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 designed 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 ano-rectal 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.

Device Description

THD Anopress with THD SensyProbe is a handheld, portable anorectal manometry device for its use on patients requiring anorectal pressure studies and evaluation of functional rectal and pelvic diseases.

The subject device consists of two main components:

. THD Anopress: This is the main unit with a keyboard for the selection of input command for pressure measurement and display for the visualization of detected pressure parameters in real time;
. THD Probes, grouped in THD PressProbe and THD SensyProbe
- THD PressProbe is non-sterile disposable probe to be connected via the dedicated Luer-Lock connector to the THD Anopress. The probe is charged with air by the pump contained into the THD Anopress main unit and then is introduced into the anal canal of patient for the detection of pressure.
- THD SensyProbe keeps the same characteristics of the THD PressProbe but it is additionally featured with a balloon positioned on the top of the introducer that is designed to be filled with air by the mean of a second inflation line and a Luer-Lock connection with a syringe. The inflation of the balloon with air allows the evaluation of the sensation thresholds of the lower rectum and to assess and trigger what is known as Recto Anal Inhibitory Reflex (RAIR).

THD Anopress may be used in conjunction with a PC for data storage (not provided with THD Anopress). For this purpose, the PC requires installation of a dedicated program (Anopress SW) and the insertion of the Bluetooth Dongle accessory into the USB port. The Bluetooth dongle as well as Anopress SW are optionally provided by THD SpA.

THD PressProbe membrane has a diameter varying from 14,4 mm (empty membrane) to 16,6 mm (membrane inflated to 150 mmHg).

THD PressProbe is inflated to 150 mmHg, then it is inserted in the anal canal 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.

AI/ML Overview

The provided text describes the THD Anopress with THD SensyProbe, a device for anorectal manometry and evaluation of rectal sensitivity. However, it does not contain acceptance criteria for the device's performance nor a study that explicitly demonstrates the device meets these criteria.

Instead, the document focuses on:

Substantial Equivalence: The primary goal of this 510(k) summary is to demonstrate that the THD Anopress with THD SensyProbe is substantially equivalent to previously cleared predicate devices (THD Anopress K161785 and Medspira Mcompass K120088).
Performance Data (Non-Clinical): It mentions non-clinical tests that were performed or referenced from the predicate device (K161785) to ensure safety and basic functionality. These include biocompatibility, electrical safety, EMC, software verification, and mechanical performance tests.
Clinical Literature: It lists clinical literature used to support the indications for use, not a specific study proving the device meets quantifiable performance metrics.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or information about sample sizes, expert ground truth, adjudication, MRMC studies, or standalone performance for a specific performance evaluation study of this device meeting its own acceptance criteria.

Here's a breakdown of what is provided regarding performance and studies, in relation to your questions:

1. A table of acceptance criteria and the reported device performance

Not provided. The document does not specify quantitative acceptance criteria (e.g., specific accuracy thresholds for pressure measurements, sensitivity, or specificity for detecting conditions). It broadly states that "Obtained results demonstrate compliance to the standards" or "The performances and the accuracy obtained are comparable with the predicate devices for all the products tested." This indicates compliance with established standards and comparability to predicates, but not a pre-defined set of performance criteria for this specific device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The non-clinical tests mentioned do not detail sample sizes of devices or test conditions beyond "different THD Anopress and different THD PressProbe" for functional performance. No clinical test set data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical test set with expert-established ground truth is described in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set with adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a measurement device for physiological parameters, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No standalone performance data for a diagnostic algorithm is presented. The device itself is a standalone measurement system. The document does not describe an "algorithm only" performance for a diagnostic task.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for clinical ground truth. For the non-clinical performance tests, the "ground truth" would be established calibration standards and engineering specifications.

8. The sample size for the training set

Not applicable. This document describes a medical device, not an AI/ML model with a discreet training set.

9. How the ground truth for the training set was established

Not applicable. As above, no training set for an AI/ML model is described.

Summary

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March 8, 2018

THD SpA Maurizio Pantaleoni Quality Assurance Via dell'Industria 1 Correggio, 42015 Italy

Re: K180135

Trade/Device Name: THD Anopress with THD SensyProbe Regulation Number: 21 CFR§ 876.1725 Regulation Name: Gastrointestinal Motility Monitoring System Regulatory Class: II Product Code: KLA Dated: January 15, 2018 Received: January 17, 2018

Dear Maurizio Pantaleoni:

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. 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 statutes and regulations administered by other Federal agencies.

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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Charles Viviano -S

For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180135

Device Name THD Anopress with THD SensyProbe

Indications for Use (Describe)

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 on the specially designed THD Probes. THD Anopress must only be used by appropriately trained medical staff.

The THD Anopress with THD SensyProbe is intended to be used in adults only.

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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510(k) Summary of the THD ANOPRESS with THD SensyProbe

This 510(k) Summary is being submitted as required by 21 CFR 807.92.

