(115 days)
Not Found
No
The summary describes a standard bronchoscope and its accessories, with no mention of AI, ML, or advanced image processing beyond basic visualization. The performance studies focus on safety and reprocessing, not algorithmic performance.
Yes
The device is described as being used for the "endoscopic treatment of the trachea and bronchial tree". The "Treatment Type" model explicitly includes a forceps channel, further indicating its use in therapeutic procedures.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree," indicating its role in diagnosis.
No
The device description explicitly states it is a series of bronchoscopes, which are physical hardware devices used for observation, diagnosis, and treatment. It also mentions being used in combination with other hardware components like video endoscope processors, light sources, and monitors.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The description clearly states the device is a bronchoscope intended for the "observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree." This involves directly visualizing and potentially treating structures inside the body.
- Input: The input is "Endoscopic video," which is live imaging from within the body, not a sample taken from the body.
- Anatomical Site: The anatomical site is the "trachea and bronchial tree," which are internal structures.
The device is an endoscopic device used for direct visualization and intervention within the respiratory system.
N/A
Intended Use / Indications for Use
The Fujinon/Fujifilm EB-530 Series Bronchoscopes are intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree.
Product codes (comma separated list FDA assigned to the subject device)
EOQ
Device Description
Fulinon/Fuilfilm EB-530 Series Bronchoscopes are intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchial tree. The Fujinon/Fujifilm EB-530 Series Bronchoscopes are used in combination with the Fujinon/Fujifilm's video endoscope processors, light source, monitor, cart, foot switch, endoscopic accessories, other peripheral devices (e.g. printer, keyboard, etc.), and the legally marketed electrosurgical instruments.
There are three models included in this submission:
- EB-530S Standard Type •
- EB-530T Treatment Type (includes 2.8mm forceps channel) .
- EB-530H Super Image Type (High resolution) .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trachea and bronchial tree
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject device has been subjected to and passed electrical safety and EMC test requirements.
Fujinon/Fujifilm EB-530 Series Bronchoscopes were evaluated in accordance with the following safety and performance requirements in addition the applicable quality requlations:
| 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 |
| ISO10993-1 | Biological evaluation of medical devices |
New pre-sterilized suction button SB-602 conforms to the applicable internal and international ISO testing requirements for Sterility.
The reprocessing instructions were updated and validated. No clinical testing was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
FUJIFILM Medical Systems U.S.A., Inc. 10 High Paint Drive Vayne: NJ 07470 Tel. (973) 533-5600
510(k) Summary
DEC 1 3 2012
,
Date: November 1, 2012
K Number: K122535
Submitter's Information:
FUJIFILM Medical Systems U.S.A., Inc. 10 High Point Drive Wayne, 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:
Fuiinon/Fuiifilm EB-530 Series Bronchoscopes Proprietary/Trade Name: Bronchoscopes Common Name: Device Class: Class 2 Review Panel: Ear Nose & Throat Classification Information:
| AND REALERS LE & LEASE & LEA BER AND
Company Court Call College Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Com
paties B . F
Classification Name | Section |
Product
Codes
Canadian Career Station Company of Children Company of Children Company of Children |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Separation Street Art A.R. P.A. P.O. Box C.C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C.
NEW YORK OF CANDRIGURANCE OF ST
Bronchoscope (flexible or rigid) and accessories | ילס ח"מת -
4 4680
Call of the country of the first and the comments of the comments of the first of the first of the comments of the comments of the comments of the comments of the comments of
and the first from the became of the many would be | and any and |
l. INDICATIONS FOR USE
The Fujinon/Fujifilm EB-530 Series Bronchoscopes are intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree.
1
FUJKFILM
FUJIFILM Medical Systems U.S.A., Inc. 10 High Pors Ony ame NJ 07470 8 1973 6325800
DEVICE DESCRIPTION II.
