The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas via suction channel under continuous flow conditions following resection using a bipolar resecting device.

Device Description

The Veloxion System consists of the following components:

Veloxion Controller (with Integrated Fluid Control and video)
- Footswitch
Veloxion Resectoscope
Veloxion Fluid Control Set
Veloxion Roll Stand

The Veloxion System also includes the following Class I accessories for handling of waste collected from the patient (these items only handle waste after it is already outside the patient), which includes:

Waste Management Tubing: To provide a conduit for transfer of aspirated fluids and tissue from the patient and from under the patient's buttocks drape
Tissue Catch: For collection of gross resected tissue pieces for pathology.

The Veloxion System provides bipolar resection and coagulation of prostate adenomas, it distends the cavity by filling with saline and it provides pressure control of the cavity to facilitate viewing with the integrated Resectoscope.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Veloxion System, a medical device used for prostate adenoma resection. The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria based on a clinical study of its diagnostic or therapeutic efficacy.

Therefore, many of the requested details regarding acceptance criteria for device performance (e.g., sensitivity, specificity, or effect size of human reader improvement with AI) and a study proving the device meets these criteria are not present in this regulatory submission document. This document is instead a technical comparison and non-clinical testing summary to assert device safety and effectiveness.

However, I can extract information related to the technical specifications and performance testing conducted to demonstrate substantial equivalence, which serves as the "acceptance criteria" for this type of regulatory submission.

Here's the closest interpretation of your request based on the provided text:

Acceptance Criteria and Device Performance (Based on Technical Specifications and Non-Clinical Testing for Substantial Equivalence)

Acceptance Criteria (Technical/Functional)	Reported Device Performance and Comparison to Predicate
Indications for Use	The device has the Same indications for use as the predicate: "The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas via suction channel under continuous flow conditions following resection using a bipolar resecting device."
Energy Type (Bipolar RF)	Same as predicate.
Optics (Integrated, Sterile, 10-degree Endoscope)	Same as predicate.
Ability to set cavity pressure on device	Same as predicate (Yes).
Continuous Flow	Same as predicate (Yes).
Irrigation Fluid	Same as predicate (Saline).
Pump Type	Same as predicate (Dual Pump for Irrigation/Aspiration).
Ability to monitor saline remaining	Same as predicate (Yes).
Programmed Flow Rate (Steady State, Coag, Aspirate)	Same as predicate: Steady State = 50ml/min, Coag = 50ml/min, ASPIRATE = 400ml/min.
Programmed Flow Rate (Cut Mode)	Difference: Subject device: 200ml/min; Predicate: 380ml/min. Justification: "Flow rate for CUT mode was reduced to shorten initial plasma ignition while not affecting the ability to evacuate tissue chip."
Passive Flow Rate (User adjustable via Roller Clamp)	Same as predicate. Nominal flow rate (clamp fully open): 360ml/min (at 20mmHg), 500ml/min (at 60mmHg).
Set Pressure Range	Same as predicate (20 to 60mmHg).
Positive action to increase pressure above 40 mmHg	Same as predicate (Yes).
Pressure Sensor (Dual, independent, direct sensing)	Same as predicate.
Over-pressure condition detection	Same as predicate (Yes).
Maximum allowable actual cavity pressure	Same as predicate (75mmHg).
Ultimate mitigation for risk of over-pressurization of cavity	Same as predicate: Non-defeatable, continuous notification tone and message: "Remove device from cavity. Check for Clog."
Max. Shaft OD (Sheath)	Same as predicate: 25Fr (8.3mm).
Working Length (Sheath)	Same as predicate: 220mm.
Materials (Electrode/Insulation)	Same as predicate: Electrode: Tungsten (99.95% purity), Insulation: FEP.
How Supplied (Sterility)	Same as predicate: Sterile, Single Use (Veloxion Resectoscope).
Software Verification and Validation	Performed per IEC 62304 and FDA guidance.
Functional Testing (Cut, Coag, Aspiration, Irrigation, Pressure Control)	Performed per approved test protocols. Conclusion: "Functional Testing for all components of the system" was performed. "Simulated Use: Tissue resection and spot coagulation of cavity pressure, imaging" was performed. Comparative testing to predicate for electrode durability, pressure control and fluid control was performed and supports substantial equivalence.
Integrity (System withstands operating pressures)	Performed per approved test protocols.
Dimensional Inspection and Testing	Performed per approved test protocols.
Maximum LED Tip Temperature	Performed per approved test protocols.
Comparative Visualization Testing (Simulated Model)	Performed per approved test protocols.
Durability Testing (Electrode)	Performed per approved test protocols for tissue resection and coagulation. Comparative testing to predicate for electrode durability.
Thermal Effects Evaluation	Performed.
Biocompatibility	Performed in accordance with ISO 10993-1.
Sterility	Performed in accordance with ISO 11135:2014, ISO 11137-1:2006, ISO 11137-2:2013.
Packaging	Performed in accordance with ASTM D4169:14 and ISO 11607-1:2006.
Shelf-life	Performed in accordance with ASTM F1980:2007.
Electrical Safety & EMC	Performed in accordance with IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-2-18:2009 and IEC 60601-2-2:2009.
Usability Testing	Use related risk evaluation performed.

