(193 days)
No reference devices were used in this submission.
No
The summary describes a rigid endoscope with optical components and a light source for visualization. There is no mention of image processing, AI, ML, or any software-based analysis of the visual data. The performance studies focus on physical and optical characteristics, not algorithmic performance.
No.
The device is described as a rigid endoscope used for diagnosis and therapy by visualizing the inside of the body during invasive surgery or via natural orifices. While it may be used during therapy, its primary function described is visualization, not actively performing a therapeutic action.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the product is used "for diagnosis and therapy." Since diagnosis is one of its stated uses, it is a diagnostic device.
No
The device description clearly states it is a rigid endoscope with physical components like a cladding tube, sheath, eyepiece, and light guide bundles, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the products are used for "diagnosis and therapy" by visualizing the inside of the body during invasive surgery or via natural orifices. This is a direct visualization of the internal anatomy for clinical assessment and intervention, not for examining samples taken from the body.
- Device Description: The device description details a rigid endoscope with an optical system for visualization. It describes how images are transferred and illuminated, and how visualization can be direct or indirect via a camera and monitor. This aligns with a device used for direct observation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on the analysis of such samples. The focus is entirely on visualizing the internal environment.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to provide visual access to the inside of the body, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The products are used in invasive surgery or via natural orifices for diagnosis and therapy and serve to visualize the inside of the body.
The products are used for interventions in different medical disciplines, such as surgery and laparoscopic interventions e.g. in urology and gynecology.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, HET, GCM
Device Description
The PANOVIEW Ultra telescopes (common name: telescopes) are rigid endoscopes which are used in invasive surgery or via natural orifices for diagnosis and therapy and serve to visualize the inside of the body.
The products are used for interventions in different medical disciplines, such as surgery and laparoscopic interventions e.g. in urology and gynecology.
The submitted devices can be grouped by working length (WL) and direction of view.
The PANOVIEW Ultra telescopes (common name: telescopes) are rigid endoscopes with a fixed eyepiece, integrated light guide, optical system, cold light connector, with screw-on adapter for fiber light cables and with color coding ring for direction of view.
The telescopes are constructed of a cladding tube, which is surrounded by a rigid sheath, a fixed eyepiece and an eyecup at the proximal end.
Within the cladding tube, images are transferred via a rod lens system to the fixed eyepiece. Illumination is provided via light guide bundles connected to a light source. Visualization can directly be performed via the fixed eyepiece (direct visualization method) or alternatively via a monitor and user interface (indirect visualization method). For the second option, a camera must be attached to the fixed eyepiece and must be connected to a monitor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical (direct and indirect visualization)
Anatomical Site
Inside of the body. Used in invasive surgery or via natural orifices.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional health care facility environment.
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)
Study Type: Non-Clinical Performance Testing
Key Results: The efficacy and safety of the submitted devices is documented by the verification and validation testing. The testing confirms that the products meet all the requirements and specifications for overall design, basic safety and essential performance, and that the design inputs and specifications are met. This includes packaging, stability testing, and temperature testing according to IEC 60601-2-18. In addition, optical performance was evaluated according to ISO 8600-1/-3/-5 for the submitted devices and parameters were compared to those of the predicate devices to prove equivalence. It could be shown that the submitted devices function as safe as effective as the predicate device and therefore can be deemed substantially equivalent.
Study Type: Reprocessing Validation
Key Results: Reprocessing validation includes the manual cleaning process, the automated cleaning process, and the sterilization process. The manual and automated cleaning process passed all acceptance criteria. The validation of the sterilization was performed according to AAMI TIR12, Annex B. The sterility assurance level (SAL) of 10-6 was achieved and therefore the sterility of the submitted devices is ensured. The results proved that the submitted devices are as safe as the predicate device and thus can be deemed substantially equivalent to the predicate device.
Study Type: Biocompatibility
Key Results: Biological testing and chemical characterization proved that the PANOVIEW Ultra telescopes are as safe as the predicate devices and thus can be deemed substantially equivalent to the predicate device.
Study Type: Performance testing bench
Key Results: Validation of the optical performance. Validation of optical performance after simulation of aging.
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 logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo 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.
