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)

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.

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for the EndoFLIP® System. It describes the device's indications for use and compares it to predicate and reference devices to demonstrate substantial equivalence. However, it does not contain specific acceptance criteria or a detailed study report with the requested performance metrics, sample sizes, ground truth establishment, or expert information typically found in a clinical study section.

Instead, it relies on a comparison to previously cleared devices and cites independent clinical studies as evidence supporting the expanded indications for use.

Therefore, most of the requested information cannot be extracted directly from this document.

Here's what can be gathered, with caveats:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document states "no design changes to the system or catheters and therefore no change in performance" and "No comparative bench testing was required as there are no design changes to the system or catheter." This implies that the performance of the current device is considered equivalent to its previously cleared versions.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided for a specific test set directly tied to this 510(k) submission. The document cites 11 independent clinical studies that have "been performed for the cited anatomical locations." The sample sizes and data provenance (country of origin, retrospective/prospective) would need to be extracted from the individual cited publications, which are not included in this document.

3. Number of Experts and Qualifications

This information is not provided in the document. This would be specific to how the ground truth was established within the cited independent clinical studies.

4. Adjudication Method

This information is not provided in the document. This would be specific to how the ground truth was established within the cited independent clinical studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study is not mentioned in the document. The device is a "Gastrointestinal motility monitoring system" for measuring pressure and dimensions, not an imaging device typically evaluated with human readers and AI assistance in an MRMC study.

6. Standalone (Algorithm Only) Performance Study

As this is a measurement device for physical parameters (pressure and dimensions) and not an AI-based diagnostic algorithm, a standalone algorithm-only performance study as typically understood for AI devices is not applicable and therefore not mentioned.

7. Type of Ground Truth Used

The type of ground truth used would be based on the nature of measurements in the cited independent clinical studies. Given the device measures "pressure and dimensions," the ground truth would likely involve direct physical measurements obtained through established medical procedures or validated alternative measurement techniques, as conducted by medical professionals in a clinical setting. However, the document does not explicitly state the type of ground truth for the cited studies.

8. Sample Size for the Training Set

This information is not provided. The document describes a medical device for measurement, not an AI/ML-based device that would typically have a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not provided. As above, it's not applicable for this type of medical device's submission.

Summary of what can be extracted from the document:

Device Name: EndoFLIP® System
Regulation Number: 21 CFR § 876.1725
Regulation Name: Gastrointestinal Motility Monitoring System
Regulatory Class: II
Product Code: FFX
Predicate Device: K991288 - G&J Electronics, Distender Series II Barostat
Reference Devices: K120997 – EndoFLIP® system – Crospon Ltd., K092850 - EndoFLIP® system - Crospon Ltd.
Indications for Use (Expanded in this submission): To measure pressure and dimensions in the esophagus, pylorus, and anal sphincters as an adjunct to other diagnostic methods for patients with symptoms consistent with gastrointestinal motility disorders. Also, to estimate stoma size with gastric bands and measure gastric sleeve size during bariatric surgery.
Technology/Design/Features/Materials/Performance Specifications: Identical to previous EndoFLIP® systems (K092850), implying no changes from previously cleared performance.
Clinical Evidence: The submission supports its expanded indications by citing 11 independent clinical studies that have evaluated the device for the new anatomical locations (anal sphincter, pylorus, upper esophageal sphincter). The details of these studies (sample size, ground truth, etc.) are not in this document but are found in the cited scientific literature.

Summary

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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.

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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/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

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Indications for Use

510(k) Number (if known) K160725

Device Name EndoFLIP® System

Indications for Use (Describe)

Other indications for use include:

· To estimate the size of a stoma produced by a gastric band (all EndoFLIP catheters)

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 Page 1 of 6 27-Apr-16

Company	Crospon Ltd.Galway Business ParkDanganGalway, 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 BarostatK120997 – EndoFLIP® system – Crospon Ltd.K092850 - EndoFLIP® system - Crospon Ltd.

Device Description:

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.

