K Number
K170178
Device Name
Ultravision Visual Field Clearing System
Date Cleared
2017-05-26

(127 days)

Product Code
Regulation Number
878.5050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Ultravision™ Visual Field Clearing System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. The Ultravision 5mm Trocar component also establishes a path of entry for instruments used in laparoscopic surgery.
Device Description
The Ultravision™ Visual Clearing System removes surgical smoke from the visual field during laparoscopic surgery by means of electrostatic precipitation. The System consists of the Ultravision Generator, the Ionwand Sterile Pack, and the Ionwand 5mm Trocar. The Ionwand is connected to the energy source and is then introduced into the body cavity near the smoke generating electrosurgical device. The Ultravision™ 5mm Trocar is a new accessory device intended for use only with the Ultravision™ Visual Field Clearing System to introduce the Ionwand while providing a pathway for laparoscopic instruments through one 5 mm trocar incision. The Ultravision™ 5mm Trocar provides an alternative to the currently available Ultravision™ Visual Field Clearing System Ionwand™ Sterile Pack for introduction of the Ionwand. The Ultravision™ 5mm Trocar is a standard dilating laparoscopic trocar compatible for use with 5mm instruments. The trocar design includes a discrete lumen that is positioned separate from the main trocar channel and which accepts the Ionwand component of the system. The trocar design allows the distal tip of the Ionwand to exit the trocar some 12mm from its distal point and at an angle to the trocar body that positions the Ionwand at a point close to but not interfering with the 5mm energy instruments that are intended to be accommodated by the trocar. The Ultravision™ 5mm trocar and Ionwand are provided packaged together in the same sterile barrier packaging. The trocar may be used with or without the Ionwand component of the system.
More Information

No
The device description and performance studies focus on mechanical and electrical functions for smoke clearing and instrument access, with no mention of AI or ML.

No.

The device is designed to clear smoke and particulate matter, and provide a path for instruments during laparoscopic surgery, not to treat a medical condition or disease.

No

Explanation: The provided text explicitly states that the Ultravision™ Visual Field Clearing System is "indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery" and "removes surgical smoke from the visual field." It also establishes a path of entry for instruments. There is no mention of the device being used to identify or analyze medical conditions, which are the functions of a diagnostic device.

No

The device description clearly outlines multiple hardware components including a generator, Ionwand, and trocar, which are physical devices used in surgery.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to clear smoke and particulate matter during laparoscopic surgery and to establish a path for surgical instruments. This is a therapeutic and surgical support function, not a diagnostic one.
  • Device Description: The device description details a system for removing smoke using electrostatic precipitation and a trocar for instrument access. It does not describe any components or processes for analyzing biological samples or providing diagnostic information.
  • Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring analytes
    • Providing information for diagnosis, monitoring, or prognosis of a disease or condition

The device is clearly intended for use during a surgical procedure to improve visualization and facilitate instrument access, which falls under the category of surgical devices, not in vitro diagnostics.

N/A

Intended Use / Indications for Use

The Ultravision™ Visual Field Clearing System is indicated for the clearance of smoke and other that is created during laparoscopic surgery.

The Ultravision 5mm Trocar component also establishes a path of entry for instruments used in laparoscopic surgery.

