(179 days)
No
The description focuses on the mechanical and ultrasonic aspects of the probe and system, with no mention of AI or ML.
No
The device is used for imaging and diagnostic purposes (intraluminal sonographic imaging), not for treating conditions.
Yes
The device is described as producing "intraluminal sonographic imaging" and "B-mode scans" of the upper airways and tracheobronchial tree, which are used to visualize and assess the anatomical structures, characteristic of a diagnostic device.
No
The device description clearly outlines a physical ultrasonic probe with specific dimensions and components (transducer, insertion tube) that is connected to other hardware (Endoscopic Ultrasound System, Probe Driving Unit, endoscope). This is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The OLYMPUS UM-S30-25R ULTRASONIC PROBE is used for intraluminal sonographic imaging. This means it uses ultrasound technology to create images of structures inside the body (specifically the upper airways and tracheobronchial tree). It does not perform tests on samples taken from the body.
- Intended Use: The intended use clearly states "intraluminal sonographic imaging," which is an in-vivo (within the living body) diagnostic procedure, not an in-vitro one.
Therefore, the device falls under the category of 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 upper airways and tracheobronchial tree.
Product codes
ITX
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 upper airways and tracheobronchial tree. 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.
Flexible endoscope: inner channel is $2.8mm, $3.2mm, $6mm and $5.5mm. Rigid endoscopes : minimum capacity is 9Fr.
UM-S30-25R Ultrasound Probe produces a B-mode scans using the de-aerated water immersion method and balloon method. The probe offers 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
Ultrasonic
Anatomical Site
Upper airways and tracheobronchial tree.
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)
K982323, K982610, K951994, K982733
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) SUMMARY OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR BROCHIAL 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 transduce |
1
| MODEL | NAME | 510(k)# |
|---|---|---|
| UM-2R | Ultrasonic Probe | K982323 |
| UM-3R | Ultrasonic Probe | K982323 |
| EU-M30 | Endoscopic Ultrasound | |
| Center | K982610(for urinary), | |
| K951994(for gastrointestinal tract), | ||
| K982323(for bronchial use) | ||
| MH-240 | Probe Driving Unit | K982610(for urinary), |
| K951994(for gastrointestinal tract), | ||
| K982323(for bronchial use) | ||
| MH-246R | Balloon Sheath | K982733 (for UM-2R/3R) |
Predicate Device:
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 upper airways and tracheobronchial tree. 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.
Flexible endoscope: inner channel is $2.8mm, $3.2mm, $6mm and $5.5mm. Rigid endoscopes : minimum capacity is 9Fr.
UM-S30-25R Ultrasound Probe produces a B-mode scans using the de-aerated water immersion method and balloon method. The probe offers 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 upper airways and tracheobronchial tree.
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
K994106 p.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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the shape of a bird in flight.
Public Health Service
JUN - 2 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive Melville, New York 11747-3157
K994106 Re: UM-S30-25R Ultrasonic Probe (for Bronchial Use) Regulatory Class: II 21 CFR 892.1570/Procode: 90 ITX Dated: March 30, 2000 Received: April 3, 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 misbranion.
This determination of substantial equivalence applies to the following transducer intended for use with the Olympus EU-M30 Endoscopic Ultrasound Center, as described in your premarket notification:
Probe Model Number
UM-S30-25R Ultrasonic Probe
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.
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.
4
Page -2- Ms. Storms-Tyler
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please 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 Assistance at its toll-free number (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 Paul M. Gammell, Ph.D. at (301) 594-1212.
Sincerely yours,
Daniel G. Schu
Daniel G. Schultz, M.I Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K994106
510(k) Number (if known):
Olympus UM-S30-25R Ultrasonic Probe and Device Name: associated ancillary equipment for bronchial use
Indications for Use:
The OLYMPUS UM-S30-25R ULTRASONIC PROBE have been designed to be used with an OLYMPUS Endoscopic Ultrasound System for intraluminal sonographic imaging of the upper airways and tracheobronchial tree.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the contribution of th
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use | ||
|---|---|---|---|---|
| (Division Sign-Off) | (Optional Format 1-2-96) | |||
| Division of Reproductive, Abdominal, ENT, | ||||
| and Radiological Devices | ||||
| 510(k) Number | K994106 |
6
CONFIDENTIAL
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:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppl | ||||||||||
| er | Amplit | |||||||||
| ude | ||||||||||
| Doppler | 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 |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:the upper airway and (bronchial use),
ﻨﺘ
(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)
E-3
Yamil A. de Leon
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devices 510(k) Number
7
K 994106
Image /page/7/Picture/1 description: The image shows the word "CONFIDENTIAL" in all caps, printed in bold black font. The word is enclosed in a rectangular box, also in black. The image appears to be a stamp or label indicating the confidential nature of a document or information.
bendix 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 | P | |||||||||
| Transrectal | P | |||||||||
| Transvaginal | ||||||||||
| Transurethral | P | |||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (Specify) | P |
N = new indication; P = previously cleared by FDA; E = added under Appendix EN = new indication; P = previously cleared by FDA; E = added under Appendix E Additional Comments:
Previously cleared indication : Intraluminal ultrasound for gastrointestinal tract and surround organs, upper air and tracheobronchial tree and 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
David li. Sigomm
(Division Sign-Off) (Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Dev 510(k) Number