(88 days)
Not Found
None
No
The document describes a smoke evacuation system and contains no mention of AI, ML, or related concepts like image processing or training/test sets.
No
The device is described as a smoke evacuation system used to remove smoke generated during operating procedures. It does not directly treat a disease or condition in a patient.
No
The device is described as a "central smoke evacuation system" intended for removing smoke generated during operating procedures. Its function is to clear the surgical field, not to diagnose or detect medical conditions.
No
The device description clearly states it is a "central smoke evacuation system," which implies hardware components for smoke removal. There is no mention of it being software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to remove smoke generated during surgical procedures. This is a physical process performed during a medical procedure, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description confirms it's a central smoke evacuation system, which aligns with the intended use of removing smoke.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's condition
- Using reagents or assays
Therefore, the SKYVAC is a medical device used in a surgical setting, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SKYVAC is a central smoke evacuation system. This system is intended to be used by medical personnel for the purpose of removing smoke generated during operating procedures by laser and electro-surgical units.
Product codes
FYD
Device Description
Not Found
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
medical personnel / operating procedures
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)
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 1997
Mr. Mark McKee President Pyramid Air Systems 122 Harris Street Grainvalley, Missouri 64029
Re: K973610 Trade Name: Skyval Regulatory Class: II Product Code: FYD Dated: September 8, 1997 Received: September 22, 1997
Dear Mr. McKee:
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 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.
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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for
1
Page 2 - Mr. McKee
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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,
to coello
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
1 of 1 Page
K973610 510(k) Number (if known):
SKYVAC Devicc Name:
Indications For Use:
This system is intended The SKYVAC is a central smoke evacuation system. to be used by medical personnel for the purpose of removing smoke generated during operating procedures by laser and electro-surgical units.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sich-Om
Division of Dontal, Info and General Hospital De 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)