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 modification to the EndoFLIP® System is the addition of display functionality. This functionality is software and is referred to as the FLIP Topography module which is a supplemental accessory.

The addition of the supplemental accessory FLIP Topography module does not modify the predicate EndoFLIP® System or change the intended use of the device. This modification does not alter the fundamental scientific technology; the EndoFLIP® System algorithm or change the hardware and accessories associated with the EndoFLIP® System.

FLIP Topography displays the traditional EndoFLIP® data plus FLIP Topography adds historical data graphs (live data for the last 40 seconds) for use by the clinician.

AI/ML Overview

This document is a 510(k) Summary for the FLIP Topography module, an accessory to the EndoFLIP® system. It outlines various aspects of the device but explicitly states that no clinical investigation was needed because the modification (adding display functionality) does not change the fundamental scientific technology or hardware/software performance. Therefore, detailed information about acceptance criteria and a study proving those criteria are met is not present in the provided text.

Based on the provided text, here's what can be extracted and what information is missing:

1. A table of acceptance criteria and the reported device performance

The document states: "Verification activities for the modification were performed and the results demonstrated that the predetermined acceptance criteria were met." However, it does not list what those predetermined acceptance criteria were or the specific reported performance against those criteria.

The verification activities included:

Data acquisition
Display characteristics (labels, accuracy, etc.)
Data management
Communication

The "Performance" row in the comparison table simply states: "No performance testing for a display device only." This implies that the performance expectations were primarily around accurate data display and handling, rather than new physiological measurements.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided as no clinical investigation or specific "test set" for performance evaluation of the FLIP Topography module was conducted or described in this document. The document explicitly states, "As there are no changes in hardware or software that will impact performance, there is no need to validate the changes through a clinical investigation."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided as no clinical investigation or expert-driven ground truth establishment was conducted for the FLIP Topography module, as per the submission's rationale.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as no clinical investigation or expert adjudication process was conducted for the FLIP Topography module.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The FLIP Topography module is a software display functionality that presents existing data from the EndoFLIP® system, not an AI or diagnostic algorithm that would typically be evaluated in an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance study of an algorithm was not done in the context of this submission for the FLIP Topography module. The module is described as display functionality, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided as no new ground truth establishment was required for this accessory, which primarily displays data. The core EndoFLIP® system, to which this is an accessory, would have had its own ground truth established during its original clearance process (K160725 and K092850), but this document does not detail it.

8. The sample size for the training set

This information is not provided. The FLIP Topography module is a display functionality and not an AI/machine learning model that typically requires a training set.

9. How the ground truth for the training set was established

This information is not provided. As above, no training set or its ground truth establishment is discussed for this display module.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 17, 2017

Crospon Ltd. Paul Dryden Consultant 24301 Woodsage Dr. Bonita Springs, Florida 34135

Re: K170833

Trade/Device Name: FLIP Topography Regulation Number: 21 CFR 876.1725 Regulation Name: Gastrointestinal Motility Monitoring System Regulatory Class: Class II Product Code: FFX Dated: March 16, 2017 Received: March 20, 2017

Dear Paul 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. 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

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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,

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

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Indications for Use

510(k) Number (if known)

K170833

Device Name

EndoFLIP® System with FLIP Topography module

Indications for Use (Describe)

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)
-------------------------------------------------	--

XX 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 5 4/14/17

Company:	Crospon Ltd.Galway Business ParkDangan, Galway, IrelandTel: +011 [353] (91) 519882
Official Contact:	John O'Dea PhD - CEO
Proprietary or Trade Name:	EndoFLIP® System with FLIP Topography module
Common/Usual Name:	Gastrointestinal motility monitoring system
Classification Name:	FFX
Device:	FLIP Topography module
Modified Device:	K160725 - EndoFLIP® System – Crospon Ltd.

Device Description:

The modification to the EndoFLIP® System is the addition of display functionality. This functionality is software and is referred to as the FLIP Topography module which is a supplemental accessory.

