(240 days)
Not Found
No
The device description focuses on the physical components and basic image capture technology (CCD sensor). There is no mention of AI, ML, or advanced image processing beyond simple display. The performance studies listed are related to electrical safety, EMC, and reprocessing, not algorithmic performance.
Yes
The "Indications for Use" section explicitly states that the devices are intended for "endoscopic treatment" in addition to observation and diagnosis.
Yes
The "Indications for Use" section explicitly states that the device is intended for "observation, diagnosis, and endoscopic treatment."
No
The device description clearly outlines physical hardware components including an insertion portion, umbilicus, glass fiber bundles, CCD image sensor, and various channels, indicating it is a hardware device with integrated software for control and image capture.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The description clearly states that these endoscopes are used for direct observation, diagnosis, and endoscopic treatment of the digestive tract within the body. They illuminate the body cavity, capture images, and allow for the introduction of accessories like biopsy forceps.
- Lack of Specimen Examination: The device does not examine specimens outside of the body. While biopsies might be taken using the forceps channel, the endoscope itself is not performing the diagnostic test on the collected tissue. The diagnostic examination of the biopsy would be performed separately in a laboratory, likely using IVD devices.
The endoscopes are medical devices used for direct visualization and intervention within the body, not for testing samples in a lab setting.
N/A
Intended Use / Indications for Use
The Fujifilm Endoscopes: EG-530CT, EC-530D, EC-530DL, and ES-530WE have the following indications for use:
Indications for Use (EG-530CT):
The EG-530CT Endoscope: This device is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Indications for Use (EG-530D):
The EG-530D Endoscope: This device is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Indications for Use (EC-530DL):
The EC-530DL Endoscope: This device is intended for the lower digestive tract, soecifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
Indications for Use (ES-530WE):
The ES-530WE Endoscope: This device is intended for the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon.
Product codes
FDS, FDF, FAM
Device Description
The endoscopes are comprised of three general sections: an insertion portion and an umbilicus. The operation section controls the angulation (up/down/left/ight) of the endoscope. The insertion portion contains glass fiber bundles, several channels and a charged couple device (CCD) image sensor. The glass fiber bundles allow light to travel through the endoscope and emit light from the insertion portion to illuminate the body cavity. This provides enough light to the CCD image sensor to capture an image and display it on the monitor. The endoscope also contains several channels to deliver air/water, provide suction, and a forceps channel. The forceps channels are used to introduce endoscope accessories such as biopsy forceps during the procedure. The umbilicus section consists of electronic components needed to operate the endoscope when plugged to the video processor and the light source.
The proposed models are used in combination with Fuilfilm's video processor, light source and peripheral devices (water tank, endoscope accessories, monitor, printer, DVD recorder, electrosurgical instruments, foot switch, and cart).
The minor modifications to the endoscopes were made for the purpose of overall product enhancement and general technological advancement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
EG-530CT, EG-530D: upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
EC-530DL: lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
ES-530WE: lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon.
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
The subject devices have been subjected to and passed electrical safety and EMC test requirements.
Fujifilm Endoscopes, EG-530CT, EC-530DL, and ES-530WE were evaluated in accordance with the following safety and performance requirements in addition to the applicable quality regulations:
- ANSI/AAMI ES60601-1:2005***: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC60601-1-2:2007***: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Compatibility - Requirements and tests
- IEC60601-2-18:2009***: Medical electrical equipment - Part 2-18: Particular requirements for the safety of endoscopic equipment
- IEC60601-1-6:2010: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC62366:2007: Medical devices - Application of usability engineering to medical devices
- ISO10993-1:2009*: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
- ISO10993-5:2009: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
- ISO10993-10:2010: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- ISO8600-1**:2013: Optics and photonics - Medical endoscopes and endotherapy devices – Part 1: General requirements
- ISO8600-3 :1997: Optics and Optical instruments - Medical endoscopes and endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics
- ISO8600-4:1997: Optics and Optical instruments – Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
- ISO17665:2006: A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
- Evaluation to ISO 10993-1 (Tested per ISO10993-10) was conducted for patient contact materials.
