(46 days)
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.
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.
The provided text is a 510(k) summary for the VIDEOSCOPE XCHF-T160, which is primarily a medical device submission to the FDA. Such documents focus on demonstrating "substantial equivalence" to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance data for a new, innovative device that would typically undergo a rigorous clinical trial.
Therefore, the document does NOT contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
The submission is based on demonstrating that the VIDEOSCOPE XCHF-T160 is "basically identical" in intended use, specifications, and performance to the predicate device, Olympus CHF-B20 Choledochoscope. This approach typically relies on engineering and performance comparisons rather than new clinical effectiveness studies with explicit acceptance criteria for performance metrics.
Here's what can be extracted based on the provided text, and what is explicitly not available:
1. A table of acceptance criteria and the reported device performance:
-
Not Available. The document does not specify quantitative acceptance criteria or reported device performance metrics in the format requested. Instead, it provides a comparison of specifications to predicate devices to demonstrate substantial equivalence.
Here's a table showing the comparison of technical specifications, which serves as the basis for demonstrating similarity to predicate devices rather than direct performance results against acceptance criteria:
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 : 8-100mmTELE : 1.5-3mm Direction of View Forward Forward Forward Type of CCD Chip Inter color CCD (37071) (Not specified)Inter color CCD (3704) Outer Diameter of Distal End φ 5.7mm φ 4.1mm φ 10.8mm Outer Diameter of Insertion Tube φ 5.5mm φ 4.5mm φ 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 φ 2.0mm φ 1.2mm φ 1.7mm φ 2.8mm The conclusion states: "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." This implies that the device meets "acceptance criteria" by being substantially equivalent to prior approved devices, rather than through a new set of defined performance metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Available. The document does not describe any specific test set of data with a sample size or provenance for evaluating the device's clinical performance. The focus is on comparing physical and technical specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Available. No test set or ground truth establishment by experts is mentioned in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Available. No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable / Not Available. This device is a videoscope, not an AI-powered diagnostic tool, so an MRMC study related to AI assistance would not be relevant or expected for this submission. The document does not mention any such study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Not Available. This device is a videoscope, which is an instrument operated by a human. There is no "algorithm only" performance to evaluate in this context.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not Available. No specific ground truth methodology is mentioned as there isn't a stated clinical study to evaluate a specific performance claim. The "ground truth" for this 510(k) essentially relies on the established safety and effectiveness of the predicate devices.
8. The sample size for the training set:
- Not Applicable / Not Available. This submission does not describe a machine learning or AI model that would require a training set.
9. How the ground truth for the training set was established:
- Not Applicable / Not Available. No training set is implied or discussed.
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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.
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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's510(k)No. |
|---|---|---|
| VIDEOSCOPEXCHF-T160 | CHOLEDOCHOSCOPECHF-B20 | K904799 |
| XCHF-T160 | EVIS EXERA Gastrointestinal VideoscopeGIF-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
182516
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 DeviceXCHF-T160 | Predicate Device 1CHF-B20 | Predicate Device 2GIF-Q160Z |
|---|---|---|---|
| Field of View | 90° | 100° | 140° |
| Depth of Field | 1-50mm | 3-50mm | WIDE : 8-100mmTELE : 1.5-3mm |
| Direction of View | Forward | Forward | Forward |
| Type of CCD Chip | Inter color CCD(37071) | Inter color CCD(3704) | |
| Outer Diameter of DistalEnd | $\phi$ 5.7mm | $\phi$ 4.1mm | $\phi$ 10.8mm |
| Outer Diameter ofInsertion Tube | $\phi$ 5.5mm | $\phi$ 4.5mm | $\phi$ 10.9mm |
| AngulationUP/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 ofInstrument 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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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 (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
Page 1 of _ 1
§ 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.