(46 days)
K991288 - G&J Electronics, Distender Series II Barostat
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on pressure and dimensional measurements, not AI/ML-driven analysis.
No.
The device is indicated for diagnostic use to measure pressure and dimensions to aid in the evaluation of gastrointestinal motility disorders and stoma/sleeve sizing, not for therapeutic purposes.
Yes.
Explanation: The "Intended Use / Indications for Use" section explicitly states that the system "is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders." This clearly indicates its role in the diagnostic process.
No
The device description explicitly states "The EndoFLIP® system and its accessory catheters are identical to the reference Crospon EndoFLIP® K120997." This indicates the device includes hardware components (the system and catheters) in addition to any software.
Based on the provided text, the EndoFLIP® System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- EndoFLIP® System Function: The description clearly states the EndoFLIP® System is used to "measure pressure and dimensions in the esophagus, pylorus, and anal sphincters" in a clinical setting. This involves direct interaction with the patient's internal anatomy, not the analysis of a specimen taken from the body.
- Intended Use: The intended use is as an "adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders." This further reinforces its role in direct patient assessment rather than laboratory analysis of specimens.
Therefore, the EndoFLIP® System is a medical device used for in-vivo measurements, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EndoFLIP® System is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders.
The EF-325 series of catheters can make pressure and dimensional measurements in the esophagus, pylorus, and anal sphincters; whereas the BF-325 series and EF-825 catheters can make dimensional measurements in the esophagus. pylorus, and anal sphincters. The EF-620 catheter can make dimensional measurements in the esophagus.
Other indications for use include:
- To estimate the size of a stoma produced by a gastric band (all EndoFLIP catheters)
- For use as an adjunct to a bougie for measuring the size of a gastric sleeve created during bariatric surgery, where it is suitable for diameter measurements for 22 to 60Fr sleeves (EF-620 catheter)
Product codes (comma separated list FDA assigned to the subject device)
FFX
Device Description
The EndoFLIP® system and its accessory catheters are identical to the reference Crospon EndoFLIP® K120997. The proposed modifications to the EndoFLIP® system is to expand the anatomical locations to encompass the measurement of pressures and dimensions in the esophagus, pylorus, and anal sphincters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus, pylorus, and anal sphincters
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical setting, Hospitals, Physician offices.
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)
Performance Testing - Bench: No comparative bench testing was required as there are no design changes to the system or catheter.
Performance Testing - Clinical: Independent clincial studies have been performed for the cited anatomical locations in the indictaions for use. There are:
- Evaluation of anal sphincter resistance and distensibility in healthy controls using 1. EndoFLIP. Alqudah MM. Gregersen H. Drewes AM. McMahon BP. Neurogastroenterol Motil. 2012:24(12) e591-9
-
- Distensibility of the anal in patients with systemic sclerosis: A study with the Functional Lumen Imaging Probe. Fynne L, Luft F, Gregersen H, Buntzen S, Lundby L, Lundager F, Laurberg S, Krogh K., Colorectal Dis. 2013:15(1) e40-7
- Functional luminal imaging probe: a new technique for dynamic evaluation of 3. mechanical properties of the anal canal. Luft F, Fynne L. Gregersen H. Lundager F. Buntzen S, Lundby L, Laurberg S, Krogh K., Tech Coloproctol. 2012:16(6) 451-7
-
- Do endoflip assessments of anal sphincter distensibility provide more information on patients with fecal incontinence than high-resolution anal manometry? Gourcerol G, Granier S, Bridoux V, Menard JF, Ducrotté P, Leroi AM., Neurogastroenterol Motil. 2015 Dec 15. doi: 10.1111/nmo.12740. [Epub ahead of print]
-
- Distensibility of the anal canal in patients with idiopathic fecal incontinence: a study with the Functional Lumen Imaging Probe. Sørensen G1, Liao D, Lundby L, Fynne L, Buntzen S, Gregersen H, Laurberg S, Krogh K., Neurogastroenterol Motil. 2014 Feb:26(2):255-63.