Study Proving the Device Meets the Acceptance Criteria:

The document describes non-clinical testing rather than a traditional clinical study with patient outcomes or reader performance data. The "study" here refers to a battery of engineering and bench tests designed to demonstrate that the small changes in the new Veloxion System (subject device) do not alter its safety or effectiveness compared to the previously cleared Veloxion System (predicate device).

Here's a breakdown of details relevant to your questions, adapted to the context of this 510(k) submission:

Sample sizes used for the test set and the data provenance:
- The document does not specify sample sizes for individual non-clinical tests (e.g., number of units tested for durability, or number of simulated uses). This information is typically detailed in the full test reports, not summarized in the 510(k) summary letter.
- Data Provenance: The data is generated from non-clinical performance testing conducted by the manufacturer, Corinth MedTech, Inc. The location of the testing is not specified, but it would typically be conducted at the manufacturer's facilities or a qualified testing lab. The nature is retrospective in the sense that these tests were completed before the 510(k) submission, and reported as final results. There is no mention of data from human subjects or real-world clinical use.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) submission. The "ground truth" for this device's regulatory pathway is established through engineering specifications, validated test methods, and comparison to a predicate device's known performance. There were no human readers or expert consensus required to establish a "ground truth" for diagnostic or analytical performance, as this is not a diagnostic AI device. The tests, like functional testing, biocompatibility, electrical safety, etc., have well-defined pass/fail criteria based on standards and engineering principles.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic imaging or AI devices, where human expert disagreement needs a resolution mechanism for ground truth. In non-clinical performance testing, the results are typically quantitative measurements against predefined specifications, or qualitative observations per a test protocol, which do not usually require a human "adjudication" process like a clinical reading study.
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:
- This is not applicable. The Veloxion System is an electrosurgical device for tissue resection, not an AI-assisted diagnostic tool. No MRMC study or AI assistance evaluation was conducted or is relevant for this type of device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable. This device is a surgical instrument system, not an AI algorithm. Its function relies on mechanical, electrical, and fluidic principles controlled by the user, not a standalone AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this device, the "ground truth" for meeting regulatory requirements is primarily based on:
  - Engineering specifications and standards: e.g., electrical safety standards (IEC 60601 series), biocompatibility standards (ISO 10993), sterility standards (ISO 11135), etc.
  - Defined functional performance criteria: for aspects like flow rates, pressure control, temperature limits, tissue cutting/coagulation performance (demonstrated in simulated use), and durability.
  - Comparison to Predicate Device: The ultimate "ground truth" for a 510(k) relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device in terms of safety and effectiveness, based on similar technological characteristics and comparable performance. Any differences (like the cut mode flow rate) must be shown not to raise new questions of safety or effectiveness, which was addressed via performance testing.
The sample size for the training set:
- This is not applicable. There is no "training set" in the context of this device, as it is not an AI/machine learning product.
How the ground truth for the training set was established:
- This is not applicable for the same reason as above. There is no training set mentioned in this context.

Summary

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February 24, 2023

Corinth MedTech, Inc. George Hsu Vice President, R&D 1190 Saratoga Ave. Ste 210 San Jose, CA 95129

K230205 Re: Trade/Device Name: Veloxion System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FJL,KQT,GEI Dated: January 24, 2023 Received: January 25, 2023

Dear George Hsu:

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,

Mark J. Antonino -S

Mark J. Antonino, M.S. Assistant 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) K230205

Device Name Veloxion System

Indications for Use (Describe)

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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I. Submitter Information

Submitter name:	Corinth MedTech, Inc.1190 Saratoga Ave. Suite 210San Jose, CA 95129
Contact person:	George HsuVice President of R&DPhone: 408-703-0722 Fax: 408-703-2411
Date Prepared:	January 24, 2023

II. Product Classification

Device Name:	Veloxion System
Common Name:	Resectoscope
Regulation:	21 CFR 876.1500
Regulation Name:	Endoscope and accessories
Class:	II
Product Code:	FJL
Additional Product Codes:	KQT, GEI

III. Predicate Devices

The predicate device is the system comprised of the following legally marketed devices as used in combination to which substantial equivalence is claimed: Primary Predicate: Veloxion System (cleared per K190099)

Predicate has not been a subject of a design related recall.

