(186 days)
Not Found
No
The description focuses on synchronizing visual field clearing with electrosurgical device activation based on direct interfacing and signal pass-through, not on learning or intelligent decision-making from data. There is no mention of AI, ML, or related concepts.
No.
The device's stated indications for use are "clearance of smoke and other particulate matter" and establishing a path for instruments, which are supportive functions for surgical procedures rather than directly treating or diagnosing a disease or condition.
No
The device description and intended use state that the Ultravision2™ System clears smoke and particulate matter during laparoscopic surgery, establishes a path for instruments, and serves as a pass-through for RF energy. These functions are therapeutic or instrumental, not diagnostic.
No
The device description explicitly mentions hardware components like the Ultravision2™ 5mm Trocar, the Ultravision2™ Generator, and the Ionwand™ pack which includes a trocar/catheter and cable. These are physical components, not just software.
Based on the provided information, the Ultravision2™ System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the clearance of smoke and particulate matter during laparoscopic surgery, establishing a path for instruments, and acting as a pass-through for RF energy. These are all related to surgical procedures performed on the patient, not on samples taken from the patient.
- Device Description: The description details a system that interfaces with electrosurgical generators and instruments used during surgery. It involves a trocar, generator, and Ionwand™ cable that delivers energy to the patient. This is consistent with a surgical device, not a diagnostic device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Ultravision2™ System's function is entirely focused on facilitating and improving the surgical environment during laparoscopic procedures.
N/A
Intended Use / Indications for Use
The Ultravision2™ System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery.
The Ultravision2™ 5mm Trocar component establishes a path of entry for instruments used in laparoscopic surgery.
The Ultravision2™ Generator interfaces directly with the electrosurgical generator and serves as a pass-through for RF energy to RF electrosurgical instruments.
Product codes (comma separated list FDA assigned to the subject device)
PQM
Device Description
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 activation of the electrosurgical device to synchronize visual field clearing with the generation of smoke. 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. The Ultravision™ 5mm Trocar includes a dedicated Ionwand™ cable. This device is for prescription use only.
Model # DPD-006-001: Ultravision2™ System, including:
• Standalone generator
• Link cables (x4)
• Equipotential cable
• Power cable
Model # DAD-001-003: Ionwand Pack, including:
• Stainless steel active cable the “Ionwand™”
• Trocar/catheter assembly
Model # DAD-003-013: Ultravision 5mm Trocar, including:
• 5mm trocar
• Ionwand cable assembly
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
General patients requiring electrosurgery in a hospital setting
Intended User / Care Setting
Operating Room
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 and software verification and validation activities were successfully completed.
Tests performed and results:
Shelf life: Standard 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 F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration, 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 5 years. Test Results: Pass.
Software verification and validation: Standard Followed: IEC62304 2006+A1:2015 Medical Device Software – Software Life Cycle Process. Acceptance Criteria: Device functions controlled by software must perform as intended. Test Results: Pass.
Electrical safety and electromagnetic compatibility: Standard 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. Test Results: Pass.
Dimensional and physical verification of unit: Standard Followed: NA. Acceptance Criteria: Device must meet dimensional specification and physical specifications as per internal standards. Test Results: Pass.
High voltage output: Standard Followed: NA. Acceptance Criteria: Device must deliver specified output, into required loads, at given temperatures and humidities, and for the specified product lifetime as per internal standards. Test Results: Pass.
Generator basic function including: Standard Followed: NA. Acceptance Criteria: Device must meet specifications for connections and functionality as per internal standards. Test Results: Pass.
Generator safety measures including: Standard Followed: NA. Acceptance Criteria: Must meet specifications for device function independent of software, extreme misuse, or single fault conditions as per internal standards. Test Results: Pass.
Generator user interface hardware control: Standard Followed: NA. Acceptance Criteria: Must meet specifications for device function independent of software, extreme misuse, or single fault conditions as per internal standards. Test Results: Pass.
