(140 days)
This ultrasound center is intended to be used with Olympus ultrasound endoscopes, Olympus ultrasound probes or Olympus esophageal ultrasound probes to observe and to store real-time ultrasound images and indicated for use within the gastrointestinal (GI) tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree, and urinary tract.
The subject system EU-Y0006 ENDOSCOPIC ULTRASOUND CENTER combines with Ultrasound videoscopes or Ultrasound probes to make an endoscopic ultrasound imaging system that can acquire and display high-resolution and high-penetration, real-time ultrasound images of the target organs. The subject system has modes of B, PWD, Color Doppler, Combined and Other (3-D Imaging and Harmonic Imaging). The subject system provides measurements and calculations of distance, area, circumference, volume, time and blood velocity, providing for the storage and retrieval of images for review and printing. The subject system enables the user to print images and record images to external recording devices. The subject system can identify and recognize the compatible Olympus transducers and display endoscopic images in addition to ultrasound images.
The document provided is a 510(k) summary for the Olympus Endoscopic Ultrasound Center EU-Y0006, submitted to the FDA. It declares the device's substantial equivalence to previously cleared predicate devices.
Acceptance Criteria and Device Performance:
The document primarily focuses on establishing substantial equivalence to predicate devices rather than defining specific performance-based acceptance criteria for diagnostic accuracy metrics. The acceptance criteria for this type of submission are typically based on demonstrating that the new device is as safe and effective as the predicate device(s) and meets relevant electrical, thermal, EMC safety, and acoustic output standards.
The "device performance" reported is its ability to perform the same functions as the predicate devices, with some additions in operating modes (Tissue Harmonic Imaging and Pulse Wave Doppler).
Here's a table summarizing the modes of operation and clinical applications for the EU-Y0006 system and its various transducers, showing which aspects are "new" (N) or "previously cleared" (P) relative to prior submissions/predicate devices. This serves as the 'performance' characteristics presented.
| Clinical Application (Specific) | Mode of Operation: B | Mode of Operation: M | Mode of Operation: PWD | Mode of Operation: CWD | Mode of Operation: Color Doppler (*2) | Combined (*3) | Other (*4) |
|---|---|---|---|---|---|---|---|
| Trans-rectal (for EU-Y0006 with no specific transducer, UM-DP12-25R, UM-DP20-25R, UM-DG20-31R) | N / P | N / P | N | N | N (*3) | ||
| Trans-urethral (for EU-Y0006 with no specific transducer, UM-DP12-25R, UM-DP20-25R, UM-DG20-31R) | N / P | N / P | N | N | N (*3) | ||
| Trans-esoph. (non-Card.) (for EU-Y0006 with no specific transducer, UM-DP12-25R, UM-DP20-25R, UM-DG20-31R, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM160) | N / P | N / P | N | N (*3) | N (*4) | ||
| Other (Specification: Gastrointestinal tract, biliary, pancreatic duct and surrounding organs, airways and tracheobronchial tree) (Various Transducers) | N / P | N / P | N | N (*3) | N (*4) | ||
| (Selected Transducers: ULTRASONIC PROBE UM-S20-20R, UM-G20-29R, UM-S20-17S, UM-S30-20R, UM-S30-25R) | P | P | P | ||||
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180F & ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UE160-AL5 | P | P (for UC180F) | P | P | N (*3) | N (*4) | |
| ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UC140P-AL5 & UCT140-AL5 & UCT180 | P | P | P | N (*3) / N (*3) N (*4) |
Notes:
- 2: Includes Power Doppler
- 3: Combination of each operating mode, B, PWD, Color Doppler and Other
- 4: 3-D Imaging, Harmonic Imaging (for some transducers); Harmonic Imaging (for others)
- N = new indication; P = previously cleared by FDA; E = added under this appendix.
Details of the Study:
The provided document is a 510(k) summary, which outlines the regulatory submission for the device. It states explicitly that no clinical studies were required to support the determination of substantial equivalence (Section 8, page 26). The device's approval is based on non-clinical testing and comparison to predicate devices.
-
Sample size used for the test set and data provenance:
- No clinical test set was used for the determination of substantial equivalence, as clinical studies were not required. Non-clinical testing was performed.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical test set was used.
-
Adjudication method for the test set:
- Not applicable as no clinical test set was used.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. The document explicitly states that clinical studies were not required.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an ultrasound system intended to be used by a human operator, not an algorithm operating independently. The testing focused on technical performance, safety, and substantial equivalence to predicate devices, not AI performance.
