(201 days)
No
The description focuses on the mechanical and filtration aspects of the device, with no mention of AI or ML capabilities. The performance studies are benchtop tests related to physical characteristics and safety, not algorithmic performance.
No
The device is designed to remove and filter smoke and aerosols from a surgical site, which is not a direct therapeutic action on the patient. Its function is to manage the surgical environment by improving air quality, rather than treating a disease or condition.
No.
The device is a smoke management system designed to remove and filter smoke and aerosols from a surgical site, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "portable, stand-alone, capital unit" comprised of a vacuum motor, aluminum, steel, and plastic components, indicating it is a hardware device with integrated software for control and modes.
Based on the provided information, the CONMED PlumeSafe® X5™ Smoke Management System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures." This describes a device used during a surgical procedure to manage the environment, not a device used to examine specimens in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details a system for air filtration and smoke evacuation, including a vacuum motor, filters, and accessories for capturing surgical smoke. This aligns with a surgical support device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic results.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The PlumeSafe® X5™ does not perform this function.
N/A
Intended Use / Indications for Use
The CONMED PlumeSafe® X5™ Smoke Management System is designed to remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures.
Product codes
FYD
Device Description
The PlumeSafe® X5™ Smoke Management System is a portable, stand-alone, capital unit, that when paired with a reusable filter and disposable accessories makes up a Smoke Management System. The smoke unit is accompanied by a reusable filter and is available in two different configurations, a 22mm or 25mm size. Each filter is designed to capture components of surgical smoke and return clean air to the environment and can connect to different accessories which include pencils, adapters, fluid traps, and tube sets. Each filter is a self-contained device that is completely enclosed to protect health care personnels from potential contamination during filter changes. Each filter is comprised of filtration (gross particulate pre-filter, Ultra-Low Penetration Air (ULPA), coconut-based carbon, impregnated alumina, and carbon dust capture media) that produce capture efficiency ratings equal to or better than 99.999% for particles ranging in size from 0.01μm to 0.2μm.
PlumeSafe® X5™ is comprised of a vacuum motor, aluminum, steel, and plastic components combined with sound reducing insulation. The vacuum motor is used to draw the surgical site, through an accessory, and into the PlumeSafe® X5™ filter. The PlumeSafe® X5™ Smoke Management System provides multiple modes (open, laparoscopic, and pencil) and settings to adjust the flow to the clinical need.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For physicians and trained hospital staff during the use of lasers or electrosurgery.
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)
Benchtop testing was completed to support substantial equivalence to the predicate as it relates to safety and effectiveness.
Non-Clinical Performance tests:
- Sound: Verify sound pressure and noise level characteristics per ISO Standards. (Pass)
- Initial Filter Efficiency: Verify filter configurations maintained the ULPA efficiency rating to remove 99.999% of the most penetrating particle sizes (MPPS) at set flow rate and concentration factor per ISO Standards. (Pass)
- Final Filter Efficiency: Verify filter configurations maintained the ULPA efficiency rating to remove 99.999% of the most penetrating particle sizes (MPPS) at set flow rate and concentration factor over a period per ISO Standards. (Pass)
- Continuous Use: Verify continuous operation and continuous surgical plume evacuation. (Pass)
- Intermittent Use: Verify the device runs intermittently over a specified amount of time without the motor stopping or overheating at a set airflow. (Pass)
- Motor Ramp-up: Verify the device can reach 90% of maximum suction within 2 seconds of activation when used with a surgical pencil. (Pass)
- Detection: Verify the device detects occlusion. (Pass)
- Reliability: Verify lifetime of motor at 350 hours. (Pass)
- Transportation: Verify the Filter and Console packaging configurations per ASTM D4169. (Pass)
- Flow: Verify airflow is maintained in Open, Pencil, and Laparoscopic modes. (Pass)
- Software verification and validation: Software testing completed per IEC 62304. (Pass)
- Electrical safety: Electrical Safety testing completed per IEC 60601-1. (Pass)
- Electromagnetic Compatibility: Electromagnetic Capability testing completed per IEC 60601-1-2 (EMC and Immunity). (Pass)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The ULPA-grade filter is 99.9997% efficiency at 0.01 to 0.20 micron particle size with a filter life of up to 35 hours.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5070 Air-handling apparatus for a surgical operating room.