May 14, 2021
Richard Wolf Medical Instruments Corporation Michael Loiterman US Head of Regulatory - OA/OC 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re: K203226
Trade/Device Name: Telescope 0 0 10mm WL 305mm / Telescope 30 O 10mm WL 305mm / Telescope 50 O 10mm WL 305mm. Telescope 0 O 10mm WL 440mm / Telescope 30 O 10mm WL 440mm / Telescope 50 O 10mm WL 440mm Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ, HET, GCM Dated: April 14, 2021 Received: April 15, 2021
Dear Michael Loiterman:
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/cdrl/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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K203226
Device Name
Rigid endoscopes TELESCOPE 0° Ø 10MM WL 305MM, TELESCOPE 30° Ø 10MM WL 305MM, TELESCOPE 50° Ø 10MM WL 305MM, TELESCOPE 0° Ø 10MM WL 440MM, TELESCOPE 30° Ø 10MM WL 440MM, TELESCOPE 50° Ø 10MM WL 440MM
Indications for Use (Describe)
The products are used in invasive surgery or via natural orifices for diagnosis and therapy and serve to visualize the inside of the body.
The products are used for interventions in different medical disciplines, such as surgery and laparoscopic interventions e.g. in urology and gynecology.
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/3 description: The image shows the logo for Richard Wolf. The words "RICHARD" and "WOLF" are stacked on top of each other, with "RICHARD" in black and "WOLF" in red. To the right of the text is a square with a cartoon dog and a nail being hammered into the ground.
510(k) Summary 5
Submitter l
Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, IL 60061
Phone:(847) 913 1113 Fax: (847) 913 0924
Contact Person, Title: Michael Loiterman, US Head of Regulatory - QA/QC Date Prepared: October 27, 2020
Legal Manufacturer
Richard Wolf GmbH Pforzheimer Straße 32 75438 Knittlingen
ll Device
The following Table 5-1 lists all devices for which clearance is requested:
| Table 5-1: Devices for which clearance is requested including classification requlations, review panel, and device class | |||||
|---|---|---|---|---|---|
| Common name | Brand name | Trade name | Type
Number | Product
classification
name | Product Code | Review
Panel | Regulation
Number and
Name | Device
Class |
|-------------|---------------------------|----------------------------------|----------------|-----------------------------------------------------|--------------|------------------------------------|--------------------------------------------------------------|-----------------|
| Telescopes | PANOVIEW Ultra telescopes | TELESCOPE 0° Ø
10MM WL 305MM | 8934461 | | | | 876.1500
Endoscope
and
accessories | II |
| | | TELESCOPE 30° Ø
10MM WL 305MM | 8934462 | Laparoscope,
General &
Plastic Surgery | GCJ | General &
Plastic
Surgery | | |
| | | TELESCOPE 50° Ø
10MM WL 305MM | 8934463 | Endoscope,
Rigid | GCM | Gastroen-
terology /
Urology | | |
| | | TELESCOPE 0° Ø
10MM WL 440MM | 89344416 | | | | | |
| | | TELESCOPE 30° Ø
10MM WL 440MM | 89344426 | Laparoscope,
Gynecologic
(And
Accessories) | HET | Obstetrics/
Gynecology | 884.1720
Gynecologic
laparoscope
and
accessories | |
| | | TELESCOPE 50° Ø
10MM WL 440MM | 89344436 | | | | | |
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Image /page/4/Picture/3 description: The image is a logo for "Richard Wolf". The words "Richard" and "Wolf" are stacked on top of each other, with "Richard" in black and "Wolf" in red. To the right of the text is a square with rounded corners, inside of which is a drawing of a dog's head with a nail being hammered into it.