Product codes

PQM

Device Description

The Ultravision™ Visual Clearing System removes surgical smoke from the visual field during laparoscopic surgery by means of electrostatic precipitation. The System consists of the Ultravision Generator, the Ionwand Sterile Pack, and the Ionwand 5mm Trocar. The Ionwand is connected to the energy source and is then introduced into the body cavity near the smoke generating electrosurgical device. The Ultravision™ 5mm Trocar is a new accessory device intended for use only with the Ultravision™ Visual Field Clearing System to introduce the Ionwand while providing a pathway for laparoscopic instruments through one 5 mm trocar incision. The Ultravision™ 5mm Trocar provides an alternative to the currently available Ultravision™ Visual Field Clearing System Ionwand™ Sterile Pack for introduction of the Ionwand. The Ultravision™ 5mm Trocar is a standard dilating laparoscopic trocar compatible for use with 5mm instruments. The trocar design includes a discrete lumen that is positioned separate from the main trocar channel and which accepts the Ionwand component of the system. The trocar design allows the distal tip of the Ionwand to exit the trocar some 12mm from its distal point and at an angle to the trocar body that positions the Ionwand at a point close to but not interfering with the 5mm energy instruments that are intended to be accommodated by the trocar. The Ultravision™ 5mm trocar and Ionwand are provided packaged together in the same sterile barrier packaging. The trocar may be used with or without the Ionwand component of the system.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Abdominal and gynecological minimally invasive procedures

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Nonclinical testing:
The equivalence of the Ultravision 5mm Trocar to the predicate devices has been though the following tests and assessments:

Test: Performance of the system to clear the visual field of smoke and particulate matter
Description: Performance comparison to the predicate device under simulated use conditions
Results: Equivalent to predicate - Pass

Test: Usability
Description: Complexity of use compared to the predicate and reference device
Results: Equivalent to predicate and reference - Pass

Test: Ionwand removal and reinsertion
Description: Repeated insertions/removals performed and forces both quantitative and qualitative evaluations performed
Results: Equivalent to predicate and reference - Pass

Test: Leak resistance and sealing, maintenance of pneumoperitoneum during use
Description: Pressure tests under high and low pressures with and without instruments or Ionwand inserted, including multiple cycles of use
Results: Equivalent to predicate or reference - Pass

Test: Strength, resistance to bending
Description: Tensile or pressure forces applied to shaft, trocar, and connections
Results: Equivalent to predicate or reference - Pass

Test: Dimensional Verification
Description: Confirmation of dimensional characteristics by dimensional evaluation
Results: Pass

Test: Luer fitting
Description: Confirmation of compliance with industry standard luer fitting
Results: Pass

Test: Electrical Safety
Description: Dielectric breakdown, radio-frequency applied parts, capacitive coupling
Results: Pass

Test: Biocompatibility per ISO 10993
Description: Appropriate biocompatibility based on tissue contact and duration
Results: Pass

Test: Sterilization and shelf life studies
Description: Validated sterilization cycle according to industry standard, shelf life studies on accelerated aging conditions including product and package evaluations
Results: Pass

Key Metrics

Not Found

Predicate Device(s)

Ultravision™ Visual Field Clearing System DEN150022

Reference Device(s)

K032676

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 26, 2017

Alesi Surgical Ltd. David Broderick Quality & Regulatory Manager Cardiff Medicentre, Heath Park Cardiff, CF14 4UJ GB

Re: K170178

Trade/Device Name: Ultravision™ Visual Field Clearing System Regulation Number: 21 CFR 878.5050 Regulation Name: Surgical Smoke Precipitator Regulatory Class: Class II Product Code: PQM Dated: April 26, 2017 Received: May 1, 2017

Dear David Broderick:

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 (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. 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.

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

1

related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Lori A. Wiggins -S6

for

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K170178

Device Name

Ultravision™ Visual Field Clearing System

Indications for Use (Describe)

The Ultravision™ Visual Field Clearing System is indicated for the clearance of smoke and other that is created during laparoscopic surgery.

