(263 days)
The Uro-N Cystoscope is intended for direction of therapeutic agents and solutions into target areas of the bladder and the lower urinary tract via a cystoscope.
The UroViu Uro-N Cystoscope System consists of (1) a hand-held, battery operated portable endoscope contained within a reusable handle and (2) a disposable cannula with an injection needle. The fully assembled Uro-N system has overall length of 522 mm (~21 inches). The disposable cannula working length is 269 mm (~11 inches) and total length is 388 mm (~15 inches). The injection needle is 23 Ga (OD 0.635mm, ID 0.318mm). The combined handle and cannula weigh less than 1 pound. The reusable handle has a connector and locking mechanism for attaching and detaching the cannula. The catheter is sterilized by electron beam and is intended for single use only.
The provided text is a 510(k) summary for the Uro-N Cystoscope, demonstrating its substantial equivalence to predicate devices rather than proving it meets specific acceptance criteria through a standalone study with performance metrics. Therefore, many of the requested sections regarding acceptance criteria, performance, sample sizes, expert ground truth, and comparative effectiveness against human readers are not directly addressed in this document.
However, I can extract information related to the device's testing and safety/effectiveness claims based on comparison to its predicates.
Here's the summary based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table of quantitative acceptance criteria with corresponding device performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices, implying that if it functions similarly and passes specified engineering and biocompatibility tests, it meets the necessary safety and effectiveness profiles.
The performance evaluation is primarily comparative and based on the established safety and effectiveness of the predicate devices.
| Aspect | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Summary) |
|:--------------------------------|:---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | Meets ISO 10993 requirements for medical devices with less than 24 hours of patient tissue contact. Materials must be biocompatible (e.g., stainless steel for the needle). | The Uro-N Cystoscope and cannula are made from materials reviewed and cleared in K171500. The only new material, stainless steel for the needle, passed cytotoxicity testing. |
| Electrical Safety | Compliance with IEC 60601-1 (medical electrical equipment - general requirements for basic safety and essential performance), specifically Class I, Type CF, defibrillation proof. | The device complies with IEC 60601-1, as reviewed and cleared in K171500 (predicate device). |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (medical electrical equipment - electromagnetic disturbances - requirements and tests). | The device complies with IEC 60601-1-2, as reviewed and cleared in K171500 (predicate device). |
| Software Verification and Validation | Software should be verified and validated to ensure proper function and safety. The software level of concern is "Moderate." | No change was made to the software from the predicate device (K171500), which was previously reviewed and cleared. |
| Mechanical Performance | The device should be mechanically sound, withstand simulated use, and maintain structural integrity (e.g., resistance to bending, pulling, torque, and leaks). It should also maintain acceptable temperature at the tip surface, field of view, direction of view, and image quality comparable to the predicate diagnostic cystoscope. | Mechanical testing included: simulated use testing, mechanical testing (bending, pulling, torque, and presence of leaks), temperature at the surface of the tip testing, field of view testing, direction of view testing, and image quality testing. The results of these tests are not provided in detail, but the conclusion states "The information submitted... confirms that the Uro-N Cystoscope raises no new questions of safety and effectiveness and that it is substantially equivalent to the predicate devices." |
| Sterility | Disposable components (cannula, needle) must achieve a Sterility Assurance Level (SAL) of 10^-6. | Disposable cannula and needle are sterile following exposure to ethylene oxide (EO) with an SAL of 10^-6. |
| Cleanability (Reusable Handle) | The reusable handle, not provided sterile, must be cleanable and disinfectable according to company instructions to prevent cross-contamination. | The handle is cleaned and disinfected following company instructions (implies this is met). |
| Duration of Use | Less than 24 hours for patient contact components. | Less than 24 hours. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of collected patient data or images for performance evaluation. The substantial equivalence argument relies on engineering and bench testing, as well as the prior clearance of the predicate devices.
- Sample Size: Not applicable as no clinical or image-based test set was used for de novo performance evaluation against acceptance criteria.
