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.
EndoFLIP® EF-620 catheter is indicated for use in measuring the size of a gastric sleeve created during bariatric surgery. It is suitable for diameter measurements for 22 to 60 French sleeves.
The EndoFLIP® system is indicated for use in a clinical setting as a pressure and dimension measurement device and as an adjunct to other methods in the comprehensive evaluation of patients with symptoms consistent with esophageal sensory hypersensitivity.
Note: EndoFLIP is a measurement system. It is not intended to perform a diagnostic test. The EF-325L has a locating LED used in conjunction with the shaft markings to locate the balloon midpoint.

Device Description

The EndoFLIP® comprises a measuring system and a single use or reusable catheter to assist in measuring the lumen diameter at 16 points (EF family) or 8 points (BF family). The EndoFLIP® comprises a measuring system and catheter to assist in measuring lumens. 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 under direct laparoscopic visualization. Once the balloon has been correctly located, it is then inflated with the diluted saline solution to a user programmed volume.

AI/ML Overview

The acceptance criteria and study information for the EndoFLIP® System with catheters (EF-325, EF325N, EF-325L, BF-325 BF-325N, EF-620) are detailed below.
This submission is for modifications to an existing device, primarily extending shelf life and adding an LED to one catheter model (EF-325L). The testing performed is focused on demonstrating that these changes do not alter the substantial equivalence to the predicate devices. The document explicitly states that the indications for use, technology, construction, environment of use, patient population, and materials in contact with the patient are "Identical, unchanged" or "similar" to the predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria (Predicate Performance)	Reported Device Performance (Proposed Device)
Shelf-Life	1 year	2 years (demonstrated through accelerated aging testing)
Indications for Use	Same as K092850, K102214, K120997 (and K983220 for LED feature)	Identical, unchanged (and similar for LED feature)
Technology, Construction, Design	Same as K092850, K102214, K120997	Unchanged (addition of low voltage LED inside balloon does not alter construction)
Environment of Use	Hospital and surgery centers	Identical, unchanged
Patient Population	K092850: Gastric band surgery patients; K102214: Bariatric procedure patients; K120997: Esophageal disorder patients	Identical, unchanged (and similar for EF-325L LED feature with K983220)
Materials in contact with Patient	Same as K092850, K102214, K120997	Identical, unchanged (LED is isolated from patient)
Diameter Range	5 to 25 mm and 7 to 20 mm	Identical, unchanged
Resolution	0.1 mm	Identical, unchanged
Accuracy	± 1mm (at 95% confidence) rounded to nearest integer	Identical, unchanged

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

Sample Size:
- For the shelf-life test, the document states "The additional accelerated aging testing demonstrated that they performed to their specifications." However, a specific sample size for this testing is not provided.
- For other aspects of substantial equivalence (indications, technology, materials, etc.), the justification relies on the device being "identical, unchanged" or "similar" to predicate devices, meaning no new clinical or non-clinical test sets are explicitly detailed with sample sizes beyond the shelf-life study.
Data Provenance: The document does not specify the country of origin for any conducted tests. The tests performed were primarily non-clinical (shelf-life, biocompatibility in earlier submissions). The data would be considered retrospective in the sense that it refers to the performance of existing predicate devices and comparative analysis rather than new prospective clinical trials for the modifications.

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

The document does not describe any test sets requiring expert ground truth establishment for the modifications. The evaluation is focused on demonstrating substantial equivalence to predicate devices, which implies that the performance characteristics of the predicate devices serve as the "ground truth" for comparison.

4. Adjudication Method for the Test Set

No adjudication method is described, as there is no mention of a test set requiring expert review or consensus for the modifications.