��� Predicate Device
Name of Predicate Devices:
| Type number | Trade name |
|---|---|
| 8934.431 | Endoscope 0° Ø 10MM |
| 8934.432 | Endoscope 30° Ø 10MM |
| 8934.433 | Endoscope 50° Ø 10MM |
510(k) Number: K993103
Regulatory Class: II
Product Code: GCJ, GCM, (KOG)
Manufacturer: Richard Wolf GmbH
The predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
5.1 Subject Device Description
5.1.1 Device Identification
| Type number | Trade name |
|---|---|
| 8934461 | TELESCOPE 0° Ø 10MM WL 305MM |
| 8934462 | TELESCOPE 30° Ø 10MM WL 305MM |
| 8934463 | TELESCOPE 50° Ø 10MM WL 305MM |
| 89344416 | TELESCOPE 0° Ø 10MM WL 440MM |
| 89344426 | TELESCOPE 30° Ø 10MM WL 440MM |
| 89344436 | TELESCOPE 50° Ø 10MM WL 440MM |
The PANOVIEW Ultra telescopes (common name: telescopes) are rigid endoscopes which are used in invasive surgery or via natural orifices for diagnosis and therapy and serve to visualize the inside of the body.
The products are used for interventions in different medical disciplines, such as surgery and laparoscopic interventions e.g. in urology and gynecology.
The submitted devices can be grouped by working length (WL) and direction of view.
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Image /page/5/Picture/3 description: The image shows the logo for Richard Wolf. The words "RICHARD" and "WOLF" are stacked on top of each other. To the right of the words is a logo of a dog with a nail being hammered into the ground.
Subject device characteristics 5.1.2
The following Table 5-2 describes the principal factors regarding the design and use of the telescopes.
Table 5-2: Subject device characteristics and their description.
| Characteristics regarding | Description |
|---|---|
| Software | The submitted devices do not contain software. |
| Materials with patient contact | The submitted devices include components with direct patient |
| contact and no patient contact. | |
| Coatings | Coating of the lenses to increase the spectral range. |
| Single use / reusable | The submitted device are reusable devices. Users are required |
| to clean, disinfect, and sterilize the device before every | |
| application and before returning devices for repair. | |
| Delivered sterile / unsterile | The submitted devices are delivered unsterile. |
| Sterilization method | The submitted devices are sterilized via moist heat/steam |
| sterilization. |
DEVICE FUNCTIONALITY
The PANOVIEW Ultra telescopes (common name: telescopes) are rigid endoscopes with a fixed eyepiece, integrated light guide, optical system, cold light connector, with screw-on adapter for fiber light cables and with color coding ring for direction of view.
The telescopes are constructed of a cladding tube, which is surrounded by a rigid sheath, a fixed eyepiece and an eyecup at the proximal end (see Figure 5-1).
Image /page/5/Figure/11 description: The image shows a diagram of a medical instrument, specifically an endoscope. The endoscope has a long, cylindrical shape with a fixed eyepiece and eyecup at one end. The diagram also labels a cladding tube surrounded by a rigid sheath, indicating the construction of the instrument's insertion tube.
Figure 5-1: The telescopes are made of a cladding tube surrounded by a rigid sheath and a fixed eyecup.
Within the cladding tube, images are transferred via a rod lens system to the fixed eyepiece. Illumination is provided via light guide bundles connected to a light source. Visualization can directly be performed via the fixed eyepiece (direct visualization method) or alternatively via a monitor and user interface (indirect visualization method). For the second option, a camera must be attached to the fixed eyepiece and must be connected to a monitor.
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05 510(k) Summary
Image /page/6/Picture/3 description: The image is a logo for "Richard Wolf". The words "Richard Wolf" are stacked on top of each other, with "Richard" in black and "Wolf" in red. To the right of the text is a square with rounded corners, inside of which is a cartoon drawing of a wolf with a nail being hammered into its head.
5.1.3 Environment of Use
The telescopes are intended to be used in professional health care facility environment.
5.1.4 Materials of Use
The telescopes consist of optical glass and stainless steel which are in direct body contact. Moreover, the telescopes include glue and soft solder. The telescopes can be classified according to ISO 10993-1 as external communicating device with contact to tissue, bone and dentin for a limited duration (≤24h).
5.1.5 Key Performance Characteristics
The telescopes provide several directions of view (0°, 30°, 50°), a spectral range from 380 -900 nm, two working lengths of 308 mm and 434 mm, and a working distance of 50 mm.
5.2 Indications for Use
5.2.1 Statement
The products are used in invasive surgery or via natural orifices for diagnosis and therapy and serve to visualize the inside of the body.
The products are used for interventions in different medical disciplines, such as surgery and laparoscopic interventions e.g. in urology and gynecology.
