← Product Code [PQM](/submissions/SU/subpart-e%E2%80%94surgical-devices/PQM) · K240868 # Ultravision2™ IonPencil (K240868) _Alesi Surgical Limited · PQM · Aug 12, 2024 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/PQM/K240868 ## Device Facts - **Applicant:** Alesi Surgical Limited - **Product Code:** [PQM](/submissions/SU/subpart-e%E2%80%94surgical-devices/PQM.md) - **Decision Date:** Aug 12, 2024 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.5050 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use The Ultravision2™ System is indicated for use in surgery including laparoscopic surgery. · The Ultravision2™ Generator is interface directly with the electrosurgical generator and serve as a passthrough for HF energy to HF electrosurgical instruments, to manage surgical smoke produced by energy-based instruments, and is indicated for use in surgery including laparoscopic surgery. · The Ionwand™ Pack is intended to be used to manage surgical smoke and is indicated for use in surgery including laparoscopic surgery. · The Ultravision™ 5mm Trocar is intended to be used to establish a path of entry for instruments and includes an Ionwand to manage surgical smoke, and is indicated for laparoscopic surgery. · The Integrated Monopolar L-Hook (H/S)™ is intended to be used to facilitate the cutting and coagulation of soft tissue, to manage surgical smoke during laparoscopic surgical procedures, and is indicated for use in laparoscopic surgery. · The IonPencil™ is intended to be used to facilitate the cutting and coagulation of soft tissue, to manage surgical smoke during general surgical procedures, and is indicated for use in surgery. ## Device Story Ultravision2™ IonPencil is a bifunctional open surgery device; combines monopolar HF tissue cutting/coagulation with electrostatic smoke management (visual field clearing). Device interfaces with Ultravision2™ Generator, which acts as a pass-through for RF energy from a third-party electrosurgical generator (ESU). Smoke management emitters activate automatically when HF cutting/coagulation is triggered via handpiece buttons (yellow for cut, blue for coag) or footswitch; clearing signal persists for a user-settable delay after HF cessation. Used in general surgery; operated by surgeons. Benefits include improved visual field clarity during procedures by managing smoke particulate. IonPencil features 69mm PTFE-coated blade; connects exclusively to Ultravision2™ generator. ## Clinical Evidence Bench testing only. Testing included electrical safety (IEC 60601-1, IEC 60601-2-2), electromagnetic compatibility (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) confirmed non-cytotoxic, non-irritating, non-sensitizing, non-hemolytic, and non-pyrogenic status. ## Technological Characteristics System comprises Ultravision2™ generator, IonPencil™ accessory, and cables. IonPencil features stainless steel shaft, fluoropolymer insulation, and PTFE-coated electrode tip. Smoke management via electrostatic precipitation (HVDC). Connectivity: interfaces with external ESU. Sterilization: EtO (SAL 10^-6). Software category: Basic Documentation. ## 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 2 System including Integrated Monopolar L-Hook (H/S) ([K231298](/device/K231298.md)) - Ultravision Visual Field Clearing System ([K200035](/device/K200035.md)) - Megadyne Pencil ([K965054](/device/K965054.md)) - Megadyne EZ Clean Electrosurgical Electrode ([K081791](/device/K081791.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). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a larger font size than the name. The name is written as "U.S. FOOD & DRUG ADMINISTRATION". August 12, 2024 Alesi Surgical Limited Pravin Patel Regulatory & Quality Manager Cardiff Medicentre, Heath Park, Cardiff, CF14 4UJ Cardiff. United Kingdom Re: K240868 Trade/Device Name: Ultravision2™M IonPencil Regulation Number: 21 CFR 878.5050 Regulation Name: Surgical Smoke Precipitator Regulatory Class: Class II Product Code: PQM, GEI Dated: March 28, 2024 Received: March 29, 2024 # Dear Pravin Patel: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Image /page/1/Picture/7 description: The image shows the name "Stephen A. Anisko" followed by "-S" and "-04'00'". The text appears to be a signature or a name with some additional information, possibly related to a timestamp or a code. Digitally signed by Stephen A. Anisko -S Date: 2024.08.12 14:11:51 for: Christopher Dugard Assistant Director DHT4C: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K240868 