(48 days)
The Scope Antifogging System is intended use for this device is to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the endoscope and laparoscope lens.
The Scope Antifogging System is a single use, sterile device that is designed to apply an antifogging solution (surfactant) and warm the scope at or above the human body temperature when used prior to and during procedures that utilize an endoscope or laparoscope. The Scope Antifogging System provides antifogging of the lens of the endoscope and laparoscope when inserted into the Scope Antifogging System for use in a laparoscopic procedure. The Scope Antifogging System is controlled by an on switch to activate the circuit containing battery power source to indicate the activation of the antifogging solution warming circuit. The activation of the warming circuit life expectancy is 5 hours. The antifogging solution is retained in the device and warmed when the device is activated in the "on" position. Subsequently, the endoscope/laparoscope is inserted into the device port for application of the warmed antifogging solution. The device's single scope insertion port of the endoscope/laparoscope accepts scopes up to 12mm in diameter. The antifogging solution is included in with the Scope Antifogging System as fluid contained in two separate bottles. The solution is dispensed into the single port opening of the housing of the Scope Antifogging System prior to use. Included with the Scope Antifogging System in the same packaging is a pair of sponge-tipped, trocar wipes. Also included with the Scope Antifogging System in the same packaging is a single-use, microfiber cloth.
This document describes the Xodus Medical Scope Antifogging System and its substantial equivalence to a predicate device, the Covidien Clearify Visualization System. The information provided focuses on performance testing to demonstrate this equivalence.
Here's an analysis of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating equivalence to the predicate device and meeting specific performance metrics for antifogging and other functions.
| Acceptance Criteria (Implied) | Reported Device Performance (Xodus Medical Scope Antifogging System) |
|---|---|
| Antifogging Effectiveness | Bench Testing: Demonstrated effectiveness in preventing fogging on simulated equipment (laparoscope and glass mirror plate) consistently, comparable to the predicate device, when subjected to a high humidity source. Animal Testing: Demonstrated effectiveness in preventing fogging of laparoscopes consistently in a live, anesthetized pig model, comparable to the predicate device, through a series of exploratory procedures with different Storz laparoscope types. |
| Warming Circuit Duration | Bench Testing: Activation period determined to be a minimum of five (5) hours. Thermal characteristics were observed during this period. |
| Trocar Wiping Effectiveness | Bench Testing: Successfully wiped away blood and tissue (general smudging) from the scope interior of the trocar in three test cases, leaving no visible debris, comparable to the predicate device's trocar wipes. |
| Scope Lens Wiping of Debris | Animal Testing: Successfully wiped away bile, blood, and tissue from the scope lens on all occasions using the microfiber cloth and the foam pad on the Antifogging System. |
| Biocompatibility | Successfully conducted to ISO 10993-1 standard. Product category determined as "External Communicating Device" with "Tissue/Bone/Dentin" contact for "A-limited, ≤24hr". Met requirements for Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, and Pyrogenicity. |
| Sterilization | Sterilized by gamma radiation based on ISO 11137-2 standard, validated to ensure 10^-6 Sterility Assurance Level (SAL) or better. Follows same processes as other FDA 510(k) cleared sterile products from Xodus Medical. |
| Electrical Safety / EMC | Successfully conducted, complying with IEC 60601-1-2 for EMC and shall be tested to IEC 60601-1 for electrical safety. |
2. Sample Size Used for the Test Set and Data Provenance
- Antifogging Validation (Bench): Not explicitly stated, but implies multiple applications and comparisons.
- Life Expectancy Validation: Not explicitly stated; "The Scope Antifogging System was activated and observed" implies at least one device, likely more for statistical relevance.
- Trocar Wiping Validation: "three test cases" were conducted.
- Antifogging Validation (Animal): "several instances" and "series of exploratory procedures with four different Storz laparoscope types" were used in "a live, anesthetized pig."
- Scope Lens Wiping of Debris (Animal): "all occasions" when matter was applied and wiped.
- Biocompatibility, Sterilization, Electrical Safety/EMC: Standardized tests typically use specific sample sizes dictated by the standards themselves.
Data Provenance: The studies were conducted internally ("Performance Testing - Bench" and "Performance Testing - Animal") by Xodus Medical, Inc. The data is prospective, generated specifically for this 510(k) submission. No information on country of origin of data beyond "Xodus Medical, Inc."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document does not specify the number or qualifications of experts used to establish the ground truth for any of the performance tests. The conclusions for antifogging efficacy ("demonstrated the effectiveness... consistently, as with the predicate device") and wiping effectiveness ("successfully wiped away... no visible signs of any debris") appear to be based on direct observation during the tests.