1. General Information

Submitter:	THD SPA
	Via dell'Industria 1, Correggio (RE), 42015, Italy
	Tel. +39 0522 634311
	Fax +39 0522634371
Consultant/ Contact:	Maurizio Pantaleoni
	THD SPA
	Via dell'Industria 1, Correggio (RE), 42015, Italy
	Mob. +393484435155
	Tel. +39 0522 634311
	Fax +39 0522 634371
	Email: regulatory@thdlab.com

Summary Prepared Date: 01/10/2018

2. Names & Classification

Trade Name: THD ANOPRESS with THD SensyProbe Common Name: Anorectal Manometry System Classification name: Gastrointestinal motility monitoring system Class II Regulation Number and Product Code: 21 CFR 876.1725; KLA

3. Predicate Devices

The THD ANOPRESS WITH THD SENSYPROBE is substantially equivalent to the following devices:

Applicant	Device name	510(k) Number
THD SpA	THD Anopress	K161785
Medspira	Mcompass	K120088

4. Device Description

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The subject device consists of two main components:

. THD Anopress: This is the main unit with a keyboard for the selection of input command for pressure measurement and display for the visualization of detected pressure parameters in real time;
. THD Probes, grouped in THD PressProbe and THD SensyProbe
- THD PressProbe is non-sterile disposable probe to be connected via the dedicated Luer-Lock connector to the THD Anopress. The probe is charged with air by the pump contained into the THD Anopress main unit and then is introduced into the anal canal of patient for the detection of pressure.
- THD SensyProbe keeps the same characteristics of the THD PressProbe but it is O additionally featured with a balloon positioned on the top of the introducer that is designed to be filled with air by the mean of a second inflation line and a Luer-Lock connection with a syringe. The inflation of the balloon with air allows the evaluation of the sensation thresholds of the lower rectum and to assess and trigger what is known as Recto Anal Inhibitory Reflex (RAIR).

THD PressProbe membrane has a diameter varying from 14,4 mm (empty membrane) to 16,6 mm (membrane inflated to 150 mmHg).

THD PressProbe is inflated to 150 mmHg, then it is inserted in the anal canal so that the sphincter exerts a compression on the membrane until 390 mmHg.

5. Indications for Use

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.

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

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Intended use comparison
	Proposed device	Predicate device	Predicate device
	THD Anopress with THD	THD Anopress	mcompass
	SensyProbe	K161785	K120088
Indicationsfor use	The THD Anopress devicemust be used exclusively toassess the average sphinctertone due to the pressureexerted by the muscles in theanal canal on the speciallydesigned THD Probes. THDAnopress must only be usedby appropriately trainedmedical staff.Furthermore, the THDSensyProbe enablesevaluation of the rectalsensitivity and capacity andthe ano-rectal inhibitoryreflex through connection toa syringe and filling of theballoon on the probe with air.The THD Anopress with THDSensyProbe is intended to be	The THD Anopress device mustbe used exclusively to assessthe average sphincter tone dueto the pressure exerted by themuscles in the anal canal on thespecially designed THD PressProbe. THD Anopress may onlybe used by appropriatelytrained medical staff.	The mcompass AnorectalManometry System is for use onpatients requiring anorectalpressure or sensation testing.
Characteristics	THD AnoPress with THD SensyProbe	THD AnoPress(K161785)	McompassAnorectal Manometry System(K120088)
Composition	• Manometer• Inflating system: pump (on THDAnopress main unit) for manometrytest and syringe for sensation test• Software on the THD Anopress device• Software on PC (optional)• Catheter (probe) :○ with one sensitiveballoon (membrane)located on theintroducer (THDPressProbe). Membraneis related to manometrytest○ with one sensitiveballoon (membrane)located on theintroducer and onelarger balloon located inthe most distal end (THDSensyProbe). Membraneis related to manometrytest, the larger balloon isrelated to rectalsensation test.	• Manometer• Inflating system: pump (on THDAnopress main unit)• Software on the THD Anopress device• Software on PC (optional)• Catheter (probe) with one sensitiveballoon (membrane) located on theprobe introducer	• Manometer• Inflating system: syringe• Software• Catheter (probe) with four sensitiveballoons located on the distal end of thecatheter and connected to pressuretransducers (manometry test). Inaddition, a larger balloon located in themost distal end of the catheter isconnected to a fifth pressure transducerand is used to measure pressure and tosimulate a various bowel levels (rectalsensation test)
Pressure DataTransmission	Wireless ; in real time	Wireless ; in real time	Wireless ; in real time
	Air-charged probe for:	Air-charged probe for :	Air-charged probe for :
Mechanism of action	measuring anal pressure formanometry test, by the meanof a membrane on the probeintroducer (all THD Probes) evaluation of RAIR and rectalsensation, by the mean of adistal end sensation balloon(only THD SensyProbe)	measuring anal pressure formanometry test, by the meanof a membrane on the probeintroducer	measuring local anorectalpressure, by the mean of foursensitive balloons located on thedistal end of the catheter evaluation of the RAIR and rectalsensation, by the mean of aballoon located on the mostdistal end of the catheter
Detected parameters	Resting Pressure Squeeze Pressure Endurance Strain Pressure Squeeze/Rest Rate Real Time Pressure Measurement Anal Contractile Reflex Cough Reflex Rectal Sensation Thresholds RAIR	Resting Pressure Squeeze Pressure Endurance Strain Pressure Squeeze/Rest Rate Real Time Pressure Measurement Anal Contractile Reflex Cough Reflex	Resting Pressure Squeeze Pressure Endurance Strain Pressure Squeeze/Rest Rate Real Time Pressure Measurement Anal Contractile Reflex Cough Reflex Rectal Sensation Thresholds RAIR
Component incontact with patient	Disposable Catheter(membrane anddistal end balloon)	Disposable Catheter (membrane)	Disposable Catheter (sensitive balloons)
Materials patientcontacting	Poly-urethane (membrane)C-Flex (SEBS - Styrene-ethylene-butadiene-styrene block polymer (distalend balloon)	Poly-urethane (membrane)	Urethane
Sterility	Non sterile	Non sterile	Non sterile

