(160 days)
No
The summary describes a device that collects and displays manometric and geometric data. There is no mention of AI or ML being used for data analysis, interpretation, or any other function. The focus is on the hardware and software for data acquisition and presentation.
No
The device is described as a diagnostic tool for evaluating anorectal function, not for treating any conditions or diseases. Its purpose is to provide data and measurements for clinicians.
Yes
Explanation: The device is described as an "anorectal manometry device for use on patients requiring anorectal pressure studies and evaluation of defecatory function." It gathers "real-time manometric data and geometric mapping information" to "enable evaluation of rectal sensitivity, rectal volume, and shape, recto anal inhibitory reflex, anal diameter during defecation, defecatory push pressure, and anorectal angle changes." This information is used by trained clinicians to assess and understand a patient's condition, which aligns with the purpose of a diagnostic device.
No
The device description clearly states that the system consists of three main components: a physical probe (AR-100 Probe), a data hub (DH-100 Data Hub), and a software application (Fecotracker App). The probe is a physical, battery-powered device inserted into the body, making it a hardware component.
Based on the provided information, the Fecobionics Anorectal System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Fecobionics Function: The Fecobionics Anorectal System is a device that is inserted into the body (rectum) to directly measure physiological parameters (pressure, volume, shape, angle changes) related to anorectal function. It does not analyze specimens taken from the body.
- Intended Use: The intended use is for "anorectal pressure studies and testing of defecatory function," which involves direct measurement within the body, not analysis of in vitro samples.
Therefore, the Fecobionics Anorectal System falls under the category of a medical device used for physiological measurement and evaluation, not an In Vitro Diagnostic.
N/A
Intended Use / 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, 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.
Product codes
KLA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Rectum
Indicated Patient Age Range
Adult Population
Intended User / Care Setting
Appropriately trained clinicians / Clinical Diagnostic Room or Labs
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A nonsignificant risk (NSR), observational, randomized clinical study was conducted to evaluate the sensory aspect of the Fecobionics Anorectal System in comparison to the predicate during fecal manometry studies. The outcomes on 10 patients met the criteria for success related to the sensory measurements as outlined in the protocol.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Preclinical and clinical tests were conducted. Testing included verification bench testing, electrical safety and EMC evaluations, software verification and validation, and clinical testing.
Functional Performance accuracy verification in simulated use conditions (new and aged devices, as appropriate): Verification of functional performance and accuracy of the Fecobionics Anorectal System for measured parameters. Results: 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 (new and aged devices, as appropriate): Mechanical Verification of probe geometric specifications (length and diameter) Probe bending force Verification of bag expanded diameter Bag peel force strength, burst volume Holding force of tether anchoring system Absence of sharp features Fill tube dimensions (outer diameter and length) and removal force Tensile testing of the joints and bonded components of the fill tube Device seal performance Ingress protection Performance System wireless transmission distance frequency Probe battery life Data Hub battery life Data Hub console cleaning. Results: 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.
Fecobionics Anorectal System Clinical Study: A nonsignificant risk (NSR), observational, randomized clinical study was conducted to evaluate the sensory aspect of the Fecobionics Anorectal System in comparison to the predicate during fecal manometry studies. Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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"
1
(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.
2
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
3
Indications for Use
Submission Number (if known)
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.
5
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
Fecobionics Anorectal System | Predicate Device
THD AnoPress with THD SensyProbe
Anorectal Manometry System
(K180135) | Equivalence
Comparison |
|-----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| 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 sensitivity,
rectal volume and shape, rectoanal
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. | The THD Anopress device must be used
exclusively to assess the average sphincter
tone due to the pressure exerted by the
muscles in the anal canal on the specially
design THD Probes. THD Anopress must only
be used by appropriately trained medical staff.
Furthermore, the THD SensyProbe enables
evaluation of rectal sensitivity and capacity and
the anorectal inhibitory reflex through
connection to a syringe and filling of the balloon
on the probe with air. The THD Anopress with
THD SensyProbe is intended to be used in
adults only. | Equivalent |
| Characteristic | Subject Device
Fecobionics Anorectal System | Predicate Device
THD Anopress with THD SensyProbe
Anorectal Manometry System
(K180135) | Equivalence
Comparison |
| Trade Name | Fecobionics Anorectal System | THD Anopress with THD SensyProbe Anorectal
Manometry System | N/A |
| Product Code | KLA | KLA | Same |
| Regulation
Number | 21 CFR 876.1725 | 21 CFR 876.1725 | Same |
| Regulatory Class | II | II | Same |
| Use | Rectal Device Single Use Probe
Reusable data hub / console | Rectal Device Single Use Probe
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
wireless transmission unit. 120V 60 Hz
(USA) for the tablet PC with display. | Battery powered for inserted device and 120V
60 Hz (USA) for the PC with display. | Same |
| Composition | Manometry system includes:
(1) Probe
Fecobionics Probe features a
bendable core with embedded
sensors and batteries inside a bag
(membrane) that may be inflated for
rectal distension. The volume and
shape of the bag is related to rectal
size, rectal sensitivity, and the
passage through the anal canal
during defecation. The motion
processor units (MPUs) measure
orientation of the device at the front
and rear and a bending angle
reflecting the anorectal angle can be
computed pressure measures
contractile capability and anal
sphincter relaxation.
