(142 days)
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No
The summary describes a physical suction device for removing surgical byproducts and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device removes smoke, odors, gases, particles, and fluids from the surgical site, which is a supportive function during surgery, not a direct treatment or therapy for a disease or condition.
No
The device is used to remove smoke, odors, gases, particles, and fluids during electrosurgery procedures. It does not provide any diagnostic information.
No
The device description clearly indicates a physical device ("BoVac Electrosurgery Suction Device") that removes smoke, odors, etc., during surgery, which is a hardware function.
Based on the provided information, the BoVac Electrosurgery Suction Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device's intended use is to remove smoke, odors, gases, particles, and fluids directly from the surgical site during electrosurgery. This is a function performed on the patient 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. The BoVac device does not perform any such tests on biological samples.
The BoVac Electrosurgery Suction Device is a surgical accessory used to manage the environment at the surgical site, not to diagnose or monitor a patient's health through analysis of biological samples.
N/A
Intended Use / Indications for Use
The BoVac Electrosurgery Suction Device removes smoke, odors, gases, particles, and fluids directly from the surgical site during electrosurgery procedures. The device is single-use and disposable.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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
surgical site
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 878.4400 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Richard T. Nock President New Leaf Medical, Incorporated 11476 Hawke Road, Suite #C Columbia Station, Ohio 44028
NUV 1 7 2006
Re: K061829
Trade/Device Name: BoVac Electrosurgery Suction Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: II Product Code: GEI Dated: October 31, 2006 Received: November 6, 2006
Dear Mr. Nock:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Nock
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Gulate Y. Michieu DmD.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number: K061829
Device Name: BoVac Electrosurgery Suction Device
Indications For Use:
The BoVac Electrosurgery Suction Device removes smoke, odors, gases, particles, and fluids directly from the surgical site during electrosurgery procedures. The device is single-use and disposable.
× AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule A. Murphy, MD
ion of Anesthesiology, General Hospital,
ion Control, Dental Devices
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Number. K