PROTOCO2L INSUFFLATOR MODEL 6400

K013219 · E-Z-Em, Inc. · FCX · Feb 19, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K013219
• Device Name: PROTOCO2L INSUFFLATOR MODEL 6400
• Applicant: E-Z-Em, Inc.
• Product Code: FCX · Gastroenterology, Urology
• Decision Date: Feb 19, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The E-Z-EM PROTOCO2L COLON Insufflator administers and regulates carbon dioxide (CO2) as a conventional insufflator for use during diagnostic and therapeutic procedures of the colon, including research and conventional Colonoscopy.

Device Story

The PROTOCO2L COLON Insufflator is a medical device designed to deliver and regulate carbon dioxide (CO2) gas during colonoscopy procedures. It functions as an insufflator, providing controlled gas delivery to distend the colon for improved visualization during diagnostic or therapeutic examinations. The device is intended for use in clinical settings by healthcare professionals. By utilizing CO2 instead of room air, the device aims to improve patient comfort post-procedure, as CO2 is absorbed more rapidly by the body. The system manages gas flow and pressure to ensure safe insufflation levels throughout the procedure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device is an insufflator designed for the administration and regulation of CO2 gas. It operates as an accessory to endoscopes. Technical specifications and materials are not detailed in the provided documentation.

Indications for Use

Indicated for use as a conventional insufflator to administer and regulate carbon dioxide (CO2) during diagnostic and therapeutic colonoscopy procedures.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 1 9 2002

Mr. Robert Williams Senior Director of Engineering E-Z-EM®, Inc. 717 Main Street WESTBURY NEW YORK 11590 Re: K013219

Trade/Device Name: PROTOCO2L COLON Insufflator Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Procode: 78 FCX Dated: January 4, 2002 Received: January 7, 2002

Dear Mr. Williams:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 31 t(t) presidentially equivalent (for the indications felereneco above and nave decembers and marketed predicate devices marketed in interstate for use stated in the enorosate) (c 10gary to 10gars) the Medical Device Amendments, or to commerce prior to May 20, 1976, are excordance with the provisions of the Federal Food, Drug, devices that have been rochasined in avere approval of a premarket approval application (PMA). and Cosmetic Act (Act) that to hot requent of the general controls provisions of the Act. The I ou may, dicierore, market are act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), II your device is classified (500 above) and stating major regulations affecting your device can be it may be subject to additions, 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 Please oe advised that I DA 3 issuation of a bacevice complies with other requirements of the Act that I DA has made a decorminations administered by other Federal agencies. You must of any Fouch statutes and rogations including, but not limited to: registration and listing comply with an the Act 3 requirements, models, good manufacturing practice requirements as set (21 CFR Part 807), labelling (21 OFF Part 820); and if applicable, the electronic forth in the quality byticles (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 11 you teen became at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on by receive to premained the Act may be obtained from the Division of Small Manufacturers, Jour roopensional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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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## INDICATIONS FOR USE

510(k) Application: Abbreviated 510(k)

E-Z-EM PROTOCO₂L COLON INSUFFLATOR Device Name:

Indications for Use:

The E-Z-EM PROTOCO₂L COLON Insufflator administers and regulates carbon dioxide (CC)) as a convention The E-Z-EM PROTOCOL COLON Insultiator administers and regaller one of the research and conventional Colonoscopy.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-the-Counter Use

David G. Severson

E-Z-EM PROTOCO2L Insufflator 510(k) Submission Page 7 of 27