(258 days)
No
The description focuses on basic pressure measurement and data display/storage, with no mention of AI/ML algorithms for analysis or interpretation.
No
The device is used for assessment and measurement of anal pressure, not for treatment.
Yes
Explanation: The device measures anal pressure and sphincter tone to assess average sphincter tone, which provides information about a patient's medical condition.
No
The device description clearly outlines two main hardware components: the THD Anopress main unit (with keyboard, display, and pump) and the THD Press Probe (a physical, disposable probe). While software (Anopress SW) is mentioned for data storage, it is optional and the core functionality relies on the described hardware.
Based on the provided information, the THD Anopress device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The THD Anopress device directly measures pressure within the anal canal of a patient. It does not analyze a biological sample like blood, urine, tissue, etc.
- The device description clearly states it's a "handheld, portable anorectal manometry device for measuring anal pressure". Manometry is a technique for measuring pressure within a body cavity, not for analyzing samples.
- The intended use is to "assess the average sphincter tone due to the pressure exerted by the muscles in the anal canal". This is a direct physiological measurement, not an analysis of a biological sample.
Therefore, the THD Anopress device falls under the category of a medical device used for physiological measurement, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
KLA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anal canal
Indicated Patient Age Range
adult patients
Intended User / Care Setting
appropriately trained medical staff / bedside
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were performed on the subject device.
- Non clinical tests performed on the subject device:
- Biocompatibility: Obtained results demonstrate compliance to the standards (ISO 10993-1, ISO 10993-5, ISO 10993-10).
- Electrical safety: Obtained results demonstrate compliance to the standard (IEC 60601-1).
- EMC: Obtained results demonstrate compliance to the standard (IEC 60601-1-2).
- Software Verification and Validation: Obtained results demonstrate compliance to the standard (IEC 62304).
- Functional Performance and accuracy verification in simulated use conditions: The performances and the accuracy obtained are comparable with the predicate device for all the products tested. Tested parameters include Strain pressure, squeeze pressure, and resting pressure using different THD AnoPress and different THDPress-Probe.
- Mechanical Performance Tests (new and aged devices) for THD Press Probe: No differences in results between aged and not aged samples. When applicable the relevant performances of THD AnoPress and THD PressProbe are comparable with the performances of the predicate device. Tests performed include:
- 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 (strain, squeeze, resting) with not aged/aged Press Probes.
- Verification of the membrane burst pressure
- Verification of tensile testing of the joints and bonded components of the tubing
- Verification of the peeling of the joints and bonded components of the membrane
Clinical tests performed on the subject device: N/A: No clinical tests were performed on the subject 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, resembling a bird in flight.
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.
1
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
2
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.
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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."
3
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
Via dell'Industria 1, Correggio (RE), 42015, Italy
Tel. +39 0522 634311
Fax +39 0522634371 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Consultant/ Contact: | Maurizio Pantaleoni
ISEMED srl
Via Altobelli Bonetti 3/a
Imola, BO40026ITALY
Mob. +393484435155
Tel. +390542683803
Fax+390542698456
Email: 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 |
4
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
Anorectal Manometry System
(K120088) |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Composition | • manometer
• Inflating system: pump
• Software on manometer
• Software on PC(optional)
• catheter (probe) with one sensitive
balloon | • manometer
• inflating system: syringe
• Software
• catheter (probe) with 5 sensitive
balloons |
| Pressure Data
Transmission | Wireless ; in real time | Wireless ; in real time |
| Mechanism of action | Air-charged probe for measuring anal
pressure | Air-charged probe for measuring local
anorectal pressure |
5
COMPANY NAME 510(K) PREMARKET NOTIFICATION
| Characteristics | THD AnoPress | Mcompass
Anorectal 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 in
contact with patient | Disposable Catheter (sensitive balloon) | Disposable Catether (sensitive balloon) |
| Materials patient
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 |
| 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 ad accuracy of the THD | ||
| Anopress at : | ||
| Strain pressure squeeze pressure resting pressure using different THD AnoPress and | ||
| different THDPress-Probe | The performances and the accuracy | |
| obtained are comparable with the | ||
| predicate device for all the products tested |
6
| Non clinical Performance test Summary-THD Press Probe | ||
|---|---|---|
| Characteristics | Test Performed | Results |
| Mechanical | ||
| Performance Tests | ||
| (new and aged | ||
| devices | • 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 (strain, squeeze, | ||
| resting) with not aged/aged Press | ||
| Probes. | ||
| • Verification of the membrane burst | ||
| pressure | ||
| • Verification of tensile testing of the | ||
| joints and bonded components of the | ||
| tubing | ||
| • Verification of the peeling of the joints | ||
| and bonded components of the | ||
| membrane | No differences in results between aged and | |
| not aged samples. | ||
| When applicable the relevant | ||
| performances of THD AnoPress and THD | ||
| PressProbe are comparable with the | ||
| 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.