The Fecobionics Anorectal System is for use on patients requiring anorectal pressure studies and testing of defecatory function. The Fecobionics System must only be used by appropriately trained clinicians. The Fecobionics System enables evaluation of rectal volume and shape, rectoanal inhibitory reflex, anal diameter during defecatory push pressure, and anorectal angle changes. The Fecobionics device is only intended to be used in adult patients.

Device Description

The Fecobionics Anorectal System (Fecobionics System) is a portable anorectal manometry device for use on patients requiring anorectal pressure studies and evaluation of defecatory function. The Fecobionics System consists of three main components: AR-100 Probe, DH-100 Data Hub, and Fecotracker App (installed on a provided PC-based laptop). The AR-100 Probe is a single-use, non-sterile disposable, battery-powered probe designed to be inserted manually into the rectum and wirelessly transmit data to the external Data Hub, which wirelessly sends the data to the PC with the Fecotracker App. The system provides clinicians with real-time manometric data and geometric mapping information in a single examination. The probe features a balloon designed to be filled with saline by means of a detachable fill tube and a Luer-Lock connection with a syringe. The inflation of the balloon allows the evaluation of sensation thresholds of the lower rectum and assesses and triggers Recto Anal Inhibitory Reflex (RAIR). To mimic the defecation process, the wireless probe is designed to be defecated as an untethered free distensible mass. In total, the Fecobionics System enables the evaluation of rectal sensitivity, rectal volume, and shape, recto anal inhibitory reflex, anal diameter during defecation, defecatory push pressure, and anorectal angle changes. The AR-100 Probe is 10cm long, and its interior bendable core is 10mm in diameter. When inflated with the allowed maximum saline inflation volume (100 mL), the balloon reaches a diameter of up to 5cm.

AI/ML Overview

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for device performance beyond the successful completion of various tests. Instead, the acceptance criteria are largely implied by meeting the requirements of recognized standards and demonstrating "no difference," "comparable," or "high correlation" with the predicate device or expected results.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Meets ISO 10993-1, -5, -10, -11, -23 standards (non-cytotoxic, non-sensitizer, non-irritant, non-pyrogenic).	"All results met acceptance criteria and demonstrate the Fecobionics Anorectal System is non-cytotoxic, a non-sensitizer, a non-irritant, non-pyrogenic, is suitable for its intended use, and is substantially equivalent to the predicate device."
Electrical Safety: Meets IEC 60601-1 standard.	"All results met acceptance criteria and demonstrate the Fecobionics Anorectal System is substantially equivalent to the predicate device."
Electromagnetic Compatibility (EMC): Meets IEC 60601-1-2 standard.	"All results met acceptance criteria and demonstrate the Fecobionics Anorectal System is substantially equivalent to the predicate device."
Software Verification and Validation: Meets IEC 62304 standard.	"All results met acceptance criteria and demonstrate the Fecobionics Anorectal System is substantially equivalent to the predicate device."
Functional Performance Accuracy: Verification in simulated use conditions (new and aged devices).	"No difference in results between aged and not aged samples. When applicable, the relevant performances and accuracy obtained are comparable with the predicate device. All results met acceptance criteria and demonstrate the Fecobionics Anorectal System is suitable for its intended use and is substantially equivalent to the predicate device."
Mechanical and Performance Tests: Verification of physical specifications, strength, sealing, wireless transmission, battery life, cleaning.	"No difference in results between aged and not aged samples. When applicable, the relevant performances are comparable with the predicate device. All results met acceptance criteria and demonstrate the Fecobionics Anorectal System is suitable for its intended use and is substantially equivalent to the predicate device."
Clinical Study (Sensory Measurement): Outcomes related to sensory measurements comparable to the predicate.	"The outcomes on 10 patients met the criteria for success related to the sensory measurements as outlined in the protocol. A high correlation was found between the sensation levels and the volume data with the two technologies. No questions of safety were raised by the study. The results demonstrate the Fecobionics Anorectal System is suitable for its intended use and is substantially equivalent to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

The only explicitly mentioned test set with a sample size is the clinical study:

Sample Size: 10 patients
Data Provenance: The document states it was a "nonsignificant risk (NSR), observational, randomized clinical study." This implies a prospective study design. The country of origin of the data is not specified.

