ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE

K990028 · Ethicon Endo-Surgery, Inc. · GCJ · Apr 1, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990028
• Device Name: ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Apr 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The intended use of the ENDOPATH® OPTIVIEW® Optical Surgical Obturator and Sleeve is to establish a path of entry for endoscopic instruments.

Device Story

ENDOPATH OPTIVIEW consists of an obturator and a 5mm, 11mm, or 12mm sleeve. The clear, tapered optical element, when used with a zero-degree endoscope, provides visualization of tissue layers during insertion. The device facilitates abdominal cavity insufflation via luer lock fittings. Available in two configurations: standard or with an integral pistol grip handle for insertion assistance. Used in OR settings by surgeons to establish access for endoscopic instruments. The device maintains pneumoperitoneum and secures the sleeve in tissue. Benefits include improved visualization during trocar entry, potentially reducing blind insertion risks.

Clinical Evidence

Bench testing only. Evaluations confirmed device performance in mating the obturator with the sleeve, insertion into the operative cavity with or without visualization, removal of the obturator, sleeve security in tissue, and maintenance of pneumoperitoneum.

Technological Characteristics

Consists of an obturator and a 5mm, 11mm, or 12mm sleeve. Features a clear, tapered optical element for endoscope integration. Includes luer lock fittings for insufflation. Available with or without an integral pistol grip handle. Non-powered, mechanical device.

Indications for Use

Indicated for patients undergoing abdominal, gynecologic, or thoracic minimally invasive surgical procedures, or endoscopic surgery of superficial veins and fascia of the lower extremities, to establish a path of entry or gain access through tissue planes and/or potential spaces for endoscopic instruments. May be used without visualization for primary and secondary insertions.

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

• ENDOPATH® OPTIVIEW® Optical Surgical Obturator and Sleeve (K990028)

Submission Summary (Full Text)

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## K990028

4545 CREEK ROAD CINCINNATI, OH 45242-2839

## Appendix A - 510(k) Summary of Safety and Effectiveness

| Device | Trade Name/Proprietary Name: ENDOPATH® OPTIVIEW® Optical Surgical Obturator and Sleeve Classification Name: Endoscope and Accessories Common Name: Surgical Trocar |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Legally<br>marketed<br>device | ENDOPATH® OPTIVIEW® Optical Surgical Obturator and Sleeve<br>manufactured by Ethicon Endo-Surgery, Inc. |
| Device<br>description | The ENDOPATH® OPTIVIEW® Optical Surgical Obturator and Sleeve<br>consists of an obturator and a 5mm, 11mm, or 12mm sleeve.<br><br>The clear, tapered optical element, when used with an endoscope, provides<br>visibility of individual tissue layers during insertion. The blunt tip maysupplied, is compatible with standard luer lock fittings and provides for<br>insufflation of the abdominal cavity. The ENDOPATH® OPTIVIEW® Optical<br>Surgical Obturator and Sleeve has a sealing range that accommodates<br>appropriately sized instruments. The obturator accommodates an<br>appropriately sized zero degree endoscope. There are two obturator<br>ergonomic options:<br>O designated codes without a handle, and H designated codes with an integral pistol grip handle which aids in the<br>insertion of the device. |
| | Continued on next page |
| Intended use | The intended use of the ENDOPATH® OPTIVIEW® Optical Surgical<br>Obturator and Sleeve is to establish a path of entry for endoscopic<br>instruments. |
| Indications for<br>use | The ENDOPATH® OPTIVIEW® Optical Surgical Obturator and Sleeve has<br>applications in abdominal, gynecologic, and thoracic minimally invasive<br>surgical procedures as well as endoscopic surgery of superficial veins and<br>fascia of the lower extremities to establish a path of entry or to gain access<br>through tissue planes and/or potential spaces for endoscopic instruments. The<br>trocar may be used without visualization for primary and secondary<br>insertions. |
| Technological<br>characteristics | The technological characteristics of the subject device are the same as the<br>predicate device. |
| Performance<br>data | Pre-clinical laboratory evaluations were performed to ensure that the device<br>can be used as designed. These studies demonstrated acceptable performance<br>to the predicate device in mating the obturator with the sleeve, insertion into<br>the operative cavity with or without visualization, removal of the obturator<br>from the sleeve, security of the sleeve in tissue, and maintenance of<br>pneumoperitoneum of the operative space. |
| Conclusion | Based on the 510(k) summaries and 510(k) statements (21 CFR §807) and the<br>information provided herein, we conclude that the subject device is<br>substantially equivalent to the predicate device under the Federal Food, Drug<br>and Cosmetic Act. |
| Contact | Chuck Tabri, Regulatory Affairs Associate<br>Ethicon Endo-Surgery, Inc.<br>4545 Creek Road<br>Cincinnati, Ohio 45242<br>Telephone [phone]<br>Fax [phone] |
| Date | December 31, 1998 |

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## 510(k) Summary of Safety and Effectiveness, Continued

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 1999

Mr. Chuck Tabri Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

Re: K990028

Trade Name: ENDOPATH® OPTIVIEW® Optical Surgical Obturator and Sleeve Regulatory Class: II Product Code: GCJ Dated: December 31, 1998 Received: January 5, 1999

Dear Mr. Tabri:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections. the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Chuck Tabri

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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

510(k) NUMBER (IF KNOWN): K990028

ENDOPATH* OPTIVIEW* Optical Surgical Obturator and Sleeve DEVICE NAME:

INDICATIONS FOR USE:

The ENDOPATH* OPTIVIEW* Optical Surgical Obturator and Sleeve has applications in abdominal, gynecologic, and thoracic minimally invasive = " surgical procedures as well as endoscopic surgery of superficial veins and fascia of the lower extremities to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments. The trocar may be used without visualization for primary and secondary insertions.

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

Concurrence of CORH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109

| OR | |
|----|----------------------|
| | Over-The-Counter-Use |
| | (Optional Format 1.) |
| | coll |

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