The Endoflip™ 300 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 esoplagus, in patients from five 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 subject Endoflip™ 300 System is equivalent to the predicate Endoflip™ 300 System (K223705) except for an update to the Endoflip™ 300 System software to remove the analysis episode feature of the predicate device. Other software updates include minor feature enhancements and bug fixes. Changes to device labeling rrom the software updates and other minor changes for clarification purposes were also addressed.

The Endoflip™ 300 System software is supplied pre-installed in the Endoflip™ 300 Display System. It is also the software used for the Endoflip™ 300 Reader in reader mode only. There is no change to the display system hardware or to how the reader is supplied (USB stick).

No changes were made to any of the other components that comprise the Endoflip™ 300 System when compared to the predicate.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Endoflip™ 300 System, which involves software updates to an existing device. This entire document is a 510(k) submission meant to demonstrate substantial equivalence to a predicate device, not a study specifically designed to establish acceptance criteria for a new device.

Therefore, many of the requested details regarding a standalone study, multi-reader multi-case study, and detailed ground truth methodologies for a specific study proving acceptance criteria are not present in this type of regulatory document.

However, based on the information provided, here's what can be extracted:

Acceptance Criteria and Device Performance:

The document's primary objective is to demonstrate substantial equivalence to the predicate device (Endoflip™ 300 System K223705) after software updates. Therefore, the "acceptance criteria" are implicitly that the updated device performs equivalently to the predicate device and does not introduce new safety or effectiveness concerns.

Specific numerical acceptance criteria and reported device performance from a clinical trial or performance study are not explicitly provided in terms of metrics like sensitivity, specificity, or error rates. Instead, the performance is evaluated through software verification.

Table of Acceptance Criteria and Reported Device Performance:

Since explicit quantitative acceptance criteria for a new device's performance are not given (as this is a 510(k) for an updated software version of an existing device), we can infer the acceptance criteria for the software updates.

Acceptance Criteria (Inferred for Software Updates)	Reported Device Performance (as per submission)
Device operates as intended with software updates.	Software verification testing confirmed proper operation.
No new safety concerns introduced by software changes.	Software changes do not raise any new questions of safety and effectiveness; supported by verification activities.
No adverse impact on existing functionality.	Software updates include minor feature enhancements and bug fixes; changes addressed for clarification in labeling. Functionality maintained.
Removal of "analysis episode feature" functions as intended without negative impact.	The analysis episode feature was successfully removed from the software.
Software complies with relevant standards and guidance documents.	Software verification performed per IEC 62304 and FDA guidance for software in medical devices (May 2005) and 510(k) evaluations (July 28, 2014).
Software maintains "moderate" level of concern and associated mitigation.	Software was considered "moderate" level of concern (prior to mitigation, failure could result in minor injury or erroneous diagnosis/delay in care leading to minor injury). Verification activities support this.

Study Details:

The document describes software verification testing as the primary study type to establish substantial equivalence for the software updates.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. Software verification typically involves testing against a range of inputs and scenarios, but a "sample size" in the context of clinical data for performance metrics is not applicable here as no clinical performance data is presented.
- Data Provenance: Not specified, as it's software verification, not a clinical data study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was software verification, not a study requiring expert-established ground truth on clinical data. The "ground truth" for software testing would be the expected behavior of the software according to its design specifications.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This was software verification.
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:
- No, a multi-reader multi-case comparative effectiveness study was not done. The device (Endoflip™ 300 System) is a "Gastrointestinal Motility Monitoring System" that measures pressure and dimensions; it's not described as an AI-powered diagnostic tool for interpretation, but rather a direct measurement device with software for processing and displaying those measurements. The updates were minor software enhancements and bug fixes.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense. The "study" was software verification, which inherently evaluates the algorithm's performance on its own against specifications, without human interpretation in the loop for diagnostic accuracy. The device itself is standalone in its measurement function, providing data to clinicians for their interpretation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For software verification, the "ground truth" would be the software's design specifications and requirements. Each test case has an expected output or behavior based on these specifications, and the software's actual output is compared against this expected behavior. This is not clinical ground truth like pathology or expert consensus.
The sample size for the training set:
- Not applicable. This was software verification testing for an updated version of an existing medical device, not a machine learning model involving a training set.
How the ground truth for the training set was established:
- Not applicable for the same reason as above.

Summary

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July 21, 2023

Covidien LLC Viviana Gonzalez Sr. Regulatory Affairs Specialist 3062 Bunker Hill Lane Santa Clara, CA 95054

Re: K231861

Trade/Device Name: Endoflip™ 300 System Regulation Number: 21 CFR 876.1725 Regulation Name: Gastrointestinal Motility Monitoring System Regulatory Class: Class II Product Code: FFX Dated: June 22, 2023 Received: June 23, 2023

Dear Viviana Gonzalez:

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.

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shanil P. Haugen -S

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231861

Device Name Endoflip™ 300 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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006 – 510(k) Summary

I. SUBMITTER

Covidien IIc (Medtronic) 3062 Bunker Hill Lane Santa Clara, CA 95054 Contact Person: Viviana I. González Sr. Requlatory Affairs Specialist Telephone: 410-940-9773 E-mail: viviana.i.gonzalez@medtronic.com Date Prepared: June 19, 2023

II. DEVICE

Name of Device:	Endoflip™ 300 System
Common or Usual Name:	System, Gastrointestinal Motility (Electrical)
Classification Name:	Gastrointestinal motility monitoring system (21 CFR 876.1725)
Regulatory Class:	II
Product Code:	FFX

III. PREDICATE DEVICE

Predicate Name:	Endoflip TM 300 System
Predicate 510(k) number:	K223705

IV. DEVICE DESCRIPTION

No changes were made to any of the other components that comprise the Endoflip™ 300 System when compared to the predicate.

V. INDICATIONS FOR USE

The Endoflip™ 300 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

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and dimensions in the esophaqus, 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.

There is no change to the indications for use when compared to the predicate device.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE Gastrointestinal motility assessment using impedance planimetry is the technological principle for both the subject and predicate devices. It requires use of a platform that includes a pump, display and cart and balloon catheters that work as functional lumen imaging probes to characterize the geometry of the measurement area. At a high level, the subject and predicate devices are based on the same technological elements:

. System comprised of a pump, display, cart and accessories, including pre-use tube, reader software and catheters
Compatibility with the same, previously cleared catheters Endoflip™ and Esoflip™ ●
o Pump is firmware controlled to move the syringe driver to inflate/deflate the balloon with saline
Real-time geometric image of the measurement area
o Provides estimated balloon diameters along the length of the balloon and historical diameter estimates and other parameters
o Fully integrated platform
Guided catheter setup during pre-check
o Key metrics capture
o Study manager feature – save studies and reports for post-procedural review
. Network connectivity

VII. PERFORMANCE DATA

Only software verification was necessary to establish substantial equivalence with the predicate device.

Software verification testing was performed per IEC 62304, and documentation was provided as recommended by the following FDA quidances: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005) and The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (July 28, 2014). The software for this device was considered a "moderate" level of concern since prior to mitigation of hazards a failure of the software could result in minor injury or a malfunction of, or a latent design flaw in, the software could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to a minor injury.

VIII. CONCLUSION

The Endoflip™ 300 System is substantially equivalent to the predicate device. The subject device has the same device classification, intended use, intended use environment, tarqet patient population and principles of operation as the predicate. The subject device design changes do not raise any new questions of safety and effectiveness when compared to the predicate and are supported by verification activities performed.

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).