The Ultravision™ Visual Field Clearing System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery.

Device Description

The Ultravision™ Visual Field Clearing System is a device that precipitates surgical smoke generated during laparoscopic procedures to clear the visual field. The device components are summarized briefly in Table 1, below.

AI/ML Overview

Acceptance Criteria and Device Performance for ULTRAVISION™ Visual Field Clearing System

The ULTRAVISION™ Visual Field Clearing System is indicated for the clearance of smoke and other particulate matter created during laparoscopic surgery. The acceptance criteria address various aspects of the device's safety, performance, and usability.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device as a "surgical smoke precipitator," the acceptance criteria were primarily qualitative and focused on safety, usability, and the ability to maintain a clear visual field.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study Supporting Performance
Biocompatibility	Absence of cytotoxic responses from patient-contacting components.	Grade 1 (mild reactivity) in cytotoxicity, Scores of 0 for sensitization, Pass for intracutaneous reactivity and acute systemic toxicity. Endotoxin levels within limits.	Biocompatibility Testing (Table 2 in source)
Chemical Safety	No measurable chemical modifications or newly generated chemical species in treated surgical smoke.	No measurable chemical modifications to surgical smoke observed.Risk assessment concluded no new patient risk beyond standard of care.	Chemical Characterization of Treated Smoke/Risk Assessment
Sterility & Shelf Life	Sterility of patient-contacting components (Ionwand™, catheter, trocar).	Sterility assurance level of 1x10^-6 achieved (ethylene oxide sterilization).	Shelf Life/Sterility section
Sterility & Shelf Life	Ethylene oxide and ethylene chlorohydrin residuals below limits.	Residuals below limits for limited exposure devices.	Shelf Life/Sterility section
Sterility & Shelf Life	Packaging integrity and device functionality maintained over identified shelf life.	Packaging and functional testing support a three-year shelf life.	Shelf Life/Sterility section
Electrical Safety	Compliance with IEC 60601-1 General requirements and specific tests.	All applicable requirements for AAMI/ANSI ES60601-1 passed. All IEC 60601-1 tests passed.	Electromagnetic Compatibility and Electrical Safety - IEC 60601-1 section
Electrical Safety	Compatibility with third-party active electrodes.	All IEC 60601-2-2 tests passed.	Electromagnetic Compatibility and Electrical Safety - IEC 60601-2-2 section
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2 for electromagnetic disturbances.	All tests passed for both generator unit and battery charging station. No modifications made to achieve compliance.	Electromagnetic Compatibility and Electrical Safety - IEC 60601-1-2 section
Software Performance	Software functions according to specification for audible alerts and fault lights.	Software functioned according to specification for alarms under fault and normal conditions. Hazards properly mitigated.	SOFTWARE section
Animal Study - Functionality & Usability	Functionality of Ionwand™ trocar/introducer assembly.	Demonstrated functionality without usability concerns.	Performance Testing - Animal
Animal Study - Visual Field Clearance	Ability to maintain a smoke-free laparoscopic surgical field.	Demonstrated ability to maintain a smoke-free field.	Performance Testing - Animal
Animal Study - Safety	Absence of clinical chemistry or histology concerns (e.g., tissue damage).	No identified clinical chemistry or histology concerns. Device demonstrated to be non-damaging.	Performance Testing - Animal
Clinical Study - Primary Endpoint: Visual Field	Maintenance of a clear visual field during surgery.	Treatment group had a higher mean proportion of procedures with effective visibility than the control group.	Summary of Clinical Information - Primary Endpoint
Clinical Study - Secondary Endpoint: Safety	No adverse events attributable to the device.	No adverse events attributable to the device. No detectable difference in CO or MetHb levels.	Summary of Clinical Information - Secondary Endpoints
Clinical Study - Secondary Endpoint: Procedure Interruptions	Reduction in interruptions due to visual field impairment.	Treatment group had 8 procedures with no interruptions; control group had no cases without interruptions.	Summary of Clinical Information - Secondary Endpoints
Clinical Study - Secondary Endpoint: Camera Cleaning	Reduction in frequency of camera cleaning.	85% of active Ultravision™ procedures required no camera cleaning vs. 35% in control group.	Summary of Clinical Information - Secondary Endpoints

