Ultravision2™ System
Device Facts
| Record ID | K231238 |
|---|---|
| Device Name | Ultravision2™ System |
| Applicant | Alesi Surgical, Ltd. |
| Product Code | PQM · General, Plastic Surgery |
| Decision Date | Oct 31, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.5050 |
| Device Class | Class 2 |
Indications for Use
The Ultravision2™ System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. The Ultravision2™ 5mm Trocar component establishes a path of entry for instruments used in laparoscopic surgery. The Ultravision2™ Generator interfaces directly with the electrosurgical generator and serves as a pass-through for RF energy to RF electrosurgical instruments.
Device Story
Ultravision2™ System is a surgical smoke precipitator for laparoscopic procedures; clears visual field via electrostatic precipitation. System comprises a generator, Ionwand™ (percutaneous 3mm trocar/catheter), and 5mm trocar. Generator interfaces with standard electrosurgical units (ESU) to pass RF energy to surgical instruments; automatically synchronizes Ionwand activation with ESU smoke-producing activity. Used in operating rooms by surgeons. Benefits include improved visualization by reducing smoke/particulate matter. Hardware-based timing controls manage energy output; software provides audio-visual status indicators but is not a risk control. System improves trocar retention via ribbed design compared to predicate.
Clinical Evidence
Bench testing only. No clinical data. Testing included shelf-life (ASTM F1980-16, F2096, F1929-15, F88/F88M-15), electrical safety/EMC (IEC 60601-1, IEC 60601-2-2, EN 60601-1-2), dimensional/physical verification, high voltage output, generator functionality/safety, and design validation under simulated use conditions.
Technological Characteristics
Materials: Implant grade stainless steel (Ionwand tip), thermoplastic (trocar), elastomer (seals). Principle: Electrostatic precipitation (9.8KV dc). Connectivity: Interfaces with external ESU. Sterilization: EtO (ISO 11135). Software: Class A per IEC 62304 (Minor Level of Concern).
Indications for Use
Indicated for clearance of smoke and particulate matter during laparoscopic surgery in general patients requiring electrosurgery in a hospital setting.
Regulatory Classification
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.
Special Controls
In combination with the general controls of the FD&C Act, the Surgical smoke precipitator is subject to the following special controls:
*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.
Predicate Devices
- Ultravision™ Visual Field Clearing System (K200035)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
October 31, 2023
Alesi Surgical Ltd % Michele Lucey Regulatory Consultant Lakeshore Medical Device Consulting, LLC 128 Blve Hill Landing Newbury, New Hampshire 03255
Re: K231238
Trade/Device Name: Ultravision2™M System Regulation Number: 21 CFR 878.5050 Regulation Name: Surgical Smoke Precipitator Regulatory Class: Class II Product Code: PQM Dated: September 25, 2023 Received: September 28, 2023
Dear Michele Lucey:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
{1}------------------------------------------------
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
# Christopher K. Dugard -S
Christopher K. Dugard, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical
{2}------------------------------------------------
and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
## Indications for Use
510(k) Number (if known) k231238
Device Name Ultravision2™ System
Indications for Use (Describe)
The Ultravision2™ System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery.
The Ultravision2™ 5mm Trocar component establishes a path of entry for instruments used in laparoscopic surgery.
The Ultravision2™ Generator interfaces directly with the electrosurgical generator and serves as a pass-through for RF energy to RF electrosurgical instruments.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image contains the logo for Alesi Surgical. The logo consists of three curved shapes in different shades of blue and purple on the left side. To the right of the shapes is the word "alesi" in a dark blue sans-serif font, with the word "surgical" in a smaller, lighter blue font underneath.
