(196 days)
No reference devices were used in this submission.
No
The summary describes a semi-rigid optical instrument for visualization and therapeutic procedures, focusing on mechanical and optical performance. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is used for "theraputic procedures" such as removal of tissue, catheters, or stones.
Yes
The intended use explicitly states "visualization of the following diagnostic and therapeutic procedures" and lists "Transurethral inspection of the ureters and renal pelvis for diagnosis" as a primary function.
No
The device description clearly states it is a reusable semi-rigid endoscope with an image relay system and outer tube, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Olympus ureteroscopes are described as semi-rigid optical instruments used for endoscopic observation and therapy within the urinary tract. They are inserted directly into the body to visualize internal structures and facilitate therapeutic procedures.
- Lack of Sample Analysis: The description does not mention the device being used to analyze samples taken from the body. Its primary function is direct visualization and manipulation within the body.
Therefore, the device falls under the category of an endoscopic surgical instrument rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Olympus ureteroscopes can be utilized for endoscopic observation and therapy in the ureters, urethra, and urinary bladder.
Semi-rigid optical instrument for the visualization of the following diagnostic and therapeutic procedures:
- Transurethral inspection of the ureters and renal pelvis for diagnosis
- Transurethral insertion of catheters, guide wires, cannulas, forceps, electrodes, baskets, lithotripsy probes and laser fibres into the ureter
- Transurethral treatment and removal of tissue, catheters, guide wires, debris and stones from urethra, urinary bladder and ureters
- Transurethral treatment and removal of tissue and stones from the ureters and renal pelvis.
The products are not intended for treatment of infants. For children (>2 years) and adults, refer to the particular constitution and anatomy of the patient.
Product codes (comma separated list FDA assigned to the subject device)
FGB
Device Description
The OES Elite Ureteroscopes are inserted directly through the natural orifice urethra and are used to visualize a wide range of therapeutic procedures or to support diagnosis. The OES Elite Ureteroscopes are reusable semi-rigid endoscopes, which consist of an image relay system inside the main body and an outer tube that guides an image fiber bundle to transmit the endoscopic image. For therapeutic procedures, the device is used in combination with surgical instruments which can be introduced through the instrument channels.
The OES Elite Ureteroscopes and accessories are delivered in non-sterile condition. They are reusable and fully reprocessable. Before first and each subsequent use the device must be inspected and reprocessed according to defined and validated reprocessing methods in the instructions for use.
The OES Elite Ureteroscopes are available in different working lengths, ocular directions, image sizes, directions of views and with one or two instrument channels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureters, urethra, urinary bladder, renal pelvis
Indicated Patient Age Range
The products are not intended for treatment of infants. For children (>2 years) and adults, refer to the particular constitution and anatomy of the patient.
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)
The following design verification and validation testing was performed on the subject devices to ensure that the subject devices function as intended and meet design specifications:
- Electrical safety as per ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18 Edition 3.0
- Thermal safety as per ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18 Edition 3.0
- Mechanical and optical performance testing as per ISO 8600-1 Edition 4, ISO 8600-3 Edition 1 and ISO 8600-4 Edition 2
- Transport and shipping testing as per ASTM D4169-16
- Tests related to the expected service life as per ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18 Edition 3.0
- Biocompatibility testing according ISO 10993-1 Ed. 5: 2018
- Reprocessing validation was conducted in accordance with the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued March 17, 2015.
- Usability validation was conducted according to IEC 62366-1 Ed. 1.0: 2015 and IEC 60601-1-6 Ed. 3.1: 2013. Usability Validation of the Instructions for Use as per FDA quidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued March 17, 2015.
- Additional comparative testing: Visible image size, distortion, internal reflections, vignetting, transmission of the optical system, transmission of the illumination system, light distribution of illumination, remaining deformation after bending stress, flow rate in first and second instrument channel
Risk analysis was carried out in accordance with established internal acceptance criteria based on ISO 14971:2007.
The performance data support the safety of the device and demonstrate that the subject devices comply with the recognized standards as specified and support a substantial equivalence determination.
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.
No reference devices were used in this submission.
