(38 days)
Not Found
No
The description focuses on electrostatic precipitation for smoke removal and does not mention any AI or ML components or functionalities.
No.
The stated intended use of the device is for the "clearance of smoke and other particulate matter that is created during laparoscopic surgery" and to "establish a path of entry for instruments used in laparoscopic surgery," not to treat a disease or condition.
No
The Ultravision™ Visual Field Clearing System is indicated for the clearance of smoke and other particulate matter during laparoscopic surgery, and establishes a path for surgical instruments. These functions are therapeutic or assistive to a surgical procedure, not diagnostic.
No
The device description clearly outlines multiple hardware components including a generator, ionwand, trocar, battery, and power supplies.
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 establish a path for instruments. This is a surgical support function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details a system for removing surgical smoke using electrostatic precipitation and a trocar for instrument access. This is a physical intervention during surgery, not a diagnostic process.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. 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 that is created during laparoscopic surgery.
The Ultravision™ 5mm Trocar establishes a path of entry for instruments used in laparoscopic surgery and includes the Ionwand for the clearance of smoke and other particulate matter that is created during laparoscopic surgery.
Product codes (comma separated list FDA assigned to the subject device)
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 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
In consideration of design control activities including risk analysis the non-clinical performance testing include testing in accordance with electromagnetic compatibility standards and an assessment of electrical safety compliance with IEC 60601.
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.
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 7, 2018 Alesi Surgical Ltd. % Michele Lucev Regulatory Affairs Advisor Lakeshore Medical Device Consulting, LLC 128 Blye Hill Landing, Newbury, New Hampshire 03255
Re: K182053
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: August 6. 2018 Received: August 9, 2018
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. 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
1
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 (reporting of medical devicerelated 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.
Clarence W. Murray lii III -S
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)
K182053
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 establishes a path of entry for instruments used in laparoscopic surgery and includes the Ionwand for the clearance of smoke and other particulate matter that is created during laparoscopic surgery.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | □ |
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3
K182053 510(K) SUMMARY
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: | September 5, 2018 | |
| Device Trade Name: | Ultravision™ Visual Field Clearing System | |
| Classification: | Class II | |
| Product Code(s): | PQM | |
| Regulation Number(s): | 878.5050 | |
| Common Name: | Surgical Smoke Precipitator | |
| Predicate Devices: | Ultravision™ Visual Field Clearing System, K170178 | |
| 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 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
K182053 Page 1 of 3
is
a
4
Ultravision™ 5mm Trocar provides an alternative to the currently available Ultravision™ Visual Field Clearing System Ionwand™ Sterile Pack for introduction of the Ionwand. 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.
Comparison to Predicate Device(s):
This Special 510(k) is for the device modification of the device to make it compatible with mains power. This change allows the system to be powered using the rechargeable battery or be used connected to mains electric power using the Ultravision™ Mains Converter, this is regarded as a new system accessory. This change does not affect the intended use of the device or alter the fundamental scientific technology of the device. The comparison chart below shows that there are no other design or material changes to the system, only the addition of an option to use mains power versus battery power.
| Substantial Equivalence Comparison Chart | |||
|---|---|---|---|
| Feature/Specification | Ultravision™ | ||
| Visual Clearing | |||
| System (modified) | Ultravision™ | ||
| Visual Clearing | |||
| System | |||
| (predicate) | Comparison | ||
| Indications | Laparoscopic surgery | Laparoscopic surgery | Same |
| 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 | 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 | Same | ||
| Materials of Construction | Polymers, elastomers, metals | Polymers, elastomers, metals | Same, materials |
| are identical | |||
| Regulatory Clearance/ | |||
| Approval Reference | NA | K170178 | NA |
| Product Code | PQM | PQM | Same |
| Regulation Number | 878.5050 | 878.5050 | Same |
| General Description | Surgical Smoke | ||
| Precipitator | Surgical Smoke | ||
| Precipitator | Same | ||
| Mechanism of Action | Electrostatic | ||
| precipitation, identical to | |||
| the predicate | Electrostatic precipitation | Same |
5
| Substantial Equivalence Comparison Chart | |||
|---|---|---|---|
| Feature/Specification | Ultravision™ Visual Clearing System (modified) | Ultravision™ Visual Clearing System (predicate) | Comparison |
| Where used | Laparoscopic surgical procedures | Laparoscopic surgical procedures | Same |
| Power source | Battery and mains | Battery | Difference is |
| inclusion of a | |||
| mains power | |||
| adapter. This | |||
| difference does | |||
| not raise new | |||
| questions of safety | |||
| and efficacy | |||
| Software | Yes, identical to | ||
| predicate | Yes | Same | |
| Alarms | Yes, identical to | ||
| predicate | Yes | Same | |
| Instructions for use | Yes, identical to | ||
| predicate except for the | |||
| inclusion of the | |||
| Ultravision™ Mains | |||
| Converter | Yes | The addition of | |
| the use of the | |||
| Mains Converter | |||
| to the IFU does | |||
| not raise new | |||
| questions of safety | |||
| and efficacy | |||
| Accessories | Yes, identical to | ||
| predicate except for the | |||
| inclusion of the | |||
| Ultravision™ Mains | |||
| Converter | Yes | The addition of | |
| the use of the | |||
| Mains Converter | |||
| accessory does not | |||
| raise new | |||
| questions of safety | |||
| and efficacy | |||
| How Supplied | Nonsterile with nonsterile | ||
| and sterile accessories | Nonsterile with nonsterile | ||
| and sterile accessories | Same | ||
| SAL (sterile accessories) | $10^{-6}$ | $10^{-6}$ | Same |
| Sterilization Method (sterile | |||
| accessories) | Ethylene Oxide | Ethylene Oxide | Same |
Nonclinical Performance Data:
In consideration of design control activities including risk analysis the non-clinical performance testing include testing in accordance with electromagnetic compatibility standards and an assessment of electrical safety compliance with IEC 60601.
Conclusion: Based on the performed nonclinical tests, the device is as safe, as effective, and performs as well as the legally marketed predicate device, K170178.