(136 days)
The Ultravision2™ System is indicated for use in surgery including laparoscopic surgery.
· The Ultravision2™ Generator is interface directly with the electrosurgical generator and serve as a passthrough for HF energy to HF electrosurgical instruments, to manage surgical smoke produced by energy-based instruments, and is indicated for use in surgery including laparoscopic surgery.
· The Ionwand™ Pack is intended to be used to manage surgical smoke and is indicated for use in surgery including laparoscopic surgery.
· The Ultravision™ 5mm Trocar is intended to be used to establish a path of entry for instruments and includes an Ionwand to manage surgical smoke, and is indicated for laparoscopic surgery.
· The Integrated Monopolar L-Hook (H/S)™ is intended to be used to facilitate the cutting and coagulation of soft tissue, to manage surgical smoke during laparoscopic surgical procedures, and is indicated for use in laparoscopic surgery.
· The IonPencil™ is intended to be used to facilitate the cutting and coagulation of soft tissue, to manage surgical smoke during general surgical procedures, and is indicated for use in surgery.
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 electrosurgical device to synchronize visual field clearing with the generation of smoke.
The components of the overall system will be:
- Ultravision2TM system comprising: .
- . Ultravision2TM generator
- Link cables (x4)
- . Power cable
- Equipotential cable .
- . IonPencil™ accessory
- . Integrated Monopolar L-Hook(H/S)TM accessory
- Ionwand™ accessory
- . Ultravision™ 5mm Trocar accessory
The IonPencil™ is a bifunctional open surgery device that combines proprietary smoke management (via visual field clearing) and monopolar HF tissue cutting and coagulation in a single device. It's addition to the Ultravision 2 System adds the general open procedure capability to the Ultravision2™ indications of use along with the new single use accessory.
The IonPencil™ can only interface with the Ultravision2 generator which connects directly to a commercially available electrosurgical generator (ESU) for its HF monopolar energy source. The IonPencil™ provides two smoke clearing emitters that are automatically activated to clear the visual field when the device cutting function (HF) is activated. The mode of action of smoke management (visual field clearing) is electrostation as per the predicate Ultravision system. When the tissue cutting or coagulation is ceased, the visual field clearing signal is automatically switched off after a short delay period that is settable on the Ultravision2™ generator user interface.
Activation of the HF function of the IonPencil™ is via a yellow (Cut) or blue (Coag) button located on the handpiece, or via a footswitch if this connected to the parent electrosurgical generator which is connected to the Ultravision2™ system. The IonPencil™ itself is incompatible with the connectors of third-party electrosurgical generators. The IonPencil™ is provided with a 69mm long PTFE coated blade.
The following cleared accessories have not changed:
• The Integrated Monopolar L-Hook(H/S)™ is a bifunctional laparoscopic device that combines proprietary smoke management (via visual field clearing) and monopolar HF tissue cutting and coagulation in a single device.
· 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 for smoke management.
- · The Ultravision™ 5mm Trocar includes a dedicated Ionwand™ cable.
The provided text describes the acceptance criteria and the results of non-clinical testing for the Ultravision2™ IonPencil. The study aims to demonstrate that the device is as safe, effective, and performs as well as or better than legally marketed predicate devices.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and the Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical safety and electromagnetic compatibility (IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2) | Device must meet the requirements of the applicable clauses in the standards. | Pass |
| Shelf Life (ASTM F1980-16, ASTM 2096, ASTM F88/F88M -15) | Product and package must demonstrate stability for the claimed shelf life of six months. | Pass |
| Mechanical robustness of device | Device must meet mechanical specification per internal standards. | Pass |
| General, visual, dimensional and electrical verification of instrument | Device must meet dimensional, electrical, and physical specifications per internal standards. | Pass |
| Visual field clearing (surgical smoke removal) | Device must meet performance specifications per the internal standards. | Pass |
| Electrical bench tests | Device must meet electrical performance and safety specifications per the internal standards. | Pass |
| Assessment of thermal depth of margin | The thermal margin must be substantially equivalent to the predicate device in terms of its potential for tissue damage. | Pass |
| Design validation under simulated use conditions | Device must achieve its intended use when used by end users and that performance is at least equivalent to the predicate device. | Pass |
| Biocompatibility Testing | ||
| Cytotoxicity (ISO 10993-5: 2009) | Under the condition of the test, the test article must be non-cytotoxic. | Pass |
| Skin Irritation Study in Rabbits (ISO10993-23: 2021) | Under the condition of the test, the test article must be non-irritating. | Pass |
| Systemic Toxicity in Mice (ISO 10993-11: 2017) | Under the condition of the test, the test article must not elicit evidence of systemic toxicity. | Pass |
| Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2021) | Under the condition of the test, the test article must be non-sensitizing. | Pass |
| Hemolysis (ISO 10993-4: 2017) | Under the condition of the test, the test article must be non-hemolytic. | Pass |
| Material Mediated Pyrogens (USP General Chapter <151>) | Under the condition of the test, the test article must be non-pyrogenic. | Pass |
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It typically does not contain the detailed methodology and results of a clinical study that would be used to prove novel device performance. The information outlines non-clinical testing and design validation under simulated use conditions.
