(292 days)
Not Found
No
The summary describes a mechanical smoke evacuation system with filtration, vacuum motor, and standard components. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
No
The device is designed to remove and filter smoke and aerosols produced during electrosurgical and laser procedures to protect healthcare personnel, and it does not directly treat or diagnose a medical condition.
No
The device is designed to remove and filter smoke and aerosols during surgical procedures. It does not analyze patient data or provide information for diagnosis.
No
The device description explicitly details physical components like a vacuum motor, aluminum and plastic components, sound reducing insulation, vacuum tubing, and a filter. It also describes mechanical and electrical verification testing, indicating it is a hardware device with integrated software.
Based on the provided information, the VISICLEAR Smoke Evacuation 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 produced during surgical procedures (electrosurgery and laser). This is a physical process performed on the air in the surgical environment, not on biological samples or specimens taken from the human body.
- Device Description: The description details a system for air filtration and vacuum, not for analyzing biological materials.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis, monitoring, or screening of diseases or conditions based on biological samples.
The VISICLEAR Smoke Evacuation System is a medical device used to improve the safety of the surgical environment by removing hazardous byproducts of certain procedures. It falls under the category of devices used in surgical settings for environmental control and safety, not for diagnostic testing.
N/A
Intended Use / Indications for Use
The VISICLEAR Smoke Evacuation System is designed to remove and filter smoke, aerosols produced during electrosurgical and laser procedures.
Indications for use for the VISICLEAR smoke evacuation system include:
a. 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
Product codes (comma separated list FDA assigned to the subject device)
FYD
Device Description
The VISICLEAR smoke evacuation system is a self-contained system that is used to remove and filter surgical smoke. The device is intended for general electrosurgical and laser applications for removing smoke generated by electrosurgery and laser procedures.
The device is constructed using the same materials and design specifications commonly found in the predicate devices in the smoke evacuation marketplace. The smoke evacuator is comprised of a vacuum motor, aluminum, and plastic components combined with sound reducing insulation. The vacuum motor is used to draw the smoke from the surgical site, through the vacuum tubing and into the VISICLEAR filter where the surgical smoke is processed by a series of filtration stages.
The vacuum flow rate for the VISICLEAR smoke evacuation device ranges from a minimum of 5 liters per minute (LPM) in Laparoscopic Mode to 30 cubic feet per minute in Open Mode. These flow rates are substantially equivalent to the flow range for the predicate devices.
The filter for the VISICLEAR smoke evacuation system, like the filters for the predicate devices, is a replaceable self-contained filter that is completely enclosed to protect health care personnel from potential contamination during filter changes. The VIROSAFE 135 filter ("VS135") is an Ultra Low Penetration Air (ULPA) grade with carbon fitter that has filter efficiency of 99.999% for particle sizes of 0.1 to 0.2 microns or greater. These characteristics are consistent with the predicate devices.
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
Like the predicate devices, the VISICLEAR is used in hospitals, operating room theaters, and doctor's offices and requires physician's prescription for use. The device and all predicates are not intended for patient contact.
For physicians and trained hospital staff during the use of lasers or electrosurgery
Used by surgeons and trained health care professionals
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)
The Buffalo Filter VISICLEAR smoke evacuation system was verified and validated through bench testing designed and conducted to show that the device operates as safe and as effective as the predicate devices, K091139 and K924732.
Verification for the VISICLEAR smoke evacuation system included mechanical, electrical, and software testing.
The electrical verification testing showed that the device met its operational mode and electrical design requirements as specified in the test protocol. Electrical safety testing was conducted for the VISICLEAR smoke evacuation system according to IEC/ANSI/AAMI 60601-1 and 1EC/ANSI/AAMI 60601-1-2. This testing indicated that the VISICLEAR met all electrical safety requirements for the referenced standards.
