(183 days)
Not Found
No
The device description focuses on the mechanical and ultrasonic aspects of the probe and its operation, with no mention of AI or ML for image processing, analysis, or any other function. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described for "Diagnostic ultrasound imaging or fluid flow analysis" and for "intraluminal ultrasonic imaging of the urinary tract," which are diagnostic purposes, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis or the human body as follows: the urinary tract." This indicates the device is used for diagnostic purposes.
No
The device description explicitly details hardware components like an ultrasonic probe, endoscopic ultrasound center, probe driving unit, and endoscope, and describes their physical interaction and function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Diagnostic ultrasound imaging or fluid flow analysis or the human body as follows: the urinary tract." This describes an in vivo diagnostic procedure, meaning it's performed within the living body.
- Device Description: The description details a probe inserted into the patient's body through an endoscope for intraluminal ultrasonic imaging. This is consistent with an in vivo imaging device.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, outside of the body. This device does not operate on such samples.
Therefore, the Olympus UM-S30-25R Ultrasonic Probe is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Olympus UM-S30-25R Ultrasonic Probe has been designed to be used with an Olympus Endoscopic Ultrasound center, Probe Driving Unit and an endoscope for intraluminal ultrasonic imaging of the urinary tract.
Diagnostic ultrasound imaging or fluid flow analysis of the human Body as follows:
Clinical Application: Transurethral (N), Other (Specify) - the urinary tract (N)
Product codes (comma separated list FDA assigned to the subject device)
90 ITX/21 CFR 892.1570
Device Description
The Olympus UM-S30-25R Ultrasonic Probe has been designed to be used with an Olympus Endoscopic Ultrasound center, Probe Driving Unit and an endoscope for intraluminal ultrasonic imaging of the urinary tract.
The probe is connected to the endoscopic ultrasound center through the probe driving unit. The probe is attached to the endoscope which allows the user to use probe. The probe is inserted into the patient through a channel of the endoscope. A probe driving unit controls the rotation of the transducer.
UM-S30-25R Ultrasound Probe produces a B-mode scans using the de-aerated water immersion method and balloon method. The probeoffers 360 degree mechanical /radial scanning of the tissue under observation. The outer diameter of the insertion tube is 2.4mm and the length is 2050mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound (B-mode scans)
Anatomical Site
urinary tract
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)
Non-clinical tests were conducted to support substantial equivalence.
Design:
Endoscopic Ultrasound Center EU-M30 and Probe Driving Unit MH-240 have been designed, manufactured and tested in compliance with IEC 60601-1 and Revised 510(k) Diagnostics ultrasound Guidance for 1993,1995. It meets the requirements of IEC 60601-1 and Revised 510(k) Diagnostics ultrasound Guidance for 1993,1995.
Ultrasonic Probe UM-S30-25R has been tested to verify electromagnetic compatibility (EMC) with IEC 60601-1-2. It meets the requirements of IEC 6060-1-1-2.
Materials:
The patient contacting materials are identical to predicate device.
Conclusions:
When compared to the predicate device, the Olympus UM-S30-25R Ultrasonic probe and associated ancillary equipment do not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness.
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.
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
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
K994069
Page 1 of 3
510(k) SUMMARY OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR URINARY TRACT USE
A. Submitter's Name, Address, Phone and Fax Numbers
1. Manufacturer of the subject devices
Name & Address of manufacturer:
Registration No .: Address, Phone and Fax Numbers: of R&D Department, Endoscope Division
Olympus Optical Co., Ltd. 2-3-1 Shinjyuku Monolis Nishishinjyuku Shinjuku-ku, Tokyo, Japan 8010047 2951 Ishikawa-Cho, Hachioji-shi, Tokyo 192-8507 Japan TEL 0426-42-5101 FAX 0426-46-2786
B. Name of Contact Person
Name: Address, Phone and Fax Numbers: Ms. Laura Storms-Tyler Olympus America Inc. Endoscope Division Two Corporate Center Drive Melville, New York 11747-3157 TEL: (516) 844-5474 FAX: (516) 844-5416
C. Device Name, Common Name, Classification Name and Predicate Devices
| Device Name: | Ultrasonic Probe UM-S30-25R
Endoscopic Ultrasound Center EU-M30
Probe Driving Unit MH-240 |
|----------------------|-------------------------------------------------------------------------------------------------|
| Common Name: | Ultrasonic Probe |
| Classification Name: | 21 CFR892.1570 Diagnostic Ultrasonic transducer |
1
K994069.
page 2 of 3
Predicate Device:
| MODEL | NAME | 510(k)# |
|---|---|---|
| UM-2R | Ultrasonic Probe | K982610 |
| UM-3R | Ultrasonic Probe | K982610 |
| EU-M30 | Endoscopic Ultrasound Center | K982610 |
| MH-240 | Probe Driving Unit | K982610 |
| MH-246 | Balloon Sheath | K982734 (for UM-2R/3R) |
D. Description of the Device(s)
The Olympus UM-S30-25R Ultrasonic Probe has been designed to be used with an Olympus Endoscopic Ultrasound center, Probe Driving Unit and an endoscope for intraluminal ultrasonic imaging of the urinary tract.