2. Sample Size Used for the Test Set and Data Provenance

Test Set (Clinical Study): 30 patients were enrolled. Follow-up data was available for 25/30 enrolled patients.
Data Provenance: The clinical study was a randomized, double-blinded, controlled, prospective trial conducted at a "single site." The location of this single site (e.g., country of origin) is not explicitly stated in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: The text refers to "The surgeons and reviewing panel" rating the treatment group's visibility. The specific number of surgeons or members of the reviewing panel is not provided.
Qualifications of Experts: The qualifications of the "surgeons" are implied by their role in performing and assessing laparoscopic cholecystectomy. The qualifications of the "reviewing panel" are not specified beyond their role in judging visual field effectiveness.

4. Adjudication Method

The text indicates that "The surgeons and reviewing panel rated the treatment group to have a higher mean proportion of procedures with effective visibility than the control group." This suggests some form of consensus or independent rating was used, but a specific adjudication method (e.g., 2+1, 3+1) is not explicitly detailed. The blinding of the surgeon to the device's activation status suggests an effort to reduce bias in assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A formal MRMC comparative effectiveness study, as typically described in imaging, was not conducted. However, a controlled clinical trial was performed where surgeons served as "readers" of the visual field.

Effect size of human readers with AI vs. without AI assistance: The device is not an AI-assisted diagnostic tool but a physical device that clears the visual field. Therefore, the "effect size" isn't about human reader improvement with AI, but rather the improvement in the surgical environment (visual field clarity) provided by the device.
- Visual Field Clarity: The treatment group (with device active) had a "higher mean proportion of procedures with effective visibility" compared to the control group (device deactivated).
- Procedure Interruptions: In the treatment group, 8 procedures had no interruptions, while in the control group, no cases were completed without interruptions due to visual field impairment.
- Camera Cleaning: 85% of procedures with the active device required no camera cleaning, compared to only 35% in the control group.

These results indicate a substantial positive impact of the device on the surgeon's ability to maintain a clear visual field and proceed without interruptions.

6. Standalone Performance Study

Yes, a standalone performance (algorithm only without human-in-the-loop performance) was implicitly done for several aspects, though not for visual field assessment.

Biocompatibility Testing (Table 2): These are laboratory tests evaluating material properties directly, independent of human interaction.
Chemical Characterization: This study assessed the effect of the device on surgical smoke chemistry, independent of human observers.
Sterilization and Shelf Life Validation: These studies verify the effectiveness of the sterilization process and integrity of the packaging over time, independent of human application.
Electrical Safety and EMC Testing: These are objective engineering tests demonstrating compliance with safety standards, not requiring human interpretation of the device's primary function.
Software Verification and Validation: These analyze the software's functionality independently.
Animal Simulated-Use Testing: While involving an animal subject, the assessment of functionality, visual field clearance, and non-damaging effects were objectively observed and recorded, serving as a standalone performance validation in a controlled environment prior to human clinical use.

7. Type of Ground Truth Used

Clinical Study: The primary endpoint, "maintenance of a clear visual field," was established by the subjective assessment and consensus of the surgeons performing the procedures and a "reviewing panel." Secondary endpoints like adverse events and physiological measurements (CO, MetHb) were objective data (lab results) but visual field was assessed by human observation.
Animal Study: The "acceptance criteria for the study were qualitative verification of performance and usability, through observed clearance of the visual field and an absence of observed clinical chemistry or histology concerns." This indicates a combination of expert observation/assessment (for visual field and usability) and objective laboratory results (clinical chemistry and histology).
Other Studies (Biocompatibility, Chemical Characterization, Electrical Safety, etc.): These rely on objective test results against established standards and scientific methodologies (e.g., ISO standards, spectrographic analysis, electrical measurements).