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/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 28, 2020
Olympus Winter & Ibe GmbH % Christina Flores Regulatory Affairs Manager Olympus Surgical Technologies America 118 Turnpike Road Southborough, MA 01772-2104
Re: K200369
Trade/Device Name: OES Elite Ureteroscopes and Accessories (WA2UR11A, WA2UR12A, WA2UR13A, WA2UR14A, WA2UR21A, WA2UR22A, WA2UR23A, WA2UR31A, WA2UR32A, WA2URADP, WA47778A) Regulation Number: 21 CFR& 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB Dated: August 3, 2020 Received: August 4, 2020
Dear Christina Flores:
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, M.S. Acting 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
OES Elite Ureteroscopes and Accessories (WA2UR12A, WA2UR13A, WA2UR14A, WA2UR21A, WA2UR22A, WA2UR23A, WA2UR31A, WA2UR32A, WA2URADP, WA47778A)
Indications for Use (Describe)
The Olympus ureteroscopes can be utilized for endoscopic observation and therapy in the ureters, urethra, and urinary bladder.
Semi-rigid optical instrument for the visualization of the following diagnostic and therapeutic procedures:
-
Transurethral inspection of the ureters and renal pelvis for diagnosis
-
Transurethral insertion of catheters, guide wires, cannulas, forceps, electrodes, baskets, lithotripsy probes and laser fibres into the ureter
-
Transurethral treatment and removal of tissue, catheters, guide wires, debris and stones from urethra, urinary bladder and ureters
-
Transurethral treatment and removal of tissue and stones from the ureters and renal pelvis.
The products are not intended for treatment of infants. For children (>2 years) and adults, refer to the particular constitution and anatomy of the patient.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
August, 3d, 2020
1. General Information
- Olympus Winter and Ibe GmbH . Manufacturer/Holder Kuehnstr. 61 22045 Hamburg Germanv Establishment Registration No.: 9610773
- Official Correspondent Ms. Christina Flores, RAC . Olympus Surgical Technologies America 118 Turnpike Road Southborough, MA 01772 Phone: (508) 808-3341 Email: Christina.Flores@olympus.com Establishment Registration No .: 3003790304
2. Device Identification
- OES Elite Ureteroscopes and Accessories (WA2UR11A, Device Trade Name: . WA2UR12A, WA2UR13A, WA2UR14A, WA2UR21A, WA2UR22A, WA2UR23A, WA2UR31A, WA2UR32A, WA2URADP, WA47778A)
- Common Name: Ureteroscopes
- Classification Name: Endoscope and Accessories .
- Regulation Number: 21 CFR 876.1500 ■
- Product Code: FGB ■
- Product Code Name: Ureteroscope and Accessories, Flexible/Rigid ■
- Regulatory Class:
3. Predicate Devices
K052044, ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes
K011849, MRO-742A Ureteroscope
No reference devices were used in this submission.
4
4. Device Description
The OES Elite Ureteroscopes are inserted directly through the natural orifice urethra and are used to visualize a wide range of therapeutic procedures or to support diagnosis. The OES Elite Ureteroscopes are reusable semi-rigid endoscopes, which consist of an image relay system inside the main body and an outer tube that guides an image fiber bundle to transmit the endoscopic image. For therapeutic procedures, the device is used in combination with surgical instruments which can be introduced through the instrument channels.
The OES Elite Ureteroscopes and accessories are delivered in non-sterile condition. They are reusable and fully reprocessable. Before first and each subsequent use the device must be inspected and reprocessed according to defined and validated reprocessing methods in the instructions for use.
The OES Elite Ureteroscopes are available in different working lengths, ocular directions, image sizes, directions of views and with one or two instrument channels.
5. Indications for Use
The Olympus ureteroscopes can be utilized for endoscopic observation and therapy in the ureters, urethra, and urinary bladder.
Semi-rigid optical instrument for the visualization of the following diagnostic and therapeutic procedures:
- Transurethral inspection of the ureters and renal pelvis for diagnosis .
- Transurethral insertion of catheters, quide wires, cannulas, forceps, baskets, lithotripsy ● probes and laser fibers into the ureter
- Transurethral treatment and removal of tissue, catheters, guide wires, debris and stones from urethra, urinarv bladder and ureters
- . Transurethral treatment and removal of tissue and stones from the ureters and renal pelvis.
The products are not intended for treatment of infants. For children (>2 years) and adults, refer to the particular constitution and anatomy of the patient.
The indications for use statement for the subject OES Elite Ureteroscopes is very similar to that of the predicate devices. A slightly different wording is chosen and specific indications are added, listing specific diagnostic and therapeutic procedures. Also, the patient population excludes the treatment of infants. .
