(46 days)
Not Found
No
The summary describes a standard video endoscope with a CCD-based optical system and explicitly states it is basically identical to predicate devices in intended use, specifications, and performance. There is no mention of AI, ML, image processing beyond basic display, or any data sets for training or testing algorithms.
No
The device is described as a flexible video endoscope used for endoscopy and endoscopic surgery, and it works with "endo-therapy accessories such as biopsy forceps," implying that it is a diagnostic or procedural tool that enables therapy rather than being a therapeutic device itself. Endoscopes are primarily for visualization and access.
No
Explanation: The device description states its use for "endoscopy and endoscopic surgery" and image display, which are procedures for visualization and intervention, not solely for diagnosis. While visualization can aid diagnosis, the primary stated function of the device is for performing procedures.
No
The device description explicitly states it is a "flexible video endoscope" and mentions a "charge coupled device (CCD) based system," indicating it is a hardware device with an optical system.
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 biliary tract. This involves direct visualization and intervention within the body, not the examination of samples taken from the body.
- Device Description: The device is described as a flexible video endoscope used for endoscopy and endoscopic surgery. This aligns with a device used for direct internal examination.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) outside of the body to provide information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose diseases or other conditions. This device is used for direct visualization and intervention 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 biliary tract.
Product codes
FBN
Device Description
The XCHF-T160, is a flexible video endoscope used for endoscopy and endoscopic surgery within the biliary tract. The XCHF-T160 is basically identical to the predicate device, Olympus CHF-B20 Choledochoscope, hereinafter referred to as CHF-B20 in intended use, specifications, performance.
The optical system of the XCHF-T160 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 14-1 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
Optical
Anatomical Site
biliary tract
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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510(k) SUMMARY
VIDEOSCOPE XCHF-T160
OCT 9 1 2008
1. General Information
- OLYMPUS MEDICAL SYSTEMS CORP. Applicant: 트 2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan Establishment Registration No: 8010047 Stacy Abbatiello Kluesner, RAC Official Correspondent: I Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway, PO Box 610 Center Valley, PA 18034-0610 Phone: (484) 896-5405 Facsimile: (484) 896-7128 Email:Stacy.Kluesner@olympus.com Establishment Registration No: 2429304 해 Manufacturer: Aizu Olympus Co., Ltd. 500 Aza-Muranishi, Ooaza-Niidera, Monden-machi, Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No .: 9610595
- August 21, 2008 ● Date Prepared:
2. Device Identification
| Device Name: | XCHF-T160 Videoscope |
|---|---|
| Common Name: | Videoscope |
| Class: | II |
| Regulation Number/Name: | 876.1500 Endoscope and accessories |
| Product Code: | FBN |
| Classification Panel: | Choledochoscope And Accessories, Flexible |
olympus medical systems corp. 2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN TELEPHONE +81-42-642-2694, TELEFAX +81-42-642-2307
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Image /page/1/Picture/0 description: The image shows the word "OLYMPUS" in a bold, sans-serif font. The letters are black and appear to have a slightly rough or textured edge, giving them a somewhat distressed look. The word is centered and takes up most of the frame, with a white background providing contrast.
Pg 2 of 3
3. Legally Marketed Device to which Substantial Equivalence is Clain
The following table shows the subject device and the predicate device to which we claim substantial equivalence.
Table 14-1. Primary Component & Predicate Device
| Subject Device
(Part of this submission) | Predicate Device | PD's
510(k)
No. |
|---------------------------------------------|-----------------------------------------------------|-----------------------|
| VIDEOSCOPE
XCHF-T160 | CHOLEDOCHOSCOPE
CHF-B20 | K904799 |
| XCHF-T160 | EVIS EXERA Gastrointestinal Videoscope
GIF-Q160Z | K011151 |
4. Device Description
The XCHF-T160, is a flexible video endoscope used for endoscopy and endoscopic surgery within the biliary tract. The XCHF-T160 is basically identical to the predicate device, Olympus CHF-B20 Choledochoscope, hereinafter referred to as CHF-B20 in intended use, specifications, performance.
The optical system of the XCHF-T160 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 14-1 in intended use, and similar in specifications, performance and materials.
5. Indications for Use
VIDEOSCOPE XCHF-T160
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.
OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN TELEPHONE +81-42-642-2694, TELEFAX +81-42-642-2307 2/3
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6. Comparison of Technological Characteristics
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The XCHF-T160 is similar to the predicate device CHF-B20 in specifications except for the material and optical system. Comparison between the subject and predicate devices is shown below.
| Specifications | Subject Device
XCHF-T160 | Predicate Device 1
CHF-B20 | Predicate Device 2
GIF-Q160Z |
|-----------------------------------------|--------------------------------------|-------------------------------|-------------------------------------|
| Field of View | 90° | 100° | 140° |
| Depth of Field | 1-50mm | 3-50mm | WIDE : 8-100mm
TELE : 1.5-3mm |
| Direction of View | Forward | Forward | Forward |
| Type of CCD Chip | Inter color CCD
(37071) | | Inter color CCD
(3704) |
| Outer Diameter of Distal
End | $\phi$ 5.7mm | $\phi$ 4.1mm | $\phi$ 10.8mm |
| Outer Diameter of
Insertion Tube | $\phi$ 5.5mm | $\phi$ 4.5mm | $\phi$ 10.9mm |
| Angulation
UP/DOWN | U 160°
D 100°
R 100°
L 100° | U 160°
D 100° | U 210°
D 90°
R 100°
L 100° |
| Working Length | 1330mm | 1870mm | 1030mm |
| Inner Diameter of
Instrument Channel | $\phi$ 2.0mm
$\phi$ 1.2mm | $\phi$ 1.7mm | $\phi$ 2.8mm |
| Table 14-2. Comparison of Specifications | |||
|---|---|---|---|
| -- | ------------------------------------------ | -- | -- |
7. Conclusion
When compared to the predicate device, the CHF-B20 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 +81-42-642-2694, TELEFAX +81-42-642-2307 રૂાર
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle with three stripes representing the feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 1 2008
OLYMPUS MEDICAL SYSTEMS CORP. c/o Stacy Abbatiello Kluesner, RAC Regulatory Affairs & Quality Assurance Olympus America, Inc. 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034-0610
K082576 Re:
Trade/Device Name: VIDEOSCOPE XCHF-T160 Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscopes and accessories Regulatory Class: II Product Code: FBN Dated: September 4, 2008 Received: September 9, 2008
Dear Ms. Kluesner:
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.
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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 (OS) 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (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 Biometrics' (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/cdrh/industry/support/index.html.
Sincerely vours.
Jorgu M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): 人 ८ 8 2 5 7 6 Device Name: VIDEOSCOPE XCHF-T160
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 biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within the biliary tract.
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
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