For the other performance tests (Biocompatibility, Electrical Safety, EMC, Software V&V, Functional Performance, Mechanical and Performance), the sample sizes are not explicitly stated. The provenance for these is "Preclinical and clinical tests" and "verification bench testing," implying laboratory or engineering testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided in the document. For the clinical study, it mentions "appropriately trained clinicians" are required to use the device, but it doesn't specify how many or their qualifications for establishing ground truth or evaluating the data. Given the comparative nature of the clinical study (comparing sensory measurements between the Fecobionics system and the predicate), it's likely the clinicians involved acted as evaluators, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. The device described is a diagnostic tool (anorectal manometry system) for measuring physiological parameters, not an AI-assisted interpretation or diagnostic aid for human readers. It provides data for clinicians to interpret, but it doesn't mention an AI component that assists human reading.
Therefore, there is no effect size related to human readers improving with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document implies the device provides raw data and measurements to clinicians ("The Fecobionics System provides clinicians with real-time manometric data and geometric mapping information in a single examination"), rather than producing an automated diagnosis or interpretation. Thus, the concept of "standalone algorithm performance" as typically applied to AI diagnostics is not directly applicable here. The device itself is a measurement system.
The "functional performance accuracy verification" and "mechanical and performance tests" can be considered standalone performance tests of the device's measurement capabilities. The clinical study, while involving patients and comparison, still focuses on the device's ability to accurately measure sensory parameters.

7. The Type of Ground Truth Used

For the clinical study:

The ground truth for sensory measurements was established by comparison to the predicate device. The study looked for "high correlation... between the sensation levels and the volume data with the two technologies," implying the predicate device served as the reference for acceptable sensory measurement.

For the other performance tests:

Engineering specifications and recognized standards served as the ground truth. For example, IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility, and internal design requirements for mechanical and functional performance.

8. The Sample Size for the Training Set

The document does not mention a training set in the context of an AI/ML algorithm. This indicates the device is not based on a machine learning model that requires a distinct training phase. The functional and clinical testing described are for verification and validation of a hardware and software system.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set or AI/ML algorithm, this question is not applicable.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 12, 2025

GI Bionics, LLC % Natalie Eagleburger GI Bionics Regulatory Consultant Cygnus Regulatory 6224 N 38th Street Paradise Valley, Arizona 85253

Re: K242666

Trade/Device Name: Fecobionics Anorectal System Regulation Number: 21 CFR 876.1725 Regulation Name: Gastrointestinal Motility Monitoring System Regulatory Class: Class II Product Code: KLA Dated: January 11, 2025 Received: January 13, 2025

Dear Natalie Eagleburger:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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For comprehensive regulatory information about medical devices and radiation-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,

Anthony Lee -S

Anthony Lee, Ph.D., M.B.A. 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

Submission Number (if known)

K242666

Device Name

Fecobionics Anorectal System

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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Fecobionics Anorectal System

l. SUBMITTER

GI Bionics, LLC 11107 Roselle Street, Suite 213 San Diego, CA 92121 USA

Phone:	858-249-7400
Contact Person:	Natalie Eagleburger
Date Prepared:	September 4, 2024

II. DEVICE

Trade Name: Fecobionics Anorectal System Common or Usual Name: Anorectal Manometry System Classification Name: Gastrointestinal motility monitoring system Regulatory Class: Class II Product Code and Requlation: KLA, 21CFR 876.1725

III. PREDICATE DEVICE

Primary Predicate

THD AnoPress with THD SensyProbe Anorectal Manometry System (K180135) This predicate has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

AR-100 Probe, ●
. DH-100 Data Hub, and
Fecotracker App (installed on a provided PC-based laptop).

The AR-100 Probe is a single-use, non-sterile disposable, battery-powered probe designed to be inserted manually into the rectum and wirelessly transmit data to the external Data Hub, which wirelessly sends the data to the PC with the Fecotracker App. The system provides clinicians with real-time manometric data and geometric mapping information in a single examination. The probe features a balloon designed to be filled with saline by means of a detachable fill tube and a Luer-Lock connection with a syringe. The inflation of the balloon allows the evaluation of sensation thresholds of the lower rectum and assesses and triggers Recto Anal Inhibitory Reflex (RAIR). To mimic the defecation process, the wireless probe is designed to be defecated as an untethered free distensible mass. In total, the Fecobionics System enables the evaluation of rectal sensitivity, rectal volume, and shape, recto anal inhibitory reflex, anal diameter during defecation, defecatory push pressure, and anorectal angle changes.

The AR-100 Probe is 10cm long, and its interior bendable core is 10mm in diameter. When inflated with the allowed maximum saline inflation volume (100 mL), the balloon reaches a diameter of up to 5cm.