-
The type of ground truth used:
- For the non-clinical testing, the "ground truth" would be established engineering specifications, relevant consensus standards (e.g., IEC, ISO, NEMA), and the performance characteristics of the identified predicate devices.
-
The sample size for the training set:
- Not applicable. This is not an AI/algorithm-driven device requiring a training set in the context of machine learning.
-
How the ground truth for the training set was established:
- Not applicable.
Summary of Non-Clinical Testing (from Section 7, page 26):
The device was evaluated for:
- Electrical, Thermal, and EMC Safety: Compliance with standards like IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-2-18.
- Acoustic Output: Measured, calculated, and derated following the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. The acoustic output did not exceed derated ISPTA of 720 mW/cm² and MI of 1.9. Compliance with NEMA UD3-2004 and NEMA UD2-2004.
- Risk Analysis: Carried out in accordance with ISO 14971:2007, leading to identified and performed design verification tests and acceptance criteria.
- Software Validation: Performed in accordance with FDA Guidance for "Moderate Level of Concern" software in medical devices.
The conclusion (Section 9, page 26) states that the device does not incorporate any significant changes in intended use, method of operation, or design that could affect safety or effectiveness when compared to the predicate device. The new modes (Tissue Harmonic Imaging and Pulse Wave Doppler) are explicitly stated to be present in one of the predicate devices (Hitachi HI VISION Preirus, K093466).
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three faces in profile, representing health and well-being. The figure is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JUL 27 2015
Olympus Medical Systems Corporation % Ms. Laura Storms-Tyler Vice President, Regulatory Affairs & Ouality Assurance Olympus America, Inc. 3500 Corporate Parkway, PO Box 610 Center Valley, PA 18034-0610
Re: K121564
Trade/Device Name: Endoscopic Ultrasound Center EU-Y0006 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, and ODG Dated (Date on orig SE ltr): September 18, 2012 Received (Date on orig SE ltr): September 19, 2012
Dear Ms. Storms-Tyler,
This letter corrects our substantially equivalent letter of October 16, 2012.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be
{1}------------------------------------------------
Page 2 -
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safetw/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use Form
510(k) Number (if known): Device Name: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Indications for Use:
This ultrasound center is intended to be used with Olympus ultrasound endoscopes, Olympus ultrasound probes or Olympus esophageal ultrasound probes to observe and to store real-time ultrasound images and indicated for use within the gastrointestinal (GI) tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree, and urinary tract.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ·
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Arnold O'Brien
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K121564
Page 1 of _ 1
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1.3.1 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler(*2) | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | N | N | N | N (*3) | N (*4) | |||
| Trans-vaginal | ||||||||
| Trans-urethral | N | N | N | N (*3) | N (*4) | |||
| Trans-esoph. (non-Card.) N | N | N | N (*3) | N (*4) | ||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (* 1) | N | N | N | N (*3) | N (*4) | |||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix
. Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs, Intraluminal ultrasound for airways and tracheobronchial tree
*2: Includes Power Doppler
*3: Combination of each operating mode, B, PWD, Color Doppler and Other
*4: 3-D Imaging, Harmonic Imaging
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K121564
19
{4}------------------------------------------------
1.3.2 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer: ULTRASONIC PROBE RU-75M-R1
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler(*2) | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel. | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
20
H
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, billiary, pancreatic duct and surrounding organs, Intraluminal ultrasound for upper airways and tracheobronchial tree
*2: Includes Power Doppler
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K121564
{5}------------------------------------------------
1.3.3 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer: ULTRASONIC PROBE RU-12M-R1
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler (*2) | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
21
ંત્ર ン
し
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs, Intraluminal ultrasound for upper airways and tracheobronchial tree
*2: Includes Power Doppler
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Salaty
510K. K121564
{6}------------------------------------------------
1.3.4 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer: ULTRASONIC PROBE UM-2R
Intended Use: Diagnostic uttrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler(*2) | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | P | |||||||
| Trans-esoph. (non-Card.) | P | |||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | |||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
`Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs, Intraluminal ultrasound for upper airways and tracheobronchial tree
*2: Includes Power Doppler
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Sefety
510K. K121564
ન્દ્ર, 41
{7}------------------------------------------------
1.3.5 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer: ULTRASONIC PROBE UM-3R
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler (*2) | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | P | |||||||
| Trans-esoph. (non-Card.) | P | |||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | |||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Cardiac | Trans-esoph. (Cardiac) | |||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication: P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, billiary, pancreatic duct and surrounding organs, Intraluminal ultrasound for upper airways and tracheobronchial tree
