(117 days)
No
The description focuses on electrostatic precipitation for smoke clearing and does not mention any AI/ML components or functionalities.
No
The device is indicated for clearing surgical smoke and particulates during surgery, not for treating a disease or condition in a patient.
No
The device is indicated for the "clearance of smoke and other particulate matter that is created during surgery" and "removes surgical smoke and particulates from the visual field." Its function is to clear the surgical field, not to diagnose a medical condition.
No
The device description explicitly details multiple hardware components including a generator, Ionwand, trocar, battery, and power supplies. It is a physical system for clearing surgical smoke.
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 surgery and to establish a path of entry for surgical instruments. This is a therapeutic and surgical support function, not a diagnostic one.
- Device Description: The device uses electrostatic precipitation to remove smoke. This is a physical process for clearing the surgical field, not a method for analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing any information about a patient's health status or disease.
- Performance Studies: The performance studies focus on smoke clearing effectiveness and safety (ozone generation), not on diagnostic accuracy or clinical outcomes related to diagnosis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
PQM
Device Description
The Ultravision™ Visual Clearing System removes surgical smoke and particulates from the visual field by means of electrostatic precipitation.
The System consists of the Ultravision Generator, the Ionwand Sterile Pack, and the Ultravision 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 intended for use only with the Ultravision™M Visual Field Clearing System to introduce the Ionwand while providing a pathway for laparoscopic instruments through one 5 mm trocar incision. The trocar may be used with or without the Ionwand component of the system. The system is powered using a rechargeable battery or through mains power. Accessories include the rechargeable battery, battery recharging station, mains converter power supply, mains converter, power supply unit, and patient return adaptor.
The purpose of this submission is to add a new indication for use in open surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
General and laparoscopic procedures
Indicated Patient Age Range
Not Found
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)
Performance Test 1
- Study Type: Comparison study under simulated use conditions
- Sample Size: Not specified (human factors evaluation with actual users/surgeons)
- Key Results: The Ultravision Visual Field Clearing System, when used in open procedures, provides equivalent performance when compared to the reference device. In terms of surgical workflow, ease of use, and risks, the Ultravision system was considered equivalent to the reference device (electrosurgical pencil equipped with suction tubing and a hand-held suction device).
Performance Test 2
- Study Type: Evaluation of device use in an oxygen rich (open) environment considering ozone generation, and tissue damage, includes empirical testing on ozone generation. Risk assessment performed.
- Sample Size: Not specified
- Key Results: There were no new risks associated with the use of Ultravision in an open procedure; risks were found to be lower. The time weighted average for ozone production was below acceptable limits - Pass. The risk from open surgery was concluded to be lower than that associated with the use of Ultravision in its current cleared laparoscopic indication.
Non-clinical Testing (Biocompatibility and Electrical Safety)
- Study Type: Cytotoxicity (ISO 10993-5), Intracutaneous Irritation (ISO 10993-10), Systemic Toxicity (ISO 10993-11), Maximization Sensitization (ISO 10993-10). Electrical safety and electromagnetic compatibility tests.
- Key Results:
- Cytotoxicity: Reactivity of grade 1 was observed - Pass.
- Intracutaneous Irritation: No evidence of intracutaneous irritation - Pass.
- Systemic Toxicity: No evidence of systemic toxicity - Pass.
- Maximization Sensitization: Not a sensitizer - Pass.
- Electrical safety and electromagnetic compatibility tests have been successfully completed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Ultravision™ Visual Field Clearing System (K182053)
Reference Device(s)
K914400, K000904, K142335, K954869
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.
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May 4, 2020
Alesi Surgical Ltd. % Michele Lucey Regulatory Affairs Advisor Lakeshore Medical Device Consulting LLC 128 Blye Hill Landing Newbury, New Hampshire 03255
Re: K200035
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: January 31, 2020 Received: February 4, 2020
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 (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 located 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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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.
CAPT Elizabeth F. Claverie, MS Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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 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.