(a)
Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.(b)
Classification. Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 05, 2024
CONMED Corporation Erin Hoffman Principal Admin of Regulatory Affairs 6455 South Yosemite Street Greenwood Village. CO 80111
Re: K240127
Trade/Device Name: PlumeSafe® X5™ Smoke Management System Regulation Number: 21 CFR 878.5070 Regulation Name: Air-Handling Apparatus For A Surgical Operating Room Regulatory Class: Class II Product Code: FYD Dated: January 15, 2024 Received: July 09, 2024
Dear Erin Hoffman:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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,
Katharine Segars -S
Katharine Segars, Ph.D. Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
Device Name
PlumeSafe® X5™ Smoke Management System
Indications for Use (Describe)
The CONMED PlumeSafe® X5™ Smoke Management System is designed to remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures.
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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510(k) Summary – K240127 PlumeSafe® X5™ Smoke Management System
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for this 510(k).
l. SUBMITTER
ConMed Corporation 525 French Road Utica, NY 13502
Company Contact:
Erin Hoffman Specialist Regulatory Affairs 720-299-6422 erinhoffman@conmed.com
Date Prepared:
Aug 02, 2024
II. DEVICE NAME
Proprietary Name: PlumeSafe® X5™ Smoke Management System
Model Numbers:
- PX5-120 PlumeSafe® X5™ Smoke Management System ●
- PX5-120NF PlumeSafe® X5™ Smoke Management System, 120V, No Filter ●
- PX5-135 PlumeSafe® X5™ Filter, 1" (25 mm), 3/8″ (9.5 mm), 1″ (25 mm), single pack ●
- PX5-1354 PlumeSafe® X5™ Filter, 1" (25 mm), 3/8″ (9.5 mm), 1″ (25 mm), 4pack .
- PX5-135-22 - PlumeSafe® X5™ Filter, 7/8″ (22 mm), 3/8″ (22 mm), single pack
- . PX5-1354-22 - PlumeSafe® X5™ Filter, 7/8″ (22 mm), 3/8″ (9.5 mm), 7/8″ (22 mm), 4pack
| Common Name: | PlumeSafe® X5™ |
|---|---|
| Panel: | General and Plastic Surgery |
| Product Code: | FYD |
| Device Class: | II |
| Regulation Number: | 21 CFR 878.5070 |
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lll. PREDICATE
| Trade Name: | VisiClear Smoke Evacuation Unit |
|---|---|
| Company Name: | CONMED |
| 510(k): | K131402 |
IV. DEVICE DESCRIPTION
The PlumeSafe® X5™ Smoke Management System is a portable, stand-alone, capital unit, that when paired with a reusable filter and disposable accessories makes up a Smoke Management System. The smoke unit is accompanied by a reusable filter and is available in two different configurations, a 22mm or 25mm size. Each filter is designed to capture components of surgical smoke and return clean air to the environment and can connect to different accessories which include pencils, adapters, fluid traps, and tube sets. Each filter is a seff-contained device that is completely enclosed to protect health care personnels from potential contamination during filter changes. Each filter is comprised of filtration (gross particulate pre-filter, Ultra-Low Penetration Air (ULPA), coconutbased carbon, impregnated alumina, and carbon dust capture media) that produce capture efficiency ratings equal to or better than 99.999% for particles ranging in size from 0.01μm to 0.2μm.
PlumeSafe® X5™ is comprised of a vacuum motor, aluminum, steel, and plastic components combined with sound reducing insulation. The vacuum motor is used to draw the surgical site, through an accessory, and into the PlumeSafe® X5™ filter. The PlumeSafe® X5™ Smoke Management System provides multiple modes (open, laparoscopic, and pencil) and settings to adjust the flow to the clinical need.
