(64 days)
Not Found
No
The summary describes a standard video endoscope and explicitly states it is "basically identical" to a predicate device from 2005 (K051886). There is no mention of AI, ML, or advanced image processing beyond basic CCD-based display.
No.
The device is an endoscope used for visualization and to facilitate endoscopic surgery, but it does not directly provide therapy itself. It is used in conjunction with "endo-therapy accessories" which would perform the therapeutic action.
No
Explanation:
The "Intended Use / Indications for Use" states that the instrument is used for "endoscopy and endoscopic surgery" and is accompanied by "endo-therapy accessories (such as a biopsy forceps)". It also mentions "endoscopic image display", which supports visualization during these procedures. While it facilitates procedures that might involve diagnosis (e.g., visual inspection, taking biopsies), the device itself is described as a tool for "endoscopy and endoscopic surgery" and not explicitly for generating a diagnosis.
No
The device description explicitly states it is a flexible video endoscope, which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as an instrument for endoscopy and endoscopic surgery within the biliary tract and pancreatic duct. This involves direct visualization and intervention within the body.
- Device Description: The device is described as a flexible video endoscope used for these procedures. It captures images of internal anatomy.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. This device operates inside the body for visualization and surgical procedures.
The information provided clearly indicates this is an endoscopic device used for direct examination and intervention, not for testing samples in vitro.
N/A
Intended Use / Indications for Use
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the biliary tract and pancreatic duct in conjunction with the EVIS Duodenoscopes with an instrument channel with a minimum diameter of 04.2mm.
Product codes (comma separated list FDA assigned to the subject device)
FBN/NWB
Device Description
The XCHF-B180Y1, is a flexible video endoscope used for endoscopy and endoscopic surgery within the biliary tract and pancreatic duct. The XCHF-B180Y1 is basically identical to the predicate device, Olympus XCHF-BP Type 160F Choledochoscope, hereinaffer referred to as XCHF-BP160F in intended use, specifications, performance. The optical system of the XCHF-B180Y1 is a charge coupled device (CCD) based system, allowing endoscopic image display on a video monitor.
The new endoscope is basically identical to each predicate device shown in Table 13-1 in intended use, and similar in specifications, performance and materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tract and pancreatic duct
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)
Not Found
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
K080586
page 1 of 3
Image /page/0/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, black letters. The font is sans-serif and the letters are closely spaced. There is a horizontal line with a grainy texture below the word. The background is plain and white.
MAY - 6 2008
510(k) SUMMARY
XCHF-B180Y1 Choledochoscope
1. General Information
| Applicant: | OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan
Establishment Registration No: 8010047 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Laura Storms-Tyler
Regulatory Affairs & Quality Assurance
Olympus America Inc.
3500 Corporate Parkway, PO Box 610
Center Valley PA 18034-0610
Phone: (484) 896-5688
Facsimile: (484) 896-7128
Email:Laura.storms-tyler@olympus.com
Establishment Registration No: 2429304 |
| Manufacturer: | |
| Light source/Video system center: | SHIRAKAWA OLYMPUS CO., LTD.
3-1, Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura,
Nishishirakawa-gun, Fukushima, Japan 961-8061
Establishment Registration No: 3002808148 |
| Choledochoscope: | Aizu Olympus Co., Ltd.
500 Aza-Muranishi, Ooaza-Niidera, Monden-machi,
Aizuwakamatsu-shi, Fukushima, Japan 965-8520
Establishment Registration No.: 9610595 |
| Date Prepared: | April 30, 2008 |
2. Device Identification
| Device Name: | XCHF-B180Y1 Choledochoscope |
|---|---|
| Common Name: | Choledochoscope |
| Class: | II |
| Regulation Number/Name: | 876.1500 Endoscope and accessories |
| Product Code: | FBN/NWB |
| Classification Panel: | Choledochoscope And Accessories, Flexible/ Rigid |
| Endoscope, accessories, narrow band spectrum |
olympus medical systems corp.
2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN TELEPHONE +81-426-42-2891, TELEFAX +81-426-42-3174
1
K080586
page 2 of 3
Image /page/1/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, black letters. The font is sans-serif and the letters are closely spaced together. Below the word, there is some illegible text in a smaller font size. The background is white.
