(202 days)
Not Found
No
The description mentions an "optical sensor to distinguish between the FHR and the maternal heart rate (MHR)". While this involves signal processing, there is no mention of AI, ML, or related terms like neural networks, deep learning, or training data. The method described appears to be a rule-based or sensor-based approach rather than an AI/ML algorithm.
No.
The device is intended to detect, display, and play fetal heart sounds. Its purpose is for monitoring, not for treating any condition or disease.
No
The device is intended to detect, display, and play fetal heart sounds and heart rate. It does not provide a medical diagnosis or assist in making one.
No
The device description explicitly states that HeraBEAT™ US is a "hand-held, battery powered audio Doppler device integrated with 2MHz probe" and includes components like an "ultrasound transducer, rechargeable battery, and internal microcontroller and Bluetooth Low Energy (BLE) chip." While it has a software component (the HeraBEAT™ application), it is fundamentally a hardware device with integrated software.
Based on the provided information, the HeraBEAT™ US device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. This typically involves blood, urine, tissue, or other biological specimens.
- The HeraBEAT™ US device uses Doppler ultrasound to detect fetal heartbeats within the body. It does not analyze a sample taken from the patient.
- The intended use and device description clearly state it's a hand-held audio Doppler device for detecting and displaying fetal heart rate and sound. This is a non-invasive method of monitoring a physiological function.
Therefore, the HeraBEAT™ US falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HeraBEAT™ US is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound. HeraBEAT™ US is indicated for use by medical professionals in clinical or home care settings for singleton pregnancies from 12 weeks gestation.
Product codes
KNG
Device Description
HeraBEAT™ US is a hand-held, battery powered audio Doppler device integrated with 2MHz probe, used for detecting and displaying the fetal heart rate (FHR) and FHR sound. The device uses an optical sensor to distinguish between the FHR and the maternal heart rate (MHR) to eliminate "crosstalk" in the FHR display.
HeraBEAT™ US includes the following components:
- The handheld HeraBEAT™ US device that incorporates an ultrasound transducer, . rechargeable battery, and internal microcontroller and Bluetooth Low Energy (BLE) chip for wireless data transfer from the HeraBEAT™ US device to the user's smartphone.
- The HeraBEAT™ application, which is downloaded from an app store to the user's . smartphone. The HeraBEAT™ application is used to communicate with the HeraBEAT™ US device using wireless BLE. It controls the operation of the device and receives the FHR values for numerical display to the user. It plays the FHR sound and stores the FHR values in a history log.
HeraBEAT™US is supplied with a battery charger (power supply), two tubes of commercially available Aquasonic 100 Ultrasound Transmission Gel (cleared under K802146), carry case and User Manual.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Doppler ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical professionals in clinical or home care settings.
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)
Non-clinical Performance Data
Bench Performance Testing: Clinical measurement accuracy was conducted per the acoustic output measurement methodology as recommended in the FDA guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers," dated September 9, 2008.
Biocompatibility: HeraBEAT™ US is a surface contact device with a short-term (
§ 884.2660 Fetal ultrasonic monitor and accessories.
(a)
Identification. A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 14, 2019
HeraMED Ltd. % Sheila Hemeon-Heyer, JD, RAC President and Founder Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst. MA 91002
Re: K191110
Trade/Device Name: HeraBEAT™US Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: KNG Dated: April 24, 2019 Received: April 26, 2019
Dear Sheila Hemeon-Heyer:
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. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device 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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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. Acting 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) K191110
Device Name
HeraBEAT™ US
Indications for Use (Describe)
HeraBEATIM US is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound. HeraBEAT™ US is indicated for use by medical professionals in clinical or home care settings for singleton pregnancies from 12 weeks gestation.
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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Page 1 of 4
510(k) SUMMARY K191110
| Device Manufacturer: | HeraMED Ltd.