8. Sample Size for the Training Set

The provided document describes a medical device, not an AI/ML algorithm that requires a "training set" in the conventional sense for model development. Therefore, there is no explicit training set sample size mentioned for an AI/ML model for this device. The clinical trial and animal studies serve as validation, not training.

9. How the Ground Truth for the Training Set Was Established

As stated above, this device is not an AI/ML algorithm that uses a "training set." Therefore, this question is not applicable in the context of the provided information.

Summary

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DE NOVO CLASSIFICATION REQUEST FOR ULTRAVISION™ VISUAL FIELD CLEARING SYSTEM

REGULATORY INFORMATION

FDA identifies this generic type of device as:

Surgical smoke precipitator: A surgical smoke precipitator is a prescription device intended for clearance of the visual field by precipitation of surgical smoke and other aerosolized particulate matter created during laparoscopic surgery.

NEW REGULATION NUMBER: 21 CFR 878.5050

CLASSIFICATION: CLASS II

PRODUCT CODE: PQM

BACKGROUND

DEVICE NAME: ULTRAVISION™ VISUAL FIELD CLEARING SYSTEM

SUBMISSION NUMBER: DEN150022

DATE OF DE NOVO: May 26, 2015

CONTACT: Alesi Surgical Suite 18, Cardiff Medicentre Health Park, Cardiff CF14 4UJ United Kingdom

INDICATIONS FOR USE

The Ultravision™ Visual Field Clearing System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery.

LIMITATIONS

The sale, distribution, and use of the device are restricted to prescription use in accordance with 21 CFR §801.109.

The Ultravision™ Visual Field Clearing System is not intended for non-laparoscopic surgeries. The provided nonclinical and clinical studies did not address open surgeries of any kind.

The Ultravision™ Visual Field Clearing System should only be used by appropriately trained medical personnel.

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PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.

DEVICE DESCRIPTION

Model #	Component Description	Purpose
DAD-001-010	Standalone, battery-operated generator	Generation of energy source
DAD-001-024	Battery recharging station	Recharging of the reusable battery
DAD-001-003	IonwandTM Sterile Pack consisting of Stainless steel active cable; the IonwandTM, Catheter and Trocar	IonwandTM: Delivery of the energy from the generator to the abdominal cavity.Catheter: Holds IonwandTM in place during surgeryTrocar: Introduction of the catheter into the abdominal cavity
DAD-001-006(Solid)DAD-001-007(Split)	Patient return adaptor	Provides common return path with electrosurgical generator

Table 1 - Device Components

The standalone battery-operated generator unit is used to generate the energy source that is responsible for the electrostatic precipitation of smoke particles.

The Ionwand™ (Figure 1) is an active cable that terminates in filaments of medical grade stainless steel. The Ionwand™ is introduced into the abdomen of the patient and provides the source of the electrons that create the negative ions that transiently charge the surgical smoke particles. The Ionwand™ is held in place during the surgical procedure using a catheter. The catheter is introduced into the abdominal cavity using a laparoscopic trocar (Figure 2). The Ionwand™ and the preassembled catheter and trocar are supplied sterile together in one singleuse disposable package (Figure 3). The catheter, trocar and Ionwand™ constitute the only tissue contacting components of the device.

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Image /page/2/Picture/0 description: The image shows a medical probe with a 3mm diameter and 11.9cm length needle. The probe has a 250 cm cable attached to it. The needle is silver in color and has a blue connector at the base. The cable is gray and coiled.

Figure 1 - Ultravision™ Visual Field Clearing System Component: Ionwand™

Image /page/2/Picture/2 description: The image shows a medical instrument with a blue handle and a dark gray shaft. The instrument is accompanied by a clear plastic sheath. Text on the image indicates the instrument's dimensions: a diameter of 3.1mm and a length of 9.8cm.

Figure 2 - Ultravision™ Visual Field Clearing System Components: Catheter and Trocar.

Image /page/2/Picture/4 description: The image shows a medical device in its packaging. The device consists of a clear tube with a blue connector at one end, a black cable, and a black rectangular component. The device is sealed in a clear plastic tray, indicating it is sterile and ready for use.

