(102 days)
Not Found
No
The summary describes a system for measuring pressure and dimensions using balloon distension. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on clinical benefit and safety, not algorithmic performance metrics.
No
The device is described as a diagnostic tool ("adjunct to other diagnostic methods," "real time assessment," "assess esophageal distensibility") and not for treating or rehabilitating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device 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 role in diagnosis.
No
The device description explicitly states that the system comprises a measuring system and a single-use catheter, indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Endoflip System measures pressure and dimensions in vivo (within the living body) in the esophagus, pylorus, and anal sphincters. It does not analyze samples taken from the body.
- Intended Use: The intended use describes measuring physical parameters within the gastrointestinal tract, not analyzing biological samples for diagnostic markers.
Therefore, the Endoflip System falls under the category of a medical device used for in vivo measurement and assessment, 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 and dimensions in the esophagus, pylorus, and anal sphincters in adults and to measure pressure and dimensions in patients from 5 years of age. 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.
Product codes
FFX
Device Description
The Endoflip System comprises a measuring system and a single use catheter to provide programmed balloon distensions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus, pylorus, and anal sphincters
Indicated Patient Age Range
adults and patients from 5 years of age
Intended User / Care Setting
clinical setting
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)
Clinical Evaluation
The body of evidence presented demonstrates the safety of the Endoflip device and highlights the potential clinical benefit of utilization in the pediatric population. Specifically, Endoflip was used in pediatric achalasia patients during myotomy surgeries enabling real time assessment of the adequacy of the myotomy. Other application described in the literature review involves the use of Endoflip in children with Eosinophilic esophagitis (EoE) to assess esophageal distensibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services USA logo, which features a stylized caduceus. To the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name in blue text.
February 15, 2019
Crospon Ltd % Avishag Metzer Regulatory Affairs Program Manager Medtronic 2 Hacarmet St. New Industrial Park POB 258 Yogneam 20962 ISRAEL
Re: K183072
Trade/Device Name: EndoFLIP System Regulation Number: 21 CFR 876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: Class II Product Code: FFX Dated: October 31, 2018 Received: November 5, 2018
Dear Avishag Metzer:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark J. Antonino -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
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Indications for Use
510(k) Number (if known) K183072
Device Name Endoflip System
Indications for Use (Describe)
The Endoflip System is indicated for use in a clinical setting to measure and dimensions in the esophagus, pylorus, and anal sphincters in adults and to measure pressure and dimensions in patients from 5 years of age. 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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
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510(k) Summary
I. SUBMITTER
| Submitter Name and Address: | Crospon Ltd. (Medtronic) |
|---|---|
| Galway Business Park | |
| Dangan | |
| Galway, Ireland | |
| Contact Person: | Avishag Metzer |
| Regulatory Affairs Program Manager | |
| Email: Avishag.Metzer@medtronic.com | |
| Phone Number: | 972 (4) 9097983 |
| Fax Number: | 972 (73) 2501545 |
| Establishment Registration Number: | 3006897778 |
| Date Prepared: | February 15, 2019 |
| II. DEVICE | |
| Device Trade Name(s): | Endoflip System |
| Device Common Name: | Gastrointestinal motility monitoring system |
| Classification: | Regulation: 21 CFR 876.1725 Gastrointestinal motility |
| monitoring system | |
| Product Code: FFX: System, Gastrointestinal Motility | |
| (Electrical) |
III. PREDICATE DEVICE(S)
Endoflip System K160725
IV. DEVICE DESCRIPTION
There is no change between the Predicate device (K160725) and Endoflip System.
The Endoflip System comprises a measuring system and a single use catheter to provide programmed balloon distensions.
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The Endoflip System and catheter are identical to the predicate (K160725). The proposed modification to the Endoflip System is to add a specific age range that includes pediatrics to the indications for use statement.
V. 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 in adults and to measure pressure and dimensions in the esophagus, in patients from 5 years of age. 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.
VI. TECHNOLOGICAL CHARACHTERISTICS
There is no change in the technological characteristics of Endoflip System from the cleared predicate device (K160725).
VII. PERFORMANCE DATA
Clinical Evaluation
The body of evidence presented demonstrates the safety of the Endoflip device and highlights the potential clinical benefit of utilization in the pediatric population. Specifically, Endoflip was used in pediatric achalasia patients during myotomy surgeries enabling real time assessment of the adequacy of the myotomy. Other application described in the literature review involves the use of Endoflip in children with Eosinophilic esophagitis (EoE) to assess esophageal distensibility.
The proposed change in this submission does not raise new performance or safety issues.
VIII. CONCLUSION
Based on the clinical evaluation presented, the company believes that the Endoflip System and the predicate device are substantially equivalent and do not raise new issues of safety or effectiveness.