The mechanical/performance verification testing showed that the device met its mechanical/performance design requirements as specified in the test protocol. Filter life verification testing was conducted for the VISICLEAR smoke evacuation system to confirm the ULPA efficiency of the filter for the maximum flow rate and filter life time. This testing indicated the filter successfully passed ULPA efficiency after 18 hours of saturation of particles at 30CFM flow rate. Flow Verification testing was conducted for the VISICLEAR smoke evacuation system to verify flow performance outlined in the design specification. This testing indicated that the VISICLEAR met all the specified flow requirements at each of the data points for each of the modes of operation. Laparoscopic Smoke Evacuation Verification was conducted for the VISICLEAR smoke evacuation system to confirm effectiveness at clearing smoke while not reducing the pneumoperitoneum. Smoke removal effectiveness verification testing was completed to demonstrate and quantify the ability of the VISICLEAR to remove smoke aerosols resulting from electrosurgical and laser procedures. Reliability testing was conducted for the VISICLEAR smoke evacuation system to demonstrate the use life of the device and no degradation in performance over that time span. Efficiency testing was conducted to ensure the fourth stage of filtration is adequately capturing the carbon fines.
The software verification testing showed that the device met the operational mode and software design requirements as specified in the protocol.
All test results for the non-clinical bench testing indicate that the VISICLEAR smoke evacuation system is substantially equivalent to the predicate devices, K091139 and K924732.
Validation testing has shown that the VISICLEAR smoke evacuation system has met its operation mode and validation requirements. Test results indicate that the VISICLEAR is substantially equivalent to the predicate devices, K091139 and K924732.
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
§ 878.5070 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.
0
MAR - 3 2014
Image /page/0/Picture/2 description: The image shows the logo for Buffalo Filter. The logo consists of the letters "LD" in a bold, blocky font on the left side of the image. To the right of the letters is the word "BUFFALO" in a similar bold, blocky font. Below the word "BUFFALO" is the word "Filter" in a smaller, but still bold font. There are three horizontal lines below the word "Filter".
510(k) Summary For VISICLEAR SMOKE EVACUATION SYSTEM
Buffaló Filter LLC 5900 Genesee Street Lančašter NY 14086 Phone (716) 835 7000 Fax No (716) 835 3414
Contact
Carrie Fermin Director of Quality and Regulatory Affairs Phone (716) 835-7000 Fax No (716) 835 3414
October 21, 2013 Summary Date
CONFIDENTIAL
1
1. Device Name
| Trade Name: | VISICLEAR Smoke Evacuation System |
|---|---|
| Common Name: | Smoke Evacuator |
| Classification Name: | Air Handling Device for a surgical operating room |
| (21 CFR 878.5070, Product Code FYD). Class II |
2. Predicate Device
Buffalo Filter, LLC ("Buffalo Filter") claims substantial equivalence to:
- a. Conmed Corporation. Conined Aer Defense Smoke Evacuator (K091139)
- b. Buffalo Filter. Porta PlumeSafe 601 Smoke Evacuation System (K924732)
3. Description of Device
The VISICLEAR smoke evacuation system is a self-contained system that is used to remove and filter surgical smoke. The device is intended for general electrosurgical and laser applications for removing smoke generated by electrosurgery and laser procedures.
The device is constructed using the same materials and design specifications commonly found in the predicate devices in the smoke evacuation marketplace. The smoke evacuator is comprised of a vacuum motor, aluminum, and plastic components combined with sound reducing insulation. The vacuum motor is used to draw the smoke from the surgical site, through the vacuum tubing and into the VISICLEAR filter where the surgical smoke is processed by a series of filtration stages.
The vacuum flow rate for the VISICLEAR smoke evacuation device ranges from a minimum of 5 liters per minute (LPM) in Laparoscopic Mode to 30 cubic feet per minute in Open Mode. These flow rates are substantially equivalent to the flow range for the predicate devices.
The filter for the VISICLEAR smoke evacuation system, like the filters for the predicate devices, is a replaceable self-contained filter that is completely enclosed to protect health care personnel from potential contamination during filter changes. The VIROSAFE 135 filter ("VS135") is an Ultra Low Penetration Air (ULPA) grade with carbon fitter that has filter efficiency of 99.999% for particle sizes of 0.1 to 0.2 microns or greater. These characteristics are consistent with the predicate devices.
2
The filter life of the VS135 is based on flow rate through the filter and is 35 hours in Laparoscopic Mode, and 18 hours at Open Mode. The filter life for the predicate devices is based on a time of use of 35 hours on Lap Mode and 18 hours on Open Mode. Bench testing has shown the filter life is substantially equivalent to the predicate filters.