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COMPANY NAME 510(K) PREMARKET NOTIFICATION

6. Comparison of technological characteristics with the predicate devices

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COMPANY NAME 510(K) PREMARKET NOTIFICATION

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7. Performance data

1) The following non clinical tests are referenced from the predicate device THD Anopress K161785, due to the components not changing:

Non clinical Performance test Summary referenced from K161785 - THD AnoPress
Characteristics	Reference standards	Results
Biocompatibility	ISO 10993-1 ISO 10993-5 ISO 10993-10	Obtained results demonstrate compliance to the standards
Electrical safety	• IEC 60601-1	Obtained results demonstrate compliance to the standard
EMC	• IEC 60601-1-2	Obtained results demonstrate compliance to the standard
Software Verification and Validation	• IEC 62304	Obtained results demonstrate compliance to the standard
Functional Performance and accuracy verification in simulated use conditions	• Verification of functional performances and accuracy of the THD Anopress at:Strain pressure Squeeze pressure Resting pressure using different THD Anopress and different THD PressProbe	The performances and the accuracy obtained are comparable with the predicate devices for all the products tested.

Characteristics	Test Performed	Results
MechanicalPerformance Tests(new and ageddevices)	Verification of geometric specifications (length and diameter) Verification of membrane expanded / unexpanded diameter Verification of membrane and tubing leak testing Verification of membrane expanded / unexpanded diameter after repeated use Verification of membrane and tubing leak testing after repeated use Verification of membrane maximum volume Verification of functional performance of the THD Anopress main unit (strain, squeeze, resting) with not aged/aged THD PressProbes Verification of the membrane burst pressure Tensile testing of the joints and bonded components of the tubing Verification of the peeling of the joints and bonded components of the membrane	The performances and the accuracy obtained are comparable with the predicate devices for all the products tested.

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1. The following non clinical tests were performed on the subject device:

Non clinical Performance test Summary - THD SensyProbe
Characteristics	Test Performed	Results
MechanicalPerformance Tests(new and ageddevices)	Verification of geometric specifications of distal end balloon Verification of inflation performances of the distal end balloon Distal end balloon and tubing leak testing (supplemental inflation line) Distal end balloon expanded / un-expanded diameter - repeated use Distal end balloon and tubing leak testing - repeated use (supplemental inflation line) Distal end balloon maximum burst volume Tensile testing of the joints and bonded components of the tubing (supplemental inflation line) Testing of the joints and bonded components of the distal end balloon	The performances obtained are comparable with the predicate device K120088 (mcompass) for all the products tested.

3) Clinical literature used to support the indications for use:

An ANMS-NASPGHAN consensus document on anorectal and colonic manometry in children - O Rodriguez L, Sood M, Di Lorenzo C, Saps M, Neurogastroenterol Motil. 2017 Jan;29(1). doi: 10.1111/nmo.12944. Epub 2016 Oct 9
Clinical applications of gastrointestinal manometry in children Jeana Hong Pediatr Gastroenterol O Hepatol Nutr. 2014 Mar; 17(1): 23-30.
Anorectal manometry in the neonatal diagnosis of Hirschsprung's disease Enríquez Zarabozo E, o Núñez Núñez R, Ayuso Velasco R, Vargas Muñoz I, Fernández de Mera JJ, Blesa Sánchez E, , Cir Pediatr. 2010 Jan;23(1):40-5
A clinical evaluation of anorectal pressure studies in the diagnosis of Hirschprung's disease lan O Aaronson and H.H. Nixon - Gut. 1972;13:138-146

8. Conclusions

In light of evidences summarized above and based on classification, intended use, technological characteristics and performance data, the subject device is substantially equivalent to the predicate devices K161785 and K120088.

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).