← Product Code [PQM](/submissions/SU/subpart-e%E2%80%94surgical-devices/PQM) · K231298 # Ultravision2™ System Integrated Monopolar L-Hook (H/S)™ (K231298) _Alesi Surgical, Ltd. · PQM · Oct 31, 2023 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/PQM/K231298 ## Device Facts - **Applicant:** Alesi Surgical, Ltd. - **Product Code:** [PQM](/submissions/SU/subpart-e%E2%80%94surgical-devices/PQM.md) - **Decision Date:** Oct 31, 2023 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.5050 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended 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 Story The Ultravision2™ Integrated Monopolar L-Hook (H/S)™ is a bifunctional laparoscopic instrument combining monopolar electrosurgery with electrostatic smoke precipitation. It connects to the Ultravision2 generator, which interfaces with a third-party electrosurgical generator (ESU) for HF energy. The device features an L-hook electrode for tissue cutting and coagulation, controlled via yellow (cut) and blue (coag) buttons on the handpiece or an external footswitch. Two recessed emitters provide electrostatic smoke clearing, activated automatically during HF use or manually via a grey button. Used in abdominal and pelvic laparoscopic surgery, the device is operated by surgeons. The electrostatic field clears the visual field by precipitating smoke particles, improving visibility during procedures. The system is intended for prescription use and is compatible with 5mm or larger trocars. ## Clinical Evidence Bench testing only. Testing included electrical safety and electromagnetic compatibility (IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2), mechanical robustness, shelf-life stability (ASTM F1980-16), and performance verification of smoke clearing and thermal margin. Biocompatibility testing (ISO 10993-4, 5, 10, 11 and USP <151>) confirmed the device is non-cytotoxic, non-irritating, non-sensitizing, non-hemolytic, and non-pyrogenic. ## Technological Characteristics Bifunctional instrument: stainless steel 17-7PH L-hook electrode with PTFE coating/insulation. Employs HVDC for electrostatic smoke precipitation and monopolar HF energy for electrosurgery. Compatible with 5mm+ trocars. Sterilized via EtO. Connectivity: proprietary link to Ultravision2 generator. Software: embedded control for smoke clearing activation/delay. ## Regulatory Identification A surgical smoke precipitator is a prescription device intended for clearance of the visual field by precipitation of surgical smoke and other aerosolized particulate matter created during laparoscopic surgery. ## Special Controls In combination with the general controls of the FD&C Act, the Surgical smoke precipitator is subject to the following special controls: *Classification.* Class II (special controls). The special controls for this device are:(1) Adverse tissue reaction must be mitigated through the following: (i) Chemical characterization and toxicological risk assessment of the treated surgical smoke. (ii) Demonstration that the elements of the device that may contact the patient are biocompatible. (2) Electrical safety and electromagnetic compatibility testing must demonstrate that the device performs as intended. (3) Software verification, validation, and hazard analysis must be performed. (4) Performance data must demonstrate the sterility of the patient contacting components of the device. (5) Performance data must support the shelf life of the sterile components of the device by demonstrating continued functionality, sterility, and package integrity over the identified shelf life. (6) Animal simulated-use testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Device must be demonstrated to be effectively inserted, positioned, and removed from the site of use. (ii) Device must be demonstrated to precipitate surgical smoke particulates to clear the visual field for laparoscopic surgeries. (iii) Device must be demonstrated to be non-damaging to the site of use and animal subject. (7) Labeling must identify the following: (i) Detailed instructions for use. (ii) Electrical safety and electromagnetic compatibility information. (iii) A shelf life. ## Predicate Devices - Ultravision™ Visual Field Clearing System ([K200035](/device/K200035.md)) - Covidien Laparoscopic Handset ([K964175](/device/K964175.md)) - Clean Coat™ Laparoscopic Wire L-Hook Monopolar Electrode ([K153265](/device/K153265.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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)
| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image 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
<151> | 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. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/PQM/K231298](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/PQM/K231298) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com