PrevisEA Device

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August 4, 2021 Entac Medical Inc. % Adam Harris Director, Regulatory Affairs Target Health LLC 261 Madison Avenue, 24th Floor New York, NY 10016 Re: K211068 Trade/Device Name: PrevisEA Device Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DOD Dated: May 5, 2021 Received: May 7, 2021 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 Federal {1}------------------------------------------------ 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-safety-reportingcombination-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, for 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K211068 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) | | |-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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 K211068 Premarket Notification # 5. 510(k) Summary ## 5.1 Entac Medical Inc. 680 Oakleaf Office Lane, Suite 201 Memphis, TN 38117 #### 5.2 Contact Person Adam Harris, MM, RAC Director, Regulatory Affairs Target Health LLC 261 Madison Avenue, 24th Floor New York, NY 10016 Telephone: (646) 218-2009 aharris@targethealth.com Date of Summary: July 8, 2021 | Device Proprietary Name | PrevisEA™ Device | | | |--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|-------------| | Common/Usual Name | Electronic Stethoscope | | | | Classification Names /<br>Numbers and Code | 21 CFR<br>870.1875 | Classification Name<br>Electronic Stethoscope | Code<br>DQD | | Regulatory Class | 2 | | | | Prescription Status | Prescription Device | | | | Classification Panel | Gastroenterology | | | | Predicate Device | K150782 | GI Logic AbStats® Gateway | | | Description of Device | PrevisEA is a non-invasive, self-contained, medical device with a<br>proprietary algorithm used to assess the digestive health of patients. The<br>device includes a stethoscope diaphragm, sound chamber, embedded<br>microphone and CPU, as well as a display screen and buttons. The<br>PrevisEA device is a convenient, single-use, disposable unit, which<br>attaches to the abdomen of the patient via an adhesive wafer on the back<br>of the device. The PrevisEA is a single-use, disposable unit, which avoids<br>the need for cleaning and disinfection.<br><br>The PrevisEA requires no cable connections for operation of the device.<br>Integration of the above components allow auscultation and digital<br>capture of digestive sounds, such as MH4.<br><br>Messages are transmitted to the easy-to-read display screen on the front<br>of the device. The PrevisEA detects the acoustic biomarker MH4 and<br>quantifies the number of MH4 detections over a 4-minute interval, which it<br>compares to a predefined threshold to determine the presence of abnormal | | | {4}------------------------------------------------ | | digestive health in patients following intestinal surgery, such as gastrointestinal<br>impairment (GII). | |-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use/Intended<br>Use | PrevisEA is a compact, non-invasive device placed on the abdomen to<br>capture the digestive sounds of patients. PrevisEA displays information<br>which assists physicians in assessing the digestive health of patients. This<br>device is for prescription use only and should be used under the direction<br>of a licensed healthcare practitioner. The PrevisEA device has not been<br>tested for and it is not intended for pediatric use. | {5}------------------------------------------------ | | Subject Device | Predicate Device | | | |----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|--| | | Entac PrevisEA Device | GI Logic Abstats Gateway | Comparison | | | 510(k) Number | K211068 | K150782 | Same | | | Product Code | DQD | DQD | Same | | | Regulation | 21 CFR 870.1875 Stethoscope | 21 CFR 870.1875 Stethoscope | Same | | | Intended Use | PrevisEA is a compact, non-<br>invasive device placed on the<br>abdomen to capture the digestive<br>sounds of patients. PrevisEA<br>displays information which assists<br>physicians in assessing the<br>digestive health of patients.<br>This device should be used under<br>the direction of a licensed<br>healthcare practitioner. The<br>PrevisEA device has not been<br>tested for and it is not intended for<br>pediatric use. | The AbStats Gateway is a compact<br>device with integrated sensor<br>interfaces and embedded<br>computing system (stethoscope)<br>that in conjunction with external<br>sensors constitutes the AbStats<br>system. The AbStats system<br>external sensors are placed on the<br>abdomen and identify the vibratory<br>signals associated with digestive<br>processes. This device should be<br>used under the direction of a<br>licensed healthcare practitioner<br>when it is required to determine<br>this patient digestive state. The<br>device has not been tested for and<br>it is not intended for pediatric use. | Substantially equivalent | | | Number of Sensors | 1 - self contained | 2 - external | Different number and location but<br>substantially equivalent<br>functionality | | | Sensor Size (mm) Active Area | 3 inches | 30 mm x 20 mm<br>400 mm2 | Different size but substantially<br>equivalent functionality | | | | Subject Device | Reference Device | Comparison | | | | Entac PrevisEA Device | GI Logic Abstats Gateway | | | | Algorithm | The PrevisEA utilizes<br>algorithm technology to<br>specifically evaluate<br>gastrointestinal