(90 days)
Not Found
No
The description details a system that uses physical measurements (saline volume, pressure, electrical impedance via electrodes) to estimate stoma diameter. There is no mention of algorithms, learning, or data processing beyond direct measurement and calculation based on physical principles.
No
The device is described as estimating the size of the stoma produced by a gastric band and does not state any therapeutic intent or function. Its purpose is measurement and assessment.
Yes
This device estimates the size of the stoma, which provides information for diagnosis or management of a medical condition related to the gastric band.
No
The device description clearly states that the EndoFLIP® comprises a measuring system and a single use catheter, indicating the presence of hardware components beyond just software.
Based on the provided information, the EndoFLIP® system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- EndoFLIP® Function: The EndoFLIP® system directly interacts with the patient's body (the stoma produced by the gastric band) using a balloon catheter. It measures physical parameters (estimated stoma diameter, balloon pressure, balloon volume) in vivo (within the living body).
- Lack of Specimen Analysis: The device does not analyze any biological specimens taken from the patient.
Therefore, the EndoFLIP® system falls under the category of a medical device used for in vivo measurement and assessment, rather than an In Vitro Diagnostic device.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
FFX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastric band (stoma)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Environment of Use -- Hospitals and sub-acute institutions, where gastric band procedures are performed
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Estimated balloon diameter (Dest) at 16 points in the balloon, displayed in numeric and graphical form, using the assumption that the balloon is 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
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.
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.
Not Found
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
§ 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).
0
K092850
PAGE 1 OF 3
Crospen
| 510(k) Summary | ||
|---|---|---|
| Page 1 of 3 | ||
| 15-Sep-09 | ||
| Company | Crospon Ltd. | |
| Galway Business Park | ||
| Dangan | ||
| 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 | |
| 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.
1
K092850
PAGE 2 OF 3
Crospom
510(k) Summary
15-Sep-09
| Patient Population -- | Patient undergoing gastric band surgery and post-operative
band adjustment |
|-----------------------|--------------------------------------------------------------------------------------|
| Environment of Use -- | Hospitals and sub-acute institutions, where gastric band
procedures are performed |
| Contraindications -- | The EndoFLIP® System is contraindicated where endoscopy is
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 | |
| Delivered | No electrical energy is delivered into the patient |
| Human Factors | Specified for 20 to 40°C operating environment |
| Touch screen user interface | |
| On screen keypad and external keypad interface provided | |
| 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 | |
| settable value of 150mmHg | |
| Maximum volume is set by the volume of solution in the syringe which is | |
| factory filled. This volume matches the balloon size on the catheter. The | |
| Balloon Inflate Volume cannot be set above the factory set syringe | |
| 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 | |
| the 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 if |
| temperature exceeds limits. | |
| Materials | |
| Biocompatibility | All materials have passed biocompatibility tests in accordance with ISO |
| 10993-1 | |
| Compatibility With The | |
| Environment And Other | |
| 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 |
| numeric and graphical form, using the assumption that the balloon is | |
| 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 |
:
. 1
2
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.
3
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
4
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
5
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)
Aorque hn why
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices K092850 510(k) Number _