(44 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-Y0008 ENDOSCOPIC ULTRASOUND CENTER, combined 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 Others (3-D Imaging and Harmonic Imaging) and Elastography function which visualizes the amount of strain in tissue (hardness of tissue) during compression and retraction. The subject system provides measurements and calculations of distance, area, circumference, volume, time and blood velocity and provides 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. Additionally, the subject system enables the user to record movies to internal memory. The subject system can identify and recognize compatible Olympus transducers and display endoscopic images in addition to ultrasound images.
I am sorry, but I am unable to extract information about acceptance criteria and study details from the provided document. The document appears to be a 510(k) Premarket Notification from the FDA for a medical device (ENDOSCOPIC ULTRASOUND CENTER EU-Y0008).
This type of document typically focuses on establishing substantial equivalence to previously cleared devices rather than presenting detailed study results or specific acceptance criteria. It mentions indications for use and technological characteristics in comparison to predicate devices, but does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or training sets.
- Data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness study results (effect size).
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth for the training set was established.
The document states that "The subject system has been designed to meet the applicable safety standards," but does not elaborate on specific performance criteria or the studies conducted to verify them. It primarily focuses on the device's intended use, modes of operation (B, PWD, Color Doppler, Combined, 3-D Imaging, Harmonic Imaging, Elastography), and its substantial equivalence to predicate devices (EU-Y0006 and HI VISION Preirus).
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
OLYMPUS MEDICAL SYSTEMS CORP. % Daphney Germain-Kolawole Regulatory Affairs Project Manager Olympus America, Inc. 3500 Corporate Parkway, P.O. Box 610 Center Valley, PA 18034-0610
JUL 2 7 2015
Re: K130058
Trade/Device Name: Endoscopic Ultrasound Center EU-Y0008 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, ITX, IYO, ODG Dated (Date on orig SE ltr): January 8, 2013 Received (Date on orig SE ltr): January 9, 2013
Dear Daphney Germain-Kolawole,
This letter corrects our substantially equivalent letter of February 22, 2013.
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Safety/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): _K1300S8
Device Name: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 210(k)
Page 1 of 21
Section1.1 Administrative Information Indications for Use Statement Page 2 of 22
20
{3}------------------------------------------------
1.1.4.1 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other(Specify) | |
| General(Track 1 Only) | ||||||||
| 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(*2) | N (*3) | N (*4) | |||
| Trans-vaginal | ||||||||
| Trans-urethral | N | N | N(*2) | N (*3) | N (*4) | |||
| Trans-esoph. (non-Card.) | N | N | N(*2) | N (*3) | N (*4) | |||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | N | N | N(*2) | 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, Intraluminal ultrasound for airways and tracheobronchial tree
*2: Includes Power Doppler
*3: Combination of each operating mode, B, PWD, Color Dopoler and Other
*4: 3-D Imaging, Harmonic Imaging
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
Section1.1 Administr: Indications for Use Statement Page 3 of 22
{4}------------------------------------------------
1.1.4.2 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 | 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 | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| 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
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
Section1.1 Administrative Information Indications for Use Statement Page 4 of 22
{5}------------------------------------------------
1.1.4.3 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 | 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) | ||||||||
| 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
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 210(K)
Section1.1 Administrative Information Indications for Use Statement Page 5 of 22
{6}------------------------------------------------
1.1.4.4 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 Transducer: ULTRASONIC PROBE UM-2R
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined (Specify) | Other (Specify) |
| (Track 1 Only) | ||||||||
| 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 | P | |||||||
| 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, billiary, pancreatic duct and surrounding organs, Intraluminal ultrasound for upper airways and tracheobronchial tree
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
Section 1. 1 Administrative Information Indications for Use Statement Page 6 of 22
{7}------------------------------------------------
1.1.4.5 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 Transducer: ULTRASONIC PROBE UM-3R
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 | 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
(Division Sign Off) Division of Radiological Health Iffice of In Vitro Diagnostic and Radiological Health 510(k)
Section1.1 Administrative Information Indications for Use Statement Page 7 of 22
{8}------------------------------------------------
1.1.4.6 Diagnostic Ultrasound Indications For Use Format '
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | 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
Section 1. 1 Administrative Information Indications for Use Statement Page 8 of 22
(Division Sign Off) Division of Radiological Health iffice of In Vitro Diagnostic and Radiological Health 510(k)
{9}------------------------------------------------
1.1.4.7 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 | 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 | 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
Section1.1 Administrative Information Indications for Use Statement Page 9 of 22
(Division Sign Off) Division of Radiological Health Iffice of In Vitro Diagnostic and Radiological Health 510(k)
{10}------------------------------------------------
1.1.4.8 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008
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 | 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 | |||||||||
| 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
Section1.1 Administrative Information Indications for Use Statement Page 10 of 22
(Division Sign Off) Division of Radiological Health ffice of In Vitro Diagnostic and Radiological Health 510(k)
{11}------------------------------------------------
1.1.4.9 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 | Specific | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other(Specify) |
| (Track 1 Only) (Tracks 1 & 3) | ||||||||
| 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 | ||||||||
| 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 wall ;biliary duct(common bile, cystic, intrahepatic); pancreatic ducts ; and surrounding organs; upper airways and tracheobronchial tree.
