(91 days)
No
The description focuses on the mechanical and optical components of the endoscope and its accessories, with no mention of AI or ML capabilities for image analysis, diagnosis, or treatment.
Yes
The device explicitly states its intention for "endoscopic treatment" in both the "Intended Use / Indications for Use" and "Device Description" sections.
Yes
The device's Intended Use / Indications for Use explicitly states it is intended for "diagnosis" and allows the tip of the scope to "reach the area of diagnosis."
No
The device description clearly outlines multiple hardware components including a control portion, flexible portion, bending portion, distal end with lens and channels, balloons, over-tube, balloon pump, processor, VCR, television monitor, and printers. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "optical visualization of the gastrointestinal tract" for "observation, diagnosis, and endoscopic treatment." This involves directly viewing the internal anatomy of the patient.
- Device Description: The description details an endoscope system with components like a control portion, flexible portion, bending portion, and distal end with lenses and channels. It also mentions accessories like balloons, an over-tube, and a balloon pump. These are all tools used for direct visualization and intervention within the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not process or analyze samples in vitro.
The device described is an endoscope, which is a medical device used for minimally invasive procedures to visualize and treat internal organs. It operates in vivo (within the living body).
N/A
Intended Use / Indications for Use
The device is intended for the optical visualization of the gastrointestinal tract. This includes the rectum, large and small intestine. It is intended for observation, diagnosis, and endoscopic treatment.
Product codes
FDF, FED
Device Description
The device is intended for the optical visualization of the gastrointestinal tract. This includes the recturn, large and small intestine. It is intended for observation, diagnosis, and endoscopic treatment.
The Fujinon double balloon enteroscopy system utilizes specialized balloons and over-tube to ensure complete positioning of the colonoscope. The tip of the scope can be smoothly inserted to reach the area of diagnosis. This allows for access to hard to reach areas within the bottom portion of the small intestine.
The EC-450B15 consists of the following portions / parts:
- . Control portion - to provide grip for holding the endoscope and for the operation of the endoscope.
- LG Flexible Portion Contains the light guide, air/water supply tube, suction tube, . and cables.
- Bending Portion .
- Distal End Contains objective lens, air/water nozzles, forceps channel. .
The EC-450Bl5 is used with balloons (BS-1 or BS-2) and an Over-Tube (TS-13101), as well as the balloon pump. The balloon pump, balloons and over-tube were introduced and included as part of the Double Balloon Enteroscopy 510(k).
The EC-450BI5 is used with a Processor (4400) and other peripheral items such as VCR, Television Monitor, and Printers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical visualization
Anatomical Site
gastrointestinal tract. This includes the rectum, large and small intestine.
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 materials in the endoscope are identical to the materials used in the predicate device. Additionally, the device contains the same electrical configurations as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
FUJI:FILM
Image /page/0/Picture/1 description: The image shows the word "FUJINON" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. The text is black against a white background, creating a high contrast and making the word easily readable.
K 090116
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510 (k) Summary
APR 2 2 2009
Date Prepared [21 CFR 807.92(a)(1)]
1/16/2009
Submitter's Information [21 CFR 807.92(a)(1)]
This 510(k) is being submitted by Joseph Azary on behalf of Fujinon Inc.
Contact / Submitter: Joseph Azary Orchid Design 80 Shelton Technology Center Shelton, CT 06484 Tel: (203) 922-0105 Fax: (203) 922-0130
Sponsor / U.S. Distributor: Fujinon Inc. 10 High Point Drive Wayne, NJ 07470 Contact: Gina Walljasper Telephone: 973-633-5600 FDA Establishment Registration# 2431293
Manufacturer: Fujinon Corporation 1-324 Uetake-Cho Kita-Ku, Saitama-Shi Saitama 331-9624, Japan Contact: Masayuji Ooyatsu
FDA Establishment Registration# 9610875
ﯩﺮ
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Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]\
Device Trade or Proprietary Name: Common, Usual, or Classification Name: Classification:
Fujinon EC-450BI5 Colonoscope Class II, 21 CFR 876.1500, FDF
Predicate Device [21 CFR 807.92(a)(3)]
Description of the Device [21 CFR 807.92(a)(4)]
The device is intended for the optical visualization of the gastrointestinal tract. This includes the recturn, large and small intestine. It is intended for observation, diagnosis, and endoscopic treatment.
The Fujinon double balloon enteroscopy system utilizes specialized balloons and over-tube to ensure complete positioning of the colonoscope. The tip of the scope can be smoothly inserted to reach the area of diagnosis. This allows for access to hard to reach areas within the bottom portion of the small intestine.
The EC-450B15 consists of the following portions / parts:
- . Control portion - to provide grip for holding the endoscope and for the operation of the endoscope.
- LG Flexible Portion Contains the light guide, air/water supply tube, suction tube, . and cables.
- Bending Portion .
- Distal End Contains objective lens, air/water nozzles, forceps channel. .
The EC-450Bl5 is used with balloons (BS-1 or BS-2) and an Over-Tube (TS-13101), as well as the balloon pump. The balloon pump, balloons and over-tube were introduced and included as part of the Double Balloon Enteroscopy 510(k).
The EC-450BI5 is used with a Processor (4400) and other peripheral items such as VCR, Television Monitor, and Printers.
Intended Use [21 CFR 807.92(a)(5)]
The device is intended for the optical visualization of the gastrointestinal tract. This includes the rectum, large and small intestine. It is intended for observation, diagnosis, and endoscopic treatment.
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Technological Characteristics [21 CFR 807.92(a)(6)]
Fujinon, Inc. believes that the subject device is substantially equivalent to the predicate device. The subject device has the same indications for use, material composition, characteristics, reprocessing/sterilization method as the predicate. The subject device uses the same processor and peripherals as the predicate device.
The main difference is the use of a colonoscope for with the double balloon enteroscopy accessories or retrograde application of the double balloon enteroscopy system.
Performance Data [21 CFR 807.92(b)(1)]
The materials in the endoscope are identical to the materials used in the predicate device. Additionally, the device contains the same electrical configurations as the predicate devices.
Conclusion [21 CFR 807.92(b)(3)]
We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three horizontal lines representing its wings or feathers. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 2009
Fujinon, Inc. % Mr. Joseph M. Azary Orchid Design 80 Shelton Technology Center Shelton CT 06484
Re: K090116
Trade/Device Name: Fujinon EC-450B15 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF, FED Dated: January 16, 2009 Received: January 23, 2009
Dear Mr. Azary:
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.
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 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
21 CFR 876.xxx 21 CFR 884.xxx 21 CFR 892.xxx Other
(Gastroenterology/Renal/Urology) (Obstetrics/Gynecology) (Radiology)
(240) 276-0115 (240) 276-0115 (240) 276-0120 (240) 276-0100
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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ 090116
Device Name: Fujinon EC-450BI5
The device is intended for the optical visualization of the gastrointestinal tract. This includes the rectum, large and small intestines. It is intended for observation, diagnosis, and endoscopic treatment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Arsmi Th. Threz
(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
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