Figure 3 - Packaged Sterile Ultravision™ Visual Field Clearing System Components: Ionwand™, Catheter and Trocar.

Reusable patient return adaptor ("PRA"). The Ultravision™ Visual Field Clearing System has been designed to operate with both instruments that require a patient return electrode (i.e., monopolar instruments) and those that do not (i.e., bipolar and ultrasonic instruments). To function, the Ultravision™ Visual Field Clearing System requires the use of a patient return electrode (not supplied). The PRA is only required when using a monopolar instrument. The PRA connects the Ultravision™ generator to the electrosurgical unit with which it is used, allowing both generators to share a common patient return pad. There are two variants of the

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PRA; one to receive a "solid" patient return electrode connector and a second that receives a "split" patient return electrode connector.

BIOCOMPATIBILITY/MATERIALS

Biocompatibility testing was conducted on the Ultravision™ Visual Field Clearing System's patient-contacting components, as described in Table 3, below.

Test	Purpose	Method	Result
In vitroCytotoxicity	Determine if the Ionwand™, catheter, and trocar elicit cytotoxic responses	ISO 10993-5:2009 Biological Evaluation of Medical Devices:Tests for Cytotoxicity: in Vitrob(4) CCI	Negative control b(4): 0Positive control b(4): 4Test article: Grade 1 (mild reactivity). PASS
Sensitization	Evaluate the potential for delayed dermal contact sensitization of the Ionwand™, catheter, and trocar	ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10 (2010): Tests for Irritation and Skin Sensitization:Maximization test.	Scores of 0 for all negative control and test samples. (PASS)
IntracutaneousReactivity	Determine whether extracts from the Ionwand™, catheter, and trocar will be irritating to the dermal tissue of the rabbit	ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10 (2010): Tests for Irritation and Skin Sensitization:Maximization test.	Pass
Acute SystemicToxicity	Evaluate acute systemic toxicity of the test article extract following a single intravenous or intraperitoneal injection in mouse	ISO 10993 standard- Part 11 (2006): Tests for Systemic Toxicity	Pass:No mortality during the study in mice injected with the test article extracts.All animals appeared clinically normal at the beginning and throughout the study
Endotoxin Levels	Detect and quantify bacterial endotoxin in the Ionwand™, catheter and trocar	ANSI/AAMI ST72:2011:Bacterial endotoxin -Test methods, routine monitoring and alternatives to batch testing	b(4) EU/devicePASS

Table 2 - Biocompatibility Testing

CHEMICAL CHARACTERIZATION OF TREATED SMOKE/RISK ASSESSMENT:

The purpose of this study was to assess potential chemical modifications and new chemical species resulting from Ultravision™ Visual Field Clearing System treatment of surgical smoke with the intention to identify and quantify any newly generated chemical species or confirm a lack of observable modifications to surgical smoke. Surgical smoke was generated in a simulated pneumoperitoneum using monopolar and ultrasonic tools. Surgical smoke was characterized using b(4) CCI Mass Spectrometry, b(4) CCI Mass Spectrometry, b(4) CCI X-ray and b(4) b(4) CCI Spectroscopy. No measureable chemical modifications to surgical smoke were observed following treatment of surgical smoke.

A risk assessment was conducted to address the effects of the use of the Ultravision TM Visual Field Clearing System on surgical smoke. As the chemical characterization did not result in identified chemical changes, the risk assessment addressed the precipitation of surgical smoke against the amount of surgical smoke that would be retained in the surgical

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site with the current practices of dilution and purging of surgical smoke. The risk assessment addresses acute irritancy and tolerance; system acute toxicity, local chronic tolerances; distributed chronic toxicity; and distributed and local carcinogenicity and mutagenicity. The risk assessment concludes that the additional amount of surgical smoke (1-40%) that is likely to remain in the patient does not introduce any new risk to the patient beyond the current standard of care.

