Fecobionics Anorectal System

K242666 · Gi Bionics, LLC · KLA · Feb 12, 2025 · Gastroenterology, Urology

Device Facts

• Record ID: K242666
• Device Name: Fecobionics Anorectal System
• Applicant: Gi Bionics, LLC
• Product Code: KLA · Gastroenterology, Urology
• Decision Date: Feb 12, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1725
• Device Class: Class 2

Intended 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, 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 Story

Portable anorectal manometry system; used by clinicians in diagnostic labs. Input: physical pressure and geometric data from rectal probe. Probe features bendable core with embedded sensors and saline-filled bag; inserted into rectum; defecated as untethered mass to mimic natural process. Probe transmits data wirelessly to Data Hub; Hub transmits to PC running Fecotracker App. Output: real-time manometric data and geometric mapping (rectal volume/shape, pressure, anorectal angle). Clinicians use output to assess defecatory function and anorectal health; aids in diagnosing motility disorders. Benefits: provides comprehensive, real-time physiological and geometric data in single examination.

Clinical Evidence

Nonsignificant risk (NSR), observational, randomized clinical study conducted on 10 patients. Evaluated sensory aspects of Fecobionics system compared to predicate during fecal manometry. Results showed high correlation between sensation levels and volume data between the two technologies. No safety concerns raised. Bench testing included verification of geometric specifications, bending force, bag burst volume, tether holding force, and wireless transmission distance.

Technological Characteristics

Class II gastrointestinal motility monitoring system. Components: disposable, battery-powered, bendable probe (silicone, polyurethane, polyamide 12, UHMWPE tether); reusable Data Hub; PC-based software. Sensing: embedded pressure sensors and motion processor units (MPUs) for orientation/anorectal angle. Saline-filled bag for rectal distension. Connectivity: wireless (RF/Wi-Fi). Non-sterile. Software: IEC 62304 compliant.

Indications for Use

Indicated for adult patients requiring anorectal pressure studies and testing of defecatory function, including evaluation of rectal sensitivity, volume, shape, rectoanal inhibitory reflex, anal diameter during defecation, and anorectal angle changes.

Regulatory Classification

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.

Predicate Devices

• THD AnoPress with THD SensyProbe Anorectal Manometry System (K180135)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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

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.

