(147 days)
Not Found
No
The document describes a mechanical system for endoscopy and does not mention any AI/ML components or image processing capabilities beyond basic visualization.
No.
The device is primarily for observation and diagnosis, though it mentions "endoscopic treatment," which could involve therapeutic procedures. However, the core function described is visualization and diagnosis, not solely treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "observation, diagnosis, and endoscopic treatment."
No
The device description explicitly lists multiple hardware components including an endoscope, over-tube, balloon, and balloon pump controller, in addition to being used with a processor and other peripherals. This indicates it is a hardware-based system, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Device Function: This device is an endoscope system used for the direct visualization and treatment of the upper gastrointestinal tract within the body. It uses optical visualization, not analysis of specimens taken from the body.
The description clearly indicates it's an endoscopic system for internal examination and treatment, which falls under the category of medical devices used for diagnosis and therapy in vivo, not in vitro.
N/A
Intended Use / Indications for Use
The device is intended for the Optical visualization of the upper gastrointestinal tract. This includes the esophagus, stomach, duodenum, and small bowel. It is intended for the observation, diagnosis, and endoscopic treatment.
Product codes (comma separated list FDA assigned to the subject device)
78, 78 KNT
Device Description
The small intestine is one of the most difficult organs to access in gastro-intestinal (GI) tract endoscopy. The Fujinon double balloon enteroscopy system facilitates diagnosis and treatment of the upper GI tract including the small intestine.
The Fujinon double balloon enteroscopy system utilized balloons and over-tube to ensure complete positioning of the enteroscope in the small intestine. The tip of the scope can be smoothly inserted to reach the area of diagnosis.
The Fujinon double balloon enteroscopy system includes the following:
- G5 endoscope / enteroscope (EN-450P5/20) .
- Over-Tube (TS-12140) .
- Balloon (BS-1) .
- Balloon Pump Controller (PB-10) .
The subject device is used with the Fujinon Series 400 processor, the same processor used with the predicate device.
The Fujinon double balloon enteroscopy system is used in conjunction with other peripherals specified in the Operation Manual such as:
- Light Source .
- . Processor
- Cart .
- Data Keyboard
- Foot Switch .
- Monitor .
- Video Printer .
- Camera and Hard Copy Unit .
- VCR .
- ElectroSurgical Tastruments .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical visualization
Anatomical Site
upper gastrointestinal tract, esophagus, stomach, duodenum, small bowel, 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 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. The balloon and overtube materials have been subjected to and passed biocompatibility testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K 040048 pg ' of 4
510 (k) Summary
JUN - 7 2004
Date Prepared [21 CFR 807.92(a)(1)]
January 9, 2004
Submitter's Information [21 CFR 807.92(a)(1)]
Joseph M. Azary C/o Fujinon Inc. 543 Long Hill Avenue Shelton, CT. 06484
Azary Technologies has received authorization to submit this 510(k) on behalf of the sponsor Fujinon Inc. 10 High Point Drive, Wayne, NJ 07470, Establishment Registration# 2431293.
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
The device trade names are: Fujinon Double Balloon Enteroscopy System Common Name: Enteroscope Classification: Class II, 21 CFR 876.1500, FDA
Predicate Device [21 CFR 807.92(a)(3)]
- Fujinon Enteroscope EN-410WM K993704 ●
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 subject device and predicate device are as follows:
- Minor differences with observation range, field of view, diameter, and length. .
- Subject device includes an overtube, balloons, and a balloon pump. ●
- The subject device includes the G5 upgrade, which is characterized by the following minor differ-. ences:
- The L-Port has been eliminated. The L-port functioned as a lens wash port . Doctors had o the option to take a syringe to inject a fluid to use it as a high pressure wash for the lens. This function was eliminated because demand was low and it was rarely used by the surgeons.
- The J-Port was repositioned. The J-Port is used as a jost water wash port. The J-Port was 0 repositioned based on doctor feedback. The port was moved from the bottom part to the top (end) of the scope. There was also a desire to eligainate check valves to facilitate reprocessing and cleaning, as well as prevent clogging.
1
K040.48 pg 2 of 4
- A G5 forceps inlet port was modified. The new port is smaller and comes with a rubber O cap. The smaller port and rubber cap help increase suction and reduce leakage.
- The jet wash line check valve was removed. Internal check valves were removed to elimio nate the potential for clogging and to facilitate cleaning, disinfection, and sterilization. The valves are now external and removable.
- The suction and air/water cylinders and valves were upgraded. They were updated to ac-0 commodate the new valves. The function of the valves is the same.
- Addition of the FOV, which is the rubber forceps inlet valve cover. This helps create a wa-O tertight seal when the endoscope is used.
- Upgrade to CA-500 cleaning adaptor. The cleaning adaptor allows the scope to be con-0 nected to tubes for cleaning.
Description of the Device [21 CFR 807.92(a)(4)}
The small intestine is one of the most difficult organs to access in gastro-intestinal (GI) tract endoscopy. The Fujinon double balloon enteroscopy system facilitates diagnosis and treatment of the upper GI tract including the small intestine.
The Fujinon double balloon enteroscopy system utilized balloons and over-tube to ensure complete positioning of the enteroscope in the small intestine. The tip of the scope can be smoothly inserted to reach the area of diagnosis.
