AdvanCE capsule endoscope delivery device

K163495 · United States Endoscopy Group, Inc. · NEZ · Mar 10, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K163495
• Device Name: AdvanCE capsule endoscope delivery device
• Applicant: United States Endoscopy Group, Inc.
• Product Code: NEZ · Gastroenterology, Urology
• Decision Date: Mar 10, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1300
• Device Class: Class 2

Intended Use

The disposable AdvanCE® capsule endoscope delivery device is a 2.5 mm single sheathed device indicated for transendoscopic delivery of Capsules (with the dimensions of 10.5mm - 11.5mm in diameter and 23.5mm in length), to the stomach or duodenum. This device is intended for patients who are either unable to swallow the capsule, or unable to pass the capsule beyond the pylorus in sufficient time to complete the desired diagnostic evaluation.

Device Story

AdvanCE is a disposable, 2.5 mm single-sheathed delivery device; facilitates transendoscopic placement of capsule endoscopes into the stomach or duodenum. Used by clinicians in a clinical setting when patients cannot swallow the capsule or experience delayed gastric emptying preventing pyloric passage. Device acts as a mechanical delivery vehicle; ensures capsule reaches target site for diagnostic imaging. Benefits include enabling successful capsule endoscopy procedures in patients with swallowing or motility difficulties.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable, 2.5 mm single-sheathed delivery device. Mechanical delivery system for capsule endoscopes (10.5-11.5mm diameter, 23.5mm length).

Indications for Use

Indicated for patients unable to swallow a capsule endoscope or unable to pass the capsule beyond the pylorus in sufficient time for diagnostic evaluation. Used for transendoscopic delivery of capsules (10.5-11.5mm diameter, 23.5mm length) to the stomach or duodenum.

Regulatory Classification

Identification

An ingestible telemetric gastrointestinal capsule imaging system is used for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an antenna array, a receiving/recording unit, a data storage device, computer software to process the images, and accessories.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance, “Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging Systems; Final Guidance for Industry and FDA.”

Submission Summary (Full Text)

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

March 10, 2017

United States Endoscopy Group, Inc. Carroll Martin Director, Regulatory Affairs 5976 Heisley Road Mentor, OH 44060

Re: K163495

> Trade/Device Name: Advance - Capsule Endoscope Delivery Device Regulation Number: 21 CFR§ 876.1300 Regulation Name: Ingestible Telemetric Gastrointestinal Capsule Imaging System Regulatory Class: II Product Code: NEZ Dated: February 7, 2017 Received: February 7, 2017

Dear Carroll Martin:

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.

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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 (reporting of medical device-related 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

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For Benjamin R. Fisher, Ph.D. Director 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K163495

#### Device Name

Advance - capsule endoscope delivery device

# Indications for Use (Describe)

The disposable AdvanCE® capsule endoscope delivery device is a 2.5 mm single sheathed device indicated for transendoscopic delivery of Capsules (with the dimensions of 10.5mm - 11.5mm in diameter and 23.5mm in length), to the stomach or duodenum. This device is intended for patients who are either unable to swallow the capsule, or unable to pass the capsule beyond the pylorus in sufficient time to complete the desired diagnostic evaluation.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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