(30 days)
The Pure Vu System is intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodly fluids and matter, e.g. blood.
It is for use only by trained medical personnel located in hospitals, clinics and doctor offices.
The Pure-Vu System enables colon cleansing during colonoscopy using a standard or slim colonoscope with a length of 1630mm – 1710mm and a slim colonoscope outer diameter range of 11.7mm – 13.3mm and a standard colonoscope outer diameter range of 12.8mm – 13.7mm. The Oversleeve, which fits over the colonoscope and is connected to an external Workstation, generates fluid to break up feces. The fecal matter & fluids are removed through the suction channels of the Oversleeve into an external waste receptacle.
The Pure-Vu System consists of the following main components:
Oversleeve (OS) and Umbilical Section (US) - The disposable Oversleeve is mounted on Standard or Slim commercially available colonoscopes to allow a physician to cleanse the colon and is connected to the external Workstation via a disposable US. Workstation (WS) – The Workstation [WS] is reusable and supplies an irrigation mixture of water/saline and gas, and evacuates fecal material & fluids. The Workstation [WS] includes the following components: A monitoring & Control Unit that controls the delivery of irrigation fluids and gas into the colon, and suction of fluids and feces from the colon. Inlet Module that includes pumps and regulators enabling fluid & gas flow into the cleansing device. Outlet Module that includes pumps to evacuate fecal matter and fluids from the colon. A foot pedal activates the cleansing, suction and purging function, and switch between cleansing modes used by the physician. Loading fixture- The loading fixture is reusable and aids in assembling the Oversleeve onto the colonoscope. Unloading aids - A disposable 60cc lure lock syringe and 3-way stopcock used in unloading the Oversleeve from the colonoscope are provided in the disposable packaging.
The provided document describes the Pure-Vu System, a device intended to facilitate intra-procedural cleaning of a poorly prepared colon during colonoscopy. This submission is a special 510(k) to improve the overall ease of use of the system by reducing the size and weight of the Workstation and making other minor modifications to the Oversleeve and loading fixture. The document asserts that these changes do not raise new issues of safety or effectiveness.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a table of acceptance criteria with specific numerical targets. Instead, it describes various tests performed to demonstrate that the modifications did not negatively impact the device's performance and that it remains substantially equivalent to the predicate device. The performance is reported as meeting "requirements" or demonstrating "efficiency and integrity."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functionality after simulated aging (1 year) | "Pure Vu Disposables functionality meets the requirements following a simulated aging of one year." |
| Sub-system and system functionality as intended | "Simulation (bench test) was conducted and to support the sub system and system's use as intended and its substantial equivalence." (Specific tests like Dimensions, Steering (Angulation), Pressure, Bond Strength were conducted). |
| Packaging efficiency and integrity after environmental conditioning and transport simulation | "Disposable package undergone environmental conditioning and transport simulation (by DDL labs) in order to demonstrate efficiency and integrity of the packaging and their accompanying labels following the simulation." |
| Absence of toxicological risk (Biocompatibility) | "biocompatibility testing was done to determine if there was any toxicological risk to the patient as per ISO 10993-5." (Implied acceptance: no toxicological risk). |
| Workstation functionality after environmental conditions and distribution cycle simulation | "After the preconditioning simulations, the Pure Vu WS undergone verification testing including visual inspection and functionality tests." (Implied acceptance: device remains functional). |
| Software validation for updated embedded software | "The embedded updated software to comply with the WS design modifications was tested via software validation." (Implied acceptance: software functions correctly and complies with design). |
| Safety and EMC compliance | "Safety and EMC tests per IEC 60601." (Implied acceptance: device complies with relevant safety and electromagnetic compatibility standards). |
| Usability and validation for WS and disposable device | "Usability and validation testing for the WS and disposable device has been performed in two separate studies with 3 physicians and 15 nurses." (Implied acceptance: usable and validated by intended users). |
| Loading and unloading validation | "Validation testing for the new sealing plug used during loading and unloading was performed." (Implied acceptance: the new component functions as intended for loading and unloading). Also "Environmental conditions and distribution cycle simulation performed by DDL (USA) as per ASTM D4169-16 along with shipping integrity. After the preconditioning simulations, the Pure Vu WS undergone verification testing including visual inspection and functionality tests." (Implied acceptance: robust against environmental stresses and functional). |
| Overall design changes not impacting performance | "Design verification and validation testing concluded that the design changes have no impact on the Pure-Vu System performance." |
| Substantial Equivalence to Predicate Device | "substantially equivalent" |
2. Sample size used for the test set and the data provenance:
- Sample Size:
- Usability Testing: 3 physicians and 15 nurses for two separate studies for the Workstation and disposable device.