The probe is connected to the endoscopic ultrasound center through the probe driving unit. The probe is attached to the endoscope which allows the user to use probe. The probe is inserted into the patient through a channel of the endoscope. A probe driving unit controls the rotation of the transducer.
UM-S30-25R Ultrasound Probe produces a B-mode scans using the de-aerated water immersion method and balloon method. The probeoffers 360 degree mechanical /radial scanning of the tissue under observation. The outer diameter of the insertion tube is 2.4mm and the length is 2050mm.
E. Intended Use of the Device(s)
The Olympus UM-S30-25R Ultrasonic Probe has been designed to be used with an Olympus Endoscopic Ultrasound center, Probe Driving Unit and an endoscope for intraluminal ultrasonic imaging of the urinary tract.
F. Summary of the Technological Characteristics of the Device compared to the Predicate Device(s)
Ultrasonic Frequency
The ultrasonic frequency is changed to 30MHz.
2
K994069
page 3 of 3
G. Summary including a Brief Discussion of Non-clinical Tests and How their Results support Determination of Substantial Equivalence
1. Design
Endoscopic Ultrasound Center EU-M30 and Probe Driving Unit MH-240 have been designed, manufactured and tested in compliance with IEC 60601-1 and Revised 510(k) Diagnostics ultrasound Guidance for 1993,1995. It meets the requirements of IEC 60601-1 and Revised 510(k) Diagnostics ultrasound Guidance for 1993,1995.
Ultrasonic Probe UM-S30-25R has been tested to verify electromagnetic compatibility (EMC) with IEC 60601-1-2. It meets the requirements of IEC 6060-1-1-2.
2. Materials
The patient contacting materials are identical to predicate device.
H. Summary including Conclusions drawn from Non-clinical Tests
When compared to the predicate device, the Olympus UM-S30-25R Ultrasonic probe and associated ancillary equipment do not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest feathers or wings.
Public Health Service
JUN - 2 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Laura Storms-Tyler Director, Regulatory Affairs and Quality Assurance Olympus America, Inc. Two Corporate Center Drive Melville, NY 11747-3157
Re: K994069
UM-S30-25R Ultrasonic Probe Regulatory Class: II Product Code: 90 ITX/21 CFR 892.1570 Dated: March 23, 2000 Received: March 29, 2000
Dear Ms. Storms-Tyler:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
This determination of substantial equivalence applies to the UM-S30-25R Ultrasonic Probe intended for use with the Olympus EU-M30 Endoscopic Ultrasound Center as described in your premarket notification.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 – Ms. Laura Storms-Tyler
This letter will allow you to begin marketing your device as described in your 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 market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and rr you desire specific as reviews and the see contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers on your responsive manaber (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Mr. Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
5
Appendix F
Diagnostic Ultrasound Indications for Use Form OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTER (ancillary system) Intended Use: Diagnostic ultrasound imaging or fluid flow analysis or the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppl | ||||||||||
| er | Amplit | |||||||||
| ude | ||||||||||
| Dopple | ||||||||||
| r | Color | |||||||||
| Veloc | ||||||||||
| ity | ||||||||||
| Imagi | ||||||||||
| ng | Combin | |||||||||
| ed | ||||||||||
| (Speci | ||||||||||
| fy) | Other | |||||||||
| (Speci | ||||||||||
| fy) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (Specify) |
N = new indication: P = previously cleared by EDA: E = added under Appendix FN = new indication; P = previously cleared by FDA; E = added under Appendix E Additional Comments:
the urinary tract.
(PLEASE DO NOT WRITE BELOW THE LINE-CONTIINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evalution (ODE) | |
|---|---|
| ------------------------------------------------------- | -- |
Prescription Use (Per 21 CFR 801.109)
F-3
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devi
510(k) Number K94406
6
Appendix F
Diagnostic Ultrasound Indications for Use Form OLYMPUS UM-S30-25R ULTRASONIC PROBE (Subject Device) Intended Use: Diagnostic ultrasound imaging or fluid flow analysis or the human body as follows:
Intended Use. Diagnostic ultrasound imaging or fluid flow analysis of the human Body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppl | ||||||||||
| er | Amplit | |||||||||
| ude | ||||||||||
| Dopple | ||||||||||
| r | Color | |||||||||
| Veloc | ||||||||||
| ity | ||||||||||
| Imagi | ||||||||||
| ng | Combin | |||||||||
| ed | ||||||||||
| (Speci | ||||||||||
| fy) | Other | |||||||||
| (Speci | ||||||||||
| fy) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | N | |||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (Specify) | N |
N = new indication; P = previously cleared by FDA; E = added under Appendix E Additional Comments: the urinary tract.
(PLEASE DO NOT WRITE BELOW THE LINE CONTIN
(PLEASE DO NOT WRITE BELOW THE LINE-CONTIINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evalution (ODE)
Prescription Use (Per 21 CFR 801.109)
F-3
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radialasia
Radiological Devices
510(k) Number K994069