Regarding the remaining questions, the provided text does not contain the requested information:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The text mentions "non-clinical testing" and "design validation under simulated use conditions" but does not specify sample sizes for these tests or the provenance of any data. These are likely bench tests and not human subject studies.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as the tests described are non-clinical, primarily focused on device specifications and performance rather than diagnostic accuracy involving human interpretation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical testing.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document describes a surgical smoke precipitator, not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device, not a software algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For non-clinical tests, "ground truth" is typically defined by engineering specifications, standard test methods, and comparison to predicate device performance. For biocompatibility, it's defined by the specific criteria of the ISO standards.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device that requires a training set.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a larger font size than the name. The name is written as "U.S. FOOD & DRUG ADMINISTRATION".
August 12, 2024
Alesi Surgical Limited Pravin Patel Regulatory & Quality Manager Cardiff Medicentre, Heath Park, Cardiff, CF14 4UJ Cardiff. United Kingdom
Re: K240868
Trade/Device Name: Ultravision2™M IonPencil Regulation Number: 21 CFR 878.5050 Regulation Name: Surgical Smoke Precipitator Regulatory Class: Class II Product Code: PQM, GEI Dated: March 28, 2024 Received: March 29, 2024
Dear Pravin Patel:
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" (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).
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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 QS 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 and Part 809); 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-safetyreporting-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 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,
Image /page/1/Picture/7 description: The image shows the name "Stephen A. Anisko" followed by "-S" and "-04'00'". The text appears to be a signature or a name with some additional information, possibly related to a timestamp or a code.
Digitally signed by Stephen A. Anisko -S Date: 2024.08.12 14:11:51
for: Christopher Dugard Assistant Director DHT4C: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control 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) K240868
Device Name Ultravision2™ IonPencil
Indications for Use (Describe)
The Ultravision2™ System is indicated for use in surgery including laparoscopic surgery.
· The Ultravision2™ Generator is interface directly with the electrosurgical generator and serve as a passthrough for HF energy to HF electrosurgical instruments, to manage surgical smoke produced by energy-based instruments, and is indicated for use in surgery including laparoscopic surgery.
· The Ionwand™ Pack is intended to be used to manage surgical smoke and is indicated for use in surgery including laparoscopic surgery.
· The Ultravision™ 5mm Trocar is intended to be used to establish a path of entry for instruments and includes an Ionwand to manage surgical smoke, and is indicated for laparoscopic surgery.
· The Integrated Monopolar L-Hook (H/S)™ is intended to be used to facilitate the cutting and coagulation of soft tissue, to manage surgical smoke during laparoscopic surgical procedures, and is indicated for use in laparoscopic surgery.
· The IonPencil™ is intended to be used to facilitate the cutting and coagulation of soft tissue, to manage surgical smoke during general surgical procedures, and is indicated for use in surgery.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Alesi Surgical. The logo consists of a stylized, abstract symbol on the left, composed of three curved shapes in different shades of blue and purple. To the right of the symbol is the word "alesi" in a bold, dark blue sans-serif font, with the word "surgical" underneath in a smaller, lighter blue font.
