(168 days)
The provided text does not contain any Reference Devices or their K/DEN numbers. The section "Reference Device(s)" clearly states "Not Found".
No
The document describes an ultrasonic surgical device for cutting and coagulation, with no mention of AI or ML capabilities in its intended use, device description, or performance studies.
Yes
The device is described as an instrument used in surgical procedures to cut and coagulate tissue, as well as to place a trocar tube within the body, which are direct interventions for treating medical conditions.
No
The device is described as an ultrasonic surgical instrument used for cutting, coagulation, and tissue manipulation during endoscopic and general surgery. Its functions are entirely therapeutic, not diagnostic.
No
The device description clearly outlines hardware components like a trocar transducer, dilator, valve, trocar tube, insertion sheath, probe, and a generator. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The SonoSurg Trocar and SonoSurg G-2 Set are described as surgical instruments used for cutting and coagulating soft tissue during various surgical procedures. They are used directly on the patient's body, not for analyzing specimens outside the body.
- Intended Use: The intended uses clearly state surgical applications (endoscopic, laparoscopic, open surgery) for cutting and coagulation of tissue within the body.
Therefore, the function and intended use of this device fall under the category of surgical instruments, not In Vitro Diagnostics.
N/A
Intended Use / Indications for 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.
2) 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.
Product codes
LFL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body cavity wall, intraabdominal, ENT (Ears, Nose, Throat), thoracic, urologic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
#K000095, #K021962, #K031305, #K031523, #K031710
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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
-
- Common/Usual Name Ultrasonic Surgical Instrument
2. Device Name SonoSurg Trocar
-
- Classification Name No classification, class II , LFL
1
C. PREDICATE DEVICES
| Device Name | 510(k) # | Manufacturer | Class | Product
Code |
|-------------------------|----------------------------------------------|-------------------------|----------------------|-----------------|
| SonoSurg Trocar XT3900 | #K000095 | Olympus
Corporation. | No
Classification | LFL |
| Olympus SonoSurg System | #K021962
#K031305
#K031523
#K031710 | Olympus
Corporation | No
Classification | LFL |
D. SUMMARY DESCRIPTION OF THE DEVICE
1. Summary
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.
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.
2
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.
3
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.
4
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
5
510(k) Number (if known): __ 1 0 4 2 1 60
Device Name: SonoSurg Trocar
Indications for 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.
2) 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.
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