(167 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on a CCD-based optical system, which is a standard imaging technology, not indicative of AI/ML.
Yes.
The device is used for both diagnosis and treatment within the bile duct, which qualifies it as a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the instrument is designed for "endoscopic diagnosis and treatment within the bile duct." The "Device Description" also reiterates its use for "endoscopic diagnosis."
No
The device description clearly states it is a flexible video endoscope, which is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "for endoscopic diagnosis and treatment within the bile duct." This describes a procedure performed directly on the patient's body using an endoscope, not a test performed in vitro (outside the body) on biological samples.
- Device Description: The description confirms it's a "flexible video endoscope used for endoscopic diagnosis and treatment within the bile duct." This reinforces its use as a tool for direct visualization and intervention within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples to diagnose a condition.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device is a tool 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, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bile duct.
Product codes
NWB, FBN
Device Description
The CHF-V choledochoscope is a flexible video endoscope used for endoscopic diagnosis and treatment within the bile duct . The CHF-V choledochoscope is basically identical to the predicate device, CHF Type P10 OES Nephroscope/Cystoscope, in intended use, spacifications, performance. The optical system of the CHF-V 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bile 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)
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.
0
OLYMPUS
.
510(k) SUMMARY
NOV - 6 2008
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 |
| | Choledocoscope: | | Aizu Olympus Co., Ltd.
500 Aza-Muranishi, Ooaza-Iidera, Monden-cho,
Aizuwakamatsu-shi, Fukushima, Japan 965-8520
Establishment Registration No.: 9610595 |
| ■ | Date Prepared: | April | 2008 |
2. Device Identification
:
| • | Device Name: | CHF-V |
|---|---|---|
| • | Common Name: | CHOLEDOCHO VIDEOSCOPE |
| • | Class: | II |
| • | Regulation Number/Name: | 876.1500 Endoscope and accessories |
| • | Product Code: | NWB - Endoscope, accessories, narrow band spectrum |
| FBN - Choledochoscope, accessories, | ||
| • | Classification Panel: | Gastroenterology/Urology |
OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN TELEPHONE +81-42-642-2694, TELÉFAX +81-42-642-2307
1
APUS
3. Legally Marketed Device to which Substantial Equivalence is Claimed
The following table shows the subject device and the predicate device to which we clalm substantial equivalence.
Table 15-1: Primary Component & Predicate Device
| Subject Device
| (Part of this submission) | Predicate Device | PD's 610(k) No. |
|---|---|---|
| CHOLEDOCHO VIDEOSCOPE | ||
| CHF-V | OES Nephroscope / Cystoscope | |
| Fiberscope CHF-P10 | K843084 |
4. Device Description
The CHF-V choledochoscope is a flexible video endoscope used for endoscopic diagnosis and treatment within the bile duct . The CHF-V choledochoscope is basically identical to the predicate device, CHF Type P10 OES Nephroscope/Cystoscope, in intended use, spacifications, performance. The optical system of the CHF-V 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.
5. Indications for Use
CHOLEDOCHO VIDEOSCOPE CHF-V
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bile duct.
OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN TELEPHONE +81-42-642-2694, TELEFAX +81-42-642-2307
2
Image /page/2/Picture/1 description: The image shows the word "OLYMPUS" in a bold, sans-serif font. The letters are large and black, creating a strong visual impact. A thin line is present underneath the word, emphasizing the brand name.
6. Comparison of Technological Characteristics
The CHF-V is similar to the predicate device CHF-P10 in specifications except for the material and optical system. Comparison between the subject and predicate devices is shown below.
| Device: OES Nephroscope / Cystoscope Fiberscope CHF-P10 (K843084) | ||
|---|---|---|
| Specifications | Control Unit (VRC CHF-V) | Rigid Device (CHF-P10) (K843084) |
| Field of View | 120° | 90° |
| Direction of View | 0° | 0° |
| Optical System | Color CCD | Image guide fiber bundle |
| Angulation | ||
| Up / Down | 160° / 130° | 160° / 130° |
| Working Length | 380mm | 330mm |
| Inner Diameter of | ||
| Instrument Channel | φ2.0mm | φ2.0mm |
Table 15-2. Comparison of Specifications Subject Device: CHOLEDOCHO VIDEOSCOPE CHF-V Predicate
6. Conclusion
When compared to the predicate device, the CHF-V 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/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, and three human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Olympus Medical Systems Corp. % Ms. Laura Storms-Tyler, Vice President Regulatory Affairs & Quality Assurance Olympus America Incorporated 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034-0610
Re: K081456
Trade Name: CHF-V Choledocho Videoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Codes: FBN Dated: October 6, 2008 Received: October 7, 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. Iisting 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.
NOV - 6 2008
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 (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/odrh/industry/support/index.html.
Sincerely yours,
loque 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
5
Indications for Use
08/456 510(k) Number (if known):
Device Name: CHF-V CHOLEDOCHO VIDEOSCOPE
Indications For Use:
CHOLEDOCHO VIDEOSCOPE OLYMPUS CHF TYPE V
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bile duct.
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)
Page 1 of 1
Arsuththethy
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K081456