K240868
510(K) SUMMARY As required by 21 CFR 807.92
| Submitter Information: | |
|---|---|
| Submitter's Name: | Alesi Surgical Ltd |
| Address: | Cardiff MedicentreHeath ParkCardiffCF14 4UJUK |
| Telephone: | +44 (0) 2920291022 |
| Contact Person: | Pravin Patel |
| Date Prepared: | August 9th, 2024 |
| Device Proprietary Name: | Ultravision2™ IonPencil |
| Common Name: | Surgical Smoke Precipitator |
| Classification Name: | Surgical Smoke Precipitator |
| Classification Regulation: | 21 CFR 878.5050 |
| Product Code: | PQM |
| Common Name: | Electrosurgical accessory |
| Classification Regulation: | 21 CFR 878.4400 |
| Product Code: | GEI |
| Regulatory Class: | Class II |
| Predicate Device: | Ultravision 2 System including Integrated Monopolar L-Hook (H/S)(K231298)Ultravision™ Visual Field Clearing System (K200035)Megadyne Pencil (K965054) andMegadyne EZ Clean Electrosurgical Electrode (K081791) |
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Indications for Use:
The Ultravision2™ System is indicated for use in surgery including laparoscopic surgery.
· The Ultravision2™ Generator is intended to interface directly with the electrosurgical generator and serve as a pass-through for HF energy to HF electrosurgical instruments, to manage surgical smoke produced by energy-based instruments, and is indicated for use in surgery including laparoscopic surgery.
· The Ionwand™ Pack is intended to be used to manage surgical smoke and is indicated for use in surgery including laparoscopic surgery.
· The Ultravision™ 5mm Trocar is intended to be used to establish a path of entry for instruments and includes an Ionwand to manage surgical smoke, and is indicated for laparoscopic surgery.
· The Integrated Monopolar L-Hook (H/S)™ is intended to be used to facilitate the cutting and coagulation of soft tissue, to manage surgical smoke during laparoscopic surgical procedures, and is indicated for use in laparoscopic surgery.
· The IonPencil™ is intended to be used to facilitate the cutting and coagulation of soft tissue, to manage surgical smoke during general surgical procedures, and is indicated for use in surgery.
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 electrosurgical device to synchronize visual field clearing with the generation of smoke.
The components of the overall system will be:
- Ultravision2TM system comprising: .
- . Ultravision2TM generator
- Link cables (x4)
- . Power cable
- Equipotential cable .
- . IonPencil™ accessory
- . Integrated Monopolar L-Hook(H/S)TM accessory
- Ionwand™ accessory
- . Ultravision™ 5mm Trocar accessory
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The IonPencil™ is a bifunctional open surgery device that combines proprietary smoke management (via visual field clearing) and monopolar HF tissue cutting and coagulation in a single device. It's addition to the Ultravision 2 System adds the general open procedure capability to the Ultravision2™ indications of use along with the new single use accessory.
The IonPencil™ can only interface with the Ultravision2 generator which connects directly to a commercially available electrosurgical generator (ESU) for its HF monopolar energy source. The IonPencil™ provides two smoke clearing emitters that are automatically activated to clear the visual field when the device cutting function (HF) is activated. The mode of action of smoke management (visual field clearing) is electrostation as per the predicate Ultravision system. When the tissue cutting or coagulation is ceased, the visual field clearing signal is automatically switched off after a short delay period that is settable on the Ultravision2™ generator user interface.
Activation of the HF function of the IonPencil™ is via a yellow (Cut) or blue (Coag) button located on the handpiece, or via a footswitch if this connected to the parent electrosurgical generator which is connected to the Ultravision2™ system. The IonPencil™ itself is incompatible with the connectors of third-party electrosurgical generators. The IonPencil™ is provided with a 69mm long PTFE coated blade.
The following cleared accessories have not changed:
• The Integrated Monopolar L-Hook(H/S)™ is a bifunctional laparoscopic device that combines proprietary smoke management (via visual field clearing) and monopolar HF tissue cutting and coagulation in a single device.
· 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 for smoke management.
- · The Ultravision™ 5mm Trocar includes a dedicated Ionwand™ cable.
