PERICSCOPE, MODEL # PERISC1

K013576 · Ethicon Endo-Surgery, Inc. · GCJ · Jan 25, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K013576
• Device Name: PERICSCOPE, MODEL # PERISC1
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jan 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PERIscope Optical Dissector is intended for dissection of connective tissue and the creation of an operative cavity in the extraperitoneal spaces and subcutaneous areas. The instrument has application in various general surgical procedures, such as laparoscopic hernia repair.

Device Story

PERIscope Optical Dissector is a manual surgical instrument consisting of a handle, scope retainer clip, cannula, and dissecting tip. Used in conjunction with a 0° rigid endoscope (max 5.5 mm diameter, 290-300 mm length) and a trocar. The device allows surgeons to visualize tissue during insertion, tunneling, and dissection. It functions by mechanically dissecting connective tissue to create an operative cavity for instrument passage. Used in clinical settings by surgeons for procedures such as laparoscopic hernia repair. Benefits include improved visualization and controlled tissue dissection during minimally invasive surgery.

Clinical Evidence

Bench testing and animal testing were performed to verify device performance. Animal testing demonstrated satisfactory performance during laparoscopic surgical procedures.

Technological Characteristics

Manual surgical instrument; includes handle, scope retainer clip, cannula, and dissecting tip. Compatible with 0° rigid endoscopes (max 5.5 mm diameter). Sterile, single-patient-use. No electronic components or software.

Indications for Use

Indicated for patients undergoing general surgical procedures, including laparoscopic hernia repair, requiring dissection of connective tissue and creation of an operative cavity in extraperitoneal or subcutaneous spaces.

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

• Cardiovations™ ClearGlide™ Optical Vessel Dissector (K973139)

Submission Summary (Full Text)

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# PERIscope™ 510(k) Summary of Safety and Effectiveness

JAN 2 5 2002

#### Company:

Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242

#### Contact:

Name: Doug Kentz Title: Regulatory Affairs Associate II

#### Date Prepared:

October 26, 2001

#### Name of Device:

Trade Name: PERIscope Optical Dissector Classification Name: Laparoscope, General and Plastic Surgery

#### Predicate Device:

Cardiovations™ ClearGlide™ Optical Vessel Dissector, cleared under K973139 on November 13, 1997.

#### Device Description:

The PERIscope Optical Dissector consists of a handle, a scope retainer clip, a cannula and a dissecting tip. The dissecting tip dissects tissue and creates a cavity that allows instrument passage. The dissecting tip allows visualization during insertion, tunneling, and dissection. The device is designed to be used with a trocar. The instrument is compatible with a 0° rigid endoscope that has a maximum diameter of 5.5 mm and is 290 mm to 300 mm in length.

#### Intended Use:

The PERIscope Optical Dissector is intended for dissection of connective tissue and the creation of an operative cavity in the extraperitoneal spaces and subcutaneous areas. The instrument has application in various general surgical procedures, such as laparoscopic hernia repair.

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## Technological Characteristics:

The PERIscope Optical Dissector is similar to the predicate device with respect to design and intended use. Both devices are also sterile, single patient use devices.

### Performance Data

Preclinical testing was performed to ensure the device performs as intended when used according to the instructions for use. Animal testing demonstrated satisfactory according to the mourblems for asso a Dissector during laparoscopic surgical procedures.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2002

Mr. Doug Kentz Regulatory Affairs Associate II Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

Re: K013576

Trade/Device Name: PERIscope Optical Dissector Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: October 26, 2001 Received: October 29, 2001

Dear Mr. Kentz:

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. Doug Kentz

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark V. Milliman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of of

510(k) Number (if known): KO1 357 b

Device Name: PERIscope Optical Dissector

Indications for Use:

The PERIscope Optical Dissector is intended for dissection of connective tissue and the creation of an operative cavity in the extraperitoneal spaces and subcutaneous areas. The instrument has application in various general surgical procedures, such as laparoscopic hernia repair.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

for Mark A. Milliken
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number K013576