OLYMPUS ULTRASONIC SURGICAL SYSTEM

K021962 · The Olympus Optical Co. · LFL · Feb 12, 2003 · SU

Device Facts

• Record ID: K021962
• Device Name: OLYMPUS ULTRASONIC SURGICAL SYSTEM
• Applicant: The Olympus Optical Co.
• Product Code: LFL · SU
• Decision Date: Feb 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Olympus Ultrasonic Surgical System has been designed to be used with the Olympus SonoSurg Generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for open and endoscopic procedures in general surgery. Also it has been designed to be used with them to cut and coagulate soft tissue for obstetric/gynecologic surgery, and for open and laparoscopic surgery.

Device Story

System comprises SonoSurg scissors/hooks, SonoSurg-T2H transducer, and SonoSurg-G2 generator. Generator converts electrical energy into mechanical ultrasonic vibration via transducer; vibration used to cut and coagulate soft tissue. Used in OR by surgeons for open and endoscopic procedures. System integrates with electrosurgical units. Provides mechanical cutting/coagulation effect; benefits patient through precise tissue management during surgery.

Clinical Evidence

Bench testing only; no clinical data provided. Device demonstrated substantial equivalence through design and performance comparisons to predicate devices.

Technological Characteristics

Ultrasonic surgical system; converts electrical energy to mechanical ultrasonic vibration. Components: SonoSurg-G2 generator, SonoSurg-T2H transducer, and various 5mm O.D. scissors/hooks. Complies with IEC 60601-1, IEC 60601-1-1, and IEC 60601-1-2 safety standards. No new patient-contacting materials.

Indications for Use

Indicated for cutting and coagulating soft tissue during open, endoscopic, laparoscopic, and obstetric/gynecologic surgical procedures.

Predicate Devices

• Harmonic Scalpel (K002981)
• Olympus SonoSurg Scissors Set T3000 (K972114)
• Hand piece (K990430)
• Olympus Transducer MAJ-336 (K972114)
• SonoSurg Generator Set SonoSurg-G2 Set (K000095)

Submission Summary (Full Text)

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### 510(k) SUMMARY Olympus Ultrasonic Surgical System

# KO21962

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Section 807.92.

#### A. Submitter's Name, Address, Phone and Fax Number

#### 1. Manufacturer of the subject device

| Name & Address of Manufacturer ; | Olympus Optical Co,. Ltd.<br>2-3-1 Shinjuku Monolis Nishi-shinjuku,<br>Shinjuku-ku, Tokyo, 163-0914<br>Japan |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Registration No : | 8010047 |
| Address, Phone and Fax Number<br>of R&D Department<br>Endoscope Division | 12951 Ishikawa-cho<br>Hachioji-shi, Tokyo 192-8507<br>Japan<br>TEL [phone]<br>FAX [phone] |
| 2 Name of Contact Person<br>Name : | Ms. Laura Storms-Tyler<br>Director, Regulatory Affairs<br>Olympus America Inc. |
| Address, Phone and Fax | Two Corporate Center Drive<br>Melville, NY 11747-3157<br>Japan<br>TEL [phone]<br>FAX [phone] |
| B. Device Name, Common Name | |
| 1. Device Name : | Olympus Ultrasonic Surgical System |
| 2. Common/Usual Name : | Ultrasonic Surgical System |
| 3. Classification Name : | Class II Instrument, Ultrasonic Surgical LFL |

#### C. Predicate Devices :

| #K002981 | Harmonic Scalpel |
|----------|----------------------------------------|
| #K972114 | Olympus SonoSurg Scissors Set T3000 |
| #K990430 | Hand piece |
| #K972114 | Olympus Transducer MAJ-336 |
| #K000095 | SonoSurg Generator Set SonoSurg-G2 Set |

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#### D. Summary Description of the Device

#### 1. Summary

The Olympus Ultrasonic Surgical System is composed of three sections, (1), (2), and (3).

- (1) Olympus SonoSurg Scissors 5mm O.D. T3050" or "Olympus SonoSurg Long Hook 5mm O.D. T3060" or "Olympus SonoSurg Long Scissors 5mm O.D. T3070", or "Olympus SonoSurg Scissors 5mm O.D., HF Series.
- (2) Olympus SonoSurg Transducer SonoSurg-T2H.
- (3) Olympus SonoSurg Generator Set SonoSurg-G2 Set (SonoSurg-G2, MAJ-51).

This device is intended to cut and coagulate soft tissue for obstetric/ gynecologic surgery, and for open and laparoscopic surgery.

#### 2. Design

"Olympus Ultrasonic Surgical System" has been designed, manufactured and tested in compliance with Voluntary Safety Standards. It meets the requirements of IEC 60601-1, IEC60601-1-1,IEC60601-1-2.

#### 3. Materials

There are no new patient-contacting materials.

#### E. Intended Use of the device

Olympus Ultrasonic Surgical System has been designed to be used with the Olympus SonoSurg Generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for open and endoscopic procedures in general surgery. Also it has been designed to be used with them to cut and coagulate soft tissue for obstetric/gynecologic surgery, and for open and laparoscopic surgery.

#### F. Technological Characteristics

Theory of the operation of "Olympus Ultrasonic Surgical System" is that the electrical energy employed in the "Olympus SonoSurg-G2" is changed to mechanical energy by ultrasonic vibration in the "Olympus SonoSurg Transducer SonoSurg-T2H". Therefore, this system can cut and coagulate body tissue by ultrasonic vibration. This system is the same as the Predicate Devices which include, "Olympus SonoSurg Scissors Set T3000(#K972114)", "Olympus Transducer MAJ-336 (#K972114)" and "Olympus SonSurg-G2 (#K000095)".

#### G. Reason for not requiring clinical data

When compared to the predicate devices, "Olympus Ultrasonic Surgical System" does not incorporate any significant changes that would effect safety or efficacy. Therefore clinical data is not necessary for its evaluation of safety.

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Public Health Service

Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle.

FEB 1 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

The Olympus Optical Company Tina Steffanie-Oak Senior Regulatory Affairs Specialist 2 Corporate Center Drive Melville, New York 11747

Re: K021962

Trade/Device Name: Olympus Ultrasonic Surgical System Regulation Name: Ultrasonic surgical system Regulatory Class: Unclassified Product Code: LFL Dated: November 8, 2002 Received: November 18, 2002

Dear Ms. Steffanie-Oak:

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 such 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); 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 - Ms. Tina Steffanie-Oak

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

Enclosure

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## Indications for Use Statement

KO 21962 510(k) Number(if known): Not-assigned-yet. Device Name: Olympus Ultrasonic Surgical System

#### Indications for Use :

OLYMPUS Ultrasonic Surgical System has been designed to be used with the Olympus SonoSurg Generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for open and endoscopic procedures in general surgery. Also it has been designed to be used with them to cut and coagulate soft tissue for obstetric/gynecologic surgery, and for open and laparoscopic surgery.

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use レ OR (Prescription 21 CFR 801.109)

Over - The - Counter Use