PrevisEA Device

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May 19, 2023 Entac Medical Inc. % Adam Harris Senior Director, Regulatory and Strategic Development Target Health LLC 450 Commerce Boulevard Carlstadt, NJ 07072 Re: K230769 Trade/Device Name: PrevisEA Device Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: March 17, 2023 Received: March 21, 2023 Dear Adam Harris: 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. 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Sincerely, # Shanil P. Haugen -S Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K230769 Device Name PrevisEA Device Indications for Use (Describe) PrevisEA is a compact, non-invasive device placed on the abdomen to capture the digestive sounds of patients. PrevisEA displays information which assists physicians in assessing the digestive health of patients. This device is for prescription use only and should be used under the direction of a licensed healthcare practitioner. The PrevisEA device has not been tested for and it is not intended for pediatric use. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.03 4.97a.75.75 0 0 0-1.08.022L7.477 9.417 5.384 7.323a.75.75 0 0 0-1.06 1.06L6.97 11.03a.75.75 0 0 0 1.079-.02l3.992-4.99a.75.75 0 0 0-.01-1.05z" fill-rule="evenodd"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ PrevisEA™ Device 510(k) Premarket Notification ## 5. 510(k) Summary #### Applicant 5.1 Entac Medical Inc. 680 Oakleaf Office Lane, Suite 201 Memphis, TN 38117 #### Contact Person 5.2 Adam Harris, MM, RAC Senior Director, Regulatory and Strategic Development 450 Commerce Boulevard Carlstadt, NJ 07072 Telephone: 646-479-2437 aharris@targethealth.com #### Date of Summary: January 27, 2023 5.3 | Device Proprietary Name | PrevisEA™ Device | | | | Subject Device | Predicate Device | |--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|------|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common/Usual Name | Electronic Stethoscope | | | | Entac PrevisEA Device | Entac PrevisEA Device | | Classification Names /<br>Numbers and Code | 21 CFR<br>870.1875 | Classification Name | Code | 510(k) Number | TBA | K211068 | | Regulatory Class | 2 | | | Product Code | DQD | DQD | | Prescription Status | Prescription Device | | | Regulation | 21 CFR 870.1875 Stethoscope | 21 CFR 870.1875 Stethoscope | | Classification Panel | Gastroenterology | | | Intended Use | PrevisEA is a compact, non-invasive device placed on the abdomen to capture the digestive sounds of patients. PrevisEA displays information which assists physicians in assessing the digestive health of patients. This device is for prescription use only and should be used under the direction of a licensed healthcare practitioner. The PrevisEA device has not been tested for and it is not intended for pediatric use. | PrevisEA is a compact, non-invasive device placed on the abdomen to capture the digestive sounds of patients. PrevisEA displays information which assists physicians in assessing the digestive health of patients. This device is for prescription use only and should be used under the direction of a licensed healthcare practitioner. The PrevisEA device has not been tested for and it is not intended for pediatric use. | | Predicate Device | K211068 | PrevisEA™ Device | | Device Description | PrevisEA is a non-invasive, self-contained, medical device with a proprietary algorithm used to assess the digestive health of patients. The device includes a stethoscope diaphragm, sound chamber, embedded microphone and CPU, as well as a display screen and buttons. The PrevisEA device is a convenient, single-use, disposable unit, which attaches to the abdomen of the patient via an adhesive wafer on the back of the device. The PrevisEA is a single-use, disposable unit, which avoids the need for cleaning and disinfection. | PrevisEA is a non-invasive, self-contained, medical device with a proprietary algorithm used to assess the digestive health of patients. The device includes a stethoscope diaphragm, sound chamber, embedded microphone and CPU, as well as a display screen and buttons. The PrevisEA device is a convenient, single-use, disposable unit, which attaches to the abdomen of the patient via an adhesive wafer on the back of the device. The PrevisEA is a single-use, disposable unit, which avoids the need for cleaning and disinfection. | | Description of Device | PrevisEA is a non-invasive, self-contained, medical device with a proprietary algorithm used to<br>assess the digestive health of patients. The device includes a stethoscope diaphragm, sound<br>chamber, embedded microphone and CPU, as well as a display screen and buttons. The<br>PrevisEA device is a convenient, single-use, disposable unit, which attaches to the abdomen of<br>the patient via an adhesive wafer on the back of the device. The PrevisEA is a single-use,<br>disposable unit, which avoids the need for cleaning and disinfection.