- Impaired fasting pyloric compliance in gastroparesis and the therapeutic response to 6. pyloric dilatation. Gourcerol G, Tissier F, Melchior C, Touchais JY, Huet E, Prevost G, Leroi AM, Ducrotte P. Aliment Pharmacol Ther. 2014 Dec 19. doi: 10.1111/apt.13053. [Epub ahead of print]
-
- Assessing pyloric sphincter pathophysiology using EndoFLIP in patients with gastroparesis. Malik Z, Sankineni A, Parkman HP., Neurogastroenterol Motil. 2015 Feb 24. doi: 10.1111/nmo.12522. [Epub ahead of print]
- Evaluation of the pylorus with concurrent intraluminal pressure and EndoFLIP in patients 8. with nausea and vomiting. Snape WJ, Lin MS, Agarwal N, Shaw RE. Neurogastroenterol Motil. 2016 Jan 27. doi: 10.1111/nmo.12772. [Epub ahead of print]
-
- New measures of upper esophageal sphincter distensibility and opening patterns during swallowing in healthy subjects using EndoFLIP. J. Regan, M Walshe, N Rommel, J Tack, BP McMahon, Neurogastroenterol Motil. 2013 Jan;25(1):e25-34
-
- 'Endoflip® evaluation of pharyngo-oesophageal segment tone and swallowing in a clinical population: a total laryngectomy case series'. Regan J. Walshe M. Timon C. McMahon BP., Clin Otolaryngol. 2015 Apr;40(2):121-9.
-
- A new evaluation of the upper esophageal sphincter using the functional lumen imaging probe: a preliminary report. Regan J. Walshe M. Rommel N. McMahon BP., Dis Esophagus. 2013 Feb-Mar;26(2):117-23
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K991288 - G&J Electronics, Distender Series II Barostat
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K120997 – EndoFLIP® system – Crospon Ltd., K092850 - EndoFLIP® system - Crospon Ltd.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing right, with a wing-like shape above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 1, 2016
Crospon Ltd. Paul E. Dryden Consultant Galway Business Park, Dangan Galway Ireland
Re: K160725 Trade/Device Name: EndoFLIP® System Regulation Number: 21 CFR§ 876.1725 Regulation Name: Gastrointestinal Motility Monitoring System Regulatory Class: II Product Code: FFX Dated: March 31, 2016 Received: April 4, 2016
Dear Paul E. Dryden:
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
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) K160725
Device Name EndoFLIP® System
Indications for Use (Describe)
The EndoFLIP® System is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus. pylorus, and anal sphincters. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders.
The EF-325 series of catheters can make pressure and dimensional measurements in the esophagus, pylorus, and anal sphincters; whereas the BF-325 series and EF-825 catheters can make dimensional measurements in the esophagus. pylorus, and anal sphincters. The EF-620 catheter can make dimensional measurements in the esophagus.
Other indications for use include:
· To estimate the size of a stoma produced by a gastric band (all EndoFLIP catheters)
· For use as an adjunct to a bougie for measuring the size of a gastric sleeve created during bariatric surgery, where it is suitable for diameter measurements for 22 to 60Fr sleeves (EF-620 catheter)
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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3
510(k) Summary Page 1 of 6 27-Apr-16
| Company | Crospon Ltd.
Galway Business Park
Dangan
Galway, Ireland |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | John O'Dea PhD |
| Proprietary or Trade Name: | EndoFLIP® System |
| Common/Usual Name: | Gastrointestinal motility monitoring system |
| Classification Name: | FFX |
| Device: | EndoFLIP® System |
| Predicate Device:
Reference Devices: | K991288 - G&J Electronics, Distender Series II Barostat
K120997 – EndoFLIP® system – Crospon Ltd.
K092850 - EndoFLIP® system - Crospon Ltd. |
Device Description:
The EndoFLIP® system and its accessory catheters are identical to the reference Crospon EndoFLIP® K120997. The proposed modifications to the EndoFLIP® system is to expand the anatomical locations to encompass the measurement of pressures and dimensions in the esophagus, pylorus, and anal sphincters.