The life of the filter is based on the initial time decrementing during operation. specifically when the smoke evacuator motor is operating. The smoke evacuator software is programmed to decrement the filter at the appropriate rate dependent on the selected mode. The filter life is an initial integer stored on an RFID tag during filter assembly that is programmed with the maximum filter life time. During operation, the smoke evacuator decrements that filter time from the RFID tag until the time expires. Since the filter life is stored directly on the RFIL tag located on each filter, when the filter is moved from one smoke evacuator to another, remaining filter life is recognized by any smoke evacuator. Once the filter is expired, time has decremented to zero, the filter will no longer operate in any smoke evacuation system. This operation cannot be bypassed, as time cannot be added back to the filter by the end user. The software verification confirmed the effectiveness of this feature to limit the filter use to only the intended life. The testing per IEC 60601-1-2 and IEC 60601-1-1 confirmed the safety and effectiveness of the technology for use in the smoke evacuation system.
4. Intended Use
The VISICLEAR Smoke Evacuation System is designed to remove and filter smoke, aerosols produced during electrosurgical and laser procedures.
Indications for use for the VISICLEAR smoke evacuation system include:
a. To remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures
ડ. Description of Safety and Substantial Equivalence
Substantial equivalence is based on two (2) predicate devices. All the above referenced predicates are Air-Handling Apparatus for a surgical operating room defined in 21 CFR 878.5070.
The Buffalo Filter VISICLEAR smoke evacuation system was verified and validated through bench testing designed and conducted to show that the device operates as safe and as effective as the predicate devices, K091139 and K924732.
Like the predicate devices, the VISICLEAR is used in hospitals, operating room theaters, and doctor's offices and requires physician's prescription for use. The device and all predicates are not intended for patient contact.
3
The VISICLEAR is equivalent in technological characteristics to the predicate devices in that like VISICLEAR, all predicate devices use a vacuum motor, user interface with motor control features, sound reducing insulation, a filter with a specific life expectancy, and accessories such as tubing to capture the surgical smoke. The device utilizes the same materials found in predicate device, "Aer Defense' with the housing comprised of a combination of plastic and metal, and sound reducing insulation. The VISICLEAR filter is equivalent in design characteristics to the predicate devices, in that multiple layers of filtration are utilized to achieve designed efficiency. These layers include a pre-filter to trap and remove gross particulate; an ULPA grade filter media that captures particulates from 0.1 to 0.2 microns ar an efficiency of 99.999%; another layer comprised of virgin activated carbon; and a final filter laver intended to reduce the migration of granular activated carbon from the self-contained filter.
Verification for the VISICLEAR smoke evacuation system included mechanical. electrical, and software testing.
The electrical verification testing showed that the device met its operational mode and electrical design requirements as specified in the test protocol. Electrical safety testing was conducted for the VISICLEAR smoke evacuation system according to IEC/ANSI/AAMI 60601-1 and 1EC/ANSI/AAMI 60601-1-2. This testing indicated that the VISICLEAR met all electrical safety requirements for the referenced standards.
The mechanical/performance verification testing showed that the device met its mechanical/performance design requirements as specified in the test protocol. Filter life verification testing was conducted for the VISICLEAR smoke evacuation system to confirm the ULPA efficiency of the filter for the maximum flow rate and filter life time. This testing indicated the filter successfully passed ULPA efficiency after 18 hours of saturation of particles at 30CFM flow rate. Flow Verification testing was conducted for the VISICLEAR smoke evacuation system to verify flow performance outlined in the design specification. This testing indicated that the VISICLEAR met all the specified flow requirements at each of the data points for each of the modes of operation. Laparoscopic Smoke Evacuation Verification was conducted for the VISICLEAR smoke evacuation system to confirm effectiveness at clearing smoke while not reducing the pneumoperitoneum. Smoke removal effectiveness verification testing was completed to demonstrate and quantify the ability of the VISICLEAR to remove smoke aerosols resulting from electrosurgical and laser procedures. Reliability testing was conducted for the VISICLEAR smoke evacuation system to demonstrate the use life of the device and no degradation in performance over that time span. Efficiency testing was conducted to ensure the fourth stage of filtration is adequately capturing the carbon fines.
