(224 days)
Not Found
No
The summary describes a standard endoscope and its accessories, with no mention of AI/ML capabilities or image processing features that would typically utilize such technology. The performance studies focus on device safety and functionality, not algorithmic performance.
Yes
The device is specifically designed for "endoscopic diagnosis and treatment," indicating its role in therapeutic procedures as well as diagnostic ones.
Yes
The "Intended Use / Indications for Use" and "Device Description" explicitly state that the device is designed for "endoscopic diagnosis and treatment."
No
The device description explicitly states the device consists of three physical parts (control section, section, and connector section) and is used with other hardware components like a video system center, light source, and monitor. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use/Indications for Use: The intended use is for "endoscopic diagnosis and treatment within the bladder, urethra, and kidney." This involves directly visualizing and potentially treating internal body structures.
- Device Description: The description focuses on the physical components of the endoscope and its use with other equipment for visualization and treatment.
- Lack of IVD Characteristics: IVDs are designed to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. This device is used inside the body for direct observation and intervention.
- Performance Studies: The performance studies listed (reprocessing, biocompatibility, software, electrical safety, bench testing) are typical for endoscopic devices, not IVDs which would focus on analytical performance with biological samples.
Therefore, the VISERA CYSTO-NEPHRO VIDEOSCOPEs are medical devices used for endoscopy, not IVDs.
N/A
Intended Use / Indications for Use
VISERA CYSTO-NEPHRO VIDEOSCOPEs OLYMPUS CYF TYPE V2, CYF TYPE V2R 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, and kidney.
CYSTO-NEPHRO VIDEOSCOPEs OLYMPUS CYF VH, and CYF VHR 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, and kidney.
Product codes (comma separated list FDA assigned to the subject device)
FAJ
Device Description
The subject device 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 bladder, urethra, and kidney.
The subject devices consist of three parts: the control section section, and the connector section. The basic principle including user interface and operation for the subject device are identical to that of the predicate device.
The VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF-V2/V2R will be packed and offered together with the devices listed in the table below. They can be used with commercially available Olympus devices as described within the Instruction Manual.
| Model No. | Device Name |
|---|---|
| BW-411B | Single Use Combination Cleaning Brush |
| MB-156 | ETO Cap |
The CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF-VH and CYF-VHR will be packed and offered together with the devices listed in the table below. They can be used with commercially available Olympus devices as described within the Instruction Manual.
| Model No. | Device Name |
|---|---|
| BW-411B | Single Use Combination Cleaning Brush |
| MAJ-1538 | Sterilization Cap |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder, urethra, kidney
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare facility/hospital
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)
-
Reprocessing validation testing: Reprocessing instruction and reprocessing method validation testing were conducted and documentations were provided as recommended by Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling".
-
Biocompatibility testing: Biocompatibility testing were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests:
- Cytotoxicity Study Using the ISO Elution Method
- ISO Intracutaneous Study in Rabbits
- ISO Guinea Pig Maximization Sensitization Test
- ISO Intracutaneous Study in Rabbits
- USP Rabbit Pyrogen Study
- ISO Acute Systemic Toxicity Study in Mice
-
Software verification and validation testing: Software verification and validation testing were conducted, and documentations were provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
-
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted in accordance with the ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2:2014 standards for EMC.
-
Performance testing - Bench: Bench testing as listed below were conducted to ensure that the subject device performs as intended and meet design specifications.
- Thermal Safety
- Composite Durability
- Color Performance
- Photobiological Safety
- Noise and Dynamic Range
- Image Intensity Uniformity
- Field of View and Direction of View
- Resolution
- Effectiveness NBI
-
Performance testing - Animal: No animal study was performed to demonstrate substantial equivalence.
-
Performance testing - Clinical: No clinical study was performed to demonstrate substantial equivalence.
-
Risk management: Risk management was performed in accordance with ISO 14971:2007. The design verification tests and their acceptance criteria were performed and identified as a result of this risk management.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 20, 2023
Olympus Medical Systems Corporation % Teffany Hutto Regulatory Affairs Consultant Olympus Corporation of the Americas 3500 Corporate Parkway P.O. Box 610 Center Valley, PA 18034
Re: K221683
Trade/Device Name: VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, CYF TYPE V2R CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF-VH, CYF-VHR Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ Dated: December 22, 2022 Received: December 22, 2022
Dear Teffany Hutto:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mark J. Antonino -S
Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name
VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, CYF TYPE V2R
Indications for Use (Describe)
VISERA CYSTO-NEPHRO VIDEOSCOPEs OLYMPUS CYF TYPE V2, CYF TYPE V2R 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, and kidney.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K221683
Device Name
CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF-VH, CYF-VHR
Indications for Use (Describe)
CYSTO-NEPHRO VIDEOSCOPEs OLYMPUS CYF VH, and CYF VHR 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, and kidney.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are all capitalized and evenly spaced. A registered trademark symbol is located to the right of the letter "S".
Date Prepared: 01/19/2023
510(k) Summary
1. GENERAL INFORMATION
- 510(k) Submitter: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507, Japan
- Contact Person: Teffany Hutto Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 512-508-6550 Fax: 484-896-7128 Email: teffany.hutto@olympus.com
- . Manufacturing site: Shirakawa Olympus Co., Ltd. 3-1 Okamiyama, Odakura, Nishigo-mura, Nishishirakawa-gun, Fukushima 961-8061, Japan
Aizu Olympus Co., Ltd., 3-1-1 Niiderakita, Aizuwakamatsu-shi, Fukushima 965-8520, Japan
2. DEVICE IDENTIFICATION
| ■ Trade/Device Name: | VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2,
CYF TYPE V2R
CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF-VH, CYF-VHR |
|-------------------------|------------------------------------------------------------------------------------------------------------------------|
| ■ Model Name: | OLYMPUS CYF-V2, CYF-V2R, CYF-VH, CYF-VHR |
| ■ Common Name: | CYSTO-NEPHRO VIDEOSCOPE |
| ■ Regulation Number: | 876.1500 |
| ■ Regulation Name: | Endoscope and accessories |
| ■ Regulatory Class: | Class II |
| ■ Product Code: | FAJ (Cystoscope and Accessories, Flexible/Rigid) |
| ■ Classification Panel: | Gastroenterology/Urology |
5
Image /page/5/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are spaced closely together, and the word is slightly angled upwards from left to right. A registered trademark symbol is located at the top right corner of the word.
3. PREDICATE DEVICE
Predicate device
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| VISERA CYSTO-NEPHRO | ||
| VIDEOSCOPE | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K133538 | |
| OLYMPUS CYF TYPE V2, CYF TYPE | ||
| VA2, CYF TYPE V2R |
4. DEVICE DESCRIPTION
■ General Description of the subject device
The subject device 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 bladder, urethra, and kidney.
Principle of Operation
The subject devices consist of three parts: the control section section, and the connector section. The basic principle including user interface and operation for the subject device are identical to that of the predicate device.
■ List of device components
The VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF-V2/V2R will be packed and offered together with the devices listed in the table below. They can be used with commercially available Olympus devices as described within the Instruction Manual.
| Model No. | Device Name |
|---|---|
| BW-411B | Single Use Combination Cleaning Brush |
| MB-156 | ETO Cap |
The CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF-VH and CYF-VHR will be packed and offered together with the devices listed in the table below. They can be used with commercially available Olympus devices as described within the Instruction Manual.
6
Image /page/6/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. A registered trademark symbol is located at the top right corner of the word.
| Model No. | Device Name |
|---|---|
| BW-411B | Single Use Combination Cleaning Brush |
| MAJ-1538 | Sterilization Cap |
5. INDICATIONS FOR USE
VISERA CYSTO-NEPHRO VIDEOSCOPEs OLYMPUS CYF TYPE V2, CYSTO-NEPHRO VIDEOSCOPEs OLYMPUS CYF-VH and CYF-VHR 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, and kidney.
6. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject device has the same technological characteristics and design as the predicate device except for the following features:
- Optical performance
- Shape of the distal end
Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness of the subject device.
| Item | Subject Device | Predicate Device |
|---|---|---|
| OLYMPUS CYF-V2, CYF-V2R | OLYMPUS CYF | |
| TYPE V2, VA2, V2R | ||
| (K133538) | ||
| Indications for Use | VISERA CYSTO-NEPHRO | |
| VIDEOSCOPEs OLYMPUS CYF TYPE | ||
| V2 and CYF TYPE V2R 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, and kidney. | 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 | ||
| bladder, urethra, ureter, and kidney. | ||
| Regulation Number | 21CFR 876.1500 | 21CFR 876.1500 |
| Regulation Name | Endoscope and accessories | Endoscope and accessories |
| Regulatory Class | Class II | Class II |
| Subject Device | Predicate Device | |
| Item | OLYMPUS CYF-V2, CYF-V2R | OLYMPUS CYF |
| TYPE V2, VA2, V2R | ||
| (K133538) | ||
| Product Code | FAJ | FAJ |
| Classification Panel | Gastroenterology/Urology | Gastroenterology/Urology |
| Use Environment | Healthcare facility/hospital | Healthcare facility/hospital |
| Reprocessing | [Cleaning] | |
| AER and manual | ||
| [Disinfection] | ||
| AER and manual | ||
| [Sterilization] |
- Ethylene oxide gas
- STERRAD NX | [Cleaning]
AER and manual
[Disinfection]
AER and manual
[Sterilization] - Ethylene oxide gas
- STERRAD NX |
| Single-Use/Reuse | Reusable | Reusable |
| Duration and type of
contact | Surface-contacting device in contact with
mucosal membranes. The contact duration
is limited exposure (