Indications for Use:
The EndoFLIP® System is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders.
The EF-325 series of catheters can make pressure and dimensional measurements in the esophagus, pylorus, and anal sphincters; whereas the BF-325 series and EF-825 catheters can make dimensional measurements in the esophagus, pylorus, and anal sphincters. The EF-620 catheter can make dimensional measurements in the esophagus.
Other indications for use include:
- To estimate the size of a stoma produced by a gastric band (all EndoFLIP catheters) .
- . For use as an adjunct to a bougie for measuring the size of a gastric sleeve created during bariatric surgery, where it is suitable for diameter measurements for 22 to 60Fr sleeves (EF-620 catheter)
Patient Population:
Patients with symptoms consistent with gastrointestinal motility disorders.
Environment of Use:
Hospitals, Physician offices.
Contraindications:
The EndoFLIP® System is contraindicated where endoscopy is contraindicated.
4
510(k) Summary
Distender Series II Barostat | EndoFLIP® | Proposed | |
---|---|---|---|
G&J Electronics | Crospon | EndoFLIP® | |
K991288 | K120997 / K092850 / K102214 | Expanded Indications | |
Indications for Use | The Distender Series II Dual Drive | ||
Barostat device with the Protocol Plus | |||
software is an electro-pneumatic device | |||
used for volume / pressure | |||
measurement in the alimentary tract. |
This device is intended to be used as an
adjunct to other diagnostic methods as
part of a comprehensive evaluation of
patients with symptoms consistent with
gastrointestinal motility disorders. | The EndoFLIP® system is indicated for
use in a clinical setting as a pressure and
dimension measurement device and for
balloon distension provocation testing in
the esophagus.
Indicated for use in patients
fitted with a gastric band. The device
is intended to estimate the size of the
stoma produced by the gastric band
Indicated for use as an adjunct to a
bougie for measuring the size of a
gastric sleeve created during bariatric
surgery. It is suitable for diameter
measurements for 22 to 60French
sleeves | The EndoFLIP® System is indicated for
use in a clinical setting to measure
pressure and dimensions in the
esophagus, pylorus, and anal sphincters.
It is intended to be used as an adjunct to
other diagnostic methods as part of a
comprehensive evaluation of patients
with symptoms consistent with
gastrointestinal motility disorders.
The EF-325 series of catheters can make
pressure and dimensional measurements
in the esophagus, pylorus, and anal
sphincters; whereas the BF-325 series
and EF-825 catheters can make
dimensional measurements in the
esophagus, pylorus, and anal sphincters.
The EF-620 catheter can make
dimensional measurements in the
esophagus.
Other indications for use include:
To estimate the size of a stoma
produced by a gastric band (all
EndoFLIP catheters) For use as an adjunct to a bougie for
measuring the size of a gastric
sleeve created during bariatric
surgery, where it is suitable for
diameter measurements for 22 to
60Fr sleeves (EF-620 catheter) |
| | Distender Series II Barostat
G&J Electronics
K991288 | EndoFLIP®
Crospon
K120997 / K092850 / K102214 | Proposed
EndoFLIP®
Expanded Indications |
| Anatomical Sites | Alimentary tract
Esophagus, stomach, small bowel,
colon and rectum | Esophagus, Stomach | Esophagus, stomach, pylorus, and
anal sphincters |
| Environments of use | Hospitals, Physician offices | Hospitals, Physician offices | Hospitals, Physician offices |
| Patient Population | Patients with symptoms consistent with
gastrointestinal motility disorders | Patients with esophageal disorders
(K120997) | Patients with symptoms consistent
with gastrointestinal disorders |
| | | Patient undergoing gastric band surgery
and post-operative band adjustment
(K092850) | Patient undergoing gastric band
surgery and post-operative band
adjustment |
| Contraindications | Not stated | The EndoFLIP® System is
contraindicated where endoscopy is
contraindicated. | The EndoFLIP® System is
contraindicated where endoscopy is
contraindicated. |
| Principle of Operation | Pneumatic device that maintains an
isobaric pressure or isovolumetric
volume within a balloon.