The Fujinon double balloon enteroscopy system includes the following:
- G5 endoscope / enteroscope (EN-450P5/20) .
- Over-Tube (TS-12140) .
- Balloon (BS-1) .
- Balloon Pump Controller (PB-10) .
The subject device is used with the Fujinon Series 400 processor, the same processor used with the predicate device.
The Fujinon double balloon enteroscopy system is used in conjunction with other peripherals specified in the Operation Manual such as:
- Light Source .
- . Processor
- Cart .
- Data Keyboard
- Foot Switch .
- Monitor .
- Video Printer .
- Camera and Hard Copy Unit .
- VCR .
- ElectroSurgical Tastruments .
2
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Specifications Chart:
| EN-450P5/20 | ||
|---|---|---|
| Viewing Direction | Forward | |
| Observation Range | 5~100mm | |
| Field of view | 120 | |
| Image size | 130% (super) | |
| Distal end diameter | 8.5mm | |
| Flexible portion diameter | 8.5mm | |
| Bending capability | See below | |
| Up | 180 | |
| Down | 180 | |
| Left | 160 | |
| Right | 160 | |
| Forceps channel diameter | 2.2mm | |
| Working length | 2000mm | |
| Total length | 2300mm |
| Lens diameter | 2.1mm |
|---|---|
| # of pixels | 411,988 pixels |
| Pixels per square mm | 83, 892 |
| Pixel size (H x V) | .0032 x .003725 |
| Active area of CCD (H x V) | 2.458 x 1.840 |
| Type of CCD chip | Interline color chip |
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Balloon Pump Controller with Remote Switch PB-10 Specifications
| Set Pressure of Balloon | 3.6 kpa - 7.6 kpa (5.6 kpa +/- 2 kpa) |
|---|---|
| Maximum flow rate of pump | 170 ml/10 sec |
| Power Supply | 120V / 230V |
| Dimensions | 300 (W) x 200(H) x 300(D) mm |
| Weight | 8.7 kg |
The balloon is composed of natural rubber, which has been subjected to and passed biocompatibility I his banding vertube is composed of polyvinylpyrolidone hydromer coating, which has been subjected to and passed biocompatibility testing.
Fujinon Inc. Double Balloon Enteroscopy 510(k) Page 5-3
3
K cttco48 Pg 4 of 4
Intended Use [21 CFR 807.92(a)(5)]
The device is intended for the Optical visualization of the upper gastrointestinal tract. This includes the esophagus, stomach, duodenum, and small bowel. It is intended for the observation, diagnosis, and endoscopic treatment.
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, 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 technological difference is the balloon and overtube as a way to facilitate diagnosis and treatment of the upper GI tract including the small intestine, as well as the minor changes associated with the G5 upgrade.
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. The balloon and overtube materials have been subjected to and passed biocompatibility testing.
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 devices.
Fujinon Inc. Double Balloon Enteroscopy 510(k) Page 5-4
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three horizontal lines above it, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 7 2004
Fujinon, Inc. c/o Mr. Joseph M. Azary Azary Technologies LLC 543 Long Hill Avenue SHELTON CT 06484
Re: K040048
Trade/Device Náme: Fujinon Double Balloon Enteroscopy System Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Product Code: 78 FDA Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Product Code: 78 KNT Regulatory Class: II Dated: May 5, 2004 Received: May 7, 2004
Dear Mr. Azary:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications ferenced above and nave acterimes ally marketed predicate devices marketed in interstate for use slated in the enolosure) is regars and ment date of the Medical Device Amendments, or to commerce prior to way 20, 1976, the exaccidance with the provisions of the Federal Food, Drug, devices that have occh receired in asse equire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, therefore, mance are as not include requirements for annual registration, listing of general controls provisions of the 1100 ling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), II your device is classified (see above) into entire regulations affecting your device can be it may be subject to additional controller Life 21, Parts 800 to 898. In addition, FDA may round in the Code of Possients concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i Tease oc advised that FDF i robation a vour device complies with other requirements of the Act that I DA has made a decommandin an administered by other Federal agencies. You must of any I ederal Statutes and regulations, but not limited to: registration and listing comply with an the rice I requirements, in 201); good manufacturing practice requirements as set (21 CFR Part 807), labemg (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QS) . og (sections 531-542 of the Act); 21 CFR 1000-1050.
5
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marteenig your ential equivalence of your device to a legally premarket notification. The PDA inding of backantal epical on 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 If you desire specific advice tor your device on one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, 101 questions on the promote of the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. Othice of Compliance at (501) 594-4057. Fab.) production of Super Bear the Division of Same by reference to premarket notification (21 OF Act may be obtained from the Division of Small
information on your responsibilities under the Act may be sitted from the 1800) 6 information on your responsionalities unec tales tales tales toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-fremation htt Manufacturers, International and Colladmor i assistement of the main.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
6
5 10(k) Number (if known): // 04 00 48
Device Name: Fujinon Inc. Double Balloon Enteroscopy System
Indications For Use: The device is intended for the Optical visualization of the upper gastrointestinal tract. This includes the esophagus, stomach, duodenum, and small bowel. It is intended for the 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)
OR
Prescription Use
(Per 21 CFR 801.109)
Allin (Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Fujinon Inc. Double Balloon Enteroscopy 510(k) Page 4