(92 days)
Not Found
No
The provided text describes a traditional ultrasonic surgical system and does not mention any AI or ML components or functionalities.
No
The device is described as an ultrasonic surgical system intended to dissect, fragment, emulsify, and aspirate tissue, which are surgical procedures, not therapeutic treatments.
No
The "Intended Use / Indications for Use" section states that the system is "intended to dissect, fragment, emulsify, and aspirate tissue," which describes a surgical function, not a diagnostic one.
No
The device description explicitly lists multiple hardware components including a generator, irrigation unit, transducers, and surgical instruments.
Based on the provided information, the Olympus SonoSurg System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is used to "dissect, fragment, emulsify, and aspirate tissue" for various surgical procedures. This describes a device used on the patient during surgery, not a device used to test samples from the patient outside of the body.
- Device Description: The description reinforces the surgical nature of the device, listing components like a generator, irrigation unit, transducers, and surgical instruments.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Olympus SonoSurg System's function is entirely surgical and therapeutic, not diagnostic.
N/A
Intended Use / Indications for Use
The Olympus SonoSurg System consists of the SonoSurg Generator (SonoSurg-G2 Set), SonoSurg Irrigation Unit (SonoSurg-IU), SonoSurg Transducers (SonoSurg-T2L-GE, SonoSurg-T2L-GE-C), and SonoSurg ultrasonic surgical instruments and surgical suction devices (T3000 Series). This system is intended to dissect, fragment, emulsify, and aspirate tissue for General Surgery, Laparoscopic Surgery, Plastic and Reconstructive Surgery, and Urological Surgery. This system may also be combined with electrosurgery using Olympus Model UES-20 or UES-30 Electrosurgical Units.
Product codes (comma separated list FDA assigned to the subject device)
LFL
Device Description
The Olympus SonoSura System has been designed and tested in compliance with voluntary safety standards. It meets the requirement of IEC 60601-1, IEC 60601-1-1 and IEC 60601-2-2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
#K021962, #K981262, #K010309, #K962952
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 032066
OCT - 3 2003
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.
A. GENERAL INFORMATION
1. Applicant
| Name & Address: | Aomori Olympus Co., Ltd. 2-248-1 Okkonoki Kuroishi-shi, Aomori-ken, Japan 036-0357 |
|---|---|
| Registration Number: | 9614641 |
- Initial Importer
| Name & Address: | Olympus America Inc. Two Corporate Center Drive, Melville, NY 11747-3157 |
|---|---|
| Registration Number: | 2429304 |
- Submission Correspondence
| Name, Address, Tel & Fax, Contact: | Olympus America Inc. Two Corporate Center Drive, Melville, NY 11747-3157 TEL 631-844-5477 FAX 631-844-5416 Tina Steffanie-Oak, Senior RA Analyst |
|---|---|
| Registration Number: | 2429304 |
B. DEVICE IDENTIFICATION
1. Common/Usual Name
Surgical System
2. Device Name
Olympus SonoSurg System
3. Classification Name
| CFR Number | Classification Name | Class | Product Code |
|---|---|---|---|
| Not established | Ultrasonic Surgical Instrument | II | LFL |
1
C. IDENTIFICATION OF LEGALLY MARKETED DEVICES WHICH WE CLAIM SUBSTANTIAL EQUIVALENCE
| Model | 510(k)# | Manufacturer | Class | Product
Code |
|----------------------------------------------------|----------|---------------------------|-------|-----------------|
| Olympus Ultrasonic
Surgical System | #K021962 | Olympus | II | LFL |
| CUSA Excel Ultrasonic
Surgical Aspirator System | #K981262 | Valleylab | II | LFL |
| SONOPET UST-2001 Ultra
Surgical Aspirator | #K010309 | Miwatec | II | LFL |
| Ultrasonic Surgical System | #K962952 | Olympus Optical Co., Ltd. | II | LBK |
Please see abbreviated comparison table of SonoSurg System and Predicate Devices.
D. DEVICE DESCRIPTION
1. Summary
In conclusion, the subject device is substantially equivalent to the predicate devices. A comparison table of the subject device and predicate devices is found in Attachment 2-A.
2. Design
The Olympus SonoSura System has been designed and tested in compliance with voluntary safety standards. It meets the requirement of IEC 60601-1, IEC 60601-1-1 and IEC 60601-2-2.
3. Materials
All the patient contacting materials used in this system are identical materials that have been cleared in the past 510(k) submissions. All materials have been confirmed with ISO 10993-1.
3. Intended Use of the device
The Olympus SonoSurg System consists of the SonoSurg Generator (SonoSurg-G2 Set), SonoSurg Irrigation Unit (SonoSurg-IU), SonoSurg Transducers (SonoSurg-T2L-GE, SonoSurg-T2L-GE-C), and SonoSurg ultrasonic surgical instruments and surgical suction devices (T3000 Series). This system is intended to dissect, fragment, emulsify, and aspirate tissue for General Surgery, Laparoscopic Surgery, Plastic and Reconstructive Surgery, and Urological Surgery. This system may also be combined with electrosurgery using Olympus Model UES-20 or UES-30 Electrosurgical Units.
5. Summary including conclusion drawn from Non-clinical Tests
When compared to the Olympus Ultrasonic Surgical System(#K021962), CUSA EXcel Ultrasonic Surgical Aspirator System(#K981262), SONOPET UST-2001 Ultra Surgical Aspirator(#K010309) and Ultrasonic Surgical System(#K962952), the Olympus Surgical System does not incorporate any significant changes in the intended use, method of operation, material, or design that could affect safety and effectiveness. Therefore clinical data is not necessary for its evaluation of safety and efficacy.
2
EPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Public Health Service
OCT - 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
The Olympus Optical Company c/o Ms. Tina Steffanie-Oak Associate Manager, Regulatory Affairs/Clinical Monitor Olympus America, Inc. Two Corporate Center Drive Melville, New York 11747-3157
Re: K032066
Trade/Device Name: Olympus SonoSurg System Regulatory Class: Unclassified Product Code: LFL Dated: July 3, 2003 Received: July 7, 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.
3
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.
Mark A Milham
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. Below the word, there is a thin, horizontal line with some illegible text.
Indications for Use Statement
510(k) Number (if known): K032066 Device Name: Olympus SonoSurg System
Indications for Use :
The Olympus SonoSurg System consists of the SonoSurg Generator (SonoSurg-G2 Set), SonoSurg Irrigation Unit (SonoSurg-IU), SonoSurg Transducers (SonoSurg-T2L-GE, SonoSurg-T2L-GE-C), and SonoSurg ultrasonic surgical instruments and surgical suction devices (T3000 Series). This system is intended to dissect, fragment, emulsify, and aspirate tissue for General Surgery, Laparoscopic Surgery, Plastic and Reconstructive Surgery, and Urological Surgery. This system may also be combined with electrosurgery using Olympus Model UES-20 or UES-30 Electrosurgical Units.
(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)
ાર
Over-The-Counter Use
(Prescription 21 CFR 801.109)
Mark N. Millerson
(Optional Format 1-2-96)
(Division Sign Off)
Cheral, Restorative and Neurological Devices
510(k) Number K032066