Generator high voltage power management: Standard Followed: NA. Acceptance Criteria: Must meet specifications for DC output under proximity and HVDC limit protection measure as per internal standards. Test Results: Pass.
Generator surgical energy detection: Standard Followed: NA. Acceptance Criteria: Device must demonstrate energy detection for external ultrasonic energy as per internal standards. Test Results: Pass.
Mechanical connections and controls: Standard Followed: NA. Acceptance Criteria: Device must demonstrate acceptable durability of link cables, fascia connections, and cable retention as per internal standards. Test Results: Pass.
Surgical generator compatibility: Standard Followed: NA. Acceptance Criteria: Device must demonstrate compatibility with applicable generators in terms of load curve characterization, CQM performance, HF leakage, and RF detection. as per internal standards. Test Results: Pass.
Design validation under simulated use conditions: Standard Followed: NA. Acceptance Criteria: Must demonstrate that the device can achieve its intended use when used by end users as per internal standards. Test Results: Pass.
Biocompatibility: The tissue contacting components of the Ultravision2™ System are identical and process to the previously cleared devices. No additional biocompatibility testing was performed.
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.
Ultravision™ Visual Field Clearing System (K200035)
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
October 31, 2023
Alesi Surgical Ltd % Michele Lucey Regulatory Consultant Lakeshore Medical Device Consulting, LLC 128 Blve Hill Landing Newbury, New Hampshire 03255
Re: K231238
Trade/Device Name: Ultravision2™M System Regulation Number: 21 CFR 878.5050 Regulation Name: Surgical Smoke Precipitator Regulatory Class: Class II Product Code: PQM Dated: September 25, 2023 Received: September 28, 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) K231238
Device Name Ultravision2™ System
Indications for Use (Describe)
The Ultravision2™ System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery.
The Ultravision2™ 5mm Trocar component establishes a path of entry for instruments used in laparoscopic surgery.
The Ultravision2™ Generator interfaces directly with the electrosurgical generator and serves as a pass-through for RF energy to RF electrosurgical instruments.
| 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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4
Image /page/4/Picture/0 description: The image contains the logo for Alesi Surgical. The logo consists of three curved shapes in different shades of blue and purple on the left side. To the right of the shapes is the word "alesi" in a dark blue sans-serif font, with the word "surgical" in a smaller, lighter blue font underneath.
K231238
510(K) SUMMARY TRADITIONAL 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: | Ultravision2™ System |
| Common Name: | Surgical Smoke Precipitator |
| Classification Name: | Surgical Smoke Precipitator |
| Classification Regulation: | 21 CFR 878.5050 |
| Regulatory Class: | Class II |
| Product Code(s): | PQM |
| Predicate Device: | Ultravision™ Visual Field Clearing System (K200035) |
5
Indications for Use:
The Ultravision2™ System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery.
The Ultravision2™ 5mm Trocar component establishes a path of entry for instruments used in laparoscopic surgery.
The Ultravision2™ Generator interfaces directly with the electrosurgical generator and serves as a pass-through for RF energy to RF electrosurgical instruments.
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 activation of the electrosurgical device to synchronize visual field clearing with the generation of smoke. 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. The Ultravision™ 5mm Trocar includes a dedicated Ionwand™ cable. This device is for prescription use only.
| Model # | Component Description |
|---|---|
| DPD-006-001 | Ultravision2™ System, including: |
| • Standalone generator | |
| • Link cables (x4) | |
| • Equipotential cable | |
| • Power cable | |
| DAD-001-003 | Ionwand Pack, including: |
| • Stainless steel active cable the “Ionwand™” | |
| • Trocar/catheter assembly | |
| DAD-003-013 | Ultravision 5mm Trocar, including: |
| • 5mm trocar | |
| • Ionwand cable assembly |
The components of the system are described as follows:
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.