As there are no changes in hardware or software that will impact performance, there is no need to validate the changes through a clinical investigation.

Modification:

The modification to the EndoFLIP® System is the addition of display functionality. This functionality is software and is named the FLIP Topography module. FLIP Topography module is software which runs on an off-the-shelf PC that connects to the EndoFLIP® via a cable and displays the data on a larger screen.

FLIP Topography displays the traditional EndoFLIP® data plus FLIP Topography adds historical data graphs (live data for the last 40 seconds) for use by the clinician.

Indications for Use:

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510(k) Summary Page 2 of 5 4/14/17

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)

The indications for use are unchanged.

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.

The EndoFLIP® System is contraindicated for use in patients with actively bleeding varices in the esophagus.

Predicate Device Comparison

The EndoFLIP® System with FLIP Topography module is compared to the EndoFLIP® System in the device comparison table below.

Summary of Modifications:

The modification to the EndoFLIP® System is the addition of display functionality; this functionality is software and is named the FLIP Topography module. FLIP Topography is software which runs on an off-the-shelf PC that connects to the EndoFLIP® via a cable and displays the data on a larger screen.

Verification and Validation Activities

Verification activities for the modification were performed and the results demonstrated that the predetermined acceptance criteria were met. These verification activities included:

. Data acquisition
. Display characteristics (labels, accuracy, etc.)
. Data management
. Communication

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510(k) Summary Page 3 of 5

	EndoFLIP® System with FLIPTopography module	Unmodified PredicateEndoFLIP® SystemK160725
Attributes
Indications for Use	The EndoFLIP® System is indicated foruse in a clinical setting to measure pressureand dimensions in the esophagus, pylorus,and anal sphincters. It is intended to beused as an adjunct to other diagnosticmethods as part of a comprehensiveevaluation of patients with symptomsconsistent with gastrointestinal motilitydisorders.The EF-325 series of catheters can makepressure and dimensional measurements inthe esophagus, pylorus, and analsphincters; whereas the BF-325 series andEF-825 catheters can make dimensionalmeasurements in the esophagus, pylorus,and anal sphincters. The EF-620 cathetercan make dimensional measurements inthe esophagus.Other indications for use include:• To estimate the size of a stoma producedby a gastric band (all EndoFLIP®catheters)• For use as an adjunct to a bougie formeasuring the size of a gastric sleevecreated during bariatric surgery, where it issuitable for diameter measurements for 22to 60Fr sleeves (EF-620 catheter)	The EndoFLIP® System is indicated foruse in a clinical setting to measure pressureand dimensions in the esophagus, pylorus,and anal sphincters. It is intended to beused as an adjunct to other diagnosticmethods as part of a comprehensiveevaluation of patients with symptomsconsistent with gastrointestinal motilitydisorders.The EF-325 series of catheters can makepressure and dimensional measurements inthe esophagus, pylorus, and analsphincters; whereas the BF-325 series andEF-825 catheters can make dimensionalmeasurements in the esophagus, pylorus,and anal sphincters. The EF-620 cathetercan make dimensional measurements inthe esophagus.Other indications for use include:• To estimate the size of a stoma producedby a gastric band (all EndoFLIP®catheters)• For use as an adjunct to a bougie formeasuring the size of a gastric sleevecreated during bariatric surgery, where it issuitable for diameter measurements for 22to 60Fr sleeves (EF-620 catheter)
Anatomical Sites	Esophagus, stomach, pylorus, and analsphincters	Esophagus, stomach, pylorus, and analsphincters
Environments ofuse	Hospitals, Physician offices	Hospitals, Physician offices
Patient Population	Patients with symptoms consistent withgastrointestinal disordersPatient undergoing gastric band surgeryand post-operative band adjustment	Patients with symptoms consistent withgastrointestinal disordersPatient undergoing gastric band surgeryand post-operative band adjustment
	4/14/11/
	EndoFLIP® System with FLIP	Unmodified Predicate
	Topography module	EndoFLIP® System
		K160725
Contraindications	The EndoFLIP® System is contraindicated	The EndoFLIP® System is contraindicated
	where endoscopy is contraindicated.	where endoscopy is contraindicated.