Type of Use (Select one or both, as applicable) Z Prescription Use (Part 21 CFR 801 Subpart D)
_Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K200035 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: | |
| Fax: | +44 (0) 2920291022 |
| +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: | 4th May 2020 |
| Device Trade Name: | Ultravision™ Visual Field Clearing System |
| Common Name | Surgical Smoke Precipitator |
| Classification Name: | 21CFR 878.5050 |
| Regulatory Class: | Class II |
| Product Code(s): | PQM |
| Predicate Device: | Ultravision™ Visual Field Clearing System (K182053) |
| Reference Devices: | 1. Smoke Evacuator pencil system comprising of Valley Lab |
| Button switch pencil E2516H (K914400) fitted with a Buffalo | |
| Penadapt tubing set (PA 2010) (K000904) and Medtronic | |
| Rapidvac smoke evacuation generator (K142335) |
- Medcare Yankauer Suction device (K954869) |
Indications for Use:
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.
Device Description:
The Ultravision™ Visual Clearing System removes surgical smoke and particulates from the visual field by means of electrostatic precipitation.
4
The System consists of the Ultravision Generator, the Ionwand Sterile Pack, and the Ultravision 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 intended for use only with the Ultravision™M Visual Field Clearing System to introduce the Ionwand while providing a pathway for laparoscopic instruments through one 5 mm trocar incision. The trocar may be used with or without the Ionwand component of the system. The system is powered using a rechargeable battery or through mains power. Accessories include the rechargeable battery, battery recharging station, mains converter power supply, mains converter, power supply unit, and patient return adaptor.
The purpose of this submission is to add a new indication for use in open surgical procedures.
| Comparison Chart | |||
|---|---|---|---|
| Feature/ | |||
| Specification | DEVICE NAME | ||
| Ultravision™ Visual | |||
| Field Clearing System | PREDICATE | ||
| DEVICE | |||
| Ultravision™ Visual | |||
| Field Clearing System | Comparison | ||
| Regulatory Clearance/ | |||
| Approval Reference | K200035 | K182053 | N/A |
| Product Code | PQM | PQM | Same |
| Regulation Number | 21 CFR 878.5050 | 21 CFR 878.5050 | Same |
| Regulation Name | Surgical Smoke | ||
| Precipitator | Surgical Smoke | ||
| Precipitator | Same | ||
| Mechanism of Action | Electrostatic | ||
| precipitation | Electrostatic | ||
| precipitation | Same | ||
| Where used | |||
| (environment) | Operating Room | Operating Room | Same |
| Anatomical Sites | General and | ||
| laparoscopic | |||
| procedures | Abdominal sites - | ||
| laparoscopic | |||
| procedures | Similar | ||
| Comparison Chart | |||
| Feature/ | |||
| Specification | DEVICE NAME | ||
| Ultravision™ Visual | |||
| Field Clearing System | PREDICATE | ||
| DEVICE | |||
| Ultravision™ Visual | |||
| Field Clearing System | Comparison | ||
| Intended Use | 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. | 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 | |||
| establishes a path of | |||
| entry for instruments | |||
| used in laparoscopic | |||
| surgery. | Similar | ||
| Software | Yes - identical to | ||
| predicate | Yes | Same | |
| Alarms | Yes - identical to | ||
| predicate | Yes | Same | |
| Accessories | Yes, identical to | ||
| predicate | Yes | Same | |
| Dimensions | Identical | Identical | Same |
| Materials | Identical | Identical | Same |
| Generator Output | 9.8KV dc | ||
| (No Change) | 9.8KV dc | ||
| (No Change) | Same | ||
| How Supplied | Non-sterile generator. | ||
| Sterile Consumable | |||
| (Ionwand) Non-sterile | |||
| accessories. Identical | Non-sterile generator. | ||
| Sterile Consumable | |||
| (Ionwand) Non-sterile | |||
| accessories. Identical | Same | ||
| Biocompatibility | Meets ISO 10993 Part | ||
| 5,10 and 11 | Meets ISO 10993 Part | ||
| 5,10 and 11 | Same | ||
| Sterilization | Ethylene Oxide | Ethylene Oxide | Same |
| Sterility Assurance | |||
| Level | 10-6 | 10-6 | Same |
Technological Characteristics Comparison Table:
Shown below is a comparison of the subject device with the predicate device.
5
6
Summary of Non-clinical Testing:
The system has been previously updated for mains power (K182053) and accordingly new electrical safety and electromagnetic compatibility tests have been successfully completed.