*2: Includes Power Doppler
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K121564
23
ಿಗೆ
ﺎ ﺗﺄﺛﻴﺮ ﻣﻦ ﺃﻳﻀﺎ ﻓﻲ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
{8}------------------------------------------------
1.3.6 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer: ULTRASONIC PROBE UM-S20-20R
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific(Track 1 Only) (Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler(*2) | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging& Other | Adult Cephalic | |||||||
| Trans-rectal | P | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | P | |||||||
| Trans-esoph. (non-Card.) | P | |||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | |||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Intravascular (Cardiac) | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs, Intraluminal ultrasound for upper airways and tracheobronchial tree
*2: Includes Power Doppler
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K121564
{9}------------------------------------------------
1.3.7 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer. ULTRASONIC PROBE UM-G20-29R
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler(*2) | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging& Other | Adult Cephalic | |||||||
| Trans-rectal | P | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | P | |||||||
| Trans-esoph. (non-Card.) | P | |||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal.(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | |||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Intravascular (Cardiac) | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs, Intraluminal ultrasound for upper ainways and tracheobronchial tree
*2: Includes Power Doppler
(Division Sign-Off)
Division of Radiological Devices Evaluation Office of In Vitro Diagnostic Device Evaluation and Safety
510K K121564
25
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{10}------------------------------------------------
1.3.8 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer: ULTRASONIC PROBE UM-BS20-26R
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler(*2) | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | P | |||||||
| Trans-esoph. (non-Card.) | P | |||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | |||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs, Intraluminal ultrasound for upper airways and tracheobronchial tree
*2: Includes Power Doppler
Division of Radiological Devices Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K121564
{11}------------------------------------------------
1.3.9 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer: ULTRASONIC PROBE UM-S20-17S
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler(*2) | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | P | |||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | |||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication: P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract wall ;biliary duct(common bile, cystic, intrahepatic); pancreatic ducts ; and surrounding organs; upper airways and trachecbronchial tree.
*2: Includes Power Doppler
510K
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5121564
{12}------------------------------------------------
1.3.10 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer: ULTRASONIC PROBE UM-S30-20R
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler(*2) | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging& Other | Adult Cephalic | |||||||
| Trans-rectal | P | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | P | |||||||
| Trans-esoph. (non-Card.) | P | |||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | |||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Intravascular (Cardiac) | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs,
Intraluminal ultrasound for upper airways and tracheobronchial tree
*2: Includes Power Doppler
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K121564
{13}------------------------------------------------
1.3.11 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer: ULTRASONIC PROBE UM-S30-25R
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler(*2) | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | P | |||||||
| Trans-esoph. (non-Card.) | P | |||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (* 1) | P | |||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Intraluminal ultrasound for Gastrointestinal tract and surrounding organs, upper airways and tracheobronchial tree
*2: Includes Power Doppler
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510K K121564
29
{14}------------------------------------------------
1.3.12 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer: ULTRASONIC PROBE UM-DP12-25R
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler(*2) | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | N(*3) | ||||||
| Trans-vaginal | ||||||||
| Trans-urethral | P | N(*3) | ||||||
| Trans-esoph. (non-Card.) | P | N(*3) | ||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | N(*3) | ||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs, Intraluminal ultrasound for upper airways and tracheobronchial tree
- *2: Includes Power Doppler
*3: 3-D Imaging
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K121564
ાર્ગ
{15}------------------------------------------------
1.3.13 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer. ULTRASONIC PROBE UM-DP20-25R
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler(*2) | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | N(*3) | ||||||
| Trans-vaginal | ||||||||
| Trans-urethral | P | N(*3) | ||||||
| Trans-esoph. (non-Card.) | P | N(*3) | ||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | N(*3) | ||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs,
Intraluminal ultrasound for upper airways and tracheobronchial tree
*2: Includes Power Doppler
*3: 3-D Imaging
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
s10K K121564
{16}------------------------------------------------
1.3.14 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer: ULTRASONIC PROBE UM-DG20-31R
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler(*2) | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | N(*3) | ||||||
| & Other | Trans-vaginal | |||||||
| Trans-urethral | P | N(*3) | ||||||
