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.

Device Description

The Endoflip System comprises a measuring system and a single use catheter to provide programmed balloon distensions.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Endoflip System, focusing on adding a specific age range (pediatrics) to its indications for use. The document does not contain information about the acceptance criteria or a study designed to prove the device meets specific performance criteria linked to those acceptance criteria.

The submission asserts that "There is no change between the Predicate device (K160725) and Endoflip System" and "There is no change in the technological characteristics of Endoflip System from the cleared predicate device (K160725)." Therefore, the performance data presented primarily focuses on the safety and clinical utility in the pediatric population, rather than proving specific performance metrics of the device itself.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document does not specify quantitative acceptance criteria for device performance (e.g., accuracy, precision, sensitivity, specificity) for the Endoflip System itself. The "Clinical Evaluation" section mentions using the Endoflip in pediatric patients to assess myotomy adequacy and esophageal distensibility, but it does not present specific performance metrics from a study against predefined acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Partially available, but not for a formal test set with defined performance metrics. The "Clinical Evaluation" mentions a "literature review" of existing studies using Endoflip in pediatric populations. It states, "Specifically, Endoflip was used in pediatric achalasia patients during myotomy surgeries..." and "Other application described in the literature review involves the use of Endoflip in children with Eosinophilic esophagitis (EoE)..."
Sample size: Not explicitly stated as a single number. It is implied that multiple studies were reviewed, involving an unspecified number of pediatric patients for achalasia and EoE.
Data provenance: Not specified (e.g., country of origin, retrospective/prospective for the individual studies reviewed). The studies were part of a "literature review."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Cannot be provided. The document does not describe a formal process of establishing ground truth by a panel of experts for a specific performance study. The "Clinical Evaluation" refers to the device being used in clinical settings where surgeons and clinicians would interpret the device output in the context of patient care and surgical outcomes (e.g., "real time assessment of the adequacy of the myotomy"), but this is not a structured ground truth establishment for a performance study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Cannot be provided. No formal adjudication method is mentioned as there isn't a described performance study with a test set requiring such a process.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The Endoflip System is a gastrointestinal motility monitoring system, not an AI or imaging interpretation device that would typically involve "human readers" or "AI assistance" in the sense of a diagnostic interpretation product. The document makes no mention of AI.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable / Cannot be provided. The Endoflip System measures physiological parameters (pressure and dimensions) which are then interpreted by clinicians. It is not an "algorithm only" device in a standalone performance context like an AI-based diagnostic tool.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Implied clinical outcomes, but not formally defined for a performance study. For the pediatric use described, ground truth might relate to surgical success (adequacy of myotomy), patient symptoms, or other clinical assessments (e.g., diagnosis of EoE or achalasia, and response to treatment). However, this is inferred from the clinical applications mentioned, not from a specific "ground truth" definition within a performance study section.

8. The sample size for the training set

Not applicable / Cannot be provided. The Endoflip System is a measurement device and not an AI/machine learning algorithm that would have a "training set" in the conventional sense.

9. How the ground truth for the training set was established

Not applicable / Cannot be provided. As it's not an AI/ML device with a training set, this question is not relevant.

In summary, the provided document is a 510(k) summary for a change to the indications for use of an existing device (Endoflip System) to include a pediatric age range. It relies on the substantial equivalence to a predicate device (K160725) and a "clinical evaluation" via literature review to support the safety and potential benefit of the device in the pediatric population, rather than presenting a de novo performance study against new acceptance criteria.

Summary

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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)

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 motilitymonitoring 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.

Regulation Number and Section

§ 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).