The EndoFLIP® system is an endoscopically placed device 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 in a clinical setting.

Device Description

The EndoFLIP® comprises a measuring system and a single use catheter to assist in measuring the stoma. In practice, the EndoFLIP® balloon catheter is attached to a syringe, pre-filled with a diluted saline solution, which is inserted into the syringe pump on the front of the EndoFLIP® system. The deflated balloon is inserted alongside an endoscope and introduced across the gastric band under direct visualization. Where available, fluoroscopy may be used to guide the catheter since the measurement electrodes are clearly visible in the image field. Once the balloon has been correctly located, it is then inflated with the diluted saline solution to a user programmed volume. The display shows the changes in the estimated stoma diameter as the gastric band is filled. The system also allows snapshots to be taken and compared to the real-time images.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the EndoFLIP® System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Range/Resolution/Accuracy)	Reported Device Performance (same as criteria as no deviation indicated)
Estimated Balloon Diameter (Dest)
Range	5 to 25 mm	5 to 25 mm
Resolution	0.1 mm	0.1 mm
Accuracy	± 1 mm rounded to nearest integer at 95% confidence	± 1 mm rounded to nearest integer at 95% confidence
Balloon Pressure
Range	-10 to 100 mmHg	-10 to 100 mmHg
Resolution	0.1 mmHg	0.1 mmHg
Accuracy	± 1 mmHg at 95% confidence	± 1 mmHg at 95% confidence
Balloon Volume
Range	0 to 50 mL	0 to 50 mL
Resolution	1 mL	1 mL
Accuracy	± 5 mL	± 5 mL

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

The provided 510(k) summary does not contain information on the sample size used for a test set, nor does it specify data provenance (country of origin, retrospective/prospective). The performance acceptance criteria are presented as specifications of the device itself, likely derived from internal validation rather than a clinical test set.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not mention any experts used to establish ground truth for a test set or their qualifications. The performance specifications appear to be technical measurements of the device's accuracy in measuring physical parameters (diameter, pressure, volume) rather than interpreting clinical images or patient outcomes.

4. Adjudication Method for the Test Set

Since no clinical test set or expert ground truthing is described, an adjudication method for a test set is not applicable and not mentioned.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or performed according to this 510(k) summary. The device focuses on measuring physical parameters rather than assisting human readers in diagnostic tasks.

6. Standalone (Algorithm Only) Performance Study

The provided text details the performance of the "EndoFLIP® system" as a whole, including its components (measuring system and catheter). The performance specifications for estimated balloon diameter, pressure, and volume are presented as the device's standalone capabilities. Therefore, a standalone performance was done for the reported specifications. However, this is for the device as a whole, rather than a distinct "algorithm only" component usually associated with AI devices.

7. Type of Ground Truth Used

The "ground truth" for the reported performance metrics (diameter, pressure, volume) would be physical measurements calibrated against known standards. For example, the accuracy of diameter measurement would be validated against objects of known diameters, and pressure/volume against calibrated sensors. The document does not explicitly state the methodology for establishing this ground truth, but it is implied by the nature of the measurements.

8. Sample Size for the Training Set

The 510(k) summary does not mention a "training set" or its sample size. The EndoFLIP® System is a physical measurement device, not a machine learning or AI-driven system that typically requires a training set for algorithm development.

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

As no training set is mentioned or applicable, the method for establishing its ground truth is not applicable and not provided.

Summary

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K092850
PAGE 1 OF 3
Crospen

	510(k) Summary
	Page 1 of 3
	15-Sep-09
Company	Crospon Ltd.Galway Business ParkDanganGalway, Ireland
Official Contact:	John O'Dea PhD
Proprietary or Trade Name:	EndoFLIP®
Common/Usual Name:	Gastrointestinal motility monitoring system
Classification Name:	FFX
Device:	EndoFLIP System and Catheter
Predicate Devices:	K991288 - G&J Electronics, Distender Series II BarostatK012232 - Sandhill Scientific, Insight Model S980000

DEC 1 5 2009#### Device Description:

Indications for Use:

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K092850
PAGE 2 OF 3

Crospom

510(k) Summary

15-Sep-09

Patient Population --	Patient undergoing gastric band surgery and post-operativeband adjustment
Environment of Use --	Hospitals and sub-acute institutions, where gastric bandprocedures are performed
Contraindications --	The EndoFLIP® System is contraindicated where endoscopy iscontraindicated

Device Attributes:

Design
Principle of Operation	Syringe pump device that targets an inflate volume within a balloon inserted into the lumen of an organ. Provides an Estimated Diameter (Dest) of the balloon at 16 points along its length when inflated with custom conductive solution. Records balloon pressure via pressure sensor located in balloon. Dest electrodes are located at 16 points along the catheter inside a balloon. The balloon is placed such that it straddles the band stoma.
Energy Used And/OrDelivered	No electrical energy is delivered into the patient
Human Factors	Specified for 20 to 40°C operating environmentTouch screen user interfaceOn screen keypad and external keypad interface providedDisplay is updated at 10 Hz.
Data Recording	Data is saved internally and can be exported to a USB mass storage device or printed to an attached USB printer
Electrical Safety	IEC60601-1 2nd Ed. + Am.1 + Am.2
Mechanical Safety	Travel limits are detected by mechanical switches
	Syringe is automatically put in its home position at power on
	Balloon pressure alarm threshold defaults to 60mmHg with a maximumsettable value of 150mmHg
	Maximum volume is set by the volume of solution in the syringe which isfactory filled. This volume matches the balloon size on the catheter. TheBalloon Inflate Volume cannot be set above the factory set syringevolume.
	The Deflate button is available after inflation has commenced.
	The syringe can be manually retracted at any time.
	Rigid syringe used to avoid potential volume errors
	Stepper motor driven lead screw is used to maintain accurate control overthe syringe piston position. Piston movement resolution is 0.003175 mm(one step)
	No calibration required
Chemical Safety	Conductive solution inside balloon is diluted saline
Thermal Safety	Internal cooling fan with enclosure temperature monitoring. Alarm iftemperature exceeds limits.
Materials
Biocompatibility	All materials have passed biocompatibility tests in accordance with ISO10993-1
Compatibility With TheEnvironment And OtherDevices	EndoFLIP operates with custom catheters only.
Sterility	Accessories are not supplied sterile, and are single patient use
Performance	Estimated balloon diameter (Dest) at 16 points in the balloon, displayed innumeric and graphical form, using the assumption that the balloon issymmetrical about its longitudinal axis at that electrode position.
	Range: 5 to 25 mm
	Resolution: 0.1 mm
	Accuracy: ± 1 mm rounded to nearest integer at 95% confidence
	Balloon pressure is measured and displayed:
	Range: -10 to 100 mmHg
	Resolution: 0.1 mmHg
	Accuracy: ± 1 mmHg at 95% confidence
	Balloon volume is displayed:
	Range: 0 to 50 mL
	Resolution: 1 mL
	Accuracy: ± 5 mL

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K092850
PAGE 3 OF 3
Crospou

510(k) Summary Page 3 of 3 15-Sep-09

Differences Between Other Legally Marketed Predicate Devices

The EndoFLIP® system is viewed as substantially equivalent to the predicate devices listed above.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with medicine and healthcare. The caduceus in the logo is depicted with a modern, abstract design.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

DEC 1 5 2009

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

Crospon Ltd. c/o Mr. Paul Dryden President ProMedic, Inc. 24301 Woodsage Drive BONITA SPRINGS FL 34134-2958

Re: K092850

Trade/Device Name: EndoFLIP® System Regulation Number: 21 CFR §876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: FFX Dated: September 15, 2009 Received: September 16, 2009

Dear Mr. 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.

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 (reporting of medical

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Page 2 -

Enclosure .

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use Statement

Page 1 of 1

510(k) Number:

(To be assigned)

Device Name:

EndoFLIP® System

Indications for Use:

The EndoFLIP® system is an endoscopically-placed device 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 in a clinical setting.

Prescription Use XX (Part 21 CFR 801 Subpart D)

Over-the-counter use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aorque hn why

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices K092850 510(k) Number _

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).