Device Name Ultravision2™ IonPencil #### Indications for Use (Describe) The Ultravision2™ System is indicated for use in surgery including laparoscopic surgery. · The Ultravision2™ Generator is interface directly with the electrosurgical generator and serve as a passthrough for HF energy to HF electrosurgical instruments, to manage surgical smoke produced by energy-based instruments, and is indicated for use in surgery including laparoscopic surgery. · The Ionwand™ Pack is intended to be used to manage surgical smoke and is indicated for use in surgery including laparoscopic surgery. · The Ultravision™ 5mm Trocar is intended to be used to establish a path of entry for instruments and includes an Ionwand to manage surgical smoke, and is indicated for laparoscopic surgery. · The Integrated Monopolar L-Hook (H/S)™ is intended to be used to facilitate the cutting and coagulation of soft tissue, to manage surgical smoke during laparoscopic surgical procedures, and is indicated for use in laparoscopic surgery. · The IonPencil™ is intended to be used to facilitate the cutting and coagulation of soft tissue, to manage surgical smoke during general surgical procedures, and is indicated for use in surgery. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------|------------------------------------------------------------------------------| |
Prescription Use (Part 21 CFR 801 Subpart D)
|
Over-The-Counter Use (21 CFR 801 Subpart C)
| #### 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Alesi Surgical. The logo consists of a stylized, abstract symbol on the left, composed of three curved shapes in different shades of blue and purple. To the right of the symbol is the word "alesi" in a bold, dark blue sans-serif font, with the word "surgical" underneath in a smaller, lighter blue font. # K240868 # 510(K) SUMMARY As required by 21 CFR 807.92 | Submitter Information: | | |----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter's Name: | Alesi Surgical Ltd | | Address: | Cardiff Medicentre
Heath Park
Cardiff
CF14 4UJ
UK | | Telephone: | +44 (0) 2920291022 | | Contact Person: | Pravin Patel | | Date Prepared: | August 9th, 2024 | | Device Proprietary Name: | Ultravision2™ IonPencil | | Common Name: | Surgical Smoke Precipitator | | Classification Name: | Surgical Smoke Precipitator | | Classification Regulation: | 21 CFR 878.5050 | | Product Code: | PQM | | Common Name: | Electrosurgical accessory | | Classification Regulation: | 21 CFR 878.4400 | | Product Code: | GEI | | Regulatory Class: | Class II | | Predicate Device: | Ultravision 2 System including Integrated Monopolar L-Hook (H/S)
(K231298)
Ultravision™ Visual Field Clearing System (K200035)
Megadyne Pencil (K965054) and
Megadyne EZ Clean Electrosurgical Electrode (K081791) | {4}------------------------------------------------ #### Indications for Use: The Ultravision2™ System is indicated for use in surgery including laparoscopic surgery. · The Ultravision2™ Generator is intended to interface directly with the electrosurgical generator and serve as a pass-through for HF energy to HF electrosurgical instruments, to manage surgical smoke produced by energy-based instruments, and is indicated for use in surgery including laparoscopic surgery. · The Ionwand™ Pack is intended to be used to manage surgical smoke and is indicated for use in surgery including laparoscopic surgery. · The Ultravision™ 5mm Trocar is intended to be used to establish a path of entry for instruments and includes an Ionwand to manage surgical smoke, and is indicated for laparoscopic surgery. · The Integrated Monopolar L-Hook (H/S)™ is intended to be used to facilitate the cutting and coagulation of soft tissue, to manage surgical smoke during laparoscopic surgical procedures, and is indicated for use in laparoscopic surgery. · The IonPencil™ is intended to be used to facilitate the cutting and coagulation of soft tissue, to manage surgical smoke during general surgical procedures, and is indicated for use in surgery. #### Device Description/Technological Characteristics: The Ultravision2™ System is a multifunctional system that synchronizes visual field clearing with the activation of smoke-producing electrosurgical devices. The system interfaces with commercially available electrosurgical instruments. The Ultravision2™ Generator connects directly to a commercially available electrosurgical generator (ESU) and passes the RF energy through to the desired electrosurgical instrument connected to the Utravision2™ Generator. The Ultravison2™ System is able to automate the activation of the Ionwand for visual field clearing to the electrosurgical device to synchronize visual field clearing with the generation of smoke. The components of the overall system will be: - Ultravision2TM system comprising: . - . Ultravision2TM generator - Link cables (x4) - . Power cable - Equipotential cable . - . IonPencil™ accessory - . Integrated Monopolar L-Hook(H/S)TM accessory - Ionwand™ accessory - . Ultravision™ 5mm Trocar accessory {5}------------------------------------------------ The IonPencil™ is a bifunctional open surgery device that combines proprietary smoke management (via visual field clearing) and monopolar HF tissue cutting and coagulation in a single device. It's addition to the Ultravision 2 System adds the general open procedure capability to the Ultravision2™ indications of use along with the new single use accessory. The IonPencil™ can only interface with the Ultravision2 generator which connects directly to a commercially available electrosurgical generator (ESU) for its HF monopolar energy source. The IonPencil™ provides two smoke clearing emitters that are automatically activated to clear the visual field when the device cutting function (HF) is activated. The mode of action of smoke management (visual field clearing) is electrostation as per the predicate Ultravision system. When the tissue cutting or coagulation is ceased, the visual field clearing signal is automatically switched off after a short delay period that is settable on the Ultravision2™ generator user interface. Activation of the HF function of the IonPencil™ is via a yellow (Cut) or blue (Coag) button located on the handpiece, or via a footswitch if this connected to the parent electrosurgical generator which is connected to the Ultravision2™ system. The IonPencil™ itself is incompatible with the connectors of third-party electrosurgical generators. The IonPencil™ is provided with a 69mm long PTFE coated blade. The following cleared accessories have not changed: • The Integrated Monopolar L-Hook(H/S)™ is a bifunctional laparoscopic device that combines proprietary smoke management (via visual field clearing) and monopolar HF tissue cutting and coagulation in a single device. · The Ionwand™ pack comprises a dedicated percutaneous 3mm trocar/catheter which accommodates the Ionwand™ cable that delivers low energy from the generator to the patient for smoke management. - · The Ultravision™ 5mm Trocar includes a dedicated Ionwand™ cable. ### Technological Characteristics Comparison: The comparison table below provides the similarities and differences between the predicate and subject devices. The modifications made to the subject device do not risk to safety or effectiveness. | Technical Characteristics Comparison Table | | | | | | |--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature/
Specification | Ultravision2™
System with
IonPencil™ | Ultravision2™
System Integrated
Monopolar L-
Hook (H/S)™
Predicate 1 | Ultravision Visual
Field Clearing
System
Predicate 2 | Megadyne Pencil
with Megadyne EZ
Clean
Electrosurgical
Electrode
Predicate 3,4 | Comparison | | Regulatory
Clearance/
Approval
Reference | K240868 | K231298 | K200035 | K965054
K081791 | N/A | | Product Code(s) | PQM
GEI | PQM
GEI | PQM
GEI | GEI | Equivalent | | Regulation
Number(s) | 878.5050
878.4400 | 878.5050
878.4400 | 878.5050 | 878.4400 | Equivalent | | Regulation
Name(s) | Surgical Smoke
Precipitator
AND | Surgical Smoke
Precipitator
AND | Surgical Smoke
Precipitator | Electrosurgical
Cutting
&Coagulation & | Same | | Technical Characteristics Comparison Table | | | | | | | Feature/
Specification | Ultravision2™
System with
IonPencil™ | Ultravision2™
System Integrated
Monopolar L-
Hook (H/S)™
Predicate 1 | Ultravision Visual
Field Clearing
System
Predicate 2 | Megadyne Pencil
with Megadyne EZ
Clean
Electrosurgical
Electrode
Predicate 3,4 | Comparison | | Electrosurgical
Cutting &
Coagulation &
Accessories | Electrosurgical
Cutting &
Coagulation &
Accessories | Electrosurgical
Cutting &
Coagulation &
Accessories | | Accessories | | | Intended Use and
Indications | The Ultravision2™
System is indicated
for use in surgery
including
laparoscopic
surgery.
• The
Ultravision2™
Generator is
intended to
interface directly
with the
electrosurgical
generator and serve
as a pass-through
for HF energy to
HF electrosurgical
instruments, to
manage surgical
smoke produced by
energy-based
instruments, and is
indicated for use in
surgery including
laparoscopic
surgery.
