(28 days)
Not Found
No
The summary explicitly states that the modification is software for display functionality and does not alter the fundamental scientific technology or the existing algorithm. There is no mention of AI, ML, or related concepts.
No
Explanation: The device is described as being indicated for "measuring pressure and dimensions" and as an "adjunct to other diagnostic methods," clearly performing a diagnostic function rather than directly treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system 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." This clearly indicates its diagnostic purpose.
No
The device description explicitly states that the modification is the addition of a software module (FLIP Topography) to the existing EndoFLIP® System, which is a hardware-based system used for measuring pressure and dimensions. The software module is described as a "supplemental accessory" and does not replace the core hardware components of the EndoFLIP® System.
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 collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- EndoFLIP® System Function: The EndoFLIP® System measures pressure and dimensions within the body (esophagus, pylorus, and anal sphincters). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it measures pressure and dimensions in the esophagus, pylorus, and anal sphincters and is used as an adjunct to other diagnostic methods. This involves direct interaction with the patient's internal anatomy, not the analysis of collected samples.
Therefore, the EndoFLIP® System falls under the category of a medical device used for in-vivo measurements, not an in-vitro diagnostic device.
N/A
Intended Use / 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)
Product codes (comma separated list FDA assigned to the subject device)
FFX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus, pylorus, and anal sphincters, stomach
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical setting; Hospitals, Physician offices.
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)
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
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.
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
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)
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)
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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. |
| Data Recording | Data is saved internally and can be | Data is saved internally and can be |
| | exported to a USB mass storage device or | exported to a USB mass storage device or |
| | printed to an attached USB printer | printed to an attached USB printer |
| | The addition of the medical grade | No change in device from Crospon - |
| Electrical Safety | computer does not change the electrical | K120997 |
| | | |
| | safety from K120997. | |
| Computer | FLIP Topography runs on an off-the-shelf | EndoFLIP® is not run on a PC |
| | medical grade computer | |
| Biocompatibility | This modification does not affect the | Identical to Crospon - K092850 |
| | accessories and materials in patient contact | |
| Compatibility With | FLIP Topography module is only to be | N/A |
| The Environment | connected to the EndoFLIP® system | |
| And Other Devices | | |
| Performance | No performance testing for a display | N/A |
| | device only. | |
6
510(k) Summary Page 4 of 5 /1/1/17
Differences Between Other Legally Marketed Predicate Devices
The Crospon EndoFLIP® System with FLIP Topography module is viewed as substantially equivalent to the predicate device because: The EndoFLIP® System with FLIP Topography uses the identical technology and has the identical indications for use. The differences that exist between the devices do not raise new concerns of safety or effectiveness.
Indications –
The indications for use are identical.
Prescriptive – Both the EndoFLIP® with FLIP Topography module and the predicate EndoFLIP® System are prescriptive.
7
510(k) Summary Page 5 of 5 4/14/17
Design and Technology - The EndoFLIP® System with FLIP Topography module has equivalent design, features, and identical technology to the predicate.
Performance and Specifications - The EndoFLIP® System with FLIP Topography module has the equivalent specifications of performance as the predicate.
Compliance with standards - The modification of adding the supplemental accessory EndoFLIP® System with FLIP Topography module does not change the compliance to IEC 60601-1 and IEC 60601-1-2.
Materials -
There are no changes in materials.
Patient Population -
The patient population is unchanged.
Non-Clinical Testing Summary:
The modification required verification activities related to the software. The predicate EndoFLIP® System had undergone bench tests as part of previous submissions. EndoFLIP® System met all requirements specifications and standards requirements as presented in K092850.
Substantial Equivalence Conclusion
Crospon maintains that the EndoFLIP® System with FLIP Topography module is substantially equivalent to the EndoFLIP® System in indications for use, patient population, environment for use, technology characteristics, specifications / performance and compliance with international standards. The addition of the FLIP Topography module as a supplemental accessory, as such, does not change the indications of the unmodified EndoFLIP® System as cleared under K160725. As presented the performance features of the FLIP Topography module as outlined in the above table and discussed in the comparison to support substantial equivalence.