The provided chemical characterization and risk assessment support the conclusion that the use of the Ultravision™ Visual Field Clearing System does not create new safetv concerns in the precipitation of surgical smoke.

SHELF LIFE/STERILITY

The sterilization process for the Ultravision™ Ionwand™ sterile package, which includes the Ionwand™, Catheter, and Trocar, has been validated in accordance with the requirements of the standard ISO 11135-1:2007, "Sterilization of health care products --Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices." Theb(4) CCI method was used, and the sterility assurance level was 1×10-6.

The ethylene oxide and ethylene chlorohydrin residuals remaining on the device after sterilization and 7 days of aeration are below the limits described in the ANSI AAMI ISO 10993-7:2008(R)2012 for a limited exposure device.

The sterile components of the Ultravision™ Visual Field Clearing System (the Ionwand™, catheter and trocar) are packaged in custom designed b(4) blister travs with lids under ISO b(4) CCI conditions. b(4) CCI b(4)

The Ultravision™ Generator (x1), Battery (x2),

Recharging Station (x1), Patient Return Adaptor (SOLID, x1) and Patient Return Adaptor (SPLIT. x1) are provided non-sterile in a shipper.

Shelf Life: The applicant provided accelerated aging test reports for a three year sterile packaging claim and supporting real time test reports conducted over one vear. Package inspections and product performance evaluations were conducted both at baseline and after aging and simulated shipping conditions.

The shelf life testing consisted of the following packaging and functional testing.

Packaging testing:

Visual inspection of the package for obvious damage, deterioration, or defects
Package seal strength Dye Penetration Testing .

Functional product testing:

. Visual inspection of the product for obvious degradation or damage
Plug secure connection test .

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The packaging and functional product testing is sufficient to support the three-year shelf life.

ELECTROMAGNETIC COMPATIBILITY AND ELECTRICAL SAFETY

The submission contained test reports for:

IEC 60601-1:2005 + C:109 + A2:10, Medical electrical equipment Part 1: . General requirements for basic safety and essential performance
. IEC 60601-1-2:2007: Medical Electrical Equipment - Part 2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and Tests

The report utilized a Risk Management process in accordance with: ISO 14971: -Application of risk management to medical devices, to determine the appropriate and applicable test clauses.

IEC 60601-1:

The sponsor addressed the differences in the tests performed versus the US requirements: the subject device passed all applicable requirements for AAMI/ANSI ES60601-1.

The following tests were completed on the device as a system:
- Power Input (IEC 60601-1 §4.11) о
- Humidity and Preconditioning (§5.7) O
- Determination of accessible parts (§7.1.2) o
- Markings: o
  - = Legibility (§7.1.2)
  - Durability (§7.1.3)
- Voltage limitation (§8.4.4) O
- o Means of Protection (§8.5.1)
  - Means of Patient protection (§8.5.1.2) ■
  - l Means of Operator protection (§8.5.1.3)
  - I Separation of Patient Connections (§8.5.2)
  - I Working voltage measurement (§8.5.4)
  - Defibrillation proof applied parts (§8.5.5)
  - Energy reduction test (§8.5.5.2)
- Leakage Current test (§8.7) o
- Dielectric Voltage withstand (§8.8.3) O
- Ball pressure (§8.8.4.1) O
- Thermal cycling test for spaces filled by insulating compound (§8.9.3) o
- Stability and Transportability (§9.4.2) O
- Acoustic Energy Measurement (§9.6.2.1) O
- Temperature test (§11) O
- Overflow, Spillage, Leakage, Cleaning, Sterilization and Disinfection, о Harmful Ingress of Liquids (§11.6)
- Abnormal Operation and Single Fault Conditions (§13) o
- Enclosure Mechanical Strength ($15.3) o

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Drop test ($15.3.4) o
o Mould stress relief (§15.3.6)
Reverse Battery connection / overcharging (§15.4.3) o
All tests passed. ●

IEC 60601-2-2:

The following tests were completed on the device ●
- o Compatibility with third party Active Electrodes
  - Neutral Electrode cord attachment (§201.15.101.2) .
  - . Neutral Electrode cord connector, no conductive parts on Patient ($201.15.101.3)
· All tests passed.

