Invu by Nuvo
Device Facts
| Record ID | K221046 |
|---|---|
| Device Name | Invu by Nuvo |
| Applicant | Nuvo- Group , Ltd. |
| Product Code | LQK · Obstetrics/Gynecology |
| Decision Date | May 6, 2022 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 884.2730 |
| Device Class | Class 2 |
Indications for Use
INVU by Nuvo™ is a maternal-fetal mon-invasively measures and displays fetal heart rate (FHR), maternal heart rate (MHR) and Uterine Activity (UA). The INVU Sensor Band™ acquires the fetal heart electrocardiogram and maternal heart electrocardiogram signals from abdominal surface electrodes and the fetal phonocardiogram and the maternal phonocardiogram signals from surface acoustic sensors. The FHR, MHR and UA tracings are derived from these signals and presented. INVU by Nuvo™ is indicated for use by pregnant women who are in their 32nd week of gestation (or later), with a singleton pregnancy. The INVU by Nuvo™ maternal-fetal monitor is intended for use by healthcare professionals in health care facilities and by the patient in the patient's home, on the order of a physician. The INVU by Nuvo™ is indicated for antepartum fetal surveillance (i.e. non-stress testing). This system does not prevent the onset of preterm labor nor will it prevent the occurrence of preterm birth.
Device Story
INVU by Nuvo™ is a non-invasive maternal-fetal monitor. It uses a sensor band worn on the maternal abdomen to acquire fetal/maternal ECG signals via surface electrodes and fetal/maternal phonocardiogram (PCG) signals via acoustic sensors. An integrated electronic module processes and transmits these signals to cloud servers. Algorithmic modules at the cloud level process and merge the inputs to derive FHR, MHR, and UA tracings. Data is presented via two applications: the INVU App (patient) displays average FHR/MHR after a minimum 30-minute session; the INVU-Pro application (physician) displays complete FHR, MHR, and UA data. Used in healthcare facilities or patient homes under physician order. Enables remote antepartum fetal surveillance, allowing healthcare providers to review tracings for clinical decision-making.
Clinical Evidence
Bench testing only. Evidence includes biocompatibility testing (cytotoxicity, irritation, sensitization), mechanical functionality and tensile strength testing for straps/buckles, electrical resistance testing for sensors, and electrical testing for frequency response and LED performance. Software validation was performed per FDA guidance for software changes.
Technological Characteristics
Materials: Polyamide, Elastane, TPU, Polycarbonate (Makrolon 2485), TPE (TM4ADT), Silver, Aluminum, Stainless Steel. Sensing: Transabdominal ECG and acoustic (PCG) sensors. Connectivity: Wireless (Bluetooth, Wi-Fi) to cloud-based processing. Power: Rechargeable battery on band. Software: Cloud-based algorithmic processing. Sterilization: Non-sterile.
Indications for Use
Indicated for pregnant women ≥32 weeks gestation with singleton pregnancy for antepartum fetal surveillance (non-stress testing).
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
- INVU by Nuvo™ (K210025)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 6, 2022
Nuvo- Group Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philladelphia, PA 19103
Re: K221046
> Trade/Device Name: INVU by Nuvo™ Regulation Number: 21 CFR§ 884.2730 Regulation Name: Home uterine activity monitor Regulatory Class: II Product Code: LQK Dated: April 8, 2022 Received: April 8, 2022
Dear Janice Hogan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
{1}------------------------------------------------
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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known) K221046
Device Name INVU by Nuvo™
#### Indications for Use (Describe)
INVU by Nuvo™ is a maternal-fetal mon-invasively measures and displays fetal heart rate (FHR), maternal heart rate (MHR) and Uterine Activity (UA).
The INVU Sensor Band™ acquires the fetal heart electrocardiogram and maternal heart electrocardiogram signals from abdominal surface electrodes and the fetal phonocardiogram and the maternal phonocardiogram signals from surface acoustic sensors. The FHR, MHR and UA tracings are derived from these signals and presented.
INVU by Nuvo™ is indicated for use by pregnant women who are in their 32nd week of gestation (or later), with a singleton pregnancy.