<br><br>The PrevisEA requires no cable connections for operation of the device. Integration of the above<br>components allow auscultation and digital capture of digestive sounds, such as MH4.<br><br>Messages are transmitted to the easy-to-read display screen on the front of the device. The<br>PrevisEA detects the acoustic biomarker MH4 and quantifies the number of MH4 detections<br>over a 4-minute interval, which it compares to a predefined threshold to determine the presence<br>of abnormal digestive health in patients following major abdominal surgery, such as<br>gastrointestinal impairment (GII). | | | | The PrevisEA requires no cable connections for operation of the device. Integration of the above components allow auscultation and digital capture of digestive sounds, such as MH4.<br>Messages are transmitted to the easy-to-read display screen on the front of the device. The PrevisEA detects the acoustic biomarker MH4 and quantifies the number of MH4 detections over a 4-minute interval, which it compares to a predefined threshold to determine the presence of abnormal digestive health in patients following major abdominal surgery, such as gastrointestinal impairment (GII). | The PrevisEA requires no cable connections for operation of the device. Integration of the above components allow auscultation and digital capture of digestive sounds, such as MH4.<br>Messages are transmitted to the easy-to-read display screen on the front of the device. The PrevisEA detects the acoustic biomarker MH4 and quantifies the number of MH4 detections over a 4-minute interval, which it compares to a predefined threshold to determine the presence of abnormal digestive health in patients following intestinal surgery, such as gastrointestinal impairment (GII). | | Indications for<br>Use/Intended Use | PrevisEA is a compact, non-invasive device placed on the abdomen to capture the digestive<br>sounds of patients. PrevisEA displays information which assists physicians in assessing the<br>digestive health of patients. This device is for prescription use only and should be used under<br>the direction of a licensed healthcare practitioner. The PrevisEA device has not been tested for<br>and it is not intended for pediatric use. | | | | | | K230769 Page 1 of 3 Entac Medical Inc. {4}------------------------------------------------ K230769 Page 2 of 3 Entac Medical Inc. ## PrevisEA™ Device 510(k) Premarket Notification ## Table 1: Substantial Equivalence Comparison Table {5}------------------------------------------------ | Technological Characteristic | Comparison | | |---------------------------------|------------------------------------------------------------------------------------------|------| | Number of Sensors | 1 - self contained | Same | | Sensor size (mm) Active<br>Area | 3 inches | Same | | Algorithm | Algorithm technology to specifically evaluate<br>gastrointestinal auditory biomarker MH4 | Same | | Sensor Technology | Standard electrical microphone | Same | | System Technology | Sensor data signal processing and computing | Same | | Power Supply | Lithium-Ion Battery | Same | | Software | Processes audio signals for display and<br>presentation to the user. | Same | | Abdomen placement | Placed in any quadrant of the patient abdomen. | Same | ## Table 2: Summary of Technological Characteristics Compared to the Predicate Device #### 5.4 Purpose of the Submission The purpose of this submission is for a change to the wording in the description of the PrevisEA Device. #### ર.ર Testing Summary No new testing was performed for this submission. Biocompatibility, electrical safety, shelf-life, and clinical testing were submitted for the original application for K211068. #### Substantial Equivalence Conclusion 5.6 For this submission, the Subject and Predicate devices are the same. The Subject and Predicate devices have the same intended use/indications for Use, and there are no differences in technological characteristics between the Subject and Predicate devices. The sponsor has provided a systematic review of published literature supporting the proposed labeling change. The information provided in this submission demonstrates that the proposed change does not raise new questions of safety and efficacy. It is the conclusion of the sponsor that the subject device is substantially equivalent to the Predicate device.