| Trans-esoph. (non-Card.) | P | N(*3) | ||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| & Other | Intravascular | |||||||
| & Other | Other (Specify) (*1). | P | N(*3) | |||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs
*2: Includes Power Doppler
*3: 3-D Imaging
Mhhal D Vok
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Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K121564
Additional Comments:
{17}------------------------------------------------
1.3.15 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006
Transducer. EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM160
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler(*2) | Combined(Specify) | Other(Specify) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging& Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | P | ||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Specify) (*1) | P | ||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs
*2: Includes Power Doppler
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
S10K: K121564
{18}------------------------------------------------
1.3.16 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer. EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180F
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler(*2) | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging& Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | P | P | P | P | N (*3) | N (*4) | ||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | P | P | P | N (*3) | N (*4) | ||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Intravascular (Cardiac) | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional Comments: 1
*1: Specification for "Other"
Intraluminal ultrasound for airways and tracheobronchial tree
*2: Includes Power Doppler
*3: Combination of each operating mode, B, PWD, Color Doppler and Other
*4: Harmonic Imaging
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K.K121564
{19}------------------------------------------------
1.3.17 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer: ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UE160-AL5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler(*2) | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | P | P | P | N (*3) | N (*4) | |||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | P | P | N (*3) | N (*4) | |||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs
*2: Includes Power Doppler
*3: Combination of each operating mode, B, PWD, Color Doppler and Other
*4: Harmonic Imaging
(Division Sign-Off)
Division of Rediological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K121564
35
{20}------------------------------------------------
1.3.18 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer: ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UC140P-AL5
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler(*2) | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | P | P | P | N (*3) | ||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | P | P | N (*3) | ||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication: P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs
*2: Includes Power Doppler
*3: Combination of each operating mode, B, PWD and Color Doppler
(Division Sign-Off)
Division of Radiological Devices Office of the Diagnostic Device Evaluation and Safety
510K K121564
{21}------------------------------------------------
1.3.19 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer. ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT140-AL5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||
|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | Color Doppler(*2) | Combined Other(Specify) (Specify) |
| Ophthalmic | Ophthalmic | ||||||
| Fetal Imaging& Other | Fetal | ||||||
| Abdominal | |||||||
| Intra-operative (Specify) | |||||||
| Intra-operative (Neuro) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small Organ (Specify) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | P | P | P | N (*3) | |||
| Musculo-skeletal(Conventional) | |||||||
| Musculo-skeletal(Superficial) | |||||||
| Intravascular | |||||||
| Other (Specify) (*1) | P | P | P | N (*3) | |||
| Cardiac | Cardiac Adult | ||||||
| Cardiac Pediatric | |||||||
| Intravascular (Cardiac) | |||||||
| Trans-esoph. (Cardiac) | |||||||
| Intra-cardiac | |||||||
| Other (Specify) | |||||||
| PeripheralVessel | Peripheral vessel | ||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs
*2: Includes Power Doppler
*3: Combination of each operating mode, B, PWD and Color Doppler
(Division Sign-Off)
Division of Radiological Devices Office of the Vit o Diagnostic Device Evaluation and Safety
510K K121564
ים חו
{22}------------------------------------------------
1.3.20 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006
Transducer. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||
|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler(*2) | Combined Other(Specify) (Specify) |
| Ophthalmic | Ophthalmic | ||||||
| Fetal Imaging& Other | Fetal | ||||||
| Abdominal | |||||||
| Intra-operative (Specify) | |||||||
| Intra-operative (Neuro) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small Organ (Specify) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | P | P | P | N (*3) N (*4) | |||
| Musculo-skeletal(Conventional) | |||||||
| Musculo-skeletal(Superficial) | |||||||
| Intravascular | |||||||
| Other (Specify) (*1) | P | P | P | N (*3) N (*4) | |||
| Cardiac | Cardiac Adult | ||||||
| Cardiac Pediatric | |||||||
| Intravascular (Cardiac) | |||||||
| Trans-esoph. (Cardiac) | |||||||
| Intra-cardiac | |||||||
| Other (Specify) | |||||||
| PeripheralVessel | Peripheral vessel | ||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract and surrounding organs
*2: Includes Power Doppler
*3: Combination of each operating mode, B, PWD, Color Doppler and Other
*4: Harmonic Imaging
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Division of Radiological Device Evaluation and Safety
510K K121564
x3
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OCT 1 6 2012
510(k) SUMMARY
April 10, 2012
1 General Information
1.1 Manufacture's Name:
.. . . . .
OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT
Address:
34-3 Hirai Hinode-Machi, Nishitama-gun, Tokyo, Japan 190-0182
Corresponding Official: Laura Storms-Tyler Olympus America Inc.
... .. . . . . . . . . . . . . . .
r
Address:
3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610
Laura. Storms-Tyler@olympus.com
OLYMPUS MEDICAL SYSTEMS CORP.
