(175 days)
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.
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.
This 510(k) summary (K053464) for the SM40SE Smoke Management System provides very limited information regarding acceptance criteria and performance studies. The document primarily focuses on establishing substantial equivalence to predicate devices and describes the intended use and general features of the device.
Here's an analysis based on the provided text, highlighting what is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not contain any specific acceptance criteria or reported device performance metrics for the SM40SE. It generally discusses the function of its integrated smoke plume evacuator to evacuate and filter smoke and odor, but without quantifiable targets or results.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe any specific test set, its sample size, or the provenance of any data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not mention any ground truth establishment or the use of experts for performance evaluation.
4. Adjudication Method for the Test Set:
Since no test set or ground truth establishment is described, there is no information on adjudication methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. There is no mention of human readers, AI assistance, or an effect size for improvement with AI. This is a medical device, not an AI software.
6. Standalone (Algorithm Only) Performance Study:
The document does not describe a standalone performance study for an algorithm. This device is a physical system with an integrated smoke evacuator, not an AI algorithm.
7. Type of Ground Truth Used:
The document does not specify any type of ground truth used, as no performance studies are detailed.
8. Sample Size for the Training Set:
The document does not mention any training set or its sample size. This is not an AI/ML device that would typically have a training set.
9. How Ground Truth for the Training Set was Established:
As no training set is described, there is no information on how its ground truth would be established.
Summary of Device and Approval:
The K053464 submission is for the SM40SE, a space management console with an integrated smoke plume evacuator.
- Intended Use: The console positions and manages devices (medical gas, electrical, communication, accessories) and the smoke plume evacuator evacuates and filters smoke and odor generated during laser or electrosurgery.
- Substantial Equivalence: The device was found substantially equivalent to:
- Approval Date: June 6, 2006.
- Classification: Class II, Product Code FYD (Surgical Exhaust Apparatus).
Conclusion:
This 510(k) summary focuses on the formulation of product equivalence rather than presenting detailed performance data against specific acceptance criteria. For devices like the SM40SE, substantial equivalence is often established through detailed comparisons of design, materials, manufacturing processes, and intended use with legally marketed predicate devices, rather than extensive clinical studies or quantitative performance metrics typically seen with diagnostic or therapeutic devices that rely on novel technologies or algorithms. The approval indicates that the FDA deemed the device as safe and effective as the predicates based on the provided information, without requiring explicit tabular performance data or discussion of AI-related study components.
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510(k) Summary of Safety and Effectiveness
| 510(k)Summary | This summary of 510(k) safety and effectiveness information is beingsubmitted in accordance with the requirements of 21 CFR § 807.92 and theSafe Medical Device Act of 1990. | ||
|---|---|---|---|
| Submitter | ConMed Integrated Systems, Canada, ULC3755 Boul. Matte, Suite FBrossard, Quebec, CanadaJ4Y 2P4 | ||
| Contact Person | Michael T. TaggartVice President, Regulatory Affairs and Quality ManagementConMed LinvatecPhone: (727) 399-5334Fax: (727) 399-5264E-mail: mtaggart@linvatec.com | ||
| Device TradeName | SM40SE | ||
| DeviceCommon Name | Space Management Systems with Integrated Smoke Plume Evacuator | ||
| DeviceClassificationNames | Surgical Exhaust Apparatus | ||
| DeviceClassification | 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 EvacuationSystem | Buffalo Filter Co., Inc. |
:
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| DeviceDescription | The SM40SE is a space management custom configured consoles into whicha variety of medical devices are integrated including a surgical smokeevacuator. |
|---|---|
| These SM40SE consoles are suspended from articulated ceiling pendant ingeneral 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 devicessuch as medical gas, high and low voltage electrical, communication andaccessories such as equipment shelves, drawers, IV poles and smokeevacuation units. |
| The smoke plume evacuator integrated into the SM40SE is intended for theevacuation and filtration of smoke plume and odor generated during laser orelectrosurgery. | |
| SubstantialEquivalence | The SM40ES is substantially equivalent in design and intended use and thepredicate devices identified below. |
| 1. PlumeSafe Whisper 602™ (K924732) | |
| The use of this device is for the evacuation of smoke fumes and odorgenerated during laser and electrosurgery. The device draws smoke plumefrom the surgical site by means of a vacuum hose into a filter. The smokeplume is then filtered through the disposable filtration device and exhaustedthrough the vacuum/blower into the surrounding area. | |
| 2. Teletom (K955750) | |
| Teletom(tm) Power Boom is intended to provide multiple platforms to supportand position equipment and to provide delivery systems for electrical powerand medical gases. The smoke plume evacuator (Televac®) integrated intothe Teletom™ Power Boom intended for the evacuation and filtration ofsmoke plume and odor generated during laser or electrosurgery. |
.
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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
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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
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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
§ 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.