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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 DriveBarostat device with the Protocol Plussoftware is an electro-pneumatic deviceused for volume / pressuremeasurement in the alimentary tract.This device is intended to be used as anadjunct to other diagnostic methods aspart of a comprehensive evaluation ofpatients with symptoms consistent withgastrointestinal motility disorders.	The EndoFLIP® system is indicated foruse in a clinical setting as a pressure anddimension measurement device and forballoon distension provocation testing inthe esophagus.Indicated for use in patientsfitted with a gastric band. The deviceis intended to estimate the size of thestoma produced by the gastric bandIndicated for use as an adjunct to abougie for measuring the size of agastric sleeve created during bariatricsurgery. It is suitable for diametermeasurements for 22 to 60Frenchsleeves	The EndoFLIP® System is indicated foruse in a clinical setting to measurepressure and dimensions in theesophagus, pylorus, and anal sphincters.It is intended to be used as an adjunct toother diagnostic methods as part of acomprehensive evaluation of patientswith symptoms consistent withgastrointestinal motility disorders.The EF-325 series of catheters can makepressure and dimensional measurementsin the esophagus, pylorus, and analsphincters; whereas the BF-325 seriesand EF-825 catheters can makedimensional measurements in theesophagus, pylorus, and anal sphincters.The EF-620 catheter can makedimensional measurements in theesophagus.Other indications for use include:To estimate the size of a stomaproduced by a gastric band (allEndoFLIP catheters) For use as an adjunct to a bougie formeasuring the size of a gastricsleeve created during bariatricsurgery, where it is suitable fordiameter measurements for 22 to60Fr sleeves (EF-620 catheter)
	Distender Series II BarostatG&J ElectronicsK991288	EndoFLIP®CrosponK120997 / K092850 / K102214	ProposedEndoFLIP®Expanded Indications
Anatomical Sites	Alimentary tractEsophagus, stomach, small bowel,colon and rectum	Esophagus, Stomach	Esophagus, stomach, pylorus, andanal sphincters
Environments of use	Hospitals, Physician offices	Hospitals, Physician offices	Hospitals, Physician offices
Patient Population	Patients with symptoms consistent withgastrointestinal motility disorders	Patients with esophageal disorders(K120997)	Patients with symptoms consistentwith gastrointestinal disorders
		Patient undergoing gastric band surgeryand post-operative band adjustment(K092850)	Patient undergoing gastric bandsurgery and post-operative bandadjustment
Contraindications	Not stated	The EndoFLIP® System iscontraindicated where endoscopy iscontraindicated.	The EndoFLIP® System iscontraindicated where endoscopy iscontraindicated.
Principle of Operation	Pneumatic device that maintains anisobaric pressure or isovolumetricvolume within a balloon.Records volume and pressure changesduring the protocol.	The catheter is positioned in the desiredlocation one volume setting and inflationrate to be made. There are up to tenisovolumetric steps which are pre-programmed. These steps areprogrammed in terms of the volume tobe delivered and the time to pausebetween each step. Alternatively thesystem can be programmed to allow thepatient to decide when the next stepcommences.	The catheter is positioned in thedesired location one volume settingand inflation rate to be made. Thereare up to ten isovolumetric stepswhich are pre-programmed. Thesesteps are programmed in terms of thevolume to be delivered and the time topause between each step.Alternatively the system can beprogrammed to allow the patient todecide when the next step commences.

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510(k) Summary

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510(k) Summary

	Distender Series II BarostatG&J Electronics	EndoFLIP®Crospon	ProposedEndoFLIP®
	K991288	K120997 / K092850 / K102214	Expanded Indications
	Pressure sensor in the device is connected tothe balloon via a measurement line.	Pressure sensor in the catheter balloon.Dest electrodes are located at 16 pointsalong the catheter inside a balloon.	Pressure sensor in the catheter balloon.Dest electrodes are located at 16 pointsalong the catheter inside a balloon. Theballoon is placed such that its midpointis located in the area to be measured.
		The balloon is placed such that itsmidpoint is located in the esophagus.(K120997)
		The balloon is placed such that itsmidpoint is located in a stoma within astomach fitted with a gastric band.(K092850)
Data Recording	4 channels of data can be recorded on a chartrecorder	Data is saved internally and can beexported to a USB mass storage deviceor printed to an attached USB printer	Data is saved internally and can beexported to a USB mass storage deviceor 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 passedbiocompatibility tests in accordance withISO 10993-1 (K092850)	Identical to Crospon - K092850
Compatibility With TheEnvironment And OtherDevices	User sources balloons and tubing.	EndoFLIP operates with customcatheters only.	EndoFLIP operates with customcatheters only.
Performance	Volume range and resolution is dependent onthe cylinder size used. Range available is 25mlto 1200ml. Resolution ranges from a pistonstep size of 0.181ml to 0.804ml	Balloon volume is controlled anddelivered volume is displayed:Range: 0 to 50 mLResolution: 1 mL	Balloon volume is controlled anddelivered volume is displayed:Range: 0 to 50 mLResolution: 1 mL

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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:

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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
1. 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
1. 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]
1. 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]
1. 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]
1. 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
1. '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.
1. 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.

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).