5.2.2 Explanation on differences to predicate device
In comparison to the predicate device, the subject device does not have the ENT indication. However, the full indication of use for the subject device is covered by the predicate device and reducing the scope does not lead to new questions regarding safety and effectiveness.
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Image /page/7/Picture/3 description: The image contains the logo for "RICHARD WOLF". The word "RICHARD" is in black, block letters above the word "WOLF", which is in larger, red, block letters. To the right of the text is a square with rounded corners containing a drawing of a wolf's head with a nail going through its mouth.
5.3 Comparison of Technological Characteristics with the Predicate Device
The submitted devices basically share the technological characteristics of the predicate device. However, there are some improved characteristics and some differences due to technical progress when comparing the submitted devices with their predicate. Additionally, the submitted devices are available in two groups of working lengths, of which one is longer than that of the predicate device. The technical characteristics that differ between the predicate and the submitted devices are shaft thickness, the connection of the eyepiece, illumination fiber properties, whole system (image quality) properties, and the material of the window mount and the light guide bundle. To prove that those changed characteristics together with the increase in working length do not question safety and effectiveness of the submitted devices, several performance tests were performed, such as:
- Validation of the reprocessing process (Section 14 = Sterilization and Shelf life) ●
- Biocompatibility testing due to new materials (Section 15 Biocompatibility) .
- . Performance testing due to the different working length, shaft thickness, new material of the light guide bundle, focal length, and distortion characteristics (Section 18 - Performance testing bench)
- Packaging validation of the subset with the working length 434 mm (Section 18 -● Performance testing bench)
The main difference between the submitted devices and the predicate is the increased spectral range of the telescopes due to a VIS-NIR coating on the lenses. This increase in spectral range from 650 to 900 nm was proven by the following procedures:
- Validation of the optical performance (Section 18 Performance testing bench) o
- Validation of optical performance after simulation of aging (Section 18 -● Performance testing bench)
Combining the test results and the shared characteristics it can be concluded that the submitted devices are as safe and as effective as the predicate devices.
5.4 Reprocessing
Reprocessing validation includes the manual cleaning process, the automated cleaning process, and the sterilization process.
The manual and automated cleaning process passed all acceptance criteria.
The validation of the sterilization was performed according to AAMI TIR12, Annex B. The sterility assurance level (SAL) of 10° was achieved and therefore the sterility of the submitted devices is ensured.
The results proved that the submitted devices are as safe as the predicate device and thus can be deemed substantially equivalent to the predicate device.
5.5 Biocompatibility
The telescopes include components with direct patient contact. Therefore, a biological risk assessment was performed considering the following standards:
- . ISO 10993-1:2018: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
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Image /page/8/Picture/3 description: The image shows the logo for Richard Wolf. The words "RICHARD WOLF" are stacked on top of each other, with "RICHARD" in black and "WOLF" in red. To the right of the text is a logo of a dog with a nail being hammered into its head.
- Use of International Standard ISO 10993, . "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", Guidance for Industry and Food and Drug Administration Staff, issued June 16, 2016
Biological testing and chemical characterization proved that the PANOVIEW Ultra telescopes are as safe as the predicate devices and thus can be deemed substantially equivalent to the predicate device.
5.6 Clinical Performance Testing
No clinical performance testing was performed.
Non-Clinical Performance Testing 5.7
The efficacy and safety of the submitted devices is documented by the verification and validation testing. The testing confirms that the products meet all the requirements and specifications for overall design, basic safety and essential performance, and that the design inputs and specifications are met.
This includes packaging, stability testing, and temperature testing according to IEC 60601-2-18. In addition, optical performance was evaluated according to ISO 8600-1/-3/-5 for the submitted devices and parameters were compared to those of the predicate devices to prove equivalence.
It could be shown that the submitted devices function as safe as effective as the predicate device and therefore can be deemed substantially equivalent.
5.8 Conclusions
The PANOVIEW Ultra telescopes have equivalent indications for use as the predicate device. The nonclinical tests demonstrate that the devices are as safe, as effective, and perform as well as the legally marketed devices.
Therefore, the submitted telescopes have been deemed to be substantially equivalent to the legally marketed devices.