K Number

Device Name

Manufacturer

AOMORI OLYMPUS CO., LTD.

Date Cleared

2005-01-25

(168 days)

Product Code

LFL

Regulation Number

N/A

Type

Traditional

Panel

General & Plastic Surgery

Reference & Predicate Devices

K000095,K021962,K031305,K031523,K031710

Predicate For

N/A

Intended Use

Indications for Use of SonoSurg Trocar

This instrument has been designed to be used with the SonoSurg generator (SonoSurg-G2) and is inserted into the body cavity wall by means of ultrasonic waves under endoscopic surgery in order to coagulate and cut soft tissue as well as to place a trocar tube within the body cavity wall.

Indications for Use of SonoSurg G-2 Set

This instrument has been designed to be used with the SonoSurg transducers and the SonoSurg ultrasonic surgical instruments for soft tissue cutting and coagulation for laparoscopic and general (open) surgery in intraabdominal and obstetric/gynecologic procedures, and endoscopic and general surgery in ENT (Ears, Nose, Throat), thoracic, and urologic procedures.

This instrument may also be combined with the SonoSurg Irrigation Unit (SonoSurg-IU). Please refer to the SonoSurg-IU instruction manual to review the intended use of this combined system.

This instrument may also be combined with the SonoSurg Trocar. Please refer to the SonoSurg Trocar instruction manual to review the intended use of this combined system.

Device Description

The SonoSurg Trocar is an Ultrasonic trocar for endoscopic surgery which enable the puncture and cutting of the abdominal wall with tissue coagulation by means of ultrasonic vibration. SonoSurg Trocar is composed of two sections, the SonoSurg Trocar and the Olympus SonoSurg Generator SonoSurg-G2.

The SonoSurg Trocar is composed of a trocar transducer, dilator, valve, trocar tube, insertion sheath, probe, and Olympus SonoSurg Generator SonoSurg-G2, which provides ultrasonic vibration to the SonoSurg Trocar.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a medical device called the "SonoSurg Trocar." It's essentially a request to the FDA to market a new device by demonstrating its substantial equivalence to a device already legally on the market.

Crucially, this type of submission (510(k)) generally does NOT include new clinical studies or detailed performance data to establish acceptance criteria for the new device itself. Instead, it relies on demonstrating that the new device is as safe and effective as a legally marketed "predicate device."

Therefore, the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for this specific submission will be largely absent because it's inherent to the 510(k) pathway that such detailed, de novo clinical studies are typically not performed or required.

Here's how to address your request based on the provided document:

Acceptance Criteria and Study for SonoSurg Trocar (K042160)

This 510(k) submission for the SonoSurg Trocar does not present new acceptance criteria or a dedicated study to prove the device meets such criteria in the way you've outlined. Instead, the submission demonstrates "substantial equivalence" to a predicate device already on the market. The implied "acceptance criteria" here are that the new device performs comparably to the predicate device and does not raise new questions of safety or effectiveness.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied by 510(k) Pathway)	Reported Device Performance (Summary from Document)
Performs comparably to predicate device in terms of coagulation and cutting of tissue.	The SonoSurg Trocar is an ultrasonic trocar that enables puncture and cutting of the abdominal wall with tissue coagulation by means of ultrasonic vibration. The document states: "Theory of the operation of SonoSurg Trocar is that the electrical energy employed in the generator is changed to mechanical energy by ultrasonic vibration in the hand piece. System can cut and coagulate body tissue by ultrasonic vibration. This system is equivalent the predicate device..."
Safe for patient contact.	Biocompatibility testing was performed in accordance with ISO 10993-1 for patient-contacting parts that were not identical to the predicate device. For identical materials, a `Certificate of Identical Materials` was provided. The document states: "The test data has shown in Attachment 5-B."
Electrical safety and EMC compliance.	The Olympus SonoSurg Generator SonoSurg-G2 (part of the system) "has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirement of IEC 60601-1: 1995, IEC 60601-1-1:2000 and IEC 60601-2-18:1996, Amendment:2000."
No significant change impacting safety and efficacy compared to the predicate device.	The FDA's determination letter states: "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...". The applicant states: "...the SonoSurg Trocar does not incorporate any significant change that impacts safety and efficacy in comparison to the predicate device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission did not involve a test set for clinical performance evaluation as part of a de novo study. The FDA determined substantial equivalence based on a comparison to the predicate device's established safety and effectiveness. The biocompatibility testing likely involved standard laboratory samples, not a clinical "test set" in the context of device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment by experts for a test set was described in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method for a test set was described.

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. This document describes a surgical instrument, not an AI-assisted diagnostic device. No MRMC study was performed or described.

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

Not applicable. This device is a surgical instrument. "Standalone algorithm performance" is not relevant.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable in the context of a new clinical performance study. The "ground truth" for this 510(k) submission is implicitly the established safety and effectiveness of the predicate device (SonoSurg Trocar XT3900, K000095, and Olympus SonoSurg System, K021962/K031305/K031523/K031710). The submission argues that the new device is comparable to this established safe and effective predicate.

8. The sample size for the training set

Not applicable. This submission does not describe an AI/ML-based device requiring a training set.

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

Not applicable. This submission does not describe an AI/ML-based device requiring a training set.

Summary of the 510(k) Approach for the SonoSurg Trocar:

The core of this submission is the claim of "substantial equivalence" to existing predicate devices.

