THD ANOPRESS

K161785 · Thd Spa · KLA · Mar 14, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K161785
• Device Name: THD ANOPRESS
• Applicant: Thd Spa
• Product Code: KLA · Gastroenterology, Urology
• Decision Date: Mar 14, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1725
• Device Class: Class 2

Intended Use

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 Story

THD Anopress is a handheld, portable anorectal manometry device used at the bedside by trained medical staff to assess anal sphincter tone in adult patients. The system consists of a main unit with a keyboard and display, and a non-sterile, disposable polyurethane THD Press Probe. The probe is connected to the unit via a Luer-Lock connector; an internal pump inflates the probe with air to 150 mmHg. Upon insertion into the anal canal, the sphincter muscles compress the membrane. The device detects pressure changes in real-time, which are visualized on the unit's display. Optionally, data can be transmitted via Bluetooth to a PC running dedicated Anopress software for storage. The device provides quantitative measurements of resting and squeeze pressures, endurance, strain, and various reflexes, assisting clinicians in evaluating anorectal function and informing clinical decision-making regarding patient treatment.

Clinical Evidence

No clinical data. Bench testing only. Performance verified through biocompatibility (ISO 10993-1, -5, -10), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and software validation (IEC 62304). Functional accuracy for strain, squeeze, and resting pressure was verified in simulated use conditions and compared to the predicate device.

Technological Characteristics

Handheld manometry system; air-charged polyurethane balloon probe; internal pump inflation; wireless Bluetooth connectivity to PC; real-time pressure monitoring. Complies with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and ISO 10993 (biocompatibility). Software developed per IEC 62304.

Indications for Use

Indicated for adult patients requiring assessment of anal sphincter tone, including resting pressure, squeeze pressure, endurance, strain pressure, squeeze/rest rate, anal contractile reflex, and cough reflex.

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

• Mcompass (K120088)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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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 SPA<br>Via dell'Industria 1, Correggio (RE), 42015, Italy<br>Tel. [phone]<br>Fax [phone] |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Consultant/ Contact: | Maurizio Pantaleoni<br>ISEMED srl<br>Via Altobelli Bonetti 3/a<br>Imola, BO40026ITALY<br>Mob. [phone]<br>Tel. [phone]<br>Fax[phone]<br>Email: [e-mail] |

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 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.

#### 5. Indications for Use

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.

#### 6. Comparison of technological characteristics with the predicate device

| Characteristics | THD AnoPress | Mcompass<br>Anorectal Manometry System<br>(K120088) |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Composition | • manometer<br>• Inflating system: pump<br>• Software on manometer<br>• Software on PC(optional)<br>• catheter (probe) with one sensitive<br>balloon | • manometer<br>• inflating system: syringe<br>• Software<br>• catheter (probe) with 5 sensitive<br>balloons |
| Pressure Data<br>Transmission | Wireless ; in real time | Wireless ; in real time |
| Mechanism of action | Air-charged probe for measuring anal<br>pressure | Air-charged probe for measuring local<br>anorectal pressure |

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#### COMPANY NAME 510(K) PREMARKET NOTIFICATION

| Characteristics | THD AnoPress | Mcompass<br>Anorectal Manometry System<br>(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 in<br>contact with patient | Disposable Catheter (sensitive balloon) | Disposable Catether (sensitive balloon) |
| Materials patient<br>contacting | 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 compliance<br>to the standards |
| Electrical safety | • IEC 60601-1 | Obtained results demonstrate compliance<br>to the standard |
| EMC | • IEC 60601-1-2 | Obtained results demonstrate compliance<br>to the standard |
| Software Verification<br>and Validation | • IEC 62304 | Obtained results demonstrate compliance<br>to the standard |
| Functional<br>Performance and<br>accuracy verification<br>in simulated use<br>conditions | • Verification of functional<br>performances ad accuracy of the THD<br>Anopress at :<br>Strain pressure squeeze pressure resting pressure using different THD AnoPress and<br>different THDPress-Probe | The performances and the accuracy<br>obtained are comparable with the<br>predicate device for all the products tested |

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| Non clinical Performance test Summary-THD Press Probe | | |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Test Performed | Results |
| Mechanical<br>Performance Tests<br>(new and aged<br>devices | • Verification of geometric<br>specifications (length and diameter)<br>• Verification of membrane<br>expanded/unexpanded diameter<br>• Verification of membrane and tubing<br>leak testing<br>• Verification of membrane expanded /<br>unexpanded diameter after repeated<br>use<br>• Verification of membrane and tubing<br>leak testing after repeated use<br>• Verification of membrane maximum<br>volume<br>• Verification of functional performance<br>of the THD AnoPress (strain, squeeze,<br>resting) with not aged/aged Press<br>Probes.<br>• Verification of the membrane burst<br>pressure<br>• Verification of tensile testing of the<br>joints and bonded components of the<br>tubing<br>• Verification of the peeling of the joints<br>and bonded components of the<br>membrane | No differences in results between aged and<br>not aged samples.<br>When applicable the relevant<br>performances of THD AnoPress and THD<br>PressProbe are comparable with the<br>performances 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.