V. INTENDED USE / INDICATIONS FOR USE
The CONMED PlumeSafe® X5™ Smoke Management System is designed to remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures.
VI. COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS
The PlumeSafe® X5™ Smoke Management System is similar to the predicate device in that the design of both includes an identical Intended Use, RFID functionality, automatic activation through the EZ Link clip accessory, material, packaging, accessories, unit housing shape, operational features, and design features. The main difference in the subject device from the predicate device is number of filtration stages, black box collection, and direct docking to the CONMED MEP-1 Electrosurgical device (cleared through K213354). The PlumeSafe® X5™ Smoke Management System is and substantially equivalent to the predicate as demonstrated by non-clinical performance testing listed in section VII.
| Subject Device (K240127) | Predicate Device (K131402) | Comparison | |
|---|---|---|---|
| Device Name | PlumeSafe® X5™ Smoke | ||
| Management System | VisiClear Smoke Evacuation System | N/A | |
| Manufacturer | CONMED | CONMED | Identical. |
| Regulation | |||
| Number | 878.5070 | 878.5070 | Identical. |
| Product Code | FYD | FYD | Identical. |
| Device | |||
| Class/Name | Class II/ Air-handling apparatus for a | ||
| surgical operating room | Class II/ Air-handling apparatus for a | ||
| surgical operating room | Identical. | ||
| Fundamental | |||
| Scientific | |||
| Technology | Smoke Management System | Smoke Management System | Identical. |
| Intended | |||
| Use/Indications for Use | The CONMED PlumeSafe® X5TM | ||
| Smoke Management System is | |||
| designed to remove and filter | |||
| smoke and aerosols from a surgical | |||
| site produced during electrosurgical | |||
| and laser procedures. | The VISICLEAR Smoke Evacuation | ||
| System is designed to remove and | |||
| filter smoke and aerosols from a | |||
| surgical site produced during | |||
| electrosurgical and laser | |||
| procedures. | Identical. | ||
| Target | |||
| Population | For physicians and trained hospital | ||
| staff during the use of lasers or | |||
| electrosurgery. | For physicians and trained hospital | ||
| staff during the use of lasers or | |||
| electrosurgery. | Identical. | ||
| Modes | Laparoscopic, Open Tubing, | ||
| Electrosurgical, Pencil | Laparoscopic, Open Tubing, | ||
| Electrosurgical Pencil | Identical. | ||
| Display | Capacitive Touch Screen | LCD | Similar. |
| Display does not impact | |||
| functionality of the device. | |||
| Power Source | Standard 100/120V alternating | ||
| current | Standard 120 Volt | Similar. | |
| Power Source does not | |||
| impact functionality of the | |||
| device. | |||
| Unit Housing | |||
| Shape | Rectangle | Trapezoid | Similar. |
| PlumeSafe® X5TM shape | |||
| designed to be stacked with | |||
| the CONMED MEP-1 | |||
| Electrosurgical Unit. The | |||
| differences in the unit | |||
| housing shape does not affect | |||
| the functionality of the | |||
| device. | |||
| Motor | 120V motor: 904098 Domel 4.75in | ||
| (1150-1250 Watts) | 120V motor: 904169 Domel 4.32in | ||
| (800 Watts) | Similar. | ||
| The larger motor in the | |||
| PlumeSafe® X5TM does not | |||
| affect the functionality of the | |||
| device. | |||
| Accessories | Footswitch, electrosurgical smoke | ||
| pencils, cables, remote activation, | |||
| fluid trap, cart | Footswitch, electrosurgical smoke | ||
| pencils, cables, remote activation, | |||
| fluid trap, cart | Identical. | ||
| Packaging | Filter is supplied with biohazard bag | ||
| for proper disposal after useful life | |||
| is expired. Some filters can be | |||
| placed inside the unit | |||
| and then bagged as part of the | |||
| packaging. | Filter is supplied with biohazard bag | ||
| for proper disposal after useful life | |||
| has expired. | Similar. | ||
| Packaging, including | |||
| biohazard bag, does not | |||
| impact functionality of the | |||
| device. | |||
| Performance | The ULPA-grade filter is 99.9997% | ||
| efficiency at 0.01 to 0.20 micron | |||
| particle size with a filter life of up to | |||
| 35 hours. |
Flow Rate Testing
In addition, compared to the
predicate, CONMED performed the
following non-clinical tests:
Sound per ISO 16571 Continuous Use Intermittent Use Motor Ramp-up Detection Transportation Reliability | The ULPA-grade filter is 99.999%
efficiency at 0.10 to 0.20 micron
particle size with a filter life of up
to 35 hours.
