(180 days)
The Ultravision 2™ Integrated Monopolar L-Hook (H/S)™ is intended to be used with applications in surgical procedures to facilitate cutting, coagulating of tissue, in combination with the clearance of smoke and other particulate matter that is created during laparoscopic surgery.
The Integrated Monopolar L-Hook (H/S)™ is a bifunctional device that combines proprietary visual field clearing and monopolar HF tissue and coagulation in a single device. The Integrated Monopolar L-Hook (H/S)™ can only interface with the Ultravision2 generator which connects directly to a commercially available electrosurgical generator (ESU) for its HF monopolar energy source. The Integrated Monopolar L-Hook (H/S)™ provides two recessed 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 visual field clearing is electrostation as per the predicate Ultravision system. When the tissue cutting is ceased, the visual field clearing signal is automatically switched off after a short delay period that is settable on the Ultravision 2 generator user interface. Activation of the HF function of the Integrated Monopolar L-Hook (H/S)™ 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 Ultravision 2 system. The Integrated Monopolar L-Hook (H/S)™ itself is incompatible with the connectors of third party electrosurgical generators. On demand visual field clearing only can also be applied by activation of a third grey button on the handle. This clearing field action is stopped immediately after release of the grey button. The Integrated Monopolar L-Hook (H/S)™ is available with of 32cm. It is intended to be introduced via standard 5mm surgical trocars as long as their internal diameter is 5.70mm or greater. The device is for prescription use only.
The provided text is a 510(k) summary for the Ultravision2™ System Integrated Monopolar L-Hook (H/S)™. It details the device's characteristics, comparison to predicate devices, and a summary of non-clinical testing.
However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of a software-driven AI device. The device described is a surgical instrument that combines visual field clearing and monopolar HF tissue cutting/coagulation. The "visual field clearing" mechanism is stated as "electrostatic precipitation," which is a physical principle, not an AI algorithm.
Therefore, many parts of your request, specifically those related to AI/software performance, ground truth establishment, expert adjudication, MRMC studies, or training sets, cannot be answered from the provided text.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics comparison and non-clinical bench testing for safety and performance of the surgical instrument itself.
Here is what can be extracted from the provided text regarding device acceptance and performance through non-AI related testing:
1. A table of acceptance criteria and the reported device performance
| Test Performed | Standard Followed | Acceptance Criteria | Result |
|---|---|---|---|
| Electrical safety and electromagnetic compatibility | IEC 60601-1 Medical Electrical Equipment, Edition 3.1; IEC 60601-2-2 High Frequency Surgical Equipment (2017-03); EN 60601-1-2:2015 + A1:2021 Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic disturbances | Device must meet the requirements of the applicable clauses in the standards | Pass |
| Shelf Life | ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Medical Device Packages; ASTM 2096 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization; ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials | Product and package must demonstrate stability for the claimed shelf life of six months. | Pass |
| Mechanical robustness of device | NA (Internal standards) | Device must meet mechanical specification per internal standards. | Pass |
| General, visual, dimensional and electrical verification of instrument | NA (Internal standards) | Device must meet dimensional, electrical, and physical specifications per internal standards. | Pass |
| Visual field clearing (surgical smoke removal) | NA (Internal standards) | Device must meet performance specifications per the internal standards. | Pass |
| Electrical bench tests | NA (Internal standards) | Device must meet electrical performance and safety specifications per the internal standards. | Pass |
| Assessment of thermal depth of margin | NA | 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 | NA | Device must achieve its intended use when used by end users and that performance is at least equivalent to the predicate device | Pass |
| Cytotoxicity | ISO 10993-5: 2009 | Under the condition of the test, the test article must be non-cytotoxic | Pass |
| Skin Irritation Study in Rabbits | ISO 10993-11: 2017 | Under the condition of the test, the test article must be non-irritating. | Pass |
| Systemic Toxicity in Mice | ISO 10993-10: 2021 | 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 |
2. Sample sized used for the test set and the data provenance:
- The document does not specify sample sizes for the various tests.
- Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned as the testing relates to the physical device and its biocompatibility/electrical safety, not clinical study data for AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This is not applicable as the device is not an AI/software device requiring expert interpretation of medical images or data. Ground truth for the described tests would be established by validated measurement techniques and laboratory protocols based on the specified ISO and ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for the type of testing described (bench testing, biocompatibility).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. The device is a surgical instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biocompatibility tests, ground truth is established by the specific chemical and biological reactions/observations as defined by the ISO and USP standards (e.g., cell viability for cytotoxicity, skin reaction for irritation, hemolysis levels).