The software verification testing showed that the device met the operational mode and software design requirements as specified in the protocol.
4
All test results for the non-clinical bench testing indicate that the VISICLEAR smoke evacuation system is substantially equivalent to the predicate devices, K091139 and K924732.
Validation testing has shown that the VISICLEAR smoke evacuation system has met its operation mode and validation requirements. Test results indicate that the VISICLEAR is substantially equivalent to the predicate devices, K091139 and K924732.
The VISICLEAR smoke evacuation system and the predicate devices do not contact the patient and are substantially equivalent regarding biocompatibility.
| Parameters | |||
|---|---|---|---|
| Models | PPS 601 | Aer Defense | VISICLEAR |
| Intended Use | Smoke Evacuation | ||
| and Filtration | Smoke Evacuation | ||
| and Filtration | Smoke Evacuation | ||
| and Filtration | |||
| Indications for | |||
| Use | Evacuation of smoke | ||
| plume and odor | |||
| generated during | |||
| laser or | |||
| electrosurgery | |||
| procedures | To remove smoke, | ||
| aerosols and mitigate | |||
| odors produced by | |||
| surgical smoke | |||
| during electrosurgical | |||
| procedures | To remove smoke | ||
| and aerosols from a | |||
| surgical site; to | |||
| mitigate odors | |||
| produced by surgical | |||
| smoke during | |||
| electrosurgical and | |||
| laser procedures. | |||
| 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 | For physicians and | ||
| trained hospital staff | |||
| during the use of | |||
| lasers or | |||
| electrosurgery | |||
| User Interface | Touch Keypad with | ||
| LED Indicator Lights | Touch Keypad with | ||
| LED Indicator Lights | Touch Keypad with | ||
| LED Indicator Lights | |||
| Energy Used | Electrical Current | Electrical Current | Electrical Current |
| Operational | |||
| Settings | On/Off Switch, | ||
| Suction level buttons | |||
| for Motor Control | On/Off Switch, | ||
| Suction level buttons | |||
| for Motor Control | On/Off Switch, | ||
| Suction level buttons | |||
| for Motor Control | |||
| Compatibility | |||
| with | |||
| Environment | |||
| & Other | |||
| Devices | Compatible, neutral | ||
| to other devices | Compatible, neutral | ||
| to other devices | Compatible, neutral | ||
| to other devices |
Technical Characteristics to Support Substantial Equivalence:
CONFIDENTIAL
5
| Intended
Marketed
| Accessories | |||
|---|---|---|---|
| Tubing, Hoses, & | |||
| Adaptors – Sterile | |||
| and Non-Sterile | Electrosurgical | ||
| pencils, Tubing, | |||
| Hoses, & Adaptors – | |||
| Sterile and Non- | |||
| Sterile | Electrosurgical | ||
| pencils, Tubing, | |||
| Hoses, & Adaptors – | |||
| Sterile and Non- | |||
| Sterile | |||
| Materials of | |||
| Construction | Stainless Steel | ||
| Housing, Insulation, | |||
| Glass micro fiber | |||
| filter media, granular | |||
| activated carbon | Coated Aluminum | ||
| Housing and ABS | |||
| Plastic Fascia, | |||
| Insulation, Glass | |||
| micro fiber filter | |||
| media, coconut shell | |||
| carbon | Powder-Coated | ||
| Aluminum Housing, | |||
| ABS -PC Plastic | |||
| Fascia, Insulation, | |||
| Glass micro fiber | |||
| filter media, granular | |||
| activated carbon | |||
| Specifications | Flow Up to 60 CFM, | ||
| Filter Efficiency of | |||
| 99.99995% at 0.12 | |||
| microns | Flow up to 25 CFM, | ||
| ULPA Filter | |||
| Efficiency of | |||
| 99.9995% at 0.12 | |||
| microns or greater | Flow up to 30 CFM, | ||
| Filter Efficiency of | |||
| 99.999% at 0.1 to 0.2 | |||
| microns | |||
| Device | |||
| Mechanism of | |||
| Action | Vacuum source with | ||
| a mechanical means | |||
| of filtration | Vacuum source with | ||
| a mechanical means | |||
| of filtration | Vacuum source with | ||
| a mechanical means | |||
| of filtration | |||
| Air Flow Path | Through Vacuum | ||
| hose or tubing, into a | |||
| filter, then vacuum | |||
| motor, and vented | |||
| into the room | Through Vacuum | ||
