(146 days)
The indications for use of the RapidVac™ Smoke Evacuator System are to remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures.
The RapidVac™ Smoke Evacuator System consists of a painted aluminum housing, a painted solid polyurethane front panel, a high suction/high flow rate variable speed centrifugal action pump, and a multi stage filter. The system can also use accessories such as sterile tubing sets in various sizes/diameters which are single-use and are used in conjunction with ultrasonic, laser or electrosurgery generators to remove and filter the smoke from the surgical field,. The RapidVac™ Smoke Evacuator System captures particulates and adsorbs gases from surgical smoke. The smoke evacuator is specifically designed to improve visibility and reduce potential health hazards associated with surgical smoke. It can be used in both open and laparoscopic procedures with available accessories. The RapidVac Smoke Evacuator System is designed with a high suction, high flow rate variable speed centrifygal action pump. The ultra-quiet motor is used to draw the smoke from the surgical site through the vacuum tubing and into the system where it is passed through four stages of filtration.
The provided text describes the RapidVac™ Smoke Evacuator System and its substantial equivalence to predicate devices, but it does not contain information about a study to prove acceptance criteria in the typical sense of AI/CADe systems.
Instead, the document focuses on performance verification testing to demonstrate that the device meets its technical and performance design requirements, and that it is substantially equivalent to existing devices based on technological characteristics and safety standards.
Therefore, many of the requested fields for AI/CADe studies cannot be directly answered from the provided text. I will answer based on the information that is present and indicate where information is not available or not applicable.
Here's the breakdown of the acceptance criteria and performance as presented in the document:
Acceptance Criteria and Device Performance (RapidVac™ Smoke Evacuator System)
| Feature / Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use (Smoke evacuation and filtration) | Demonstrated to be for smoke evacuation and filtration, equivalent to predicate devices. |
| Indications for Use (Removal and filtration of smoke and aerosols from a surgical site produced during electrosurgical and laser procedures.) | Device's indications for use are the same as one predicate (Visiclear™) and similar to another (Optimumm™). |
| Target Population (Physicians and trained hospital staff during the use of lasers or electrosurgery) | Same as predicate devices. |
| Materials of Construction (Painted Aluminum Housing, Painted solid polyurethane front panel, Four-stage filter) | Utilizes similar materials and a four-stage filter (prefilter, ULPA grade filter, virgin activated carbon, woven fiberglass), comparable to predicate devices. |
| Energy Used (Electrical Current) | Same as predicate devices. |
| Filtration Efficiency (ULPA filter is 99.999% efficiency at .1 to .2 micron particle size) | The ULPA filter is 99.999% efficiency at .1 to .2 micron particle size, which is compliant with the predicate (Visiclear™) and comparable to the other predicate (99.999% at .12 micron particle size minimum for Optimumm™). Filter life verification testing was conducted to confirm ULPA efficiency for maximum flow rate and filter lifetime. |
| Filter Life (e.g., 25 hours minimum) | Reported filter life is 25 hours. (Predicate devices report 35 hours). The document mentions "Filter life verification testing was conducted... to confirm... filter lifetime." |
| Electrical Safety (Compliant with IEC 60601-1 and IEC 60601-1-2) | Tested and compliant with IEC 60601-1 and IEC 60601-1-2. |
| Mechanical Safety (Compliant with IEC 60601-1) | Tested and compliant with IEC 60601-1. |
| Chemical Safety (Neutral pH, non-patient contact) | Same as predicate devices. |
| Thermal Safety (Operation of device does not result in harmful temperatures, tested and compliant per IEC 60601-1) | Operation of device does not result in harmful temperatures, tested and compliant per IEC 60601-1. |
| Radiation Safety (Non-radioactive) | Non-radioactive. |
| Technical and Performance Design Requirements (overall) | The performance verification of the RapidVac Smoke Evacuator System showed that the device met the technical and performance design requirements. This included: - Filter life verification of ULPA efficiency. - Flow verification testing to meet specified flow requirements for each mode of operation. - Product verification and validation testing to meet all product requirements.- Smoke removal verification via flow testing.- Reliability testing to demonstrate longevity and no degradation.- Laparoscopic Smoke Evacuation Verification to confirm ability to maintain pneumoperitoneum while clearing smoke.- Smoke Removal Effectiveness via particulate count. |
| Substantial Equivalence (to predicate devices: Visiclear™ Smoke Evacuation System (K131402) and Optimumm™ Smoke Evacuation System (K980915) regarding smoke evacuation technologies, mechanical, electrical, software, and safety.) | Found to be substantially equivalent to the predicate devices based on shared technological characteristics and compliance with safety standards. |
2. Sample size used for the test set and the data provenance:
The document describes performance verification testing rather than a clinical trial or AI model testing with a distinct "test set" of patient data. The testing appears to be primarily laboratory/bench testing of the device's physical and functional attributes.
