(262 days)
Not Found
No
The document describes a standard endoscopic video system and does not mention any AI or ML capabilities, image processing beyond basic video display, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is used for "treatment" within the bladder, urethra, ureter, and kidney, which indicates it has a therapeutic function.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the system is designed for "endoscopic diagnosis."
No
The device description explicitly lists multiple hardware components (videoscopes, video system center, light source, etc.) as primary components of the system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the devices are for "endoscopic diagnosis and treatment within the bladder, urethra, ureter, and kidney." This involves direct visualization and intervention within the body.
- Device Description: The description details a system for endoscopic procedures, including endoscopes, a video system center, and a light source. These are tools for internal examination and treatment.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information. IVDs are designed to perform tests on biological specimens.
The device described is an endoscopic system used for direct visualization and procedures within the urinary tract and kidneys, which falls under the category of medical devices used for diagnosis and treatment in vivo.
N/A
Intended Use / Indications for Use
The EVIS EXERA II 180 SYSTEM is intended for endoscopic diagnosis, treatment and video observation.
VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, CYF TYPE VA2, CYF TYPE V2R : These instruments have 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 bladder, urethra, ureter, and kidney.
EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 : This video system center has been designed to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180 : This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
Product codes (comma separated list FDA assigned to the subject device)
NWB, FAJ
Device Description
The EVIS EXERA II 180 SYSTEM consists of Olympus camera heads, endoscopes, video system center, light source, monitors, EndoTherapy accessories and other ancillary equipment. This system with the compatible cystoscopes is intended for endoscopic diagnosis, treatment and video observation of the bladder, urethra, ureter, and kidney.
The primary components of the subject system are:
- VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, CYF TYPE VA2, CYF TYPE V2R (CYF-V2, CYF-VA2, CYF-V2R)
- EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180
- EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bladder, urethra, ureter, and kidney.
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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of three faces in profile, stacked on top of each other. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2014
OLYMPUS MEDICAL SYSTEMS CORP. % Sheri L. Musgnung Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway, PO Box 610 Center Valley, PA 18034-0610
Re: K133538
Trade/Device Name: EVIS EXERA II 180 SYSTEM Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NWB, FAJ Dated: June 30, 2014 Received: July 1, 2014
Dear Sheri L. Musgnung,
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 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.
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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.
Herbert P. Lerner -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K133538
Device Name EVIS EXERA II 180 SYSTEM
Indications for Use (Describe)
VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, CYF TYPE VA2, CYF TYPE V2R : These instruments have 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 bladder, urethra, ureter, and kidney.
EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 :
This video system center has been designed to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180 :
This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
- Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, yellow line. Below the line, the words "Your Vision, Our Future" are written in a smaller font.
510(k) Summary
1. General Information
. Applicant: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan Establishment Registration No.: 8010047
- Sheri L. Musgnung . Official Correspondent: Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-3147 FAX: 484-896-7128
- Prepared Date: November 15, 2013
2. Device Identification
| ■ | Device Trade Name: | EVIS EXERA II 180 SYSTEM |
|---|---|---|
| ■ | Common Name: | ENDOSCOPIC VIDEO IMAGING SYSTEM |
| ■ | Regulation Number: | 876.1500 |
| ■ | Regulation Name: | Endoscope and Accessories |
| ■ | Regulatory Class: | II |
| ■ | Classification Panel: | Gastroenterology and urology |
| ■ | ■ Product Code: | NWB (endoscope, accessories, narrow band spectrum) FAJ (cystoscope and accessories, flexible/rigid) |
3. Predicate Devices
EVIS EXERA II 180 SYSTEM (K062049)
Section6 510(k) Summary Page 2 of 4
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Image /page/4/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, dark blue letters. Underneath the word is a thin, horizontal, yellow line. Below the line, the words "Your Vision, Our Future" are written in a smaller font.
4. Device Description
The EVIS EXERA II 180 SYSTEM consists of Olympus camera heads, endoscopes, video system center, light source, monitors, EndoTherapy accessories and other ancillary equipment. This system with the compatible cystscopes is intended for endoscopic diagnosis, treatment and video observation of the bladder, urethra, ureter, and kidney.
The primary components of the subject system are:
- VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, ◆
- CYF TYPE VA2, CYF TYPE V2R (CYF-V2, CYF-VA2, CYF-V2R) EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180
- EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180
5. Indications for Use
VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, CYF TYPE VA2, CYF TYPE V2R :
These instruments have 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 bladder, urethra. ureter, and kidney.
EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 :
This video system center has been designed to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis. treatment and video observation.
EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180 :
This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
6. Technological Characteristics
The purpose of this notification is to add additional urology-related marketing claims to this system, add an additional Cysto-nephro videoscope, add additional compatible items, and add a change to a type of material. There are no new technological features incorporated in this system. The proposed video system center and xenon light source and the subject endoscopes have identical technological features to the predicate device. The subject system has been designed to meet the applicable safety standards.
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Image /page/5/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, yellow line. Underneath the line, the words "Your Vision, Our Future" are written in a smaller, lighter font.
7. Summary of Non-clinical Testing
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
8. Conclusion
When compared to the predicate devices, the EVIS EXERA II 180 SYSTEM does not incorporate any significant changes in intended use, methods of operation, materials, or design that could affect the safety or effectiveness. Based on the design control activities, Olympus believes the EVIS EXERA II 180 SYSTEM and the predicate device selected are substantially equivalent and do not change fundamental scientific technology and intended use of the market-cleared device.