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

No MRMC comparative effectiveness study was done. This device is a measurement system and does not involve AI assistance or human readers for interpretation, therefore, this type of study is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No standalone algorithm performance study was done. The device and its modifications are mechanical/electronic measurement tools, not an algorithm or AI system. Its performance (e.g., diameter and pressure measurement accuracy) is inherent to the device's design and verified through engineering testing, not standalone algorithm performance.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the device's original performance (diameter, resolution, accuracy) would be based on physical and engineering measurements against known standards, established during the initial clearances for the predicate devices. For the current submission, the "ground truth" for the new device is its identity or similarity to these already cleared predicate devices for all specified characteristics.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML device that requires a training set.

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

Not applicable. As stated above, this device does not utilize a training set.

Summary

{0}------------------------------------------------

510(k) SummaryPage 1 of 7
	JUL 1 7 2013
Date Prepared	28-Jun-13
Company	Crospon Ltd.Galway Business ParkDanganGalway, IrelandTel - 011 [353] (91) 519882Fax - 011 [353] (91) 519873
Official Contact:	John O'Dea PhD
Proprietary or Trade Name:	EndoFLIP® CathetersEF-325, EF-325L, EF-325N,BF-325, BF-325NEF-620
Common/Usual Name:	Gastrointestinal motility monitoring system
Classification / CFR:	FFX / CFR 876.1725 / Class 2
Device:	EndoFLIP® System and Catheter
Predicate Devices:	K092850 - Crospon - EndoFLIP®K102214 - Crospon - EndoFLIP®K120997 – Crospon – EndoFLIP®

Device Description:

Modifications of these devices vs. Predicates:

The following is a list of the changes to the EndoFLIP® catheters.

(1) Addition of a model designated as EF-325L that has a locating LED (colored red) positioned inside the wire lumen at the balloon midpoint. It is used in conjunction with the shaft markings to locate the balloon midpoint.

{1}------------------------------------------------

510(k) Summary

Page 2 of 7 28-Jun-13

(2) Extension of the shelf life from 1 year to 2 years for the following products:
- EF-325 and BF-325 family of catheters a.
- EF-620 family of catheters b.

Indications for Use:

K 092850 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.
. K 102214 - EndoFLIP® EF-620 catheter is indicated for use in measuring the size of a gastric sleeve created during bariatric surgery. It is suitable for diameter measurements for 22 to 60 French sleeves.
. K 120997 - The EndoFLIP® system is indicated for use in a clinical setting as a pressure and dimension measurement device and as an adjunct to other methods in the comprehensive evaluation of patients with symptoms consistent with esophageal sensory hypersensitivity.
. Note: EndoFLIP is a measurement system. It is not intended to perform a diagnostic test. The EF-325L has a locating LED used in conjunction with the shaft markings to locate the balloon midpoint.

Patient Population:	Patients undergoing bariatric surgery
Environment of Use:	Hospitals and Surgery Centers
Contraindications:	The EndoFLIP® System is contraindicated where endoscopy iscontraindicated.

Predicate Device Comparison:

Table 1 compares the Catheters, while Table 2 compares the EF-325L to the Predicate. One will note that the difference between EF-325 and BF-325 is that they are identical except in the number of electrodes and sensors.

The EF-325L is identical to the EF-325 other than the addition of a locating LED mounted on the shaft inside the balloon.

Note that the reference to "Nasal" is the tip design (deflective tip) and not to how the catheter is placed. All of these catheters are placed orally.

The catheters for use with the EndoFLIP® system are viewed as substantially equivalent to the predicate catheters because:

{2}------------------------------------------------

510(k) Summary Page 3 of 7 28-Jun-13

Indications -

The indications for use are identical to the predicates. Discussion - The indications for use are unchanged from the predicates, EndoFLIP® - K092850, K102214, and K120997.

Technology -

The technology, construction and design are unchanged. Discussion - The technology is unchanged from the predicates, EndoFLJP® - K092850, K102214, and K120997.

Environment of Use -

The environments of use - Hospital and surgery centers - are identical. Discussion - The environments of use are unchanged and identical to the predicates, EndoFLIP® - K092850, K102214, and K120997.

Patient Population -

The patient populations are identical and unchanged.