auditory<br>biomarker MH4 | The Abstats Gateway utilizes algorithm<br>technology to recognize and classify<br>gastrointestinal signals | Different but Subject and<br>Reference devices have similar<br>functionality | | | Sensor Technology | Standard Electrical<br>Microphone | Standard Electrical Microphone | Substantially equivalent | | | System Technology | Sensor data signal processing<br>and computing | Sensor data signal processing<br>and computing | Substantially equivalent | | | Interface to PC | None required (no PC<br>Interface) | None required (no PC Interface) | Substantially equivalent | | | Power Supply | Lithium-Ion Battery | 5V USB Power Source | Different but substantially<br>equivalent functionality | | | Sensor Cable Length (m) | N/A – none required | 2.0 m | Different but substantially<br>equivalent functionality | | | IEC60601 1-1:2005 3rd Edition<br>Medical Electrical Equipment Part<br>1: General Requirement or Safety | Conforms | Conforms | Substantially equivalent | | | EN60601-1-2, 2007/03, EMC<br>Requirements for Safety, 2.<br>Collateral Standard –<br>Electromagnetic Compatibility<br>Requirements and Tests | Conforms | Conforms | Substantially Equivalent | | | Immunity Requirements for Medical<br>Electrical Equipment Part 1:<br>General | Conforms | Conforms | Substantially Equivalent | | | | Subject Device | Reference Device | Comparison | | | | Entac PrevisEA Device | GI Logic Abstats Gateway | | | | Biocompatibility | Testing demonstrated all<br>patient contacting materials<br>for the PrevisEA device to be<br>safe and biocompatible | No biocompatibility testing performed as the<br>only patient contact consists of commercially<br>available dermal adhesive dressings | Substantially Equivalent | | | Software | The PrevisEA software<br>processes audio signals for<br>display and presentation to<br>the user. | The AbStats software processes<br>audio signals for display<br>and presentation to the user. | Substantially Equivalent | | | Auscultation Performance Tests:<br>Bench Testing | Passed/Conforms | Passed/Conforms | Substantially Equivalent | | | Clinical performance validation | Listens for the MH4 acoustic<br>biomarker | Listens for acoustic event rates to determine<br>an intestinal motility | Different mechanism/parameter<br>of assessment but does not raise<br>new issues of safety and efficacy. | | | Abdomen Placement | The PrevisEA is placed in<br>any quadrant of the patient's<br>abdomen.<br>Image: PrevisEA device on a human torso | AbStats external sensors placed on the<br>abdomen,<br>Image: AbStats external sensors placed on a human abdomen | Substantially Equivalent | | # Table 1: Substantial Equivalence Comparison Table {6}------------------------------------------------ # Table 1: Substantial Equivalence Comparison Table (Continued) {7}------------------------------------------------ # Table 1: Substantial Equivalence Comparison Table (Continued) {8}------------------------------------------------ | Characteristics | PrevisEA | Abstats Gateway | |-------------------------------|----------|-----------------| | Electronic Stethoscope | Yes | Yes | | Non-invasive system | Yes | Yes | | Attach to abdomen | Yes | Yes | | Auscultation device | Yes | Yes | | Assess digestion specifically | Yes | Yes | | Algorithm technology | Yes | Yes | | Self-contained sensors | Yes | No | | Batter powered | Yes | No | ### Table 2: Summary of Technological Characteristics Compared to the Predicate Device ### 5.3 Biocompatibility Testing Biocompatibility tests were conducted with the PrevisEA Device according to ISO 10993-1:2018 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process. These studies demonstrated the PrevisEA Device is biocompatible. #### 5.4 Electrical Safety and Electromagnetic Compatibility (EMC) Electrical product safety, electromagnetic compatibility, and battery safety testing were performed for the PrevisEA Device. All testing met acceptance criteria and demonstrated the PrevisEA Device to be safe and electromagnetically compatible. ### ર્સ્ડ Clinical Testing - PrevisEA Optimization Trial Clinical data was submitted in support of this 510k Premarket Notification. Clinical testing demonstrated the PrevisEA Device accomplishes its intended use. Trial Registration: ClinicalTrials.gov NCT03505476 75 subjects undergoing intestinal resection surgery had PrevisEA applied at the completion of surgery. This study demonstrated the capability of the PrevisEA Device in listening/capturing the acoustic biomarker, MH4 while in clinical use (attached to patient abdomens). #### 5.6 Conclusion Since the comparison of bench testing to clinical outcomes is still not well understood for this type of device, clinical testing was required to support substantial equivalence. {9}------------------------------------------------ The clinical data submitted validates the intended use of the PrevisEA Device. The nonclinical data support the safety and effectiveness of the device, and the bench demonstrates the device meets its own specifications. The hardware and software verification and validation demonstrate that the PrevisEA device performs as intended in the specified use conditions. Though there are minor differences in technological characteristics, the data provided in this submission and the comparisons demonstrate these differences do 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 and reference devices.