(193 days)
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.
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.
The provided document, K203226, is a 510(k) Premarket Notification for rigid endoscopes (Telescopes) manufactured by Richard Wolf Medical Instruments Corporation. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance study results that would typically be associated with AI/ML devices or new diagnostic tests.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts, MRMC studies, AI improvement effect size, training set details) are not applicable (N/A) because this submission pertains to a physical medical device (endoscope) and its manufacturing and performance validation, not a software-driven or AI-based diagnostic tool.
The document describes non-clinical performance testing (bench testing) to demonstrate the safety and effectiveness of the device, primarily by comparing its characteristics and performance to a legally marketed predicate device.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Device Performance for Rigid Endoscopes (K203226)
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of quantifiable acceptance criteria with corresponding performance metrics in a way commonly seen for software or AI/ML device clearances. Instead, the acceptance criteria are implicitly or explicitly stated through the validation of various engineering and functional aspects, and performance is demonstrated by meeting these and showing equivalence to the predicate.
| Category | Acceptance Criteria (Implied/Stated in Document) | Reported Device Performance |
|---|---|---|
| Reprocessing | - Manual cleaning process: Must pass all acceptance criteria. - Automated cleaning process: Must pass all acceptance criteria. - Sterilization (moist heat/steam): Must achieve a Sterility Assurance Level (SAL) of 10⁻⁶ (according to AAMI TIR12, Annex B). | - Manual cleaning process: "passed all acceptance criteria." - Automated cleaning process: "passed all acceptance criteria." - Sterilization: SAL of 10⁻⁶ "was achieved" (sterility ensured). |
| Biocompatibility | - Biological risk assessment performed according to ISO 10993-1:2018 and FDA guidance. - Biological testing and chemical characterization to demonstrate safety (for materials with direct patient contact: optical glass, stainless steel, glue, soft solder, classified as external communicating device with contact to tissue, bone, and dentin for ≤24h). | - Biological testing and chemical characterization "proved that the PANOVIEW Ultra telescopes are as safe as the predicate devices." |
| Performance Testing (Bench) | - Optical performance validation (according to ISO 8600-1/-3/-5 for parameters like spectral range, working lengths, working distance). - Optical performance validation after simulation of aging. - Performance testing addressing differences from predicate: different working length, shaft thickness, new material of light guide bundle, focal length, distortion. - Functionality: ability to visualize inside the body, image transfer via rod lens system, illumination via light guide bundles. - Packaging validation (specifically for 434 mm working length). - Stability testing. - Temperature testing (according to IEC 60601-2-18). - Overall design, basic safety, and essential performance requirements and specifications met. | - Optical performance validated; parameters compared to predicate devices "to prove equivalence." - Optical performance after aging validated. - Confirmed that changed characteristics (e.g., working length) "do not question safety and effectiveness." - Function as described (e.g., "images are transferred via a rod lens system," "illumination is provided via light guide bundles"). - Packaging validated for the 434mm subset. - Stability testing performed. - Temperature testing performed. - "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." |
| Equivalence to Predicate | Functional and safety equivalence to the predicate device (Endoscope 0°/30°/50° Ø 10MM, K993103). | - "the submitted devices are as safe and as effective as the predicate devices." - "submitted devices function as safe as effective as the predicate device" - "deemed to be substantially equivalent to the legally marketed devices." |
2. Sample Size Used for the Test Set and Data Provenance:
* Sample Size: Not explicitly stated as a number of "cases" or "patients" as this is a physical device, not an AI/ML diagnostic. The testing involved various bench tests on the device units themselves. The number of physical units tested for each validation (reprocessing, biocompatibility, optical performance, etc.) is not specified in this summary.
* Data Provenance: Not applicable in the context of patient data (e.g., retrospective/prospective, country of origin). The data comes from internal laboratory/bench testing of the physical medical device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
* N/A. Ground truth, in the sense of expert consensus on medical images or patient outcomes, is not applicable here. The "truth" for this device's performance is established by objective engineering measurements against established standards (e.g., ISO, IEC) and manufacturer specifications in a laboratory setting. No medical experts were described as establishing a "ground truth" for the test set.
4. Adjudication Method for the Test Set:
* N/A. Given that this is bench testing of a physical device against engineering standards, an "adjudication method" involving human experts is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
* N/A. This device is an endoscope, not an AI/ML-assisted diagnostic tool or software. No MRMC study was performed as it is not relevant to the clearance of this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Performance was Done:
* N/A. This applies to algorithms. The device itself is a standalone physical instrument used by a human operator for visualization. Its "standalone performance" refers to its optical and mechanical integrity, which was evaluated through bench testing.
7. The Type of Ground Truth Used:
* The "ground truth" for this device's performance is based on adherence to engineering specifications, international standards (e.g., ISO 8600-1/-3/-5 for optical performance, AAMI TIR12 for sterilization, ISO 10993-1 for biocompatibility, IEC 60601-2-18 for temperature testing), and validation against the characteristics of a predicate device. There is no "expert consensus," "pathology," or "outcomes data" ground truth in the traditional sense for this type of device clearance.
8. The Sample Size for the Training Set:
* N/A. This document describes a physical medical device, not a software or AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
* N/A. As there is no training set mentioned or implied for this physical device, the concept of establishing ground truth for it is not applicable.
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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.
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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 | TypeNumber | Productclassificationname | Product Code | ReviewPanel | RegulationNumber andName | DeviceClass |
|---|---|---|---|---|---|---|---|---|
| Telescopes | PANOVIEW Ultra telescopes | TELESCOPE 0° Ø10MM WL 305MM | 8934461 | 876.1500Endoscopeandaccessories | II | |||
| TELESCOPE 30° Ø10MM WL 305MM | 8934462 | Laparoscope,General &Plastic Surgery | GCJ | General &PlasticSurgery | ||||
| TELESCOPE 50° Ø10MM WL 305MM | 8934463 | Endoscope,Rigid | GCM | Gastroen-terology /Urology | ||||
| TELESCOPE 0° Ø10MM WL 440MM | 89344416 | |||||||
| TELESCOPE 30° Ø10MM WL 440MM | 89344426 | Laparoscope,Gynecologic(AndAccessories) | HET | Obstetrics/Gynecology | 884.1720Gynecologiclaparoscopeandaccessories | |||
| TELESCOPE 50° Ø10MM 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 patientcontact 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 requiredto clean, disinfect, and sterilize the device before everyapplication 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/steamsterilization. |
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.
§ 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.