(36 days)
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No
The document describes a filtration system and does not mention any AI or ML components or capabilities.
No
The device is described as a filtration system for contaminants from smoke generated during laparoscopic surgery, not as a device for treating a disease or condition in a patient.
No
The device is described as a filtration system for contaminants from smoke generated during laparoscopic surgery, indicating a therapeutic or supportive function rather than a diagnostic one. It removes substances, but does not identify or diagnose any condition.
No
The device description clearly states "Pall Laparoscopic Smoke Filtration System," indicating a physical system for filtration, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to filter contaminants from surgical smoke. This is a process performed outside of the body on a substance generated during a surgical procedure.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not analyze biological samples to diagnose or monitor a medical condition.
The device is a filtration system for surgical smoke, which is a different category of medical device.
N/A
Intended Use / Indications for Use
- The proposed device is intended for the filtration of contaminants from smoke, generated during laparoacopic surgery, which can contain volatile organic products of combustion (including those which are perceived as odor) and particulates (including cellular debris, bacteria, and viruses).
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
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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
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Key Metrics
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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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 20 1999
Leonard S. Berman, Ph.D. Director of Scientific Affairs Pall Medical 2200 Northern Boulevard East Hills, New York 11548
Re: K992361
Trade Name: Pall Surgiclear Laparoscopic Smoke Filtration System, Model CLSF1 Regulatory Class: II Product Code: FYD Dated: July 13, 1999 Received: July 15, 1999
Dear Dr. Berman:
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 requirement, as set forth in the Quality System Regulation (OS) 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Leonard S. Berman, Ph.D.
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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 vour 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,
Thurell W. Hagen
Sor 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
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Page_1________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): __ K992361
Device Name: Pall Laparoscopic Smoke Filtration System
Indications For Use: "
- The proposed device is intended for the filtration of contaminants from smoke, generated during laparoacopic surgery, which can contain volatile organic products of combustion (including those which are perceived as odor) and particulates (including cellular debris, bacteria, and viruses).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBOED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Russell V. Ryan sorr
(Division Sign-Off) Division of General Restorative De 510(k) Number _
Prescription Use (Per 21 CFR 801.109) .
OR
Over-The-Counter Use
(Optional Formal 1-2-96)
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