- Other tests (e.g., disposable units, disposable package, workstation environmental, loading/unloading) do not specify a "sample size" in terms of clinical cases or patients. These are primarily engineering verification and validation tests performed on manufactured units.
- Data Provenance: The document does not specify the country of origin for the participants in the usability studies or whether these studies were retrospective or prospective. Bench testing was performed by various laboratories (Carmel Environmental Laboratory, DDL labs, Hermon Laboratory, DDL (USA)).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the usability studies, the "experts" were the users themselves: 3 physicians and 15 nurses. Their qualifications are not further detailed beyond their professional roles.
- For other engineering tests, the acceptance criteria are likely against established engineering specifications and regulations (e.g., ISO, ASTM, IEC standards), so no explicit "ground truth experts" in the medical sense are mentioned for these tests.
4. Adjudication method for the test set:
The document does not describe any formal adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth, particularly in a medical diagnostic context. The usability studies would likely involve observation and feedback collection, but not a consensus determination of a medical finding.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is an intra-procedural cleaning system for colonoscopy, not an AI-assisted diagnostic imaging device requiring human reader interpretation studies.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
Not applicable. This is a medical device for physical intervention (cleaning), not a standalone diagnostic algorithm. The device works with a human operator (trained medical personnel).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the usability studies, the "ground truth" would be user feedback and observed performance regarding ease of use and functionality, rather than a medical diagnostic ground truth. For the engineering tests, the ground truth is against established technical specifications, regulatory standards (e.g., ISO 10993 for biocompatibility, IEC 60601 for safety/EMC), and internal functional requirements.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
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). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
June 6, 2019
Motus GI Medical Technologies Ltd. % Randy Prebula Partner Hogan Lovells US LLP 555 Thirteenth Street NW Washington, DC 20004
K191220 Re:
Trade/Device Name: Pure Vu System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDF Dated: May 4, 2019 Received: May 7, 2019
Dear Randy Prebula:
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. You must comply with all the Act's
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shanil P. Haugen, Ph.D. Acting Assistant Division Director DHT3A: Division of Renal. Gastrointestinal, Obesity and Transplant 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) K191220
Device Name Pure Vu System
Indications for Use (Describe)
The Pure Vu System is intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodly fluids and matter, e.g. blood.
It is for use only by trained medical personnel located in hospitals, clinics and doctor offices.
| 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/1 description: The image contains the logo for "PURE-VU by MOTUS GI". The logo features a circular design on the left, composed of multiple blue dots arranged in a spiral pattern. To the right of the circular design, the text "PURE-VU" is displayed in a stylized, sans-serif font, with the letters rendered in a gradient of blue shades. Below "PURE-VU", the text "by MOTUS GI" is written in a smaller, sans-serif font, with the "MOTUS" portion in a darker gray and the "GI" portion in a lighter gray.
510(k) Summary
This special 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
| Applicant Information: | Motus GI Medical Technologies Ltd.22 KerenHa'yesod Str.Tirat Carmel, 3902638IsraelTel.: +972-4-6214446Fax: +972-4-6214442 |
|---|---|
| Contact Person: | Ravit Peled |
| Phone Number: | +972-4-6214447 |
| Fax Number: | +972-4-6214442 |
| EstablishmentRegistration #: | 3011816755 |
| Date Prepared: | May 4th, 2019 |
| Trade Name(s): | Pure Vu System |
| CommonName: | Pure Vu System |
| Classification Name: | Endoscope and accessories |
| Classification: | Regulation No: 876.1500 Class: IIPanel: Gastroenterology and Urology |
| Predicate Device(s): | Pure Vu System (K181437) |
| Intended Use: | The Pure-Vu System is intended to connect to standard colonoscopes tohelp facilitate intra-proceduralcleaning of a poorly prepared colon byirrigating or cleaning the colon and evacuating the irrigation fluid (water),feces and other bodily fluids and matter, e.g. blood.It is for use only by trained medical personnel located in hospitals,clinics, and doctors' offices. |
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Image /page/4/Picture/1 description: The image shows the logo for "PURE-VU by MOTUS GI". The logo features a circular design made up of small blue dots on the left side. To the right of the dots, the words "PURE-VU" are written in a stylized blue font. Below "PURE-VU", the words "by MOTUS GI" are written in a smaller, gray font.
