(30 days)
K# 993041, K# 912120, K# 931154, K# 981543
Not Found
No
The summary describes a standard endoscopic device with improved resolution and a change in image capture technology (image guide to CCD). There is no mention of AI, ML, or any related concepts like image processing beyond basic capture.
Yes
The device is used for "treatment within the bladder and urethra," indicating a therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the instrument is designed for "endoscopic diagnosis and treatment within the bladder and urethra."
No
The device description explicitly states it is an "instrument" with an "optical system" modified from "image guide to CCD," indicating it is a hardware device with physical components for image acquisition.
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 device is for "endoscopic diagnosis and treatment within the bladder and urethra." This involves direct visualization and intervention within the body, which is characteristic of an in vivo diagnostic or therapeutic device, not an in vitro diagnostic.
- Device Description: The description reinforces its use for "endoscopic diagnosis and treatment within the bladder and urethra," focusing on the optical system for visualization.
- Lack of IVD Characteristics: IVD devices typically involve testing samples (like blood, urine, tissue) outside the body to diagnose conditions. The provided information does not mention any sample collection or analysis.
Therefore, this device falls under the category of an endoscopic device used for direct visualization and intervention within the body, not an in vitro diagnostic device.
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, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder and urethra.
Product codes
FAJ
Device Description
The subject device is used for endoscopic diagnosis and treatment within the bladder and urethra. The optical system is modified from the image guide to CCD and the resolution is improved.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder and urethra
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)
K# 993041, K# 912120, K# 931154, K# 981543
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
OLYMPUS AMERICA, INC. Ms. Laura Storms-Tyler Director, Regulatory Affairs and Quality Assurance Two Corporate Center Drive Melville, NY 11747-3157
JUL 27 2015
Re: . . . K021074
Trade/Device Name: Olympus VISCERA Cystovideoscope Type CYF V/VA Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ Dated (Date on orig SE ltr): March 29, 2002 Received (Date on orig SE ltr): April 2, 2002
Dear Ms. Storms-Tyler,
This letter corrects our substantially equivalent letter of May 2, 2002.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be
1
Page 2 -
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Benjamin R. Fisher -S
Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
510(k) Number (if known): ___ K021074
Qlympus VISCERA Cystovideoscope type CYF V/VA Device Name:
Indications for Use:
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, endo-therapy accessories, and other
source, documentation equipment, display monitor, endo-therapy accessories, and other an source, documentation equipment, usplay moment within the bladder and urethra.
(Please do not write below this line. Continue on another page is needed.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Over-the-Counter Use __
Prescription Use __
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
3
Ko 21074.
MAY 0-2 2002
SMDA 510(k) SUMMARY
VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA
A. Submitter's Name, Address, Phone and Fax Numbers
Name & Address of manufacturer:
Registration No .: Address, Phone and Fax Numbers: Olympus Optical Co., Ltd. 2-3-1 Shinjuku Monolis Nishi-Shinjuku, Shinjuku-ku Tokyo, Tokyo 163-0914 Japan 8010047 2951 Ishikawa-Cho, Hachioji-shi, Tokyo 192-8507 Japan 81- 426-42-2891 TEL FAX 81-426-46-5613
B. Name of Contact Person
Name: Address, Phone and Fax Numbers: Laura Storms-Tyler Olympus America Inc. Two Corporate Center Drive Melville, New York 11747-3157 TEL: (631) 844-5688 FAX: (631) 844-5416
C. Device Name, Common Name, Classification Name and Predicate Devices
| Trade Name: | VISERA CYSTOVIDEOSCOPE OLYMPUS CYF
TYPE V/VA |
|-------------------|----------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Cystofiberscope / Nephrofiberscope, accessories and
ancillary equipment |
| Classification: | 21 CFR 876.1500 Endoscope and accessories,
21 CFR 876.4300 Endoscopic electrosurgical unit and
accessories, Class II |
| Predicate Device: | XCYF-1T3 (K# 993041)
URF-P2 (K# 912120)
BF-200 (K# 931154)
LF-TP/DP (K# 981543) |
4
D. Description of the Device(s)
The subject device is used for endoscopic diagnosis and treatment within the bladder and urethra. The optical system is modified from the image guide to CCD and the resolution is improved.
E. Intended Use of the Device(s)
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder and urethra.