- Data Provenance: Not applicable. The testing was laboratory/bench-based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. As no clinical test set requiring expert interpretation was used for de novo performance evaluation, no experts were involved in establishing ground truth in this context.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was reportedly done. The submission is a 510(k) for substantial equivalence, not a clinical efficacy study involving human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The Uro-N Cystoscope is a medical device, not an AI algorithm. Its performance is evaluated through physical, electrical, and materials testing, and by demonstrating equivalence in function and safety to predicate devices.
7. Type of Ground Truth Used
The "ground truth" for the device's acceptable performance is based on demonstrating compliance with regulatory standards (e.g., ISO, IEC), confirmed biocompatibility, and functional equivalence to legally marketed predicate devices through various engineering and bench tests. There is no biological or diagnostic "ground truth" (like pathology or outcomes data) established for a test set in this summary.
8. Sample Size for the Training Set
Not applicable. The Uro-N Cystoscope is a physical device, not an AI/machine learning model, so there is no training set in the context of data for algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 2, 2019
UroViu Corporation Thomas Lawson, Ph.D. Vice President, Regulatory Affairs 5337 - 14th Place SE Bellevue, WA 98006
Re: K182876 Trade/Device Name: Uro-N Cystoscope Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FAJ, FBK Dated: June 4, 2019 Received: June 5, 2019
Dear Thomas Lawson:
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.
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.
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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 (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 mediation-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,
Glenn B. Bell. Ph.D. Assistant Division 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
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Indications for Use
510(k) Number (if known) K182876
Device Name
Uro-N Cystoscope
Indications for Use (Describe)
The Uro-N Cystoscope is intended for direction of therapeutic agents and solutions into target areas of the bladder and the lower urinary tract via a cystoscope.
| 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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SECTION 5. 510(k) Summary
General Information
| Submitter | UroViu Corporation |
|---|---|
| Address | 5337 – 145th Place SEBellevue, WA 98006 |
| FDA Registration Number | 3007498664 |
| Correspondence Person | Thomas Lawson, PhDVice President, Clinical & Regulatory AffairsUroViu Corp. |
| Contact Information | Email: thom@uroviu.comPhone: 510-206-1794 |
| Date Prepared | 1 July 2019 |
Proposed Device
| Trade Name | Uro-N Cystoscope |
|---|---|
| Common Name | Uro-N cystoscope |
| Regulation Number andClassification Name | 21 CFR§876.1500, Endoscope and Accessories |
| Product Code | FAJ, FBK |
| Regulatory Class | II |
Predicate Device
| Trade Name | Williams Cystoscopic Injection Needle |
|---|---|
| Common Name | Williams injection needle |
| Premarket Notification | K171602 |
| Regulation Number andClassification Name | 21 CFR§876.1500, Endoscope and Accessories |
| Product Code | FBK |
| Regulatory Class | II |
| Note: This predicate device has not been subject to a design-related recall. |
Predicate Device
| Trade Name | Uro-V Cystoscope |
|---|---|
| Common Name | Uro-V cystoscope |
| Premarket Notification | K171500 |
| Regulation Number and | 21 CFR§876.1500, Endoscope and Accessories |
| Classification Name |
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| Product Code | FAJ |
|---|---|
| Regulatory Class | II |
| Note: This predicate device has not been subject to a design-related recall. |
Device Description
The UroViu Uro-N Cystoscope System consists of (1) a hand-held, battery operated portable endoscope contained within a reusable handle and (2) a disposable cannula with an injection needle. The fully assembled Uro-N system has overall length of 522 mm (~21 inches). The disposable cannula working length is 269 mm (~11 inches) and total length is 388 mm (~15 inches). The injection needle is 23 Ga (OD 0.635mm, ID 0.318mm). The combined handle and cannula weigh less than 1 pound. The reusable handle has a connector and locking mechanism for attaching and detaching the cannula. The catheter is sterilized by electron beam and is intended for single use only.
The Uro-N cystoscope's injection needle and cannula are in contact with patient tissue for less than 24 hours and are made of materials that are biocompatible.
This Traditional 510(k) builds on the Uro-V cystoscope cleared in K171500 (predicate device), with the added component of an injection needle, which is equivalent to the intended use of the Williams injection needle (K171602), the other predicate device.