6
| Feature/
Specification | Ultravision2TM System | UltravisionTM Visual Field
Clearing System | Comparison |
|------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory
Clearance/
Approval
Reference | K231238
Subject Device | K200035
Predicate Device | N/A |
| Product Code(s) | PQM | PQM | Equivalent |
| Regulation
Number(s) | 21 CFR 878.5050 | 21 CFR 878.5050 | Equivalent |
| Regulation
Name(s) | Surgical Smoke Precipitator | Surgical Smoke Precipitator | Equivalent |
| Where used
(environment) | Operating Room | Operating Room | Equivalent |
| Anatomical Sites | 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 | Equivalent |
| Mechanism of
Action for Visual
Field Clearing | Electrostatic precipitation of
smoke to clear the visual
field during laparoscopic
surgical procedures | Electrostatic precipitation of
smoke to clear the visual
field during laparoscopic
surgical procedures | Equivalent |
| Generator output
Smoke
Precipitation | 9.8KV dc | 9.8KV dc | Equivalent |
| Current | Ionwand- intermittent max
20μA | Continuous max 10μA | Similar
This difference does not
raise new questions of
safety and effectiveness.,
confirmed by electrical
safety testing |
| Ionwand tip
material | Implant grade Stainless
steel, annealed | Implant grade Stainless steel,
annealed. | Equivalent |
| Ionwand tip
exposed length | 4.0mm | 4.0mm | Equivalent |
| Ionwand insulation
wall thickness | 0.7mm | 0.7mm | Equivalent |
| Plug and cable
length | 2.5mm | 2.5mm | Equivalent |
| Ionwand energy
modality | HVDC | HVDC | Equivalent |
| Ionwand working
length | 109mm | 109mm | Equivalent |
| Mechanism of
action of visual
field clearance | Electrostatic precipitation | Electrostatic precipitation | Equivalent |
| Generator smoke
clearing activation. | Automatic on/off timed
output triggered by energy
detection or user selection
(manual button press on
generator) | Continuous output until
switched off on generator | Different, results in less
activation of the Ionwand
during the procedure. This
difference does not raise
new questions about safety
and effectiveness |
| Feature/
Specification | Ultravision2™ System | Ultravision™ Visual Field
Clearing System | Comparison |
| Generator
Compatibility to
Electrosurgical
Energy Input | Commercially available
Electrosurgical generators,
Monopolar, and Bipolar
energy input | NA | Compatibility and
electrical safety is shown
through performance
testing. This difference
does not raise new
questions about safety and
effectiveness. |
| Generator
Compatibility to
Handpiece | Universal compatibility for
monopolar and bipolar
energy types | NA | Compatibility is shown
through safety and
performance testing. This
difference does not raise new
questions about safety
and effectiveness. |
| 5mm IonWand
trocar material | Thermoplastic | Thermoplastic | Equivalent |
| Retention features | Ribbed | Micro- ridges | Different, results in
improved retention of the
trocar during the
procedure. This difference
does not raise new
questions about safety and
effectiveness |
| Type of sealing
employed | Duckbill valve and separate
seal | Duckbill valve and separate
seal | Equivalent |
| Valve and seal
material | Elastomer | Elastomer | Equivalent |
| Software Controls | Software is not a risk
control. Provides an audio-
visual indication if the
IonWand is touching tissue
or a metallic instrument
(output is timed with a
predetermined shut-off
therefore this is not
considered to be an alarm) | Software is a risk control
providing an audio-visual
alarm if the IonWand is
touching tissue or a metallic
instrument (required as the
output is continuous once
manually turned on at the
generator) | Different, UV2 has a
predetermined timed
output which is controlled
by hardware only. Thus,
software has no role in
energy output and is not
considered to be a risk
control. This difference
does not raise new
questions of safety and
effectiveness. |
| Software Safety
Classification/Lev
el of Concern | Minor Level of Concern
(Basic documentation)
Class A per IEC 62304 | Moderate Level of Concern
(Category 2)
Class B per IEC 62304 | Different, the reduction in
safety concerns compared
to the predicate does not
raise new questions of
safety and effectiveness |
| Applicable
Electrical Safety
Standards | IEC 60601-1
ISO 60601-1-6
IEC 60601-2-2 | IEC 60601-1
ISO 60601-1-6
IEC 60601-2-2 | Equivalent |
| Applicable
Electromagnetic
Compatibility
Standards | IEC 60601-1-2 | IEC 60601-1-2 | Equivalent |
| Applicable
Software
Standards | IEC 62304 | IEC 62304 | Equivalent |
| Feature/
Specification | Ultravision2TM System | UltravisionTM Visual Field
Clearing System | Comparison |
| Biocompatibility | Meets ISO 10993 | Meets ISO 10993 | Equivalent |
| Sterilization | EtO, validated per ISO
11135 | EtO, validated per ISO
11135 | Equivalent |
| Sterility Assurance
Level | 10-6 | 10-6 | Equivalent |
| How Supplied
(single use) | Ionwand and trocar -
supplied sterile in single
blister pack or pouch | Ionwand, trocar -supplied
sterile in single blister or
pouch | Equivalent |
Technological Characteristics Comparison Table
7
8
Summary of Non-clinical Testing:
Testing demonstrated acceptable device performance for the device's intended use. System and software verification and validation activities were successfully completed.
