ENDOFLIP ECD

K110531 · Crospon, Ltd. · FED · Oct 6, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K110531
• Device Name: ENDOFLIP ECD
• Applicant: Crospon, Ltd.
• Product Code: FED · Gastroenterology, Urology
• Decision Date: Oct 6, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The EndoFLIP® EF-800 is an external channel for an endoscope (9.0 to 12.2 mm in diameter) used to aid in the insertion, advancement, and removal of endoscopic devices during endoscopic procedures. The EndoFLIP® ECD is single patient use, disposable. Environments of use - Hospitals, Sub-acute care institutions, Surgery Centers, doctor's offices where endoscopic procedures may be performed.

Device Story

EndoFLIP® ECD EF-800 is an endoscopic accessory providing an external channel for endoscopes (9.0-12.2 mm diameter). Device features a dual-lumen shaft, reinforcing wire, and tapered tip. It allows insertion, advancement, and removal of endoscopic instruments while preserving the endoscope's primary working channel. Used in hospitals, surgery centers, and clinics by physicians during endoscopic procedures. Device is single-patient use and disposable. By providing an additional access route, it facilitates therapeutic or diagnostic interventions without requiring endoscope withdrawal, potentially reducing procedure time and improving clinical efficiency.

Clinical Evidence

Bench testing only. Performance testing included age testing and compatibility testing with endoscopes to ensure proper sliding function. Biocompatibility testing conducted per ISO 10993-1 (cytotoxicity, irritation, sensitization).

Technological Characteristics

Dual-lumen shaft, reinforcing wire, tapered tip. Overall OD 20.3 mm, working lumen ID 4.0 mm, working length 700 mm. Single-patient use, disposable, non-sterile. Biocompatibility per ISO 10993-1. No software or electronic components.

Indications for Use

Indicated for patients undergoing endoscopic procedures to aid in the insertion, advancement, and removal of endoscopic devices using an endoscope (9.0-12.2 mm diameter). Contraindicated where endoscopy is contraindicated.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• US Endoscopy Enteroscopy Overtube (K100081)
• Smart Medical NaviAID BGE (K060923)

Submission Summary (Full Text)

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# K110531

| Company | Crospon Ltd.<br>Galway Business Park<br>Dangan<br>Galway, Ireland<br><br>Tel - 011 [353] (91) 519882<br>Fax - 011 [353] (91) 519873 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | John O'Dea, Ph.D. |
| Proprietary or Trade Name: | EndoFLIP® ECD EF-800 |
| Common/Usual Name: | Endoscopic access overtube, gastroenterology-urology |
| Classification / CFR: | FED / CFR 876.1500 |
| Device: | EndoFLIP® ECD EF-800 |
| Predicate Devices: | US Endoscopy Enteroscopy Overtube (K100081)<br>Smart Medical NaviAID BGE (K060923) |

# Device Description:

The EndoFLIP® ECD EF-800 External Channel Device (ECD) is an endoscopic accessory designed to provide an additional channel external to the endoscope for inserting, advancing, and removing endoscopic devices thereby preserving the working channel of the endoscope for other instruments.

# Indications for Use:

The EndoFLIP® EF-800 is an external channel for an endoscope (9.0 - 12.2 mm in diameter) used to aid in the insertion, advancement, and removal of endoscopic devices during endoscopic procedures

| Patient Population: | Patients undergoing endoscopic procedures | Attributes | EndoFLIP®<br>ECD EF-800 | Smart Medical<br>NaviAID BGE – K060923 | US Endoscopy<br>Enteroscopy Overtube - K100081 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Environment of Use: | Hospitals, Sub-acute care institutions, Surgery Centers, doctor's<br>offices where endoscopic procedures may be performed | Indications for Use | The EndoFLIP® EF-800 is an<br>external channel for an endoscope<br>(9.0 to 12.2 mm in diameter) used<br>to aid in the insertion advancement<br> | An accessory to an endoscope and<br>is intended to ensure complete<br>positioning of a standard<br>endoscope in the small intestine<br>(i.e., an endoscope that is 10 -13<br>mm in diameter and is used for<br>standard intestinal endoscopic<br>visualization | Indicated for use to aid the insertion,<br>advancement, and removal of<br>appropriately sized endoscopes and<br>endoscopic devices during<br>diagnostic and therapeutic<br>endoscopic procedures in the upper<br>gastrointestinal tract, including the<br>small intestine |
| Contraindications: | The ECD EF-800 is contraindicated where endoscopy is<br>contraindicated. | Environments of use | Hospitals, Sub-acute care<br>institutions, Surgery Centers,<br>doctor's offices where endoscopic<br>procedures may be performed | Hospitals, Sub-acute care<br>institutions, Surgery Centers,<br>doctor's offices where endoscopic<br>procedures may be performed | Hospitals, Sub-acute care<br>institutions, Surgery Centers,<br>doctor's offices where endoscopic<br>procedures may be performed |
| Patient Population | Patients undergoing endoscopic<br>procedures | Patients undergoing endoscopic<br>procedures | Patients undergoing endoscopic<br>procedures | | |
| Contraindications | The ECD EF-800 is contraindicated<br>where endoscopy is contraindicated. | The contraindications include<br>those specific to the endoscopic<br>procedure. Relative<br>contraindications include:<br>• Bowel obstruction<br>• Concomitant Coumadin use<br>• Diverticulitis<br>Recent (within the last 3 months)<br>coronary ischemia or CVA<br>(stroke) | Not stated | | |