The Ultravision 5mm Trocar component also establishes a path of entry for instruments used in laparoscopic surgery.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)

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3

SECTION 6

510(K) SUMMARY

4

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
Telephone:
Fax:++44 (0)2920 682106
++44 (0)2920 750239
Contact Person:
Telephone :Michele Lucey
603-748-1374
Date Prepared:19th May 2017
Device Trade Name:Ultravision™ Visual Field Clearing System
Classification:Class II
Product Code(s):POM
Regulation Number(s):878.5050
Predicate Devices:Ultravision™ Visual Field Clearing System DEN150022
Intended Use:The Ultravision™ Visual Field Clearing System is indicated for
the clearance of smoke and other particulate matter that is created
during laparoscopic surgery.
The Ultravision 5mm Trocar component also establishes a path of
entry for instruments used in laparoscopic surgery.
Device Description:The Ultravision™ Visual Clearing System removes surgical smoke
from the visual field during laparoscopic surgery by means of
electrostatic precipitation. The System consists of the Ultravision
Generator, the Ionwand Sterile Pack, and the Ionwand 5mm
Trocar. The Ionwand is connected to the energy source and is
then introduced into the body cavity near the smoke generating
electrosurgical device. The Ultravision™ 5mm Trocar is a new
accessory device intended for use only with the Ultravision™
Visual Field Clearing System to introduce the Ionwand while

5

providing a pathway for laparoscopic instruments through one 5 mm trocar incision. The Ultravision™ 5mm Trocar provides an alternative to the currently available Ultravision™ Visual Field Clearing System Ionwand™ Sterile Pack for introduction of the Ionwand. The Ultravision™ 5mm Trocar is a standard dilating laparoscopic trocar compatible for use with 5mm instruments. The trocar design includes a discrete lumen that is positioned separate from the main trocar channel and which accepts the Ionwand component of the system. The trocar design allows the distal tip of the Ionwand to exit the trocar some 12mm from its distal point and at an angle to the trocar body that positions the Ionwand at a point close to but not interfering with the 5mm energy instruments that are intended to be accommodated by the trocar. The Ultravision™ 5mm trocar and Ionwand are provided packaged together in the same sterile barrier packaging. The trocar may be used with or without the Ionwand component of the system.

Nonclinical testing:

The equivalence of the Ultravision 5mm Trocar to the predicate devices has been though the following tests and assessments:

TestDescriptionResults
Performance of the system to
clear the visual field of smoke
and particulate matterPerformance comparison to the
predicate device under
simulated use conditionsEquivalent to
predicate - Pass
UsabilityComplexity of use compared to
the predicate and reference
deviceEquivalent to
predicate and
reference - Pass
Ionwand removal and
reinsertionRepeated insertions/removals
performed and forces both
quantitative and qualitative
evaluations performedEquivalent to
predicate and
reference - Pass
Leak resistance and sealing,
maintenance of
pneumoperitoneum during usePressure tests under high and
low pressures with and without
instruments or Ionwand
inserted, including multiple
cycles of useEquivalent to
predicate or
reference - Pass
Strength, resistance to bendingTensile or pressure forces
applied to shaft, trocar, and
connectionsEquivalent to
predicate or
reference - Pass

6

| Dimensional Verification | Confirmation of dimensional
characteristics by dimensional
evaluation | Pass |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Luer fitting | Confirmation of compliance
with industry standard luer
fitting | Pass |
| Electrical Safety | Dielectric breakdown, radio-
frequency applied parts,
capacitive coupling | Pass |
| Biocompatibility per ISO
10993 | Appropriate biocompatibility
based on tissue contact and
duration | Pass |
| Sterilization and shelf life
studies | Validated sterilization cycle
according to industry standard,
shelf life studies on accelerated
aging conditions including
product and package
evaluations | Pass |

The results of the testing demonstrated acceptable performance for the device and substantial equivalence to the predicate device.