Flow Rate Testing | Similar.
Both include ULPA-grade filter
and can accommodate the
same filter life. The
PlumeSafe® X5TM can filter a
smaller particle size.
Flow rate testing
demonstrated similar flow
rates and does not impact
functionality.
Discussion of nonclinical tests
performed are provided in
table 2 below. |
| Electrical
Safety and
EMC Testing | Fulfills Electrical Safety
requirements per IEC 60601-1.
Fulfills Electromagnetic
compatibility (EMC) per IEC 60601-
1-2. | Fulfills Electrical Safety
requirements per IEC 60601-1.
Fulfills Electromagnetic
compatibility (EMC) per IEC 60601-
1-2. | Identical. |
| Software | Software Verification and Validation
per IEC 62304. | Software Verification and Validation
per IEC 62304. | Identical. |
| Test | Brief Description | Applicable Standards | Results
(Pass/Fail) |
| Sound | Verify sound pressure and noise level characteristics per ISO Standards. | ISO 3744
ISO16571 | Pass |
| Initial Filter
Efficiency | Verify filter configurations maintained the ULPA efficiency rating to remove 99.999% of the most penetrating particle sizes (MPPS) at set flow rate and concentration factor per ISO Standards. | ISO 29463-5:2018 | Pass |
| Final Filter
Efficiency | Verify filter configurations maintained the ULPA efficiency rating to remove 99.999% of the most penetrating particle sizes (MPPS) at set flow rate and concentration factor over a period per ISO Standards. | ISO 29463-5:2018 | Pass |
| Continuous Use | Verify continuous operation and continuous surgical plume evacuation. | N/A | Pass |
| Intermittent
Use | Verify the device runs intermittently over a specified amount of time without the motor stopping or overheating at a set airflow. | N/A | Pass |
| Motor Ramp-up | Verify the device can reach 90% of maximum suction within 2 seconds of activation when used with a surgical pencil. | N/A | Pass |
| Detection | Verify the device detects occlusion. | N/A | Pass |
| Reliability | Verify lifetime of motor at 350 hours. | N/A | Pass |
| Transportation | Verify the Filter and Console packaging configurations per ASTM D4169. | ASTM D4169 | Pass |
| Flow | Verify airflow is maintained in Open, Pencil, and Laparoscopic modes. | N/A | Pass |
| Software
verification and
validation | Software testing completed per IEC 62304. | IEC 62304 | Pass |
| Electrical safety | Electrical Safety testing completed per IEC 60601-1 | IEC 60601-1 | Pass |
| Electromagnetic
Compatibility | Electromagnetic Capability testing completed per IEC 60601-1-2 (EMC and Immunity) | IEC 60601-1-2 | Pass |
Table 1 - Comparison of Subject PlumeSafe® X5™ and Predicate VisiClear (K131402) Devices
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VII. SUMMARY OF NONCLINICAL TESTING
Benchtop testing was completed to support substantial equivalence to the predicate as it relates to safety and effectiveness. The following tests were conducted to support substantial equivalence for this submission:
Table 2: Non-Clinical Performance tests
VIII. SUMMARY OF CLINICAL TESTING
N/A
8
IX. CONCLUSION
The subject PlumeSafe® X5™ Smoke Management System is substantially equivalent in design, materials, indications for use, principles of operation and technological characteristics to the predicate VisiClear. The conclusions drawn from the nonclinical performance testing (discussed above) demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device, VisiClear (K131402).