(132 days)
No
The description focuses on a physical measurement system using a balloon catheter and saline solution to estimate diameter. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is indicated for measuring the size of a gastric sleeve during bariatric surgery, not for treating any condition.
No
The device is described as an adjunct to a bougie for measuring the size of a gastric sleeve and estimates the gastric sleeve diameter. It does not diagnose a disease or condition, but rather measures an anatomical dimension.
No
The device description explicitly 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® EF-620 catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is performed outside of the body.
- EndoFLIP® EF-620 Function: The EndoFLIP® EF-620 catheter is used inside the body during surgery to directly measure the diameter of a gastric sleeve. It does not analyze specimens taken from the patient.
Therefore, the EndoFLIP® EF-620 falls under the category of an in vivo (within the living body) medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EndoFLIP® EF-620 catheter is indicated for use as an adjunct to a bougie for measuring the size of a gastric sleeve created during bariatric surgery. It is suitable for diameter measurements for 22 to 60 French sleeves.
The EF-620 catheter is to be used only with the EndoFlip System.
Product codes
FFX
Device Description
The EndoFLIP® comprises a measuring system and a single use catheter to assist in measuring the gastric sleeve. 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 into the stomach by an anesthesiologist with placement being confirmed by the surgeon under direct laparoscopic visualization. One the balloon has been correctly located, it is then inflated with the diluted saline solution to user programmed volume. The display estimates the gastric sleeve diameter at sixteen points along the balloon. The system also allows snapshots to be taken and compared to real-time images.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastric sleeve, stomach
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)
We performed the appropriate bench testing to demonstrate that the new catheter in combination with the EndoFLIP® controller performs within the specifications of the predicate catheter with the EndoFLIP® controller.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Estimated balloon diameter (Dest) at 16 points in the balloon, displayed in numeric and graphical form Range: 7 to 20 mm Resolution: 0.1 mm Accuracy: ± 1 mm (at 95% confidence) rounded to nearest integer
Predicate Device(s)
K092850 – Crospon – EndoFLIP®
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K102214
Page 1 of 3
510(k) Summary Page 1 of 3 9-Dec-10
DEC 1 6 2010
| 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® |
| Common/Usual Name: | Gastrointestinal motility monitoring system |
| Classification / CFR: | FFX / CFR 876.1725 |
| Device: | EndoFLIP® System and Catheter |
| Predicate Devices: | K092850 – Crospon – EndoFLIP® |
Device Description:
The EndoFLIP® comprises a measuring system and a single use catheter to assist in measuring the gastric sleeve. 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 into the stomach by an anesthesiologist with placement being confirmed by the surgeon under direct laparoscopic visualization. One the balloon has been correctly located, it is then inflated with the diluted saline solution to user programmed volume. The display estimates the gastric sleeve diameter at sixteen points along the balloon. The system also allows snapshots to be taken and compared to real-time images.
Indications for Use:
The EndoFLIP® EF-620 catheter is indicated for use as an adjunct to a bougie for measuring the size of a gastric sleeve created during bariatric surgery. It is suitable for diameter measurements for 22 to 60 French sleeves.
The EF-620 catheter is to be used only with the EndoFlip System.
| Patient Population: | Patients undergoing bariatric surgery |
|---|---|
| Environment of Use: | Hospitals and Surgery Centers |
| Contraindications: | The EndoFLIP® System is contraindicated where endoscopy is |
| contraindicated. |
1
510(k) Summary Page 2 of 3
9-Dec-10
Device Attributes:
.
. . . . .
:
11.000
.
| 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. | |
| Dest electrodes are located at 16-points along the catheter inside a | |
| balloon. | |
| Energy Used And/Or | No electrical energy is delivered into the patient |
| Delivered | |
| Human Factors | Specified for 20 to 40°C operating environment |
| Touch screen user interface | |
| On screen keypad and external keypad interface provided | |
| 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 | |
| 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. | |
| Biocompatibility | All materials have passed biocompatibility tests in accordance with |
| ISO 10993-1 | |
| Compatibility With The | EndoFLIP operates with custom catheters only |
| Environment And Other | |
| Devices | |
| Sterility | Accessories are supplied non-sterile and are single patient use |
| Performance | EndoFLIP ® passed the performance testing : |
| Estimated balloon diameter (Dest) at 16 points in the balloon, | |
| displayed in numeric and graphical form | |
| Range: 7 to 20 mm | |
| Resolution: 0.1 mm | |
| Accuracy: ± 1 mm (at 95% confidence) rounded to nearest integer |
2
510(k) Summary Page 3 of 3 9-Dec-10
Substantial Equivalence:
The EndoFLIP® system with EF-620 catheter is viewed as substantially equivalent to the predicate device because:
Indications:
Similar to predicate - K092850 - Crospon EndoFLiP® system with catheter measure the diameter of the stoma during gastric band procedures while the proposed indication of the EndoFLIP® EF-620 catheter is for use in measuring the size of a gastric sleeve created during bariatric surgery.
Technology:
Identical technology to predicate - K092850 - Crospon EndoFLIP® system with catheter
Both catheters can only be used with the predicate EndoFLIP® controller and the construction and materials of the new catheter are identical to the predicate.
Materials:
The materials in contact with the patient are identical to predicate device K092850 – Crospon EndoFLIP® system with catheter.
Environment of Use:
Identical to predicate - K092850 -- Crospon EndoFLIP® system with catheter
Patient Population:
Identical to predicate - K092850 - Crospon EndoFLIP® system with catheter
Comparative Performance and Specifications:
We performed the appropriate bench testing to demonstrate that the new catheter in combination with the EndoFLIP® controller performs within the specifications of the predicate catheter with the EndoFLIP® controller.
Therefore one can find that the EndoFLIP® system with new catheter and the new indications for use are viewed as substantially equivalent to the predicate device.
3
Image /page/3/Picture/0 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized depiction of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the upper half of the circle, following its curvature.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Crospon, Ltd. c/o Mr. Paul E. Dryden President and Regulatory Consultant ProMedic, Inc. 24301 Woodsage Drive BONITA SPRINGS FL 34134-2958
DEC 1 6 2010
ﺮ ﺟﺰﻳﺮ ﺍﻟ
Re: K102214
Trade/Device Name: EndoFLIP® System
Regulation Number: 21 CFR §876:1725
Regulation Name: Gastrointestinal motility and monitoring system
Regulatory Class: II
Product Code: FFX
Dated: December 9, 2010 Received: December 10, 2010
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. 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. 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 of medical device-related
4
Page 2
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,
Hukal Lemur MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number: K102214
Device Name:
EndoFLIP® System
Indications for Use:
The EndoFLIP® EF-620 catheter is indicated for use as an adjunct to a bougie for measuring the size of a gastric sleeve created during bariatric surgery. It is suitable for diameter measurements for 22 to 60 French sleeves.
The EF-620 catheter is to be used only with the EndoFlip System.
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)
ductive, Gastro-Renal, and