| hose or tubing, into a | |||
| filter, then vacuum | |||
| motor, and vented | |||
| into the room | Through Vacuum | ||
| hose or tubing, into a | |||
| filter, then vacuum | |||
| motor, and vented | |||
| into the room | |||
| Performance | 25 Hours filter life, | ||
| capture and filtration | |||
| of smoke plume at | |||
| 99.99995% efficiency | The ULPA-grade | ||
| filter is 99.9995% | |||
| efficiency at 0.12 | |||
| micron particle size | |||
| with a filter life of up | |||
| to 35 hours | 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 | |||
| Human Factors | Used by surgeons and | ||
| trained health care | |||
| professionals | Used by surgeons and | ||
| trained health care | |||
| professionals | Used by surgeons and | ||
| trained health care | |||
| professionals | |||
| Electrical | |||
| Safety | Tested and Compliant | ||
| to IEC 60601-1:1990 | IEC 60601-1 tested | ||
| and compliant | Tested and Compliant | ||
| to IEC 60601-1 and | |||
| IEC 60601-1-2 | |||
| Mechanical | |||
| Safety | Tested and compliant | ||
| per IEC60601-1 for | |||
| mechanical safety | Tested and compliant | ||
| per IEC60601-1 for | |||
| mechanical safety | Tested and compliant | ||
| per IEC60601-1 for | |||
| mechanical safety | |||
| Chemical | |||
| Safety | Neutral pH, non- | ||
| patient contact | Neutral pH, non- | ||
| patient contact | Neutral pH, non- | ||
| patient contact |
6
| Thermal Safety | Operation of the
device does not result | Operation of the
device does not result | Operation of the
device does not result |
|---------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|
| | in harmful
temperatures, tested
and compliant per
IEC60601-1 | in harmful
temperatures, tested
and compliant per
IEC60601-1 | in harmful
temperatures, tested
and compliant per
IEC60601-1 |
| Radiation
Safety | Non-radioactive | Non-radioactive | Non-radioactive |
The design, operational and technical characteristics, performance and non-clinical testing of the VISICLEAR smoke evacuation system are substantially equivalent to and as effective as that of the predicate devices.
The differences noted in the chart between the VISICLEAR smoke evacuation system and the listed predicates are the filter life performance and maximum air flow performance. Testing has demonstrated the VISICLEAR system operates as effective as the listed predicate devices.
The VISICLEAR is as safe and performs as well as the previously identified legally marketed predicate devices. The VISICLEAR's intended use and indications statement for use are substantially supported by the previously cleared predicate devices; and do not impact the safety and effectiveness of the device when used as labeled.
7
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 3, 2014
Buffalo Filter, LLC Ms. Carrie Termin Director of Ouality and Regulatory Affairs 5900 Genesee Street Lancaster, NY 14086
Re: K131402
Trade/Device Name: VISICLEAR Smoke Evacuation System Regulation Number: 21 CFR 878.5070 Regulation Name: Air Handling Device for a Surgical Operating Room Regulatory Class: II Product Code: FYD Dated: January 17, 2014 Received: January 24, 2014
Dear Ms. Termin:
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.
8
Page 2 - Ms. Termin
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 device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
FOR
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Sincerely yours.
Enclosure
9
Indications for Use
510(k) Number: K131402
Device Name: VisiClear Smoke Evacuation System
Indications For Use:
The VisiClear Smoke Evacuation System is designed to remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/9/Picture/11 description: The image shows a digitally signed document by Sreekanth Gutala -S. The document includes information such as the date, which is 2014.02.28 11:45:19 -05'00'. It also includes information such as U.S. Government, ou=FDA, ou=People, 19200300.100.1.1=2000, and cn=Sreekanth Gutala -S.
CONFIDENTIAL
October 21, 2013
Section 004, Page 4-1