Who is the manufacturer of EndoFLIP® System with FLIP Topography module?

Crospon, Ltd. filed the 510(k) submission for EndoFLIP® System with FLIP Topography module (K170833).

What is the FDA product code for EndoFLIP® System with FLIP Topography module?

FFX. It is classified under 21 CFR 876.1725 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for EndoFLIP® System with FLIP Topography module?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like EndoFLIP® System with FLIP Topography module?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EndoFLIP® System with FLIP Topography module

K170833 · Crospon, Ltd. · FFX · Apr 17, 2017 · Gastroenterology, Urology

Device Facts

Record ID	K170833
Device Name	EndoFLIP® System with FLIP Topography module
Applicant	Crospon, Ltd.
Product Code	FFX · Gastroenterology, Urology
Decision Date	Apr 17, 2017
Decision	SESE
Submission Type	Special
Regulation	21 CFR 876.1725
Device Class	Class 2

Intended Use

The EndoFLIP® System is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders. The EF-325 series of catheters can make pressure and dimensional measurements in the esophagus, pylorus, and anal sphincters; whereas the BF-325 series and EF-825 catheters can make dimensional measurements in the esophagus, pylorus, and anal sphincters. The EF-620 catheter can make dimensional measurements in the esophagus. Other indications for use include: · To estimate the size of a stoma produced by a gastric band (all EndoFLIP® catheters) · For use as an adjunct to a bougie for measuring the size of a gastric sleeve created during bariatric surgery, where it is suitable for diameter measurements for 22 to 60Fr sleeves (EF-620 catheter)

Device Story

EndoFLIP® System measures pressure and dimensions in esophagus, pylorus, and anal sphincters using specialized catheters (EF-325, BF-325, EF-825, EF-620). Catheters are positioned in target anatomy; system performs pre-programmed isovolumetric inflation steps or patient-controlled steps. FLIP Topography module is a software accessory running on an off-the-shelf medical-grade PC; connects via cable to EndoFLIP® unit. Displays real-time data on larger screen; provides historical graphs of readings over last 40 seconds. Used in hospitals and physician offices by clinicians. Output assists in comprehensive evaluation of motility disorders, stoma sizing for gastric bands, and gastric sleeve sizing during bariatric surgery. Benefits include enhanced visualization of motility data to aid clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only; verification activities focused on software data acquisition, display characteristics, data management, and communication.

Technological Characteristics

System consists of catheter-based pressure/dimension measurement hardware and software module. Connectivity via cable to off-the-shelf medical-grade PC. Complies with IEC 60601-1 and IEC 60601-1-2. No changes to materials or fundamental sensing technology.

Indications for Use

Indicated for patients with symptoms consistent with gastrointestinal motility disorders, including those undergoing gastric band surgery and post-operative adjustment. Contraindicated where endoscopy is contraindicated or in patients with actively bleeding esophageal varices.

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

EndoFLIP® System (K160725)

Reference Devices

EndoFLIP® System (K120997)
EndoFLIP® System (K092850)