7

| Feature/
Specification | Ultravision™
Visual Field
Clearing System | Ultravision™
Visual Field
Clearing System | Ethicon Endopath
Excel Bladeless
Trocar with
Stability Sleeve 5 -
12mm | Comparison |
|--------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| | Subject Device | Primary Predicate
Device | Reference Device | |
| Regulatory
Clearance/ | Pending | DEN150022 | K032676 | N/A |
| Product Code | PQM | PQM | GCJ | N/A |
| Regulation
Number | 878.5050 | 878.5050 | 876.1500 | Equivalent |
| Regulation
Name | Surgical Smoke
Precipitator | Surgical Smoke
Precipitator | Endoscopes and
Accessories. | Equivalent |
| Where
used
(environment) | Laparoscopic surgery | Laparoscopic surgery | Abdominal, thoracic
and gynecological
minimally invasive
procedures | Equivalent (laparoscopic surgery
includes all the predicate
anatomical sites) |
| Anatomical
Sites | Abdominal and
gynecological
minimally invasive
procedures | Abdominal and
gynecological
minimally invasive
procedures | As above | Equivalent |
| Trocar type | Blunt trocar with
dilating tip | N/A | Blunt trocar with
dilating tip | Equivalent |
| Trocar material | Thermoplastic | N/A | Thermoplastic | Equivalent |
| Retention
features | Micro- ridges | N/A | Ridges | Similar feature but different
dimension with no impact on
performance or safety |
| Type of sealing
employed | Duckbill valve and
separate seal | N/A | Duckbill valve and
separate seal | Equivalent |
| Valve and seal
material | Elastomer | Elastomer | Elastomer | Equivalent |

Summary of Technological Characteristics Demonstrating Substantial Equivalence:

8

| Feature/
Specification | Ultravision™
Visual Field
Clearing System
Subject Device | Ultravision™
Visual Field
Clearing System
Primary Predicate
Device | Ethicon Endopath
Excel Bladeless
Trocar with
Stability Sleeve 5 -
12mm
Reference Device | Comparison |
|-------------------------------------------|-------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Trocar working
length | 94mm | N/A | 100 / 102mm | Similar feature but different
dimension with no impact on
performance or safety |
| Trocar main
lumen | 5.8mm | N/A | 5.95 / 13mm | Similar feature but different
dimension with no impact on
performance or safety |
| Trocar O/D | 10.0mm | N/A | 8.0 / 15.2mm
(Covers the range of
items from predicate
submission) | Similar feature but different
dimension with no impact on
performance or safety |
| Ionwand™M
working length | 129mm | 109mm | N/A | Similar feature but different
dimension with no impact on
performance or safety |
| Ionwand™M
overall diameter | 1.4mm | 2.0mm | N/A | Similar feature but different
dimension with no impact on
performance or safety |
| Ionwand™ tip
material | Implant grade
Stainless steel.
annealed | Implant grade
Stainless steel.
annealed. | N/A | Equivalent |
| Ionwand™ tip,
exposed length | 4.0mm | 4.0mm | N/A | Equivalent |
| Ionwand™M
insulation wall
thickness | 0.4mm | 0.7mm | N/A | Similar feature but different
dimension with no impact on
performance or safety |
| Plug and cable
length | 2.5mm | 2.5mm | N/A | Equivalent |
| Generator | Ultravision™
generator (fixed
power output) | Ultravision™
generator (fixed
power output) | N/A | Equivalent |
| How Supplied | Supplied sterile in
single pouches | Supplied sterile in
single blister | Supplied sterile in
single pouches | Equivalent |

9

| Feature/
Specification | Ultravision™
Visual Field
Clearing System
Subject Device | Ultravision™M
Visual Field
Clearing System
Primary Predicate
Device | Ethicon Endopath
Excel Bladeless
Trocar with
Stability Sleeve 5 -
12mm
Reference Device | Comparison |
|------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Biocompatibility | Meets ISO 10993
Part 5,10 and 11 | Meets ISO 10993 Part
5,10 and 11 | Unknown | Assume predicate is
biocompatible since it is an
approved device |
| Sterilization | EtO | EtO | Gamma Irradiation | Similar feature but different
dimension with no impact on
performance or safety |
| Sterilitv
Assurance Level | 10-6 | 10-6 | 10-6 | Assume predicate has the
standard sterility assurance level
since it is an approved device |

Conclusion:

The subject device is substantially equivalent to the predicate device.