(28 days)
No
The description focuses on the mechanical and optical components of the endoscope and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The "Intended Use / Indications for Use" states that the device is intended for "endoscopic treatment of the trachea and bronchus," indicating a therapeutic purpose in addition to diagnosis and observation.
Yes
The "Intended Use / Indications for Use" section explicitly states that the endoscope is "intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchus". Diagnosis is a key function of a diagnostic device.
No
The device description clearly outlines physical hardware components such as an insertion portion, bending portion, insertion tube, distal end with imaging section, objective lens, light guide, CMOS image sensor, cabling, and a control portion with mechanical parts. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "observation, diagnosis and endoscopic treatment of the trachea and bronchus". This involves direct visualization and intervention within the body.
- Device Description: The description details a bronchoscope, which is an instrument used to visualize the airways. It describes the physical components and how it's used to navigate and interact with the anatomical site.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. This device does not perform any such analysis of specimens.
The device is an endoscope, which is a medical device used for internal examination of the body.
N/A
Intended Use / Indications for Use
Endoscope Model EB-710XT is a bronchoscope intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchus at medical facilities under the management of physicians. Never use this product for any other purposes.
Product codes
EOQ
Device Description
The proposed device consists of a non-insertion portion. The insertion portion is inserted trans-nasally or perorally into the trachea and bronchial tree during clinical use.
The insertion portion is flexible and consists of the bending portion") and the insertion tube (hereinafter "flexible portion"). The bending portion features a mechanism that bends the tip up and down. The insertion portion can also be rotated so that the distal end of the endoscope is steered to the anatomic region of interest. The insertion portion of the endoscopes comes into contact with the mucosal membrane.
The tip of the insertion portion is called the "Distal end" which contains the lmaging section, Distal cap, Instrument channel outlet, Objective lens, and Light guide.
The bending portion is controlled by lever on the control portion section to angulate the distal end to certain angles.
The flexible portion contains light guides), an instrument/suction channel, a complementary metal-oxide semiconductor (CMOS) image sensor, and cabling. The glass fiber bundles allow light to travel through the endoscope to illuminate the body cavity, thereby providing enough light to the CMOS image sensor to capture an image on a monitor.
The control portion provides a grip on the endoscopes and contains mechanical parts to operate the endoscopes. The control portion features an angle lever and a rotation ring which control the angulation and the distal end. The instrument/suction channel runs through the control portion for introducing the endoscopic accessories or electrosurgical instrument, as well as providing suction.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trachea and bronchus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical facilities under the management of physicians.
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 changes to the proposed device models are in the dimeter, flexible portion diameter, forceps channel diameter, and maximum insertion diameter, and the down bending capability. To determine if the safety or efficacy of the subject device, performance testing was conducted, and the passed all test objectives. It was determined that the new endoscope models are substantially equivalent to the predicate device.
Endoscope specific testing was conducted according to ISO 8600-1: 2015
The proposed device met performance specifications in the following additional testing:
- Field of view
- Bending capability
- Working length
- Diameter of forceps channel
- Viewing direction
- Resolution
- LG output
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 7, 2024
Fujifilm Healthcare Americas Corporation Chaitrali Kulkarni Sr. Regulatory Affairs Specialist 81 Hartwell Ave Suite 300 Lexington, Massachusetts 02421
Re: K240075
Trade/Device Name: FUJIFILM Endoscope Model EB-710XT Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: January 10, 2024 Received: January 10, 2024
Dear Chaitrali Kulkarni:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joyce C. Lin -S
for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
FUJIFILM Endoscope Model EB-710XT
Indications for Use (Describe)
Endoscope Model EB-710XT is a bronchoscope intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchus at medical facilities under the management of physicians.
