SERVICE MANAGER SM40SE

K053464 · Conmed Integrated Systems, Canada, Ulc · FYD · Jun 6, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K053464
• Device Name: SERVICE MANAGER SM40SE
• Applicant: Conmed Integrated Systems, Canada, Ulc
• Product Code: FYD · General, Plastic Surgery
• Decision Date: Jun 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5070
• Device Class: Class 2

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.

Device Story

SM40SE is a ceiling-mounted, articulated console system for operating rooms, minimally invasive surgery suites, and post-anesthesia care units. It functions as a support platform for medical gas, electrical, communication, and accessory equipment (shelves, drawers, IV poles). It integrates a smoke plume evacuator that uses a vacuum hose to draw smoke and odor from the surgical site into a disposable filtration device, exhausting filtered air into the surrounding area. Operated by surgical staff, the device manages surgical workspace and improves air quality by removing hazardous smoke plume generated during laser or electrosurgical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ceiling-mounted articulated console system; integrated vacuum-based smoke evacuation unit; disposable filtration media; mechanical support for medical gas, electrical, and communication utilities.

Indications for Use

Indicated for the evacuation and filtration of smoke plume and odor generated during laser or electrosurgery procedures in clinical settings.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Teletom (K955750)
• Plumesafe Whisper 602™ Smoke Evacuation System (K924732)

Submission Summary (Full Text)

{0}------------------------------------------------

K053464

# 510(k) Summary of Safety and Effectiveness

| 510(k)<br>Summary | This summary of 510(k) safety and effectiveness information is being<br>submitted in accordance with the requirements of 21 CFR § 807.92 and the<br>Safe Medical Device Act of 1990. | | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|--|
| Submitter | ConMed Integrated Systems, Canada, ULC<br>3755 Boul. Matte, Suite F<br>Brossard, Quebec, Canada<br>J4Y 2P4 | | |
| Contact Person | Michael T. Taggart<br>Vice President, Regulatory Affairs and Quality Management<br>ConMed Linvatec<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] | | |
| Device Trade<br>Name | SM40SE | | |
| Device<br>Common Name | Space Management Systems with Integrated Smoke Plume Evacuator | | |
| Device<br>Classification<br>Names | Surgical Exhaust Apparatus | | |
| Device<br>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<br>System | Buffalo Filter Co., Inc. |

:

{1}------------------------------------------------

| Device<br>Description | The SM40SE is a space management custom configured consoles into which<br>a variety of medical devices are integrated including a surgical smoke<br>evacuator. |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | These SM40SE consoles are suspended from articulated ceiling pendant in<br>general operating rooms, minimally invasive surgery suites and post-<br>anaesthesia care units. |
| Intended Use | The intended use for the SM40SE console is to position and manage devices<br>such as medical gas, high and low voltage electrical, communication and<br>accessories such as equipment shelves, drawers, IV poles and smoke<br>evacuation units. |
| | The smoke plume evacuator integrated into the SM40SE is intended for the<br>evacuation and filtration of smoke plume and odor generated during laser or<br>electrosurgery. |
| Substantial<br>Equivalence | The SM40ES is substantially equivalent in design and intended use and the<br>predicate devices identified below. |
| | 1. PlumeSafe Whisper 602™ (K924732) |
| | The use of this device is for the evacuation of smoke fumes and odor<br>generated during laser and electrosurgery. The device draws smoke plume<br>from the surgical site by means of a vacuum hose into a filter. The smoke<br>plume is then filtered through the disposable filtration device and exhausted<br>through the vacuum/blower into the surrounding area. |
| | 2. Teletom (K955750) |
| | Teletom(tm) Power Boom is intended to provide multiple platforms to support<br>and position equipment and to provide delivery systems for electrical power<br>and medical gases. The smoke plume evacuator (Televac®) integrated into<br>the Teletom™ Power Boom intended for the evacuation and filtration of<br>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 [phone]. 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 [phone] or [phone] 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