LAP DISC 120 X 120MM X 2CM #LD111; LAP DISC 120 X 120MM X 7CM #LD112

K020307 · Hakko Shoji Co., Ltd. · GCJ · Apr 26, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K020307
• Device Name: LAP DISC 120 X 120MM X 2CM #LD111; LAP DISC 120 X 120MM X 7CM #LD112
• Applicant: Hakko Shoji Co., Ltd.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Apr 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The LAP DISC Hand Access Device is intended to provide extracorporeal extension of pneumoperitoneum and abdominal access for the surgeon during laparoscopic surgery. The LAP DISC is indicated for use in laparoscopic procedures, where entry of the surgeon's hand may facilitate the procedure, and for extraction of large specimens. The LAP DISC has application in colorectal, urological and general surgical procedures. This indication for use includes the specific procedures which fall under these broad categories.

Device Story

Sterile, single-use abdominal wall closure device; consists of three interconnected plastic rings and silicone rubber. Bottom ring utilizes shape-memory alloy for flexibility; top ring features camera-aperture-style 'Iris Valve'. Device maintains peritoneal gas pressure during laparoscopic surgery while allowing surgeon hand insertion or specimen extraction. Used in OR by surgeons. Modification from predicate includes longer sleeve length to accommodate body wall thickness between 5cm and 9cm. Benefits include maintained pneumoperitoneum during hand-assisted laparoscopic procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Three-ring plastic structure interconnected by silicone rubber; bottom ring uses shape-memory alloy; top ring features Iris Valve mechanism. Single-use, sterile. Modification: increased sleeve length for 5cm-9cm body wall thickness.

Indications for Use

Indicated for patients undergoing laparoscopic procedures (colorectal, urological, general surgery) where surgeon hand entry facilitates the procedure or large specimen extraction is required.

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

• LAP DISC Hand Access Device (K010870)

Submission Summary (Full Text)

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APR 2 6 2002

Ethicon Endo-Surgery, Inc. 510(k) Premarket Notification for LAP DISC Hand Access Device

# KO20307

# LAP DISC Hand Access Device 510(k) Summary of Safety and Effectiveness

#### Company

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

#### Contact

Elizabeth Miller Regulatory Affairs Specialist

### Date Prepared:

January 28, 2002

#### Name of Device

Trade Name: LAP DISC Hand Access Device Classification Name: Laparoscope, General & Plastic Surgery

#### Predicate Devices:

LAP DISC Hand Access Device, cleared under K010870 on 06/18/01

#### Device Description

The LAP DISC is a sterile, single-use disposable device. The LAP DISC is an abdominal wall closure unit consisting of three overlaid plastic rings that are interconnected by means of a silicone rubber. The two lower rings hold the abdominal wall to maintain peritoneal gas pressure. The bottom ring is a flexible ring made with a shape-memory alloy. The top ring has a structure similar to the aperture in a camera (an Iris Valve). Because the aperture of the Iris Valve can be adjusted continuously, the system can maintain constant peritoneal gas pressure while allowing the insertion of the surgeon's hand and alternatively, it can be used as an insertion site.

#### Intended Use

The LAP DISC Hand Access Device is intended to provide extracorporeal extension of pneumoperitoneum and abdominal access for the surgeon during laparoscopic surgery. The LAP DISC is indicated for use in laparoscopic procedures, where entry of the surgeon's hand may facilitate the procedure, and for extraction of large specimens. The LAP DISC has application in colorectal, urological and general surgical procedures. This indication for use includes the specific procedures which fall under these broad categories.

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## Technological Characteristics

The LAP DISC Hand Access Device, product code LD112 is a modification to the predicate device, the LAP DISC Hand Access Device, product code LD111. The modification is for a longer sleeve length to accommodate body wall thickness between 5cm and 9cm.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract shapes or lines, possibly representing people or services.

#### Public Health Service

Food and Drug Administra 9200 Corporate Boulevard Rockville MD 20850

APR 26 2002

Hakko Shoji Co., Ltd. c/o Ms. Elizabeth Miller Regulatory Affairs Specialist Ethicon Endo-Surgery, Inc 4545 Creek Road Cincinnati, OH 45242-2839

Re: K020307

Trade/Device Name: LAP DISC Hand Access Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: January 28, 2002 Received: January 29, 2002

Dear Ms. Miller:

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 - Ms. Elizabeth Miller

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,

Miriam C. Provost

for Celia 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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# 510(k) Number (if known): KOQQ3

· Device Name: LAP DISC Hand Access Device

Indications for Use:

The LAP DISC Hand Access Device is intended to provide extracorporeal extension of pneumoperitoneum and abdominal access for the surgeon during laparoscopic surgery. The LAP DISC is indicated for use in laparoscopic procedures, where entry of the surgeon's hand may facilitate the procedure, and for extraction of large specimens. The LAP DISC has application ir. colorectal, urological and general surgical procedures. This indication for use includes the specific procedures which fall under these broad categories.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

(Optional Format 3-10-98)

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K020307