Never use this product for any other purposes.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | ----------------------------------------------- |
|X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Prepared on: 2024-01-09
Contact Details
21 CFR 807.92(a)(
| Applicant Name | Fujifilm Healthcare Americas Corporation |
|---|---|
| Applicant Address | 81 Hartwell ave suite 300 Lexington MA 02421 United States |
| Applicant Contact Telephone | 704-517-4886 |
| Applicant Contact | Ms. Chaitrali Kulkarni |
| Applicant Contact Email | chaitrali.kulkarni@fujifilm.com |
Device Name
21 CFR 807.92(a)(2)
| Device Trade Name | FUJI FILM Endoscope Model EB-710XT |
|---|---|
| Common Name | Bronchoscope (flexible or rigid) and accessories |
| Classification Name | Bronchoscope (Flexible Or Rigid) |
| Regulation Number | 874.4680 |
| Product Code | EOQ |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K220957 | FUJIFILM Endoscope Model EB-710P | EOQ |
Device Description Summary
21 CFR 807.92(a)(4)
A. Intended Use/indications for Use
Endoscope Model EB-710XT is a bronchoscope intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchus at medical facilities under the management of physicians. Never use this product for any other purposes.#### B. Technological Characteristics
The proposed device consists of a non-insertion portion. The insertion portion is insertion portion is inserted trans-nasally or perorally into the trachea and bronchial tree during clinical use.
The insertion portion is flexible and consists of the bending portion") and the insertion tube (hereinafter "flexible portion"). The bending portion features a mechanism that bends the tip up and down. The insertion portion can also be rotated so that the distal end of the endoscope is steered to the anatomic region of interest. The insertion portion of the endoscopes comes into contact with the mucosal membrane.
The tip of the insertion portion is called the "Distal end" which contains the lmaging section, Distal cap, Instrument channel outlet, Objective lens, and Light guide.
The bending portion is controlled by lever on the control portion section to angulate the distal end to certain angles.
The flexible portion contains light guides), an instrument/suction channel, a complementary metal-oxide
4
semiconductor (CMOS) image sensor, and cabling. The glass fiber bundles allow light to travel through the endoscope to illuminate the body cavity, thereby providing enough light to the CMOS image sensor to capture an image on a monitor.
The control portion provides a grip on the endoscopes and contains mechanical parts to operate the endoscopes. The control portion features an angle lever and a rotation ring which control the angulation and the distal end. The instrument/suction channel runs through the control portion for introducing the endoscopic accessories or electrosurgical instrument, as well as providing suction.
C. Principles of Operation
The proposed device function on the same principles of operation as the predicate device, EB-710P (K220957). They are bronchoscopes that can be inserted trans-nasally into the trachea and bronchial tree for observation, diagnosis, and treatment of these regions. After connecting to the light source and video processor, the devices guide the light through the fiber bundles situated inside the insertion of the devices. The light that emits from the distal end of the insertion portion reflects from the target region and forms an image on the CMOS image sensor through a group of object lenses placed
at the distal end of the devices. An electric signal from the inage sensor is transmitted to the devices. The video processor converts the electric signal ind displays an image on a monitor. This image is used for the visualization of the trachea and bronchial tree.
Intended Use/Indications for Use
Endoscope Model EB-710XT is a bronchoscope intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchus at medical facilities under the management of physicians. Never use this product for any other purposes.
Indications for Use Comparison
The intended use of the subject device and the predicate device (K220957) are the same.
Technological Comparison
There is a difference in the sizes of the distal end diameter, forcep channel diameter, and maximum insertion diameter in comparison to the predicate device. Although the sizes are larger then the sizes of the distal end diameter, flexible portion diameter, forcep channel diameter are smaller than the reference device (EVISEXERA III Bronchovideoscope Olympus BF-XT190, K183419), therefore there are no new concerns for safety or effectiveness.
The Bending Capability Up is different than the predicate device has a smaller degree of bending than the predicate device, therefore there is no new concern for safety and effectiveness.
Some parts of the device have a different material used in the subject device compared to the predicate device, however the material used is used other other parts of the predicate device, there is no new concern for safety or effectiveness.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The changes to the proposed device models are in the dimeter, flexible portion diameter, forceps channel diameter, and maximum insertion diameter, and the down bending capability. To determine if the safety or efficacy of the subject device, performance testing was conducted, and the passed all test objectives. It was determined that the new endoscope models are substantially equivalent to the predicate device.
Endoscope specific testing was conducted according to ISO 8600-1: 2015
The proposed device met performance specifications in the following additional testing:
- Field of view
- Bending capability
- · Working length
- Diameter of forceps channel
- Viewing direction
- · Resolution
- LG output
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)