### K231238
#### 510(K) SUMMARY TRADITIONAL As required by 21 CFR 807.92
### Submitter Information:
| Submitter's Name: | Alesi Surgical Ltd |
|----------------------------|-----------------------------------------------------|
| Address: | Cardiff Medicentre |
| | Heath Park |
| | Cardiff |
| | CF14 4UJ |
| | UK |
| Telephone: | +44 (0) 2920291022 |
| Fax: | +44 (0) 2920750239 |
| Contact Person: | Michele Lucey |
| | Lakeshore Medical Device Consulting LLC. |
| | 128 Blye Hill Landing. |
| | Newbury, |
| | New Hampshire 03255 |
| Telephone: | 603-748-1374 |
| Date Prepared: | October 31, 2023 |
| Device Proprietary Name: | Ultravision2™ System |
| Common Name: | Surgical Smoke Precipitator |
| Classification Name: | Surgical Smoke Precipitator |
| Classification Regulation: | 21 CFR 878.5050 |
| Regulatory Class: | Class II |
| Product Code(s): | PQM |
| Predicate Device: | Ultravision™ Visual Field Clearing System (K200035) |
{5}------------------------------------------------
#### Indications for Use:
The Ultravision2™ System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery.
The Ultravision2™ 5mm Trocar component establishes a path of entry for instruments used in laparoscopic surgery.
The Ultravision2™ Generator interfaces directly with the electrosurgical generator and serves as a pass-through for RF energy to RF electrosurgical instruments.
#### Device Description/Technological Characteristics:
The Ultravision2™ System is a multifunctional system that synchronizes visual field clearing with the activation of smoke-producing electrosurgical devices. The system interfaces with commercially available electrosurgical instruments. The Ultravision2™ Generator connects directly to a commercially available electrosurgical generator (ESU) and passes the RF energy through to the desired electrosurgical instrument connected to the Utravision2™ Generator. The Ultravison2™ System is able to automate the activation of the Ionwand for visual field clearing to the activation of the electrosurgical device to synchronize visual field clearing with the generation of smoke. The Ionwand™ pack comprises a dedicated percutaneous 3mm trocar/catheter which accommodates the Ionwand™ cable that delivers low energy from the generator to the patient. The Ultravision™ 5mm Trocar includes a dedicated Ionwand™ cable. This device is for prescription use only.
| Model # | Component Description |
|-------------|----------------------------------------------------------------------------------------------------------------------------|
| DPD-006-001 | Ultravision2™ System, including:<br>• Standalone generator<br>• Link cables (x4)<br>• Equipotential cable<br>• Power cable |
| DAD-001-003 | Ionwand Pack, including:<br>• Stainless steel active cable the “Ionwand™”<br>• Trocar/catheter assembly |
| DAD-003-013 | Ultravision 5mm Trocar, including:<br>• 5mm trocar<br>• Ionwand cable assembly |
The components of the system are described as follows:
#### Technological Characteristics Comparison:
The comparison table below provides the similarities and differences between the predicate and subject devices. The modifications made to the subject device do not raise any risk to safety or effectiveness.
{6}------------------------------------------------
| Feature/<br>Specification | Ultravision2TM System | UltravisionTM Visual Field<br>Clearing System | Comparison |
|------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory<br>Clearance/<br>Approval<br>Reference | K231238<br>Subject Device | K200035<br>Predicate Device | N/A |
| Product Code(s) | PQM | PQM | Equivalent |
| Regulation<br>Number(s) | 21 CFR 878.5050 | 21 CFR 878.5050 | Equivalent |
| Regulation<br>Name(s) | Surgical Smoke Precipitator | Surgical Smoke Precipitator | Equivalent |
| Where used<br>(environment) | Operating Room | Operating Room | Equivalent |
| Anatomical Sites | Abdominal and pelvic<br>cavity | Abdominal and pelvic<br>cavity. | Equivalent |
| Target population | General patients requiring<br>electrosurgery in a hospital<br>setting | General patients requiring<br>electrosurgery in a hospital<br>setting | Equivalent |
| Mechanism of<br>Action for Visual<br>Field Clearing | Electrostatic precipitation of<br>smoke to clear the visual<br>field during laparoscopic<br>surgical procedures | Electrostatic precipitation of<br>smoke to clear the visual<br>field during laparoscopic<br>surgical procedures | Equivalent |
| Generator output<br>Smoke<br>Precipitation | 9.8KV dc | 9.8KV dc | Equivalent |
| Current | Ionwand- intermittent max<br>20μA | Continuous max 10μA | Similar<br>This difference does not<br>raise new questions of<br>safety and effectiveness.,<br>confirmed by electrical<br>safety testing |
