(45 days)
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No
The summary describes a mechanical suction device and makes no mention of AI or ML.
No
The device is used to evacuate gases, body fluids, and smoke during electro-cauterization procedures, which are supportive functions for the procedure rather than directly treating a medical condition.
No
The device is described as an "add-on device used to provide an air suction path for the reduction of gases, body fluids, and smoke" during electro-cauterization procedures. Its purpose is to evacuate substances from the surgical field, not to diagnose medical conditions.
No
The device description explicitly states it is an "add-on device" used to provide an "air suction path," indicating a physical component for fluid and smoke evacuation, not solely software.
Based on the provided information, the Surgiform Saf-T-Vac® Smoke and Fluid Evacuator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use and device description clearly state that the Saf-T-Vac® is used to evacuate gases, body fluids, and smoke associated with the use of electro-cauterization systems. It's a device used during a procedure on the patient, not for analyzing samples outside the body.
- The function is related to air suction and evacuation. This is a physical process for removing byproducts of a surgical procedure, not a diagnostic test performed on a biological sample.
The description aligns with a surgical accessory or a device used in a clinical setting during a procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Surgiform Saf-T-Vac® Smoke and Fluid Evacuator is an add-on device used to provide an air suction path for the reduction of gases, body fluids, and smoke associated with the use of most electro-cauterization systems that are not designed with integrated smoke evacuation capabilities. The Saf-T-Vac® is intended to be used with currently designed and distributed electro-cauterization systems, and most standard operating room suction systems.
Product codes
GEI
Device Description
Saf-T-Vac® Smoke and Fluid Evaluator is an add-on device used to provide an air suction path for the reduction of gases, body fluids, and smoke associated with the use of most electro-cauterization systems that are not designed with integrated smoke evacuation capabilities.
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 (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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2017
Surgical Technology Laboratories, Inc. Mr. Mathew Fairfax President 1566 Whiting Way Lugoff, South Carolina 29078
Re: K170582
Trade/Device Name: Saf-T-Vac Smoke and Fluid Evacuator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: February 23, 2017 Received: February 28, 2017
Dear Mr. Fairfax:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170582
Device Name
Saf-T-Vac® Smoke and Fluid Evaluator
Indications for Use (Describe)
The Surgiform Saf-T-Vac® Smoke and Fluid Evacuator is an add-on device used to provide an air suction path for the reduction of gases, body fluids, and smoke associated with the use of most electro-cauterization systems that are not designed with integrated smoke evacuation capabilities. The Saf-T-Vac® is intended to be used with currently designed and distributed electro-cauterization systems, and most standard operating room suction systems.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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