- For electrical safety and mechanical tests, ground truth is established by direct physical measurements against engineering specifications and international standards (IEC, EN, ASTM).
- For "Visual field clearing" and "Design validation under simulated use conditions," the ground truth is against internal performance specifications, aiming for equivalence to predicate devices, implying practical demonstration of effectiveness.
8. The sample size for the training set:
- Not applicable as this is not an AI/machine learning device.
9. 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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 31, 2023
Alesi Surgical Ltd. % Michele Lucey President Lakeshore Medical Device Consulting 128 Blve Hill Landing Newbury, New Hampshire 03255
Re: K231298
Trade/Device Name: Ultravision2™ System Integrated Monopolar L-Hook (H/S)™ Regulation Number: 21 CFR 878.5050 Regulation Name: Surgical Smoke Precipitator Regulatory Class: Class II Product Code: PQM, GEI Dated: May 2, 2023 Received: May 4, 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"
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(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
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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) K231298
Device Name
Ultravision2™ System Integrated Monopolar L-Hook (H/S)™
Indications for Use (Describe)
The Ultravision 2™ Integrated Monopolar L-Hook (H/S)™ is intended to be used with applications in surgical procedures to facilitate cutting, coagulating of tissue, in combination with the clearance of smoke and other particulate matter that is created during laparoscopic 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/4/Picture/0 description: The image shows the logo for Alesi Surgical. The logo consists of three teardrop shapes in different shades of blue and purple arranged in a triangular formation on the left. To the right of the shapes is the word "alesi" in a dark blue sans-serif font, with the word "surgical" in a lighter blue sans-serif font underneath.
K231298
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 |
| Fax: | +44 (0) 2920750239 |
| Contact Person: | Michele LuceyLakeshore Medical Device Consulting LLC.128 Blye Hill Landing.Newbury,New Hampshire 03255 |
| Telephone: | 603-748-1374 |
| Date Prepared: | October 31, 2023 |
| Device Proprietary Name: | Ultravision2TM Integrated Monopolar L-Hook(H/S) TM |
| Common Name: | Surgical Smoke Precipitator |
| Classification Name: | Surgical Smoke Precipitator |
| Classification Regulation: | 21 CFR 878.5050 |
| Product Code: | PQM |
| Common Name: | Electrosurgical accessory, laparoscopic electrode |
| Classification Regulation: | 21 CFR 878.4400 |
| Product Code: | GEI |
| Regulatory Class: | Class II |
| Predicate Device: | UltravisionTM Visual Field Clearing System (K200035)Covidien Laparoscopic Handset K964175 andClean CoatTM Laparoscopic Wire L-Hook Monopolar ElectrodeK153265 (electrode) |
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Indications for Use:
The Ultravision 2™ Integrated Monopolar L-Hook (H/S)™ is intended to be used with applications in surgical procedures to facilitate cutting, coagulating of tissue, in combination with the clearance of smoke and other particulate matter that is created during laparoscopic surgery.
Device Description/Technological Characteristics:
The Integrated Monopolar L-Hook (H/S)™ is a bifunctional device that combines proprietary visual field clearing and monopolar HF tissue and coagulation in a single device.
The Integrated Monopolar L-Hook (H/S)™ can only interface with the Ultravision2 generator which connects directly to a commercially available electrosurgical generator (ESU) for its HF monopolar energy source. The Integrated Monopolar L-Hook (H/S)™ provides two recessed 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 visual field clearing is electrostation as per the predicate Ultravision system. When the tissue cutting is ceased, the visual field clearing signal is automatically switched off after a short delay period that is settable on the Ultravision 2 generator user interface.
Activation of the HF function of the Integrated Monopolar L-Hook (H/S)™ 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 Ultravision 2 system. The Integrated Monopolar L-Hook (H/S)™ itself is incompatible with the connectors of third party electrosurgical generators.
On demand visual field clearing only can also be applied by activation of a third grey button on the handle. This clearing field action is stopped immediately after release of the grey button.