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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 Device<br>Fecobionics Anorectal System | Predicate Device<br>THD AnoPress with THD SensyProbe<br>Anorectal Manometry System<br>(K180135) | Equivalence<br>Comparison |
|-----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Indications for<br>Use | The Fecobionics Anorectal System is for<br>use on patients requiring anorectal<br>pressure studies and testing of defecatory<br>function. The Fecobionics System must<br>only be used by appropriately trained<br>clinicians. The Fecobionics System<br>enables evaluation of rectal sensitivity,<br>rectal volume and shape, rectoanal<br>inhibitory reflex, anal diameter during<br>defecation, defecatory push pressure, and<br>anorectal angle changes. The<br>Fecobionics device is only intended to be<br>used in adult patients. | The THD Anopress device must be used<br>exclusively to assess the average sphincter<br>tone due to the pressure exerted by the<br>muscles in the anal canal on the specially<br>design THD Probes. THD Anopress must only<br>be used by appropriately trained medical staff.<br>Furthermore, the THD SensyProbe enables<br>evaluation of rectal sensitivity and capacity and<br>the anorectal inhibitory reflex through<br>connection to a syringe and filling of the balloon<br>on the probe with air. The THD Anopress with<br>THD SensyProbe is intended to be used in<br>adults only. | Equivalent |
| Characteristic | Subject Device<br>Fecobionics Anorectal System | Predicate Device<br>THD Anopress with THD SensyProbe<br>Anorectal Manometry System<br>(K180135) | Equivalence<br>Comparison |
| Trade Name | Fecobionics Anorectal System | THD Anopress with THD SensyProbe Anorectal<br>Manometry System | N/A |
| Product Code | KLA | KLA | Same |
| Regulation<br>Number | 21 CFR 876.1725 | 21 CFR 876.1725 | Same |
| Regulatory Class | II | II | Same |
| Use | Rectal Device Single Use Probe<br>Reusable data hub / console | Rectal Device Single Use Probe<br>Reusable 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 and<br>wireless transmission unit. 120V 60 Hz<br>(USA) for the tablet PC with display. | Battery powered for inserted device and 120V<br>60 Hz (USA) for the PC with display. | Same |
| Composition | Manometry system includes:<br>(1) Probe<br>Fecobionics Probe features a<br>bendable core with embedded<br>sensors and batteries inside a bag<br>(membrane) that may be inflated for<br>rectal distension. The volume and<br>shape of the bag is related to rectal<br>size, rectal sensitivity, and the<br>passage through the anal canal<br>during defecation. The motion<br>processor units (MPUs) measure<br>orientation of the device at the front<br>and rear and a bending angle<br>reflecting the anorectal angle can be<br>computed pressure measures<br>contractile capability and anal<br>sphincter relaxation.<br>The bag is manually inflated by the<br>clinician with saline.<br>(2) Main Unit<br>Main unit (data hub) processes<br>manometry data from the probe and<br>send it wirelessly (Wi-Fi) to<br>Fecotracker app<br>(3) App<br>Provides data to users who are<br>medically trained in these procedures<br>and familiar with a variety of<br>parametric data.<br>Saline filled bag surrounding probe | Manometry system includes:<br>(1) Probe<br>THD Anopress catheter has two probe<br>options as follows:<br>• one sensitive balloon (membrane) located<br>on the introducer (THD PressProbe).<br>• with one sensitive balloon (membrane)<br>located on the introducer and one larger<br>balloon located in the most distal end<br>(THD SensyProbe). Membrane is related<br>to manometry test; the larger balloon is<br>related to rectal sensation test.<br>The balloon is inflated with air by the main<br>unit for the manometry test and manually<br>inflated by the clinician with air for the<br>sensation test.<br>(2) Main Unit<br>Main unit (console) processes manometry<br>data from the probe and send it wirelessly<br>(Bluetooth) to THD app<br>(3) App<br>Provides data to users who are medically<br>trained in these procedures and familiar<br>with a variety of parametric data. | Similar /<br>Equivalent |
| Mechanism of<br>Action | measures pressure, contractile force, anal<br>sphincter tone, anal relaxation, RAIR. Bag<br>allows measurement of rectal size and<br>sensitivity and diameter during anal canal<br>passage. Pressures that measures MPUs<br>that measure orientation and anorectal<br>angle | Air-filled balloon on probe for:<br>measuring anal pressure for manometry test,<br>by the means of a membrane on the probe<br>(all THD Probes) and evaluation of RAIR and<br>rectal sensation, by the mean of a distal end<br>sensation balloon (only THD SensyProbe) | Equivalent |
| Characteristic | Subject Device<br>Fecobionics Anorectal System | Predicate Device<br>THD Anopress with THD SensyProbe<br>Anorectal Manometry System<br>(K180135) | Equivalence<br>Comparison |
| Detected<br>Parameters | Resting rectal Pressure<br>Contractile pressure during defecation<br>Anal Squeeze Pressure<br>Anal relaxation<br>Front-rear pressure difference<br>Straining pressure and angle<br>Real Time Pressure Measurement<br>Anal Contractile Reflex<br>Cough Reflex<br>Rectal Sensation Thresholds<br>Bag volume and shape<br>RAIR | Resting Pressure<br>Squeeze Pressure<br>Endurance<br>Strain Pressure<br>Squeeze/Rest Rate<br>Real Time Pressure Measurement<br>Anal Contractile Reflex<br>Cough Reflex<br>Rectal Sensation Thresholds<br>RAIR | Equivalent |
