Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on physical measurement using a balloon catheter and saline inflation, with no mention of AI/ML algorithms for data analysis or interpretation.

Therapeutic

No

The device is described as a "pressure and dimension measurement device" and a "measuring system" used to estimate stoma size, measure gastric sleeve size, and evaluate esophageal sensory hypersensitivity. Its intended uses are for measurement and evaluation, not for treating or preventing a disease or condition.

Diagnostic

No

The prompt explicitly states: "Note: EndoFLIP is a measurement system. It is not intended to perform a diagnostic test." While it assists in the evaluation of patients, it's described as a measurement device and an adjunct, not a diagnostic one itself.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the EndoFLIP® comprises a "measuring system and a single use or reusable catheter" and describes the physical process of attaching a syringe, inserting a balloon catheter, and inflating it. This indicates the presence of significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the EndoFLIP® system is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states that the device is used to estimate the size of anatomical structures (gastric stoma, gastric sleeve, esophageal dimensions) and measure pressure. It is explicitly stated that "EndoFLIP is a measurement system. It is not intended to perform a diagnostic test." IVDs are designed to perform diagnostic tests on samples taken from the human body (like blood, urine, tissue).
Device Description: The device description details a system that uses a balloon catheter and saline solution to measure dimensions in vivo (within the living body). This is a direct measurement of physical properties within the patient, not an analysis of a sample taken from the patient.
Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or other processes typically associated with IVD devices.

In summary, the EndoFLIP® system is a medical device used for in vivo measurement and evaluation of anatomical structures and pressure, not for performing diagnostic tests on in vitro samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

FFX

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.
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.
(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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

gastric, esophageal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Environment of Use: Hospitals and Surgery Centers

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)

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,

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

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.

K092850, K102214, K120997

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.

K983220

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

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).

Summary

0

| 510(k) Summary

Page 1 of 7
	JUL 1 7 2013
Date Prepared	28-Jun-13
Company	Crospon Ltd.
Galway Business Park
Dangan
Galway, Ireland
Tel - 011 [353] (91) 519882
Fax - 011 [353] (91) 519873
Official Contact:	John O'Dea PhD
Proprietary or Trade Name:	EndoFLIP® Catheters
EF-325, EF-325L, EF-325N,
BF-325, BF-325N
EF-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:

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.

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 is
contraindicated.

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 catheter
K092850, K102214, K120997 | Proposed
EndoFLIP® Catheters |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Indications for Use | K092850
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. | Identical, unchanged |
| | K102214
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. | |
| | K120997
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. | |
| 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 adjustment
K 102214 - Patients undergoing
bariatric procedures
K 120997 - Patients with esophageal
disorders
The EndoFLIP® System is
contraindicated where endoscopy is
contraindicated.
biocompatibility tests in accordance
with ISO 10993-1
Only operates with EndoFLIP®
system
Accessories are supplied non-sterile.
and are single patient use, disposable
Range: 5 to 25 mm
and 7 to 20 mm
Resolution: 0.1 mm
Accuracy: ± 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 for
use under K092850, K102214, and
K120997 plus the new feature

Transillumination is intended to help
the surgeon with placement of EF-
325L catheter | Specific indication for helping to
locate or position devices

Esophageal transilluminating dilation
device with a reusable illumination
source, and a combined single use
disposable fiberoptic light guide,
nasogastric tube and balloon dilation
system. Intended to transilluminate
and dilate the esophagus during
fundoplication procedure.

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 Devices
510(k) Number	K130906

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