The Integrated Monopolar L-Hook (H/S)™ is available with of 32cm. It is intended to be introduced via standard 5mm surgical trocars as long as their internal diameter is 5.70mm or greater. The device is for prescription use only.
| Model # | Component Description |
|---|---|
| DPD-006-001 | Ultravision2™ System, including:• Standalone generator• Link cables (monopolar and return)• Equipotential cable• Power cable |
| DPD-006-201 | The Integrated Monopolar L-Hook (H/S)™ |
When used with the Ultravision2 generator the components of the system will be:
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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.
| Technical Characteristics Comparison Table | ||||
|---|---|---|---|---|
| Feature/Specification | Integrated MonopolarL-HookTMSubject Device | Ultravision VisualField ClearingSystem(UV1)Predicate 1 | Covidien LaparoscopicHandset withCleanCoatTMLaparoscopic Wire L-Hook MonopolarElectrodePredicate 2 | Comparison |
| RegulatoryClearance/ApprovalReference | K231298 | K200035 | K964175 (handpiece)K153265 (electrode) | N/A |
| Product Code(s) | PQMGEI | PQM | GEI | Equivalent |
| RegulationNumber(s) | 878.5050878.4400 | 878.5050 | 878.4400 | Equivalent |
| RegulationName(s) | Surgical SmokePrecipitatorANDElectrosurgicalCutting&Coagulation &Accessories | Surgical SmokePrecipitator | ElectrosurgicalCutting&Coagulation &Accessories | Equivalent |
| Where used(environment) | Laparoscopicsurgery | Surgery, includinglaparoscopicsurgery | Minimally invasivesurgical proceduresincludinglaparoscopic andthoracoscopic | Equivalent |
| Anatomical Sites | Abdominal andpelvic cavity. | Abdominal andpelvic cavity. | Abdominal andpelvic cavity. | Equivalent |
| Target population | General patientsrequiringelectrosurgery in ahospital setting | General patientsrequiringelectrosurgery in ahospital setting | General patientsrequiringelectrosurgery in ahospital setting | Equivalent |
| Technical Characteristics Comparison Table | ||||
| Feature/Specification | Integrated MonopolarL-Hook™Subject Device | Ultravision VisualField ClearingSystem(UV1)Predicate 1 | Covidien LaparoscopicHandset withCleanCoat™Laparoscopic Wire L-Hook MonopolarElectrodePredicate 2 | Comparison |
| Current | Ionwand-intermittent max20μAIntegrated L-Hookinstrument- 2 x20μA intermittentmax | Continuous max10μA | N/A | SimilarThis difference doesnot raise newquestions of safetyand effectiveness.,confirmed throughstandardizedelectrical safetytesting |
| Visual fieldclearingmechanism ofaction | ElectrostaticPrecipitation | ElectrostaticPrecipitation | N/A | Equivalent |
| Ionwand tipmaterial | Implant gradeStainless steel,annealed | Implant gradeStainless steel,annealed. | N/A | Equivalent |
| Ionwand energymodality | HVDC | HVDC | N/A | Equivalent |
| Ionwand workinglength | N/A- integratedinto instrument -refer to electrodeworking length | 109mm | N/A | Similar feature butdifferent dimension |
| HandpieceElectrode modality | Monopolar forelectrosurgeryHVDC for visualfield clearance | N/A | Monopolar forelectrosurgery | Equivalent |
| HandpieceOperation Principle | Colored andsegregated fingerswitches fora) Cutting (yellow)b) Coagulation(blue)c) Smokeprecipitation (grey) | N/A | Rocker switch fora) Cutting (yellow)b) Coagulation (blue)c) Vacuum control -2 buttonsd) Irrigation port | Equivalent RFcontrolsBoth include smokeclearingThe absence ofirrigation inUltravision 2 doesnot raise newquestions aboutsafety and |
| Technical Characteristics Comparison Table | ||||
| Feature/Specification | Integrated MonopolarL-Hook™Subject Device | Ultravision VisualField ClearingSystem(UV1)Predicate 1 | Covidien LaparoscopicHandset withCleanCoat™Laparoscopic Wire L-Hook MonopolarElectrodePredicate 2 | Comparison |
| effectiveness | ||||
| Handpiece physicaland dimensionalcharacteristics | Includes electrodeand handpiece inan integrated form | N/A | Comprises separatehandpiece andelectrode | Equivalent in anintegrated form |
| Electrode Workinglength | 32cm | N/A | 36cm & 45cm32cm whenconnected to thehandset | Equivalent |
| Handpiece shaftand shaft insulationmaterials | Stainless steelshaft,fluoropolymershaft insulation | N/A | Stainless steel shaft,polyolefin shaftinsulation | Commonly usedinsulation materialsused |
| Handpiece totalelectrode resistance(tip to plug) | $1Ω$ max | N/A | Less than $100 mΩ$ | Similar |