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 risk to safety or effectiveness.
| Technical Characteristics Comparison Table | |||||
|---|---|---|---|---|---|
| Feature/Specification | Ultravision2™System withIonPencil™ | Ultravision2™System IntegratedMonopolar L-Hook (H/S)™Predicate 1 | Ultravision VisualField ClearingSystemPredicate 2 | Megadyne Pencilwith Megadyne EZCleanElectrosurgicalElectrodePredicate 3,4 | Comparison |
| RegulatoryClearance/ApprovalReference | K240868 | K231298 | K200035 | K965054K081791 | N/A |
| Product Code(s) | PQMGEI | PQMGEI | PQMGEI | GEI | Equivalent |
| RegulationNumber(s) | 878.5050878.4400 | 878.5050878.4400 | 878.5050 | 878.4400 | Equivalent |
| RegulationName(s) | Surgical SmokePrecipitatorAND | Surgical SmokePrecipitatorAND | Surgical SmokePrecipitator | ElectrosurgicalCutting&Coagulation & | Same |
| Technical Characteristics Comparison Table | |||||
| Feature/Specification | Ultravision2™System withIonPencil™ | Ultravision2™System IntegratedMonopolar L-Hook (H/S)™Predicate 1 | Ultravision VisualField ClearingSystemPredicate 2 | Megadyne Pencilwith Megadyne EZCleanElectrosurgicalElectrodePredicate 3,4 | Comparison |
| ElectrosurgicalCutting &Coagulation &Accessories | ElectrosurgicalCutting &Coagulation &Accessories | ElectrosurgicalCutting &Coagulation &Accessories | Accessories | ||
| Intended Use andIndications | The Ultravision2™System is indicatedfor use in surgeryincludinglaparoscopicsurgery.• TheUltravision2™Generator isintended tointerface directlywith theelectrosurgicalgenerator and serveas a pass-throughfor HF energy toHF electrosurgicalinstruments, tomanage surgicalsmoke produced byenergy-basedinstruments, and isindicated for use insurgery includinglaparoscopicsurgery.• The Ionwand™Pack is intended tobe used to managesurgical smoke andis indicated for usein surgeryincludinglaparoscopicsurgery.• The Ultravision™5mm Trocar isintended to be usedto establish a pathof entry forinstruments andincludes anIonwand to managesurgical smoke, | The Ultravision 2™IntegratedMonopolar L-Hook(H/S)™ is intendedto be used withapplications insurgical proceduresto facilitate cutting,coagulating oftissue, incombination withthe clearance ofsmoke and otherparticulate matterthat is createdduring laparoscopicsurgery. | The Ultravision™Visual FieldClearing System isindicated for theclearance of smokeand otherparticulate matterthat is createdduring surgery,includinglaparoscopicsurgery.The Ultravision™5mm Trocarcomponentestablishes a pathof entry forinstruments used inlaparoscopicsurgery. | E-Z Cleanelectrosurgicalelectrodes areintended to conductradio frequency(RF) current forcutting andcoagulation fromthe REelectrosurgicalgenerator to targetsoft tissue in abroad range ofsurgical proceduresrequiring the use ofelectrosurgery forcutting andcauterization. Sometip configurationshave a specificgeometry thatminimizesblanching andthermal damage inskin incisions whenused in conjunctionwith the generator'sAdvanced CuttingEffect (ACE) mode. | SimilarThe predicatedevices includeintegration ofsmokemanagement withelectrosurgicalfunction and coverlaparoscopic andgeneral surgeryindications for bothfunctions |
| Technical Characteristics Comparison Table | |||||
| Feature/Specification | Ultravision2™System withIonPencil™ | Ultravision2™System IntegratedMonopolar L-Hook (H/S)™Predicate 1 | Ultravision VisualField ClearingSystemPredicate 2 | Megadyne Pencilwith Megadyne EZCleanElectrosurgicalElectrodePredicate 3,4 | Comparison |
| and is indicated forlaparoscopicsurgery.• The IntegratedMonopolar L-Hook(H/S)™ is intendedto be used tofacilitate thecutting andcoagulation of softtissue, to managesurgical smokeduring laparoscopicsurgicalprocedures, and isindicated for use inlaparoscopicsurgery• The IonPencil™is intended to beused to facilitatethe cutting andcoagulation of softtissue, to managesurgical smokeduring generalsurgicalprocedures, and isindicated for use insurgery. | |||||
| Where used(environment) | GeneralSurgery(open),includinglaparoscopicsurgery | Laparoscopicsurgery | General Surgery(open), includinglaparoscopicsurgery | General Surgery(open) | Similar |
| Anatomical Sites | Soft tissue in abroad range ofsurgical procedures | Abdominal andpelvic cavity. | Abdominal andpelvic cavity. | Soft tissue in abroad range ofsurgical procedures | Similar |