	The EndoFLIP® System is contraindicated	The EndoFLIP® System is contraindicated
	for use in patients with actively bleeding	for use in patients with actively bleeding
	varices in the esophagus.	varices in the esophagus.
Principle of	The catheter is positioned in the desired	The catheter is positioned in the desired
Operation	location one volume setting and inflation	location one volume setting and inflation
	rate to be made. There are up to ten	rate to be made. There are up to ten
	isovolumetric steps which are pre-	isovolumetric steps which are pre-
	programmed. These steps are programmed	programmed. These steps are programmed
	in terms of the volume to be delivered and	in terms of the volume to be delivered and
	the time to pause between each step.	the time to pause between each step.
	Alternatively the system can be	Alternatively the system can be
	programmed to allow the patient to decide	programmed to allow the patient to decide
	when the next step commences.	when the next step commences.
FLIP Topography	Software that displays EndoFLIP® data on	EndoFLIP® displays data on its integrated
	a larger screen and provides a historical	screen.
	graph that shows readings over time.
		Does not have a historical graph option to
		show readings over time.
Data Recording	Data is saved internally and can be	Data is saved internally and can be
	exported to a USB mass storage device or	exported to a USB mass storage device or
	printed to an attached USB printer	printed to an attached USB printer
	The addition of the medical grade	No change in device from Crospon -
Electrical Safety	computer does not change the electrical	K120997

	safety from K120997.
Computer	FLIP Topography runs on an off-the-shelf	EndoFLIP® is not run on a PC
	medical grade computer
Biocompatibility	This modification does not affect the	Identical to Crospon - K092850
	accessories and materials in patient contact
Compatibility With	FLIP Topography module is only to be	N/A
The Environment	connected to the EndoFLIP® system
And Other Devices
Performance	No performance testing for a display	N/A
	device only.

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510(k) Summary Page 4 of 5 /1/1/17

Differences Between Other Legally Marketed Predicate Devices

The Crospon EndoFLIP® System with FLIP Topography module is viewed as substantially equivalent to the predicate device because: The EndoFLIP® System with FLIP Topography uses the identical technology and has the identical indications for use. The differences that exist between the devices do not raise new concerns of safety or effectiveness.

Indications –

The indications for use are identical.

Prescriptive – Both the EndoFLIP® with FLIP Topography module and the predicate EndoFLIP® System are prescriptive.

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510(k) Summary Page 5 of 5 4/14/17

Design and Technology - The EndoFLIP® System with FLIP Topography module has equivalent design, features, and identical technology to the predicate.

Performance and Specifications - The EndoFLIP® System with FLIP Topography module has the equivalent specifications of performance as the predicate.

Compliance with standards - The modification of adding the supplemental accessory EndoFLIP® System with FLIP Topography module does not change the compliance to IEC 60601-1 and IEC 60601-1-2.

Materials -

There are no changes in materials.

Patient Population -

The patient population is unchanged.

Non-Clinical Testing Summary:

The modification required verification activities related to the software. The predicate EndoFLIP® System had undergone bench tests as part of previous submissions. EndoFLIP® System met all requirements specifications and standards requirements as presented in K092850.

Substantial Equivalence Conclusion

Crospon maintains that the EndoFLIP® System with FLIP Topography module is substantially equivalent to the EndoFLIP® System in indications for use, patient population, environment for use, technology characteristics, specifications / performance and compliance with international standards. The addition of the FLIP Topography module as a supplemental accessory, as such, does not change the indications of the unmodified EndoFLIP® System as cleared under K160725. As presented the performance features of the FLIP Topography module as outlined in the above table and discussed in the comparison to support substantial equivalence.

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).