ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE

K972578 · Ethicon Endo-Surgery, Inc. · GCJ · Oct 1, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K972578
• Device Name: ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Oct 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The intended use of the New Device is to establish a path of entry for minimally invasive instruments.

Device Story

ENDOPATH® OPTIVIEW™ Optical Surgical Obturator and Sleeve facilitates minimally invasive surgery entry. Device comprises optical obturator and trocar sleeve. Obturator utilizes optical element to visualize tissue layers during insertion; dilates and separates tissue along entry path. Sleeve maintains pneumoperitoneum via seals during instrument exchange. Used in abdominal, thoracic, and gynecological procedures. Operated by surgeons. Sleeve features include optional stopcock for insufflation, desufflation lever, and stability threads. Available in 3mm to 12mm diameters and 65mm to 155mm lengths. Provides surgeon with visual feedback during access, potentially reducing blind entry risks.

Clinical Evidence

Bench testing only. Pre-clinical laboratory evaluations demonstrated acceptable performance in obturator-sleeve mating, insertion with/without visualization, removal, sleeve security in tissue, and maintenance of pneumoperitoneum.

Technological Characteristics

Optical obturator and trocar sleeve system. Sizes: 3mm-12mm diameter, 65mm-155mm length. Features: optical visualization element, sealing mechanism for pneumoperitoneum, optional stopcock, desufflation lever, and stability threads. Mechanical design for tissue dilation and separation.

Indications for Use

Indicated for patients undergoing abdominal, thoracic, or gynecological minimally invasive surgical procedures to establish an entry path for endoscopic instruments. The device allows for visualization of tissue layers during insertion via an optical element; it may also 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.

Submission Summary (Full Text)

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OCT - 1 1997

# K972578

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

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| Statement | Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR §807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency. |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device description | The ENDOPATH® OPTIVIEW™ Optical Obturator and Sleeve consists of two main components: an obturator with an optical element and a trocar sleeve. |
| | The optical obturator provides visualization of tissue as it passes through each layer by dilating and separating the tissue along its path of entry. |
| | The sleeve component has sealing capability to maintain pneumoperitoneum when instrumentation is inserted and withdrawn through the trocar sleeve during a surgical procedure |
| | The ENDOPATH® OPTIVIEW™ Optical Surgical Obturator and Sleeve shall be provided in a variety of size sleeves from 3mm to 12mm in diameter and 65mm to 155mm in length. |
| | The sleeve component of the device will be supplied with or without a stopcock for insufflation, with seals to maintain pneumoperitoneum as instruments are passed through the trocar sleeve, with or without a desufflation lever, and with or without stability threads for additional retention of the sleeve while it is in tissue. |
| Intended use | The intended use of the New Device is to establish a path of entry for minimally invasive instruments. |
| | Continued on next page |

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#### Appendix A: 510(k) Summary of Safety and Effectiveness, Continued �

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| Indications<br>statement | The ENDOPATH® OPTIVIEW™ Optical Surgical Obturator and Sleeve has<br>applications in abdominal, thoracic and gynecological minimally invasive<br>surgical procedures to establish a path of entry for endoscopic instruments.<br>The device utilizes an optical element to visualize tissue layers during<br>insertion. The obturator can be used without visualization for primary and<br>secondary insertions. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>characteristics | The technological characteristics of the New 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. The studies demonstrated acceptable performance to<br>the Predicate Device in mating the obturator with the sleeve, insertion into the<br>operative cavity with or without visualization, removal of the obturator from<br>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 New Device is<br>substantially equivalent to the Predicate Device under the Federal Food, Drug<br>and Cosmetic Act. |
| Contact | Ivan S. Placko<br>Project Manager<br>Regulatory Affairs Department<br>Ethicon Endo-Surgery, Inc.<br>4545 Creek Road<br>Cincinnati, Ohio 45242 |
| Date | July 8, 1997 |

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OCT - 1 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. Ivan S. Placko .Project Manager, Regulatory Affairs Ethicon Endo-Surgery , Inc. 4545 Creek Road Cincinnati, Ohio 45242-2839

K972578 Re:

Trade Name: ENDOPATH® Optiview™ Optical Surgical Obturator and Sleeve Regulatory Class: II Product Code: GCJ Dated: July 8, 1997 Received: July 10, 1997

Dear Mr. Placko:

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 requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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. Ivan S. Placko

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,

Ascollaro

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

Enclosure

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### Appendix B: Indications for Use Statement

Following is the Indications for Use Statement: Statement

> 510(k) Number: K_972578 Device Name: ENDOPATH® OPTIVIEW™ Optical Surgical Obturator and Sleeve

#### Indications for Use:

The ENDOPATH® OPTIVIEW™ Optical Surgical Obturator and Sleeve has applications in abdominal, thoracic and gynecological minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The obturator can be used without visualization for primary and secondary insertions.

**Prescription Use**
(Per 21 CFR 801.109)

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General Restor