| Reason for Submission: | The purpose of this special 510(k) is to improve the overall ease ofuse of the Pure-Vu system by reduce the size and weight of the WorkStation (WS) for better access in the procedure room and easiermobility. |
|---|---|
| The fundamental scientific technology of the device remainsunchanged. Modifications have been made as listed below: | |
| • Pure-Vu Workstation modifications to improve the usability ofthe system. The key improvements are reducing the size andweight of the WS, simplifying the evacuation algorithm duringcleansing and improve the interface with the disposableOversleeve. The embedded software was updated to complywith the WS design modifications. | |
| • Disposable Oversleeve modifications include extending thelength of the hydrophilic lubricious coating from 60 cm to 80cm on the distal end of the Pure-Vu Oversleeve to enhanceadvancement, Outer and inner sleeves are made of 80Adurometer polyurethane as opposed to combination of 80Aand 70A durometer polyurethane and added an In-Lineconnector to ease management and assembly of theUmbilical tubing. All manufacturing locations and keyprocesses remain the same. | |
| • The loading fixture was modified to reduce its size and weight.The sealing clamp and plug used on the distal end of thedevice was modified to be a one-piece assembly that is nowdisposable to improve ease of loading. No new materials wereintroduced and there were no modifications to the compressorbox (the only electrical assembly part of the fixture) thatgenerates the inflation pressure used to open the sleeve forloading. In addition, the unloading process is performed withthe disposable sealing clamp as opposed to an off the shelfKelly clamp used for unloading in the predicate device. |
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Image /page/5/Picture/1 description: The image shows the logo for "PURE-VU by MOTUS GI". The logo features a circular design on the left, composed of multiple blue dots arranged in a spiral pattern. To the right of the circular design is the text "PURE-VU" in a bold, sans-serif font, with the letters in varying shades of blue. Below "PURE-VU" is the text "by MOTUS GI" in a smaller, lighter font.
| TechnologicalCharacteristics: | The Pure-Vu System enables colon cleansing during colonoscopy using a standard or slim colonoscope with a length of 1630mm – 1710mm and a slim colonoscope outer diameter range of 11.7mm – 13.3mm and a standard colonoscope outer diameter range of 12.8mm – 13.7mm. The Oversleeve, which fits over the colonoscope and is connected to an external Workstation, generates fluid to break up feces. The fecal matter & fluids are removed through the suction channels of the Oversleeve into an external waste receptacle.The Pure-Vu System consists of the following main components:Oversleeve (OS) and Umbilical Section (US) - The disposable Oversleeve is mounted on Standard or Slim commercially available colonoscopes to allow a physician to cleanse the colon and is connected to the external Workstation via a disposable US. Workstation (WS) – The Workstation [WS] is reusable and supplies an irrigation mixture of water/saline and gas, and evacuates fecal material & fluids. The Workstation [WS] includes the following components: A monitoring & Control Unit that controls the delivery of irrigation fluids and gas into the colon, and suction of fluids and feces from the colon. Inlet Module that includes pumps and regulators enabling fluid & gas flow into the cleansing device. Outlet Module that includes pumps to evacuate fecal matter and fluids from the colon. A foot pedal activates the cleansing, suction and purging function, and switch between cleansing modes used by the physician. Loading fixture- The loading fixture is reusable and aids in assembling the Oversleeve onto the colonoscope. Unloading aids - A disposable 60cc lure lock syringe and 3-way stopcock used in unloading the Oversleeve from the colonoscope are provided in the disposable packaging. |
|---|---|
| ----------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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Image /page/6/Picture/1 description: The image shows the logo for "PURE-VU by MOTUS GI". The logo is primarily blue, with a circular pattern of blue dots on the left side. The text "PURE-VU" is in a sans-serif font, with a gradient effect from dark to light blue. "by MOTUS GI" is in a smaller font size and is located below the "PURE-VU" text.
| Performance Data: | Verification and Validation Testing tests were conducted for all modificationsto the Pure Vu System component as follows: |
|---|---|
| 1) Pure- Vu Disposable parts (Oversleeve and Workstation connector) | |
| All disposable units undergone preconditioning simulations tests performed byCarmel Environmental Laboratory (Israel) including but not limited toEnvironmental conditioning and Shelf life simulation to demonstrate that thePure Vu Disposables functionality meets the requirements following asimulated aging of one year. | |
| Simulation (bench test) was conducted and to support the sub system andsystem's use as intended and its substantial equivalence as follows:Dimensions Test Steering (Angulation) System Test Pressure Test Bond Strength Test | |
| Disposable package undergone environmental conditioning and transportsimulation (by DDL labs) in order to demonstrate efficiency and integrity of thepackaging and their accompanying labels following the simulation.In addition, biocompatibility testing was done to determine if there was anytoxicological risk to the patient as per ISO 10993-5. | |
| 2) Pure-Vu Workstation (WS)The Modified WS undergone the following tests:Environmental conditions and distribution cycle simulation performedby Hermon Laboratory (Israel) as per ASTM D4169-16 along withshipping integrity. After the preconditioning simulations, the Pure VuWS undergone verification testing including visual inspection andfunctionality tests. The embedded updated software to comply with the WS designmodifications was tested via software validation. Safety and EMC tests per IEC 60601 Usability and validation testing for the WS and disposable device hasbeen performed in two separate studies with 3 physicians and 15nurses. | |
| 3) Pure-Vu Loading and UnloadingValidation testing for the new sealing plug used during loading andunloading was performed. Environmental conditions and distribution cycle simulation performedby DDL (USA) as per ASTM D4169-16 along with shipping integrity.After the preconditioning simulations, the Pure Vu WS undergoneverification testing including visual inspection and functionality tests. | |
| Design verification and validation testing concluded that the design changeshave no impact on the Pure-Vu System performance. | |
L
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Image /page/7/Picture/1 description: The image shows the logo for "PURE-VU by MOTUS GI". The logo is in blue and gray. To the left of the text is a circular design made up of many small blue circles.
