(57 days)
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Not Found
No
The provided text describes a smoke evacuation system and does not mention any AI or ML capabilities.
No
Explanation: The device is described as a smoke evacuation system used to remove smoke plumes during surgical procedures. Its purpose is to manage the surgical environment by removing contaminants, not to directly treat a patient's disease or condition through physical, mechanical, or chemical means.
No
The device is described as a "Smoke Evacuation System" used to remove surgical smoke plumes, which is a therapeutic/supportive function, not a diagnostic one.
No
The description clearly states the device is a "STERIS Smoke Evacuation System," which is a hardware system designed to evacuate smoke. There is no mention of software as the primary or sole component.
Based on the provided information, the STERIS Smoke Evacuation System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to evacuate smoke plume generated during surgical procedures. This is a physical process performed during a medical procedure on a patient, not a test performed on a sample taken from a patient to diagnose or monitor a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring analytes or biomarkers
- Using reagents or assays
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The STERIS Smoke Evacuation System's function is to manage airborne contaminants in the surgical environment, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The STERIS Smoke Evacuation System will be used to evacuate the smoke plume created by electrosurgery, laser surgery, or power tool procedures. Locations for use include the OR, Trauma, Endoscopy and Laparoscopy Suites.
Product codes
FYD
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
OR, Trauma, Endoscopy and Laparoscopy Suites.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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
Image /page/0/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three overlapping human profiles facing to the right, with flowing lines suggesting movement or connection.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1999 JUN
Mr. Robert H. M Call Senior Regulatory Affairs Specialist STERIS Corporation 2720 Gunter Park Drive East Montgomery, Alabama 36109
Re : K991167 STERIS Smoke Evacuation System™ Trade Name: Regulatory Class: II Product Code: FYD Dated: April 6, 1999 Received: April 7, 1999
Dear Mr. MºCall:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. MªCall
this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Attachment 2
("")
| Indications for Use Statement | |||
|---|---|---|---|
| 510(k) Number (if known) | K991167 | ||
| Device Name | STERIS Smoke Evacuation System | ||
| Indications for Use | The STERIS Smoke Evacuation System will be used to evacuate the smoke plume created by electrosurgery, laser surgery, or power tool procedures. Locations for use include the OR, Trauma, Endoscopy and Laparoscopy Suites. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use | ||
|---|---|---|---|---|
| (Division Sign-Off) | ||||
| Division of Dental, Infection Control, | ||||
| and General Hospital Devices | ||||
| 510(k) Number | K991167 |