IV. Device Description

The Veloxion System consists of the following components:

· Veloxion Controller (with Integrated Fluid Control and video)
- o Footswitch
Veloxion Resectoscope
Veloxion Fluid Control Set
· Veloxion Roll Stand

Waste Management Tubing: To provide a conduit for transfer of aspirated fluids and tissue from the patient and from under the patient's buttocks drape
· Tissue Catch: For collection of gross resected tissue pieces for pathology.

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The Veloxion Controller provides bipolar radiofrequency outputs (for cut and coagulation) and fluid/pressure control through the use of two integrated peristaltic pumps, provides the user interface to establish the desired set pressure, monitors intracavitary pressure using dual independent pressure sensors mechanically connected to the Veloxion Fluid Control Set irrigation lumen. The software then monitors, controls and notifies the user when the limits are reached or when specific conditions are met. Furthermore, the controller provides control of the camera, light, display image to a commercially available monitor, stores image and video selected by the user from a session, and provides a USB connection for a USB Stick download of stored media by the user.
The Veloxion Resectoscope is a sterile single use hand held bipolar radiofrequency device configured to provide camera and light for visualization of the anatomy for the resection of tissue and aspiration of resected chips. Fluid inflow and aspiration of the resected chips are controlled by the Controller's peristaltic pumps.
The Veloxion Fluid Control Set is a sterile single use device that provides conduits for fluid inflow, aspiration of resected tissue and fluids and a diaphragm (pressure membrane) that provides mechanism for the Controller to measure cavity pressure (through the irrigation lumen) during the procedure thereby facilitating the insufflation function.
The Veloxion Roll Stand enables monitoring of saline remaining in the saline bag.

V. Indications for Use

There is no difference in the indications for use for the subject device when compared to the predicate device.

Comparison of Indications for Use
Device	Indications For Use
Modified VeloxionSystem(Subject Device)	The Veloxion System is intended for use by trained urologists forendoscopically controlled tissue chip resection and coagulation, andremoval of prostate adenomas via suction channel under continuous flowconditions following resection using a bipolar resecting device.
Veloxion SystemK190099(Predicate Device)	The Veloxion System is intended for use by trained urologistsendoscopically controlled tissue chip resection and coagulation andremoval of prostate adenomas via suction channel under continuous flowconditions following resection using a bipolar resecting device.

Comparison of Indications for Use

VI. Comparison of Technological Characteristics with the Predicate Device

The subject Veloxion System and the previously cleared Veloxion System (K190099) have the same or similar technological characteristics in terms of basic operating principle and basic design features with one key difference being that the predicate Veloxion System has a separate Controller and Video Control Unit, whereas the subject system combines the video functions into the Controller.

