(60 days)
No
The summary describes a standard ultrasonic endoscope and its components. There is no mention of AI, ML, or any advanced image processing that would suggest the use of such technologies. The performance studies focus on electrical safety, biocompatibility, and reprocessing validation, not algorithmic performance.
Yes
The device is intended for "endoscopic treatment" and supports "ultrasound guided needle aspiration," which are therapeutic interventions.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "intended for the observation, diagnosis and endoscopic treatment".
No
The device description clearly indicates it is a physical endoscope with an ultrasonic transducer, requiring connection to various hardware components (processor, light source, monitor, etc.) to function. It is not solely software.
Based on the provided information, the Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The EB-530US is an endoscope that is inserted directly into the body (trachea, bronchial tree) to visualize and perform procedures using ultrasonic imaging. It works in vivo (within the living body), not in vitro (in a test tube or laboratory setting).
- Intended Use: The intended use clearly states "observation, diagnosis and endoscopic treatment of the trachea, bronchial tree and surrounding organs using ultrasonic images." This is a direct examination and intervention within the body.
- Lack of Sample Testing: The description does not mention the device being used to analyze samples taken from the patient.
Therefore, the EB-530US falls under the category of an in vivo diagnostic and therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
The Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is intended for the observation, diagnosis and endoscopic treatment of the trachea, bronchial tree and surrounding organs using ultrasonic images. It is used with Fujinon/Fujifilm ultrasonic processor, video processor, light source, other peripheral equipment and endoscopic accessories. It is not intended for use on children and infants.
Product codes
EOQ, ITX
Device Description
Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is intended for the observation, diagnosis and endoscopic treatment of the trachea, bronchial tree and surrounding organs using ultrasonic images. EB-530US is used in combination with the Fujinon/Fujifilm's ultrasonic processor, video endoscope processor, light source, monitor, cart, foot switch, endoscope accessories and other peripheral devices. When used with a Fujinon/Fujifilm's ultrasonic processor, EB-530US emits ultrasound wave and scans the reflected signals to orovide ultrasonic images. For ultrasound procedure, EB-530US can be used with a single-patient-use balloon inflated with sterile water for an ultrasonic endoscope eliminates air between the ultrasonic transducer and target tissue so that the ultrasound wave can travel with little interference. Additionally EB-530US supports ultrasound guided needle aspiration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonic images
Anatomical Site
trachea, bronchial tree and surrounding organs
Indicated Patient Age Range
It is not intended for use on children and infants.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
No clinical testing was conducted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
FUJIFILM
JUN - 4 2012
510(k) Summary
Date: June 4, 2012
Submitter's Information:
FUJIFILM Medical Systems U.S.A., Inc. 10 High Point Drive Wavne, NJ 07470 USA FDA Establishment Registration Number: 2431293
Contact Person:
| Name: | Gina Walljasper |
|---|---|
| Title: | Director, Quality and Regulatory Compliance |
| Telephone: | (973) 633-5600 Ext. 484 |
| Facsimile: | (973) 633-8818 |
| E-Mail: | gwalljasper@fujifilm.com |
Identification of the Proposed Device:
Proprietary/Trade Name: Common Name: Device Class: Review Panel:
Fuiinon/Fuiifilm Ultrasonic Endoscope EB-530US Ultrasonic Bronchoscope Class 2 Ear Nose & Throat
Classification Information:
| Classification Name | CFR Section | Product Codes |
|---|---|---|
| Bronchoscope (flexible or rigid) and accessories | 21 CFR 874.4680 | EOQ |
| Diagnostic Ultrasonic Transducer | 21 CFR 892.1570 | ITX |
INDICATIONS FOR USE l,
The Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is intended for the observation, diagnosis and endoscopic treatment of the trachea, bronchial tree and surrounding organs using ultrasonic images. It is used with Fujinon/Fujifilm ultrasonic processor, video processor, light source, other peripheral equipment and endoscopic accessories. It is not intended for use on children and infants.
DEVICE DESCRIPTION II.
Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is intended for the observation, diagnosis and endoscopic treatment of the trachea, bronchial tree and surrounding organs using ultrasonic images. EB-530US is used in combination with the Fujinon/Fujifilm's ultrasonic processor, video endoscope processor, light source, monitor, cart, foot switch, endoscope accessories and other peripheral devices. When used with a Fujinon/Fujifilm's ultrasonic processor, EB-530US emits ultrasound wave and scans the reflected signals to orovide ultrasonic images. For ultrasound procedure, EB-530US can be used with a
1
K12/035
FUJKFILM
single-patient-use balloon inflated with sterile water for an ultrasonic endoscope eliminates air between the ultrasonic transducer and target tissue so that the ultrasound wave can travel with little interference. Additionally EB-530US supports ultrasound guided needle aspiration.
