ENDOPATH ENDOSCOPIC INSTRUMENTS

K984240 · Ethicon Endo-Surgery, Inc. · GEI · Jun 22, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K984240
• Device Name: ENDOPATH ENDOSCOPIC INSTRUMENTS
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 22, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ENDOPATH Endoscopic Instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection and transection of tissue.

Device Story

ENDOPATH Endoscopic Instruments are sterile, single-patient-use laparoscopic tools. Device features rotating insulated shaft (3mm, 5mm, or 10mm diameter) with 360-degree rotation knob. Ring handles activate jaws or scissor blades. Curved scissors and dissectors include monopolar cautery connector for electrosurgery when attached to standard cautery cable and generator. Used by surgeons in minimally invasive procedures to facilitate tissue manipulation and transection. Device provides mechanical grasping/cutting and electrical cauterization to assist in surgical workflows.

Clinical Evidence

Bench testing only. Pre-clinical studies evaluated ergonomics, tissue trauma, grasping, dissecting, cauterizing, and cutting performance. Results demonstrated performance equivalent to the predicate device.

Technological Characteristics

Sterile, single-use laparoscopic instruments. Rotating insulated shaft (3mm, 5mm, 10mm). Monopolar electrosurgical capability via integrated connector. Mechanical actuation via ring handles. No software or electronic processing components.

Indications for Use

Indicated for use in minimally invasive surgical procedures for grasping, mobilization, dissection, and transection of tissue. Prescription use only.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• ENDOPATH Endoscopic Instruments (K910831)

Submission Summary (Full Text)

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# K 984240

JUN 22 2 1999

## 510(k) Summary of Safety and Effectiveness

| Submitter | Ethicon Endo-Surgery, Inc.<br>4545 Creek Rd.<br>Cincinnati, OH 45242 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Jackie A. Strasser, MT (ASCP), MS<br>Regulatory Affairs Associate<br>Telephone [phone] Fax [phone] |
| Date | November 23, 1998 |
| New Device | <ul><li>Name: ENDOPATH® Endoscopic Instruments</li><li>Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories</li><li>Common Name: Laparoscopic Surgical Instruments</li><li>Trade Name/Proprietary Name: ENDOPATH® Endoscopic Instruments</li></ul> |
| Legally<br>marketed<br>device | The Predicate Device legally marketed under K910831:<br>[Symbiosis] ENDOPATH Endoscopic Instruments |
| Device<br>description | The ENDOPATH Endoscopic Instruments are sterile, single patient use instruments designed for use through appropriate ENDOPATH Surgical Trocars and FLEXIPATH® Flexible Surgical Trocars. The instruments have a rotating insulated shaft with a diameter of either 3mm, 5mm or 10mm. The rotation knob located on the handle rotates the shaft 360 degrees in either direction. The ring handles are compressed and released to activate the instrument jaws or scissor blades. Each of the curved scissors and dissectors has a monopolar cautery connector that extends from the top of the handle. The connector is used for electrosurgery when properly attached to a standard cautery cable and a proper generator. |

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

| Intended use | The ENDOPATH Endoscopic Instruments have application in a variety of<br>minimally invasive procedures to facilitate grasping, mobilization, dissection<br>and transection 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 data were used to evaluate the performance to ensure that the<br>device can be used as designed. The studies demonstrated acceptable<br>performance to the Predicate Device in reliability and design. The<br>performance evaluated are ergonomics of the handle and rotating knob tissue<br>trauma, grasping, dissecting, cauterizing ability and cutting ability. From the<br>date generated, it can be concluded that the New Device performs equivalent<br>to the Predicate Device. |
| Conclusion | Based on the information provided herein and the Decision-Making Process<br>Chart (Appendix E), we conclude that the New Device is substantially<br>equivalent to the Predicate Device under the Federal Food, Drug and<br>Cosmetic Act. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 22 1999

Ms. Jackie A. Strasser, MT (ASCP), MS Associate, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

Re: K984240

. .

Trade Name: ENDOPATH® Endoscopic Instruments Regulatory Class: II Product Code: GEI Dated: March 22, 1999 Received: March 24, 1999

Dear Ms. Strasser:

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 (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 - Ms. Jackie A. Strasser, MT (ASCP), MS

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 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 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,

focottefa

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 A

The following is the Indications for Use Statement: Statement

> 510(k) Number: K 984240 Device Name: ENDOPATH Endoscopic Instruments

Indications for Use:

The ENDOPATH Endoscopic Instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection and transection of tissue.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | X |
|------------------------------------------|---|
|------------------------------------------|---|

OR

Over-The-Counter-Use (Optional Format 1-2-96)

.; ''

Pcostelo

(Division Sign-Off) Division of General Restorative Devices 510(k) Number