| Test
Performed | Standard Followed | Acceptance Criteria | Test
Results |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Shelf life | ASTM F1980-16 Standard
Guide for Accelerated Aging
of Sterile Medical Device
Packages | Product and package must demonstrate
stability for the claimed shelf life of 5 years. | Pass |
| | ASTM 2096 Standard Test
Method for Detecting Gross
Leaks in Packaging by
Internal Pressurization | | |
| | ASTM F1929-15 Standard
Test Method for Detecting
Seal Leaks in Porous Medical
Packaging by Dye Penetration | | |
| | ASTM F88/F88M -15
Standard Test Method for Seal
Strength of Flexible Barrier
Materials | | |
| Software verification
and validation | IEC62304 2006+A1:2015
Medical Device Software –
Software Life Cycle Process | Device functions controlled by software must
perform as intended | Pass |
| Electrical safety and
electromagnetic
compatibility | 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 High
Frequency Surgical
Equipment (2017-03)
evaluation | | |
| | EN 60601-1-2:2015 +
A1:2021 Medical electrical
equipment General | | |
| Test
Performed | Standard Followed | Acceptance Criteria | Test
Results |
| | requirements for basic safety
and essential performance.
Collateral Standard:
Electromagnetic disturbances | | |
| Dimensional
and physical
verification
of unit | NA | Device must meet dimensional specification
and physical specifications as per internal
standards. | Pass |
| High voltage output | NA | Device must deliver specified output, into
required loads, at given temperatures and
humidities, and for the specified product
lifetime as per internal standards. | Pass |
| Generator basic
function including: | NA | Device must meet specifications for
connections and functionality as per internal
standards. | Pass |
| Generator safety
measures including: | NA | | |
| Generator user
interface
hardware control | NA | Must meet specifications for device function
independent of software, extreme misuse, or
single fault conditions as per internal
standards. | Pass |
| Generator high
voltage power
management | NA | Must meet specifications for DC output under
proximity and HVDC limit protection measure
as per internal standards. | Pass |
| Generator surgical
energy detection | NA | Device must demonstrate energy detection for
external ultrasonic energy as per internal
standards. | Pass |
| Mechanical
connections and
controls | NA | Device must demonstrate acceptable durability
of link cables, fascia connections, and cable
retention as per internal standards. | Pass |
| Surgical generator
compatibility | NA | Device must demonstrate compatibility with
applicable generators in terms of load curve
characterization, CQM performance, HF
leakage, and RF detection. as per internal
standards. | Pass |
| Design validation
under simulated use
conditions | NA | Must demonstrate that the device can achieve
its intended use when used by end users as per
internal standards. | Pass |
9
Biocompatibility
The tissue contacting components of the Ultravision2™ System are identical and process to the previously cleared devices. No additional biocompatibility testing was performed.
Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(k) submission, K231238 is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K200035, Class II (21 CFR 878.5050), product code PQM.