IEC 60601-1-2:

The test report confirms that there were no modifications made to the devices in order ● to achieve compliance.
. The system encompasses two components that require separate types of testing (battery charging station and the generator unit).
- These two components work independently of each other and do not need to о be tested as a system.
The following tests were completed of the generator unit: .
- Electromagnetic radiation disturbance(§6.1.1.1) O
- O Electrostatic Discharge (ESD) (§6.2.2.1)
- Radiated RF Electromagnetic Fields (§6.2.3.1) O
- Conducted Disturbances, Induced by RF fields (§6.2.6.1) O
- Power Frequency magnetic fields (§6.2.8.1) O
- o All tests passed.
The following tests were completed of the battery charging station: ●
- o Electromagnetic radiation disturbance (§6.1.1.1)
  - Mains terminal disturbance ■
- Harmonic Distortion (§6.1.3.1.1) o
- o Voltage fluctuation and flicker (§6.1.3.1.2)
- Electrostatic Discharge (ESD) (§6.2.2.1) O
- Radiated RF Electromagnetic Fields (§6.2.3.1) O
- o Electrical fast transients and bursts (§6.2.4.1)
- Surges (§6.2.5.1) O
- Conducted Disturbances, Induced by RF fields (§6.2.6.1) O
- O Voltage Dips, short interruptions and voltage variations on power supply input lines (§6.2.7.1)
- Power Frequency magnetic fields ($6.2.8.1) o
- All tests passed. O

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SOFTWARE

The first function of the software in the Ultravision™ generator is to generate the audible alerts through the speaker that indicate when the system is in 'proximity alarm' mode i.e., in contact with tissue or another conductive surface and hence not able to operate at full smoke-clearing efficiency. This is a parallel alert to the visual indicators alongside the Ionwand™ and return sockets on the front of the generator, which are not under software control.

The second function of the software is to illuminate the fault light on the generator upper membrane in the situation where the speaker becomes accidentally disconnected from the main processor board of the generator.

The software is considered to have a moderate level of concern (LOC) because:

The software does not control the high potential voltage source. The hardware has built in back-off control.
The software only controls audible alarms as detected by the hardware. 3) The audible alarms are additional signals and risk controls to those

implemented in hardware.

Under any condition where the hardware backs off the high potential source, this would reduce the effectiveness of the device clearing smoke and thus give a clear visual indication of under-performance to the user. This can be diagnosed independent of the audio alarm and resolved by the user.

It appears that the only harm failure the software could cause is ineffective clearing of the surgical smoke.

The applicant has provided adequate software documentation per FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

The sponsor has tested its specifications of the alarm both under fault and normal conditions and the software functioned according to specification. Therefore, based on the traceability analysis, all identified hazards are properly mitigated.

PERFORMANCE TESTING - ANIMAL

A safety and simulated use performance validation of the Ultravision™ Visual Field Clearing System was conducted in a GLP animal study. Simulated laparoscopic surgeries (50-100 minutes in duration) were performed on porcine omentum using monopolar, bipolar and ultrasonic electrosurgical instruments, followed by 28 day recovery period. Histology, coagulation and clinical chemistry were evaluated for preoperative, immediate post-operative and 28 day post-operative conditions.

The study had the following objectives:

· Demonstration of the functionality of the Ultravision™ Ionwand™ trocar/ introducer assembly

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Demonstration of the ability of Ultravision™ Visual Field Clearing System to maintain a smoke free laparoscopic surgical field during normal use of monopolar, bipolar and ultrasonic electrosurgical cutting and ablation devices.
· Evaluation on anesthetic control of the subject device.
Evaluation of effects on pneumoperitoneum
Verification of alarm if Ionwand™ touches tissue/organs
· Evaluation of effect of device on hematology, clinical chemistry and coagulation

Acceptance criteria for the study were qualitative verification of performance and usability, through observed clearance of the visual field and an absence of observed clinical chemistry or histology concerns.