There are no changes to the materials and processing of patient contact materials from the submissions in DEN150022 and K170178, consequently no additional biocompatibility testing is required.
Tests carried out to support the added indication for use in open surgical procedures includes the following:
| Name of the Test | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Cytotoxicity | |||
| ISO 10993-5 | To analyze the | ||
| potential of the test | |||
| article to induce a | |||
| cytotoxic effect | Must not cause cell | ||
| lysis or toxicity | |||
| greater than a grade of | |||
| 2 (mild reactivity) | Reactivity of grade 1 | ||
| was observed - Pass | |||
| Intracutaneous | |||
| Irritation | |||
| ISO 10993-10 | To analyze the | ||
| potential of the test | |||
| article to induce a | |||
| local irritation | |||
| response | No evidence of | ||
| significant | |||
| intracutaneous | |||
| irritation | No evidence of | ||
| intracutaneous | |||
| irritation - Pass | |||
| Systemic Toxicity | |||
| ISO 10993-11 | To analyze the | ||
| potential of the test | |||
| article to induce a | |||
| systemic response | No evidence of | ||
| significant systemic | |||
| toxicity or mortality | |||
| after test article | |||
| extracts injection | No evidence of | ||
| systemic toxicity - | |||
| Pass | |||
| Maximization | |||
| Sensitization | |||
| ISO 10993-10 | To analyze the | ||
| potential of the test | |||
| article to induce a | |||
| sensitization or | |||
| allergic response | No evidence of | ||
| induced delayed | |||
| sensitization | Not a sensitizer - Pass | ||
| Performance Test 1 | |||
| Simulated Use | Comparison of smoke | ||
| clearing | |||
| characteristics of | |||
| Ultravision versus | |||
| other smoke clearing | |||
| devices | Must be considered at | ||
| least equivalent to | |||
| comparators | Results of the | ||
| evaluation | |||
| demonstrated that | |||
| Ultravision was at | |||
| least equivalent to the | |||
| comparator devices - | |||
| Pass | |||
| Performance Test 2 | |||
| Risk Assessment | |||
| comparing the risks | |||
| associated with open | |||
| procedure use versus | |||
| laparoscopic use | Evaluation of device | ||
| use in an oxygen rich | |||
| (open) environment | |||
| considering ozone | |||
| generation, and tissue | |||
| damage, includes | |||
| empirical testing on | |||
| ozone generation | The risks associated | ||
| with the use of | |||
| Ultravision in an open | |||
| procedure must not be | |||
| greater than those for | |||
| a laparoscopic | |||
| procedure. Ozone | |||
| generation must | |||
| comply with 21 CFR | There were no new | ||
| risks associated with | |||
| the use of Ultravision | |||
| in an open procedure; | |||
| risks were found to be | |||
| lower. The time | |||
| weighted average for | |||
| ozone production was | |||
| below acceptable | |||
| limits - Pass |
7
Performance Test 1
A comparison study was conducted under simulated use conditions to demonstrate that the Ultravision Visual Field Clearing System when used in open procedures provides equivalent performance when compared to the reference device. To support this, a human factors evaluation was also conducted during simulated surgery by actual users (surgeons). The users compared the Ultravision device to an electrosurgical pencil equipped with suction tubing and provided feedback comparing the Ultravision to a hand-held suction device (reference devices).
It was concluded from this feedback that in terms of surgical workflow, ease of use and risks, that the Ultravision system was considered equivalent to the reference device.
Performance Test 2
It was recognized that a potential risk of the system being used in an oxygen rich (open) environment might be the production of ozone. Accordingly, the level of ozone generation in a worst-case model was analyzed. Risk assessment was performed to address the expected relative levels of tissue damage and injury when moving from the original cleared laparoscopic environment to the proposed open environment. This was assessed over six attributes namely, principle of operation, Ultravision Settings, Ultravision components to be utilized to clear surgical technique, principal electrosurgical modalities used with Ultravision and finally the volumes and composition of smoke produced by electrosurgical devices to be used with Ultravision. This concluded that the risk from open surgery was lower than that associated with the use of Ultravision in its current cleared laparoscopic indication.
Conclusion
Based on a review of bench top assessments, comparison of the device classification, intended use, operating principle, technological characteristics, sterility, and biocompatibility the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, K182053.