(60 days)
Not Found
Unknown
The summary mentions a "proprietary algorithm" used to assess digestive health and detect/quantify an "acoustic biomarker MH4". While this involves signal processing and analysis, the description does not explicitly state that this algorithm utilizes AI or ML techniques. The lack of mention of training/test sets or performance metrics typically associated with AI/ML models further contributes to the uncertainty.
No
The device captures digestive sounds and displays information to assist physicians in assessing digestive health. It does not actively treat or provide therapy.
Yes
The device assists physicians in assessing digestive health and detects the acoustic biomarker MH4 to determine the presence of abnormal digestive health, which are diagnostic purposes.
No
The device description explicitly states it includes hardware components such as a stethoscope diaphragm, sound chamber, embedded microphone and CPU, display screen, and buttons.
Based on the provided text, the PrevisEA device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- PrevisEA's Function: The PrevisEA device works by capturing and analyzing digestive sounds from the patient's abdomen. This is a non-invasive method that does not involve testing samples taken from the body.
- Method of Operation: The device uses a stethoscope diaphragm, microphone, and algorithm to analyze acoustic signals, not biological or chemical markers in a sample.
Therefore, while it is a medical device used for diagnosis or assessment, it does not fit the definition of an In Vitro Diagnostic.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
DQD
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdomen
Indicated Patient Age Range
The PrevisEA device has not been tested for and it is not intended for pediatric use.
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D), under the direction of a licensed healthcare practitioner.
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)
No new testing was performed for this submission. Biocompatibility, electrical safety, shelf-life, and clinical testing were submitted for the original application for K211068.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 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
1
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
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) | |
|---|---|
| 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 CFR | |||||
| 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 | |||||
| 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). | | | | 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 for
Use/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. | | | | | |
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) Active | ||
| Area | 3 inches | Same |
| Algorithm | Algorithm technology to specifically evaluate | |
| 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 | |
| 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.