(122 days)
K#801623, K#910696, K#921251, K#950945, K#883091
Not Found
No
The document describes a traditional ultrasonic surgical aspirator and does not mention any AI or ML components or functionalities.
Yes.
The device is used for "smashing and aspirating disease tissues" and "fragmentation, emulsification, and aspiration of soft tissue" to treat conditions like "cerebral tumor, cerebral hematoma, cerebral aneurysm/varicosity," which are therapeutic applications.
No
The device is described as an ultrasonic system used for the fragmentation, emulsification, and aspiration of soft tissue in neurosurgery, specifically to smash and aspirate diseased tissues like cerebral tumors or hematomas. This describes a surgical tool, not a device used to acquire, process, or analyze medical images or signals for the purpose of making a diagnosis.
No
The device description explicitly details hardware components like a hand piece, ultrasound actuator, probe, and sheath, which are integral to its function of smashing and aspirating tissue. This is not a software-only device.
Based on the provided text, the Olympus USU is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "smash and aspirate disease tissues in the Neuro surgery field." This describes a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a device that uses ultrasonic vibration to fragment and aspirate tissue in situ during surgery. It's a surgical tool, not a diagnostic test.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples outside the body).
- Providing diagnostic information based on the analysis of these samples.
- Using reagents or assays.
The device is clearly described as a surgical instrument used for tissue removal during neurosurgery.
N/A
Intended Use / Indications for Use
The Olympus Ultrasonic System is indicated for use in the fragmentation, emulsification, and aspiration of soft tissue in the neurosurgery field.
Product codes
Not Found
Device Description
The Olympus USU is specially designed for open procedure in the Neurosurgery field, in order to smash and aspirate disease tissue such as cerebral tumor, cerebral hematoma, cerebral aneurysm/varicosity.
Actuation mechanisms of the above systems is the same as the USU based as the following:
The small ultrasound vibration which is generated by the ultrasound actuator built-in hand piece, is transferred to the probe which is mounted on the edge of hand piece. The tissue is smashed by the shock force exchanged from the vibration on the probe with pushing to the tissue.
The smashed tissue is taken out by the suction space between the probe and sheath of hand piece.
The Olympus USU mainly is used in microscopic surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue in the neurosurgery field
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.
Cavitron Ultrasonic Surgical Aspirator CUSA® Type NS-100 (K#801623), CUSA® System 200c/200t/200m/200h Ultrasonic Aspirator (K#910696), CUSA® System 200c and 200t Ultrasonic Aspirator (K#921251), Cooper Laser Sonics CUSA® Model 200 (K#950945), Sharplan ULTRA Ultrasonic Aspirator (K#883091)
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
Not Found
N/A
0
NEW YORK ACADEMY OF MEDICINE
EXHIBIT #1 Page 1 of 3
510(K) SUMMARY OLYMPUS ULTRASOUND SURGICAL SYSTEM
NOV 29 1996
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K962952
| Device Name: | Olympus Ultrasonic Surgical System |
|---|---|
| Common/Usual Name: | Olympus USU |
| Classification Name: | Ultrasonic Surgical System/Ultrasonic Aspirator |
| Predicate Devices: | Cavitron Ultrasonic Surgical Aspirator CUSA® Type NS-100 |
| (K#801623) | |
| CUSA® System 200c/200t/200m/200h Ultrasonic | |
| Aspirator (K#910696) | |
| CUSA® System 200c and 200t Ultrasonic Aspirator | |
| (K#921251) | |
| Cooper Laser Sonics CUSA® Model 200 (K#950945) | |
| Sharplan ULTRA Ultrasonic Aspirator (K#883091) | |
| Prepared By: | Mr. Yoshihito Shimizu |
| Manager | |
| Product Development Department | |
| Endoscope Division | |
| Olympus Optical Co., Ltd. | |
| 2954 Ishikawa-cho | |
| Hachioji-shi, Tokyo, Japan | |
| Summary Preparation | |
| Date: | July 22, 1996 |
Statement of Intended Use:
The intended use of the Olympus USU is identical to the currently marketed CUSA® system 200 which was cleared for marketing in 510(k)#s K#910696 and K#921251.
Both systems are used for smashing and aspirating disease tissues in the Neuro surgery field.
1
EXHIBIT #1 Page 2 of 3
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Thus, when compared to the predicate device, the Olympus USU does not raise any questions regarding the safety to the subject device.
The Olympus Ultrasonic System is indicated for use in the fragmentation, emulsification, and aspiration of soft tissue in the neurosurgery field.
Device Description:
The Olympus USU is specially designed for open procedure in the Neurosurgery field, in order to smash and aspirate disease tissue such as cerebral tumor, cerebral hematoma, cerebral aneurysm/varicosity.
The predicate devices for this system are the following:
- Cavitron Ultrasonic Surgical Aspirator CUSA® Type NS-100 (K#801623) a.
- b. CUSA® System 200c/200t/200m/200h Ultrasonic Aspirator (K#910696)
- CUSA® System 200c and 200t Ultrasonic Aspirator (K#921251) C.
- Cooper Laser Sonics CUSA® Model 200 (K#950945) d.
- Sharplan ULTRA Ultrasonic Aspirator (K#883091) e.
Actuation mechanisms of the above systems is the same as the USU based as the following:
The small ultrasound vibration which is generated by the ultrasound actuator built-in hand piece, is transferred to the probe which is mounted on the edge of hand piece. The tissue is smashed by the shock force exchanged from the vibration on the probe with pushing to the tissue.
The smashed tissue is taken out by the suction space between the probe and sheath of hand piece.
The Olympus USU mainly is used in microscopic surgery.
2
EXHIBIT #1 Page 3 of 3
- 3 -
General Safety:
The Olympus USU is designed, manufactured and tested in compliance with Voluntary Safety Standards. It meets the requirements of IEC 601-1 and 601-1-2, as well as CISPR 11.
When compared to the predicate devices, the Olympus USU does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness.