3200 Hz. The 3125Hz burst rate sets the rate at which 1MHz pulses are transmitted and the echoes are sampled and received. The 3200Hz sampling rate may result in a negligible increase in the resolution of the fetal heart rate (FHR) at the high end of the FHR range. This difference between the two systems does not raise any safety and effectiveness concerns.

A detailed comparison of the technological characteristics of the Sense4Baby System and the referenced predicate device is in section 5.3. No applicable performance standards have been issued under Section 514 of the Food, Drug, and Cosmetic Act for this device type. FDA Form 3654 is included in this submission to identify national and international standards used in the development and testing of the Sense4Baby System Model B+ including the following voluntary safety standards:

- . IEC 60601-1:2005 + CORR.2 (2007) + A1(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. 1 (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 60601-1-11:2010. Medical electrical equipment Part 1-11: General requirements for basic ● safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- . 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 and skin sensitization.
- . ASTM D4169:2009 Standard Practice for Performance Testing of Shipping Containers and Systems.
- . IEC 60529:1989 + A1(1999) Degrees of protection provided by enclosures (IP Code). Additional standards used in the development and risk analyses of the Sense4Baby System Model B+ are listed below:
- . ISO14971:2007 Medical Devices- Application of risk management to medical devices.
- ISO13485:2003 Medical Devices- Quality management systems- Requirements for regulatory purposes.

{9}------------------------------------------------

### Sense4Babv System B+ 510(k) Submission

### 1.5. Test Summary

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. Executed 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)
- Formative Usability Testing
- . Summative Usability Testing

#### 1.6. Conclusion:

Therefore AirStrip Technologies, Inc. (S4B) is seeking pre-market clearance to introduce the Sense4Baby System Model B+ (MSA) maternal/fetal monitoring system into commercial distribution, with patient use as part of the indications for use. This document inclusive of its attachments contains a complete description of the Sense4Baby System Model B+ (MSA) Fetal monitoring system, a side by side comparison of the Sense4Baby System Model B+ (MSA) to the Huntliegh Healthcare Limited Fetal Assist (K020390) predicate device, a summary of all testing performed and the test results obtained. This information, when considered in its totality provides ample objective evidence that the Sense4Baby System Model B+ (MSA) has been demonstrated to be substantially equivalent to the predicate devices, and raises no new concerns related to safety or efficacy; allowing FDA to make a determination of substantial equivalence and clear the device as described for commercial distribution.

S4B conducted two separate studies to determine the ability of the user to operate the device in the home environment. These studies focused on key aspects of…