Related Devices

K160725 — EndoFLIP · Crospon, Ltd. · May 1, 2016
K223705 — EndoflipTM 300 · Covidien, LLC · Apr 14, 2023
K231861 — EndoflipTM 300 System · Covidien, LLC · Jul 21, 2023
K183072 — EndoFLIP System · Crospon, Ltd. · Feb 15, 2019
K130906 — ENDOFLIP CATHETER · Crospon, Ltd. · Jul 17, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing, abstract design connecting them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 17, 2017 Crospon Ltd. Paul Dryden Consultant 24301 Woodsage Dr. Bonita Springs, Florida 34135 Re: K170833 Trade/Device Name: FLIP Topography Regulation Number: 21 CFR 876.1725 Regulation Name: Gastrointestinal Motility Monitoring System Regulatory Class: Class II Product Code: FFX Dated: March 16, 2017 Received: March 20, 2017 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 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 {1}------------------------------------------------ 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 Industry and Consumer Education 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" (21 CFR 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 Industry and Consumer Education 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, Charles Viviano -S For 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K170833 Device Name # EndoFLIP® System with FLIP Topography module Indications for Use (Describe) The EndoFLIP® System is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders. The EF-325 series of catheters can make pressure and dimensional measurements in the esophagus, pylorus, and anal sphincters; whereas the BF-325 series and EF-825 catheters can make dimensional measurements in the esophagus, pylorus, and anal sphincters. The EF-620 catheter can make dimensional measurements in the esophagus. Other indications for use include: - · To estimate the size of a stoma produced by a gastric band (all EndoFLIP® catheters) · For use as an adjunct to a bougie for measuring the size of a gastric sleeve created during bariatric surgery, where it is suitable for diameter measurements for 22 to 60Fr sleeves (EF-620 catheter) | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| XX Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 510(k) Summary Page 1 of 5 4/14/17 | Company: | Crospon Ltd. Galway Business Park Dangan, Galway, Ireland Tel: +011 [353] (91) 519882 | |----------------------------|------------------------------------------------------------------------------------------------| | Official Contact: | John O'Dea PhD - CEO | | Proprietary or Trade Name: | EndoFLIP® System with FLIP Topography module | | Common/Usual Name: | Gastrointestinal motility monitoring system | | Classification Name: | FFX | | Device: | FLIP Topography module | | Modified Device: | K160725 - EndoFLIP® System – Crospon Ltd. | ## Device Description: The modification to the EndoFLIP® System is the addition of display functionality. This functionality is software and is referred to as the FLIP Topography module which is a supplemental accessory. The addition of the supplemental accessory FLIP Topography module does not modify the predicate EndoFLIP® System or change the intended use of the device. This modification does not alter the fundamental scientific technology; the EndoFLIP® System algorithm or change the hardware and accessories associated with the EndoFLIP® System. As there are no changes in hardware or software that will impact performance, there is no need to validate the changes through a clinical investigation. # Modification: The modification to the EndoFLIP® System is the addition of display functionality. This functionality is software and is named the FLIP Topography module. FLIP Topography module is software which runs on an off-the-shelf PC that connects to the EndoFLIP® via a cable and displays the data on a larger screen. FLIP Topography displays the traditional EndoFLIP® data plus FLIP Topography adds historical data graphs (live data for the last 40 seconds) for use by the clinician. # Indications for Use: The EndoFLIP® System is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders. {4}------------------------------------------------ #### 510(k) Summary Page 2 of 5 4/14/17 The EF-325 series of catheters can make pressure and dimensional measurements in the esophagus, pylorus, and anal sphincters; whereas the BF-325 series and EF-825 catheters can make dimensional measurements in the esophagus, pylorus, and anal sphincters. The EF-620 catheter can make dimensional measurements in the esophagus. Other indications for use include: - To estimate the size of a stoma produced by a gastric band (all EndoFLIP® catheters) - . For use as an adjunct to a bougie for measuring the size of a gastric sleeve created during bariatric surgery, where it is suitable for diameter measurements for 22 to 60Fr sleeves (EF-620 catheter) The indications for use are unchanged. ## Patient Population: Patients with symptoms consistent with gastrointestinal motility disorders. #### Environment of Use: Hospitals, Physician offices. ## Contraindications: The EndoFLIP® System is contraindicated where endoscopy is contraindicated. The EndoFLIP® System is contraindicated for use in patients with actively bleeding varices in the esophagus. #### Predicate Device Comparison The EndoFLIP® System with FLIP Topography module is compared to the EndoFLIP® System in the device comparison table below. #### Summary of Modifications: The modification to the EndoFLIP® System is the addition of display functionality; this functionality is software and is named the FLIP Topography module. FLIP Topography is software which runs on an off-the-shelf PC that connects to the EndoFLIP® via a cable and displays the data on a larger screen. #### Verification and Validation Activities Verification activities for the modification were performed and the results demonstrated that the predetermined acceptance criteria were met. These verification activities included: - . Data acquisition - . Display characteristics (labels, accuracy, etc.) - . Data management - . Communication {5}------------------------------------------------ # 510(k) Summary Page 3 of 5 | | EndoFLIP® System with FLIP Topography module | Unmodified Predicate EndoFLIP® System K160725 | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Attributes | | | | Indications for Use | The EndoFLIP® System is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders. The EF-325 series of catheters can make pressure and dimensional measurements in the esophagus, pylorus, and anal sphincters; whereas the BF-325 series and EF-825 catheters can make dimensional measurements in the esophagus, pylorus, and anal sphincters. The EF-620 catheter can make dimensional measurements in the esophagus. Other indications for use include: • To estimate the size of a stoma produced by a gastric band (all EndoFLIP® catheters) • For use as an adjunct to a bougie for measuring the size of a gastric sleeve created during bariatric surgery, where it is suitable for diameter measurements for 22 to 60Fr sleeves (EF-620 catheter) | The EndoFLIP® System is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders. The EF-325 series of catheters can make pressure and dimensional measurements in the esophagus, pylorus, and anal sphincters; whereas the BF-325 series and EF-825 catheters can make dimensional measurements in the esophagus, pylorus, and anal sphincters. The EF-620 catheter can make dimensional measurements in the esophagus. Other indications for use include: • To estimate the size of a stoma produced by a gastric band (all EndoFLIP® catheters) • For use as an adjunct to a bougie for measuring the size of a gastric sleeve created during bariatric surgery, where it is suitable for diameter measurements for 22 to 60Fr sleeves (EF-620 catheter) | | Anatomical Sites | Esophagus, stomach, pylorus, and anal sphincters | Esophagus, stomach, pylorus, and anal sphincters | | Environments of use | Hospitals, Physician offices | Hospitals, Physician offices | | Patient Population | Patients with symptoms consistent with gastrointestinal disorders Patient undergoing gastric band surgery and post-operative band adjustment | Patients with symptoms consistent with gastrointestinal disorders Patient undergoing gastric band surgery and post-operative band adjustment | | | 4/14/11/ | | | | EndoFLIP® System with FLIP | Unmodified Predicate | | | Topography module | EndoFLIP® System | | | | K160725 | | Contraindications | The EndoFLIP® System is contraindicated | The EndoFLIP® System is contraindicated | | | where endoscopy is contraindicated. | where endoscopy is contraindicated. | | | | | | | The EndoFLIP® System is contraindicated | The EndoFLIP® System is contraindicated | | | for use in patients with actively bleeding | for use in patients with actively bleeding | | | varices in the esophagus. | varices in the esophagus. | | Principle of | The catheter is positioned in the desired | The catheter is positioned in the desired | | Operation | location one volume setting and inflation | location one volume setting and inflation | | | rate to be made. There are up to ten | rate to be made. There are up to ten | | | isovolumetric steps which are pre- | isovolumetric steps which are pre- | | | programmed. These steps are programmed | programmed. These steps are programmed | | | in terms of the volume to be delivered and | in terms of the volume to be delivered and | | | the time to pause between each step. | the time to pause between each step. | | | Alternatively the system can be | Alternatively the system can be | | | programmed to allow the patient to decide | programmed to allow the patient to decide | | | when the next step commences. | when the next step commences. | | FLIP Topography | Software that displays EndoFLIP® data on | EndoFLIP® displays data on its integrated | | | a larger screen and provides a historical | screen. | | | graph that shows readings over time. | | | | | Does not have a historical graph option to | | | | show readings over time.…