| Targetpopulation | General patientsrequiringelectrosurgery in ahospital setting | General patientsrequiringelectrosurgery in ahospital setting | General patientsrequiringelectrosurgery in ahospital setting | General patientsrequiringelectrosurgery in ahospital setting | Same |
| Current | Ionwand-intermittent max$20\mu A$Integrated L-Hookinstrument &IonPencil™ | Ionwand-intermittent max$20\mu A$Integrated L-Hookinstrument- 2 x | Continuous max$10\mu A$ | N/A | Similar |
| Technical Characteristics Comparison Table | |||||
| Feature/Specification | Ultravision2™System withIonPencil™ | Ultravision2™System IntegratedMonopolar L-Hook (H/S)™Predicate 1 | Ultravision VisualField ClearingSystemPredicate 2 | Megadyne Pencilwith Megadyne EZCleanElectrosurgicalElectrodePredicate 3,4 | Comparison |
| emitters (40μAtotal) intermittentmax | intermittent max | ||||
| Visual fieldclearingmechanism ofaction | ElectrostaticPrecipitation | ElectrostaticPrecipitation | ElectrostaticPrecipitation | NA | Same |
| Ultravision2SoftwareCategory | BasicDocumentation | BasicDocumentation | BasicDocumentation | NA | Same |
| Ionwand tipmaterial | Implant gradeStainless steel,annealed | Implant gradeStainless steel,annealed | Implant gradeStainless steel,annealed | N/A | Same |
| Ionwand energymodality | HVDC | HVDC | HVDC | N/A | Same |
| Ionwand workinglength | N/A- integratedinto instrument -refer to electrodeworking length | N/A- integrated intoinstrument - refer toelectrode workinglength | 109mm | N/A | Similar feature butdifferent dimension |
| Handpieceelectrosurgicalenergy modality | Monopolar | Monopolar | N/A | Monopolar | Same |
| HandpieceOperationPrinciple | Colored andsegregated fingerswitches fora) Cutting (yellow)b) Coagulation(blue) | Colored andsegregated fingerswitches fora) Cutting (yellow)b) Coagulation(blue)c) Manual Smokeprecipitation (grey) | NA | Colored segregatedfinger switchesa) Cutting (yellow)b) Coagulation(blue) | Same |
| Handpiecephysical anddimensionalcharacteristics | Includes electrodeand handpiece inan integrated form | Includes electrodeand handpiece in anintegrated form | N/A | Comprises separatehandpiece andelectrode | Similar |
| Handpiece shaftand shaftinsulationmaterials | Stainless steelshaft,fluoropolymershaft insulation | Stainless steel shaft,fluoropolymer shaftinsulation | NA | Stainless steel shaft,polyolefin shaftinsulation | Similar |
| Handpiece totalelectroderesistance (tip to | 5Ω max | 5Ω max | N/A | Unknown | Similar |
| Feature/Specification | Ultravision2TMSystem withIonPencilTM | Ultravision2TMSystem IntegratedMonopolar L-Hook (H/S)TMPredicate 1 | Ultravision VisualField ClearingSystemPredicate 2 | Megadyne Pencilwith Megadyne EZCleanElectrosurgicalElectrodePredicate 3,4 | Comparison |
| (plug) | |||||
| Electrode tipinsulation | PTFE electrode tipinsulationPTFE coatedelectrode | PTFE electrode tipinsulationPTFE coatedelectrode | N/A | PTFE electrode tipinsulation, non-coated electrode,and PTFE coatedelectrode | Similar |
| Electrode tipdesign | Stainless steel | L- wire, stainlesssteel | N/A | stainless steel | Similar |
| Handpieceperformance | Performs cut andcoagulation inelectrosurgicalproceduresANDVisual fieldclearing | Performs cut andcoagulation inelectrosurgicalproceduresANDVisual field clearing | Visual fieldclearing | Performs cut andcoagulation inelectrosurgicalprocedures | Similar |
| Handpiececompatibility | Compatible withthe Ultravision2TMGenerator | Compatible with5mm cannular orlargerCompatible with theUltravision2TMGenerator | N/A | Compatible withMegadyneGenerator | Similar. Thedifference ingeneratorcompatibility doesnot raise newquestions of safetyand effectiveness |
| How Supplied(single use) | IonPencil -suppliedsterile in singleblister pack orpouch | Integratedhandpiece -suppliedsterile in singleblister pack orpouch | Ionwand, trocar -supplied sterile insingle blister orpouch | Supplied sterile insingle pouches | Same |
| Biocompatibility | Meets ISO 10993Part 5,10 and 11 | Meets ISO 10993Part 5,10 and 11 | Meets ISO 10993Part 5,10 and 11 | Biocompatible | Same |
| Sterilization | EtO | EtO | EtO | Gamma Irradiation | Similar. All usestandardsterilizationmodalities |
