(340 days)
Not Found
No
The summary does not mention AI, ML, or any related technologies, and the device description focuses on mechanical and optical modifications.
Yes
The device is indicated for "endoscopic surgery," which is a therapeutic intervention.
Yes
The device is indicated for "endoscopy and endoscopic surgery," which involves visualization of internal body structures for diagnosis and/or treatment. Endoscopy is a diagnostic procedure.
No
The device description clearly states it is a flexible video endoscope, which is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the instrument is for "endoscopy and endoscopic surgery within the biliary tract and the duodenum." This involves direct visualization and intervention within the body.
- Device Description: The device is described as a "flexible video endoscope." Endoscopes are used to visualize internal body cavities and organs.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device does not perform any such analysis on specimens.
The device is a medical instrument used for direct visualization and procedures within the body, which falls under the category of an endoscopic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment. This instrument is intended to be used without a DUODENOSCOPE.
The CHOLEDOCHO VIDEOSCOPE CHF-Y0005 is indicated for endoscopy and endoscopic surgery within the biliary tract and the duodenum.
Product codes (comma separated list FDA assigned to the subject device)
FBN, NWB
Device Description
The CHF-Y0005 is designed as a flexible video endoscope used for endoscopy and endoscopic surgery within the biliary tract and the duodenum.
The CHF-Y0005 is modified from the predicate XCHF TYPE T160 as it has two bending sections, a gas feeding function when connected to an Endoscopic CO2 regulation unit, Narrow Band Imaging observation and is now compatible with specified electrosurgical units and electrosurgical accessories.
Mentions image processing
Narrow Band Imaging observation
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tract and the duodenum.
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 following non-clinical tests were performed.
Basic safety and performance testing was performed in accordance with IEC 60601-1, 60601-1-1, 60601-1-2, 60601-2-18. In addition, verification and comparison studies were conducted to evaluate the mechanical and functional performance.
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.
K082576, K032177, K080586, K100584
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
K113120 page 1 of 4
SEP 25 2012
510(k) SUMMARY
CHOLEDOCHO VIDEOSCOPE CHF-Y0005
General Information 1
. ।
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트 Applicant:
. -
트 Official Correspondent:
OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047
Stacy Abbatiello Kluesner, M.S., RAC Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5405 FAX: 484-896-7128 Email: stacy.kluesner@olympus.com
Aizu Olympus Co., Ltd. 500 Aza-Muranishi, Ooaza-lidera, Monden-cho; Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No.: 9610595
Device Identification 2
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i Device Trade Name:
Manufacturer: -
Common Name:
-
Regulation Number:
-
Regulation Name:
-
I Regulatory Class:
-
Classification Panel: .
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Product Code: E
CHF-Y0005
CHOLEDOCHO VIDEOSCOPE
21 CFR 876.1500 .
Endoscope and accessories
ll
Choledochoscope And Accessories, Flexible Endoscope, Accessories, Narrow Band Spectrum
FBN, NWB
1
Predicate Device Information 3
| Subject Device
(Part of this Submission) | Predicate Device | PD's
510(k)
No. |
|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-----------------------|
| CHOLEDOCHO VIDEOSCOPE
CHF-Y0005
(Hereinafter referred
to as
CHF-Y0005) | VIDEOSCOPE OLYMPUS XCHF TYPE T160
(XCHF-T160) | K082576 |
| | GASTROINTESTINALVIDEOSCOPE
XGIF-Q140M (XGIF-Q140M) | K032177 |
| | CHOLEDOCHOSCOPE OLYMPUS XCHF
TYPE B180Y1 (XCHF-B180Y1) | K080586 |
| | EVIS EXERA II GASTROINTESTINAL
VIDEOSCOPE OLYMPUS GIF TYPE N180
(GIF-N180) | K100584 |
Device Description ব
The CHF-Y0005 is designed as a flexible video endoscope used for endoscopy and endoscopic surgery within the biliary tract and the duodenum.
The CHF-Y0005 is modified from the predicate XCHF TYPE T160 as it has two bending sections, a gas feeding function when connected to an Endoscopic CO2 regulation unit, Narrow Band Imaging observation and is now compatible with specified electrosurgical units and electrosurgical accessories.
Indications for Use 5
This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment. This instrument is intended to be used without a DUODENOSCOPE.
The CHOLEDOCHO VIDEOSCOPE CHF-Y0005 is indicated for endoscopy and endoscopic surgery within the biliary tract and the duodenum.