Records volume and pressure changes
during the protocol. | The catheter is positioned in the desired
location one volume setting and inflation
rate to be made. There are up to ten
isovolumetric steps which are pre-
programmed. These steps are
programmed in terms of the volume to
be delivered and the time to pause
between each step. Alternatively the
system can be programmed to allow the
patient to decide when the next step
commences. | The catheter is positioned in the
desired location one volume setting
and inflation rate to be made. There
are up to ten isovolumetric steps
which are pre-programmed. These
steps are programmed in terms of the
volume to be delivered and the time to
pause between each step.
Alternatively the system can be
programmed to allow the patient to
decide when the next step commences. |
5
510(k) Summary
6
510(k) Summary
| | Distender Series II Barostat
G&J Electronics | EndoFLIP®
Crospon | Proposed
EndoFLIP® |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K991288 | K120997 / K092850 / K102214 | Expanded Indications |
| | Pressure sensor in the device is connected to
the balloon via a measurement line. | Pressure sensor in the catheter balloon.
Dest electrodes are located at 16 points
along the catheter inside a balloon. | Pressure sensor in the catheter balloon.
Dest electrodes are located at 16 points
along the catheter inside a balloon. The
balloon is placed such that its midpoint
is located in the area to be measured. |
| | | The balloon is placed such that its
midpoint is located in the esophagus.
(K120997) | |
| | | The balloon is placed such that its
midpoint is located in a stoma within a
stomach fitted with a gastric band.
(K092850) | |
| Data Recording | 4 channels of data can be recorded on a chart
recorder | Data is saved internally and can be
exported to a USB mass storage device
or printed to an attached USB printer | Data is saved internally and can be
exported to a USB mass storage device
or printed to an attached USB printer |
| Electrical Safety | Not stated | IEC60601-1 2nd Ed. + Am.1 + Am.2 | No change in device from K120997 |
| Biocompatibility | User sources balloons and tubing. | All materials have passed
biocompatibility tests in accordance with
ISO 10993-1 (K092850) | Identical to Crospon - K092850 |
| Compatibility With The
Environment And Other
Devices | User sources balloons and tubing. | EndoFLIP operates with custom
catheters only. | EndoFLIP operates with custom
catheters only. |
| Performance | Volume range and resolution is dependent on
the cylinder size used. Range available is 25ml
to 1200ml. Resolution ranges from a piston
step size of 0.181ml to 0.804ml | Balloon volume is controlled and
delivered volume is displayed:
Range: 0 to 50 mL
Resolution: 1 mL | Balloon volume is controlled and
delivered volume is displayed:
Range: 0 to 50 mL
Resolution: 1 mL |
7
Substantial Equivalence
The EndoFLIP® system with the expanded indications for use is viewed as substantially equivalent to the predicate and reference devices presented above. In summary we have found that the following key elements support a determination of substantially equivalent:
Indications -
The proposed indications for use are similar to the predicate. G&J Barostat K991288 when expanded to include the alimentary tract.
The other indications for use are identical to the reference, Crospon EndoFLIP® system, K120997
Discussion - The inclusion of the alimentary tract is consistent with the predicate K991288 Distender Series II Dual Drive Barostat and a subset of which are already within the scope of the current EndoFLIP® clearances.
Environment of Use -
The proposed environments of use are identical to the predicate, K991288 Distender Series II Dual Drive Barostat and reference EndoFLIP® K120997 / K092850. Discussion - There have been no changes in the environments of use.
Patient Population -
The proposed patient population is patients with gastrointestinal motility disorders, identical to the predicate K991288 Distender Series II Dual Drive Barostat and reference EndoFLIP® K120997 which list patients with symptoms consistent with gastrointestinal disorders, which are equivalent.
Discussion - There have been no changes in the patient population.