| Electrode tipinsulation | PTFE electrode tipinsulationPTFE coatedelectrode | N/A | PTFE electrode tipinsulation, non-coated electrode, andPTFE coatedelectrode | Equivalent |
| Handpiece tipdesign | L- wire, stainlesssteel 17-7PH | N/A | L-wire, stainless steel | Equivalent |
| Handpieceperformance | Performs cut andcoagulation inelectrosurgicalproceduresANDVisual fieldclearing | Visual fieldclearing | Performs cut andcoagulation inelectrosurgicalprocedures andsmoke evacuationand irrigation | Similar except forsuction which is notneeded forUltravision. Theabsence of irrigationin the subject devicedoes not raise newquestions aboutsafety andeffectiveness |
| Handpiececompatibility | Compatible with5mm cannular orlarger | N/A | Compatible withelectrosurgical with0.093" nozzle andwith 5mm cannula or | The difference ingeneratorcompatibility doesnot raise new |
| Technical Characteristics Comparison Table | ||||
| Feature/Specification | Integrated MonopolarL-HookTMSubject Device | Ultravision VisualField ClearingSystem(UV1)Predicate 1 | Covidien LaparoscopicHandset withCleanCoatTMLaparoscopic Wire L-Hook MonopolarElectrodePredicate 2 | Comparison |
| Compatible withthe Ultravision2TMGenerator | largerCompatible withValleylab RF energyplatforms | questions of safetyand effectiveness | ||
| How Supplied(single use) | Integratedhandpiece -supplied sterile insingle blister packor pouch | Ionwand, trocar -supplied sterile insingle blister orpouch | Supplied sterile insingle pouches | Equivalent |
| Biocompatibility | Meets ISO 10993Part 5,10 and 11 | Meets ISO 10993Part 5,10 and 11 | Assumebiocompatibility wasdemonstrated | Equivalent |
| Sterilization | EtO | EtO | Gamma Irradiation | All use standardsterilizationmodalities |
| Sterility AssuranceLevel | 10-6 | 10-6 | 10-6 | Equivalent |
| Mechanism ofaction of visualfield clearance | Electrostaticprecipitation | Electrostaticprecipitation | NA | Equivalent |
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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 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 equipment | Device must meet therequirements of theapplicable clauses in thestandards | Pass |
| Test Performed | Standard Followed | Acceptance Criteria | Results |
| General requirements for basicsafety and essential performance.Collateral Standard:Electromagnetic disturbances | |||
| 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 | NA | Device must meetmechanical specificationper internal standards. | Pass |
| General, visual,dimensional and electricalverification of instrument | NA | Device must meetdimensional, electrical,and physicalspecifications per internalstandards. | Pass |
| Visual field clearing(surgical smoke removal) | NA | Device must meetperformancespecifications per theinternal standards. | Pass |
| Electrical bench tests | NA | Device must meetelectrical performanceand safety specificationsper the internal standards. | Pass |
| Assessment of thermaldepth of margin | NA | The thermal margin mustbe substantiallyequivalent to the predicatedevice in terms of itspotential for tissuedamage | Pass |
| Design validation undersimulated use conditions | NA | Device must achieve itsintended use when usedby end users and thatperformance is at leastequivalent to the predicatedevice | Pass |
| 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 | ISO 10993-11: 2017 | Under the condition of the test,the test article must be non-irritating. | Pass |
| Systemic Toxicity inMice | ISO 10993-10: 2021 | 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 |
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Biocompatibility
The tissue contacting components of the Integrated Monopolar L-Hook (H/S)™ are substantially equivalent to the material and process to the predicate devices. Biocompatibility testing was performed to demonstrate that the device is biocompatible. The following testing was completed with acceptable results:
Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(k) submission, K231298 is as safe, as effective, and performs as well as or better than the legally marketed predicate devices cleared under K200035, Class II (21 CFR 878.5050), product code PQM, and K153265, K964175, 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.