Comparison of Technological Characteristics 6
The CHF-Y0005 is basically identical to the predicate devices in intended use, and similar in specifications.
When compared to the predicate devices the subject device has the similar technological features such as the depth of field, direction of forward view and bending section angulation. The differences include two bending sections, a gas feeding function when connected to an
2
Endoscopic CO2 regulation unit, Narrow Band Imaging observation and is now compatible with specified electrosurgical units and electrosurgical accessories.
Substantially Equivalent Discussion 7
The indications for use, principles of operation and fundamental technology of the CHF-Y0005 are similar to the predicate devices.
The major differences from the predicate devices are as follows:
Bending Section:
When compared with predicate XCHF-T160 device (K082576), the predicate XCHF-T160 device has one bending section with four bending directions (Up/Down/Right/Left).
The predicate device XGIF-Q140M (K032177) also has two bending sections. The first bending section has four bending directions (Up/Down/Right/Left) while the second bending section passively bends in 4 directions (Up/Down/Left/Right).
As the CHF-Y0005 has the same degree of movement as the predicate XCHF-T160.
Gas Feeding:
The gas feeding function was added to allow for insufflations with CO2 which aids in the insertion of the choleodocho scope through the GI tract.
The predicate XCHF-T160 device (K082576) does not have a gas feeding function. However, the predicate XGIF-Q140M (K032177) does have a gas feeding function.
Narrow Band Imaging:
The predicate XCHF-B180Y1 device (K080586) which has similar indications for use to the subject device, was cleared with NBI observation mode.
Compatibility with electrosurgical units:
The distal end of the subject CHF-Y0005 is equivalent to the predicate XGIF-Q140M (K032177) and therefore is compatible with the specified electrosurgical units
The above functions have been confirmed that the safety and effectiveness are equivalent as compared with the predicate devices. The CHF-Y0005 is similar or identical in the method of operation, materials and design as the predicate devices.
Summary of Non-Clinical Testing 8
The following non-clinical tests were performed.
Basic safety and performance testing was performed in accordance with IEC 60601-1, 60601-1-1, 60601-1-2, 60601-2-18. In addition, verification and comparison studies were conducted to evaluate the mechanical and functional performance.
3
The following standards were used during the design and validation of the subject devices.
-
IEC 60601-1: 1988, A1: 1991, A2: 1995
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IEC 60601-1-1: 2000, 3) IEC 60601-1-2: 2001, A1: 2004
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IEC 60601-2-18: 1996, A1: 2000
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ISO 14971: 2007
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ASTM E1837-96: 2007
-
ANSI/AAMI/ISO 11135-1: 2007
-
ISO 10993-7: 2008
The risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of their risk analysis assessment.
Conclusion 9
When compared to the predicate device, the subject CHF-Y0005 device does not incorporate . any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device. Therefore, the CHF-Y0005 is substantially equivalent to the identified predicate devices.
4
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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OLYMPUS MEDICAL SYSTEMS CORP. % Ms. Sheri Musgnung Associate Manager, Regulatory Affairs Olympus America Inc. 3500 Corporate Parkway, P.O. Box 610 CENTER VALLEY PA 18034-0610
SEP 25 2012
Re: K113120
Trade/Device Name: CHOLEDOCHO VIDEOSCOPE CHF-Y0005 Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBN, NWB Dated: September 14, 2012 Received: September 17, 2012
Dear Ms. Musgnung:
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 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. 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
5
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set device-related adverse evones) (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QS) regardines (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
s and the many of the comments of any connect off and complised on the II you desire specific advice for your ac neves contracts offices/ucm115809.html for go to inter.har.gov/rtbound Drives Health's (CDRH's) Office of Compliance. Also, please the Center for Devices and Radioregiven on premarket notification' (21CFR Path note the regulation entitled, "Misoranding of references of promises
807.97). For questions 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 ou may obtain other general mornational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
(600) 050-2011 of (2011 of (201) industry/default.html
Sincerely yours,
Benjamin K. Evans
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
6
Indications for Use
510(k) Number (if known): Device Name: CHOLEDOCHO VIDEOSCOPE CHF-Y0005 Indications For Use:
This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment. This instrument is intended to be used without DUODENOSCOPE.
The CHOLEDOCHO VIDEOSCOPE CHF-Y0005 is indicated for endoscopy and endoscopic surgery within the biliary tract and the duodenum.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
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)
Aogui mrz
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