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V. INDICATIONS FOR USE

The Fecobionics Anorectal System is for use on patients requiring anorectal pressure studies and testing of defecatory function. The Fecobionics System must only be used by appropriately trained clinicians. The Fecobionics System enables evaluation of rectal volume and shape, recto anal inhibitory reflex, anal diameter during defecation, defecatory push pressure, and anorectal angle changes. The Fecobionics device is only intended to be used in adult patients.

A comparison of the intended use of the proposed device and the predicate device is provided in the table below:

Characteristic	Subject DeviceFecobionics Anorectal System	Predicate DeviceTHD AnoPress with THD SensyProbeAnorectal Manometry System(K180135)	EquivalenceComparison
Indications forUse	The Fecobionics Anorectal System is foruse on patients requiring anorectalpressure studies and testing of defecatoryfunction. The Fecobionics System mustonly be used by appropriately trainedclinicians. The Fecobionics Systemenables evaluation of rectal sensitivity,rectal volume and shape, rectoanalinhibitory reflex, anal diameter duringdefecation, defecatory push pressure, andanorectal angle changes. TheFecobionics device is only intended to beused in adult patients.	The THD Anopress device must be usedexclusively to assess the average sphinctertone due to the pressure exerted by themuscles in the anal canal on the speciallydesign THD Probes. THD Anopress must onlybe used by appropriately trained medical staff.Furthermore, the THD SensyProbe enablesevaluation of rectal sensitivity and capacity andthe anorectal inhibitory reflex throughconnection to a syringe and filling of the balloonon the probe with air. The THD Anopress withTHD SensyProbe is intended to be used inadults only.	Equivalent
Characteristic	Subject DeviceFecobionics Anorectal System	Predicate DeviceTHD Anopress with THD SensyProbeAnorectal Manometry System(K180135)	EquivalenceComparison
Trade Name	Fecobionics Anorectal System	THD Anopress with THD SensyProbe AnorectalManometry System	N/A
Product Code	KLA	KLA	Same
RegulationNumber	21 CFR 876.1725	21 CFR 876.1725	Same
Regulatory Class	II	II	Same
Use	Rectal Device Single Use ProbeReusable data hub / console	Rectal Device Single Use ProbeReusable main unit / console	Same
Target Population	Adult Population	Adult Population	Same
Anatomical Sites	Rectum	Rectum	Same
Where Used	Clinical Diagnostic Room or Labs	Clinical Diagnostic Room or Labs	Same
Energy Used	Battery powered for inserted device andwireless transmission unit. 120V 60 Hz(USA) for the tablet PC with display.	Battery powered for inserted device and 120V60 Hz (USA) for the PC with display.	Same
Composition	Manometry system includes:(1) ProbeFecobionics Probe features abendable core with embeddedsensors and batteries inside a bag(membrane) that may be inflated forrectal distension. The volume andshape of the bag is related to rectalsize, rectal sensitivity, and thepassage through the anal canalduring defecation. The motionprocessor units (MPUs) measureorientation of the device at the frontand rear and a bending anglereflecting the anorectal angle can becomputed pressure measurescontractile capability and analsphincter relaxation.The bag is manually inflated by theclinician with saline.(2) Main UnitMain unit (data hub) processesmanometry data from the probe andsend it wirelessly (Wi-Fi) toFecotracker app(3) AppProvides data to users who aremedically trained in these proceduresand familiar with a variety ofparametric data.Saline filled bag surrounding probe	Manometry system includes:(1) ProbeTHD Anopress catheter has two probeoptions as follows:• one sensitive balloon (membrane) locatedon the introducer (THD PressProbe).• with one sensitive balloon (membrane)located on the introducer and one largerballoon located in the most distal end(THD SensyProbe). Membrane is relatedto manometry test; the larger balloon isrelated to rectal sensation test.The balloon is inflated with air by the mainunit for the manometry test and manuallyinflated by the clinician with air for thesensation test.(2) Main UnitMain unit (console) processes manometrydata from the probe and send it wirelessly(Bluetooth) to THD app(3) AppProvides data to users who are medicallytrained in these procedures and familiarwith a variety of parametric data.	Similar /Equivalent
Mechanism ofAction	measures pressure, contractile force, analsphincter tone, anal relaxation, RAIR. Bagallows measurement of rectal size andsensitivity and diameter during anal canalpassage. Pressures that measures MPUsthat measure orientation and anorectalangle	Air-filled balloon on probe for:measuring anal pressure for manometry test,by the means of a membrane on the probe(all THD Probes) and evaluation of RAIR andrectal sensation, by the mean of a distal endsensation balloon (only THD SensyProbe)	Equivalent
Characteristic	Subject DeviceFecobionics Anorectal System	Predicate DeviceTHD Anopress with THD SensyProbeAnorectal Manometry System(K180135)	EquivalenceComparison