** Evaluation to ISO8600-1 (Tested per ISO8600-3 and ISO8600-4) was conducted for medical endoscopes and accessories.
*** Evaluation to ANSI/AAMI ES60601-1, IEC60601-1-2, and IEC60601-2-18 was conducted for Fujifilm Endoscopes EG-530D, EG-530CT, EC-530DL, and ES-530WE.
The reprocessing instructions were updated and validation was performed in conformance with AAMI TIR 30:2011 and AAMI TIR12:2010. A Reprocessing validation certificate is included with this premarket notification. Steam sterilization was validated per ISO 17665-1:2006. 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
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 14, 2015
Fujifilm Medical System U.S.A., Inc. Mary Moore Senior Director, Regulatory Affairs and Quality Assurance 10 High Point Drive Wayne, NJ 07470
Re: K142629
Trade/Device Name: EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscopes and accessories Regulatory Class: II Product Code: FDS, FDF, FAM Dated: April 8, 2015 Received: April 8, 2015
Dear Mary Moore,
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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,
Joyce M. Whang -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K142629
Device Name
EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes
Indications for Use (Describe)
The Fujifilm Endoscopes: EG-530CT, EC-530D, EC-530DL, and ES-530WE have the following indications for use:
Indications for Use (EG-530CT):
The EG-530CT Endoscope: This device is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Indications for Use (EG-530D):
The EG-530D Endoscope: This device is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Indications for Use (EC-530DL):
The EC-530DL Endoscope: This device is intended for the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
Indications for Use (ES-530WE):
The ES-530WE Endoscope: This device is intended for the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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 Druq 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
510(k) SUMMARY
FUJIFILM Medical Systems U.S.A., Inc.'s EG-530D, EG-530CT, EC-530DL, and ES-530WE Endoscopes
Date: September 16, 2014
Submitter's Information
FUJIFILM Medical Systems U.S.A., Inc., Endoscopy Division 10 High Point Drive Wayne, NJ 07470 USA FDA Establishment Registration Number: 2431293
Contact Person:
Mary K. Moore Senior Director, Regulatory Affairs and Quality Assurance Telephone: (800) 385-4666 ext. 522498 Facsimile: (973) 686-2616 E-Mail: mkmoore@fujifilm.com
Identification of the Proposed Device:
Proprietary/Trade Name: Fujifilm EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes
| Common Name: | Video Endoscope |
|---|---|
| Device Class: | Class II |
| Review Panel: | Gastroenterology/Urology |
Classification Information:
| Classification Name | CFR Section | Product Codes |
|---|---|---|
| Gastroscope and Accessories (Flexible/Rigid) | 21 CFR 876.1500 | FDS |
| Colonoscope and Accessories (Flexible/Rigid) | 21 CFR 876.1500 | FDF |
| Sigmoidoscope and Accessories (Flexible/Rigid) | 21 CFR 876.1500 | FAM |
Predicate Devices
4
Intended Use / Indications for Use
The Fujifilm Endoscopes: EG-530CT, EG-530D, and ES-530WE have the following indications for use:
Indications for Use (EG-530CT):
The EG-530CT Endoscope: This device is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Indications for Use (EG-530D):
The EG-530D Endoscope: This device is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Indications for Use (EC-530DL):
The EC-530DL Endoscope: This device is intended for the lower digestive tract, soecifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
Indications for Use (ES-530WE):
The ES-530WE Endoscope: This device is intended for the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon.
Technological Characteristics
Fujifilm proposed endoscopes are modified versions of previously cleared endoscopes. Fujinon G5 Gastroscope, EG-450WR5 (K042043) and Fujinon Colonoscope, EC-530HL2 (K112391).
The endoscopes are comprised of three general sections: an insertion portion and an umbilicus. The operation section controls the angulation (up/down/left/ight) of the endoscope. The insertion portion contains glass fiber bundles, several channels and a charged couple device (CCD) image sensor. The glass fiber bundles allow light to travel through the endoscope and emit light from the insertion portion to illuminate the body cavity. This provides enough light to the CCD image sensor to capture an image and display it on the monitor. The endoscope also contains several channels to deliver air/water, provide suction, and a forceps channel. The forceps channels are used to introduce endoscope accessories such as biopsy forceps during the procedure. The umbilicus section consists of electronic components needed to operate the endoscope when plugged to the video processor and the light source.