6 Meir Ariel Street
Netanya, 4059300, Israel | | |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|--|
| 510(k) Contact: | Sheila Hemeon-Heyer
President and Founder
Heyer Regulatory Solutions LLC
413-330-8578
Sheila@Heyer-Regulatory.com | | |
| Date Prepared: | November 13, 2019 | | |
| Name of Device: | HeraBEAT™ US | | |
| Common or Usual Name: | Fetal Ultrasonic Monitor and Accessories | | |
| Classification: | Product Code:
Regulation No:
Regulatory Class:
Classification Panel: | KNG
21 C.F.R. §884.2660
II
Obstetrics/Gynecology | |
| Predicate Device: | MD800, cleared under K112911 | | |
This predicate device has not been subject to a design related recall.
Intended Use / Indications for Use
HeraBEAT™ US is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound. HeraBEAT™ US is indicated for use by medical professionals in clinical or home care settings for singleton pregnancies from 12 weeks gestation.
Device Description
HeraBEAT™ US is a hand-held, battery powered audio Doppler device integrated with 2MHz probe, used for detecting and displaying the fetal heart rate (FHR) and FHR sound. The device uses an optical sensor to distinguish between the FHR and the maternal heart rate (MHR) to eliminate "crosstalk" in the FHR display.
HeraBEAT™ US includes the following components:
- The handheld HeraBEAT™ US device that incorporates an ultrasound transducer, . rechargeable battery, and internal microcontroller and Bluetooth Low Energy (BLE) chip for wireless data transfer from the HeraBEAT™ US device to the user's smartphone.
- The HeraBEAT™ application, which is downloaded from an app store to the user's .
4
smartphone. The HeraBEAT™ application is used to communicate with the HeraBEAT™ US device using wireless BLE. It controls the operation of the device and receives the FHR values for numerical display to the user. It plays the FHR sound and stores the FHR values in a history log.
HeraBEAT™US is supplied with a battery charger (power supply), two tubes of commercially available Aquasonic 100 Ultrasound Transmission Gel (cleared under K802146), carry case and User Manual.
| Device & Predicate Device(s): | K191110 | K112911 |
|---|---|---|
| General Device Characteristics | ||
| Device Name | HeraBEAT™ US | MD800 |
| Indications for Use | HeraBEAT™ US is intended | |
| to detect fetal heart beats, | ||
| display fetal heart rate, and | ||
| play the fetal heart sound. | ||
| HeraBEAT™US is indicated | ||
| for use by medical | ||
| professionals in clinical or | ||
| home care settings for | ||
| singleton pregnancies from | ||
| 12 weeks gestation. | The Fetal Doppler is a | |
| hand-held, battery | ||
| powered audio Doppler | ||
| device used for | ||
| detecting fetal heart | ||
| beats. | ||
| Intended patient population | Pregnant women | Pregnant women |
| Intended device operator | Healthcare professionals | Healthcare |
| professionals | ||
| Gestational age | 12 weeks | 12 weeks |
| Environment of use | Professional and home | |
| healthcare environment | Professional and home | |
| healthcare environment | ||
| FHR measurement method | Doppler ultrasound | Doppler ultrasound |
| Device Features | ||
| Battery/Power Supply | Lithium ion rechargeable | |
| battery supplied with charger | 2 AA alkaline batteries, | |
| assumed replaceable | ||
| Display | Smart phone application | LCD |
| Bluetooth | Yes | - |
| Technical Specifications | ||
| Working mode | Continuous wave | Continuous wave |
| Ultrasound nominal frequency | 2 MHz | 2 MHz |
| FHR measuring range | 50-240 bpm | 50-210 bpm |
| Resolution | 1bpm | 1 bpm |
| Accuracy | +/- 2bpm | +/- 2bpm |
Substantial Equivalence Discussion
The HeraBEAT™US device has the same intended use and similar technological characteristics and principles of operation as the MD800 fetal ultrasonic monitor. Different technological features include the use of Bluetooth technology, different battery/power supply,
5
different ingress protection, and different display modalities. The technological differences between the HeraBEAT™US device and the predicate device do not raise different questions of safety and effectiveness.
Non-clinical Performance Data
Bench Performance Testing
Clinical measurement accuracy was conducted per the acoustic output measurement methodology as recommended in the FDA guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers," dated September 9, 2008.
Biocompatibility
HeraBEAT™ US is a surface contact device with a short-term (