(131 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the performance studies focus on usability and equivalence to a predicate device without indicating AI/ML-driven analysis.
No
The device is described as a monitoring system for fetal and maternal health, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section states that the device is indicated for "conventional antepartum fetal monitoring applications" including "antenatal monitoring (e.g., non-stress testing and/or uterine activity monitoring)". Monitoring to assess physiological states and activity is a form of diagnosis.
No
The device description explicitly states it is a "non-invasive, wireless, external monitoring system" and mentions "Hardware testing" and "Mechanical testing" in the performance studies, indicating it includes physical hardware components beyond just software.
Based on the provided information, the Sense4Baby System Model B+ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality.
- Sense4Baby System Function: The Sense4Baby System Model B+ is a non-invasive, external monitoring system that measures physiological parameters (fetal heart rate, maternal heart rate, and uterine contractions) directly from the maternal abdomen using ultrasound. It does not examine specimens derived from the human body.
- Intended Use: The intended use is for conventional antepartum fetal monitoring, which involves directly monitoring the fetus and mother, not analyzing biological samples.
Therefore, the Sense4Baby System Model B+ falls under the category of a non-invasive medical device for physiological monitoring, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LOK, MOH, HGM
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Pulsed Doppler Ultrasound
Anatomical Site
Maternal Abdomen
Indicated Patient Age Range
Pregnancies greater than or equal to 24 weeks gestation.
Intended User / Care Setting
Health care professionals and patients on the order of a physician, in a health care setting or home.
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. 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
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 the system use. These basic functional aspects of the system were deemed necessary to determine the ability of the user to successfully operate the system in the home environment.
These studies (both formative and summative) provided documented objective evidence that the device was usable by lay users, even when the provided instruction materials was limited to a Quick Start Guide, with a success rate of use in the home environment that was statistically equivalent to the results obtained in the health care provider environment.
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.
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.
Not Found
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
§ 884.2730 Home uterine activity monitor.
(a)
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.(b)
Classification. Class II (special controls); guidance document (Class II Special Controls Guidance for Home Uterine Activity Monitors).
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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) |
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3
1. 510(k) Summary
| Submitter: | Airstrip Technologies, Inc. |
|---|---|
| Address: | 565 Pearl St suite 209 |
| La Jolla, CA 92037 | |
| Phone number: | (201) 847-4496 |
| Fax number: | (201) 847-4845 |
| Contact person: | Curtis M. Egan |
| Phone number: | (951) 723-7261 |
| Fax number: | (858) 675-8201 |
| 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 | |
| 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. | The FETAL ASSIST is suitable for use in all conventional antepartum
fetal monitoring application from a gestation age of approximately 26
weeks. It is particularly intended for use in the following specific areas:
Antenatal monitoring in the hospital, doctors office, health clinic,
home or community.
External Labor monitoring.
Waterbith monitoring using optional waterproof transducers.
Home Uterine Activity Monitoring (HUAM) in conjunction with
standard high-risk care, for the daily at-home measurement of uterine
activity for women with history of preterm birth.
Domiciliary Non Stress Testing Applications.
NB: before being used in domiciliary HUAM and/or Non Stress Testing
applications the mother would be instructed in the use of the equipment.
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
System B+ (MSA) | Huntliegh Healthcare Limited
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
System B+ (MSA) | Huntliegh Healthcare Limited
Fetal Assist (K020390) |
| Technology | Relative pressure sensor
(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
System B+ | Huntliegh Healthcare Limited
Fetal Assist (K020390) |
| Size | 25mm(H) x 95mm(W) x 75MM(D) | 2" (50mm) x 10" (250mm) x 6 (150mm) |
| Weight |