The proposed models are used in combination with Fuilfilm's video processor, light source and peripheral devices (water tank, endoscope accessories, monitor, printer, DVD recorder, electrosurgical instruments, foot switch, and cart).
The minor modifications to the endoscopes were made for the purpose of overall product enhancement and general technological advancement.
5
SUMMARY OF STUDIES
The subject devices have been subjected to and passed electrical safety and EMC test requirements.
Fujifilm Endoscopes, EG-530CT, EC-530DL, and ES-530WE were evaluated in accordance with the following safety and performance requirements in addition to the applicable quality regulations:
| ANSI/AAMI ES60601-
1:2005*** | Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC60601-1-2:2007*** | Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance -
Collateral standard: Electromagnetic Compatibility -
Requirements and tests |
| IEC60601-2-18:2009*** | Medical electrical equipment - Part 2-18: Particular
requirements for the safety of endoscopic equipment |
| IEC60601-1-6:2010 | Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance -
Collateral standard: Usability |
| IEC62366:2007 | Medical devices - Application of usability engineering to
medical devices |
| ISO10993-1:2009* | Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process. |
| ISO10993-5:2009 | Biological evaluation of medical devices – Part 5: Tests for
in vitro cytotoxicity |
| ISO10993-10:2010 | Biological evaluation of medical devices - Part 10: Tests
for irritation and skin sensitization. |
| ISO8600-1**:2013 | Optics and photonics - Medical endoscopes and
endotherapy devices – Part 1: General requirements |
| ISO8600-3 :1997 | Optics and Optical instruments - Medical endoscopes and
endoscopic accessories - Part 3: Determination of field of
view and direction of view of endoscopes with optics |
| ISO8600-4:1997 | Optics and Optical instruments – Medical endoscopes and
certain accessories - Part 4: Determination of maximum
width of insertion portion |
| ISO17665:2006 | A compendium of processes, materials, test methods, and
acceptance criteria for cleaning reusable medical devices |
- Evaluation to ISO 10993-1 (Tested per ISO10993-10) was conducted for patient contact materials.
** Evaluation to ISO8600-1 (Tested per ISO8600-3 and ISO8600-4) was conducted for medical endoscopes and accessories.
** Evaluation to ANSI/AAMI ES60601-1, IEC60601-1-2, and IEC60601-2-18 was conducted for Fujifilm Endoscopes EG-530D, EG-530CT, EC-530DL, and ES-530WE.
The reprocessing instructions were updated and validation was performed in conformance with AAMI TIR 30:2011 and AAMI TIR12:2010. A Reprocessing validation certificate is included with this premarket notification. Steam sterilization was validated per ISO 17665-1:2006. No clinical testing was conducted.
6
Substantial Equivalence
Fujifilm Endoscopes EG-530D, EG-530CT, EC-530DL, and ES-530WE are substantially equivalent to the following devices.
| Proposed Device | Legally Marketed Device(s) | 510(k) # |
|---|---|---|
| Fujifilm Endoscope EG-530D | Fujinon G5 Gastroscope, EG-450WR5 | K042043 |
| Fujifilm Endoscope EG-530CT | Fujinon G5 Gastroscope, EG-450WR5 | K042043 |
| Fujifilm Endoscope EC-530DL | Fujinon Colonoscopes, EC-530HL2 | K112391 |
| Fujifilm Endoscope ES-530WE | Fujinon Colonoscopes, EC-530HL2 | K112391 |
The Fujifilm EG-530CT, EG-530D, and ES-530WE Endoscopes are as safe and effective as the Fujinon G5 Gastroscope, EG-450WR5 (K042043) and the Fujinon Colonoscopes, EC-530HL2 (K112391). The Fujifilm EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes have intended uses and similar indications, technological characteristics, and principles of operation as the predicate devices. The minor technological differences between the Fujifilm EG-530CT, EG-530D, EC-530WE Endoscopes and the predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Fujifilm EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes are as safe and effective as the Fujinon G5 Gastroscope, EG-450WR5 (K042043) and the Fujinon Colonoscopes, EC-530HL2 (K112391). Thus, the Fujifilm EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes are substantially equivalent.
Conclusions
Fujifilm Endoscopes, EG-530CT, EC-530DL, and ES-530WE are substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards.