(247 days)
No
The summary describes a standard endoscope with a CCD for image transfer and mentions software validation according to a 2005 guidance, which predates widespread AI/ML in medical devices. There are no mentions of AI, ML, or related concepts, nor any descriptions of training or test sets typically associated with AI/ML development.
Yes
The "Intended Use" explicitly states that the instrument is designed for "endoscopic diagnosis and treatment within the ureter and kidney," indicating a therapeutic purpose in addition to diagnosis.
Yes
The "Intended Use / Indications for Use" section explicitly states that the instrument is designed for "endoscopic diagnosis and treatment within the ureter and kidney." This directly indicates a diagnostic purpose.
No
The device description explicitly states it is an endoscope composed of physical components like an insertion tube, control section, connectors, and a CCD for image transfer, indicating it is a hardware device. The performance studies also mention reprocessing validation, electromagnetic compatibility, and electric safety, which are typical for hardware medical devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endoscopic diagnosis and treatment within the ureter and kidney." This involves direct visualization and intervention within the body, not the examination of specimens in vitro (outside the body).
- Device Description: The description details a flexible endoscope with components for image transfer and manipulation within the body. This aligns with an endoscopic device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples to provide diagnostic information.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device's function is to visualize and potentially treat structures 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 ureter and kidney.
Product codes
FGB, NWB
Device Description
This endoscope is composed from flexible insertion tube, control section, light guide connector and video connector, and equipped CCD for image transfer system.
URF-V2R has identification marking for opposite bending direction on the control section and the bending section of the URF-V2R moves in the direction opposite to the conventional endoscopes, such as the URF-V2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureter and 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)
The technological characteristic differences between the predicate device and the subject device have been confirmed that they are substantially equivalent through the following tests and standards.
·Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
·Biocompatibility testing is performed in accordance with the FDA Guidance. Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" issued on June 16 2016.
•Performance testing was carried out to verify the safety and the effectiveness of the subject device.
·The reprocessing validation test was performed in accordance with the FDA guidance "Guidance for Industry and FDA Staff - Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling issued on March 17, 2015"
•The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005.
·Electromagnetic compatibility and electric safety have been validated in accordance with FDA`s currently recognized standards.
The results of the above performance testing demonstrated that the subject device has no concerns on safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K072957 VISERA URETERO-RENO VIDEOSCOPE OLYMPUS XURF TYPE V
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
March 30, 2018
Olympus Medical Systems Corp. % Sheri L. Musgnung Regulatory Affairs Manager Olympus Corporation of the Americas 3500 Corporate Parkway, P.O. Box 610 Center Valley, PA 18034-0610
Re: K172246
Trade/Device Name: Olympus URF-V2/V2R Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB. NWB Dated: February 26, 2018 Received: February 27, 2018
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.
1
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); 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.
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and is set against a white background. The letters are clearly legible and well-spaced.
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
2
Indications for Use
510(k) Number (if known) K172246
Device Name Olympus URF-V2/V2R
Indications for Use (Describe) Olympus URF-V2/V2R
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 ureter and kidney.
| 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) |
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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. Underneath the line is the text "Your Vision, Our Future".
510(k) Summary
February 26, 2018
1. General Information
■ Applicant: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan Establishment Registration No.: 8010047
- Official Correspondent: Sheri L. Musgnung Regulatory Affairs Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-3147 FAX: 484-896-7128 Email: sheri.musgnung@olympus.com Manufacturer: Aizu Olympus Co., Ltd.
- 500 Aza-Muranishi, Ooaza-Iidera, Monden-cho, Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No.: 9610595
2. Device Identification
| ■ | Device Trade Name: | OLYMPUS URF-V2/V2R |
|---|---|---|
| ■ | Common Name: | URETERO-RENO VIDEOSCOPE |
| ■ | Regulation Number: | 876.1500 |
| ■ | Regulation Name: | Endoscope and Accessories |
| ■ | Regulatory Class: | II |
| ■ | Classification Panel: | Gastroenterology and urology |
| ■ | Product Code: | FGB (Ureteroscope And Accessories, Flexible/Rigid) |
| NWB (Endoscope, accessories, narrow band spectrum) |
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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, blue letters. A thin, yellow line is underneath the word. Below the line, the words "Your Vision, Our Future" are written in a smaller, black font.
3. Predicate Device
K072957 VISERA URETERO-RENO VIDEOSCOPE OLYMPUS XURF TYPE V
4. Device Description
This endoscope is composed from flexible insertion tube, control section, light guide connector and video connector, and equipped CCD for image transfer system.
URF-V2R has identification marking for opposite bending direction on the control section and the bending section of the URF-V2R moves in the direction opposite to the conventional endoscopes, such as the URF-V2.
5. 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 ureter and kidney.
The Indications for Use statement for the OLYMPUS URF-V2/V2R is not identical to the predicate device; however, the difference on the limitation of applicable anatomical sites for the subject device does not alter the intended diagnosis and treatment use nor do they affect the safety and effectiveness of the device relative to the predicate. Both of the subject and predicate device have the same intended use for the endoscopic diagnosis and treatment of urinary organs.