Intended Use
The Uro-N Cystoscope is intended for direction of therapeutic agents and solutions into target areas of the bladder and the lower urinary tract via a cystoscope.
Both the subject device and the predicate device have the same intended use.
Comparison of Technological Characteristics with the Predicate Devices
The Uro-N Cystoscope System builds on the Uro-V cystoscope (K171500), which is a predicate device in this submission. The Williams Cystoscopic Injection Needle (K171602) is another predicate device for the injection needle component of the system that is supplied with the disposable cannula of the Uro-N cystoscope. The Williams Cystoscopic Injection Needle is used for cystoscopic-directed injection of medications and solutions into the urethra, bladder neck, and bladder wall, as is the needle component of the Uro-N cystoscope's disposable cannula.
Both the Uro-N system's injection needle component of the cannula and the Williams Cystoscopic Injection Needle are designed to inject medications and solutions into tissue
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within the lower urinary system. Both devices are introduced into the urinary system through the working channel of a cystoscope that visualizes the target area for the injection and guides the needle into the target tissue. The needles for both devices are pushed into the tissue and then medication and solution are injected using a syringe that is attached to the luer lock hub at the proximal end of the needle.
The imaging component of the Uro-N cystoscope system is the same as that of the predicate device, the Uro-V cystoscope. When the cannula of the system is attached to the handle, it forms a fully functional cystoscope that provides images on a screen that the user can reference as the device is being advanced within the urinary tract. As with the Uro-V cystoscope system, the Uro-N cystoscope system's cannula has a camera at its tip that transmits images to the viewing screen on the device's handle. In this way, the user can navigate the urinary tract with minimal contact or injury to the walls of the urethra and then permit the examination of the bladder and direct injection of therapeutic agents and solutions as needed.
The imaging capability of the cannula of the Uro-N system is the same as that of the predicate device, the Uro-V system, and it is this imaging that permits direction of agents and solutions via the needle component that is housed in the working channel of the Uro-N system. Similarly, the second predicate device, the Williams cystoscopic injection needle, is advanced via the working channel of a cystoscope and using the images generated by the cystoscope, the Williams needle can be directed to the place within the bladder or urinary tract that is to receive the injection.
| Subject Device | Predicate Device | Predicate Device | |
|---|---|---|---|
| Uro-N Cystoscopesystem withinjection cannula(UroViu Corp.)(This Submission) | WilliamsCystoscopicInjectionNeedle(Cook Medical)K171602 | Uro-V Cystoscopewith diagnosticcannula(UroViu Corp.)K171500 | |
| Indication for Use | The Uro-Ncystoscope isindicated forinjection of | The WilliamsCystoscopicInjectionNeedle is | The Uro-Vcystoscope isindicated fordiagnostic |
| indicated forinjection oftherapeutic agentsin the bladder andlower urinary tractfor neurogenicbladder, overactivebladder syndrome,increasedfrequency andurgency ofurination, scarringof the bladderneck, and Hunner'sulcer. | indicated forinjection oftherapeuticagents in thebladder andlower urinarytract. | cystoscopy ofsymptomaticvoidingdysfunction,hematuria, bladdertumor surveillance,recurrent lowerurinary tractinfections, andpelvic painsyndromes. | |
| Intended use | Directed injectionof therapeuticagents andsolutions intotarget areas of thebladder and thelower urinary tractvia a cystoscope | Directedinjection oftherapeuticagents into theurethra, bladderneck, andbladder wall viaa cystoscope | Endoscopicdiagnosis andinfusion ofirrigating fluidwithin the bladderand urethra |
| Route of Advancement | The cannula of thecystoscope isadvanced to thebladder via theurethra, with theinjection needleadvanced to thebladder via aworking channel ofthe cystoscope | The injectionneedle isadvanced to thebladder via theworkingchannel of acystoscope | The cannula of thecystoscope isadvanced to thebladder via theurethra |
| Site of Use | Hospitals andphysician offices | Same | Same |
| Device Features | |||