The INVU by Nuvo™ maternal-fetal monitor is intended for use by healthcare professionals in health care facilities and by the patient in the patient's home, on the order of a physician.
The INVU by Nuvo™ is indicated for antepartum fetal surveillance (i.e. non-stress testing).
This system does not prevent the onset of preterm labor nor will it prevent the occurrence of preterm birth.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 12px;"></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
| <div> <span> <span style="font-size: 12px;"></span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
### 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}------------------------------------------------
### Special 510(k) SUMMARY - K221046
Nuvo Group Ltd.'s INVU by Nuvo™
### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Nuvo-Group Ltd. Yigal Alon 94 St., Alon Tower 1 Tel Aviv, Israel 6789155 Phone: +972-54 3063996 Contact Person: Chen Rubinstein
Date Prepared: May 4, 2022
### Device Information
| Trade Name | INVU by Nuvo™ |
|----------------------|-------------------------------------|
| Common Name | Home Uterine Activity Monitor |
| Regulation Number | 21 CFR 884.2730 |
| Regulation Name | Home uterine activity monitor |
| Product Code | LQK (Home Uterine Activity Monitor) |
| Classification Panel | Obstetrics/Gynecology |
| Regulatory Class | II |
#### Predicate Device
K210025 INVU by Nuvo™
The predicate device has not been subject to a design-related recall.
### Device Description
INVU by Nuvo™ is a non-invasive medical device that acquires and displays vital signs of the pregnant woman and her fetus. It measures and processes signals picked up on the abdominal surface using highly sensitive sensors, special electronic circuitry, and processing software. Two types of sensors pick up the signals: ECG-like sensors that pick-up bio-potential signals, and acoustic sensors. The bio-potential (ECG-like) sensors pick up the fECG (of the fetus), the mECG signals (of the pregnant woman) and the acoustic sensors measure the sounds from the pregnant woman's abdomen (PCG -phonocardiogram and fPCG - fetal PCG). The FHR, MHR, and UA tracings are derived from these signals and presented.
INVU by Nuvo™ is an integrated platform that uses a signal acquisition tool to provide input related to fetal heart rate (FHR), maternal heart rate (MHR), to two separate software applications, one for the patient (INVU App) and one for the physician (INVU-Pro application), which also provides uterine activity (UA) tracings. Sensors are incorporated in a belt that is worn on the abdomen of the pregnant woman, where it acquires both biopotential and acoustic signals. The signals are processed at a cloudserver level. The sensors are attached to the pregnant woman's abdomen by a belt (INVU by Nuvo™ sensory band). An integrated electronic module receives, processes and transmits the measured data to algorithmic modules at cloud servers, where the
{4}------------------------------------------------
inputs from the sensors are processed, merged, and sent to the INVU by Nuvo™ (patient) application to display the average FHR and average MHR after a 30 minute (minimum) monitoring session and to the INVU by Nuvo™ Pro (physician) application to display the complete FHR, MHR, and uterine activity data from a monitoring session. A monitoring session can only be scheduled by a health care provider.
The purpose of this special 510(k) is to implement several minor improvements to straps, buckles and LED used in the device. There have also been several minor changes to the software.
### Indications for Use
INVU by Nuvo™ is a maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), maternal heart rate (MHR) and Uterine Activity (UA).
The INVU Sensor Band™ acquires the fetal heart electrocardiogram and maternal heart electrocardiogram signals from abdominal surface electrodes and the fetal phonocardiogram and the maternal phonocardiogram signals from surface acoustic sensors. The FHR, MHR and UA tracings are derived from these signals and presented.
INVU by Nuvo™ is indicated for use by pregnant women who are in their 32nd week of gestation (or later), with a singleton pregnancy.
The INVU by Nuvo™ maternal-fetal monitor is intended for use by healthcare professionals in health care facilities and by the patient's home, on the order of a physician.
The INVU by Nuvo™ is indicated for antepartum fetal surveillance (i.e. non-stress testing).
This system does not prevent the onset of preterm labor nor will it prevent the occurrence of preterm birth.
