(342 days)
This 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.
Fujinon Colonoscope EC-530HL2 and EC-530LS2 are modified versions of our previouslycleared Fujinon G5 Colonoscopes, Model EC-450HL5 and EC-250HL5 as described in K041903. The modified models are intended for observation, diagnosis, and endoscopic treatment of the lower digestive tract, which includes rectum, sigmoid colon, and large intestine, which remains the same as K041903.
The endoscopes are comprised of three general sections: an operation section, a flexible portion and an umbilicus. The operation section controls the angulation (up/down/left/right) of the distal end of the endoscope. The flexible insertion portion contains glass fiber bundles, several channels and a charged couple device (CCD). The glass fiber bundles allow light to travel through the endoscope to illuminate the body cavity thereby providing enough light to the CCD to capture an image and display the image on the monitor. The endoscope also contains several channels to deliver air/water, provide suction and a working channel. The forceps channel or working channel is used to introduce endoscope accessories such as biopsy forceps. The umbilicus contains electronic components needed to operate the endoscope when plugged to the video processor and the light source.
The modified models are used in combination with Fujinon's video processor, light source, monitor, cart, foot switch, endoscope accessories and other peripheral devices.
This 510(k) premarket notification describes the Fujinon Colonoscopes EC-530HL2 and EC-530LS2, which are modified versions of previously cleared devices (K041903). The submission asserts substantial equivalence to the predicate devices and does not describe a new AI/ML-based device or a clinical study that evaluates its performance against acceptance criteria.
Therefore, most of the requested information cannot be found in the provided document.
Here's what can be extracted based on the input:
This submission did not involve an AI/ML device. It is for a medical device (colonoscope) and thus the following information is not applicable in the context of an AI/ML study.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria for diagnostic performance in the context of an AI/ML algorithm. Instead, it refers to compliance with safety and performance requirements for the colonoscope.
| Acceptance Criteria (Safety and Performance Requirements) | Reported Device Performance |
|---|---|
| IEC 60601-1 (General requirements for safety) | Evaluated in accordance |
| IEC60601-1-1 (Safety requirements for medical electrical systems) | Evaluated in accordance |
| IEC60601-1-2 (Electromagnetic compatibility) | Evaluated in accordance |
| IEC60601-2-18 (Safety of endoscopic equipment) | Evaluated in accordance |
| ISO10993 (Biological evaluation of medical devices) | Evaluated in accordance |
| Reprocessing instructions updated and validated | Updated and validated using a third party lab |
2. Sample size used for the test set and the data provenance: Not applicable. No clinical test was conducted for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test was conducted.
4. Adjudication method for the test set: Not applicable. No clinical test was conducted.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used: Not applicable. No clinical test was conducted. The ground truth for device safety and performance here would be compliance with the cited international standards and successful third-party validation for reprocessing.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
Summary from the provided document:
The submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices (Fujinon G5 Colonoscopes, Model EC-450HL5 and EC-250HL5, K041903). The modifications are described as minor dimensional changes, material changes, and relocation of the water jet inlet, which are stated not to adversely affect safety and effectiveness.
The "studies" mentioned are primarily focused on compliance with recognized international safety and performance standards for medical electrical equipment and biocompatibility, along with validation of reprocessing instructions. No clinical tests were conducted for this 510(k) submission to evaluate diagnostic performance of a new feature or an AI algorithm, as this is a device modification submission.
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K-112391
JUL 2 6 2012
510(k) Summary
Date: February 27, 2012
Submitter's Information:
Fujifilm Medical Systems U.S.A., Inc. 10 High Point Drive Wayne, NJ 07470 USA
Contact Person:
| Name: | Gina Walljasper |
|---|---|
| Title: | Director, Quality and Regulatory Compliance |
| Telephone: | (973) 633-5600 |
| Facsimile: | (973) 633-8818 |
| E-Mail: | gwalljasper@fujifilm.com |
Identification of the Proposed Device:
Proprietary/Trade Name: Common Name: Device Class: Review Panel: Classification Information: Fujinon Colonoscopes, EC-530HL2 and EC-530LS2 Colonoscope Class 2 Gastroenterology/Urology
Classification Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Colonoscope and accessories, Flexible/Rigid | 21 CFR 876.1500 FDF
l. INDICATIONS FOR USE
This 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.
