Anesthesiology
Review Panel
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- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- ERYDrape, Surgical, Ent2Product Code
- EYXDrape, Pure Latex Sheet, With Self-Retaining Finger Cot2Product Code
- EYYDrape, Urological, Disposable2Product Code
- FXOSuit, Surgical1Product Code
- FXPCover, Shoe, Operating-Room1Product Code
- FXXMask, Surgical2Product Code
- FXYHood, Surgical2Product Code
- FXZHelmet, Surgical1Product Code
- FYAGown, Surgical2Product Code
- FYBGown, Patient2Product Code
- FYCGown, Isolation, Surgical2Product Code
- HMTDrape, Patient, Ophthalmic2Product Code
- HMWDrape, Microscope, Ophthalmic2Product Code
- KGOSurgeon'S Gloves1Product Code
- KGQCream, Gloving, Surgeon'S1Product Code
- KGTDrape, Adhesive, Aerosol1Product Code
- KKXDrape, Surgical2Product Code
- LGXTable, Examination, Medical, Powered1Product Code
- LYUAccessory, Surgical Apparel1Product Code
- MACDecontamination Kit1Product Code
- MMPCover, Barrier, Protective2Product Code
- MSHRespirator, Surgical2Product Code
- NZPSealant, Microbial2Product Code
- OEANon-Surgical Isolation Gown1Product Code
- OKFBody Fluid Disposal Kit2Product Code
- OKGBody Fluid Clean Up Kit2Product Code
- OKHBody Fluids Barrier Kit2Product Code
- OKIEmergency Response Safety Kit2Product Code
- ONTN95 Respirator With Antimicrobial/Antiviral Agent2Product Code
- OPAPowder-Free Non-Natural Rubber Latex Surgeon'S Gloves1Product Code
- OUKSurgical Mask With Antimicrobial/Antiviral Agent2Product Code
- OVRKit, First Aid, Talking1Product Code
- OXZPediatric/Child Facemask2Product Code
- PIRMercy Tape 2d And 3d Models1Product Code
- PLYAntimicrobial Drapes2Product Code
- PQMSurgical Smoke Precipitator2Product Code
- QBWSurgical Apparel With Material Claims2Product Code
- QMXLabel Or Tag, Non-Sterile1Product Code
- QPCGown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection2Product Code
- QSOMedical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs2Product Code
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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- OphthalmicReview Panel
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- UnknownReview Panel
Surgical Smoke Precipitator
- Page Type
- Product Code
- Definition
- The device is intended to precipitate surgical smoke to allow surgeons adequately visualize laparoscopic surgeries in the using surgical smoke/aerosolized particulate surgical tools.
- Physical State
- The device consists of an ion delivery system and a power source.
- Technical Method
- The device is introduced into the laparoscopic site and provides the source of the ions that charge the surgical smoke particles and facilitate precipitation of surgical smoke and other aerosolized particulates
- Target Area
- The device is intended for laparoscopic surgery sites.
- Regulation Medical Specialty
- General and Plastic Surgery
- Review Panel
- General Hospital
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 878.5050
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 878.5050 Surgical smoke precipitator
§ 878.5050 Surgical smoke precipitator.
(a) Identification. A surgical smoke precipitator is a prescription device intended for clearance of the visual field by precipitation of surgical smoke and other aerosolized particulate matter created during laparoscopic surgery.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) Adverse tissue reaction must be mitigated through the following:
(i) Chemical characterization and toxicological risk assessment of the treated surgical smoke.
(ii) Demonstration that the elements of the device that may contact the patient are biocompatible.
(2) Electrical safety and electromagnetic compatibility testing must demonstrate that the device performs as intended.
(3) Software verification, validation, and hazard analysis must be performed.
(4) Performance data must demonstrate the sterility of the patient contacting components of the device.
(5) Performance data must support the shelf life of the sterile components of the device by demonstrating continued functionality, sterility, and package integrity over the identified shelf life.
(6) Animal simulated-use testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Device must be demonstrated to be effectively inserted, positioned, and removed from the site of use.
(ii) Device must be demonstrated to precipitate surgical smoke particulates to clear the visual field for laparoscopic surgeries.
(iii) Device must be demonstrated to be non-damaging to the site of use and animal subject.
(7) Labeling must identify the following:
(i) Detailed instructions for use.
(ii) Electrical safety and electromagnetic compatibility information.
(iii) A shelf life.
[83 FR 4143, Jan. 30, 2018]