| Ionwand tip<br>material | Implant grade Stainless<br>steel, annealed | Implant grade Stainless steel,<br>annealed. | Equivalent |
| Ionwand tip<br>exposed length | 4.0mm | 4.0mm | Equivalent |
| Ionwand insulation<br>wall thickness | 0.7mm | 0.7mm | Equivalent |
| Plug and cable<br>length | 2.5mm | 2.5mm | Equivalent |
| Ionwand energy<br>modality | HVDC | HVDC | Equivalent |
| Ionwand working<br>length | 109mm | 109mm | Equivalent |
| Mechanism of<br>action of visual<br>field clearance | Electrostatic precipitation | Electrostatic precipitation | Equivalent |
| Generator smoke<br>clearing activation. | Automatic on/off timed<br>output triggered by energy<br>detection or user selection<br>(manual button press on<br>generator) | Continuous output until<br>switched off on generator | Different, results in less<br>activation of the Ionwand<br>during the procedure. This<br>difference does not raise<br>new questions about safety<br>and effectiveness |
| Feature/<br>Specification | Ultravision2™ System | Ultravision™ Visual Field<br>Clearing System | Comparison |
| Generator<br>Compatibility to<br>Electrosurgical<br>Energy Input | Commercially available<br>Electrosurgical generators,<br>Monopolar, and Bipolar<br>energy input | NA | Compatibility and<br>electrical safety is shown<br>through performance<br>testing. This difference<br>does not raise new<br>questions about safety and<br>effectiveness. |
| Generator<br>Compatibility to<br>Handpiece | Universal compatibility for<br>monopolar and bipolar<br>energy types | NA | Compatibility is shown<br>through safety and<br>performance testing. This<br>difference does not raise new<br>questions about safety<br>and effectiveness. |
| 5mm IonWand<br>trocar material | Thermoplastic | Thermoplastic | Equivalent |
| Retention features | Ribbed | Micro- ridges | Different, results in<br>improved retention of the<br>trocar during the<br>procedure. This difference<br>does not raise new<br>questions about safety and<br>effectiveness |
| Type of sealing<br>employed | Duckbill valve and separate<br>seal | Duckbill valve and separate<br>seal | Equivalent |
| Valve and seal<br>material | Elastomer | Elastomer | Equivalent |
| Software Controls | Software is not a risk<br>control. Provides an audio-<br>visual indication if the<br>IonWand is touching tissue<br>or a metallic instrument<br>(output is timed with a<br>predetermined shut-off<br>therefore this is not<br>considered to be an alarm) | Software is a risk control<br>providing an audio-visual<br>alarm if the IonWand is<br>touching tissue or a metallic<br>instrument (required as the<br>output is continuous once<br>manually turned on at the<br>generator) | Different, UV2 has a<br>predetermined timed<br>output which is controlled<br>by hardware only. Thus,<br>software has no role in<br>energy output and is not<br>considered to be a risk<br>control. This difference<br>does not raise new<br>questions of safety and<br>effectiveness. |
| Software Safety<br>Classification/Lev<br>el of Concern | Minor Level of Concern<br>(Basic documentation)<br>Class A per IEC 62304 | Moderate Level of Concern<br>(Category 2)<br>Class B per IEC 62304 | Different, the reduction in<br>safety concerns compared<br>to the predicate does not<br>raise new questions of<br>safety and effectiveness |
| Applicable<br>Electrical Safety<br>Standards | IEC 60601-1<br>ISO 60601-1-6<br>IEC 60601-2-2 | IEC 60601-1<br>ISO 60601-1-6<br>IEC 60601-2-2 | Equivalent |
| Applicable<br>Electromagnetic<br>Compatibility<br>Standards | IEC 60601-1-2 | IEC 60601-1-2 | Equivalent |
| Applicable<br>Software<br>Standards | IEC 62304 | IEC 62304 | Equivalent |
| Feature/<br>Specification | Ultravision2TM System | UltravisionTM Visual Field<br>Clearing System | Comparison |
| Biocompatibility | Meets ISO 10993 | Meets ISO 10993 | Equivalent |
| Sterilization | EtO, validated per ISO<br>11135 | EtO, validated per ISO<br>11135 | Equivalent |
| Sterility Assurance<br>Level | 10-6 | 10-6 | Equivalent |
| How Supplied<br>(single use) | Ionwand and trocar -<br>supplied sterile in single<br>blister pack or pouch | Ionwand, trocar -supplied<br>sterile in single blister or<br>pouch | Equivalent |
## Technological Characteristics Comparison Table
{7}------------------------------------------------
{8}------------------------------------------------
#### Summary of Non-clinical Testing:
Testing demonstrated acceptable device performance for the device's intended use. System and software verification and validation activities were successfully completed.
