(152 days)
Not Found
No
The summary describes a traditional ultrasonic surgical system for cutting and coagulating tissue, with no mention of AI or ML capabilities in the intended use, device description, or specific sections for AI/ML information.
No.
The device is used to cut and coagulate soft tissue, which are surgical functions, not therapeutic ones.
No
The device is an ultrasonic surgical system designed to cut and coagulate soft tissue, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly lists hardware components (scissors, transducer, generator set) that are integral to the device's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to "cut and coagulate soft tissue" during surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The description details a surgical system composed of scissors, a transducer, and a generator. These are all components used for physical manipulation of tissue during surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is a surgical tool used on the patient, not a diagnostic tool used on patient samples.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
LFL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K012176, K972114, K972114, K000095
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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, Okkonoki
Kuroishi-shi, Aomori-ken,
036-0357 Japan
(Registration No .: 9614641) |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Submission Correspondent | Mayumi Ishii
Olympus Optical Co., Ltd.
2951 Ishikawa-cho, Hachioji-shi,
Tokyo 192-8507, Japan
TEL: 81-426-42-2891
FAX: 81-426-42-2291
(Registration No .: 8010047) |
| 3. Official Correspondent | Tina Steffanie-Oak
Senior R.A. Analyst
Olympus America Inc.
Two Corporate Center Drive, Melville,
NY 11747-3157
TEL: 631-844-5477
FAX: 631-844-5554
E-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
1
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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Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, black letters. The font is sans-serif and the letters are closely spaced together. The word is centered and takes up most of the frame.
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 :
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ==============================================================================================================================================================================
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
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