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.

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.
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.

AI/ML Overview

The provided text is a 510(k) summary for the Fujinon EG-530N Gastroscope. It describes the device, its intended use, comparison to a predicate device, and a conclusion on substantial equivalence. However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets performance criteria in the way a clinical trial or algorithm validation study would.

The "Performance Data" section states: "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." This indicates engineering and materials testing, but not clinical performance metrics like diagnostic accuracy, sensitivity, or specificity.

Therefore, many of your requested items cannot be extracted from this document, as it is a regulatory submission focused on substantial equivalence rather than a clinical performance study report.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria	Reported Device Performance
Electrical Safety	Passed electrical safety testing requirements.
Thermal	Passed thermal testing requirements.
EMC (Electromagnetic Compatibility)	Passed EMC testing requirements.
Material Composition	Materials are identical to the predicate device (Fujinon EG-450WR5).
Indications for Use	Same as predicate device (Fujinon EG-450WR5), with the addition of transnasal insertion (which is equivalent to Olympus XGFF-N200H).
Technological Characteristics	Substantially equivalent to predicate device (Fujinon EG-450WR5) with minor differences in field of view, smaller diameter, and transnasal indication. Uses the same processor and peripherals.

2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a test set or clinical study for evaluating diagnostic performance. The "testing" mentioned refers to engineering and safety tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth establishment by experts for clinical performance is described.

4. Adjudication method for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a gastroscope, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an endoscope, not an algorithm.

7. The type of ground truth used: Not applicable. The "ground truth" here is the device's adherence to engineering standards and technical specifications, not clinical outcomes or pathology.

8. The sample size for the training set: Not applicable. As this is not an AI/algorithm-based device, there is no training set in that context.

9. How the ground truth for the training set was established: Not applicable.

Summary of what the document implies about "meeting acceptance criteria":

The document effectively states that the Fujinon EG-530N Gastroscope meets its "acceptance criteria" by demonstrating substantial equivalence to existing legally marketed devices (predicates). This is the primary regulatory pathway used here. The criteria for acceptance by the FDA were that the device is as safe and effective as its predicates, which was argued based on:

Similar indications for use.
Identical material composition.
Similar viewing direction, image size, bending, reprocessing/sterilization methods.
Use of the same processor and peripherals.
Minor differences (e.g., smaller diameter, field of view) were deemed not to raise new safety or effectiveness concerns.
The addition of transnasal indication was supported by existing FDA clearance for similar devices.
Passing of standard engineering safety tests (electrical, thermal, EMC).

Summary

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FUJIFILM

FUJINON

K063316

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

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$\K_{0}633/6$

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 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.

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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)]

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.

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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

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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

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Indications for Use

063316 510(k) Number (if known):

Device Name: Fujinon EG-530N Trans Nasal Insertion

Indications For Use:

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.

Page 1 of 1

Regulation Number and Section

§ 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.