Telephone:
484-896-5688
484-896-7128
Facsimile: west with and so and wo ... ﺎﺳﺘﻦ E-mail:
Applicant's Name:
Address:
1.2
2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 ﺤﺮ ﻣﺎ،
Initial Distributor Name/Title/Firm:
Address:
3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610
Telephone:
484-896-5688
Olympus America Inc.
.....
... .. ... ... .. .. .. .. .. .. . . . . . . . .
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2 Device Identification
- Device Trade Name:
ENDOSCOPIC ULTRASOUND CENTER EU-Y0006
| Common Name: | Diagnostic Ultrasound System | |
|---|---|---|
| Regulation Number: | 892.1550 Ultrasonic pulsed doppler imaging system892.1560 Ultrasonic pulsed echo imaging system876.1500 Endoscope and Accessories892.1570 Diagnostic ultrasound transducer | |
| Regulatory Class: | II | |
| Product Code: | IYN. IYO. KOG. ITX |
3 Predicate Device Information
- Ultrasound System
| Subject device | Predicate device | ||
|---|---|---|---|
| Name | Manufacturer | 510(k)-number | |
| EU-Y0006ENDOSCOPICULTRASOUND CENTER | XEU-M60AENDOSCOPICULTRASOUND CENTER | OLYMPUSMEDICALSYSTEMS CORP. | K063683 |
| HITACHI HI VISION PreirusDiagnostic UltrasoundScanner | Hitachi MedicalCorporation | K093466 |
4 Device Description ------------------
The subject system EU-Y0006 ENDOSCOPIC ULTRASOUND CENTER combines with Ultrasound videoscopes or Ultrasound probes to make an endoscopic ultrasound imaging system that can acquire and display high-resolution and high-penetration, real-time ultrasound images of the target organs.
The subject system has modes of B, PWD, Color Doppler, Combined and Other (3-D Imaging and Harmonic Imaging).
The subject system provides measurements and calculations of distance, area, circumference, volume, time and blood velocity, providing for the storage and retrieval of
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images for review and printing. The subject system enables the user to print images and record images to external recording devices.
The subject system can identify and recognize the compatible Olympus transducers and display endoscopic images in addition to ultrasound images.
The basic design; system configuration, general operation and user interface of this subject system are substantially equivalent to the predicate devices.
5_Indications for Use
This ultrasound center is intended to be used with Olympus ultrasound endoscopes, Olympus ultrasound probes or Olympus esophageal ultrasound probes to observe and to store real-time ultrasound images and indicated for use within the gastrointestinal (GI) tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree, and urinary tract.
6 Comparison of Technological Characteristics
The subject system EU-Y0006 ENDOSCOPIC ULTRASOUND CENTER is comparable with and substantially equivalent to the XEU-M60A ENDOSCOPIC ULTRASOUND CENTER (K063683) and the Diagnostic Ultrasound Scanner HITACHI HI VISION Preirus (K093466).
The subject system has same technological characteristics, key features, indications for use, and operation modes as the predicate devices.
The EU-Y0006 differs from the predicate device, XEU-M60A (K033683), in that it contains two new modes, Tissue Harmonic Imaging (THE) and Pulse Wave Doppler (PW) for However, the predicate device, Hitachi HI VISION Preirus ultrasound observation. (K093466) contains these two modes.
7 Summary of non-clinical testing
The FEU-Y0006 - ENDOSCOPIC ULTRASOUND CENTER has been evaluated for electrical, thermal, and EMC safety. The acoustic output exposure levels will be
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. ... ........................................................................................................................................................................ will was and to will be would and a w
measured, calculated and derated following the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment and in all cases, the acoustic output does not exceed derated ISPTA of 720 mW/cm² and MI of 1.9.
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
Software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Moderate Level of Concern."
The ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 is designed to comply with the followiñg standaïds: 300 mar ... ... ... .
-IEC 60601-1: 1988, Amendment 1: 1991, Amendment 2: 1995
- . -IEC 60601-1-1: 2000
- -IEC 60601-1-2: 2007
- -IEC 60601-2-37: 2001, Amendment 1: 2004, Amendment 2: 2005
- -IEC 60601-2-18: 1996, Amendment 1: 2000
- -ISO 14971: 2007
- -NEMA UD3-2004
- -NEMA UD2-2004
8 Summary of clinical testing
The ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 did not require dinical studies to support the determination of substantial equivalence.
9 Conclusion
When compared to the predicate device, the ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 does not incorporate any significant changes in intended use, method of operation, or design that could affect the safety or effectiveness of the device.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.