| SubstantialEquivalenceDiscussion: | The Pure Vu System has the same intended use, indications, principles of operationand similar technological characteristics as its predicate device. The differencesbetween the device and its predicate device due to the modifications as detailed inthis submission do not raise any new issues of safety or effectiveness.Performance data demonstrate that the Pure-Vu System is substantially equivalent. |
|---|---|
| Conclusion: | The Pure-Vu System is substantially equivalent to the predicate device.The intended of use of this product meets the requirements of 21 CFR 801.4 |
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Image /page/8/Picture/1 description: The image shows the logo for PURE-VU by MOTUS GI. The logo features a circular design on the left, composed of many small blue circles. To the right of the circular design is the text "PURE-VU" in a blue gradient color. Below the text "PURE-VU" is the text "by MOTUS GI" in a smaller font size.
| Characteristics Comparison: | ||
|---|---|---|
| Modified Device | Predicate Device | |
| Manufacturer | Motus GI Medical Technologies Ltd. | |
| Description | Pure-Vu System | |
| Intended Use | Same | The Pure-Vu System is intended toconnect to standard colonoscopes tohelp facilitate intra-procedural cleaning ofa poorly prepared colon by irrigating orcleaning the colon and evacuating theirrigation fluid (water), feces and otherbodily fluids and matter, e.g. blood. |
| It is for use only by trained medicalpersonnel located in hospitals, clinics | ||
| Environment of Use | Same | Hospitals, clinics and doctors' offices |
| Prescriptive | Same | Yes, only trained medical personnel |
| Disposable | Same | Single patient, single use |
| Distal tip design | Same | Multi irrigation hole Two distal suction holes |
| Principle ofoperation | Same | Distal attachment to an endoscope,sleeve ensuring attachment along entirelength, suction and irrigation tubesrunning along the endoscope, suctionand irrigation head at the distal tip.Enables irrigation and suction at any timeduring the procedure without removingany tools, which may be inserted in theendoscope's working channel. |
| OperationalProcedures | 1) Same2) Same3) Same | 1) Attachment to a standard andSlim colonoscope2) Intra-procedure colon cleansingduring standard colonoscopy3) Evacuation of water and feces |
| SystemComponents | The Pure-Vu System consists of thesame main components as thepredicate device but each one has hadminor modifications. The detailedinformation on the modifications doneplease refer to: Section 9: "DesignControl Activities" | 1) Pure-Vu Workstation2) Pure-Vu Standard and Slimcolonoscope Oversleeves3) Pure-Vu WS Connector4) Pure-Vu Loading Fixture |
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Image /page/9/Picture/0 description: The image shows the logo for "PURE-VU by MOTUS GI". The logo features a circular design on the left, composed of multiple blue dots arranged in a circular pattern. To the right of the circular design, the word "PURE-VU" is written in large, blue, sans-serif font. Below the "PURE-VU" text, the words "by MOTUS GI" are written in a smaller, gray, sans-serif font.
| Oversleeve outerdiameter | Same | 21 mm |
|---|---|---|
| Irrigation &suction system | Same | Irrigation: 4 nozzle x 0.7 mm²Suction: 2 nozzles x 12.5 mm² |
| Disposable length | Same | 167 cm attached to colonoscope |
| Air / Waterpressurespecification(bar) | SameSame | Up to 23 psiSuction specifications: - 0.5 Bar |
| Flow rate(cc / min) | Same | Water - Up to 645 cc/minAir - up to 1350 cc/min |
| DimensionsWorkstation | W250mm \ D476mm (516 with pumphead) \ H-358 mm | W460 \ D480 (520 with pump head) \ H340mm |
| Weight Workstation | 18Kg | 25Kg |
| Electrical Input | Same | 100V-240V50/60 Hz |
| Material | Same | Complies with ISO 10993 |
| Sterilization | Same | Clean, Non-sterile |
| Safety Standards | Same | Complies with:• IEC 60601-1• IEC 60601-1-2 |
§ 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.