### Substantial Equivalence
A table comparing the intended use and technological characteristics of the subject and predicate device is provided below.
| | Subject Device: INVU by Nuvo | Predicate Device: INVU by Nuvo |
|----------------------|---------------------------------------------------------------|---------------------------------------------------------------|
| 510(k) Number | K221046 | K210025 |
| Product Code | LQK | LQK |
| Classification | 21 CFR 884.2730 | 21 CFR 884.2730 |
| Device Type | Maternal-fetal monitor | Maternal-fetal monitor |
| Prescription Use | Trained medical personnel or patients on order of a physician | Trained medical personnel or patients on order of a physician |
| Anatomical Site | Maternal abdomen | Maternal abdomen |
| Target Population | Women who are ≥32 weeks gestation. | Women who are ≥32 gestational weeks with singleton pregnancy. |
| Intended Environment | Healthcare setting or home | Healthcare setting or home |
| Use/Reuse | Reusable by a single patient | Reusable by a single patient |
| Sterility | Non-sterile | Non-sterile |
{5}------------------------------------------------
| Patient interface | Maternal abdomen connected to surface ECG-like bio-potential sensors and acoustic sensors | Maternal abdomen connected to surface ECG-like bio-potential sensors and acoustic sensors |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FHR/MHR/UA Technology | Transabdominal electrocardiography signals and acoustic signals | Transabdominal electrocardiography signals and acoustic signals |
| FHR/MHR Sensors | bio-potential sensors and acoustic sensors | bio-potential sensors and acoustic sensors |
| FHR/MHR Sensor Power Source | Rechargeable battery (on band) | Rechargeable battery (on band) |
| Data Collected from Sensor Array | Fetal Heart Rate, Maternal Heart Rate, Uterine Contractions | Fetal Heart Rate, Maternal Heart Rate, Uterine Activity |
| Data Transmission | Wireless communication (Bluetooth, Wi-Fi) | Wireless communication (Bluetooth, Wi-Fi), cloud server |
| Information displayed on | Cloud or mobile based software applications | Cloud or mobile based software applications |
| Patient Contacting Material | Band fabric: 80% Polyamide and 20% Elastane and TPU [Polyesterbased Thermoplastic Polyurethane] Sensors: Polycarbonate, Polyamide, Elastomer, Silver, Polyurethane, Aluminum, and Stainless Steel. Back buckle: polycarbonate Makrolon 2485 Plastic components: PC Makrolon 2485. TPE - TM4ADT | Band fabric: 80% Polyamide and 20% Elastane and TPU [Polyester-based Thermoplastic Polyurethane] Sensors: Polyamide, Elastomer, Silver, Polyurethane, and Aluminum Back buckle: polycarbonate Makrolon 2485 Plastic components: PA220 (Nylon12) |
The primary technological difference between the subject and the predicate device are modifications made to the INVU Sensor band. These changes include changes in material of manufacture, buckles, belt material, band length, and the LED used during device charging. There have been no modifications that affect sensor position or performance. There have also been minor modifications to the accessory components that are supplied with the monitor (ECG gel and electrodes). Lastly, there have also been minor modifications to the mobile app used by the mother-to-be and the web software used by the healthcare professionals to improve user experience. These differences do not raise different questions of safety and effectiveness.
### Performance Data
To support the changes to the subject device, a risk analysis and associated verification and validation for the following assessments were provided:
- . Biocompatibility testing including cytotoxicity, irritation, and sensitization per the recommendations in the 2020 guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
{6}------------------------------------------------
- Software documentation and validation per the recommendations in the 2017 guidance ● document "Deciding When to Submit a 510(k) for a Software Change to an Existing Device"
- Functional testing to demonstrate the straps and buckles have adequate mechanical . performance (e.g., mechanical functionality testing and tensile strength testing)
- Electrical resistance testing to demonstrate continued electrical performance of the . snapping feature of the sensor.
- Electrical testing including bio-potential frequency response and charge mode testing to . demonstrate continued electrical performance of the LED light.
## Conclusions
The results of the testing described above demonstrate that the INVU by Nuvo™ is as safe and effective as the predicate device and supports a determination of substantial equivalence.
