LAGIS ENDOSCOPIC INSTRUMENTS

K090309 · Lagis Enterprises Co, Ltd. · GEI · Aug 28, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090309
• Device Name: LAGIS ENDOSCOPIC INSTRUMENTS
• Applicant: Lagis Enterprises Co, Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 28, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lagis Endoscopic Instruments are designed for use in a variety of surgical procedures to facilitate grasping, dissecting, and transecting of tissues.

Device Story

Sterile, single-use electrosurgical instrument; 4.5-5.0 mm diameter shaft for use in 6mm+ trocars. Features rotating shaft (360 degrees) and handle-actuated jaws/scissors. Monopolar electrical connector links to external HF generator. Used by surgeons in endoscopic procedures. Device facilitates tissue manipulation and electrosurgical cutting/coagulation. Benefits include precise tissue access and control during minimally invasive surgery.

Clinical Evidence

Bench testing only. Evaluated unit packaging integrity, functional performance (tip rotation, grasping force, cutting capability), shaft sturdiness, and electrical safety. Materials tested for cytotoxicity, sensitization, intracutaneous reactivity, and systemic toxicity per ISO 10993 and FDA G-95 standards.

Technological Characteristics

Monopolar electrosurgical instrument; 4.5-5.0 mm shaft; manual handle actuation; 360-degree rotation. Materials biocompatibility per ISO 10993. Single-use. No software or electronic processing components.

Indications for Use

Indicated for use in surgical procedures to facilitate grasping, dissecting, and transecting of tissues. No specific patient population, age, or gender restrictions provided.

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

• Auto Suture ENDO Clinch II (K951589)
• ConMed Graspers & Scissors (K924469)

Submission Summary (Full Text)

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### 510(k) SUMMARY

K090309

Pre-market Notification for Lagis Endoscopic instruments

# 1. Submitter's Name

LAGIS ENTERPRISE CO. LTD. No. 33, Lane 908, Sect. I, Jhongshan Road Dajia, Taichung TAIWAN Zip Code; 437 Joanne Chen, Manager, R&D Contact Person:

## 2. Name of Device

| Common/Usual Name: | Electrosurgical instruments |
|----------------------|------------------------------------------------------|
| Proprietary Name: | Lagis Endoscopic Instruments |
| Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Regulation Number: | CFR 878.4400 |
| Product Code: | GEI |

## 3. Predicate Device

| Device Name | 510(k) Number | Clearance Date |
|----------------------------|---------------|----------------|
| Auto Suture ENDO Clinch II | K951589 | 05/03/1995 |
| ConMed Graspers & Scissors | K924469 | 04/07/1993 |

## 4. Device Description

The Lagis Endoscopic Instruments is a sterile, single use device having an insulated shaft with a diameter of 4.5-5.0 mm for use in 6mm and larger size trocar. The shaft can be rotated through the actions of a roller knob. A pair of plastic handles manipulates closing or opening of the tip scissors or graspers. An electrical connector allows for connection of the instrument to a generator for electrosurgical applications.

## 5. Indication for Use

The Lagis Endoscopic Instruments are designed for use in a variety of surgical procedures to facilitate grasping, dissecting, and transecting of tissues.

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#### Technological Characteristics 6.

Same as predicate devices, when the handles of the Lagis Endoscopic Instruments are compressed or released, the instrument jaws or scissor blades close or open accordingly. The rotating knob located on the handle can be turned for rotating the shaft 360 degrees in either direction. A monopolar electrical connector extending from the handle allows for connection with a standard cable to a proper HF generator. Due to different functional requirements, the tip can be of various designs such as straight scissors, curved scissors, and graspers, etc. The materials of construction are similar to the predicate devices and are satisfactorily tested for cytotoxicity, sensitization, intracutaneous reactivity and systematic toxicity per ISO 10993 and US FDA G-95 requirements

## 7. Performance Summary

Performance bench tests were carried out to verify design characteristics and to ensure that the device can be used as intended. The studies included testing of unit packaging integrity, functional and performance characteristics, as well as electrical safety of the devices. Test results demonstrated acceptable results with respect to predicate devices in tip rotation, shaft sturdiness, shaft dielectric strength, grasping force, and cutting capability of the instrument, etc.

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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 features a stylized depiction of an eagle or bird with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Lagis Enterprises Co., Ltd. % Innomedtech LLC Joseph J. Chang, Ph.D. Consultant 7128 Staffordshire Street Houston, Texas 77030

AUG 2 8 2009

Re: K090309

Trade Name: Lagis Endoscopic Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 20, 2009 Received: July 22, 2009

Dear Dr. Chang:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 - Joseph J. Chang, Ph.D.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/MedicalDevices/Resourcesfor You/Industry/default}htm.

Sincerely yours,

for

Mark N. Melkerson
Director

Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) Number (if known): K090309

Device Name: Lagis Endoscopic Instruments

## Indication for Use:

The Lagis Endoscopic Instruments are designed for use in a variety of surgical procedures to facilitate grasping, dissecting, and transecting of tissues.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Lawrence P. Payne

(Division Sign-Off) Division of Surgical, Orthopedic. and Restorative Devices

510(k) Number K090309