(180 days)
Not Found
No
The description focuses on the electrosurgical and smoke clearing functions, which are based on standard electrical and mechanical principles, not AI/ML. There is no mention of AI, ML, or related concepts like image processing or data-driven decision making.
Yes.
The device is used to facilitate cutting and coagulating tissue during surgical procedures, which are therapeutic actions to treat a medical condition.
No
The device is described as facilitating cutting and coagulating tissue, and clearing smoke during laparoscopic surgery, which are therapeutic functions. It does not mention any capabilities related to diagnosing conditions or collecting diagnostic information.
No
The device description clearly outlines a physical surgical instrument (L-Hook) with integrated hardware components for cutting, coagulation, and smoke clearing. It interfaces with a generator and is introduced via surgical trocars, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting, coagulating of tissue, in combination with the clearance of smoke and other particulate matter that is created during laparoscopic surgery." This describes a surgical tool used directly on the patient's tissue during a procedure.
- Device Description: The description details a device that uses monopolar HF energy for tissue manipulation and electrostation for smoke clearing. These are physical actions performed on the patient's body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) in vitro (outside the body) to provide diagnostic information about a patient's health or condition.
- Anatomical Site: The device is used within the "Abdominal and pelvic cavity," which is an in vivo (within the body) application.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
PQM, GEI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdominal and pelvic cavity.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
General patients requiring electrosurgery in a hospital setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
Electrical safety and electromagnetic compatibility in accordance with IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2 including capacitive coupling assessment. Standards Followed: IEC 60601-1 Medical Electrical Equipment, Edition 3.1, which is Edition 3.0 (2005-12) as modified by AM1 (2012-07) evaluation; IEC 60601-2-2 High Frequency Surgical Equipment (2017-03) evaluation; EN 60601-1-2:2015 + A1:2021 Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic disturbances. Acceptance Criteria: Device must meet the requirements of the applicable clauses in the standards. Results: Pass.
Shelf Life. Standards Followed: 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. Acceptance Criteria: Product and package must demonstrate stability for the claimed shelf life of six months. Results: Pass.
Mechanical robustness of device. Acceptance Criteria: Device must meet mechanical specification per internal standards. Results: Pass.
General, visual, dimensional and electrical verification of instrument. Acceptance Criteria: Device must meet dimensional, electrical, and physical specifications per internal standards. Results: Pass.
Visual field clearing (surgical smoke removal). Acceptance Criteria: Device must meet performance specifications per the internal standards. Results: Pass.
Electrical bench tests. Acceptance Criteria: Device must meet electrical performance and safety specifications per the internal standards. Results: Pass.
Assessment of thermal depth of margin. Acceptance Criteria: The thermal margin must be substantially equivalent to the predicate device in terms of its potential for tissue damage. Results: Pass.
Design validation under simulated use conditions. Acceptance Criteria: Device must achieve its intended use when used by end users and that performance is at least equivalent to the predicate device. Results: Pass.
Biocompatibility:
Cytotoxicity. Standard followed: ISO 10993-5: 2009. Acceptance Criteria: Under the condition of the test, the test article must be non-cytotoxic. Results: Pass.
Skin Irritation Study in Rabbits. Standard followed: ISO 10993-11: 2017. Acceptance Criteria: Under the condition of the test, the test article must be non-irritating. Results: Pass.
Systemic Toxicity in Mice. Standard followed: ISO 10993-10: 2021. Acceptance Criteria: Under the condition of the test, the test article must not elicit evidence of systemic toxicity. Results: Pass.
Guinea Pig Maximization Sensitization Test. Standard followed: ISO 10993-10: 2021. Acceptance Criteria: Under the condition of the test, the test article must be non-sensitizing. Results: Pass.
Hemolysis. Standard followed: ISO 10993-4: 2017. Acceptance Criteria: Under the condition of the test, the test article must be non-hemolytic. Results: Pass.
