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 Description

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.

AI/ML Overview

This 510(k) summary for the Olympus Ultrasonic Surgical System (K021962) explicitly states that clinical data was not required for its evaluation of safety and efficacy.

Therefore, the study that proves the device meets acceptance criteria, and many of the associated details you requested, are not provided in this document. The decision was based on a finding of "substantial equivalence" to predicate devices, implying that the new device does not incorporate any significant changes that would affect safety or efficacy when compared to existing, legally marketed devices.

Here's a breakdown of what can be extracted from the provided text according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable/Not provided. The document states: "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."

The "acceptance criteria" are implied to be the standards met by the predicate devices and the voluntary safety standards the new device complies with.

Acceptance Criteria (Implied)	Reported Device Performance
Meets requirements of IEC 60601-1, IEC60601-1-1, IEC60601-1-2.	Designed, manufactured, and tested in compliance. Meets requirements.
Substantially equivalent to predicate devices (#K002981, #K972114, #K990430, #K000095) in terms of safety and efficacy.	Demonstrated substantial equivalence through comparison. Does not incorporate significant changes affecting safety or efficacy.
No new patient-contacting materials.	Confirmed.
Functions to cut and coagulate soft tissue by ultrasonic vibration.	Theory of operation is consistent with predicate devices. Functions as intended.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided. No clinical test set was used. The substantial equivalence determination was based on design, materials, and functional characteristics compared to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. No clinical test set or ground truth established by experts was used.

4. Adjudication method for the test set

Not applicable/Not provided. No clinical test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not provided. This device is an ultrasonic surgical system, not an AI-assisted diagnostic or interpretative tool that would involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable/Not provided. This is a surgical device, not an algorithm.

7. The type of ground truth used

Not applicable/Not provided. No clinical ground truth was established as no clinical study was performed. The "ground truth" for the device's acceptable performance is its substantial equivalence to previously cleared devices and compliance with relevant safety standards.

8. The sample size for the training set

Not applicable/Not provided. No AI/machine learning model, therefore no training set.

9. How the ground truth for the training set was established

Not applicable/Not provided. No AI/machine learning model, therefore no training set or ground truth for it.

In summary: The Olympus Ultrasonic Surgical System (K021962) received 510(k) clearance based on its substantial equivalence to existing predicate devices and adherence to recognized safety standards (IEC 60601 series). No specific clinical study or data related to acceptance criteria, test sets, or expert-established ground truth was required or performed for this premarket notification.

Summary

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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.2-3-1 Shinjuku Monolis Nishi-shinjuku,Shinjuku-ku, Tokyo, 163-0914Japan
Registration No :	8010047
Address, Phone and Fax Numberof R&D DepartmentEndoscope Division	12951 Ishikawa-choHachioji-shi, Tokyo 192-8507JapanTEL 81-426-42-5101FAX 81-426-46-2786
2 Name of Contact PersonName :	Ms. Laura Storms-TylerDirector, Regulatory AffairsOlympus America Inc.
Address, Phone and Fax	Two Corporate Center DriveMelville, NY 11747-3157JapanTEL (631)844-5688FAX (631)844-5416
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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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 :

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use レ OR (Prescription 21 CFR 801.109)

Over - The - Counter Use

Regulation Number and Section

N/A