6. Comparison of Technological Characteristics
Compared to the predicate device, the subject device differs as it relates to labeling, technology/ engineering/ performance, and materials. The main modifications are as follows:
-
- The physical properties of the insertion section and optical parameters are slightly changed.
-
- The patient-contact material is changed.
-
- Software is implemented to the subject device.
-
- Sterilization method by hydrogen peroxide is added.
-
- Internal structure is improved to enhance the mechanical durability.
Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness of the subject device.
A side by side comparison of the subject device and the predicate device is provided below.
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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, and below that is the text "Your Vision, Our Future".
| Item | ||
|---|---|---|
| URF-V2/V2R | XURF-V (K072957) | |
| 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 ureter and | ||
| kidney. | 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, | ||
| urethra, ureter, and kidney. | ||
| Common name | URETERO-RENO | |
| VIDEOSCOPE | URETERO-RENO | |
| VIDEOSCOPE | ||
| Regulation number | 876.1500 | 876.1500 |
| Regulation name | Endoscope and Accessories | Endoscope and Accessories |
| Regulatory class | II | II |
| Classification panel | Gastroenterology and urology | Gastroenterology and urology |
| Product code | FGB, NWB | FGB, NWB |
| Environment of use | Healthcare facility/hospital | Healthcare facility/hospital |
| Single/repeat use | Repeat use | Repeat use |
| Sterile/non-sterile | Marketed as non-sterile | Marketed as non-sterile |
| Sterilization method | Ethylene oxide; Hydrogen | |
| peroxide | Ethylene oxide; | |
| Energy source | Electricity | Electricity |
| Material composition | ||
| of main patient- | ||
| contact parts and | ||
| duration and type of | ||
| contact | Material composition of main | |
| patient-contact parts |
Distal tip: stainless steel
Insertion tube: fluoro resin
Bending rubber: fluoro rubber
Lens: glass
Adhesive: epoxy
Surface-contacting device in
contact with mucosal
membranes. The contact
duration is limited exposure
(i.e. contact is up to 24 hours). | Material composition of main
patient-contact parts
Distal tip: stainless steel
Insertion tube: fluoro resin
Bending rubber: fluoro rubber
Lens: glass
Adhesive: epoxy
Surface-contacting device in
contact with mucosal
membranes. The contact
duration is limited exposure
(i.e. contact is up to 24 hours). |
6
Image /page/6/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. A thin, yellow line is underneath the word. Below the line, the words "Your Vision, Our Future" are written in a smaller, gray font.
7. Summary of Non-clinical Testing
The technological characteristic differences between the predicate device and the subject device have been confirmed that they are substantially equivalent through the following tests and standards.
·Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
·Biocompatibility testing is performed in accordance with the FDA Guidance. Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" issued on June 16 2016.
•Performance testing was carried out to verify the safety and the effectiveness of the subject device.
·The reprocessing validation test was performed in accordance with the FDA guidance "Guidance for Industry and FDA Staff - Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling issued on March 17, 2015"
•The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005.
·Electromagnetic compatibility and electric safety have been validated in accordance with FDA`s currently recognized standards.
The results of the above performance testing demonstrated that the subject device has no concerns on safety and effectiveness.
| Standard No. | Standard Title |
|---|---|
| ISO 14971 Second | Medical Devices - Application Of Risk Management To |
| Edition: 2007-03-01 | Medical Devices |
| ISO 10993-1 Fourth | |
| Edition:2009-10-15 | Biological Evaluation Of Medical Devices - Part1: |
| Evaluation And Testing Within A Risk Management | |
| Process [Including: Technical Corrigendum 1 (2010)] | |
| AAMI ANSI ISO | Biological Evaluation Of Medical Devices - Part5: Tests |
| 10993-5:2009/(R)2014 | For In Vitro Cytotoxicity |
Also, the following standards have been applied to the subject device:
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Image /page/7/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. A thin, yellow line is underneath the word. Below the line, the text "Your Vision, Our Future" is written in a smaller font.
| Standard No. | Standard Title |
|---|---|
| ISO 10993-10 Third | |
| Edition: 2010-08-01 | Biological Evaluation Of Medical Devices - Part 10: Tests |
| For Irritation And Skin Sensitization | |
| AAMI ANSI ES60601- | |
| 1:2005/(R)2012 and | |
| A1:2012 | Medical Electrical Equipment - Part 1: General |
| Requirements for Basic Safety And Essential Performance |
- Amendment 1: 2012 |
| IEC 60601-1-2 Edition
4.0: 2014-02 | Medical Electrical Equipment – Part 1-2: General
Requirements for Safety - Collateral standard:
Electromagnetic Compatibility – Requirements and Tests |
| IEC 60601-2-18 Edition
3.0: 2009-08 | Medical Electrical Equipment - Part 2-18: Particular
Requirements For The Basic Safety And Essential
Performance Of Endoscopic Equipment. |
8. Conclusion
In comparison to the predicate device, Olympus URF-V2/V2R has the same intended use and the technical differences do not cause any significant changes that could affect the safety or effectiveness of the device. Therefore, the subject device is substantially equivalent to the predicate device.