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 laparoscopic and intrabdominal procedures in general (open) surgery. Also it has been designed to be used with them to cut and coagulate soft tissue for open and endoscopic procedures in ENT(Ears, Nose, Throat) 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 open and endoscopic procedures in ENT(Ears, Nose, Throat) surgery.

AI/ML Overview

This document is a 510(k) summary for the Olympus Ultrasonic Surgical System. It's a premarket notification for a medical device seeking clearance from the FDA, asserting substantial equivalence to previously cleared devices.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device's design and technological characteristics but does not explicitly state specific acceptance criteria (e.g., performance thresholds of a certain metric). Instead, it focuses on demonstrating that the device meets safety standards and operates on the same principles as its predicate devices.

Acceptance Criterion	Reported Device Performance
Safety Standards Adherence	Designed, manufactured, and tested in compliance with Voluntary Safety Standards (IEC 60601-1, IEC60601-1-1, IEC60601-1-2).
Material Equivalence	No new patient-contacting materials introducing new risks.
Technological Equivalence (Theory of Operation)	Theory of operation (electrical energy to ultrasonic vibration for tissue cutting/coagulation) is the same as predicate devices.
Intended Use Equivalence	Intended use (cutting and coagulating soft tissue for open, endoscopic, laparoscopic, and intra-abdominal procedures in general and ENT surgery) is consistent with predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly 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."

This means:

Sample size for the test set: Not applicable, as no external test set or clinical study was conducted for this 510(k) submission.
Data provenance: Not applicable.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable, as no clinical study or test set requiring expert ground truth was conducted for this 510(k) submission.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical study or test set requiring adjudication was conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The submission explicitly states that clinical data was not necessary due to substantial equivalence to predicate devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a surgical instrument system, not an AI algorithm. Its performance is inherent to its physical design, materials, and operating principle, which are compared to existing, cleared devices.

7. Type of Ground Truth Used:

Not applicable. The "ground truth" in this context is the safety and efficacy established for the predicate devices through prior regulatory clearances and adherence to recognized safety standards. The new device demonstrates equivalence to this established performance.

8. Sample Size for the Training Set:

Not applicable, as this is a physical medical device and not an AI/machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

In summary:

This 510(k) submission for the Olympus Ultrasonic Surgical System relies on demonstrating substantial equivalence to already cleared predicate devices. The core argument is that the device has the same intended use, similar technological characteristics, and adheres to the same safety standards, with no significant changes to safety or efficacy. Therefore, no new clinical studies, test sets, or ground truth establishment (as would be typical for a novel diagnostic or AI device) were deemed necessary by the submitter and subsequently agreed upon by the FDA for clearance.

Summary

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K 031305 1/2

510(k) SUMMARY Olympus Ultrasonic Surgical System

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. General Information

1. Applicant	Aomori Olympus Co., Ltd.2-248-1, OkkonokiKuroishi-shi, Aomori-ken,036-0357 Japan(Registration No .: 9614641)
2. Submission Correspondent	Mayumi IshiiOlympus Optical Co., Ltd.2951 Ishikawa-cho, Hachioji-shi,Tokyo 192-8507, JapanTEL: 81-426-42-2891FAX: 81-426-42-2291(Registration No .: 8010047)
3. Official Correspondent	Tina Steffanie-OakSenior R.A. AnalystOlympus America Inc.Two Corporate Center Drive, Melville,NY 11747-3157TEL: 631-844-5477FAX: 631-844-5554E-mail: Tina.Steffanie-Oak@olympus.com( Registration No .: 2429304)

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 :

#K012176 Harmonic Scalpel #K972114 Olympus SonoSurg Scissors Set T3000 #K972114 Olympus Transducer MAJ-336 #K000095 SonoSurg Generator Set SonoSurg-G2 Set

D. Summary Description of the Device

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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 open and endoscopic procedures in ENT(Ears, Nose, Throat) 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 laparoscopic and intraabdominal procedures in general(open) surgery. Also it has been designed to be used with them to cut and coagulate soft tissue for open and endoscopic procedures in ENT(Ears. Nose, Throat) 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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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The eagle is depicted in a simple, bold line drawing style.

Public Health Service

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 2003

Olympus Optical Co., Ltd c/o Ms. Tina Steffanie-Oak Senior R.A. Analyst Olympus America, Inc. Two Corporate Center Drive Melville, New York 11747-3157

Re: K031305

Trade/Device Name: Olympus Ultrasonic Surgical System Regulatory Class: Unclassified Product Code: LFL Dated: July 25, 2003 Received: July 29, 2003

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). 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 (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

510(k) Number(if known): _ Not assigned yet. K 0 3 13 0 5 Device Name: Olympus Ultrasonic Surgical System

Indications for Use :

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Prescription 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Miriam C. Provost

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

510(k) Number K63/305

Regulation Number and Section

N/A