- Sample Size: Not explicitly stated in terms of a "test set" size. The document refers to various tests performed on the device(s).
- Data Provenance: Not applicable in the context of patient data. The testing was conducted on the RapidVac™ Smoke Evacuator System itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the study involved engineering and performance testing of a medical device, not interpretation of clinical data requiring expert consensus or ground truth in the AI context. Device compliance with standards and functional performance were assessed.
4. Adjudication method for the test set:
Not applicable. The testing described focuses on objective measurements and compliance with established engineering and safety standards (e.g., IEC standards), rather than subjective interpretation requiring adjudication among experts.
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. This study is for a physical medical device (smoke evacuator) and not an AI or CADe system. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No. This is not an AI/algorithm-based device. The "standalone" performance refers to the device's functional capabilities (e.g., filtration, flow rate) as a piece of equipment.
7. The type of ground truth used:
The "ground truth" for this device's performance is based on:
- Engineering specifications and design requirements: The device was tested against its own design specifications.
- Industry standards: Compliance with standards such as IEC 60601-1 and IEC 60601-1-2.
- Performance metrics: Objective measurements of filtration efficiency (ULPA), flow rates, particulate counts, and duration (filter life).
- Bench testing: Laboratory verification of various operational aspects, including smoke removal effectiveness and laparoscopic pneumoperitoneum maintenance.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 14, 2015
Covidien Jose Marquez Regulatory Affairs Manager 15 Hampshire Street Mansfield, MA 02048
Re: K142335
Trade/Device Name: RapidVac™ Smoke Evacuator System (Model: SE3690) Regulation Number: 21 CFR 878.5070 Regulation Name: Air-Handling Apparatus For A Surgical Operating Room Regulatory Class: Class II Product Code: FYD Dated: December 17, 2014 Received: December 18, 2014
Dear Mr. Marquez,
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.
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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin Keith Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142335
Device Name
RapidVacTM Smoke Evacuator System (Model: SE3690)
Indications for Use (Describe)
The indications for use of the RapidVac™ Smoke Evacuator System are 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
Date summary prepared: January 13, 2015
510(k) Submitter/Holder
Covidien 15 Hampshire Street Mansfield, MA 02048
Contact
Jose Marquez Regulatory Affairs Manager Telephone: 508-452-4160 Fax: 508-452-1941 Email: jose.a.marquez@covidien.com
Name of Device
| Trade Name: | RapidVac™ Smoke Evacuator System (Model: SE3690) |
|---|---|
| Common Name: | Smoke Evacuation System |
| Classification Name: | Air-handling apparatus for surgical operating room (21 CFR § 878.5070, Class II, FYD). |
Predicate Device
The RapidVac™ Smoke Evacuator System was compared and found to be substantially equivalent to the following products of comparable type in commercial distribution:
Device Common Name: Smoke Evacuation System Trade Name: Visiclear™ Smoke Evacuation System Catalog Number: VV120, VV220 510(k) Number: K131402 (cleared 3/3/2014) Manufacturer: Buffalo Filter, LLC
Device Common Name: Smoke Evacuation System Trade Name: Optimumm™ Smoke Evacuation System Catalog Number: Optimumm 510(k) Number: K980915 (cleared 6/29/1998) Manufacturer: Valleylab, Inc.
Device Description
The RapidVac™ Smoke Evacuator System consists of a painted aluminum housing, a painted solid polyurethane front panel, a high suction/high flow rate variable speed centrifugal action pump, and a multi stage filter. The system can also use accessories such as sterile tubing sets in various sizes/diameters which are single-use and are used in conjunction with ultrasonic, laser or electrosurgery generators to remove and filter the smoke from the surgical field,.
The RapidVac™ Smoke Evacuator System captures particulates and adsorbs gases from surgical smoke. The smoke evacuator is specifically designed to improve visibility and reduce potential health hazards associated with surgical smoke. It can be used in both open and laparoscopic procedures with available accessories. The RapidVac Smoke Evacuator System is designed with a high suction,
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high flow rate variable speed centrifygal action pump. The ultra-quiet motor is used to draw the smoke from the surgical site through the vacuum tubing and into the system where it is passed through four stages of filtration.