| Test<br>Performed | Standard Followed | Acceptance Criteria | Test<br>Results |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Shelf life | ASTM F1980-16 Standard<br>Guide for Accelerated Aging<br>of Sterile Medical Device<br>Packages | Product and package must demonstrate<br>stability for the claimed shelf life of 5 years. | Pass |
| | ASTM 2096 Standard Test<br>Method for Detecting Gross<br>Leaks in Packaging by<br>Internal Pressurization | | |
| | ASTM F1929-15 Standard<br>Test Method for Detecting<br>Seal Leaks in Porous Medical<br>Packaging by Dye Penetration | | |
| | ASTM F88/F88M -15<br>Standard Test Method for Seal<br>Strength of Flexible Barrier<br>Materials | | |
| Software verification<br>and validation | IEC62304 2006+A1:2015<br>Medical Device Software –<br>Software Life Cycle Process | Device functions controlled by software must<br>perform as intended | Pass |
| Electrical safety and<br>electromagnetic<br>compatibility | IEC 60601-1 Medical<br>Electrical Equipment,<br>Edition 3.1, which is Edition<br>3.0 (2005-12) as modified by<br>AM1 (2012-07) evaluation. | Device must meet the requirements of the<br>applicable clauses in the standards | Pass |
| | IEC 60601-2-2 High<br>Frequency Surgical<br>Equipment (2017-03)<br>evaluation | | |
| | EN 60601-1-2:2015 +<br>A1:2021 Medical electrical<br>equipment General | | |
| Test<br>Performed | Standard Followed | Acceptance Criteria | Test<br>Results |
| | requirements for basic safety<br>and essential performance.<br>Collateral Standard:<br>Electromagnetic disturbances | | |
| Dimensional<br>and physical<br>verification<br>of unit | NA | Device must meet dimensional specification<br>and physical specifications as per internal<br>standards. | Pass |
| High voltage output | NA | Device must deliver specified output, into<br>required loads, at given temperatures and<br>humidities, and for the specified product<br>lifetime as per internal standards. | Pass |
| Generator basic<br>function including: | NA | Device must meet specifications for<br>connections and functionality as per internal<br>standards. | Pass |
| Generator safety<br>measures including: | NA | | |
| Generator user<br>interface<br>hardware control | NA | Must meet specifications for device function<br>independent of software, extreme misuse, or<br>single fault conditions as per internal<br>standards. | Pass |
| Generator high<br>voltage power<br>management | NA | Must meet specifications for DC output under<br>proximity and HVDC limit protection measure<br>as per internal standards. | Pass |
| Generator surgical<br>energy detection | NA | Device must demonstrate energy detection for<br>external ultrasonic energy as per internal<br>standards. | Pass |
| Mechanical<br>connections and<br>controls | NA | Device must demonstrate acceptable durability<br>of link cables, fascia connections, and cable<br>retention as per internal standards. | Pass |
| Surgical generator<br>compatibility | NA | Device must demonstrate compatibility with<br>applicable generators in terms of load curve<br>characterization, CQM performance, HF<br>leakage, and RF detection. as per internal<br>standards. | Pass |
| Design validation<br>under simulated use<br>conditions | NA | Must demonstrate that the device can achieve<br>its intended use when used by end users as per<br>internal standards. | Pass |
{9}------------------------------------------------
#### Biocompatibility
The tissue contacting components of the Ultravision2™ System are identical and process to the previously cleared devices. No additional biocompatibility testing was performed.
#### Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(k) submission, K231238 is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K200035, Class II (21 CFR 878.5050), product code PQM.
