(20 days)
No
The summary describes a standard video laparoscope with an optical system and CCD sensor. There is no mention of AI, ML, image processing beyond basic signal conversion, or any data processing that would suggest AI/ML capabilities. The performance studies focus on safety and biocompatibility, not algorithmic performance.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "treatment" in various abdominal, gynecologic, and thoracic areas, which implies a therapeutic function beyond just diagnosis or observation.
Yes
The "Intended Use / Indications for Use" states that the device is intended for "minimally invasive observation, diagnosis and treatment". The explicit mention of "diagnosis" indicates that it is a diagnostic device.
No
The device description explicitly states it is comprised of physical components like a rigid insertion portion, cable portion, scope connector, optical system, CCD image sensor, and electrical circuits, indicating it is a hardware device.
Based on the provided information, the FUJIFILM Video Laparoscope EL-R740M is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's 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. This is consistent with an endoscope used for internal imaging.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples. IVD devices are specifically designed for such purposes.
Therefore, the FUJIFILM Video Laparoscope EL-R740M is a medical device used for internal visualization and procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GCJ
Device Description
Video Laparoscope EL-R740M 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 quide 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
Photobiological safety of the subject device was performed in accordance with IEC 62471:2006.
Biocompatibility of the subject device was evaluated using the following consensus standards: ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-11:2017. 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 June 16, 2016.
Endoscope specific testing was conducted according to ISO 8600-1:2015.
Key Metrics
Not Found
Predicate Device(s)
FUJIFILM Video Laparoscope EL-R740S (K192918)
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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August 20, 2020
Fujifilm Corporation % Kamila Sak Regulatory Affairs Specialist Fujifilm Medical Systems U.S.A. Inc. 81 Hartwell Avenue, Suite 300 Lexington, Massachusetts 02421
Re: K202130
Trade/Device Name: FUJIFILM Video Laparoscope, Model EL-R740M Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: July 30, 2020 Received: July 31, 2020
Dear Kamila Sak:
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/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.
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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 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.
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202130
Device Name
FUJIFILM Video Laparoscope Model EL-R740M
Indications for Use (Describe)
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.
| 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) |
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K202130
510(k) SUMMARY FUJIFILM Video Laparoscope EL-R740M
Date: August 19, 2020
Submitter's Information:
FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, 258-8538, Japan FDA Establishment Registration Number: 3001722928
Contact Person:
Kamila Sak Regulatory Affairs Specialist Telephone: (347) 577-2309 E-Mail: kamila.sak@fujifilm.com
Identification of the Proposed Device:
| Device Name: | FUJIFILM Video Laparoscope, Model EL-R740M |
|---|---|
| Common Name: | Laparoscope |
| Classification Number: | 21 C.F.R. § 876.1500 |
| Classification Name: | Endoscope and accessories |
| Regulatory Class: | Class II |
| Device Panel: | General & Plastic Surgery |
Product Code Information:
| Product Code Name | CFR Section | Product Code |
|---|---|---|
| Laparoscope, General & Plastic Surgery | 21 CFR 876.1500 | GCJ |
Predicate Device:
- FUJIFILM Video Laparoscope EL-R740S (K192918)
Intended Use / Indications for Use:
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.
4
Device Description:
Video Laparoscope EL-R740M 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 quide fiber bundles are connected to the scope connector through the laparoscope.
Technological Characteristics:
The subject and predicate devices share the same mode of operation and intended use. The proposed Video Laparoscope Model EL-R740M differs from the predicate device in the following minor modifications:
- . Dimensional and material changes to the insertion portion
Performance Data:
Photobiological safety of the subject device was performed in accordance with IEC 62471:2006.
Biocompatibility of the subject device was evaluated using the following consensus standards: ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-11:2017. 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 June 16, 2016.
Endoscope specific testing was conducted according to ISO 8600-1:2015.
Substantial Equivalence:
The subject device FUJIFILM Video Laparoscope EL-R740M is substantially equivalent to the predicate device FUJIFILM Video Laparoscope EL-R740S (K192918). The subject and predicate devices share the same intended use and indications. Bench testing demonstrates that the differences in technological characteristics and materials raise no new issues of safety or effectiveness. Thus, FUJIFILM Video Laparoscope EL-R740M is substantially equivalent to the predicate device.
Conclusions:
The subject device Video Laparoscope EL-R740M is substantially equivalent to the predicate device based on the same intended use, indications for use, and substantially equivalent technological characteristics and materials.