DetectedParameters	Resting rectal PressureContractile pressure during defecationAnal Squeeze PressureAnal relaxationFront-rear pressure differenceStraining pressure and angleReal Time Pressure MeasurementAnal Contractile ReflexCough ReflexRectal Sensation ThresholdsBag volume and shapeRAIR	Resting PressureSqueeze PressureEnduranceStrain PressureSqueeze/Rest RateReal Time Pressure MeasurementAnal Contractile ReflexCough ReflexRectal Sensation ThresholdsRAIR	Equivalent
Component incontact withpatient	Disposable probe (including bag) and filltubing	Disposable Catheter/probe (includingmembrane and distal end balloon), inflation/filltubing and connections and cables	Equivalent
InsertedComponentDimensions	The Fecobionics Device core is 10cmlong and 10mm in diameter and isbendable. The surrounding bag isapproximately 9 cm long and can be filledwith saline up to 100ml and a diameter ofup to 5cm.Pressures can be measured reliably up to250mmHg	THD PressProbe membrane has a diametervarying from 14.4 mm (empty membrane) to16.6 mm (membrane inflated to 150 mmHg),The THD PressProbe is inserted in the analcanal and inflated to up to 150 mmHg, so thatthe sphincter exerts a compression on themembrane until 390 mmHg.THD SensyProbe membrane has the samediameter and performances as the THDPressProbe. The additional balloon positionedon the top of the introducer reaches a diameterof 70 mm when inflated with 200 ml of air. Theallowed maximum inflation volume for distal endballoon is 180 ml of air.	Similar /Equivalent
Pressure DataTransmission	Wireless, real-time (RF) to main unitWireless, real-time (Wi-Fi) from main unitto app	Wired, real-time to main unitWireless, real-time (Bluetooth) from main unit toapp	Similar /Equivalent
Performance	Bench, clinical, and comparative testing	Bench and Comparative Testing	Similar/Equivalent
Patient ContactingMaterials	Silicone (bag, outer surface of probe)Polyurethane and polyamide 12 (fill tube)2-0 suture, ultra-high molecular weightpolyethylene (UHMWPE) (tether)	Poly-urethane (membrane)C-Flex (SEBS - Styrene-ethylene-butadiene-styrene block polymer) (distal end balloon)	Similar/Equivalent
Contact Type	Surface Contacting (Mucosal Membranes,limited duration <24 hrs)ISO 10993-1	Surface Contacting (Mucosal Membranes,limited duration <24 hrs)ISO 10993-1	Same
Sterilization	Non-Sterile	Non-Sterile	Same
Test	Reference Standards OR Test MethodSummary	Results and Conclusions
Biocompatibility	ISO 10993-1 ISO 10993-5 ISO 10993-10 ISO 10993-11 ISO 10993-23	All results met acceptance criteria anddemonstrate the Fecobionics AnorectalSystem is non-cytotoxic, a non-sensitizer, anon-irritant, non-pyrogenic, is suitable for itsintended use, and is substantially equivalent tothe predicate device.
Electrical Safety	IEC 60601-1	All results met acceptance criteria anddemonstrate the Fecobionics AnorectalSystem is substantially equivalent to thepredicate device.
ElectromagneticCompatibility (EMC)	IEC 60601-1-2	All results met acceptance criteria anddemonstrate the Fecobionics AnorectalSystem is substantially equivalent to thepredicate device.
Software Verificationand Validation	IEC 62304	All results met acceptance criteria anddemonstrate the Fecobionics AnorectalSystem is substantially equivalent to thepredicate device.
FunctionalPerformance accuracyverification in simulateduse conditions(new and ageddevices, asappropriate)	Verification of functional performance andaccuracy of the Fecobionics AnorectalSystem for measured parameters.	No difference in results between aged and notaged samples.When applicable, the relevant performancesand accuracy obtained are comparable withthe predicate device.All results met acceptance criteria anddemonstrate the Fecobionics AnorectalSystem is suitable for its intended use and issubstantially equivalent to the predicatedevice.
Mechanical andPerformance Tests(new and ageddevices, asappropriate)	Mechanical Verification of probe geometricspecifications (length and diameter) Probe bending force Verification of bag expandeddiameter Bag peel force strength, burstvolume Holding force of tether anchoringsystem Absence of sharp features Fill tube dimensions (outer diameterand length) and removal force Tensile testing of the joints andbonded components of the fill tube Device seal performance Ingress protection Performance System wireless transmissiondistance	No difference in results between aged and notaged samples.When applicable, the relevant performancesare comparable with the predicate device.All results met acceptance criteria anddemonstrate the Fecobionics AnorectalSystem is suitable for its intended use and issubstantially equivalent to the predicatedevice.
Test	Reference Standards OR Test MethodSummary	Results and Conclusions
	frequencyProbe battery life Data Hub battery life Data Hub console cleaning
Fecobionics AnorectalSystem Clinical Study	A nonsignificant risk (NSR), observational,randomized clinical study was conducted toevaluate the sensory aspect of theFecobionics Anorectal System in comparisonto the predicate during fecal manometrystudies.	The outcomes on 10 patients met the criteriafor success related to the sensorymeasurements as outlined in the protocol. Ahigh correlation was found between thesensation levels and the volume data with thetwo technologies. No questions of safety wereraised by the study. The results demonstratethe Fecobionics Anorectal System is suitablefor its intended use and is substantiallyequivalent to the predicate device.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.