II. DEVICE DESCRIPTION
Fujinon Colonoscope EC-530HL2 and EC-530LS2 are modified versions of our previouslycleared Fujinon G5 Colonoscopes, Model EC-450HL5 and EC-250HL5 as described in K041903. The modified models are intended for observation, diagnosis, and endoscopic treatment of the lower digestive tract, which includes rectum, sigmoid colon, and large intestine, which remains the same as K041903.
The endoscopes are comprised of three general sections: an operation section, a flexible The operation section controls the angulation and an umbilicus. portion (up/down/left/right) of the distal end of the endoscope. The flexible insertion portion contains glass fiber bundles, several channels and a charged couple device (CCD). The
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FUJKFILN
glass fiber bundles allow light to travel through the endoscope to illuminate the body cavity thereby providing enough light to the CCD to capture an image and display the image on the monitor. The endoscope also contains several channels to deliver air/water, provide suction and a working channel. The forceps channel or working channel is used to introduce endoscope accessories such as biopsy forceps. The umbilicus contains electronic components needed to operate the endoscope when plugged to the video processor and the light source.
The modified models are used in combination with Fujinon's video processor, light source, monitor, cart, foot switch, endoscope accessories and other peripheral devices.
���. SUMMARY OF STUDIES
Fujinon Colonoscope EC-530HL2 and EC-530LS2 were evaluated in accordance with following safety and performance requirements in addition to the applicable quality system regulations:
| IEC 60601-1 | Medical electrical equipment - Part 1: General requirements forsafety |
|---|---|
| IEC60601-1-1 | Medical electrical equipment - Part 1-1: General requirements forsafety - Collateral standard: Safety requirements for medicalelectrical systems |
| IEC60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for thebasic safety and essential performance - Collateral standard:Electromagnetic compatibility - Requirements and tests |
| IEC60601-2-18 | Medical electrical equipment - Part 2-18: Particular requirements forthe safety of endoscopic equipment |
| ISO10993 | Biological evaluation of medical devices |
The reprocessing instructions were updated and validated using a third party lab. No clinical test was conducted.
SUBSTANTIAL EQUIVALENCE IV.
Fujinon Colonoscopes EC-530HL2 and EC-530LS2 are substantially equivalent to the following device:
| Legally Marketed Device College Comment Comment (1) = (510(k) # = ============================================================================================================ | |
|---|---|
| ' Fujinon G5 Colonoscopes, Model EC-450HL5 and EC-250HL5 | K041903 |
EC-530HL2 and EC-530LS2 colonoscopes have the same indications for use as the legally marketed device. The minor dimensional changes, material changes and relocation of the water jet inlet do not adversely affect the safety and effectiveness of the subject colonoscopes.
V. CONCLUSION
Fujinon Colonoscopes EC-530HL2 and EC-530LS2 are substantially equivalent to the legally marketed device and conforms to applicable medical device safety and performance standards.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Gina Walljasper Director Quality and Regulatory Compliance Fujifilm Medical Systems U.S.A., Inc. 10 High Point Drive WAYNE NJ 07470
JUL 26 2012
Re: K112391
Trade/Device Name: Fujinon Colonoscopes EC-530HL2 and EC-530LS2 Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: July 25, 2012 Received: July 25, 2012
Dear Ms. Walljasper:
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 for are barrant 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). and Cosmeter For (. 10) in the device, subject to the general controls provisions of the Act. The r ou may, attrefery, interes of the Act include requirements for annual registration, listing of genoral controls provisioning practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 or any I vath all the Act's requirements, including, but not limited to: registration and listing లంగippy "Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de vice-related adverse overse) (21 CFR Part 820); and if applicable, the electronic forth in the quality by bellions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 70d don't specific an 14boutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please the conter tol Do 1000 and ing by reference to premarket notification" (21CFR Part nove the regulations regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the I va may other buttor ground and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Dayana K-Euker
Benjamin C. Fisher, Ph.D.
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K112391
Device Name: Fujinon Colonoscopes EC-530HL2 and EC-530LS2
Indications for Use:
This 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
§ 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.