K092850 - Patients undergoing gastric band surgery and post-operative band adjustment

K 102214 - Patients undergoing bariatric procedures

K 120997 - Patients with esophageal disorders

Discussion - The patient population is unchanged and identical to the predicates, EndoFLIP® -K092850, K102214, and K120997.

Non-clinical Testing Summary -

We performed:

Shelf-life Test .
Packaging is identical to the predicate devices. The additional accelerated aging testing demonstrated that they performed to their specifications and thus are substantially equivalent to the predicate devices,

Materials -

The materials in contact with the patient are identical to predicate. Discussion - The materials are unchanged and identical to the predicates, EndoFLIP® -K092850, K102214, and K120997.

{3}------------------------------------------------

510(k) Summary Page 4 of 7 28-Jun-13

Table 1 – Comparison of Proposed Device vs. Predicate

	EndoFLIP® system with catheterK092850, K102214, K120997	ProposedEndoFLIP® Catheters
Indications for Use	K092850The EndoFLIP® system is anendoscopically placed deviceindicated for use in patients fittedwith a gastric band. The device isintended to estimate the size of thestoma produced by the gastric band ina clinical setting.	Identical, unchanged
	K102214EndoFLIP® EF-620 catheter isindicated for use in measuring thesize of a gastric sleeve created duringbariatric surgery. It is suitable fordiameter measurements for 22 to 60French sleeves.
	K120997The EndoFLIP® system is indicatedfor use in a clinical setting as apressure and dimension measurementdevice and as an adjunct to othermethods in the comprehensiveevaluation of patients with symptomsconsistent with esophageal sensoryhypersensitivity.
	Note: EndoFLIP® is a measurementsystem. It is not intended to perform adiagnostic test.
Environments of use	Hospital and surgery centers	Identical, unchanged

{4}------------------------------------------------

510(k) Summary

28-Jun-13

EndoFLIP® system with catheter	Proposed
K092850, K102214, K120997	EndoFLIP® Catheters
K092850 - Patients undergoing	Identical, unchanged







	Identical, unchanged


Prescription use	Identical, unchanged
Provides an Estimated Diameter	Identical, unchanged
(Dest) of the balloon at 16 or 8 points
along its length when inflated with
saline solution.

Records balloon pressure.
All materials have passed	Identical to K092850, unchanged


	Identical, unchanged


	Accessories are supplied non-sterile,
	and are single patient use, disposable
	Identical, unchanged




integer
	gastric band surgery and post-operative band adjustmentK 102214 - Patients undergoingbariatric proceduresK 120997 - Patients with esophagealdisordersThe EndoFLIP® System iscontraindicated where endoscopy iscontraindicated.biocompatibility tests in accordancewith ISO 10993-1Only operates with EndoFLIP®systemAccessories are supplied non-sterile.and are single patient use, disposableRange: 5 to 25 mmand 7 to 20 mmResolution: 0.1 mmAccuracy: ± 1mm (at 95%confidence) rounded to nearest

{5}------------------------------------------------

510(k) Summary Page 6 of 7 28-Jun-13

Table 2 - Locating LED Comparison to Predicate

	Proposed EndoFLIP®EF-325L catheter	Predicate Stryker InfraVision™K983220
Indications for Use	All of the EndoFLIP indications foruse under K092850, K102214, andK120997 plus the new featureTransillumination is intended to helpthe surgeon with placement of EF-325L catheter	Specific indication for helping tolocate or position devicesEsophageal transilluminating dilationdevice with a reusable illuminationsource, and a combined single usedisposable fiberoptic light guide,nasogastric tube and balloon dilationsystem. Intended to transilluminateand dilate the esophagus duringfundoplication procedure.Transillumination is intended to helpthe surgeon placement of medicaldevices within body tissue.
Environments of use	Hospital and surgery centers	Identical
Patient Population	Identical to K092850, K102214,K120997	Similar
Contraindications	The EndoFLIP® System iscontraindicated where endoscopy iscontraindicated.	Not stated
Prescription/OTC	Prescription use	Prescription use
Principle of Operation	LED to assist with transilluminationLED located inside balloon	Light source for transilluminatingSeparate light source
Materials used	The LED is located inside thecatheter balloon and is isolated fromthe patient	N/A

The Locating LED feature does not alter the primary indications for use for the EF-325 catheter. It is to assist the user in locating the balloon mid-point. As the primary indications for use has not changed this feature can be as being substantially equivalent to the predicate because:

Indications -

The indications for use are identical to the predicate catheter and the predicate Stryker InfraVision™ system (K983220).