The results of the study indicated that the device functions as intended without usability concerns and that there were no identified clinical chemistry concerns.

The study was concluded to be adequate to demonstrate performance of the device and supports safe use of the device.

SUMMARY OF CLINICAL INFORMATION

The applicant completed a randomized, double-blinded, controlled, prospective trial consisting of 30 patients with six weeks of follow-up on 25/30 enrolled patients. The 30 patients underwent elective cholecystectomy at a single site with an active device and a de-activated control device to blind the surgeon. The primary endpoint of the study was the maintenance of a clear visual field during surgery. Secondary endpoints included patient safety (based on details of adverse events and bloodstream measurement of carboxyhemoglobin before and after surgery), pain score at discharge, and number of times a procedure was interrupted due to impairment of visual field by presence of particulates or smoke. Additional secondary endpoints were included in the study as potential metrics of device effectiveness, but these metrics were not considered necessary to support granting of this de novo request.

All patients in the study had a single-use sterile Ionwand™ placed percutaneously by the surgeon. The Ultravision™ generator was switched on throughout surgery. All surgical procedures were video-recorded using a direct output link from the laparoscopic camera in use to a digital video recorder. Relevant events of note and any problems associated with the use of the Ultravision™ Visual Field Clearing System that occurred during surgery were recorded by an independent member of the research team present.

All patients had a 6-week postoperative visit and assessment by their surgeon. At this visit patients were asked about postoperative pain, nausea, infection and medications taken. Each patient indicated their pain on a 100mm visual analog scale (VAS).

The following results were provided:

Primary Endpoint: The Ultravision™ Visual Field Clearing System was determined to be effective at maintaining a clear visual field during the surgeries. The surgeons and

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reviewing panel rated the treatment group to have a higher mean proportion of procedures with effective visibility than the control group.

Secondary Endpoints: There were no adverse events that could be attributed to the device. There was no detectable difference in either Carbon Monoxide (CO) or Methemogloblin (MetHb) levels between the two groups of patients both pre- and post-surgery. Pain scores were similar between treatment and control groups.

Treatment and control groups both had procedure interruptions, but in the treatment group there were eight procedures that had no interruptions. In the control group, no cases were completed without interruptions resulting from impairment of the visual field. The frequency with which the surgeon needed to remove the laparoscopic camera for cleaning was also different between the two groups of patients. In 85% of the procedures during which Ultravision™ Visual Field Clearing System was active, there was no requirement to remove the camera for cleaning. However, in the control group, only 35% of the procedures could be completed without camera cleaning.

This study confirmed safe performance of the device in a clinical setting as demonstrated by the controlled clinical trial, and contributed to the benefit/risk assessment.

Pediatric Extrapolation

In this de novo request, existing data were not leveraged to support the use of the device in a pediatric patient population.

LABELING

The labeling is sufficient and meets the requirements of 21 CFR 801.109. The user manual contains the indications for use, summary device description, warnings and precautions, instructions for use, instructions for device maintenance, troubleshooting instructions, shelf life, and information related to electromagnetic compatibility.

RISKS TO HEALTH

Table 4 below identifies the risks to health that may be associated with use of the Surgical smoke precipitator and the measures necessary to mitigate these risks.

Identified Risk	Mitigation Measures
Electrical shock	Electrical safety testingLabeling
Electromagnetic interference with otherdevices	Electromagnetic compatibility testingLabeling
Infection	Sterilization validationShelf-life validationLabeling
Adverse tissue reaction	Biocompatibility evaluation

Table 4 - Identified Risks to Health and Mitigation Measures

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Tissue injurys	Animal testingSoftware verification, validation, and hazardanalysisLabeling
--------------------	-----------------------------------------------------------------------------------------

SPECIAL CONTROLS

In combination with the general controls of the FD&C Act, the Surgical smoke precipitator is subject to the following special controls:

1. Adverse tissue reaction must be mitigated through the following:
- a. Chemical characterization and toxicological risk assessment of the treated surgical smoke.
- b. Demonstration that the elements of the device that may contact the patient are biocompatible.
1. Electrical safety and electromagnetic compatibility testing must demonstrate that the device performs as intended.
1. Software verification, validation, and hazard analysis must be performed.
1. Performance data must demonstrate the sterility of the patient contacting components of the device.
1. Performance data must support the shelf life of the sterile components of the device by demonstrating continued functionality, sterility and package integrity over the identified shelf life.
1. Animal simulated-use testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
- Device must be demonstrated to be effectively inserted, positioned and removed from a. the site of use.
- b. Device must be demonstrated to precipitate surgical smoke particulates to clear the visual field for laparoscopic surgeries.
- c. Device must be demonstrated to be non-damaging to the site of use and animal subject.
1. Labeling must identify the following:
- Detailed instructions for use. a.
- b. Electrical safety and electromagnetic compatibility information.
- c. A shelf life.

BENEFIT/RISK DETERMINATION

The risks of the device are based on nonclinical laboratory, animal studies, and the clinical study described above. There were no device-related adverse events during the clinical study. Additionally, there was no detectable difference in either CO or MetHb levels between the two groups of patients both pre- and post-surgery despite greater volume of gas administered in the control group for the 30 patient trial.

The probable benefits of the device are also based on the nonclinical laboratory, animal, and clinical study described above. The probable benefits are:

1. Improved visual field

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1. Less gas volume needed for insufflation
1. Less frequent need to stop procedures to clean the camera lens or vent accumulated debris and gas.

The subject device does not directly benefit the patient. However, the device appears to benefit surgeons performing laparoscopic procedures through maintenance of a clear visual field. The use of this device may allow the surgeon to proceed without having to stop procedures to clean the camera lens and/or vent the accumulated debris.

Patient Perspectives

Patient-reported pain scores were recorded for both treatment and control groups in the clinical trial. Pain scores were based on the VAS scale and were similar between both groups.

Benefit/Risk Conclusion

Maintaining a clear visual field is critical during laparoscopic procedures. Use of this device may allow the surgeon to proceed without having to stop procedures to clean the camera lens and/or vent the accumulated debris. No adverse events were attributed to the device in the clinical study.

In conclusion, given the available information above, the data support that for precipitation of surgical smoke for laparoscopic procedures, the probable benefits outweigh the probable risks for the Ultravision™ Visual Field Clearing System. The device provides benefits and the risks can be mitigated by the use of general and the identified special controls.

CONCLUSION

The de novo request for the Ultravision™ Visual Field Clearing System is granted and the device is classified under the following:

Product Code: PQM Device Type: Surgical smoke precipitator Class: Class II Regulation: 21 CFR 878.5050

Regulation Number and Section

§ 878.5050 Surgical smoke precipitator.

(a)
Identification. A surgical smoke precipitator is a prescription device intended for clearance of the visual field by precipitation of surgical smoke and other aerosolized particulate matter created during laparoscopic surgery.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Adverse tissue reaction must be mitigated through the following:
(i) Chemical characterization and toxicological risk assessment of the treated surgical smoke.
(ii) Demonstration that the elements of the device that may contact the patient are biocompatible.
(2) Electrical safety and electromagnetic compatibility testing must demonstrate that the device performs as intended.
(3) Software verification, validation, and hazard analysis must be performed.
(4) Performance data must demonstrate the sterility of the patient contacting components of the device.
(5) Performance data must support the shelf life of the sterile components of the device by demonstrating continued functionality, sterility, and package integrity over the identified shelf life.
(6) Animal simulated-use testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Device must be demonstrated to be effectively inserted, positioned, and removed from the site of use.
(ii) Device must be demonstrated to precipitate surgical smoke particulates to clear the visual field for laparoscopic surgeries.
(iii) Device must be demonstrated to be non-damaging to the site of use and animal subject.
(7) Labeling must identify the following:
(i) Detailed instructions for use.
(ii) Electrical safety and electromagnetic compatibility information.
(iii) A shelf life.