ENDOFLIP

K092850 · Crospon, Ltd. · FFX · Dec 15, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K092850
• Device Name: ENDOFLIP
• Applicant: Crospon, Ltd.
• Product Code: FFX · Gastroenterology, Urology
• Decision Date: Dec 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1725
• Device Class: Class 2

Intended 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.

Device Story

EndoFLIP system consists of a syringe pump and single-use catheter with an inflatable balloon. Used in clinical settings by physicians during endoscopic procedures. Catheter inserted alongside endoscope across gastric band; balloon inflated with diluted saline via stepper-motor-driven syringe. Electrodes along balloon length measure impedance to estimate stoma diameter at 16 points. System records balloon pressure and volume. Real-time data displayed on touch screen; snapshots allow comparison. Provides objective measurements of stoma size to assist clinicians in gastric band adjustment. Benefits include improved accuracy in assessing stoma diameter during band management.

Clinical Evidence

No clinical data provided. Bench testing only, including biocompatibility per ISO 10993-1, electrical safety per IEC 60601-1, and performance verification of diameter, pressure, and volume measurement accuracy.

Technological Characteristics

Syringe pump system with single-use catheter. Balloon contains 16 electrodes for impedance-based diameter estimation. Stepper motor control for syringe piston. Touch screen interface. Data export via USB. Biocompatibility per ISO 10993-1. Electrical safety per IEC 60601-1. Non-sterile accessories. No electrical energy delivered to patient.

Indications for Use

Indicated for patients fitted with a gastric band undergoing surgery or post-operative band adjustment. Contraindicated where endoscopy is contraindicated.

Regulatory Classification

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.

Predicate Devices

• G&J Electronics, Distender Series II Barostat (K991288)
• Sandhill Scientific, Insight Model S980000 (K012232)

Submission Summary (Full Text)

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K092850
PAGE 1 OF 3
Crospen

| | 510(k) Summary | |
|----------------------------|-----------------------------------------------------------------------------------------------------------------|--|
| | Page 1 of 3 | |
| | 15-Sep-09 | |
| Company | Crospon Ltd.<br>Galway Business Park<br>Dangan<br>Galway, 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 Barostat<br>K012232 - Sandhill Scientific, Insight Model S980000 | |

DEC 1 5 2009#### 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.

#### 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.

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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-operative<br>band adjustment |
|-----------------------|--------------------------------------------------------------------------------------|
| Environment of Use -- | Hospitals and sub-acute institutions, where gastric band<br>procedures are performed |
| Contraindications -- | The EndoFLIP® System is contraindicated where endoscopy is<br>contraindicated |

## 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/Or<br>Delivered | No electrical energy is delivered into the patient |
| Human Factors | Specified for 20 to 40°C operating environment<br>Touch screen user interface<br>On screen keypad and external keypad interface provided<br>Display 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 maximum<br>settable value of 150mmHg |
| | Maximum volume is set by the volume of solution in the syringe which is<br>factory filled. This volume matches the balloon size on the catheter. The<br>Balloon Inflate Volume cannot be set above the factory set syringe<br>volume. |
| | 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 over<br>the syringe piston position. Piston movement resolution is 0.003175 mm<br>(one step) |
| | No calibration required |
| Chemical Safety | Conductive solution inside balloon is diluted saline |
| Thermal Safety | Internal cooling fan with enclosure temperature monitoring. Alarm if<br>temperature exceeds limits. |
| Materials | |
| Biocompatibility | All materials have passed biocompatibility tests in accordance with ISO<br>10993-1 |
| Compatibility With The<br>Environment And Other<br>Devices | 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 in<br>numeric and graphical form, using the assumption that the balloon is<br>symmetrical 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 [phone] or [phone] 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)

or

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)

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