(201 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the CONMED PlumeSafe® X5™ Smoke Management System, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test Performed) | Reported Device Performance (Result) | Applicable Standards |
|---|---|---|
| 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. This criteria is met if the reported filter efficiency is 99.9997% at 0.01 to 0.20 micron particle size. | 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 (EMC and Immunity) | Electromagnetic Capability testing completed per IEC 60601-1-2. | Pass |
2. Sample size used for the test set and the data provenance:
- The document describes "benchtop testing" and "non-clinical performance testing." These are physical device tests, not tests on a clinical dataset.
- Therefore, there is no "test set" in the sense of a collection of patient data or images. The "samples" would be the physical devices, filters, and components themselves, tested under specific laboratory conditions.
- The provenance of data is not applicable in the context of clinical data, as this is solely benchtop testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable. "Ground truth" in the context of expert review typically refers to a clinical diagnosis or labeling of medical images/data. Since this is benchtop device testing, there is no "ground truth" established by clinical experts for a test set. The acceptance criteria are based on engineering specifications and international standards, and the "ground truth" is measured by laboratory equipment and procedures.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods are used for resolving discrepancies in expert interpretations of clinical data. For benchtop testing, results are typically objective measurements against predefined thresholds, not subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a smoke management system, not an AI-powered diagnostic tool. The testing performed is related to the physical performance and safety of the device in filtering smoke and aerosols.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The device is a physical smoke management system, not an algorithm or software that operates standalone for diagnostic or interpretive purposes. Its performance is measured independently of human interaction in terms of its ability to filter air, maintain flow, etc., but this is inherent to the device's function, not "standalone algorithm performance."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the benchtop tests, the "ground truth" is established by adherence to recognized international standards (e.g., ISO, IEC, ASTM) and engineering specifications. The performance metrics (e.g., efficiency, flow rates, sound levels, motor lifetime) are objectively measured using calibrated laboratory equipment. There is no clinical "ground truth" in the form of expert consensus, pathology, or outcomes data for this type of device testing.
8. The sample size for the training set:
- This question is not applicable. The device is a hardware product, not a machine learning model; therefore, there is no "training set" in the context of artificial intelligence.
9. How the ground truth for the training set was established:
- This question is not applicable, as there is no training set for this device.
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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™ SmokeManagement System | VisiClear Smoke Evacuation System | N/A |
| Manufacturer | CONMED | CONMED | Identical. |
| RegulationNumber | 878.5070 | 878.5070 | Identical. |
| Product Code | FYD | FYD | Identical. |
| DeviceClass/Name | Class II/ Air-handling apparatus for asurgical operating room | Class II/ Air-handling apparatus for asurgical operating room | Identical. |
| FundamentalScientificTechnology | Smoke Management System | Smoke Management System | Identical. |
| IntendedUse/Indications for Use | The CONMED PlumeSafe® X5TMSmoke Management System isdesigned to remove and filtersmoke and aerosols from a surgicalsite produced during electrosurgicaland laser procedures. | The VISICLEAR Smoke EvacuationSystem is designed to remove andfilter smoke and aerosols from asurgical site produced duringelectrosurgical and laserprocedures. | Identical. |
| TargetPopulation | For physicians and trained hospitalstaff during the use of lasers orelectrosurgery. | For physicians and trained hospitalstaff during the use of lasers orelectrosurgery. | Identical. |
| Modes | Laparoscopic, Open Tubing,Electrosurgical, Pencil | Laparoscopic, Open Tubing,Electrosurgical Pencil | Identical. |
| Display | Capacitive Touch Screen | LCD | Similar.Display does not impactfunctionality of the device. |
| Power Source | Standard 100/120V alternatingcurrent | Standard 120 Volt | Similar.Power Source does notimpact functionality of thedevice. |
| Unit HousingShape | Rectangle | Trapezoid | Similar.PlumeSafe® X5TM shapedesigned to be stacked withthe CONMED MEP-1Electrosurgical Unit. Thedifferences in the unithousing shape does not affectthe functionality of thedevice. |
| Motor | 120V motor: 904098 Domel 4.75in(1150-1250 Watts) | 120V motor: 904169 Domel 4.32in(800 Watts) | Similar.The larger motor in thePlumeSafe® X5TM does notaffect the functionality of thedevice. |
| Accessories | Footswitch, electrosurgical smokepencils, cables, remote activation,fluid trap, cart | Footswitch, electrosurgical smokepencils, cables, remote activation,fluid trap, cart | Identical. |
| Packaging | Filter is supplied with biohazard bagfor proper disposal after useful lifeis expired. Some filters can beplaced inside the unitand then bagged as part of thepackaging. | Filter is supplied with biohazard bagfor proper disposal after useful lifehas expired. | Similar.Packaging, includingbiohazard bag, does notimpact functionality of thedevice. |
| Performance | The ULPA-grade filter is 99.9997%efficiency at 0.01 to 0.20 micronparticle size with a filter life of up to35 hours.Flow Rate TestingIn addition, compared to thepredicate, CONMED performed thefollowing 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 micronparticle size with a filter life of upto 35 hours.Flow Rate Testing | Similar.Both include ULPA-grade filterand can accommodate thesame filter life. ThePlumeSafe® X5TM can filter asmaller particle size.Flow rate testingdemonstrated similar flowrates and does not impactfunctionality.Discussion of nonclinical testsperformed are provided intable 2 below. |
| ElectricalSafety andEMC Testing | Fulfills Electrical Safetyrequirements per IEC 60601-1.Fulfills Electromagneticcompatibility (EMC) per IEC 60601-1-2. | Fulfills Electrical Safetyrequirements per IEC 60601-1.Fulfills Electromagneticcompatibility (EMC) per IEC 60601-1-2. | Identical. |
| Software | Software Verification and Validationper IEC 62304. | Software Verification and Validationper IEC 62304. | Identical. |
| Test | Brief Description | Applicable Standards | Results(Pass/Fail) |
| Sound | Verify sound pressure and noise level characteristics per ISO Standards. | ISO 3744ISO16571 | Pass |
| Initial FilterEfficiency | 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 FilterEfficiency | 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 |
| IntermittentUse | 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 |
| Softwareverification andvalidation | Software testing completed per IEC 62304. | IEC 62304 | Pass |
| Electrical safety | Electrical Safety testing completed per IEC 60601-1 | IEC 60601-1 | Pass |
| ElectromagneticCompatibility | 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
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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).
§ 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.