(134 days)
No
The summary describes a standard endoscope and its components, with no mention of AI, ML, or advanced image processing beyond basic visualization.
No.
The device is used for visualization, diagnosis, and endoscopic treatment, but its primary function as described doesn't involve inherent therapeutic action. The "endoscopic treatment" mentioned is likely enabled by instruments passed through the scope, rather than the scope itself performing a treatment function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "observation, diagnosis, and endoscopic treatment." The inclusion of "diagnosis" confirms its diagnostic function.
No
The device description clearly outlines physical components like a control portion, flexible portion, bending portion, and distal end, which are hardware components of an endoscope. It also mentions being used with a Processor and other peripheral hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The description clearly states the device is an endoscope intended for the visualization and treatment of the upper digestive tract inside the body. It is inserted orally or trans nasally to directly observe the esophagus, stomach, and duodenal bulb.
- No Sample Analysis: There is no mention of the device analyzing samples taken from the patient. Its function is direct observation and intervention within the body.
Therefore, this device falls under the category of a medical device used for direct examination and treatment within the body, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The device can be inserted orally or trans nasally.
Product codes
FDS
Device Description
The EG-530N consists of the following portions / parts:
- Control portion to provide grip for holding the endoscope and for the operation of the endoscope.
- 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 EG-530N 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
Not Found
Anatomical Site
esophagus, stomach, and duodenal bulb
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 device has been subjected to and passed electrical safety, thermal, and EMC testing requirements. The materials in the endoscope are identical to the materials used in the predicate device.
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
FUJIFILM
FUJINON
pg 1 of 3
510 (k) Summary
MAR 16 2007
Date Prepared [21 CFR 807.92(a)(1)]
10/26/06
Submitter's Information [21 CFR 807.92(a)(1)]
This 510(k) is being submitted by Joseph Azary on behalf of Fujinon Inc.
Contact: Joseph Azary 543 Long Hill Avenue Shelton, CT 06484 Tel: (203) 944-9320 Fax: (203) 944-9317.
Sponsor / U.S. Distributor: Fujinon Inc. 10 High Point Drive Wayne, NJ 07470 FDA Establishment Registration# 2431293.
Manufacturer: Fujinon Corporation 1-324 Uetake-Cho Kita-Ku, Saitama-Shi Saitama 331-9624, Japan FDA Establishment Registration# 9610875
1
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pg 2 of 3
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)|
Device Trade Name: Fujinon EG-530N Device Common, Usual, or Classification Names: Gastroscope Classification: Class II, 21 CFR 876.1500, FDS
Predicate Device [21 CFR 807.92(a)(3)]
- Fujinon EG-450WR5 (K042043) .
The subject device have the same indications for use, material composition, viewing direction, image size, bending, reprocessing/sterilization method, and working dimensions as the predicate. The subject device uses the same processor and peripherals as the predicate device.
The main differences between the EG-450WR5 and the EG-530N are as follows:
- Minor differences in Field of View .
- Smaller diameter of distal end and flexible portion .
- . Smaller diameter of Forcep channel
- . The addition of the trans nasal indication
Trans Nasal insertion for gastroscopes has received FDA marketing clearance in the following 510(k) Premarket Notifications:
- K001766 Olympus XGFF-N200H .
The EG-530N has the same indications for use, similar diameter and working channel as the Olympus device.
Description of the Device [21 CFR 807.92(a)(4)]
The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The device can be inserted orally or trans nasally.
The EG-530N 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 EG-530N is used with a Processor (4400) and other peripheral items such as VCR, Television Monitor, and Printers. The Product Specifications document (89A71999A01) has been included in Annex 5.
2
Specifications Chart:
| EG-530N | ||
|---|---|---|
| Viewing Direction | Forward | |
| Observation Range | 3-100mm | |
| Field of view | 120 degrees | |
| Image size | Super Image | |
| Distal end diameter | 5.9 mm | |
| Flexible portion diameter | 5.9 mm | |
| Up | Bending capability | 210 degrees |
| Down | 90 degrees | |
| Left | 100 degrees | |
| Right | 100 degrees | |
| Forceps channel diameter | 2.0mm | |
| Working length | 1100mm | |
| Total length | 1400mm | |
| Processor | 400 Series |
K 063316
Pg 3 of 3
Intended Use [21 CFR 807.92(a)(5)]
The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The device can be inserted orally or trans nasally.
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 have the same indications for use, material composition, viewing direction, image size, bending, reprocessing/sterilization method as the predicate. The subject device uses the same processor and peripherals as the predicate device.
The main differences relate to the trans nasal insertion and the smaller diameter of the device compared to the Fujinon G5 Gastroscopes.
Transnasal insertion of gastroscopes (or any type of endoscopes) is a method in use for several years. It is a viable option for patient's that gag easily or feel uncomfortable with oral insertion of scopes.
Performance Data [21 CFR 807.92(b)(1)]
The subject device has been subjected to and passed electrical safety, thermal, and EMC testing requirements. The materials in the endoscope are identical to the materials used in the predicate device.
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/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAR 1 6 2007
FUJINON, Inc. c/o Mr. Joseph M. Azary Azary Technologies LLC 543 Long Hill Avenue SHELTON CT 06484
Re: K063316
Trade/Device Name: Fujinon EG-530N Trans Nasal Insertion Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDS Dated: February 22, 2007 Received: February 26, 2007
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 (Premarket Approval), it may be subject to such 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.
Image /page/3/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top, and the letters "FDA" are in the center. Below the letters, the word "Centennial" is written in a cursive font. There are three stars below the word "Centennial". The text around the circle reads "Leading in Consumer Protection for 100 Years".
Protecting and Promoting Public Health
4
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmam.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
063316 510(k) Number (if known):
Device Name: Fujinon EG-530N Trans Nasal Insertion
Indications For Use:
The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The device can be inserted orally or trans nasally.
Prescription Use X (Part 21 CFR 801 Subpart D)
Image /page/5/Picture/6 description: The image shows the words AND/OR. The word AND has a line through it, indicating that it is not selected. The word OR is not crossed out, indicating that it is the selected option. The text is in a simple, sans-serif font.
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number.
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