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 Press Probe. THD Anopress may only be used by appropriately trained medical staff.

Device Description

THD Anopress is a handheld, portable anorectal manometry device for measuring anal pressure, and especially the average sphincter tone, at the bedside on adult patients population.

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 Press Probe: This is a 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 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 Press Probe is inflated to 150 mmHg, then it is inserted in the anal so that the sphincter exerts a compression on the membrane until 390mmHg.

AI/ML Overview

The provided text describes the THD ANOPRESS device, categorized as a Gastrointestinal Motility Monitoring System (Class II, 21 CFR 876.1725; KLA). The device is intended to assess the average sphincter tone due to the pressure exerted by the muscles in the anal canal.

Based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of "acceptance criteria" for performance in the typical sense of numerical thresholds for sensitivity, specificity, accuracy, etc., as one might find for diagnostic algorithms. Instead, the performance evaluation for this device is based on showing compliance with established standards and comparable performance to a predicate device. The "acceptance criteria" can be inferred as meeting these standards and demonstrating comparability.

Acceptance Criteria (Inferred from testing)	Reported Device Performance (Summary)
Biocompatibility	Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10
Electrical Safety	Compliance with IEC 60601-1
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2
Software Verification & Validation	Compliance with IEC 62304
Functional Performance & Accuracy	Comparable to the predicate device (K120088) for strain, squeeze, and resting pressures in simulated use conditions
Mechanical Performance (New & Aged)	No significant differences between new and aged samples; comparable to the predicate device where applicable

2. Sample size used for the test set and the data provenance

The document does not describe a "test set" in the context of an AI/algorithm-based device using data for performance evaluation. The "tests" performed are primarily engineering and bench testing on the device itself and its components. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) for a data-driven test set is not applicable to this submission. The "samples" referred to are physical units of the THD Anopress and THD Press Probe for mechanical and functional testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the submission does not involve a data-driven "test set" requiring expert-established ground truth. The device is a measurement system, and its performance is evaluated against physical standards and comparison to a predicate, not against a clinical "ground truth" established by experts on a dataset.

4. Adjudication method for the test set

This information is not applicable for the reasons stated above.

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

An MRMC comparative effectiveness study is not applicable to this device. The THD ANOPRESS is a direct measurement device, not an AI or imaging system that assists human readers in interpretation. The document explicitly states "No clinical tests were performed on the subject device."

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

This concept is not applicable. The THD ANOPRESS is a hardware device with embedded software for measuring anal pressure, not an AI algorithm that performs a standalone diagnosis or analysis. Its performance is inherent to its functional design as a measurement tool.

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

The "ground truth" for this device's performance evaluation lies in the established technical standards (e.g., IEC, ISO) for medical devices and the performance characteristics of the legally marketed predicate device (Medspira Mcompass, K120088). The device is assessed based on its ability to accurately measure pressure in simulated conditions, its compliance with safety and compatibility standards, and its comparability to the predicate's known performance for parameters like resting pressure, squeeze pressure, etc.

8. The sample size for the training set

This information is not applicable. The THD ANOPRESS is not an AI/machine learning device that requires a "training set" to learn from data.

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

This information is not applicable for the reasons stated above.

In summary:

The submission for the THD ANOPRESS focuses on demonstrating substantial equivalence to a predicate device through engineering and bench testing, compliance with relevant international standards, and functional comparison. It is explicitly stated that "No clinical tests were performed on the subject device." This type of submission does not involve AI or machine learning, and therefore, many of the requested elements pertaining to data sets, expert review, and algorithm performance are not relevant or present in the document.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 14, 2017

THD S.p.A. % Maurizio Pantaleoni CEO of Isemed (THD's Consultant) ISEMED S.R.L. Via A. Altobelli Bonetti 3/A Imola, BO 40026 Italy

Re: K161785

Trade/Device Name: THD ANOPRESS Regulation Number: 21 CFR§ 876.1725 Regulation Name: Gastrointestinal Motility Monitoring System Regulatory Class: II Product Code: KLA Dated: February 3, 2017 Received: February 8, 2017

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely,

Joyce M. Whang -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name THD ANOPRESS

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 Press Probe. THD Anopress may only be used by appropriately trained medical staff.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

_ | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary of the THD ANOPRESS

This 510(k) Summary is being submitted as required by21 CFR 807.92.

1. General Information

Submitter:	THD SPAVia dell'Industria 1, Correggio (RE), 42015, ItalyTel. +39 0522 634311Fax +39 0522634371
Consultant/ Contact:	Maurizio PantaleoniISEMED srlVia Altobelli Bonetti 3/aImola, BO40026ITALYMob. +393484435155Tel. +390542683803Fax+390542698456Email: regulatory@isemed.eu

Summary Prepared Date: 07/03/2017

2. Names & Classification

Trade Name: THD ANOPRESS 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 is substantially equivalent to the following device:

Applicant	Device name	510(k) Number
Medspira	Mcompass	K120088

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4. Device Description

THD Anopress is a handheld, portable anorectal manometry device for measuring anal pressure, and especially the average sphincter tone, at the bedside on adult patients population.

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 Press Probe: This is a 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 PressProbe membrane has a diameter varying from 14,4 mm (empty membrane) to 16,6 mm (membrane inflated to 150 mmHg).

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

5. Indications for Use

6. Comparison of technological characteristics with the predicate device

Characteristics	THD AnoPress	McompassAnorectal Manometry System(K120088)
Composition	• manometer• Inflating system: pump• Software on manometer• Software on PC(optional)• catheter (probe) with one sensitiveballoon	• manometer• inflating system: syringe• Software• catheter (probe) with 5 sensitiveballoons
Pressure DataTransmission	Wireless ; in real time	Wireless ; in real time
Mechanism of action	Air-charged probe for measuring analpressure	Air-charged probe for measuring localanorectal pressure

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COMPANY NAME 510(K) PREMARKET NOTIFICATION

Characteristics	THD AnoPress	McompassAnorectal Manometry System(K120088)
Detected parameters	Resting Pressure	Resting Pressure
	Squeeze Pressure	Squeeze Pressure
	Endurance	Endurance
	Strain Pressure	Strain Pressure
	Squeeze/Rest Rate	Squeeze/Rest Rate
	Real Time Pressure Measurement	Real Time Pressure Measurement
	Anal Contractile Reflex	Anal Contractile Reflex
	Cough Reflex	Cough Reflex
Component incontact with patient	Disposable Catheter (sensitive balloon)	Disposable Catether (sensitive balloon)
Materials patientcontacting	Poly-urethane	Urethane
Sterility	Non sterile	Non sterile

7. Performance data

1) Non clinical tests performed on the subject device:

Non clinical Performance test Summary-THD AnoPress
Characteristics	Reference standards	Results
Biocompatibility	ISO 10993-1 ISO 10993-5 ISO 10993-10	Obtained results demonstrate complianceto the standards
Electrical safety	• IEC 60601-1	Obtained results demonstrate complianceto the standard
EMC	• IEC 60601-1-2	Obtained results demonstrate complianceto the standard
Software Verificationand Validation	• IEC 62304	Obtained results demonstrate complianceto the standard
FunctionalPerformance andaccuracy verificationin simulated useconditions	• Verification of functionalperformances ad accuracy of the THDAnopress at :Strain pressure squeeze pressure resting pressure using different THD AnoPress anddifferent THDPress-Probe	The performances and the accuracyobtained are comparable with thepredicate device for all the products tested

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Non clinical Performance test Summary-THD Press Probe
Characteristics	Test Performed	Results
MechanicalPerformance Tests(new and ageddevices	• Verification of geometricspecifications (length and diameter)• Verification of membraneexpanded/unexpanded diameter• Verification of membrane and tubingleak testing• Verification of membrane expanded /unexpanded diameter after repeateduse• Verification of membrane and tubingleak testing after repeated use• Verification of membrane maximumvolume• Verification of functional performanceof the THD AnoPress (strain, squeeze,resting) with not aged/aged PressProbes.• Verification of the membrane burstpressure• Verification of tensile testing of thejoints and bonded components of thetubing• Verification of the peeling of the jointsand bonded components of themembrane	No differences in results between aged andnot aged samples.When applicable the relevantperformances of THD AnoPress and THDPressProbe are comparable with theperformances of the predicate device.

2) Clinical tests performed on the subject device:

N/A: No clinical tests were performed on the subject device.

8. Conclusions

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