4. Adjudication Method
Not applicable/not specified. The performance testing described suggests direct observation and comparison to the predicate device's performance, rather than an adjudication process involving multiple human reviewers to establish a consensus ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an antifogging system, not an AI-powered diagnostic or assistive tool for human readers/clinicians, therefore, no MRMC study or AI-related effect size data is presented.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. As this device is a physical system for preventing fogging, the concept of a "standalone algorithm" is not relevant. The performance tests ("Bench" and "Animal") are essentially standalone evaluations of the device's physical function.
7. The Type of Ground Truth Used
- Antifogging: Direct observation of the presence or absence of fogging on the simulated equipment or laparoscope lens. The "ground truth" for effectiveness was the visual clear state of the lens, and the comparison was against the identical function of the predicate device.
- Warming Circuit Duration: Measurement of the duration the circuit remained activated and thermal characteristics were maintained.
- Wiping Effectiveness: Direct visual observation of the absence of debris (blood, tissue, bile, smudging) after wiping.
- Biocompatibility, Sterilization, Electrical Safety/EMC: Ground truth is established by adherence to and successful completion of specified international standards (ISO 10993-1, ISO 11137-2, IEC 60601-1-2, IEC 60601-1).
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, so there is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an algorithm, this question is not applicable.
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September 19, 2018
Xodus Medical, Inc. Mr. Paul Lloyd Vice President, Global QA/RA & Technology 702 Prominence Drive New Kensington, Pennsylvania 15068
Re: K182080
Trade/Device Name: Scope Antifogging System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ, OCT Dated: July 27, 2018 Received: August 2, 2018
Dear Mr. Lloyd:
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 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
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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,
David Krause -S
- for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182080
Device Name Scope Antifogging System
Indications for Use (Describe)
The Scope Antifogging System is intended use for this device is to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the endoscope and laparoscope lens.
| 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/0 description: The image is a company logo for Xodus Medical. The logo has a symbol on the left that is made up of two overlapping shapes, one in black and one in blue. To the right of the symbol is the company name, "XODUS MEDICAL", in bold black letters. Below the company name is the tagline "Making Surgery Safer" in blue letters.
SECTION 5 - 510(k) Summarv
- 510(k) Owner: Xodus Medical, Inc. Westmoreland Business & Research Park 702 Prominence Drive New Kensington, PA 15068 Phone: 724-337-5500 Fax: 724-337-1131 Contact: Paul Lloyd (Vice President, Global QA/RA & Technology)
Establishment Registration Number: 2530138
Date Prepared: July 27, 2018
1. Device Information:
Trade/Device Name: Scope Antifogging System Common Name: Endoscope Antifogging Device Classification Name: Endoscope and/or Accessories Regulation Number: 21 CFR 876.1500 Product Code: GCJ; OCT Regulatory Class: II
2. Legally Marketed Devices to which Xodus Medical claims Substantial Equivalence:
Device Name: Clearify Visualization System Common Name: Endoscope Antifogging Device 510(k) Number: K062779 510(k) Owner: Covidien LLC Classification Name: Endoscope and/or Accessories Regulation Number: 21 CFR 876.1500 Product Code: GCJ; OCT Regulatory Class: II
*The Covidien predicate device is formerly known as New Wave Surgical's DHELP, FDA 510k K062779, acquired by Medtronic/Covidien and marketed as Clearify Visualization System under a name change only.
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Image /page/4/Picture/0 description: The image is a logo for Xodus Medical. The logo features a stylized "X" formed by two overlapping shapes, one in black and the other in blue. To the right of the symbol is the text "XODUS MEDICAL" in bold, black letters, with the tagline "Making Surgery Safer" in a smaller, lighter blue font underneath.
3. Device Description
The Scope Antifogging System is a single use, sterile device that is designed to apply an antifogging solution (surfactant) and warm the scope at or above the human body temperature when used prior to and during procedures that utilize an endoscope or laparoscope.
The Scope Antifogging System provides antifogging of the lens of the endoscope and laparoscope when inserted into the Scope Antifogging System for use in a laparoscopic procedure. Fogging occurs when the ambient temperature of the lens of the endoscope/laparoscope is cooler than the temperature of the human body and condensation forms on the lens. This is especially important in a surgical procedure where a surgeon must have a clear view of the operative site to safely perform surgery.
The Scope Antifogging System is controlled by an on switch to activate the circuit containing battery power source to indicate the activation of the antifogging solution warming circuit. The activation of the warming circuit life expectancy is 5 hours.
The antifogging solution is retained in the device and warmed when the device is activated in the "on" position. Subsequently, the endoscope/laparoscope is inserted into the device port for application of the warmed antifogging solution. The device's single scope insertion port of the endoscope/laparoscope accepts scopes up to 12mm in diameter.