Fulinon/Fuilfilm EB-530 Series Bronchoscopes are intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchial tree. The Fujinon/Fujifilm EB-530 Series Bronchoscopes are used in combination with the Fujinon/Fujifilm's video endoscope processors, light source, monitor, cart, foot switch, endoscopic accessories, other peripheral devices (e.g. printer, keyboard, etc.), and the legally marketed electrosurgical instruments.
There are three models included in this submission:
- EB-530S Standard Type •
- EB-530T Treatment Type (includes 2.8mm forceps channel) .
- EB-530H Super Image Type (High resolution) .
lll. SUMMARY OF STUDIES
The subject device has been subjected to and passed electrical safety and EMC test requirements.
Fujinon/Fujifilm EB-530 Series Bronchoscopes were evaluated in accordance with the following safety and performance requirements in addition the applicable quality requlations:
| 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 |
| ISO10993-1 | Biological evaluation of medical devices |
New pre-sterilized suction button SB-602 conforms to the applicable internal and international ISO testing requirements for Sterility.
The reprocessing instructions were updated and validated. No clinical testing was conducted.
2
FUJIFILM
FUJIFILM Medical Systems U.S.A., Inc. 0 High Point Drive Wavne, NJ 07470 1. (973) 833-5600
SUBSTANTIAL EQUIVALENCE IV.
Fuilnon/Fujifilm EB-530 Series Bronchoscopes are substantially equivalent to the following device:
| Legally Marketed Device(s) | 510(k) # |
|---|---|
| Fujinon G5 Bronchoscopes | K050907 |
Comparison is outlined in the table below.
| | Legally marketed
Fujinon G5
Bronchoscope
EB-470S (K050907) | Proposed Device
Model EB-530S | Proposed Device
Model EB-530T | Proposed Device
Model EB-530H |
|--------------------------------|---------------------------------------------------------------------|----------------------------------|----------------------------------|----------------------------------|
| Viewing
direction | Forward/0degree | Forward/0degree | Forward/0degree | Forward/0degree |
| Observation
range | 3-100mm | 3-100mm | 3-100mm | 3-100mm |
| Field of view | 120 degrees | 120 degrees | 120 degrees | 140 degrees |
| Distal end
diameter | 4.9mm | 4.9mm | 5.8mm | 5.4mm |
| Flexible portion
diameter | 4.9mm | 4.9mm | 5.9mm | 4.9mm |
| Bending | Up: 180 degrees | Up: 180 degrees | Up: 180 degrees | Up: 180 degrees |
| capability | Down: 130 degrees | Down: 130
degrees | Down: 130
degrees | Down: 130
degrees |
| Forceps
channel
diameter | 2.0mm | 2.0mm | 2.8mm | 2.0mm |
| Working length | 600 mm | 600 mm | 600 mm | 600 mm |
| Total length | 870mm | 870mm | 870mm | 870mm |
All patient contact materials used in the proposed EB-530 Series Bronchoscopes remain the same as the legally marketed device.
V. CONCLUSION
Fujinon/Fujifilm EB-530 Series Bronchoscopes are substantially equivalent to the legally marketed device and conform to applicable medical device safety and performance: standards.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of three overlapping human figures.
December 13, 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
FUJIFILM Medical Systems U.S.A., Inc. % Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW. Buffalo, MN 55313
Re: K122535
Trade/Device Name: Fujinon/Fujifilm EB-530 Series Bronchoscopes (EB-530S, EB-530T and EB-530H) Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOQ Dated: November 1, 2012 Received: November 2, 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.
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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Eric A. Mann
Malvina B. Eydelman, M.D. Director Division of Ophthalmic 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): K122535
Device Name: Fujinon/Fujifilm EB-530 Series Bronchoscopes (EB-530S, EB-530T AND EB-230H)
Indications for Use: This device is intended for the observation, diagnosis, and endoscopic treatment of the frachea and bronchial tree.
X 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number __
Prescription Use
(Per 21 CFR 801.109)
K122535; Fujinon/Fujifilm EB-530 Series Bronchoscopes