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Specification	Special 510K submission	Predicate Device (K190099)	Comparison
Indications foruse	The Veloxion System is intendedfor use by trained urologists forendoscopically controlled tissuechip resection and coagulation,and removal of prostateadenomas via suction channelunder continuous flowconditions following resectionusing a bipolar resecting device.	The Veloxion System is intendedfor use by trained urologists forendoscopically controlled tissuechip resection and coagulation,and removal of prostateadenomas via suction channelunder continuous flowconditions following resectionusing a bipolar resecting device.	Same
Monopolar orBipolar	Bipolar	Bipolar	Same
Energy Type	Radiofrequency, bipolar	Radiofrequency, bipolar	Same
Optics	Integrated, Sterile, 10degreeEndoscope	Integrated, Sterile, 10degreeEndoscope	Same
Able to setcavity pressureon device	Yes	Yes	Same
Continuousflow?	Yes	Yes	Same
Irrigation Fluid	Saline	Saline	Same
Pump	Dual Pump (Irrigation,Aspiration)	Dual Pump (Irrigation,Aspiration)	Same
Able to monitorsaline remaining	Yes	Yes	Same
ProgrammedFlow rate	Programmed flow rate constantfor each mode:Steady State = 50ml/min,Cut = 200ml/minCoag = 50ml/minASPIRATE = 400ml/min	Programmed flow rate constantfor each mode:Steady State = 50ml/min,Cut = 380ml/minCoag = 50ml/minASPIRATE = 400ml/min	Flow rate for CUTmode wasreduced toshorten initialplasma ignitionwhile not affectingthe ability toevacuate tissuechip.
Passive flow	User adjustable flow rate usingRoller Clamp installed duringmanufacturing. The nominalpassive flow rate when Roller	User adjustable flow rate usingRoller Clamp installed duringmanufacturing. The nominalpassive flow rate when Roller	Same
Specification	Special 510K submission	Predicate Device (K190099)	Comparison
	Clamp is fully open is:• 360ml/min (at 20mmHg)• 500ml/min (at 60mmHg)	Clamp is fully open is:• 360ml/min (at 20mmHg)• 500ml/min (at 60mmHg)
Set PressureRange	20 to 60mmHg	20 to 60mmHg	Same
Positive actionto increaseabove 40 mmHg	Yes	Yes	Same
Pressure sensor	Dual, independent, directsensing of cavity pressure	Dual, independent, directsensing of cavity pressure	Same
Over-pressureconditiondetection	Yes	Yes	Same
Maximumallowable actualcavity pressure	75mmHg	75mmHg	Same
Ultimatemitigation forrisk of over-pressurizationof cavity if alldesignedmitigations areunsuccessful	• Non-defeatable, continuousnotification tone• Notification displayed:"Remove device from cavity.Check for Clog."	• Non-defeatable, continuousnotification tone• Notification displayed:"Remove device from cavity.Check for Clog."	Same
Max. Shaft OD(Sheath):	With Sheath Assembled: 25Fr(8.3mm)	With Sheath Assembled: 25Fr(8.3mm)	Same
Working Length	Sheath Working Length: 220mm	Sheath Working Length: 220mm	Same
Materials(Electrode/Insulation)	Electrode: Tungsten (99.95%purity) Insulation: FEP	Electrode: Tungsten (99.95%purity) Insulation: FEP	Same
How Supplied(Sterility):	Sterile, Single Use (VeloxionResectoscope)	Sterile, Single Use (VeloxionResectoscope)	Same

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Corinth MedTech, Inc.

The main technological differences between the subject Veloxion System and the predicate Veloxion System are the following:

The subject Veloxion System includes a sterile, single-use Resectoscope whose camera and LED are in a single tube assembly while the predicate Veloxion System uses a sterile, singleuse Resectoscope whose camera and LED are in separate tube assemblies.
. The subject Veloxion System includes a Controller that provides the RF generator, pressure/flow control, user interface to control, monitor, and provide notification with integrated resectoscope video streaming and light control while the predicate Veloxion System includes a Controller that provides the RF generator, pressure/flow control, user interface to control, monitor, and provide notification and a separate Video Control Unit that provides resectoscope video streaming and resectoscope light control.
. The subject Veloxion System includes programmed electrode oscillation rate and flow rate slightly different from the predicate Veloxion System as a result to facilitate initial plasma ignition on the electrode without impact on the tissue evacuation capability. The differences outlined were evaluated through performance testing to demonstrate safety and effectiveness of the subject Veloxion System.

VII. Non-Clinical Testing Data

The following performance data have been provided in support of the substantial equivalence determination.

Software Verification and Validation Testing performed per IEC 62304 and documentation . provided per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Other Tests were performed per approved test protocols which included:
- Integrity: System withstands operating pressures O
- O Functional Testing: Cut and coagulation, aspiration, irrigation, pressure control
- O Dimensional Inspection and Testing
- Functional Testing for all components of the system O
- O Maximum LED Tip Temperature
- Comparative visualization testing in a simulated model O
- O Simulated Use: Tissue resection and spot coagulation of cavity pressure, imaging
- Durability Testing: Electrode durability testing for tissue resection and coagulation. O
- O Comparative testing to predicate for electrode durability, pressure control and fluid control.
- Thermal effects evaluation. O
- Biocompatibility Testing: In accordance with ISO 10993-1 O
- Sterility: In accordance with ISO 11135:2014, ISO 11137-1:2006, ISO 11137-2:2013 O
- Packaging: In accordance with ASTM D4169:14 and ISO 11607-1:2006. O
- Shelf-life: In accordance with ASTM F1980:2007. O
- O Electrical Safety & EMC: In accordance with IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-2-18:2009 and IEC 60601-2-2:2009.
- Usability Testing: Use related risk evaluation O

In order to prove substantial equivalence, testing performed on the Veloxion System was either identical to the testing protocols used for the predicate device (except for part number and

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Corinth MedTech, Inc.

documentation number), or were a subset of the testing performed only on the changes to the device but based on the predicate's testing protocols.

VIII. Conclusions

Based on the results of performance tests, the subject Veloxion System is considered to be substantially equivalent and as safe and effective as the predicate Veloxion System (K190099).

Regulation Number and Section

§ 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.