The antifogging solution is included in with the Scope Antifogging System as fluid contained in two separate bottles. The solution is dispensed into the single port opening of the housing of the Scope Antifogging System prior to use.
Included with the Scope Antifogging System in the same packaging is a pair of sponge-tipped, trocar wipes. The trocar wipes are a single-use, radiopaque accessory used to wipe debris from the inside of the trocar during the surgical procedure. The trocar wipe sponge tip diameters are 7mm and 12mm.
Also included with the Scope Antifogging System in the same packaging is a single-use, microfiber cloth. The microfiber cloth is an accessory used as a method to wipe the endoscope/laparoscope lens of any debris buildup.
This product is sold sterile to healthcare professionals only.
The Scope Antifogging System has not been previously submitted for 510(k) clearance. However, the Xodus Medical Scope Antifogging System component, Antifog solution. is also a separately sold product, and is currently marketed by Xodus Medical with FDA clearance under 510k number K063587.
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Image /page/5/Picture/0 description: The image is a logo for Xodus Medical. The logo consists of a stylized "X" made up of two overlapping parallelograms, one in black and one in blue. To the right of the "X" is the text "XODUS MEDICAL" in bold, black letters. Below that, in a smaller blue font, is the tagline "Making Surgery Safer™".
4. Intended Use:
The Xodus Medical Scope Antifogging System intended use is identified to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.
5. Indications for Use:
The Scope Antifogging System is a single use, sterile device to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.
6. Description of Safety and Substantial Equivalence
The Xodus Medical Scope Antifogging System has the same intended use as the predicate device, Covidien Clearify Visualization System, which is, "Use prior to and during endoscopic and laparoscopic procedures to prevent the fogging of the scope lens". The Xodus Medical Scope Antifogging System and Covidien Clearify Visualization System are based on the same technological elements shown in the table below.
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Image /page/6/Picture/0 description: The image shows the logo for Xodus Medical. The logo consists of a blue and black abstract symbol on the left, followed by the text "XODUS MEDICAL" in black, bold letters. Below the company name, the tagline "Making Surgery Safer" is written in a smaller, blue font with a trademark symbol.
Comparison Table to Predicate Device
| Name of Device | Xodus Medical Inc.'s Scope | Covidien's Clearify |
|---|---|---|
| Antifogging System | Visualization System | |
| Intended Use | Scope Antifogging Systemintended to be used prior to andduring endoscopic andlaparoscopic procedures to preventthe fogging of the scope lens. | Clearify Visualization Systemintended to be used prior to andduring endoscopic andlaparoscopic procedures toprevent the fogging of the scopelens. |
| Usage | Hospitals and/or surgery centerson or by the order of a physician | Hospitals and/or surgery centerson or by the order of a physician |
| Materials | Antifogging Solution: Water,Isopropanol, Ethanol, Surfactant.Material difference in housingusing polycarbonate plastic. | FDA approved ShurClens, awound cleaning surfactant;Water, alcohol, and surfactant.Material difference in housingusing polyurethane foam. |
| PhysicalCharacteristics | Antifogging Solution of Clear/colorless, odorless, water solubleliquid.Similar physical footprint-Xoduslower profile; Shape is triangulardesign. | Antifogging Solution of Clear/colorless, odorless, water solubleliquid.Physical footprint with rounded,oval design, higher profile. |
| Sterilization | Gamma radiation | Gamma radiation |
| Design/Packaging | Sterile barrier of polyethyleneplastic and Tyvek | Sterile barrier of polyethyleneplastic and Tyvek |
| Mechanism ofAction | Heating and dipping of distal endof endoscope/laparoscope intosolution | Heating and dipping of distalend of endoscope/laparoscopeinto solution |
| BiocompatibilityStandardsCompliant | Yes, per ISO 10993-1 | Yes |
| Target Population | Physicians, Nurses, Health CareProfessionals, General Surgery | Physicians, Nurses, Health CareProfessionals, General Surgery |
| Power Source | Battery | Battery |
| Single Use | Yes | Yes |
| Sterility | Sterile | Sterile |
| 510(k) Number | TBD | K062779 |
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Image /page/7/Picture/0 description: The image shows the Xodus Medical logo. The logo consists of a stylized "X" formed by two intersecting blue and black shapes. To the right of the "X" is the text "XODUS MEDICAL" in bold, black letters. Below "XODUS MEDICAL" is the tagline "Making Surgery Safer" in a smaller, blue font, with a trademark symbol next to the word "Safer".
