(114 days)
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 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 intestinal surgery, such as gastrointestinal impairment (GII).
Based on the provided text, here's a detailed breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document doesn't explicitly state a table of quantifiable acceptance criteria with corresponding performance metrics for the clinical effectiveness of the PrevisEA device. However, it does mention that "All testing met acceptance criteria" for electrical safety, electromagnetic compatibility, and battery safety. For clinical performance, the acceptance criteria are implicitly tied to demonstrating the device's capability in "listening/capturing the acoustic biomarker, MH4 while in clinical use" and validating its intended use in assessing digestive health.
| Category | Acceptance Criteria (Implicit/Stated) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Conformance to ISO 10993-1:2018 | Testing demonstrated PrevisEA Device is biocompatible. |
| Electrical Safety | Conformance to safety standards (e.g., IEC60601 1-1:2005 3rd Ed.) | All testing met acceptance criteria and demonstrated safety. |
| Electromagnetic | Conformance to EMC standards (e.g., EN60601-1-2, 2007/03) | All testing met acceptance criteria and demonstrated EMC. |
| Battery Safety | Conformance to battery safety standards | All testing met acceptance criteria and demonstrated safety. |
| Auscultation Performance (Bench Testing) | Demonstrated conformity | Passed/Conforms |
| Clinical Performance | Capability in listening/capturing MH4 acoustic biomarker in vivo; validation of intended use. | Demonstrated capability of capturing MH4 while in clinical use; validated intended use. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: 75 subjects
- Data Provenance: The study involved subjects undergoing intestinal resection surgery, which implies a clinical setting. While the specific country of origin is not explicitly stated, the FDA clearance suggests it was likely conducted in the US or under protocols acceptable to the FDA. The study is prospective as devices were applied at the completion of surgery.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications. The output of the PrevisEA device is "information which assists physicians in assessing the digestive health of patients," and it "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." The "ground truth" seems to be related to the device's ability to detect MH4 and, implicitly, its correlation with digestive health post-surgery. However, the method for establishing this ground truth (e.g., against a gold standard for "abnormal digestive health") is not detailed.
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, the document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The study described focuses on the device's ability to detect a specific biomarker in a clinical setting, not on comparing the performance of human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the described "Clinical Testing - PrevisEA Optimization Trial" appears to be a standalone (algorithm only) performance study. The device itself "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." The study demonstrated the device's capability in "listening/capturing the acoustic biomarker, MH4 while in clinical use." There is no mention of human readers interpreting the raw sounds or the device's direct output except that the device "displays information which assists physicians." The focus is on the device's intrinsic ability to detect and quantify MH4.
7. The Type of Ground Truth Used:
The type of ground truth is indirectly a form of outcome data or physiological measurement (acoustic biomarker detection). The device specifically listens for the "MH4 acoustic biomarker" and "quantifies the number of MH4 detections." The study's objective was to demonstrate the device's capability in "listening/capturing the acoustic biomarker, MH4 while in clinical use." The implication is that the detection of MH4 itself serves as the ground truth for the device's primary function, with the ultimate goal of assisting in the assessment of digestive health. However, the direct clinical ground truth for "abnormal digestive health" against which the MH4 detection was validated is not elaborated.
8. The Sample Size for the Training Set:
The document does not provide any information regarding the sample size for the training set. The clinical trial described (75 subjects) is presented as a validation or optimization trial, not a training set. The term "proprietary algorithm" suggests internal development, but details on its training are absent.
9. How the Ground Truth for the Training Set Was Established:
The document does not provide any information on how the ground truth for the training set was established.
