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 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 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.

AI/ML Overview

The provided text describes a Special 510(k) submission (K221046) for the INVU by Nuvo™ maternal-fetal monitor, which is an updated version of a previously cleared device (K210025). The focus of this submission is on minor improvements to straps, buckles, LED, and software, rather than significant changes to the core functionality or algorithms. As such, the performance data presented is primarily focused on demonstrating that these minor changes do not negatively impact safety and effectiveness and that the device remains substantially equivalent to its predicate.

Therefore, the acceptance criteria and study details provided in the document are not structured in a way that directly addresses the comprehensive set of questions about device performance in terms of accuracy or efficacy against a ground truth, as would be expected for a de novo device or a submission with significant algorithmic changes.

Here's a breakdown of the information available based on your request:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative "acceptance criteria" for clinical performance (e.g., FHR accuracy, UA detection sensitivity/specificity) or report specific device performance metrics against such criteria in the way you might expect from a comprehensive clinical validation study. Instead, the performance data focuses on demonstrating that the modifications to the device (straps, buckles, LED, software) do not compromise the safety and effectiveness relative to the predicate device.

The study listed in the document for performance evaluation include:

Acceptance Criteria (Implied)	Reported Device Performance (Demonstrated by Testing)
Biocompatibility: Device components in contact with the patient are biocompatible.	Passed: Biocompatibility testing (cytotoxicity, irritation, sensitization) per ISO 10993-1.
Software: Software changes maintain safety and effectiveness and comply with regulations.	Passed: Software documentation and validation per 2017 guidance document "Deciding When to Submit a 510(k) for a Software Change to an Existing Device".
Mechanical Performance: Straps and buckles have adequate mechanical integrity.	Passed: Functional testing (mechanical functionality and tensile strength testing) of straps and buckles.
Electrical Performance (Snapping Feature): Continued electrical performance of the sensor snapping feature.	Passed: Electrical resistance testing to demonstrate continued electrical performance of the snapping feature.
Electrical Performance (LED): Continued electrical performance of the LED light.	Passed: Electrical testing (bio-potential frequency response and charge mode testing) to demonstrate continued electrical performance of the LED light.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not mention specific sample sizes for test sets related to human subjects or patient data. The performance data described are related to engineering and software validation tests for the modifications, not a clinical trial on a large patient cohort. Therefore, details like country of origin or retrospective/prospective nature of data for clinical performance are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The listed tests (biocompatibility, software validation, mechanical, electrical) do not typically involve experts establishing clinical ground truth for diagnostic accuracy in the way a clinical study would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. The performance data pertains to technical verification and validation of device changes, not the adjudication of clinical outcomes or interpretations by multiple experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no indication that an MRMC comparative effectiveness study was conducted or that the device involves "AI assistance" in a way that would alter human reader performance. The device is described as measuring and displaying FHR, MHR, and UA, with signals processed at a cloud server level, but the submission focuses on hardware and minor software changes rather than new AI algorithms for interpretation or augmentation of human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes the device as a "maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), maternal heart rate (MHR) and Uterine Activity (UA)." While signals are processed at a "cloud server level," the submission's focus on hardware and minor software changes to an existing device means that a standalone algorithm performance study, distinct from overall device function, is not described or required for this particular 510(k). The device presents tracings that healthcare professionals use for "antepartum fetal surveillance (i.e. non-stress testing)."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Given that the listed performance data relates to engineering and software validation of device modifications, rather than clinical efficacy studies, there is no mention of clinical ground truth (like expert consensus, pathology, or outcomes data) in the context of device performance reporting for this submission. The "ground truth" for the tests performed would be established by standard engineering and testing protocols related to biocompatibility, mechanical properties, and electrical performance.

8. The sample size for the training set

This information is not provided. The document doesn’t mention a training set, as the evaluation focuses on verifying hardware and minor software modifications to an already cleared device, rather than the development or re-training of a new diagnostic algorithm.

9. How the ground truth for the training set was established

This information is not provided, as there is no mention of a training set or its associated ground truth in the context of this 510(k) submission.

Summary

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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.

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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

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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).

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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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

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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).

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

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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"

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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.

Regulation Number and Section

§ 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).