Section 1.1 Administrative Information Indications for Use Statement Page 11 of 22
(Division Sign Off) Division of Radiological Health office of In Vitro Diagnostic and Radiological Health 210(K)
{12}------------------------------------------------
1.1.4.10 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 | 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
Section1.1 Administrative Information Indications for Use Statement Page 12 of 22
(Division Sign Off) Division of Radiological Health office of In Vitro Diagnostic and Radiological Health 510(k)
{13}------------------------------------------------
1.1.4.11 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 | 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
Section1.1 Administrative Information Indications for Use Statement Page 13 of 22
(Division Sign Off) Division of Radiological Health ffice of In Vitro Diagnostic and Radiological Health 510(k)
{14}------------------------------------------------
1.1.4.12 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 | |||||||
|---|---|---|---|---|---|---|---|---|
| Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined Other(Specify) | Other(Specify) | |
| General(Track 1 Only) | ||||||||
| 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 | P(*2) | ||||||
| Trans-esoph. (non-Card.) | P | P(*2) | ||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | P(*2) | ||||||
| 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: 3-D Imaging
(Division Sign Off) Division of Radiological Health iffice of In Viro Diagnostic and Radiological Health 510(K) --
Section1.1 Administrative Information Indications for Use Statement Page 14 of 22
{15}------------------------------------------------
1.1.4.13 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 | Combined Other(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 | P(*2) | ||||||
| Trans-vaginal | ||||||||
| Trans-urethral | P | P(*2) | ||||||
| Trans-esoph. (non-Card.) | P | P(*2) | ||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | P(*2) | ||||||
| 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: 3-D Imaging
(Division Sign Off) Division of Radiological Health ›ffice of In Vitro Diagnostic and Radiological Health 510(k)
Section 1. 1 Administrative Information Indications for Use Statement Page 15 of 22
{16}------------------------------------------------
1.1.4.14 Diagnostic Uitrasound Indications For Use Format
.
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 | Specific | B | M | PWD | CWD | Color . | Combined Other | |
| (Track 1 Only)(Tracks 1 & 3) | Doppler (Specify) | (Specify) | ||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging | Adult Cephalic | |||||||
| & Other | Trans-rectal | P | P(*2) | |||||
| Trans-vaginal | ||||||||
| Trans-urethral | D | P(*2) | ||||||
| Trans-esoph. (non-Card.) P | P(*2) | |||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*. 1) | P | P(*2) | ||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Cardiac | Trans-esoph. (Cardiac) | |||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| 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: 3-D Imaging
(Division Sign Off) Division of Radiological Health iffice of In Vitro Diagnostic and Radiological Health 510(k)_
Section1.1 Administrative Information Indications for Use Statement Page 16 of 22 .
