(179 days)
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.
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. 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.
This document is a 510(k) Summary for the OLYMPUS UM-S30-25R ULTRASONIC PROBE and associated ancillary equipment for bronchial use. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly addressed in this type of regulatory submission. The document emphasizes non-clinical tests for design and material compliance to established standards, which are a different kind of "acceptance criteria."
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance (from Non-Clinical Tests) |
|---|---|
| Compliance with IEC 60601-1 (for EU-M30 and MH-240) | Meets the requirements of IEC 60601-1 |
| Compliance with Revised 510(k) Diagnostics ultrasound Guidance for 1993, 1995 (for EU-M30 and MH-240) | Meets the requirements of Revised 510(k) Diagnostics ultrasound Guidance for 1993, 1995 |
| Electromagnetic Compatibility (EMC) with IEC 60601-1-2 (for UM-S30-25R) | Meets the requirements of IEC 60601-1-2 |
| Patient contacting materials identical to predicate device | Patient contacting materials are identical to predicate device |
| No significant changes in intended use, method of operation, material, or design that could affect safety or effectiveness compared to predicate device | The device does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness. |
| Intraluminal ultrasonic imaging of the upper airways and tracheobronchial tree (Intended Use) | Design supports this intended use. |
| Ultrasonic Frequency of 30MHz (Technological Characteristic) | The ultrasonic frequency is changed to 30MHz. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The document refers to non-clinical tests (e.g., for electrical safety, EMC, material compatibility) rather than a clinical "test set" with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as there is no mention of a formal clinical test set or ground truth establishment by experts in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there is no mention of a formal clinical test set or adjudication process in this document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study is not mentioned in this 510(k) summary. This document is for an ultrasonic probe, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
A standalone performance study for an algorithm is not applicable and not mentioned in this document, as the device is an ultrasonic probe and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided as there is no mention of a formal clinical test set or ground truth in this document. The "ground truth" for this type of submission largely resides in meeting prescribed engineering and safety standards, as well as demonstrating equivalence to previously cleared devices.
8. The sample size for the training set
This information is not applicable as this document describes a physical medical device (ultrasonic probe), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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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-S30-25REndoscopic Ultrasound Center EU-M30Probe Driving Unit MH-240 |
|---|---|
| Common Name: | Ultrasonic Probe |
| Classification Name: | 21 CFR892.1570 Diagnostic Ultrasonic transduce |
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| MODEL | NAME | 510(k)# |
|---|---|---|
| UM-2R | Ultrasonic Probe | K982323 |
| UM-3R | Ultrasonic Probe | K982323 |
| EU-M30 | Endoscopic UltrasoundCenter | 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.
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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.
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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.
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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
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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 |
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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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| LaparoscopicMusculo-skeletalConventional | ||||||||||
| 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
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K 994106
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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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| 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 | ||||||||||
| LaparoscopicMusculo-skeletalConventional | ||||||||||
| 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
§ 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.