(119 days)
The device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
The Fujinon G5 Colonoscopes are medical endoscopes used for visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. The G5 colonoscopes include minor changes that improve the useability, ergonomics, and cleaning of the devices. The G5 Scopes do not have a lens wash port. The J-Port was repositioned. A G5 forceps inlet port was modified. The jet wash line check valve was removed. The suction and air/water cylinders and valves were upgraded. The G5 colonoscopes also feature the addition of the FOV, which is the rubber forceps inlet valve cover. Upgrade to CA-500 cleaning adaptor. The G5 colonoscopes are used with a processor (EPX-201 for EC-250HL5 and VP-402 for EC-450HL5), a colonoscopy unit, and a cart. Each colonoscope is packaged in a protective carrying case with lens cleaner, silicon oil, forceps valve, waterproof cap, S connector cap, adapters, valves, and the Operation Manual. The Fujinon G5 colonoscopes are 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 Instruments.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Fujinon G5 Colonoscopes:
Overview:
The provided document is a 510(k) summary for the Fujinon G5 Colonoscopes. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent safety and effectiveness through extensive clinical trials. Therefore, the information regarding acceptance criteria and performance studies will differ significantly from what would be found in a PMA (Premarket Approval) application.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, there are no explicit acceptance criteria defined in a quantitative, measurable manner for the performance of the Fujinon G5 Colonoscopes as a standalone device. Instead, the entire submission hinges on demonstrating substantial equivalence to existing predicate devices.
The "performance" is implicitly defined by the device's technological characteristics and its similarity to the predicate.
| Feature / Characteristic | Predicate Device Specification (Implicit Acceptance Criteria) | Fujinon G5 Colonoscopes Reported Performance |
|---|---|---|
| Indications for Use | "visualization of the lower digestive tract, for observation, diagnosis, and endoscopic treatment of the rectum and large intestine." | "visualization of the lower digestive tract, for observation, diagnosis, and endoscopic treatment of the rectum and large intestine." |
| Composition of Patient Contact Materials | Identical to predicate device | "identical to the materials used in the predicate device." |
| Viewing Direction | Forward | Forward |
| Observation Range | K944620 (EC-400HL): Not explicitly stated, but assumed to be within acceptable clinical range | EC-450HL5: 3-100mm; EC-250HL5: 7-100mm (These range specifications may differ slightly but are considered "minor differences" and acceptable within the context of substantial equivalence). |
| Field of View | K944620 (EC-400HL): Not explicitly stated, but assumed to be 140 degrees for equivalence. | EC-450HL5: 140 degrees; EC-250HL5: 140 degrees |
| Image Size | Super Image | Super Image |
| Bending Capacity | K944620 (EC-400HL): Not explicitly stated, but assumed to be similar. | UP: 180 deg, DOWN: 180 deg, LEFT: 160 deg, RIGHT: 160 deg (for both models) |
| Reprocessing/Sterilization Method | Same method as predicate | Same method as predicate |
| Processors and Peripherals | Same as predicate devices | Same as predicate devices |
| Electromagnetic Compatibility (EMC) | Met EMC testing requirements (implicit) | "subject device has been subjected to and passed EMC testing requirements." |
2. Sample Size for Test Set and Data Provenance
The document does not describe a "test set" in the traditional sense of evaluating a new device's performance against ground truth data. Instead, it relies on demonstrating equivalence to predicate devices which have already been cleared.
- Sample Size: Not applicable in the context of this 510(k) submission for direct performance testing. The "sample" is the device itself and its technical specifications compared to the predicate.
- Data Provenance: Not applicable for performance data generation. The data provenance relevant here refers to the previous clearance of the predicate devices (K944620 and K944759), and the previous clearance of the G5 upgrade in K040048. These are regulatory clearances, not clinical study data provenance.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable. Ground truth, in the context of clinical performance, was not established for this 510(k) submission.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable. No test set requiring expert adjudication was described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices to assess reader performance with and without an AI aid, or to compare different diagnostic methods. The Fujinon G5 Colonoscopes are endoscopes, primarily tools for visualization and intervention, not an AI-assisted diagnostic system.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: No, a standalone performance study was not done. This device is a physical endoscope with minor design changes, not a standalone algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable for this 510(k) submission. The "ground truth" for the predicate devices' safety and effectiveness would have been established through their initial clearances (which might have involved clinical data, engineering analyses, etc.), but this document relies on similarity to those cleared devices. For the G5 colonoscopes themselves, the "truth" being established is their equivalence to the predicate via technical specifications and existing regulatory clearances.
8. Sample Size for Training Set
- Sample Size: Not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a training set.
9. How Ground Truth for Training Set Was Established
- Ground Truth for Training Set: Not applicable.
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NOV I 0 2000
510 (k) Summary
2041903
Pg 1 of 4
Date Prepared [21 CFR 807.92(a)(1)]
July 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 bealf of the sponsor Fujinon Inc., 10 Azaly Tochilonographias 10001 07470, Establishment Registration# 2431293.
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
The device trade names are: Fujinon G5 Colonoscopes Common Name: Colonoscope Classification: Class II, 21 CFR 876.1500, FDF
Predicate Device [21 CFR 807.92(a)(3)}
The G5 changes were described and cleared by FDA in the 510(k) submission for the Fujinon Double Balloon Enteroscopy System - K040048.