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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
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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
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 /Numbers and Code | 21 CFR870.1875 | Classification NameElectronic Stethoscope | CodeDQD |
| 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 aproprietary algorithm used to assess the digestive health of patients. Thedevice includes a stethoscope diaphragm, sound chamber, embeddedmicrophone and CPU, as well as a display screen and buttons. ThePrevisEA device is a convenient, single-use, disposable unit, whichattaches to the abdomen of the patient via an adhesive wafer on the backof the device. The PrevisEA is a single-use, disposable unit, which avoidsthe need for cleaning and disinfection.The PrevisEA requires no cable connections for operation of the device.Integration of the above components allow auscultation and digitalcapture of digestive sounds, such as MH4.Messages are transmitted to the easy-to-read display screen on the frontof the device. The PrevisEA detects the acoustic biomarker MH4 andquantifies the number of MH4 detections over a 4-minute interval, which itcompares to a predefined threshold to determine the presence of abnormal |
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| digestive health in patients following intestinal surgery, such as gastrointestinalimpairment (GII). | |
|---|---|
| Indications for Use/IntendedUse | PrevisEA is a compact, non-invasive device placed on the abdomen tocapture the digestive sounds of patients. PrevisEA displays informationwhich assists physicians in assessing the digestive health of patients. Thisdevice is for prescription use only and should be used under the directionof a licensed healthcare practitioner. The PrevisEA device has not beentested for and it is not intended for pediatric use. |
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| 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-invasive device placed on theabdomen to capture the digestivesounds of patients. PrevisEAdisplays information which assistsphysicians in assessing thedigestive health of patients.This device should be used underthe direction of a licensedhealthcare practitioner. ThePrevisEA device has not beentested for and it is not intended forpediatric use. | The AbStats Gateway is a compactdevice with integrated sensorinterfaces and embeddedcomputing system (stethoscope)that in conjunction with externalsensors constitutes the AbStatssystem. The AbStats systemexternal sensors are placed on theabdomen and identify the vibratorysignals associated with digestiveprocesses. This device should beused under the direction of alicensed healthcare practitionerwhen it is required to determinethis patient digestive state. Thedevice has not been tested for andit is not intended for pediatric use. | Substantially equivalent | |
| Number of Sensors | 1 - self contained | 2 - external | Different number and location butsubstantially equivalentfunctionality | |
| Sensor Size (mm) Active Area | 3 inches | 30 mm x 20 mm400 mm2 | Different size but substantiallyequivalent functionality | |
| Subject Device | Reference Device | Comparison | ||
| Entac PrevisEA Device | GI Logic Abstats Gateway | |||
| Algorithm | The PrevisEA utilizesalgorithm technology tospecifically evaluategastrointestinal auditorybiomarker MH4 | The Abstats Gateway utilizes algorithmtechnology to recognize and classifygastrointestinal signals | Different but Subject andReference devices have similarfunctionality | |
| Sensor Technology | Standard ElectricalMicrophone | Standard Electrical Microphone | Substantially equivalent | |
| System Technology | Sensor data signal processingand computing | Sensor data signal processingand computing | Substantially equivalent | |
| Interface to PC | None required (no PCInterface) | None required (no PC Interface) | Substantially equivalent | |
| Power Supply | Lithium-Ion Battery | 5V USB Power Source | Different but substantiallyequivalent functionality | |
| Sensor Cable Length (m) | N/A – none required | 2.0 m | Different but substantiallyequivalent functionality | |
| IEC60601 1-1:2005 3rd EditionMedical Electrical Equipment Part1: General Requirement or Safety | Conforms | Conforms | Substantially equivalent | |
| EN60601-1-2, 2007/03, EMCRequirements for Safety, 2.Collateral Standard –Electromagnetic CompatibilityRequirements and Tests | Conforms | Conforms | Substantially Equivalent | |
| Immunity Requirements for MedicalElectrical Equipment Part 1:General | Conforms | Conforms | Substantially Equivalent | |
| Subject Device | Reference Device | Comparison | ||
| Entac PrevisEA Device | GI Logic Abstats Gateway | |||
| Biocompatibility | Testing demonstrated allpatient contacting materialsfor the PrevisEA device to besafe and biocompatible | No biocompatibility testing performed as theonly patient contact consists of commerciallyavailable dermal adhesive dressings | Substantially Equivalent | |
| Software | The PrevisEA softwareprocesses audio signals fordisplay and presentation tothe user. | The AbStats software processesaudio signals for displayand presentation to the user. | Substantially Equivalent | |
| Auscultation Performance Tests:Bench Testing | Passed/Conforms | Passed/Conforms | Substantially Equivalent | |
| Clinical performance validation | Listens for the MH4 acousticbiomarker | Listens for acoustic event rates to determinean intestinal motility | Different mechanism/parameterof assessment but does not raisenew issues of safety and efficacy. | |
| Abdomen Placement | The PrevisEA is placed inany quadrant of the patient'sabdomen.Image: PrevisEA device on a human torso | AbStats external sensors placed on theabdomen,Image: AbStats external sensors placed on a human abdomen | Substantially Equivalent |
Table 1: Substantial Equivalence Comparison Table
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Table 1: Substantial Equivalence Comparison Table (Continued)
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Table 1: Substantial Equivalence Comparison Table (Continued)
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| 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.
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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.
§ 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.