Technology / Design / Features -
The technology is identical to the predicate EndoFLIP® systems (K092850) with no hardware or software changes.
Discussion - There have been no changes in the proposed device vs. the reference devices.
Materials -
There are no material changes from the predicate K092850. Discussion - The identical accessory catheters are used therefore there have been no changes in the materials in patient contact.
Performance Specifications -
There are no design changes to the system or catheters and therefore no change in performance. Discussion - There have been no changes in the performance specification vs. the reference devices.
Performance Testing - Bench
No comparative bench testing was required as there are no design changes to the system or catheter.
Performance Testing - Clinical
Independent clincial studies have been performed for the cited anatomical locations in the indictaions for use. There are:
8
- Evaluation of anal sphincter resistance and distensibility in healthy controls using 1. EndoFLIP. Alqudah MM. Gregersen H. Drewes AM. McMahon BP. Neurogastroenterol Motil. 2012:24(12) e591-9
-
- Distensibility of the anal in patients with systemic sclerosis: A study with the Functional Lumen Imaging Probe. Fynne L, Luft F, Gregersen H, Buntzen S, Lundby L, Lundager F, Laurberg S, Krogh K., Colorectal Dis. 2013:15(1) e40-7
- Functional luminal imaging probe: a new technique for dynamic evaluation of 3. mechanical properties of the anal canal. Luft F, Fynne L. Gregersen H. Lundager F. Buntzen S, Lundby L, Laurberg S, Krogh K., Tech Coloproctol. 2012:16(6) 451-7
-
- Do endoflip assessments of anal sphincter distensibility provide more information on patients with fecal incontinence than high-resolution anal manometry? Gourcerol G, Granier S, Bridoux V, Menard JF, Ducrotté P, Leroi AM., Neurogastroenterol Motil. 2015 Dec 15. doi: 10.1111/nmo.12740. [Epub ahead of print]
-
- Distensibility of the anal canal in patients with idiopathic fecal incontinence: a study with the Functional Lumen Imaging Probe. Sørensen G1, Liao D, Lundby L, Fynne L, Buntzen S, Gregersen H, Laurberg S, Krogh K., Neurogastroenterol Motil. 2014 Feb:26(2):255-63.
- Impaired fasting pyloric compliance in gastroparesis and the therapeutic response to 6. pyloric dilatation. Gourcerol G, Tissier F, Melchior C, Touchais JY, Huet E, Prevost G, Leroi AM, Ducrotte P. Aliment Pharmacol Ther. 2014 Dec 19. doi: 10.1111/apt.13053. [Epub ahead of print]
-
- Assessing pyloric sphincter pathophysiology using EndoFLIP in patients with gastroparesis. Malik Z, Sankineni A, Parkman HP., Neurogastroenterol Motil. 2015 Feb 24. doi: 10.1111/nmo.12522. [Epub ahead of print]
- Evaluation of the pylorus with concurrent intraluminal pressure and EndoFLIP in patients 8. with nausea and vomiting. Snape WJ, Lin MS, Agarwal N, Shaw RE. Neurogastroenterol Motil. 2016 Jan 27. doi: 10.1111/nmo.12772. [Epub ahead of print]
-
- New measures of upper esophageal sphincter distensibility and opening patterns during swallowing in healthy subjects using EndoFLIP. J. Regan, M Walshe, N Rommel, J Tack, BP McMahon, Neurogastroenterol Motil. 2013 Jan;25(1):e25-34
-
- 'Endoflip® evaluation of pharyngo-oesophageal segment tone and swallowing in a clinical population: a total laryngectomy case series'. Regan J. Walshe M. Timon C. McMahon BP., Clin Otolaryngol. 2015 Apr;40(2):121-9.
-
- A new evaluation of the upper esophageal sphincter using the functional lumen imaging probe: a preliminary report. Regan J. Walshe M. Rommel N. McMahon BP., Dis Esophagus. 2013 Feb-Mar;26(2):117-23
Substantial Equivalence Conclusion
The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.