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510(k) Summary

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Table of Comparison of Proposed Device vs. Predicate

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| Functions | EndoFLIP®<br>ECD EF-800 | Smart Medical<br>NaviAID BGE - K060923 | US Endoscopy<br>Enteroscopy Overtube - K100081 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| | aid in the insertion advancement<br>and removal of endoscopic<br>accessories during endoscopic<br>procedures. | aid the insertion, advancement,<br>and removal of appropriately<br>sized endoscopes and endoscopic<br>devices | aid the insertion, advancement, and<br>removal of appropriately sized<br>endoscopes and endoscopic devices |
| Intraoperative use | Yes | Yes | Yes |
| Design | | | |
| Components | | | |
| Dual lumen shaft | Yes | Yes | No (single lumen) |
| Clip | Yes | Yes | No |
| Reinforcing wire | Yes | Yes | Yes |
| Tapered tip | Yes | Yes | Yes |
| Dual lumen | | | |
| Working | Yes | Yes | No |
| Endoscope | Yes | Yes | Yes Only a channel for endoscope |
| Dimensions (mm) | | | |
| Overall OD | 20.3 mm | 20.3 mm | 19.5 mm (single lumen) |
| Working lumen ID | 4.0 mm | 4.0 mm | Not available |
| Endoscope lumen | Up to 13 mm | Up to 13 mm | 16.7 mm |
| Overall length | 718 mm | 1900 mm | 500 mm |
| Working length | 700 mm | -- | -- |
| Sterility | Supplied non-sterile, and are<br>single patient use, disposable | Supplied non-sterile, and are<br>single patient use, disposable | Supplied non-sterile, and are single<br>patient use, disposable |
| Performance Testing | | | |
| Shelf life | Age testing | Age testing | -- |
| Ability to slide over<br>endoscope | Compatibility testing | Compatibility testing | Not available |
| Materials | | | |
| Biocompatibility | ISO 100993-1 | ISO 10993-1 | ISO 10993-1 |

510(k) Summary

Page 59

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# 510(k) Summary Page 4 of 4 30-Sep-11

### Substantial Equivalence:

The EndoFLIP® ECD EF-800 is viewed as substantially equivalent to the predicate devices because:

#### Indications -

Equivalent to predicate - K100081 - US Endoscopy overtube - indicated for use to aid the insertion, advancement, and removal of appropriately sized endoscopes and endoscopic devices during diagnostic and therapeutic endoscopic procedures in the upper gastrointestinal tract, including the small intestine.

#### Technology -

Similar to the predicate K060923, without the balloon accessory, Smart Medical - NaviAID BGE, a simple double lumen tube with a tapered tip at one end.

#### Materials -

The materials in contact were tested to ISO 109931 - Cytotoxicity, Irritation, and Sensitization

#### Environment of Use -

Identical to predicate - K060923 - Smart Medical NaviAID BGE - Hospitals, Sub-acute care institutions, Surgery Centers, doctor's offices where endoscopic procedures may be performed.

#### Patient Population -

Identical to predicate - K060923 - Smart Medical NaviAID BGE - Patients undergoing endoscopic procedures.

## Comparative Performance and Specifications

We have performed age testing and compatibility with endoscopes similar to the tests performed by the predicate K060923 Smart Medical - NaviAID BGE.

The ECD EF-800 raises no new safety or efficacy concerns.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Crospon Ltd. % Mr. Paul Dryden President ProMedic, Inc. 24301 Woodsage Drive BONITA SPRINGS FL 34134

OCT - 6 2011

Re: K110531

Trade/Device Name: EndoFLIP® EF-800 External Channel Device Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: 11 Product Code: FED Dated: September 30, 2011 Received: October 4, 2011

Dear Mr. 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-related

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Page 2

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Hubert Lemmer MD

Herbert P. Lemer, M.D., Director (Acting) 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 Statement

Page 1 of 1

K110531 510(k) Number:

Device Name: EndoFLIP® EF-800 External Channel Device

Indications for Use:

1:

The EndoFLIP® EF-800 is an external channel for an endoscope (9.0 to 12.2 mm in diameter) used to aid in the insertion, advancement, and removal of endoscopic devices during endoscopic procedures

The EndoFLIP® ECD is single patient use, disposable.

Environments of use - Hospitals, Sub-acute care institutions, Surgery Centers, doctor's offices where endoscopic procedures may be performed.

Prescription Use XX (Part 21 CFR 801 Subpart D) or

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

uctive, Gastro-Renal, and