Material Mediated Pyrogens. Standard followed: USP General Chapter . Acceptance Criteria: Under the condition of the test, the test article must be non-pyrogenic. Results: Pass.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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"
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) 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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4
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 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: | 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 and | |
| Clean CoatTM Laparoscopic Wire L-Hook Monopolar Electrode | |
| K153265 (electrode) |
5
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:
6
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 Monopolar | |||
| L-HookTM | ||||
| Subject Device | Ultravision Visual | |||
| Field Clearing | ||||
| System | ||||
| (UV1) | ||||
| Predicate 1 | Covidien Laparoscopic | |||
| Handset with | ||||
| CleanCoatTM | ||||
| Laparoscopic Wire L- | ||||
| Hook Monopolar | ||||
| Electrode | ||||
| Predicate 2 | Comparison | |||
| Regulatory | ||||
| Clearance/ | ||||
| Approval | ||||
| Reference | K231298 | K200035 | K964175 (handpiece) | |
| K153265 (electrode) | N/A | |||
| Product Code(s) | PQM | |||
| GEI | PQM | GEI | Equivalent | |
| Regulation | ||||
| Number(s) | 878.5050 | |||
| 878.4400 | 878.5050 | 878.4400 | Equivalent | |
| Regulation | ||||
| Name(s) | Surgical Smoke | |||
| Precipitator | ||||
| AND | ||||
| Electrosurgical | ||||
| Cutting | ||||
| &Coagulation & | ||||
| Accessories | Surgical Smoke | |||
| Precipitator | Electrosurgical | |||
| Cutting | ||||
| &Coagulation & | ||||
| Accessories | Equivalent | |||
| Where used | ||||
| (environment) | Laparoscopic | |||
| surgery | Surgery, including | |||
| laparoscopic | ||||
| surgery | Minimally invasive | |||
| surgical procedures | ||||
| including | ||||
| laparoscopic and | ||||
| thoracoscopic | Equivalent | |||
| Anatomical Sites | Abdominal and | |||
| pelvic cavity. | Abdominal and | |||
| pelvic cavity. | Abdominal and | |||
| pelvic cavity. | Equivalent | |||
| Target population | General patients | |||
| requiring | ||||
| electrosurgery in a | ||||
| hospital setting | General patients | |||
| requiring | ||||
| electrosurgery in a | ||||
| hospital setting | General patients | |||
| requiring | ||||
| electrosurgery in a | ||||
| hospital setting | Equivalent | |||
| Technical Characteristics Comparison Table | ||||
| Feature/ | ||||
| Specification | Integrated Monopolar | |||
| L-Hook™ | ||||
| Subject Device | Ultravision Visual | |||
| Field Clearing | ||||
| System | ||||
| (UV1) | ||||
| Predicate 1 | Covidien Laparoscopic | |||
| Handset with | ||||
| CleanCoat™ | ||||
| Laparoscopic Wire L- | ||||
| Hook Monopolar | ||||
| Electrode | ||||
| Predicate 2 | Comparison | |||
| Current | Ionwand- | |||
| intermittent max | ||||
| 20μA | ||||
| Integrated L-Hook | ||||
| instrument- 2 x | ||||
| 20μA intermittent | ||||
| max | Continuous max | |||
| 10μA | N/A | Similar | ||
| This difference does | ||||
| not raise new | ||||
| questions of safety | ||||
| and effectiveness., | ||||
| confirmed through | ||||
| standardized | ||||
| electrical safety | ||||
| testing | ||||
| Visual field | ||||
| clearing | ||||
| mechanism of | ||||
| action | Electrostatic | |||
| Precipitation | Electrostatic | |||
| Precipitation | N/A | Equivalent | ||
| Ionwand tip | ||||
| material | Implant grade | |||