{17}------------------------------------------------
1.1.4.15 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008
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 | 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 | |||||||
| 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
Section1.1 Administrative Information Indications for Use Statement Page 17 of 22
(Division Sign Off) Division of Radiological Health Iffice of In Vitro Diagnostic and Radiological Health 510(k)
35
{18}------------------------------------------------
1.1.4.16 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other (Specify) | ||
| General(Track 1 Only) | Specific(Tracks 1 & 3) | |||||||
| 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(*2) | P(*3) | P(*4) | |||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | P | P(*2) | P(*3) | P(*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: 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
Section1.1 Administrative Information Indications for Use Statement Page 18 of 22
(Division Sign Off) Division of Radiological Health Iffice of In Vitro Diagnostic and Radiological Health 510(k)
{19}------------------------------------------------
1.1.4.17 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 | 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(*2) | P(*3) | P(*4) | |||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | P | P(*2) | P(*3) | P(*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
Section1.1 Administrative Information Indications for Use Statement Page 19 of 22
(Division Sign Off) Division of Radiological Health office of In Vitro Diagnostic and Radiological Health 510(k)
{20}------------------------------------------------
1.1.4.18 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 Transducer: ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UC140P-AL5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| Specific | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other(Specify) | |
| General(Track 1 Only) | (Tracks 1 & 3) | |||||||
| 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(*2) | P(*3) | ||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | P | P(*2) | P(*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 Health Iffice of In Vitro Diagnostic and Radiological Health 210(k)
Section1.1 Administrative Information Indications for Use Statement Page 20 of 22
{21}------------------------------------------------
1.1.4.19 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 | |||||||
|---|---|---|---|---|---|---|---|---|
| Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other(Specify) | |
| General(Track 1 Only) | ||||||||
| 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(*2) | P(*3) | ||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | P | P(*2) | P(*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
Section1.1 Administrative Information Indications for Use Statement Page 21 of 22
(Division Sign Off) Division of Radiological Health. Iffice of In Vitro Diagnostic and Radiological Health 510(k)
{22}------------------------------------------------
1.1.4.20 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008
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 | 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(*2) | P(*3) | P(*4) | |||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | P | P(*2) | P(*3) | P(*4) | |||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vesselOther (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
42: Includes Power Doppler
*3: Combination of each operating mode, B, PWD, Color Doppler and Other
*4: Harmonic Imaging
Smir
Section 1. 1 Administrative Information Indications for Use Statement Page 22 of 22
(Division Sign Off) Division of Radiological Health Iffice of In Vitro Diagnostic and Radiological Health K130058 < I Wレ)
{23}------------------------------------------------
Image /page/23/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, black letters. A horizontal line is underneath the word. Below the line, the words "Your Vision, Our Future" are written in a smaller font.
OLYMPUS MEDICAL SYSTEMS CORP. 510(k) Premarket Notification ENDOSCOPIC ULTRASOUND CENTER EU-Y0008
510(k) Summary
FEB 2 2 2013
1. General Information
1 Applicant: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507
- 1 Official Correspondent: Daphney Germain-Kolawole Regulatory Affairs Project Manager Olympus America, Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5691 FAX: 484-896-7128
- 행 Prepared Date: January 8, 2013
2. Device Identification
| Device Name: | ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 |
|---|---|
| Common Name: | Diagnostic Ultrasound System |
| Regulation Number | 892.1550 Ultrasonic pulsed doppler imaging system892.1560 Ultrasonic pulsed echo imaging system892.1570 Diagnostic ultrasound transducer876.1500 Endoscope and Accessories |
| Regulatory Class: | II |
| Product Code: | IYN, IYO, ITX, and KOG |
3. Predicate Devices
- ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 (K121564) 1
- (K093466) HI VISION Preirus Diagnostic Ultrasound Scanner
{24}------------------------------------------------
Image /page/24/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, black letters. Below the word is a black line, and below the line is the text "Your Vision, Our Future" in a smaller font.
4. Device Description
The subject system, EU-Y0008 ENDOSCOPIC ULTRASOUND CENTER, combined 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.
1
The subject system has modes of B, PWD, Color Doppler, Combined and Others (3-D Imaging and Harmonic Imaging) and Elastography function which visualizes the amount of strain in tissue (hardness of tissue) during compression and retraction.
The subject system provides measurements and calculations of distance, area, circumference, volume, time and blood velocity and provides 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. Additionally, the subject system enables the user to record movies to internal memory.
The subject system can identify and recognize 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. Technological Characteristics
The subject system, EU-Y0008 ENDOSCOPIC ULTRASOUND CENTER, is comparable with and substantially equivalent to the EU-Y0006 ENDOSCOPIC ULTRASOUND CENTER (K121564) and the Diagnostic Ultrasound Scanner HITACHI HI VISION Preirus (K093466). The key technological differences from the EU-Y0006 (K121564) in comparison to the EU-Y0008 (subject) are the addition of the Elastography function, TIC Analysis function, and movie storage. These new functions are present in the Hitachi HI VISION Preirus (K093466) device. The subject system has the same technological characteristics, key features, indications for use, and mode of operation as the predicate devices. The subject system has been designed to meet the applicable safety standards.
{25}------------------------------------------------
Image /page/25/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, black letters. There is a horizontal line below the word. Underneath the line, the text "Your Vision, Our Future" is written in a smaller font size.
7. Conclusion
When compared to the predicate devices, the EU-Y0008 ENDOSCOPIC ULTRASOUND CENTER does not incorporate any significant changes in intended use, mode 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.