3. Legally Marketed Device to which Substantial Equivalence is Claimed
The following table shows the subject device and the predicate device to which we claim substantial equivalence.
Table 13-1: Primary Component & Predicate Device
| Subject Device
| (part of this submission) | Predicate Device | 510(k) No. |
|---|---|---|
| XCHF-B180Y1 Choledochoscope | CHOLEDOCHOSCOPE | |
| XCHF-BP160F | K051886 |
4. Device Description
The XCHF-B180Y1, is a flexible video endoscope used for endoscopy and endoscopic surgery within the biliary tract and pancreatic duct. The XCHF-B180Y1 is basically identical to the predicate device, Olympus XCHF-BP Type 160F Choledochoscope, hereinaffer referred to as XCHF-BP160F in intended use, specifications, performance. The optical system of the XCHF-B180Y1 is a charge coupled device (CCD) based system, allowing endoscopic image display on a video monitor.
The new endoscope is basically identical to each predicate device shown in Table 13-1 in intended use, and similar in specifications, performance and materials.
5. Indications for Use
XCHF-B180Y1 Choledochoscope
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the biliary tract and pancreatic duct in conjunction with the EVIS DUODENOSCOPE with an instrument channel with a minimum diameter of @4.2mm.
olympus medical systems corp.
2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN TELEPHONE +81-426-42-2891, TELEFAX +81-426-42-3174
2
K080586
page 3 of 3
Image /page/2/Picture/1 description: The image shows the word "OLYMPUS" in bold, black letters. The font is sans-serif and the letters are tightly spaced. The word is centered and takes up most of the frame. The background is plain white.
6. Comparison of Technological Characteristics
The XCHF-B180Y1 is similar to the predicate device XCHF-BP160F in specifications except for the material and optical system. Comparison between the subject and predicate devices is shown below.
| Specifications | Subject Device
XCH-B180Y1 | Predicate Device
XCH-LR160F
(K051806) |
|-----------------------------------------|------------------------------|---------------------------------------------|
| Field of View | 90° | 90° |
| Direction of View | Forward Viewing 0° | Forward Viewing 0° |
| Depth of Field | 250mm | 250mm |
| Type of CCD Chip | Color CCD | Color CCD |
| Outer Diameter of
Distal End | ⌀ 3.4mm | ⌀ 2.8mm |
| Outer Diameter of
Insertion Tube | ⌀ 3.8mm | ⌀ 3.7mm |
| Angulation | UP : 70
DOWN : 70 | UP : 70
DOWN : 70 |
| Working Length | 2000mm | 2000mm |
| Inner Diameter of
Instrument Channel | ⌀ 1.2mm | ⌀ 1.2mm |
Table 13-2. Comparison of Specifications
6. Conclusion
When compared to the predicate device, the XCHF-B180Y1 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.
olympus medical systems corp. 2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN TELEPHONE +81-426-42-2891, TELEFAX +81-426-42-3174 3/3
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
- 6 2008
OLYMPUS MEDICAL SYSTEMS CORP. % Ms. Laura Storms-Tyler Regulatory Affairs & Quality Assurance Olympus America, Inc. 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034-0610
Re: K080586
Trade/Device Name: CHOLEDOCHOSCOPE XCHF-B180Y1 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBN Dated: February 28, 2008 Received: March 5, 2008
Dear Ms. Storms-Tyler:
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 r your we roo 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.
Image /page/3/Picture/10 description: The image is a circular seal with the text "1906-2006" at the top. The letters "FDA" are in the center of the seal, with the word "Centennial" underneath. The seal is surrounded by text that reads "U.S. Food & Drug Administration".
Protecting and Promoting Public Health
4
Page 2
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.
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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdri/industry/support/index.html.
Sincerely yours.
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): Device Name: CHOLEDOCHOSCOPE XCHF-B180Y1
Indications For Use:
CHOLEDOCHOSCOPE XCHF-B180Y1
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the biliary tract and pancreatic duct in conjunction with the EVIS Duodenoscopes with an instrument channel with a minimum diameter of 04.2mm.
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)
Signature
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number
Page 1 of __