| SterilityAssurance Level | 10-6 | 10-6 | 10-6 | 10-6 | Same |
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Summary of Non-clinical Testing:
Testing demonstrated acceptable device performance for the device's intended use. System verification and validation activities were successfully completed as follows:
| Test Performed | Standard/Specification Followed | Acceptance Criteria | Results |
|---|---|---|---|
| Electrical safety andelectromagneticcompatibility inaccordance with IEC60601-1, | IEC 60601-1 Medical ElectricalEquipment, Edition 3.1, which isEdition 3.0 (2005-12) as modifiedby AM1 (2012-07) evaluation. | Device must meet therequirements of theapplicable clauses in thestandards | Pass |
| IEC 60601-2-2, IEC60601-1-2 includingcapacitive couplingassessment. | IEC 60601-2-2 High FrequencySurgical Equipment (2017-03)evaluationEN 60601-1-2:2015 + A1:2021Medical electrical equipmentGeneral requirements for basicsafety and essential performance.Collateral Standard:Electromagnetic disturbances | Device must meet therequirements of theapplicable clauses in thestandards | Pass |
| Shelf Life | ASTM F1980-16 Standard Guidefor Accelerated Aging of SterileMedical Device PackagesASTM 2096 Standard Test Methodfor Detecting Gross Leaks inPackaging by InternalPressurizationASTM F88/F88M -15 StandardTest Method for Seal Strength ofFlexible Barrier Materials | Product and packagemust demonstratestability for the claimedshelf life of six months. | Pass |
| Mechanical robustness ofdevice | Internal Specification | Device must meetmechanical specificationper internal standards. | Pass |
| General, visual,dimensional and electricalverification of instrument | Internal Specification | Device must meetdimensional, electrical,and physicalspecifications per internalstandards. | Pass |
| Visual field clearing(surgical smoke removal) | Internal Specification | Device must meetperformancespecifications per theinternal standards. | Pass |
| Electrical bench tests | Internal Specification | Device must meetelectrical performanceand safety specificationsper the internal standards. | Pass |
| Test Performed | Standard/Specification Followed | Acceptance Criteria | Results |
| Assessment of thermaldepth of margin | Internal Specification | The thermal margin mustbe substantiallyequivalent to the predicatedevice in terms of itspotential for tissuedamage | Pass |
| Design validation undersimulated use conditions | Internal Specification | Device must achieve itsintended use when usedby end users and thatperformance is at leastequivalent to the predicatedevice | Pass |
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Biocompatibility
The tissue contacting components of the Ultravision2™ IonPencil are similar to the materials of the predicate devices. Biocompatibility testing was performed to demonstrate that the device is biocompatible. The following testing was completed with acceptable results:
| Test Name | Standard | Acceptance Criteria | Pass/Fail |
|---|---|---|---|
| Cytotoxicity | ISO 10993-5: 2009 | Under the condition of the test,the test article must be non-cytotoxic | Pass |
| Skin Irritation Study inRabbits | ISO10993-23: 2021 | Under the condition of the test,the test article must be non-irritating. | Pass |
| Systemic Toxicity inMice | ISO 10993-11: 2017 | Under the condition of the test,the test article must not elicitevidence of systemic toxicity. | Pass |
| Guinea PigMaximizationSensitization Test | ISO 10993-10: 2021 | Under the condition of the test,the test article must be non-sensitizing. | Pass |
| Hemolysis | ISO 10993-4: 2017 | Under the condition of the test,the test article must be non-hemolytic. | Pass |
| Material MediatedPyrogens | USP General Chapter<151> | Under the condition of the test,the test article must be non-pyrogenic | Pass |
Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(k) submission, K240868 is as safe, as effective, and performs as well as or better than the legally marketed predicate devices cleared under K231298, K200035, Class II (21 CFR 878.5050), product code PQM, and K965054, K081791, Class II (21 CFR 878.4400), product code GEI.
§ 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.