SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE

K080050 · Spirus Medical, Inc. · FED · May 6, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K080050
• Device Name: SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE
• Applicant: Spirus Medical, Inc.
• Product Code: FED · Gastroenterology, Urology
• Decision Date: May 6, 2008
• 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-ileum during diagnostic and therapeutic upper GI endoscopy and enteroscopy. The Endo-Ease is used with an endoscope of appropriate diameter and length (such as an enteroscope or pediatric colonoscope).

Device Story

The Endo-Ease Endoscopic Overtube is a sterile, single-use, flexible overtube designed to facilitate the insertion and advancement of flexible endoscopes into the lower GI tract, specifically reaching the mid-ileum. It is used in conjunction with an endoscope of appropriate diameter and length. The device is operated by a clinician during diagnostic and therapeutic procedures. By providing a stable conduit, the overtube assists the physician in navigating the endoscope through the GI tract, potentially improving access to the mid-ileum for clinical evaluation and treatment.

Clinical Evidence

Clinical study of 101 patients; ileum reached in 48% of patients; mid-ileum reached in 6% of cases.

Technological Characteristics

Flexible, single-use, sterile overtube. Designed for use with flexible endoscopes in the lower GI tract.

Indications for Use

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

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

• Endo-Ease Endoscopic Overtube (K060235)

Submission Summary (Full Text)

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1080050

### Section 5-510(k) Summary

General Information

Owner's Name: Address:

Telephone Number: Fax Number: Contact Person:

#### Subject Device Name:

- Trade Name: Common/Usual Name: Product Code: FDA Regulation: Device Classification:
1063 Tumpike Street Stoughton, MA 02072 [phone] [phone] Robert Ailinger

Spirus Medical, Inc.

MAY - 6 2008

Endo-Ease Endoscopic Overtube Endo-Ease Endoscopic Overtube Endoscopic Overtube FDA 21 CFR 876.1500 - Endoscope & accessories Class II

#### Predicate Device Name:

Trade Name: Common/Usual Name: Product Code: FDA Regulation: Device Classification: Premarket Notification: Endo-Ease Endoscopic Overtube (Spirus Medical, Inc.) Endoscopic Overtube FDA 21 CFR 876.1500 - Endoscope & accessories Class II K060235

#### Product Description:

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

### Indications for Use

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

#### Substantial Equivalence

Substantial Equivalence for the Spirus Medical, Inc. Endo-Ease Overtube is based upon physical comparison to the predicate device as well as a clinical study demonstrating the device's effectiveness in reaching the ileum. In a study involving the treatment of 101 patients, the user successfully reached the ileum in 48% of patients; the mid-ileum was reached in 6% of cases.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

## - 6 2008

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

Re: K080050

Trade/Device Name: Endo-Ease™ Endoscopic Overtube Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Dated: April 29, 2008 Received: May 2, 2008

Dear Ms. Papineau:

We have reviewed your Section 510(k) premarket notification of intent to market the device w one ro reviewed your books are ined the device is substantially equivalent (for the indications for referentod above and nort 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 provisions 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 oonwols provibions or ullabeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket It your de roo be subject to such additional controls. Existing major regulations affecting your Applo rarf, to they be oble of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/1/Picture/10 description: The image is a circular logo or seal. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo, with the word "Centennial" underneath. There are stars and other symbols around the perimeter of the circle.

Protesting and Promoting Public Health.

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Page 2

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

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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Spirus Medical, Inc. Endo-Ease™ Endoscopic Overtube

# Section 4 - Indications for Use Statement

510(k) Number (if known):

080050

Device Name:

Endo-EaseTM Endoscopic Overtube

Indications for Use:

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

Prescription Use X (Per 21 CFR 801 Subpart D) OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulu Remin

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number