This 510(k) captures some minor design changes that have occurred during the evolution of the product line I his 310(k) captures some manor economic the changes are believed to be minor, the 510(k) is being submitted to account for "design resp" and to ensure that FDA has the most current information concerning the Fujinon Colonoscopes.
The subject device have the same indications for use, composition of patient contact materials, viewing di-I the subject device for the same instructs in sterilization method as the predicate. The subject devices use the same processors 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. .
- 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 ం the option to take a syringe to inject a fluid to use it as a high pressure wash for the lens.
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Ko 41903
pg. 2 of 4
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 jet 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 eliminate check valves to facilitate reprocessing and cleaning, as well as prevent clogging.
- processing and cleaning, as well as pr. The new port is smaller and comes with a rubber ಂ A OF foresps into 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 I he jet wasn' nine chook vario nee 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-O The subtion and walves. The function of the valves is the same.
- continodate the FOV, which is the rubber forceps inlet valve cover. This helps create a wa-ಂ tertight seal when the endoscope is used.
- Upgrade to CA-500 cleaning adaptor. The cleaning adaptor allows the scope to be con-ಂ nected to tubes for cleaning.
Description of the Device [21 CFR 807.92(a)(4)]
The Fujinon G5 Colonoscopes are medical endoscopes used for visualization of the lower digestive tract, spe-I fic rujilor OJ Colonosooper and miagnosis, and endoscopic treatment of the rectum and large intestine.
The G5 colonoscopes include minor changes that improve the useability, ergonomics, and cleaning of the dei ile CJ colonoscopes motuor minor onanges and increased as a lens wash port. Doctors had the option vices. The OJ Scopes do not have 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 jet water wash port. The J-Port was repositioned based on I he s- on was reportioned from the bottom part to the top (end) of the scope. There was also a desire to eliminate check valves to facilitate reprocessing and cleaning, as well as prevent clogging.
A G5 forceps inlet port was modified. The new port is smaller and comes with a rubber cap. The new design helps increase suction and reduce leakage.
The jet wash line check valve was removed. Internal check valves were removed to eliminate the potential for I ho joi wasn' mile only raire ning, disinfection, and sterilization. The valves are now external and removable.
The suction and air/water cylinders and valves were upgraded. They were updated to accommodate the new valves. The function of the valves is the same.
The G5 colonoscopes also feature the addition of the FOV, which is the rubber forceps inlet valve cover. This helps create a watertight seal when the endoscope is used. Upgrade to CA-500 cleaning adaptor. The cleaning adaptor allows the scope to be connected to tubes for cleaning.
The G5 colonoscopes are used with a processor (EPX-201 for EC-250HL5 and VP-402 for EC-450HL5), a I he UJ connioscopy unit, and a cart. Each colonoscope is packaged in a protective carrying case with lens
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Kc 4 1903
pg 3 of 4
cleaner, sillcon oil, forceps valve, waterproof cap, S connector cap, adapters, valves, and the Operation Manual.
The Fujinon G5 colonoscopes are used in conjunction with other perified in the Operation Manual such as:
- Light Source .
- Processor ●
- Cart �
- Data Keyboard �
- Foot Switch .
- 4 Monitor
- Video Printer 4
- Camera and Hard Copy Unit 4
- VCR e
- ElectroSurgical Instruments t
| EC-450HL5 | EC-250HL5 | |
|---|---|---|
| Viewing Direction | Forward | Forward |
| Observation Range | 3-100mm | 7-100mm |
| Field of View | 140 degrees | 140 degrees |
| Image Size | Super Image | Super Image |
| Distal End Diameter | 12.8mm | 12.9mm |
| Flexible Portion Diameter | 12.8mm | 12.8mm |
| Bending Capacity UP | 180 degrees | 180 degrees |
| Bending Capacity DOWN | 180 degrees | 180 degrees |
| Bending Capacity LEFT | 160 degrees | 160 degrees |
| Bending Capacity RIGHT | 160 degrees | 160 degrees |
| Forceps Channel Diameter | 3.8mm | 3.8mm |
| Working Length | 1690mm | 1690mm |
| Total Length | 1990mm | 1990mm |
Specifications for EC-450HL5 and EC-250HL5
Intended Use [21 CFR 807.92(a)(5)}
The device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
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, composition of patient contact material, viewing direction, image size, bending, and reprocessing/sterilization method as the predicate. The subject devices use the same processors and peripherals as the predicate devices.
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The main differences are the minor changes associated with the G5 upgrade. The G5 changes were previously cleared by FDA in the 510(k) submission for the Fujinon Double Balloon Enteroscopy System --K040043.
Performance Data [21 CFR 807.92(b)(1)]
The subject device has been subjected to and passed EMC testing requirements. The patient contact materials in the colonoscopes 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 devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 2004
Fujinon, Inc. c/o Mr. Joseph M. Azary Azary Technologies"" LLC 543 Long Hill Avenue SHELTON CT 06484
Re: K041903
Trade/Device Name: Fujinon Inc. G5 Colonoscopes Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FDF Dated: October 17, 2004 Received: October 19, 2004
Dear Mr. Azary:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed be are costine device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the enorologics to e enactment date of the Medical Device Amendments, or to devices that have been rear 20, 1770, and clares 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 do ice, 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 Apple 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); 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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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/cdrb/dsmamain.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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RO4 1903 510(k) Number (if known):
Device Name: Fujinon Inc. G5 Colonoscopes
The device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Page 4
(Per 21 CFR 801.109)
Nareuc hoadon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
§ 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.