7. Performance Data:
7.1 Performance Testing - Bench
The following bench tests were performed for this submission:
7.1.1 Scope Lens Fogging Validation:
Lens fogging validation testing was performed using the Xodus Medical Scope Antifogging System and the predicate device. The testing performed was to verify the effectiveness of the Scope Antifogging System at preventing fogging from occurring on simulated equipment. A laparoscope and a glass mirror plate were used in the testing and subjected to a high humidity source. Using a control, the antifogging solutions of both products were applied to the simulated equipment, the laparoscope and glass mirror plate. The testing conclusions were the Xodus Medical Scope Antifogging System demonstrated the effectiveness of preventing the fogging of the simulated equipment consistently, as with the predicate device.
7.1.2 Life Expectancy Validation
Testing of the duration of activation of the warming circuit was performed. The Scope Antifogging System was activated and observed for duration of the activation period. Thermal characteristics were observed during the activation period and determined the activation to be a minimum for five (5) hours.
7.1.3 Trocar Wiping Validation
Testing of the wiping of the inside of the trocar to clear any debris following application of blood and tissue (general smudging) from beef liver and extracting the scope was conducted.
The blood and tissue were applied to the scope interior of the trocar and successfully wiped away on three test cases using the trocar wipes of the Scope Antifogging System and the Covidien Clearify Visualization system trocar wipes. There were no visible signs of any debris left behind following the wiping of the inside of the trocar.
7.2 Performance Testing -Animal
The following animal tests were performed for this submission:
7.2.1 Scope Lens Fogging Validation
Testing of the Xodus Medical Scope Antifogging System and the predicate device was conducted with a live, anesthetized pig. A Karl Storz endoscopy system was used with a 5mm and 10mm Storz laparoscope. A
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Image /page/8/Picture/0 description: The image shows the Xodus Medical logo. The logo consists of a stylized "X" formed by two intersecting shapes, one in black and one in blue. To the right of the "X" is the text "XODUS MEDICAL" in bold, black letters. Below "XODUS MEDICAL" is the tagline "Making Surgery Safer" in a smaller, blue font, with a trademark symbol next to the word "Safer".
series of exploratory procedures with four different Storz laparoscope types were used. Cleaning and application of antifogging solution to the scopes for determination of fogging prevention was performed in several instances. In all cases, the Scope Antifogging System demonstrated effectiveness of preventing the fogging of the laparoscopes consistently, as with the predicate device.
7.2.2 Scope Lens Wiping of Debris Validation
Testing of the wiping of the scope lens following application of bile, blood, and tissue was conducted. The matter was applied to the scope lens and subsequently successfully wiped away successfully on all occasions using the microfiber cloth and the foam pad on the Scope Antifogging System.
7.3 Biocompatibility
The Scope Antifogging System was successfully conducted to the ISO 10993-1 standard, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a Risk Management System". The biocompatibility tests performed are shown below. These tests were determined to be applicable to the product according to the device classification according to ISO 10993-1 Appendix A. Table A.1.
The product category was determined to be "External Communicating Device": Contact determined to be "Tissue/Bone/Dentin; with Contact Duration "A-limited, ≤24hr"; and Biological Effect determined to be "Cytotoxicity, Sensitization, and Intracutaneous Reactivity". Additional biocompatibility tests included were include in the biocompatibility testing, the Acute Systemic Toxicity, and Pyrogenicity.
7.4 Sterilization
The Scope Antifogging System shall be sterilized by gamma radiation based on the ISO 11137-2 standard; "Sterilization of Health Care Products - Part 2: Establishing the Sterilization Dose". The process shall be validated to ensure 10-6 sterility assurance or better is achieved.
The sterilization shall follow the same processes as currently marketed Xodus Medical FDA 510(k) cleared sterile products to include Antifog Solution 510(k) K063587, ES Pencils and Electrodes 510(k) K081647; Cautery Tip Cleaner 510(k) K053433, and Light Guard Light Handle 510(k) K053321.
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Image /page/9/Picture/0 description: The image shows the logo for Xodus Medical. The logo consists of a stylized "X" formed by two overlapping blue shapes on the left. To the right of the "X" is the text "XODUS MEDICAL" in black, with the tagline "Making Surgery Safer" in blue below it. The logo is clean and modern, with a focus on the company's name and mission.
7.5 Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC compatibility testing was successfully conducted on the Scope Antifogging System. The system complies with the IEC 60601-1-2 standard for EMC.
The Scope Antifogging system shall be electrical safety tested to the standard IEC 60601-1.
8. Conclusion:
The design, characteristics, and performance of the Scope Antifogging System substantiate that the device is working as intended (use prior to and during endoscopic and laparoscopic procedures to prevent the fogging of the scope lens). The Xodus Medical Scope Antifogging System is substantially equivalent to its predicate device, Covidien's Clearify Visualization System.
§ 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.