(96 days)
Not Found
No
The summary describes a standard duodenoscope with a CCD-based optical system and makes no mention of AI, ML, or related concepts.
Yes
The device is used for "endoscopic diagnosis and treatment within the duodenum," indicating a therapeutic purpose in addition to diagnosis. The mention of "endo-therapy accessories (such as a biopsy forceps)" further supports its use in therapeutic procedures.
Yes
The device description states that the duodenoscope is used for "endoscopic diagnosis and treatment within the duodenum."
No
The device description clearly states it is a flexible video endoscope with a CCD-based optical system, indicating it 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 clearly states the instrument is for "endoscopy and endoscopic surgery within the duodenum." This involves direct visualization and intervention within the body, not the examination of samples taken from the body (which is the core of IVD).
- Device Description: The description confirms it's a "flexible video endoscope used for endoscopic diagnosis and treatment within the duodenum." Again, this points to an in-vivo (within the living body) procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body.
IVD devices are designed to perform tests on specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device is a tool for directly visualizing and operating within the body.
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 duodenum.”
Product codes (comma separated list FDA assigned to the subject device)
NWB, FDT, KNT
Device Description
“The XTJF-Q160VF1 duodenoscope is a flexible video endoscope used for endoscopic diagnosis and treatment within the duodenum . The XTJF-Q160VF1 duodenoscope is basically identical to the predicate device, Olympus XTJF Type 160AF Duodenovideoscope, in intended use, specifications, performance. The optical system of the XTJF-Q160VF1 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 15-1 in intended use, and similar in specifications, performance and materials. The CV-180 identifies an NBI-compatible scope when it is connected by using the Scope ID function provided with the scopes.”
Mentions image processing
“The optical system of the XTJF-Q160VF1 is a charge coupled device (CCD) based system, allowing endoscopic image display on a video monitor.”
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video Endoscopy
Anatomical Site
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)
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
Image /page/0/Picture/0 description: The image shows a handwritten text string. The string appears to be "K08040". The characters are written in a cursive style, with some characters connected. The text is black against a white background.
510(k) SUMMARY
EVIS EXERA II 180 SYSTEM
MAY 20 2008
1. General Information
- OLYMPUS MEDICAL SYSTEMS CORP. Applicant: 2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan Establishment Registration No: 8010047
- Official Correspondent: Laura Storms-Tyler Vice President 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
E Manufacturer:
■
예
Light source/Video system center:
Duodenoscope:
SHIRAKAWA OLYMPUS CO., LTD. 3-1, Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura, Nishishirakawa-gun, Fukushima, Japan 961-8061 Establishment Registration No: 3002808148
Aizu Olympus Co., Ltd. 500 Aza-Muranishi, Ooaza-lidera, Monden-cho, Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No .: 9610595
노 Date Prepared: February 8, 2008
2. Device Identification
- Device Name:
Class:
Common Name:
XTJF-160AF Duodenoscope
Regulation Number/Name:
- Product Code:
Duodenoscope II
876.1500 Endoscope and accessories NWB - Endoscope, accessories, narrow band spectrum FDT - Duodenoscope, Esophago Gastro KNT - Tubes, gastrointestinal (and accessories)
Classification Panel:
Gastroenterology/Urology
OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN TELEPHONE +81-426-42-2891, TELEFAX +81-426-42-3174
1
Image /page/1/Picture/0 description: The image shows the word "OLYMPUS" in a bold, sans-serif font. The letters are large and closely spaced, filling most of the frame. The text appears to be a logo or brand name, presented in a simple, impactful way.
3. Legally Marketed Device to which Substantial Equivalence is Claimed
The following table shows the primary components of the EVIS EXERA II 180 System and each device to which we claim substantial equivalence (predicate device).
| Subject Device
(part of this submission) | Predicate Device | PD's
510(k) No. |
|---------------------------------------------|---------------------------------|--------------------|
| DUODENOVIDEOSCOPE
XTJF TYPE Q160VF1 | Duodenovideoscope
XTJF-160AF | K024033 |
4. Device Description
The XTJF-Q160VF1 duodenoscope is a flexible video endoscope used for endoscopic diagnosis and treatment within the duodenum . The XTJF-Q160VF1 duodenoscope is basically identical to the predicate device, Olympus XTJF Type 160AF Duodenovideoscope, in intended use, specifications, performance. The optical system of the XTJF-Q160VF1 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 15-1 in intended use, and similar in specifications, performance and materials. The CV-180 identifies an NBI-compatible scope when it is connected by using the Scope ID function provided with the scopes.
5. Indications for Use
DUODENOVIDEOSCOPE XTJF-Q160VF1
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 duodenum.
2
Image /page/2/Picture/0 description: The image shows the word "OLYMPUS" in bold, black letters. The font is sans-serif and the letters are closely spaced together. The word is likely a logo or brand name.
K 080403
pg 3 of 3
6. Comparison of Technological Characteristics
The XTJF-Q160VF1 is similar to the predicate device XTJF-160AF in specifications except for the material and optical system. Comparison between the subject and predicate devices is shown below.
Table 15-2. Comparison of Specifications Subject Device: DUODENOVIDEOSCOPE XTJF TYPE Q160VF1 Predicate Device: Duodenovideoscope XTJF-160AF (K024033)
| Specifications | Subject Device
XTJF-Q160VF1 | Predicate Device
XTJF-160AF
(K024033) |
|-----------------------------------------|-----------------------------------------------------|-----------------------------------------------------|
| Field of View | 100° | 100° |
| Direction of View | Backward
Sideviewing 5° | Backward
Sideviewing 5° |
| Depth of Field | 560mm | 560mm |
| Optical System | color | color |
| Outer Diameter of
Distal End | φ13.2mm | φ13.2mm |
| Outer Diameter of
Insertion Tube | φ11.3mm | φ11.6mm |
| Angulation | UP : 120
DOWN : 90
RIGHT : 110°
LEFT : 90° | UP : 120
DOWN : 90
RIGHT : 110°
LEFT : 90° |
| Working Length | 1240mm | 1240mm |
| Inner Diameter of
Instrument Channel | φ4.2mm | φ4.2mm |
6. Conclusion
When compared to the predicate device, the XTJF-160AF 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.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the perimeter. Inside the circle is a stylized representation of a human figure embracing a globe. The figure is composed of three wavy lines that form the shape of a person with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 2008
Olympus Medical Systems Corporation % Ms. Laura Storm-Tyler Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 CENTER VALLEY PA 18034-0610
Re: K080403
Trade/Device Name: XTJF Q160VF1 DUODENOVIDEOSCOPE Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDT Dated: February 13, 2008 Received: February 14, 2008
Dear Ms. Storm-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 (PMA), it may be subject to such 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.
4
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 nequirements 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 is 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 100-1050.
and the contraction of the starter of the may be the state of the states of the states
ないとかなるとなってきたのですが、その時間になってきませんですけどうしてきました
This letter will allow you to begin marketing your device as described in your $ection 510(k) premarket notification. The FDA finding of substantial equivalence of your device to Igally, 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 a 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, rolease contact CDRF 8 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 Leporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may othin 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/cdrh/industry/support/index.html U
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
5
Indications for Use
510(k) Number (if known): K080403 Device Name: XTJF-Q160VF1 DUODENOVIDEOSCOPE
Indications For Use:_
DUODENOVIDEOSCOPE XTJF-Q160VF1
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 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)
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Page 1 of _ 1
1932 Specifical