ENDOSCOPIC APPLICATOR

K051732 · ETHICON, Inc. · GCJ · Aug 9, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K051732
• Device Name: ENDOSCOPIC APPLICATOR
• Applicant: ETHICON, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Aug 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5mm trocar or larger.

Device Story

The Endoscopic Applicator is a sterile, single-use, disposable device designed to deliver hemostatic agents to bleeding surgical sites. It consists of a minimally reflective stainless steel cannula and a plastic stylet (obturator). The device features a luer connector for attachment to a syringe containing the hemostatic agent. It is operated by a clinician during endoscopic procedures, passing through a 5mm or larger trocar to reach the target site. By facilitating the precise application of hemostatic agents, the device assists in controlling bleeding during surgery.

Clinical Evidence

No clinical data provided; clinical data was deemed unnecessary to demonstrate equivalence to the predicate device.

Technological Characteristics

Consists of a stainless steel cannula and plastic stylet (obturator). Features a luer connector for syringe attachment. Provided sterile, single-use, and disposable. Packaged in a laminated film and TYVEK pouch.

Indications for Use

Indicated for the delivery of hemostatic agents to bleeding surgical sites in patients undergoing procedures requiring a 5mm trocar or larger.

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

• Endoscopic Applicator (K051732)

Submission Summary (Full Text)

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K051732

AUG 9 - 2005

Rige 18

#### SECTION 7

## SUMMARY OF SAFETY AND EFFECTIVENESS

- Information supporting claims of substantial equivalence, 510(k) Summary of as defined under the Federal Food, Drug and Cosmetic Safety and Effectiveness as define safety and effectiveness is summarized Act, resposuring convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule 15 1010(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence 007) anyone requesting it from the Agency. NEW DEVICE NAME: Endoscopic Applicator PREDICATE DEVICE NAME: Endoscopic Applicator 510(k) SUMMARY The Endoscopic Applicator device is a sterile single use, Device Description disposable device intended for use in delivering hemostatic agents to bleeding surgical sites through a 5mm trocar or larger. The Endoscopic Applicator consists of two components; (1) a minimally reflective stainless steel connula and (2) a plastic stylet (obturator). The Endoscopic Applicator is designed with a luer connector, for connection to a syringe containing the hemostatic agent. The packaging used for the Endoscopic Applicator is a pouch that consists of a see-through laminated film and TYVEK. Alternatively, a second pouch may be used. Either package configuration is placed within a paperboard carton. The Endoscopic Applicator is intended for use in delivering Intended Use hemostatic agents to bleeding surgical sites through a 5mm trocar or larger. Continued on next page

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Kor1732

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## SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

| Indications Statement | The Endoscopic Applicator is indicated for use in delivering<br>hemostatic agents to bleeding surgical sites through a 5mm<br>trocar or larger. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | The technological characteristics of the new device are the<br>same as the predicate device in that they both consist of a<br>cannula and a stylet that is used to deliver hemostatic<br>agents to bleeding sites through a 5mm trocar or larger. The<br>new device is provided sterile, for single patient use and is<br>disposable. |
| Performance Data | The Endoscopic Applicator( New Device) and the predicate<br>device have the same intended use. The new device is<br>substantially equivalent to the predicate device in intended<br>use, technological characteristics, design, components and<br>materials, therefore, performance testing was considered<br>unnecessary. Clinical data was deemed unnecessary to<br>demonstrate equivalence of the new device to the predicate<br>device for its intended purpose. |
| Conclusions | Based on the 510(k) summaries and 510(k) statements (21<br>CFR 807) and the information provided herein, we<br>conclude that the new device is substantially equivalent to<br>the Predicate Device under the Federal Food, Drug, and<br>Cosmetic Act. |
| Contact | Peter M. Cecchini<br>Fellow, Regulatory Affairs<br>ETHICON, Inc.<br>Rt. #22, West<br>Somerville, NJ 08876-0151 |
| Date | June 27, 2005 |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle faces left and is enclosed within a circle of text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 9 - 2005

Mr. Peter M. Cecchini Fellow, Regulatory Affairs ETHICON, Inc. Route 22 West Somerville, New Jersey 08876

Re: K051732

Trade/Device Name: Endoscopic Applicator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: June 27, 2005 Received: June 28, 2005

Dear Mr. Cecchini:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. 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.

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#### Page 2- Mr. Peter M. Cecchini

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and wyour he FDA finding of substantial equivalence of your device to a legally promance hotel 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 If you assno office of Compliance at [phone]. 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 other gotting to thernational 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,

Barbara Buchund
for

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K051732

## INDICATION FOR USE

510(k) Number (if known):

Endoscopic Applicator Device Name:

Indications for Use:

The Endoscopic Applicator is intended for use in delivering I he Endoscopic Appreator is interior in interior in Smm trocar or larger.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-The Counter Use

(Pcr 21 CFR 801.109)

(Optional Format 1-2-9G)

Caroline Buechler for MCM

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