ENDOPATH ULTRA-RETRACTOR/ ENDOPATH VESSEL DISSECTOR

K973139 · Ethicon Endo-Surgery, Inc. · GCJ · Nov 13, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K973139
• Device Name: ENDOPATH ULTRA-RETRACTOR/ ENDOPATH VESSEL DISSECTOR
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Nov 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ENDOPATH® Ultra-Retractor has application for the creation and maintenance of an operative cavity in the extraperitoneal spaces such as the retroperitoneal, preperitoneal and subcutaneous areas. The device may be used in all types of surgical procedures requiring dissection and retraction of tissue. The Vessel Dissector has application for use in the blunt dissection of tubular structures such as veins, arteries, nerves and ducts. The device may also be used in all types of surgical procedures requiring dissection of tissue.

Device Story

ENDOPATH Ultra-Retractor and Vessel Dissector are manual surgical instruments used for tissue dissection and retraction. The Ultra-Retractor features a handle, wide shaft, and transparent blunt tip; the tip allows visualization during insertion and tunneling. The wide shaft maintains the created cavity. A luer lock on the handle allows connection to suction or gas (CO2, nitrogen, air) to clear smoke, mist, or endoscope lenses during electrosurgery or ultrasonic procedures. The device is compatible with rigid endoscopes (max 5.5mm diameter, 290-300mm length). Operated by surgeons in clinical/OR settings, the device facilitates access to surgical sites, aiding visualization and tissue manipulation, potentially reducing procedural complexity.

Clinical Evidence

Bench testing only. Pre-clinical laboratory evaluations were performed to ensure the device functions as designed and demonstrates performance equivalent to the predicate device.

Technological Characteristics

Manual surgical instrument consisting of a handle, wide shaft, and transparent blunt tip. Includes a luer lock for suction or gas (CO2, nitrogen, air) insufflation/clearing. Compatible with rigid endoscopes (max 5.5mm diameter, 290-300mm length). No electronic or software components.

Indications for Use

Indicated for surgical patients requiring tissue dissection and retraction, specifically for creating/maintaining operative cavities in extraperitoneal spaces (retroperitoneal, preperitoneal, subcutaneous) or blunt dissection of tubular structures (veins, arteries, nerves, ducts).

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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4545 CREEK ROAD
CINCINNATI, OH 45242-2839

K973139

Nov 1 3 1997

510(k) Summary of Safety and Effectiveness

Information supporting claims of substantial equivalence, as defined under the Statement 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.

The ENDOPATH® Ultra-Retractor consists of a handle, a wide shaft, and a Device transparent blunt tip dissector (two instruments are available with a variation description in the tip size). The blunt tip dissects tissue and creates a cavity that allows instrument passage. The wide shaft maintains the space created by the transparent tip. The tip is transparent to allow visualization during insertion, tunneling, and dissection. Also, the device is provided with a luer lock, located on the handle, for the attachment of suction or gas, such as CO2, nitrogen, or air, as an aid for the removal of mist or smoke when used in combination with electrosurgery or ultrasonic devices and/or clearing the endoscope lens.

> The instrument is compatible with a rigid endoscope that has maximum diameter of 5.5mm and is 290mm to 300mm in length.

The ENDOPATH® Ultra-Retractor and Vessel Dissector are intended for use Intended use in dissecting and retracting in all types of surgical procedures requiring dissection and retraction of tissue.

Continued on next page

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

| Indications<br>statement | The ENDOPATH™ Ultra-Retractor has application for the creation and<br>maintenance of an operative cavity in the extraperitoneal spaces such as the<br>retroperitoneal, preperitoneal, and subcutaneous areas. The device may be<br>used in all types of surgical procedures, requiring dissection and retraction of<br>tissue. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Vessel Dissector has application for use in the blunt dissection of tubular<br>structures such as veins, arteries, nerves, and ducts. The device may also be<br>used in all types of surgical procedures requiring dissection of tissue. |
| 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. |
| Conclusion | Based on the 510(k) summaries and 510(k) statements (21 CFR §807) and<br>the information provided herein, we conclude that the New Device is<br>substantially equivalent to the Predicate Device under the Federal Food,<br>Drug and Cosmetic Act. |
| Contact | Lonnie Pace<br>Project Manager<br>Regulatory Affairs Department<br>Ethicon Endo-Surgery, Inc.<br>4545 Creek Road<br>Cincinnati, Ohio 45242 |
| Date | August 18, 1997 |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 1 3 1997

Mr. Lonnie Pace Project Manager, Regulatory Affairs Department Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

Re: K973139

> Trade Name: Endopath® Ultra-Retractor and Endopath® Vessel Dissector Regulatory Class: II Product Code: GCJ Dated: August 18, 1997 Received: August 21, 1997

Dear Mr. Pace:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 (QS) 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. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions 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. Lonnie Pace

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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,

Sincerely yours,

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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## Indications for Use Statement Appendix B

Following is the Indications for Use Statement: Statement

> 510(k) Number: K973139 Device Name:

Indications for Use:

The ENDOPATH® Ultra-Retractor has application for the creation and maintenance of an operative cavity in the extraperitoneal spaces such as the retroperitoneal, preperitoneal and subcutaneous areas. The device may be used in all types of surgical procedures requiring dissection and retraction of tissue.

The Vessel Dissector has application for use in the blunt dissection of tubular structures such as veins, arteries, nerves and ducts. The device may also be used in all types of surgical procedures requiring dissection of tissue.

Prescription Use
(Per 21 CFR 801.109)

Division Sign Off

on Sian-Off Division of General Restorative Device 510(k) Number