| Stainless steel, | ||||
| annealed | Implant grade | |||
| Stainless steel, | ||||
| annealed. | N/A | Equivalent | ||
| Ionwand energy | ||||
| modality | HVDC | HVDC | N/A | Equivalent |
| Ionwand working | ||||
| length | N/A- integrated | |||
| into instrument - | ||||
| refer to electrode | ||||
| working length | 109mm | N/A | Similar feature but | |
| different dimension | ||||
| Handpiece | ||||
| Electrode modality | Monopolar for | |||
| electrosurgery | ||||
| HVDC for visual | ||||
| field clearance | N/A | Monopolar for | ||
| electrosurgery | Equivalent | |||
| Handpiece | ||||
| Operation Principle | Colored and | |||
| segregated finger | ||||
| switches for | ||||
| a) Cutting (yellow) | ||||
| b) Coagulation | ||||
| (blue) | ||||
| c) Smoke | ||||
| precipitation (grey) | N/A | Rocker switch for | ||
| a) Cutting (yellow) | ||||
| b) Coagulation (blue) | ||||
| c) Vacuum control - | ||||
| 2 buttons | ||||
| d) Irrigation port | Equivalent RF | |||
| controls | ||||
| Both include smoke | ||||
| clearing | ||||
| The absence of | ||||
| irrigation in | ||||
| Ultravision 2 does | ||||
| not raise new | ||||
| questions about | ||||
| safety and | ||||
| Technical Characteristics Comparison Table | ||||
| Feature/ | ||||
| Specification | Integrated Monopolar | |||
| L-Hook™ | ||||
| Subject Device | Ultravision Visual | |||
| Field Clearing | ||||
| System | ||||
| (UV1) | ||||
| Predicate 1 | Covidien Laparoscopic | |||
| Handset with | ||||
| CleanCoat™ | ||||
| Laparoscopic Wire L- | ||||
| Hook Monopolar | ||||
| Electrode | ||||
| Predicate 2 | Comparison | |||
| effectiveness | ||||
| Handpiece physical | ||||
| and dimensional | ||||
| characteristics | Includes electrode | |||
| and handpiece in | ||||
| an integrated form | N/A | Comprises separate | ||
| handpiece and | ||||
| electrode | Equivalent in an | |||
| integrated form | ||||
| Electrode Working | ||||
| length | 32cm | N/A | 36cm & 45cm | |
| 32cm when | ||||
| connected to the | ||||
| handset | Equivalent | |||
| Handpiece shaft | ||||
| and shaft insulation | ||||
| materials | Stainless steel | |||
| shaft, | ||||
| fluoropolymer | ||||
| shaft insulation | N/A | Stainless steel shaft, | ||
| polyolefin shaft | ||||
| insulation | Commonly used | |||
| insulation materials | ||||
| used | ||||
| Handpiece total | ||||
| electrode resistance | ||||
| (tip to plug) | $1Ω$ max | N/A | Less than $100 mΩ$ | Similar |
| Electrode tip | ||||
| insulation | PTFE electrode tip | |||
| insulation | ||||
| PTFE coated | ||||
| electrode | N/A | PTFE electrode tip | ||
| insulation, non- | ||||
| coated electrode, and | ||||
| PTFE coated | ||||
| electrode | Equivalent | |||
| Handpiece tip | ||||
| design | L- wire, stainless | |||
| steel 17-7PH | N/A | L-wire, stainless steel | Equivalent | |
| Handpiece | ||||
| performance | Performs cut and | |||
| coagulation in | ||||
| electrosurgical | ||||
| procedures | ||||
| AND | ||||
| Visual field | ||||
| clearing | Visual field | |||
| clearing | Performs cut and | |||
| coagulation in | ||||
| electrosurgical | ||||
| procedures and | ||||
| smoke evacuation | ||||
| and irrigation | Similar except for | |||
| suction which is not | ||||
| needed for | ||||
| Ultravision. The | ||||
| absence of irrigation | ||||
| in the subject device | ||||
| does not raise new | ||||
| questions about | ||||
| safety and | ||||
| effectiveness | ||||
| Handpiece | ||||
| compatibility | Compatible with | |||
| 5mm cannular or | ||||
| larger | N/A | Compatible with | ||