| Component in<br>contact with<br>patient | Disposable probe (including bag) and fill<br>tubing | Disposable Catheter/probe (including<br>membrane and distal end balloon), inflation/fill<br>tubing and connections and cables | Equivalent |
| Inserted<br>Component<br>Dimensions | The Fecobionics Device core is 10cm<br>long and 10mm in diameter and is<br>bendable. The surrounding bag is<br>approximately 9 cm long and can be filled<br>with saline up to 100ml and a diameter of<br>up to 5cm.<br>Pressures can be measured reliably up to<br>250mmHg | THD PressProbe membrane has a diameter<br>varying from 14.4 mm (empty membrane) to<br>16.6 mm (membrane inflated to 150 mmHg),<br>The THD PressProbe is inserted in the anal<br>canal and inflated to up to 150 mmHg, so that<br>the sphincter exerts a compression on the<br>membrane until 390 mmHg.<br>THD SensyProbe membrane has the same<br>diameter and performances as the THD<br>PressProbe. The additional balloon positioned<br>on the top of the introducer reaches a diameter<br>of 70 mm when inflated with 200 ml of air. The<br>allowed maximum inflation volume for distal end<br>balloon is 180 ml of air. | Similar /<br>Equivalent |
| Pressure Data<br>Transmission | Wireless, real-time (RF) to main unit<br>Wireless, real-time (Wi-Fi) from main unit<br>to app | Wired, real-time to main unit<br>Wireless, real-time (Bluetooth) from main unit to<br>app | Similar /<br>Equivalent |
| Performance | Bench, clinical, and comparative testing | Bench and Comparative Testing | Similar/<br>Equivalent |
| Patient Contacting<br>Materials | Silicone (bag, outer surface of probe)<br>Polyurethane and polyamide 12 (fill tube)<br>2-0 suture, ultra-high molecular weight<br>polyethylene (UHMWPE) (tether) | Poly-urethane (membrane)<br>C-Flex (SEBS - Styrene-ethylene-butadiene-<br>styrene block polymer) (distal end balloon) | Similar/<br>Equivalent |
| Contact Type | Surface Contacting (Mucosal Membranes,<br>limited duration <24 hrs)<br>ISO 10993-1 | Surface Contacting (Mucosal Membranes,<br>limited duration <24 hrs)<br>ISO 10993-1 | Same |
| Sterilization | Non-Sterile | Non-Sterile | Same |
| Test | Reference Standards OR Test Method<br>Summary | Results and Conclusions | |
| Biocompatibility | ISO 10993-1 ISO 10993-5 ISO 10993-10 ISO 10993-11 ISO 10993-23 | All results met acceptance criteria and<br>demonstrate the Fecobionics Anorectal<br>System is non-cytotoxic, a non-sensitizer, a<br>non-irritant, non-pyrogenic, is suitable for its<br>intended use, and is substantially equivalent to<br>the predicate device. | |
| Electrical Safety | IEC 60601-1 | All results met acceptance criteria and<br>demonstrate the Fecobionics Anorectal<br>System is substantially equivalent to the<br>predicate device. | |
| Electromagnetic<br>Compatibility (EMC) | IEC 60601-1-2 | All results met acceptance criteria and<br>demonstrate the Fecobionics Anorectal<br>System is substantially equivalent to the<br>predicate device. | |
| Software Verification<br>and Validation | IEC 62304 | All results met acceptance criteria and<br>demonstrate the Fecobionics Anorectal<br>System is substantially equivalent to the<br>predicate device. | |
| Functional<br>Performance accuracy<br>verification in simulated<br>use conditions<br>(new and aged<br>devices, as<br>appropriate) | Verification of functional performance and<br>accuracy of the Fecobionics Anorectal<br>System for measured parameters. | No difference in results between aged and not<br>aged samples.<br>When applicable, the relevant performances<br>and accuracy obtained are comparable with<br>the predicate device.<br>All results met acceptance criteria and<br>demonstrate the Fecobionics Anorectal<br>System is suitable for its intended use and is<br>substantially equivalent to the predicate<br>device. | |
| Mechanical and<br>Performance Tests<br>(new and aged<br>devices, as<br>appropriate) | Mechanical Verification of probe geometric<br>specifications (length and diameter) Probe bending force Verification of bag expanded<br>diameter Bag peel force strength, burst<br>volume Holding force of tether anchoring<br>system Absence of sharp features Fill tube dimensions (outer diameter<br>and length) and removal force Tensile testing of the joints and<br>bonded components of the fill tube Device seal performance Ingress protection Performance System wireless transmission<br>distance | No difference in results between aged and not<br>aged samples.<br>When applicable, the relevant performances<br>are comparable with the predicate device.<br>All results met acceptance criteria and<br>demonstrate the Fecobionics Anorectal<br>System is suitable for its intended use and is<br>substantially equivalent to the predicate<br>device. | |
| Test | Reference Standards OR Test Method<br>Summary | Results and Conclusions | |
| | frequency<br>Probe battery life Data Hub battery life Data Hub console cleaning | | |
| Fecobionics Anorectal<br>System Clinical Study | A nonsignificant risk (NSR), observational,<br>randomized clinical study was conducted to<br>evaluate the sensory aspect of the<br>Fecobionics Anorectal System in comparison<br>to the predicate during fecal manometry<br>studies. | The outcomes on 10 patients met the criteria<br>for success related to the sensory<br>measurements as outlined in the protocol. A<br>high correlation was found between the<br>sensation levels and the volume data with the<br>two technologies. No questions of safety were<br>raised by the study. The results demonstrate<br>the Fecobionics Anorectal System is suitable<br>for its intended use and is substantially<br>equivalent to the predicate device.…