Rationale for not requiring clinical data: "When compared to the predicate device, the SonoSurg Trocar does not incorporate any significant change that impacts safety and efficacy in comparison to the predicate device. Therefore, clinical data is not necessary to establish the subject device."
Demonstration of Equivalence:
- Intended Use: The intended uses of the SonoSurg Trocar system are presented and are consistent with the predicate.
- Technological Characteristics: The theory of operation is stated to be equivalent to the predicate device.
- Design and Materials: Compliance with voluntary safety standards (IEC 60601 series) for the generator and biocompatibility testing for non-identical patient-contacting materials (ISO 10993-1) are referenced.
- Predicate Device: Clearly identifies the Olympus SonoSurg Trocar XT3900 (K000095) and the Olympus SonoSurg System (multiple 510(k)s) as predicate devices.

In essence, the "study" for this device was a comparison against established, already-cleared devices, rather than a novel clinical trial with specific performance endpoints.

Summary

{0}------------------------------------------------

JAN 2 5 2005

K 042160

SMDA 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR, Part 807, Subpart E, Section 807.92.

9614641

A. GENERAL INFORMATION

1. Applicant

Name & Address:

Registration Number:

2. Initial Importer

Name & Address:

Olympus America Inc. Two Corporate Center Drive, Melville, NY 11747-9058 2429304

Aomori Olympus Co., Ltd.

2-248-1 Okkonoki Kuroishi-shi, Aomori-ken, Japan 036-0357

Registration Number:

3. Submission Correspondence

Name, Address, Tel & Fax:

Tina Steffanie-Oak Associate Manager, Regulatory Affairs/Clinical Monitor Olympus America Inc. Two Corporate Center Drive, Melville, NY 11747-9058 TEL 631-844-5477 FAX 631-844-5554 2429304

Registration Number:

B. DEVICE IDENTIFICATION

1. Common/Usual Name Ultrasonic Surgical Instrument

2. Device Name SonoSurg Trocar

1. Classification Name No classification, class II , LFL

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C. PREDICATE DEVICES

Device Name	510(k) #	Manufacturer	Class	ProductCode
SonoSurg Trocar XT3900	#K000095	OlympusCorporation.	NoClassification	LFL
Olympus SonoSurg System	#K021962#K031305#K031523#K031710	OlympusCorporation	NoClassification	LFL

D. SUMMARY DESCRIPTION OF THE DEVICE

1. Summary

2. Design

The Olympus SonoSurg Generator SonoSurg-G2 has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirement of IEC 60601-1: 1995, IEC 60601-1-1:2000 and IEC 60601-2-18:1996, Amendment:2000.

3. Materials

Concerning the patient contacting part, some materials are identical to the predicate device. Certificate of Identical Materials is included in Attachment 5-A. As the others are not identical to the predicate device, biocompatibility testing was performed in accordance with ISO 10993-1. The test data has shown in Attachment 5-B.

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E. INTENDED USE OF THE DEVICE

SonoSurg Trocar

These instruments have been designed to be used with the SonoSurg generator (SonoSurg-G2) to be inserted into the body cavity wall by means of ultrasonic waves under endoscopic surgery in order to coagulate and cut living tissue as well as to place a trocar tube on the body cavity wall.

SonoSurg -G-2

This instrument has been designed to be used with the SonoSurg transducers and the SonoSurg ultrasonic surgical instruments to cut and coagulate soft tissue for laparoscopic and general (open) surgery in intraabdominal and obsteric/gynecologic procedure, and endoscopic and, general surgery in ENT (Ears, Nose, Throat), thoracic, and urologic procedures. This instrument may also be combined with SonoSurg Irrigation unit (SonoSurg-IU). Please refer to the SonoSurg-IU instruction manual to review the intended use of this combined svstem.

This instrument may be combined with SonoSurg Trocar. Please refer to the SonoSurg Trocar instruction manual to review the intended use of this combined system.

F. TECHNOLOGICAL CHARACTERISTICS

Theory of the operation of SonoSurg Trocar is that the electrical energy employed in the generator is changed to mechanical energy by ultrasonic vibration in the hand piece. System can cut and coagulate body tissue by ultrasonic vibration. This system is equivalent the predicate device, the Olympus SonoSurg System SonoSurg-G2(#K000095).

G. REASON FOR NOT REQUIRING CLINICAL DATA

When compared to the predicate device, the SonoSurg Trocar does not incorporate anv significant change that impacts safety and efficacy in comparison to the predicate device. Therefore, clinical data is not necessary to establish the subject device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

JAN 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aomori Olympus Co.,Ltd. c/o Ms. Laura Storms-Tyler Executive Director, RA/QA Olympus America, Inc. Two Corporate Center Drive Melville, New York 11747

Re: K042160

Trade/Device Name: SonoSurg Trocar Regulatory Class: Unclassified Product Code: LFL Dated: December 22, 2004 Received: December 30, 2004

Dear Ms. Storms-Tyler:

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. Laura Storms-Tyler

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin manceing your and equivalence of your device to a legally premaired notification: "The Pro intembly sification 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 If you desire specific at now its for your access inte the regulation entitled, Comaci the Office of Companise market notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/industry/support/index.html.

Sincerely yours,

Miriam C. Provost

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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510(k) Number (if known): __ 1 0 4 2 1 60

Device Name: SonoSurg Trocar

Indications for Use:

Indications for Use of SonoSurg Trocar

2) Indications for Use of SonoSurg G-2 Set

This instrument may also be combined with the SonoSurg Irrigation Unit (SonoSurg-IU). Please refer to the SonoSurg-IU instruction manual to review the intended use of this combined system.

This instrument may also be combined with the SonoSurg Trocar. Please refer to the SonoSurg Trocar instruction manual to review the intended use of this combined system.

L PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDEDL

Concurrence of CDRH, Office of Device EvaluationLODEL Prescription Use_ Vse_L______________OR Over-The-Counter Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)

iriam C. Provost

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

510(k) Number_K042160

Regulation Number and Section

N/A