ENDO-EASE ENDOSCOPIC OVERTUBE

K060235 · Spirus Medical, Inc. · FDA · Aug 4, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K060235
• Device Name: ENDO-EASE ENDOSCOPIC OVERTUBE
• Applicant: Spirus Medical, Inc.
• Product Code: FDA · Gastroenterology, Urology
• Decision Date: Aug 4, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Spirus Medical, Inc. Endo-Ease Endoscopic Overtube is indicated to aid endoscopic insertion and advancement to the mid-jejunum during diagnostic and therapeutic upper GI endoscopy. The Endo-Ease is used with an endoscope of appropriate diameter and length (such as an enteroscope or pediatric colonoscope).

Device Story

Endo-Ease is a sterile, single-use, flexible endoscopic overtube; designed to facilitate insertion and advancement of flexible endoscopes into the mid-jejunum during upper GI procedures. Device acts as a conduit for endoscope passage; assists clinician in navigating complex anatomy. Used in clinical settings by physicians; provides mechanical support for endoscope. Benefits include improved access to mid-jejunum for diagnostic/therapeutic interventions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Flexible, single-use, sterile endoscopic overtube. Designed for use with standard flexible endoscopes (enteroscopes or pediatric colonoscopes) in the upper GI tract.

Indications for Use

Indicated for patients undergoing diagnostic or therapeutic upper GI endoscopy requiring insertion and advancement to the mid-jejunum. Used with compatible endoscopes (e.g., enteroscopes or pediatric colonoscopes).

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

• Spirus Medical Endo-Ease Overtube (K052084)
• Balloon Overtube (Fujinon Corp.) (K040048)
• Bard Endoscopic Overtube (C.R. Bard, Inc.) (K973500)
• Disposable Overtube (U.S. Endoscopy) (K040836)

Submission Summary (Full Text)

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Kobo235

# 510(k) Summary

| Trade Name: | Endo-Ease™ | AUG - 4 2000 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Sponsor: | Spirus Medical, Inc.<br>1063 Turnpike Street<br>Stoughton, MA 02072<br>FDA Registration No. not yet assigned | |
| Device Common<br>Name: | Endoscopic overtube | |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class II. | |
| Predicate Devices: | K052084 - Spirus Medical Endo-Ease Overtube<br>K040048 - Balloon Overtube (Fujinon Corp.)<br>K973500 - Bard Endoscopic Overtube (C.R. Bard, Inc.)<br>K040836 - Disposable Overtube (U.S. Endoscopy) | |

# Product Description:

The device described in this 510(k) consists of a sterile, single use, flexible overtube designed for use with currently marketed flexible endoscopes in the upper GI tract.

### Indications for Use:

The Spirus Medical, Inc. Endo-Ease Endoscopic Overtube is indicated to aid endoscopic insertion and advancement to the mid-jejunum during diagnostic and therapeutic upper GI endoscopy. The Endo-Ease is used with an endoscope of appropriate diameter and length (such as an enteroscope or pediatric colonoscope).

# Safety and Performance:

Substantial equivalence for the new device was based on design characteristics and comparison to legally marketed predicate devices.

### Conclusion:

Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the proposed Spirus Medical, Inc. Endo-Ease Endoscopic Overtube has been shown to be safe and effective for its intended use.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG - 4 2006

Spirus Medical, Inc. % Ms. Pamela Papineau, RAC Consultant Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue AYER MA 01432

Re: K060235

Trade/Device Name: Endo-EASE Endoscopic Overtube Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDA Dated: July 12, 2006 Received: July 14, 2006

Dear Ms. Papineau:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your contrained the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce aso stated in the enerebate) enactment date of the Medical Device Amendments, or to devices that prov to thay 20, 1978, in accordance with the provisions of the Federal Food, Drug, and Cosmetic nave bech roomsomed in accessor val of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, mailter are as the Act include requirements for annual registration, listing of devices, good oonerols provision practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket ir your device is elassified (500 arch additional controls. Existing major regulations affecting your Apployally, it they be bacreer of Regulations, Title 21, Parts 800 to 898. In addition, FDA device our of found mouncements concerning your device in the Federal Register.

Image /page/1/Picture/10 description: The image shows a circular logo with the text "FDA Centennial" in the center. Above the text, the years "1906-2006" are displayed. The logo is surrounded by text that appears to be part of the organization's name or motto. The overall design suggests a commemorative emblem for the centennial anniversary of the Food and Drug Administration.

oling Public 9

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely vours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Endo-Ease Endoscopic Overtube Device Name:

Indications for Use:

The Spirus Medical, Inc. Endo-Ease Endoscopic Overtube is indicated to aid endoscopic insertion and advancement to the mid-jejunum during diagnostic and therapeutic upper G1 endoscopy. The Endo-Ease is used with an endoscope of appropriate diameter and length (such as an enteroscope or pediatric colonoscope).

Prescription Use
(Per 21 CFR 801 Subpart D)

Over-the -Counter Use (Per 21 CFR 801 Subpart C)

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segmen

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device

510(k) Number_

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