Intended Use
The RapidVac™ Smoke Evacuator System is to remove and filter smoke and aerosols from asurgical site produced during electrosurgical and laser procedures.
Summary comparing the technological characteristics of the subject and predicate devices
The RapidVac Smoke Evacuation System is substantially equivalent to the predicate devices with reqard to smoke evacuation technologies.
Technological and Performance Characteristics
| RapidVac™ Smoke EvacuatorSystem (Proposed) | Visiclear SmokeEvacuationSystem (Predicate) | Optimmum™ SmokeEvacuation System (Predicate) | |
|---|---|---|---|
| Intended Use | Smoke evacuation and filtration | same | same |
| Indications | The Indications for Use of theRapidVac Smoke EvacuatorSystem is to remove and filtersmoke and aerosols from asurgical site produced duringelectrosurgical and laserprocedures. | same | The Indications for Use of theValleylab OptiMumm™ SmokeEvacuator system are for theremoval of smoke and incidentalfluids produced duringelectrosurgery and/or lasersurgery. The removal of smokefrom the surgical site improvesvisibility and reduces potentialhealth hazards associated withsurgical smoke. |
| Target Population | For physicians and trainedhospital staff during the use oflasers or electrosurgery | same | same |
| Materials of Construction | Painted Aluminum Housing,Painted solid polyurethane frontpanel, Four-stage filter (prefilter,ULPA grade filter, virginactivated carbon, wovenfiberglass) | Powder-Coated AluminumHousing, ABS-PC Plastic Fascia,Insulation, Four-stage filter(prefilter, ULPA grade filter,virgin activated carbon, wovenfiberglass) | Aluminum housing, Plastic frontpanel, Three-stage filter(prefilter, ULPA grad filter,integrated charcoal component) |
| Energy Used | Electrical Current | same | same |
| Intended Marketed Accessories | Electrosurgical pencils, tubing,hoses & adapters, sterile andnon-sterile | same | same |
| Filtration | The ULPA filter is 99.999%efficiency at .1 to .2 micronparticle size | same | The ULPA filter is 99.999%efficiency at .12 micron particlesize minimum |
| Filter Life | 25 hours | 35 hours | same |
| Electrical Safety | Tested and compliant with IEC60601-1 and IEC 60601-1-2. | same | same |
| Mechanical Safety | Tested and compliant with IEC60601-1 | same | same |
| Chemical Safety | Neutral pH, non-patient contact | same | same |
| Thermal Safety | Operation of device does notresult in harmful temperatures, | same | same |
Technical Characteristics to Support Substantial Equivalence
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| tested and compliant per IEC60601-1 | |||
|---|---|---|---|
| Radiation Safety | Non-radioactive | same | same |
Performance
The performance verification of the RapidVac Smoke Evacuator System showed that the device met the technical and performance design requirements. Filter life verification testing was conducted for the device to confirm that the ULPA (Ultra Low Penetration Air) efficiency of the filter for the maximum flow rate (25 hours) and filter lifetime. Flow verification testing was conducted for the RapidVac device to verify flow performance outlined in the design specification. The results indicated that the product met all specified flow requirement for each mode of operation. Product verification and validation testing was confirm that the RapidVac Smoke Evacuator System meets all product requirements. Smoke removal verification testing was completed through flow verification testing. Reliability testing was conducted to demonstrate the of the device and show no degradation in performance over that life span. Laparoscopic Smoke Evacuation Verification was conducted for the RapidVac Smoke Evacuation System to confirm the ability to maintain pneumoperitoneum while effectively clearing smoke. Smoke Removal Effectiveness was also conducted with the subject device to demonstrate and quantify via particulate count, the ability of RapidVac to remove aerosols from electrosurgical and laser surgeries.
There was no clinical or pre-clinical performance testing needed to determine the performance of the RapidVac™ Smoke Evacuator System and to make a substantial equivalence comparison.
The RapidVac™ Smoke Evacuator System and accessories were evaluated for mechanical, electrical, performance, and sterility safety using the following standards: IEC 60601-1:2005 and IEC 60601-1-2:2007 .
Conclusion
The Electrical (IEC 60601-1:2005), Mechanical, Software, and Safety (IEC 60601-1-2:2007) and performance testing of the RapidVac™ Smoke Evacuator System has shown it to be substantially equivalent to the predicate devices, Visiclear™ Smoke Evacuation System (K131402) and Optimmum™ Smoke Evacuation System (K980915).
§ 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.