The bag is manually inflated by the
clinician with saline.
(2) Main Unit
Main unit (data hub) processes
manometry data from the probe and
send it wirelessly (Wi-Fi) to
Fecotracker app
(3) App
Provides data to users who are
medically trained in these procedures
and familiar with a variety of
parametric data.
Saline filled bag surrounding probe | Manometry system includes:
(1) Probe
THD Anopress catheter has two probe
options as follows:
• one sensitive balloon (membrane) located
on the introducer (THD PressProbe).
• with one sensitive balloon (membrane)
located on the introducer and one larger
balloon located in the most distal end
(THD SensyProbe). Membrane is related
to manometry test; the larger balloon is
related to rectal sensation test.
The balloon is inflated with air by the main
unit for the manometry test and manually
inflated by the clinician with air for the
sensation test.
(2) Main Unit
Main unit (console) processes manometry
data from the probe and send it wirelessly
(Bluetooth) to THD app
(3) App
Provides data to users who are medically
trained in these procedures and familiar
with a variety of parametric data. | Similar /
Equivalent |
| Mechanism of
Action | measures pressure, contractile force, anal
sphincter tone, anal relaxation, RAIR. Bag
allows measurement of rectal size and
sensitivity and diameter during anal canal
passage. Pressures that measures MPUs
that measure orientation and anorectal
angle | 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 and
rectal sensation, by the mean of a distal end
sensation balloon (only THD SensyProbe) | Equivalent |
| Characteristic | Subject Device
Fecobionics Anorectal System | Predicate Device
THD Anopress with THD SensyProbe
Anorectal Manometry System
(K180135) | Equivalence
Comparison |
| Detected
Parameters | Resting rectal Pressure
Contractile pressure during defecation
Anal Squeeze Pressure
Anal relaxation
Front-rear pressure difference
Straining pressure and angle
Real Time Pressure Measurement
Anal Contractile Reflex
Cough Reflex
Rectal Sensation Thresholds
Bag volume and shape
RAIR | Resting Pressure
Squeeze Pressure
Endurance
Strain Pressure
Squeeze/Rest Rate
Real Time Pressure Measurement
Anal Contractile Reflex
Cough Reflex
Rectal Sensation Thresholds
RAIR | Equivalent |
| Component in
contact with
patient | Disposable probe (including bag) and fill
tubing | Disposable Catheter/probe (including
membrane and distal end balloon), inflation/fill
tubing and connections and cables | Equivalent |
| Inserted
Component
Dimensions | The Fecobionics Device core is 10cm
long and 10mm in diameter and is
bendable. The surrounding bag is
approximately 9 cm long and can be filled
with saline up to 100ml and a diameter of
up to 5cm.
Pressures can be measured reliably up to
250mmHg | THD PressProbe membrane has a diameter
varying from 14.4 mm (empty membrane) to
16.6 mm (membrane inflated to 150 mmHg),
The THD PressProbe is inserted in the anal
canal and inflated to up to 150 mmHg, so that
the sphincter exerts a compression on the
membrane until 390 mmHg.
THD SensyProbe membrane has the same
diameter and performances as the THD
PressProbe. The additional balloon positioned
on the top of the introducer reaches a diameter
of 70 mm when inflated with 200 ml of air. The
allowed maximum inflation volume for distal end
balloon is 180 ml of air. | Similar /
Equivalent |
| Pressure Data
Transmission | Wireless, real-time (RF) to main unit
Wireless, real-time (Wi-Fi) from main unit
to app | Wired, real-time to main unit
Wireless, real-time (Bluetooth) from main unit to
app | Similar /
Equivalent |
| Performance | Bench, clinical, and comparative testing | Bench and Comparative Testing | Similar/
Equivalent |
| Patient Contacting
Materials | Silicone (bag, outer surface of probe)
Polyurethane and polyamide 12 (fill tube)
2-0 suture, ultra-high molecular weight
polyethylene (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