The Fecobionics Anorectal System and predicate THD Anopress with THD SensyProbe are identical in that both are portable anorectal manometry devices for anorectal pressure studies and evaluation of defecatory function. Both devices utilize probes inserted into the rectum that measure and wirelessly transmit that data from the probe to a main unit to the computer. The probes both feature balloons or bags designed to be filled, allowing additional measurements. The Fecobionics Anorectal System has design and technological characteristics similar to the predicate THD Anopress with THD SensyProbe, including similar principles of operation and energy sources. Minor differences in technological characteristics do not raise new questions of safety and efficacy when all listed warnings and cautions are followed.

The key technological differences center around the Fecobionics probe being designed to more closelv imitate the defecation process compared to the predicate and provide real-time geometric mapping and manometric profile data. Specific technological differences are as follows:

The Fecobionics probe is bendable, utilizes several different patient-contacting materials, and ● contains multiple pressure sensors as opposed to the stiff predicate device. The Fecobionics probe has additional measurement capabilities to allow provision of real-time geometric mapping and manometric profile data to clinicians in a single examination,
The measurement bladder configuration differs in that the Fecobionics probe is surrounded by a . single bag which is filled with saline instead of the multiple air-filled balloons of the predicate device, and
The Fecobionics probe may be detached from the fill tube following fill. ●

The results from preclinical and clinical evaluations demonstrate that the Fecobionics Anorectal System's technological and performance characteristics meet defined design requirements and can safely perform anorectal manometry in a manner equivalent to the predicate for its intended use. Performance data demonstrate that the Fecobionics Anorectal System performs as intended and is substantially equivalent to its predicate.

A comparison of the technological characteristics of the subject device and the predicate device is provided in the table below:

510 (k) Summary - Fecobionics Anorectal System

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Preclinical and clinical tests were conducted on the Fecobionics Anorectal System to demonstrate that it meets defined design requirements and can perform in a manner equivalent to devices currently on the market used for its intended use. Testing included verification bench testing, electrical safety and EMC evaluations, software verification and validation, and clinical testing. The design, testing, and technical information provided for the Fecobionics Anorectal System also comply with relevant recognized consensus standards where applicable and as defined in the table below summarizes the performance testing conducted.

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Manufacturing and traceability of devices tested were conducted in accordance with 21 CFR Part 820 Good Manufacturing Practices. In all instances, the Fecobionics Anorectal System functioned as intended and the results observed were as expected. These test results confirm that Fecobionics Anorectal System complies with the recognized standards, meets the design specifications and performance requirements for the intended use, and is substantially equivalent to the predicate.

VIII. CONCLUSIONS

The Fecobionics Anorectal System is substantially equivalent to the THD SensyProbe Anorectal Manometry System predicate device (K180135). The Fecobionics Anorectal System and its predicate share the same Product Code and classification as a Gastrointestinal motility monitoring system. The Fecobionics Anorectal System has an equivalent intended use as the predicate device and the same indications for use. The Fecobionics Anorectal System also has a similar design and technological characteristics as the predicate device. Minor differences in design and technological characteristics do not raise different questions of safety and efficacy when all listed warnings and cautions are followed.

The results from preclinical and clinical evaluations demonstrate that the technological and performance characteristics of the Fecobionics Anorectal System meet defined design requirements. Performance and clinical data demonstrate that the Fecobionics Anorectal System performs as intended and is substantially equivalent to its predicate. This conclusion is based upon equivalence in the device's (1) design, (2) material technological characteristics, (3) technological characteristics, (4) principles of operation, (5) and intended use.

Regulation Number and Section

§ 876.1725 Gastrointestinal motility monitoring system.

(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).