| Components of theSystem | Reusable handlewith a video screenthat acts as anendoscopeAttachable cannulawith an injection | InjectionNeedlewith a hub | Reusable handlewith a video screenthat acts as anendoscopeAttachable cannulawith a working |
| needle, a workingchannel along its | channel along itslength and an | ||
| length, and anillumination sourceand camera at its tip | illumination sourceand camera at its tip | ||
| Imaging Transmission | Image transmittedfrom a videocamera at the tip ofthe cannula to avideo monitor onthe handle | No imagingcomponent | Image transmittedfrom a videocamera at the tip ofthe cannula to avideo monitor onthe handle |
| Illumination LightSource | LEDs | N/A | LEDs |
| LCD Monitor DisplaySize | 3.5 inches(diagonal) on thehandle | N/A | 3.5 inches(diagonal) on thehandle |
| Field of View | 140 degrees | N/A | 140 degrees |
| Focal Length | 5 to 50 mm | N/A | 5 to 25 mm |
| Direction of View fromCenter Axis | 15 degrees | N/A | 30 degrees |
| Electrical Safety | Class I, Type CF,defibrillation proofIEC 60601-1 | N/A | Class I, Type CF,defibrillation proofIEC 60601-1 |
| Electromagneticcompatibility | IEC 60601-1-2 | N/A | IEC 60601-1-2 |
| Software Level ofConcern | Moderate | N/A | Moderate |
| Sterilization method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Sterility AssuranceLevel | 10-6 | Same | Same |
| Biocompatibility ofMaterials | Meets ISO 10993requirements | Same | Same |
| OperationalCharacteristics | |||
| Length of cannula | 269 mm | N/A | 254 mm |
| Working Channel InnerDiameter | 2.6 mm | N/A | 2.8 mm |
| Needle Gauge | 23 gauge | 23 gauge | N/A |
| Needle Tip Length | 12 mm | 8 mm | N/A |
| Needle Bevel Type | Standard | Standard | N/A |
| Needle Material | Stainless Steel | Stainless Steel | N/A |
| Length of NeedleAssembly | 35 cm | 35 cm | N/A |
| Procedure Site | |||
| Hospitals, clinics, and physician offices | Same | Same | |
| Anatomical Site of Use | Bladder and lower urinary tract | Same | Same |
| Duration of Use | < 24 hours | Same | Same |
| Provided Sterile? | Yes | Yes | Yes |
| Sterilization Method | Disposable cannula and needle are sterile following exposure to ethylene oxide (EO)The handle is not provided sterile. The handle is cleaned and disinfected following company instructions. | Disposable needle is sterile following exposure to ethylene oxide (EO) | Disposable cannula is sterile following exposure to ethylene oxide (EO)The handle is not provided sterile. The handle is cleaned and disinfected following company instructions. |
| Single-use | Yes, for the cannula and the needle | Yes | Yes, for the cannula |
Comparison of the Uro-N Cystoscope System to the two predicate devices, the Williams Cystoscopic Injection Needle, and the Uro-V Cystoscope.
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Traditional 510(k) Notification Uro-N Cystoscope System
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Performance Data
The performance testing conducted establishes that the Uro-N Cystoscope and cannula do not raise new questions of the safety and effectiveness from those noted for the Uro-V Cystoscope cleared under K171500.
Biocompatibility testing
The Uro-N Cystoscope and cannula are manufactured from materials reviewed in K171500. The only new material is a stainless steel needle, which passed cytotoxicity testing.
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Electrical safety and electromagnetic compatibility (EMC)
The predicate and subject devices comply with IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC, which was reviewed and cleared in K171500.
Software Verification and Validation Testing
There was no change to the software for the subject device from the predicate device reviewed and cleared in K171500.
Mechanical Testing
The mechanical testing of the subject device included:
- Simulated use testing; ●
- Mechanical testing (bending, pulling, torque, and presence of leaks); ●
- Temperature at the surface of the tip testing; .
- Field of view testing; ●
- Direction of view testing; and ●
- Image quality testing.
Animal Testing
No animal testing of the subject device was necessary.
Clinical Studies
No clinical testing of the subject device was necessary.
Conclusion
The information submitted in this premarket notification confirms that the Uro-N Cystosope raises no new questions of safety and effectiveness and that it is substantially equivalent to the predicate 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.