SUMMARY OF STUDIES lll.
Fujinon/Fujifilm Ultrasonic Endoscope EB-530US conforms to the following internal and international IEC testing requirements in addition to the applicable quality system regulations:
| IEC 60601-1 | Medical electrical equipment - Part 1: General requirements for safety |
|---|---|
| IEC60601-1-1 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
| IEC60601-1-2 | Medical electrical equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and tests |
| IEC60601-2-18 | Medical electrical equipment - Part 2-18: Particular requirements for the safety of endoscopic equipment |
| IEC 60601-2-37 | Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
| ISO10993-1 | Biological evaluation of medical devices |
The balloon, B20BU for the Fujinon/Fujifilm Ultrasonic Endoscope EB-530US conform to the applicable internal and international IEC testing requirements for Sterility.
The reprocessing instructions were validated.
No clinical testing was conducted.
SUBSTANTIAL EQUIVALENCE IV.
Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is substantially equivalent to the following device:
| Legally Marketed Device(s) | 510(k) # |
|---|---|
| EVIS EXERA Ultrasonic Bronchofibervideoscope | K042140 |
| OLYMPUS BF type UC160F-OL8 |
2
FUJIFILM
Comparison is outlined in the table below.
| | Legally Marketed Device
K042140 | Proposed Device
Model EB-530US |
|--------------------------------|------------------------------------|------------------------------------------------------|
| Viewing direction | 35 degree forward oblique | 10 degree forward oblique |
| Observation range | 2-50 mm | 3-100 mm |
| Field of view | 80 degree | 120 degree |
| Distal end diameter | 6.9 mm | 6.7 mm |
| Flexible portion diameter | 6.2 mm | 6.3 mm |
| Bending capability Up | 120 degree | 130 degree |
| Bending capability Down | 90 degree | 90 degree |
| Forceps channel diameter | 2.0 mm | 2.0 mm |
| Working length | 600 mm | 610 mm |
| Total length | 890 mm | 880 mm |
| Scanning method | Electrical curved linear array | Electrical curved linear array |
| Scanning range | 50 degree | 60 degree (with SU-7000)
65 degree (with SU-8000) |
| Ultrasonic operating frequency | 7.5 MHz | 5 MHz, 7.5 MHz, 10 MHz,
12 MHz |
All patient contact materials used in the proposed EB-530US remain the same as the previously-cleared Fujinon/Fujifilm endoscopes.
V. CONCLUSION
Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is substantially equivalent to the legally marketed device and conforms to applicable medical device safety and performance standards.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like strokes. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FUJIFILM Medical Systems U.S.A., Inc. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, MN 55313
Re: K121035
Trade/Device Name: Fujinon/Fujifilm Ultrasonic Endoscope EB-530US Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOQ, ITX Dated: April 4, 2012 Received: April 5, 2012
Dear Mr. Job:
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 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.
JUN - 4 2012
4
Page 2 - Mr. Mark Job
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): __
Device Name: Fujinon/Fujifilm Ultrasonic Endoscope EB-530US To be used with Fujinon/Fujifilm Ultrasonic Processor (SU-7000/SU-8000)]
Indications for Use:
The Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is intended for the observation, . The Tighton't ajimm Oneonent of the trachea, bronchial tree and surrounding organs using ultrasonic images. It is used with Fujinon/Fujifilm ultrasonic processor, video processor, light source, other peripheral equipment and endoscopic accessories. It is not intended for use on children and infants.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
. Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
121035
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
6
i2 10 35
Diagnostic Ultrasound Indications For Use
510(k) Number (If Known):
Fujinon/Fujifilm Ultrasonic Processor (SU-7000/SU-8000) System Name: Ultrasonic Endoscope EB-530US Transducer:
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 | ||
| Doppler | Combined¹ | Other | ||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ | ||||||||
| (Thyroid, Breast, Testes, etc.) | ||||||||
| Neonatal Cephalic | ||||||||
| General | Adult Cephalic | |||||||
| Application | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Tran-esoph. (non-Card.) | N | N | N | N | N¹ | |||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | N¹ | |||||||
| Other (Specify) | N | N | N | N | N¹ | |||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Tran-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vascular | Other (Specify) |
vessel
Combined modes includes B+M, B+CD, B+PWD, B+CD+PWD modes
Other (Specify): Trachea, bronchial tree and surrounding organs
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices
510(k) Number
Prescription Use (Per 21 CFR 801.109)