(274 days)
Not Found
No
The summary describes a standard ultrasonic probe and associated equipment for endoscopic ultrasound imaging. There is no mention of AI, ML, or any advanced image processing that would suggest the use of these technologies. The performance studies focus on compliance with standards and comparison to predicate devices based on design, materials, and basic functionality.
No
The device is described as an ultrasonic probe for intraluminal ultrasonic imaging of the gastrointestinal tract, indicating a diagnostic rather than therapeutic purpose.
Yes
Explanation: The device is an "ULTRASONIC PROBE" used for "intraluminal ultrasonic imaging of the gastrointestinal tract and surrounding organs," which is explicitly stated as a "Diagnostic ultrasound imaging" modality. This indicates its purpose is to image and therefore diagnose conditions.
No
The device description clearly details a physical ultrasonic probe with specific dimensions and a mechanical scanning mechanism, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "intraluminal ultrasonic imaging of the gastrointestinal tract and surrounding organs." This describes an in vivo diagnostic procedure (imaging within the living body), not an in vitro diagnostic procedure (testing samples outside the body).
- Device Description: The description details a probe inserted into the patient's body through an endoscope to perform ultrasound imaging. This is consistent with an in vivo imaging device.
- Input Imaging Modality: The input modality is "Diagnostic ultrasound imaging," which is an in vivo imaging technique.
- Performance Studies: The performance studies focus on compliance with standards for medical electrical equipment (IEC 60601-1, IEC 60601-1-2) and diagnostic ultrasound guidance, which are relevant to in vivo medical devices. There is no mention of studies related to the analysis of biological samples.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device directly images structures within the body.
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 gastrointestinal tract and surrounding organs.
The OLYMPUS UM-S30-25R ULTRASONIC PROBE have been designed to be The OEFAIT OD ONPUS Endoscopic Ultrasound System for intraluminal ason with an OD ing of the gastrointestinal tract and surrounding organs.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis or the human body as follows:
the gastrointestinal tract and the surrounding organs (GI use)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis or the human body as follows:
Previously cleared indication : Intraluminal ultrasound for gastrointestinal tract and surround organs, upper air and tracheobronchial tree and urinary tract.
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 gastrointestinal tract and surrounding organs. 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.
Applicable endoscopes are as follows: Flexible endoscope: inner channel is φ2.8mm, φ3.2mm,φ6mm and φ5.5mm. 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
B-mode scans
Anatomical Site
gastrointestinal tract and surrounding organs
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.
K944610, K982610, K951994, K982323
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
K994103
Page 1 of 4
පිහිටා පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහි
,一个人在线
ATTACHMENT 11.
510(k) Summary
1
K994103
Page 2 of 4
510(k) SUMMARY OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR GASTROINTESTINAL TRACT
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
2
K994103
Page 3 of 4
Predicate Device:
| MODEL | NAME | 510(k)# |
|---|---|---|
| UM-2R | Ultrasonic Probe | K944610 |
| UM-3R | Ultrasonic Probe | K944610 |
| EU-M30 | Endoscopic Ultrasound Center | K982610(for urinary), |
| K951994(for gastrointestinal tract), | ||
| K982323(for bronchial use)4 | ||
| MH-240 | Probe Driving Unit | K982610(for urinary), |
| K951994(for gastrointestinal tract), | ||
| K982323(for bronchial use) | ||
| MH-240 | Balloon Sheath | K944610 (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 gastrointestinal tract and surrounding organs. 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 φ2.8mm, φ3.2mm,φ6mm and φ5.5mm. 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 gastrointestinal tract and surrounding organs.
F. Summary of the Technological Characteristics of the Device compared to the Predicate Device(s)
Ultrasonic Frequency
The ultrasonic frequency is changed to 30MHz.
3
Image /page/3/Picture/0 description: The image shows handwritten text. The text at the top reads "K994103". Below that, the text reads "page 4 of 4". The handwriting is somewhat messy, but the text is still legible.
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.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 2000
Ms. Laura Storms-Tyler Director, Regulatory Affairs and Quality Assurance Olympus America, Inc. Two Corporate Center Drive Melville, NY 11747-3157
Re: K994103
UM-S30-25R Ultrasonic Probe (Gastrointestinal Tract Use) Regulatory Class: II Product Code: 90 ITX/21 CFR 892.1570 Dated: March 30, 2000 Received: July 20, 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.
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.
5
Page -2- Ms. Laura Storms-Tyler
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 ( If you desire specific advice for your device on on Arceling (ogmiiance at (301) 594-4591. Additionally, for in for in vitro diagnostic devices), prease contact une Office of Coffice of Compliance at (31) 594-1
questions on the promotion and advertising of your device, please contact t questions on the promotion and advertising of your develop by reference to premarket notification" (21 CFR
4639). Also, please note the regulation entitled, "Misbranding by r 4639. Associetal information on your responsibilities of er the Act may be obtained from the Division of
807.97). Other general information on your responsibilities under in 807.97). Other general information on your responsibilities and in the many of (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. Schultz, M.D.
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
Enclosure
6
510(k) Number (if known):
Device Name:
Olympus UM-S30-25R Ultrasonic Probe and associated ancillary equipment for gastrointestinal tract
Indications for Use:
The OLYMPUS UM-S30-25R ULTRASONIC PROBE have been designed to be The OEFAIT OD ONPUS Endoscopic Ultrasound System for intraluminal ason with an OD ing of the gastrointestinal tract and surrounding organs.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
David A. Bryson
OR
(Optional Format 1-2-96)
Over-The-Counter Use
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1794103 510(k) Number .
7
Diagnostic Ultrasound Indications for Use Form OLYMPUS UM-S30-25R ULTRASONIC PROBE (Subject Device) OLYMPUS UM-S30-25R ULTAASONIO PRODE (Subject Solary of Start)
Intended Use: Diagnostic uttrasound imaging or fluid flow analysis or the human body as follows:
Appendix F
Intended Use: Diagnostic ultrasound imaging
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | N | |||||||||
| Transrectal | N | |||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (Specify) | N |
Note: N = new indication; P = previously cleared by FDA; F = added under Appendix EOther (open))
N = new indication; P = previously cleared by FDA; E = added under Appendix i Additional Comments:
the gastrointestinal tract and the surrounding organs (GI use)
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON AVOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evalution (ODE)
F-3
Prescription Use (Per 21 CFR 801.109)
Omid A. Moghadam
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number.
8
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:
| 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 | | | | | | | | |
Other (open))
N = new indication; P = previously cleared by FDA; E = added under Appendix E Additional Comments:
Additional Oonlinens.
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 UNE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evalution (ODE)
Prescription Use (Per 21 CFR 801.109)
David b. Syzmm
(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
F-3