CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144

K040494 · United States Endoscopy Group, Inc. · NEZ · Jun 23, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K040494
• Device Name: CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144
• Applicant: United States Endoscopy Group, Inc.
• Product Code: NEZ · Gastroenterology, Urology
• Decision Date: Jun 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1300
• Device Class: Class 2

Indications for Use

The disposable Capsule Delivery Device is a single sheathed device indicated for transendoscopic delivery of the M2A® Capsule Endoscope to the duodenum in patients who are either unable to swallow the M2A® Capsule Endoscope, or unable to pass the M2A® Capsule Endoscope beyond the pylorus in sufficient time to complete the desired diagnostic evaluation.

Device Story

The Capsule Delivery Device is a single-use, sheathed instrument designed for transendoscopic delivery of the M2A® Capsule Endoscope. It is used by physicians in a clinical setting to assist in placing the capsule into the duodenum when patients cannot swallow the device or when the capsule fails to pass the pylorus naturally. The device facilitates the diagnostic procedure by ensuring the capsule reaches the target site for imaging. It does not perform analysis itself but acts as a mechanical delivery aid to enable the function of the M2A® Capsule Endoscope.

Clinical Evidence

No clinical data provided; device is a mechanical delivery accessory.

Technological Characteristics

Single-use, sheathed mechanical delivery device. Designed for transendoscopic use. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients unable to swallow the M2A® Capsule Endoscope or unable to pass it beyond the pylorus in time for diagnostic evaluation; facilitates transendoscopic delivery to the 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center - WO66-G609
Silver Spring, MD 20993-0002

United States Endoscopy Group, Inc.
Ms. Gretchen Y. Cohen
Executive Vice President
5976 Heisley Road
Mentor, OH 44060

JUL 27 2015

Re: K040494
Trade/Device Name: Capsule Delivery Device
Regulation Number: 21 CFR 876.1300
Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system
Regulatory Class: II
Product Code: NEZ
Dated (Date on orig SE ltr): May 24, 2004
Received (Date on orig SE ltr): May 25, 2004

Dear Ms. Cohen,

This letter corrects our substantially equivalent letter of June 23, 2004.

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

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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 (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 Small Manufacturers, International and Consumer Assistance 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” (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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

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

510(k) Number (if known): K040494

Device Name: Capsule Delivery Device

Indications for Use:

The disposable Capsule Delivery Device is a single sheathed device indicated for transendoscopic delivery of the M2A® Capsule Endoscope to the duodenum in patients who are either unable to swallow the M2A® Capsule Endoscope, or unable to pass the M2A® Capsule Endoscope beyond the pylorus in sufficient time to complete the desired diagnostic evaluation.

Prescription Use ☑
(Part 21 CFR 801 Subpart D)

AND/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)

David A. Symons
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K040494

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