• The Ionwand™
Pack is intended to
be used to manage
surgical smoke and
is indicated for use
in surgery
including
laparoscopic
surgery.
• The Ultravision™
5mm Trocar is
intended to be used
to establish a path
of entry for
instruments and
includes an
Ionwand to manage
surgical smoke, | 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 Ultravision™
Visual Field
Clearing System is
indicated for the
clearance of smoke
and other
particulate matter
that is created
during surgery,
including
laparoscopic
surgery.
The Ultravision™
5mm Trocar
component
establishes a path
of entry for
instruments used in
laparoscopic
surgery. | E-Z Clean
electrosurgical
electrodes are
intended to conduct
radio frequency
(RF) current for
cutting and
coagulation from
the RE
electrosurgical
generator to target
soft tissue in a
broad range of
surgical procedures
requiring the use of
electrosurgery for
cutting and
cauterization. Some
tip configurations
have a specific
geometry that
minimizes
blanching and
thermal damage in
skin incisions when
used in conjunction
with the generator's
Advanced Cutting
Effect (ACE) mode. | Similar
The predicate
devices include
integration of
smoke
management with
electrosurgical
function and cover
laparoscopic and
general surgery
indications for both
functions | | Technical Characteristics Comparison Table | | | | | | | Feature/
Specification | Ultravision2™
System with
IonPencil™ | Ultravision2™
System Integrated
Monopolar L-
Hook (H/S)™
Predicate 1 | Ultravision Visual
Field Clearing
System
Predicate 2 | Megadyne Pencil
with Megadyne EZ
Clean
Electrosurgical
Electrode
Predicate 3,4 | Comparison | | | and is indicated for
laparoscopic
surgery.
• The Integrated
Monopolar L-Hook
(H/S)™ is intended
to be used to
facilitate the
cutting and
coagulation of soft
tissue, to manage
surgical smoke
during laparoscopic
surgical
procedures, and is
indicated for use in
laparoscopic
surgery
• The IonPencil™
is intended to be
used to facilitate
the cutting and
coagulation of soft
tissue, to manage
surgical smoke
during general
surgical
procedures, and is
indicated for use in
surgery. | | | | | | Where used
(environment) | General
Surgery(open),
including
laparoscopic
surgery | Laparoscopic
surgery | General Surgery
(open), including
laparoscopic
surgery | General Surgery
(open) | Similar | | Anatomical Sites | Soft tissue in a
broad range of
surgical procedures | Abdominal and
pelvic cavity. | Abdominal and
pelvic cavity. | Soft tissue in a
broad range of
surgical procedures | Similar | | 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 | General patients
requiring
electrosurgery in a
hospital setting | Same | | Current | Ionwand-
intermittent max
$20\mu A$
Integrated L-Hook
instrument &
IonPencil™ | Ionwand-
intermittent max
$20\mu A$
Integrated L-Hook
instrument- 2 x | Continuous max
$10\mu A$ | N/A | Similar | | Technical Characteristics Comparison Table | | | | | | | Feature/
Specification | Ultravision2™
System with
IonPencil™ | Ultravision2™
System Integrated
Monopolar L-
Hook (H/S)™
Predicate 1 | Ultravision Visual
Field Clearing
System
Predicate 2 | Megadyne Pencil
with Megadyne EZ
Clean
Electrosurgical
Electrode
Predicate 3,4 | Comparison | | | emitters (40μA
total) intermittent
max | intermittent max | | | | | Visual field
clearing
mechanism of
action | Electrostatic
Precipitation | Electrostatic
Precipitation | Electrostatic
Precipitation | NA | Same | | Ultravision2
Software
Category | Basic
Documentation | Basic
Documentation | Basic
Documentation | NA | Same | | Ionwand tip
material | Implant grade
Stainless steel,
annealed | Implant grade
Stainless steel,
annealed | Implant grade
Stainless steel,
annealed | N/A | Same | | Ionwand energy
modality | HVDC | HVDC | HVDC | N/A | Same | | Ionwand working
length | N/A- integrated
into instrument -
refer to electrode
working length | N/A- integrated into
instrument - refer to
electrode working
length | 109mm | N/A | Similar feature but
different dimension | | Handpiece
electrosurgical
energy modality | Monopolar | Monopolar… --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/PQM/K240868](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/PQM/K240868) **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