For the Locating LED feature Transillumination is intended to help the surgeon with placement of EF-325L catheter K983220 is indicated for helping to locate or position devices

Note: EndoFLIP® is a measurement system. It is not intended to perform a diagnostic test.

{6}------------------------------------------------

510(k) Summary

Page 7 of 7 28-Jun-13

Discussion - The indications for use are unchanged for the catheter from the predicates, EndoFLJP® - K092850. K102214, and K120997 and the Locating LED feature is similar to the predicate Stryker InfraVision (K983220).

Technology -

The technology, construction and design are unchanged. The addition of a low voltage LED with the pressure sensor inside the balloon does not alter the construction.

Discussion - The technology is unchanged from the predicates, EndoFLIP® - K092850, K102214, and K120997 and the addition of a LED for a light source is similar to the predicate Stryker InfraVision (K983220).

Materials -

The materials in contact with the patient are identical to predicate. Discussion - The materials are unchanged and identical to the predicates, EndoFLIP® - K092850, K102214, and K120997.

Environment of Use -

The environments of use - Hospital and surgery centers - are identical. Discussion - The environments of use are unchanged and identical to the predicates, EndoFLIP® -K092850, K102214, and K120997.

Patient Population -

The patient populations are identical and unchanged.

K092850 Patients undergoing gastric band surgery and post-operative band adjustment K102214 Patients undergoing bariatric procedures K120997 Patients with esophageal disorders

Discussion - The patient population is unchanged and identical to the predicates. EndoFLIP® -K092850, K102214, and K120997.

Non-clinical Testing Summary -

There was no additional non-clinical testing for the locating LED feature.

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.

{7}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 17, 2013

Crospon Ltd. % Paul Dryden Regulatory Consultant 24301 Woodsage Dr. Bonita Springs, FL 34134-2958

Re: K130906

Trade/Device Name: EndoFLIP® System with catheters (EF-325, EF325N, EF-325L, BF-325 BF-325N, EF-620) Regulation Number: 21 CFR §876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: FFX Dated: June 28, 2013 Received: July 1, 2013

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 r ou may, derestere, manns of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and advises, 200 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.

{8}------------------------------------------------

Page 2 - Paul Dryden

You must comply with all the Act's requirements, including, but not limited to: registration and Iisting (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 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/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin 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

{9}------------------------------------------------

Indications for Use Statement

Page 1 of 1

510(k) Number:

K130906

Device Name:

EndoFLIP® System with catheters o EF-325 o EF-325N o EF-325L o BF-325 o BF-325N o EF-620

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.
EndoFLIP® EF-620 catheter is indicated for use in measuring the size of a gastric . sleeve created during bariatric surgery. It is suitable for diameter measurements for 22 to 60 French sleeves.
The EndoFLIP® system is indicated for use in a clinical setting as a pressure and . dimension measurement device and as an adjunct to other methods in the comprehensive evaluation of patients with symptoms consistent with esophageal sensory hypersensitivity.

Note: EndoFLIP is a measurement system. It is not intended to perform a diagnostic test. The EF-325L has a locating LED used in conjunction with the shaft markings to locate the balloon midpoint.

Prescription Use XX	or	Over-the-counter use
(Part 21 CFR 801 Subpart D)		(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)
Benjamin R. Fisher -S
	2013.07.07.116 447-23 -04'00'
(Division Sign-Off)
	Division of Reproductive, Gastro-Renal, and
Urological Devices510(k) Number	K130906

Page 4.3

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).