EndoflipTM 300 System

K231861 · Covidien, LLC · FFX · Jul 21, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K231861
• Device Name: EndoflipTM 300 System
• Applicant: Covidien, LLC
• Product Code: FFX · Gastroenterology, Urology
• Decision Date: Jul 21, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1725
• Device Class: Class 2
• Attributes: Pediatric

Intended 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 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 Story

Endoflip™ 300 System utilizes impedance planimetry to assess gastrointestinal lumen geometry; system includes pump, display, cart, and balloon catheters. Pump inflates/deflates balloon with saline; system captures real-time geometric images and pressure data. Used in clinical settings by healthcare providers to evaluate motility disorders; provides estimated balloon diameters and key metrics for post-procedural review. Output assists clinicians in diagnosing motility conditions; benefits patients through comprehensive evaluation of esophageal, pyloric, or anal sphincter function.

Clinical Evidence

Bench testing only. Software verification performed per IEC 62304 and relevant FDA guidance documents. No clinical data presented.

Technological Characteristics

Impedance planimetry; firmware-controlled pump for saline balloon inflation; display system; network connectivity. Software-based analysis of geometric and pressure data. Moderate level of concern software.

Indications for Use

Indicated for adults requiring measurement of pressure and dimensions in the esophagus, pylorus, and anal sphincters, and patients aged 5+ for esophageal measurements. Used as an adjunct diagnostic tool for gastrointestinal motility disorders.

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™ 300 System (K223705)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [phone] E-mail: [e-mail] 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

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.

#### 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.