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.

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.

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.

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).

AI/ML Overview

This document, K230769, is a 510(k) premarket notification for the PrevisEA Device. It's important to note that this specific submission is for a change in wording in the device description and states that no new testing was performed for this submission as biocompatibility, electrical safety, shelf-life, and clinical testing were submitted for the original application for K211068.

Therefore, the information regarding acceptance criteria and performance study details would reside in the documentation for K211068, which is the predicate device for this submission and essentially the same device. This document explicitly states: "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."

Given the information provided in K230769, I cannot provide a detailed answer to your request regarding acceptance criteria and the study that proves the device meets them from this document alone. This document clearly states that no new testing was performed for this submission.

However, based on the information present, I can infer what type of information would have been in the original K211068 submission and highlight what is missing from this current document according to your request.

Here's what can be extracted/inferred from K230769 and what is missing based on your request:

General Device Information (from K230769):

Device Name: PrevisEA Device
Regulation Number: 21 CFR 870.1875
Regulation Name: Stethoscope
Regulatory Class: Class II
Product Code: DQD
Intended Use/Indications for 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.
Device Description: PrevisEA is a non-invasive, self-contained, medical device with a proprietary algorithm used to assess the digestive health of patients. It includes a stethoscope diaphragm, sound chamber, embedded microphone and CPU, display screen, and buttons. It's a convenient, single-use, disposable unit that attaches to the abdomen via an adhesive wafer. It detects the acoustic biomarker MH4 and quantifies the number of MH4 detections over a 4-minute interval, comparing it to a predefined threshold to determine the presence of abnormal digestive health in patients following major abdominal surgery, such as gastrointestinal impairment (GII).

Addressing Your Specific Points Based on K230769 (and what's missing):

A table of acceptance criteria and the reported device performance:
- Information in K230769: This document explicitly states: "No new testing was performed for this submission. Biocompatibility, electrical safety, shelf-life, and clinical testing were submitted for the original application for K211068."
- Missing from K230769: The actual clinical acceptance criteria (e.g., sensitivity, specificity, accuracy for detecting abnormal digestive health) and the reported performance metrics against those criteria are not present in this document. This would have been detailed in the K211068 submission.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Missing from K230769: This information is not provided in this document. It would have been part of the clinical study report in K211068.
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):
- Missing from K230769: This information is not provided in this document. This detail would be found in the clinical study methodology in K211068.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Missing from K230769: This information is not provided in this document. This detail would be found in the clinical study methodology in K211068.
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:
- Information in K230769: The device "assists physicians in assessing the digestive health of patients." This implies human-in-the-loop use. However, the exact type of study (MRMC) and the effect size of human improvement are not detailed in this document. It refers to "clinical testing" in K211068.
- Missing from K230769: Details on a specific MRMC study, if conducted, and the quantitative effect size of AI assistance are not available in this document.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Information in K230769: The device's description states it "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." This suggests the algorithm performs an analysis independently to reach a determination. The device then "displays information which assists physicians." This implies both a standalone algorithmic function and a human-in-the-loop assistance. However, specific standalone performance metrics (e.g., sensitivity, specificity of the algorithm itself) from a standalone study are not provided in this document.
- Missing from K230769: Direct evidence or results from a dedicated standalone performance study are not detailed here.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Missing from K230769: The specific method for establishing ground truth (e.g., clinical diagnosis of GII based on patient outcomes, expert review of acoustic data, etc.) is not provided in this document. This would be crucial information in the K211068 clinical study.
The sample size for the training set:
- Missing from K230769: This information is not provided in this document. It would have been part of the development process for the proprietary algorithm mentioned.
How the ground truth for the training set was established:
- Missing from K230769: This information is not provided in this document. Similar to the test set ground truth, the methodology for the training set would be part of the algorithm development documentation.

In summary, K230769 is a notification about a minor change (wording in the description) to an already cleared device (K211068). It explicitly refers back to the original K211068 submission for all performance and testing details. To answer your questions comprehensively, you would need to review the K211068 documentation.

Summary

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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 and Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a larger font size than the name. The name is written as "U.S. FOOD & DRUG ADMINISTRATION".

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. 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

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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 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-safetyreporting-combination-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-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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,

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

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Indications for Use

510(k) Number (if known) K230769

Device Name PrevisEA Device

Indications for Use (Describe)

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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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 /Numbers and Code	21 CFR870.1875	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 toassess the digestive health of patients. The device includes a stethoscope diaphragm, soundchamber, embedded microphone and CPU, as well as a display screen and buttons. ThePrevisEA device is a convenient, single-use, disposable unit, which attaches to the abdomen ofthe 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.The PrevisEA requires no cable connections for operation of the device. Integration of the abovecomponents allow auscultation and digital capture of digestive sounds, such as MH4.Messages are transmitted to the easy-to-read display screen on the front of the device. ThePrevisEA detects the acoustic biomarker MH4 and quantifies the number of MH4 detectionsover a 4-minute interval, which it compares to a predefined threshold to determine the presenceof abnormal digestive health in patients following major abdominal surgery, such asgastrointestinal 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.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.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 forUse/Intended Use	PrevisEA is a compact, non-invasive device placed on the abdomen to capture the digestivesounds of patients. PrevisEA displays information which assists physicians in assessing thedigestive health of patients. This device is for prescription use only and should be used underthe direction of a licensed healthcare practitioner. The PrevisEA device has not been tested forand it is not intended for pediatric use.

K230769 Page 1 of 3 Entac Medical Inc.

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K230769 Page 2 of 3 Entac Medical Inc.

PrevisEA™ Device 510(k) Premarket Notification

Table 1: Substantial Equivalence Comparison Table

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Technological Characteristic	Comparison
Number of Sensors	1 - self contained	Same
Sensor size (mm) ActiveArea	3 inches	Same
Algorithm	Algorithm technology to specifically evaluategastrointestinal 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 andpresentation 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.

Regulation Number and Section

§ 870.1875 Stethoscope.

(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.