(50 days)
No
The document describes a standard anorectal manometry device that measures pressure and volume. There is no mention of AI or ML algorithms for data analysis, interpretation, or decision support. The device displays real-time pressure and allows for data storage on a PC, but the processing appears to be purely based on physical measurements.
No
The device is used for assessment and evaluation, not for treating or preventing a condition.
Yes
The device is described as "for its use on patients requiring anorectal pressure studies and evaluation of functional rectal and pelvic diseases," and its intended use is "to assess the average sphincter tone" and "evaluation of rectal sensitivity and capacity and the ano-rectal inhibitory reflex." These functions are all diagnostic in nature, as they involve assessing a patient's physiological state to identify or characterize a condition.
No
The device description clearly outlines hardware components including the main unit (THD Anopress) with a keyboard and display, and physical probes (THD PressProbe and THD SensyProbe) that are inserted into the patient. While there is optional software for data storage, the core device functionality relies on hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The THD Anopress with THD SensyProbe directly measures physical parameters within the patient's body (pressure in the anal canal and rectum, rectal sensitivity and capacity, and the ano-rectal inhibitory reflex). It does not analyze samples taken from the body.
- Intended Use: The intended use is to "assess the average sphincter tone due to the pressure exerted by the muscles in the anal canal" and "evaluation of rectal sensitivity and capacity and the ano-rectal inhibitory reflex." These are direct physiological measurements, not analyses of biological specimens.
Therefore, the THD Anopress with THD SensyProbe is 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 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.
Product codes
KLA
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.
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
adults only
Intended User / Care Setting
appropriately trained medical staff
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:
-
The following non clinical tests are referenced from the predicate device THD Anopress K161785, due to the components not changing:
- Biocompatibility to ISO 10993-1, ISO 10993-5, ISO 10993-10: Obtained results demonstrate compliance to the standards.
- Electrical safety to IEC 60601-1: Obtained results demonstrate compliance to the standard.
- EMC to IEC 60601-1-2: Obtained results demonstrate compliance to the standard.
- Software Verification and Validation to IEC 62304: Obtained results demonstrate compliance to the standard.
- Functional Performance and accuracy verification in simulated use conditions (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.
- Mechanical Performance Tests (new and aged devices) including verification of geometric specifications, membrane expanded/unexpanded diameter, membrane and tubing leak testing, membrane maximum volume, functional performance of THD Anopress main unit with not aged/aged THD PressProbes, membrane burst pressure, tensile testing of joints and bonded components of tubing, peeling of joints and bonded components of membrane: The performances and the accuracy obtained are comparable with the predicate devices for all the products tested.
-
The following non clinical tests were performed on the subject device (THD SensyProbe):
- Mechanical Performance Tests (new and aged devices) including verification of geometric specifications of distal end balloon, inflation performances of 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 joints and bonded components of tubing (supplemental inflation line), testing of joints and bonded components of distal end balloon: The performances obtained are comparable with the predicate device K120088 (mcompass) for all the products tested.
-
Clinical literature was used to support the indications for use, including:
- 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
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
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 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
2
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.
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.
| 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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3
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
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.
4
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 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.
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 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.
A comparison of the intended use of the proposed device and the predicate devices is provided in the table below:
5
| Intended use comparison | |||
|---|---|---|---|
| Proposed device | Predicate device | Predicate device | |
| THD Anopress with THD | THD Anopress | mcompass | |
| SensyProbe | K161785 | K120088 | |
| 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 Probes. THD | |||
| Anopress must only be used | |||
| by appropriately trained | |||
| medical staff. | |||
| Furthermore, the THD | |||
| SensyProbe enables | |||
| evaluation of the 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 | 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. | The mcompass Anorectal | ||
| Manometry System is for use on | |||
| patients requiring anorectal | |||
| pressure or sensation testing. | |||
| Characteristics | THD AnoPress with THD SensyProbe | THD AnoPress | |
| (K161785) | Mcompass | ||
| Anorectal Manometry System | |||
| (K120088) | |||
| Composition | • Manometer | ||
| • Inflating system: pump (on THD | |||
| Anopress main unit) for manometry | |||
| test and syringe for sensation test | |||
| • Software on the THD Anopress device | |||
| • Software on PC (optional) | |||
| • Catheter (probe) : | |||
| ○ with one sensitive | |||
| balloon (membrane) | |||
| located on the | |||
| introducer (THD | |||
| PressProbe). Membrane | |||
| is related to manometry | |||
| test | |||
| ○ 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. | • Manometer | ||
| • Inflating system: pump (on THD | |||
| Anopress main unit) | |||
| • Software on the THD Anopress device | |||
| • Software on PC (optional) | |||
| • Catheter (probe) with one sensitive | |||
| balloon (membrane) located on the | |||
| probe introducer | • Manometer | ||
| • Inflating system: syringe | |||
| • Software | |||
| • Catheter (probe) with four sensitive | |||
| balloons located on the distal end of the | |||
| catheter and connected to pressure | |||
| transducers (manometry test). In | |||
| addition, a larger balloon located in the | |||
| most distal end of the catheter is | |||
| connected to a fifth pressure transducer | |||
| and is used to measure pressure and to | |||
| simulate a various bowel levels (rectal | |||
| sensation test) | |||
| Pressure Data | |||
| Transmission | 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 for | ||
| manometry test, by the mean | |||
| of a membrane on the probe | |||
| introducer (all THD Probes) evaluation of RAIR and rectal | |||
| sensation, by the mean of a | |||
| distal end sensation balloon | |||
| (only THD SensyProbe) | measuring anal pressure for | ||
| manometry test, by the mean | |||
| of a membrane on the probe | |||
| introducer | measuring local anorectal | ||
| pressure, by the mean of four | |||
| sensitive balloons located on the | |||
| distal end of the catheter evaluation of the RAIR and rectal | |||
| sensation, by the mean of a | |||
| balloon located on the most | |||
| distal 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 in | |||
| contact with patient | Disposable Catheter | ||
| (membrane and | |||
| distal end balloon) | Disposable Catheter (membrane) | Disposable Catheter (sensitive balloons) | |
| Materials patient | |||
| contacting | Poly-urethane (membrane) | ||
| C-Flex (SEBS - Styrene-ethylene- | |||
| butadiene-styrene block polymer (distal | |||
| end balloon) | Poly-urethane (membrane) | Urethane | |
| Sterility | Non sterile | Non sterile | Non sterile |
6
COMPANY NAME 510(K) PREMARKET NOTIFICATION
6. Comparison of technological characteristics with the predicate devices
7
COMPANY NAME 510(K) PREMARKET NOTIFICATION
8
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 |
|---|---|---|
| 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 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. |
9
-
- The following non clinical tests were performed on the subject device:
| Non clinical Performance test Summary - THD SensyProbe | ||
|---|---|---|
| Characteristics | Test Performed | Results |
| Mechanical | ||
| Performance Tests | ||
| (new and aged | ||
| devices) | 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.