(175 days)
Not Found
No
The document describes a console for managing medical devices and a smoke evacuator, with no mention of AI or ML capabilities.
No.
The core console primarily manages and positions other integrated medical devices and accessories. While it integrates a smoke plume evacuator, which functions to evacuate and filter smoke generated during procedures, the device itself does not directly treat a medical condition or ailment. It is supportive equipment within a surgical environment.
No
Justification: The device's intended use is to position and manage other medical devices, and the integrated smoke plume evacuator is for filtration of smoke and odor. There is no mention of the device being used to diagnose a medical condition or disease.
No
The device description clearly states it is a physical console with integrated medical devices, including a surgical smoke evacuator, suspended from a ceiling pendant. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes positioning and managing medical devices and evacuating surgical smoke. This is a physical function related to the surgical environment and procedures performed on a patient, not the examination of specimens derived from the human body.
- Device Description: The description reinforces that it's a console for integrating and suspending medical devices, including a smoke evacuator. This aligns with supporting surgical procedures, not performing diagnostic tests on samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the SM40SE console and its integrated smoke evacuator fall under the category of medical devices used in a surgical setting, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The intended use for the SM40SE console is to position and manage devices such as medical gas, high and low voltage electrical, communication and accessories such as equipment shelves, drawers, IV poles and smoke evacuation units.
The smoke plume evacuator integrated into the SM40SE is intended for the evacuation and filtration of smoke plume and odor generated during laser or electrosurgery.
Product codes
FYD
Device Description
The SM40SE is a space management custom configured consoles into which a variety of medical devices are integrated including a surgical smoke evacuator. These SM40SE consoles are suspended from articulated ceiling pendant in general operating rooms, minimally invasive surgery suites and post-anaesthesia care units.
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
general operating rooms, minimally invasive surgery suites and post-anaesthesia care units.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
510(k) Summary of Safety and Effectiveness
| 510(k)
Summary | This summary of 510(k) safety and effectiveness information is being
submitted in accordance with the requirements of 21 CFR § 807.92 and the
Safe Medical Device Act of 1990. | | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|--|
| Submitter | ConMed Integrated Systems, Canada, ULC
3755 Boul. Matte, Suite F
Brossard, Quebec, Canada
J4Y 2P4 | | |
| Contact Person | Michael T. Taggart
Vice President, Regulatory Affairs and Quality Management
ConMed Linvatec
Phone: (727) 399-5334
Fax: (727) 399-5264
E-mail: mtaggart@linvatec.com | | |
| Device Trade
Name | SM40SE | | |
| Device
Common Name | Space Management Systems with Integrated Smoke Plume Evacuator | | |
| Device
Classification
Names | Surgical Exhaust Apparatus | | |
| Device
Classification | Device Class | II | |
| | Product Code | FYD | |
| | Classification Panel | General & Plastic Surgery | |
| | Regulation Number | 878.5070 | |
Predicate / Legally Marketed Devices
| 510(k) Number | Device | Manufacturer |
|---|---|---|
| K955750 | Teletom | Berchtold Holding GMBH |
| K924732 | Plumesafe Whisper 602™ Smoke Evacuation | |
| System | Buffalo Filter Co., Inc. |
:
1
| Device
Description | The SM40SE is a space management custom configured consoles into which
a variety of medical devices are integrated including a surgical smoke
evacuator. |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | These SM40SE consoles are suspended from articulated ceiling pendant in
general operating rooms, minimally invasive surgery suites and post-
anaesthesia care units. |
| Intended Use | The intended use for the SM40SE console is to position and manage devices
such as medical gas, high and low voltage electrical, communication and
accessories such as equipment shelves, drawers, IV poles and smoke
evacuation units. |
| | The smoke plume evacuator integrated into the SM40SE is intended for the
evacuation and filtration of smoke plume and odor generated during laser or
electrosurgery. |
| Substantial
Equivalence | The SM40ES is substantially equivalent in design and intended use and the
predicate devices identified below. |
| | 1. PlumeSafe Whisper 602™ (K924732) |
| | The use of this device is for the evacuation of smoke fumes and odor
generated during laser and electrosurgery. The device draws smoke plume
from the surgical site by means of a vacuum hose into a filter. The smoke
plume is then filtered through the disposable filtration device and exhausted
through the vacuum/blower into the surrounding area. |
| | 2. Teletom (K955750) |
| | Teletom(tm) Power Boom is intended to provide multiple platforms to support
and position equipment and to provide delivery systems for electrical power
and medical gases. The smoke plume evacuator (Televac®) integrated into
the Teletom™ Power Boom intended for the evacuation and filtration of
smoke plume and odor generated during laser or electrosurgery. |
.
:
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health and Human Services (HHS) in the United States. The seal features the department's emblem, which consists of a stylized caduceus, a symbol often associated with medicine and healthcare. The emblem is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN -6 2006
ConMed Linvatec. % Mr. Michael Taggart VP, Quality Management and Regulatory Affairs 11311 Concept Boulevard Largo, Maryland 33773-4908
Re: K053464
Trade/Device Name: SM40SE Regulation Number: 21 CFR 878.5070 Regulation Name: Air-handling apparatus for a surgical operating room Regulation Class: II Product Code: FYD Dated: April 21, 2006 Received: April 24, 2006
Dear Mr. Taggart:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
3
Page 2 - Mr. Michael Taggart
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
CONFIDENTIAL
Indications for Use
KOS3464 510(k) Number (if known):
Device Name:
SM40SE
Indications for Use
The intended use for the SM40SE console is to position and manage devices such as medical gas, high and low voltage electrical, communication and accessories such as equipment shelves, drawers, IV poles and smoke evacuation units.
The smoke plume evacuator integrated into the SM40SE is intended for the evacuation and filtration of smoke plume and odor generated during laser or electrosurgery.
Prescription Use X_ (Part 21 CFR 801 subpart D) OR
Over-the-Counter Use _ (Part 21 CFR 807 subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative. and Neurological Devices
510(k) Number_ko53464