The differences do not alter the intended use of the device nor do they raise different questions of safety and effectiveness of the device relative to the predicate.
5
6. Summary of Technological Characteristics
The technological characteristics of the subject devices are considered equivalent to the predicate devices. Details can be found in the following table.
| Characteristic | Subject Devices | Predicate Devices |
|---|---|---|
| General technology | A ureteroscope is a semi-rigid endoscope. An image relay system of image fibers transmits the endoscopic image. A bundle of optical fibers transmits light from a light source to illuminate the operating field | Same as subject device |
| Distal end | Functional components: objective cover glass, instrument channel(s), light emission surface | Same functional component as subject device. |
| Proximal end | All distal ends have the following functional components: irrigation connector, instrument port, eyepiece cup, finger rests and light guide connector. | |
| Some models have incorporated stopcocks. | ||
| The subject device models differ in the positioning of these elements and the design of the finger rests. Some models are available with angled others with straight ocular. | Same functional components as subject device, exept for built-in stopcocks and finger rests. | |
| Insertion tube | Profile form distal: Triangular (dual-channel) and oval (single-channel). | Profile form distal: Triangular (dual-channel) and oval (single-channel), but minor differences exist. |
| Irrigation inflow | 0.7 ml/min - 9.7ml/min with inserted wire | 0.2 ml/min - 17 ml/min with inserted wire |
| Maximum working length | (330 mm - 430 mm) ± 1 mm | (330 mm - 430 mm) ± 5 mm |
| Outer circumference on distal tip | (8.4 Fr - 10.4 Fr) ± 0.4 Fr. | 7 Fr - 8.4 Fr |
| Maximum insertion portion width | 11.7 Fr. - 13.05 Fr. | 10.2 Fr - 11.2 Fr |
| Minimum instrument channel width | 2.4 Fr. - 5.4 Fr. | 2.3 Fr - 5.4 Fr |
| Direction of view | 5° ± 5° or 0° ± 5° | 5° ± 3° |
| Field of view | (86° - 95°) ± 12° | 61° ± 3° |
| Illumination | Minimum: (0.081 - 0.150) mlm/klx | (0.193 - 0.277) mlm/klx |
| Resolution | ≥ 9.5 lp/mm @ best working distance | ≥ 5 lp/mm @ best working distance |
| Distortion | Relative Distortion in air (max value): -40.0% | Relative Distortion in air (max value): -19.8 % |
| Moiré filter | Included | Not included |
| Total number of fibers/pixels | 30000 pixel or 50000 pixel | 30000 pixel |
| Automated cleaning | yes | no |
| Autoclavibility | yes | yes |
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As stated above, the subject and predicate devices have similar design characteristics and show comparable performance. As demonstrated in the nonclinical testing the different technological characteristics do not raise any new questions of safety and effectiveness when compared to the predicate device.
7. Performance Data
The following design verification and validation testing was performed on the subject devices to ensure that the subject devices function as intended and meet design specifications:
- Electrical safety as per ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 and IEC . 60601-2-18 Edition 3.0
- . Thermal safety as per ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18 Edition 3.0
- Mechanical and optical performance testing as per ISO 8600-1 Edition 4, ISO 8600-3 Edition 1 and ISO 8600-4 Edition 2
- . Transport and shipping testing as per ASTM D4169-16
- Tests related to the expected service life as per ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18 Edition 3.0
- . Biocompatibility testing according ISO 10993-1 Ed. 5: 2018
- Reprocessing validation was conducted in accordance with the FDA guidance . document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued March 17, 2015.
- Usability validation was conducted according to IEC 62366-1 Ed. 1.0: 2015 and IEC . 60601-1-6 Ed. 3.1: 2013. Usability Validation of the Instructions for Use as per FDA quidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued March 17, 2015.
- Additional comparative testing: Visible image size, distortion, internal reflections, ● vignetting, transmission of the optical system, transmission of the illumination system, light distribution of illumination, remaining deformation after bending stress, flow rate in first and second instrument channel
Risk analysis was carried out in accordance with established internal acceptance criteria based on ISO 14971:2007.
8. Conclusion
The performance data support the safety of the device and demonstrate that the subject devices comply with the recognized standards as specified and support a substantial equivalence determination.