| electrosurgical with | ||||
| 0.093" nozzle and | ||||
| with 5mm cannula or | The difference in | |||
| generator | ||||
| compatibility does | ||||
| not raise new | ||||
| Technical Characteristics Comparison Table | ||||
| Feature/ | ||||
| Specification | Integrated Monopolar | |||
| L-HookTM | ||||
| Subject Device | Ultravision Visual | |||
| Field Clearing | ||||
| System | ||||
| (UV1) | ||||
| Predicate 1 | Covidien Laparoscopic | |||
| Handset with | ||||
| CleanCoatTM | ||||
| Laparoscopic Wire L- | ||||
| Hook Monopolar | ||||
| Electrode | ||||
| Predicate 2 | Comparison | |||
| Compatible with | ||||
| the Ultravision2TM | ||||
| Generator | larger | |||
| Compatible with | ||||
| Valleylab RF energy | ||||
| platforms | questions of safety | |||
| and effectiveness | ||||
| How Supplied | ||||
| (single use) | Integrated | |||
| handpiece - | ||||
| supplied sterile in | ||||
| single blister pack | ||||
| or pouch | Ionwand, trocar - | |||
| supplied sterile in | ||||
| single blister or | ||||
| pouch | Supplied sterile in | |||
| single pouches | Equivalent | |||
| Biocompatibility | Meets ISO 10993 | |||
| Part 5,10 and 11 | Meets ISO 10993 | |||
| Part 5,10 and 11 | Assume | |||
| biocompatibility was | ||||
| demonstrated | Equivalent | |||
| Sterilization | EtO | EtO | Gamma Irradiation | All use standard |
| sterilization | ||||
| modalities | ||||
| Sterility Assurance | ||||
| Level | 10-6 | 10-6 | 10-6 | Equivalent |
| Mechanism of | ||||
| action of visual | ||||
| field clearance | Electrostatic | |||
| precipitation | Electrostatic | |||
| precipitation | NA | Equivalent |
7
8
9
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 and | |||
| electromagnetic | |||
| compatibility in | |||
| accordance with IEC | |||
| 60601-1, | IEC 60601-1 Medical Electrical | ||
| Equipment, Edition 3.1, which is | |||
| Edition 3.0 (2005-12) as modified | |||
| by AM1 (2012-07) evaluation. | Device must meet the | ||
| requirements of the | |||
| applicable clauses in the | |||
| standards | Pass | ||
| IEC 60601-2-2, IEC | |||
| 60601-1-2 including | |||
| capacitive coupling | |||
| assessment. | IEC 60601-2-2 High Frequency | ||
| Surgical Equipment (2017-03) | |||
| evaluation | |||
| EN 60601-1-2:2015 + A1:2021 | |||
| Medical electrical equipment | Device must meet the | ||
| requirements of the | |||
| applicable clauses in the | |||
| standards | Pass | ||
| Test Performed | Standard Followed | Acceptance Criteria | Results |
| General requirements for basic | |||
| safety and essential performance. | |||
| Collateral Standard: | |||
| Electromagnetic disturbances | |||
| 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 | Device must meet | |
| mechanical specification | |||
| per internal standards. | Pass | ||
| General, visual, | |||
| dimensional and electrical | |||
| verification of instrument | NA | Device must meet | |
| dimensional, electrical, | |||
| and physical | |||
| specifications per internal | |||
| standards. | Pass | ||
| Visual field clearing | |||
| (surgical smoke removal) | NA | Device must meet | |
| performance | |||
| specifications per the | |||
| internal standards. | Pass | ||
| Electrical bench tests | NA | 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 | ||
| 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 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 |
| Under the condition of the test,
the test article must be non-
pyrogenic | Pass |
10
11
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.