(77 days)
Not Found
No
The document describes a standard video laparoscope and its components. There is no mention of AI, ML, image processing beyond basic video signal handling, or any data sets/performance metrics typically associated with AI/ML devices.
No.
The device is used for "observation, diagnosis, and treatment," which indicates it is used in a surgical or diagnostic capacity, but it does not independently provide therapy. It is an instrument used during therapeutic procedures.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "observation, diagnosis and treatment".
No
The device description explicitly states it is comprised of a rigid insertion portion, cable portion, and scope connector, and contains an optical system, CCD image sensor, and electrical circuits. These are hardware components.
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 "minimally invasive observation, diagnosis and treatment in general abdominal, gynecologic and thoracic areas." This describes a device used within the body for direct visualization and intervention, not for testing samples outside the body.
- Device Description: The description details a rigid insertion portion, optical system, CCD image sensor, and light guide fiber bundles. These are components of an endoscope used for internal imaging, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or performing tests on samples in vitro (in glass or outside the body).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is direct visualization and intervention within the body.
N/A
Intended Use / Indications for Use
FUJIFILM Video Laparoscope EL-R740M30 is intended to be used with a video processor, light source, monitor, hand instruments, electrosurgical unit and other ancillary equipment for minimally invasive observation, diagnosis and treatment in general abdominal, gynecologic and thoracic areas.
Product codes
GCJ
Device Description
Video Laparoscope EL-R740M30 is comprised of a rigid insertion portion, cable portion, and scope connector. An optical system, CCD image sensor and electrical circuits are located within the distal end portion of the laparoscope. The video signal lines from the CCD sensor and the light guide fiber bundles are connected to the scope connector through the laparoscope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general abdominal, gynecologic and thoracic areas
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
Electrical, laser, and photobiological safety of the subject device conforms to the following standards: ANSI/AAMI ES60601-1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2013, IEC 60601-2-18:2009, IEC 60825-1:2007, and IEC 62471:2006.
Biocompatibility of the subject device was evaluated using the following consensus standards: ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2010. Biocompatibility testing was performed in accordance with FDA's guidance, "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," published September 4, 2020.
Endoscope specific testing was conducted according to ISO 8600-1:2015.
Validation of the cleaning and sterilization instructions for the subject device EL-R740M30 was evaluated in accordance with FDA's quidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," published March 17, 2015.
Software was evaluated according to ANSI/AAMI/IEC 62304:2006/A1:2016 and the FDA guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," published May 11, 2005. Cybersecurity controls were developed according to the FDA guidance, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," published October 2, 2014.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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December 2, 2021
FUJIFILM Corporation % Dhara Buch Regulatory Affairs Specialist FUJIFILM Medical Systems U.S.A. Inc. 81 Hartwell Avenue, Suite 300 Lexington, Massachusetts 02421
Re: K212950
Trade/Device Name: FUJIFILM Video Laparoscope EL-R740M30 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: October 8, 2021 Received: October 12, 2021
Dear Dhara Buch:
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. 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 located at https://www.accessdata.fda.gov/scripts/cdrl/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.
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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) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212950
Device Name
FUJIFILM Video Laparoscope Model EL-R740M30
Indications for Use (Describe)
FUJIFILM Video Laparoscope EL-R740M30 is intended to be used with a video processor, light source, monitor, hand instruments, electrosurgical unit and other ancillary equipment for minimally invasive observation, diagnosis and treatment in general abdominal, gynecologic and thoracic areas.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | _ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY FUJIFILM Corporation Video Laparoscope Model EL-R740M30
Date: September 15, 2021
Submitter's Information:
FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, 258-8538, Japan
Contact Person:
Dhara Buch Regulatory Affairs Specialist Phone: 781-824-2708 E-Mail: dhara.buch@fujifilm.com
ldentification of the Proposed Device:
| Device Name: | Video Laparoscope Model EL-R740M3 |
|---|---|
| Common Name: | Laparoscope |
| Device Class: | Class II |
| Classification Number: | 21 C.F.R. § 876.1500 |
| Classification Name: | Endoscope and accessories |
| Device Panel: | General & Plastic Surgery |
| Product Code: | GCJ |
Predicate Devices:
- FUJIFILM Video Laparoscope EL-R740M (K202130) ●
Intended Use / Indications for Use
FUJIFILM Video Laparoscope EL-R740M30 is intended to be used with a video processor, light source, monitor, hand instruments, electrosurgical unit and other ancillary equipment for minimally invasive observation, diagnosis and treatment in general abdominal, gynecologic and thoracic areas.
Device Description
Video Laparoscope EL-R740M30 is comprised of a rigid insertion portion, cable portion, and scope connector. An optical system, CCD image sensor and electrical circuits are located within the distal end portion of the laparoscope. The video signal lines from the CCD sensor and the light guide fiber bundles are connected to the scope connector through the laparoscope.
4
Technological Characteristics
A comparison of technological characteristics between EL-R740M30 and the predicate EL-R740M is provided below:
| Device Details | Predicate Device | Subject Device |
|---|---|---|
| Device Name | Video Laparoscope EL- R740M | Video Laparoscope EL- R740M30 |
| To be assigned | ||
| 510(k) Number | K202130 | |
| Product Code | GCJ | GCJ |
| Manufacturer | FUJIFILM Corporation | FUJIFILM Corporation |
| Indications for use (IFU) | FUJIFILM Video | |
| Laparoscope EL-R740M | ||
| is intended to be used with a | ||
| video processor, light source, | ||
| monitor, hand instruments, | ||
| electrosurgical unit and other | ||
| ancillary equipment for | ||
| minimally invasive | ||
| observation, diagnosis and | ||
| treatment in general | ||
| abdominal, gynecologic and | ||
| thoracic areas. | Same as K202130 | |
| Viewing Direction | Forward / 0 degrees | 30 degrees |
| Distal end diameter | 5.4mm | Same as K202130 |
| Maximum insertion | ||
| Diameter | 5.4mm | Same as K202130 |
| Working length | 330mm | Same as K202130 |
| CPU/Software | Installed | Same as K202130 |
| Light Source/Video | ||
| Processor | BL-7000/VP-7000 | BL-7000/VP-7000 |
| BL-7000X/VP-7000 | ||
| LCI | Available | Same as K202130 |
| Adjustment Ring | No | Yes |
Performance Data
Electrical, laser, and photobiological safety of the subject device conforms to the following standards: ANSI/AAMI ES60601-1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2013, IEC 60601-2-18:2009, IEC 60825-1:2007, and IEC 62471:2006.
Biocompatibility of the subject device was evaluated using the following consensus standards: ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2010. Biocompatibility testing was performed in accordance with FDA's guidance, "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," published September 4, 2020.
Endoscope specific testing was conducted according to ISO 8600-1:2015.
5
Validation of the cleaning and sterilization instructions for the subject device EL-R740M30 was evaluated in accordance with FDA's quidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," published March 17, 2015.
Software was evaluated according to ANSI/AAMI/IEC 62304:2006/A1:2016 and the FDA guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," published May 11, 2005. Cybersecurity controls were developed according to the FDA guidance, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," published October 2, 2014.
Conclusions
The subject device FUJIFILM Video Laparoscope EL-R740M30 is substantially equivalent to the predicate device FUJIFILM Video Laparoscope EL-R740M (K202130). The subject and predicate devices share the same intended use and indications. Bench testing demonstrates that the differences in technological characteristics raise no new issues of safety or effectiveness. Thus, FUJIFILM Video Laparoscope EL-R740M30 is substantially equivalent to the predicate device based on the same intended use, indications for use, and substantially equivalent technological characteristics and materials.