(74 days)
Not Found
No
The description focuses on the electrosurgical mechanism, saline delivery, and physical components. There is no mention of AI, ML, or any computational analysis of data for decision-making or control.
Yes
The device is described as an electrosurgical device intended to cut and coagulate soft tissue, which directly treats a condition (e.g., diseased tissue or bleeding) through a physical intervention.
No
Explanation: The device is described as an electrosurgical device for cutting and coagulating soft tissue, which are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines physical components such as an Insulated Handle, Shaft, Electrode Tip, tubing, and power cord, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting and coagulating soft tissue" using radiofrequency current and saline. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a surgical instrument with a handle, shaft, and electrode tip designed for delivering energy and saline to tissue.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a person's health. This device does not interact with specimens in this way.
The device is an electrosurgical device used for surgical procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Resection Device is a sterile, single use electrosurgical device intended to be used in conjunction with an electrosurgical generator for the delivery of radiofrequency ("RF") current and sterile saline for cutting and coagulating soft tissue. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
Product codes
GEI
Device Description
The Resection Device is a sterile, single use electrosurgical device intended to be used in conjunction with an electrosurgical generator for the delivery of radiofrequency ("RF") current and sterile saline for cutting and coagulating soft tissue.
-
- Insulated Handle: The Insulated Handle encases the controlling mechanism for the flow of saline, and activation of the RF current for the device. The activation of RF current is accomplished by a single push button on the top of the handle. The Handle has a flow control mechanism so the flow of saline can be regulated by the user within the sterile field. The tubing length is approximately ten (10) feet in length and incorporates an I.V. spike on the end to attach directly to a hanging IV (saline) bag. The Handle power cord is approximately ten (10) feet in length and incorporates a 3-prong electrical plug. The insulation of the Insulated Handle and Power Cord meets the requirements for Dielectric Withstands of Accessories.
-
- Shaft and Electrode Tip: The electrode tip delivers RF energy for cutting and coagulation and delivers saline which is gravity-fed from an Intravenous bag to the tip.
Resection Devices are provided sterile, sterilized using ethylene oxide gas, and are for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Page 1 of 3
510(k) SUMMARY (per CFR21 807.92(c))
082 5568
GENERAL INFORMATION:
NOV 1 7 2008
510k Owner's Name Address
Bovie Medical 7100 30th Avenue North St. Petersburg, Florida 33710-2902
Richard A. Kozloff Vice-President; Quality Assurance/Regulatory Affairs Telephone #: (727) 384-2323 FAX Number: (727) 347-9144
Date Prepared:
Contact Person
September 2, 2008
DEVICE DESCRIPTION:
Trade Name:
Common Name:
Classification Name:
Saline Enhanced Electrosurgical Resection (SEER) Device
Resection (Cutting and Coagulation) Device
Electrosurgical Cutting and Coagulation Devices and Accessories (21CFR 878.4400; Class II; Product Code: GEI)
Predicate Device:
TissueLink Solid Cylinder Monopolar Device (K-01260)
1
Page 2 of 3
510(k) SUMMARY (per CFR21 807.92(c))
DEVICE DESCRIPTION:
Predicate Devices:
TissueLink: Solid Cylinder Monopolar Device
INTENDED USE:
The Resection Device is a sterile, single use electrosurgical device intended to be used in conjunction with an electrosurgical generator for the delivery of radiofrequency ("RF") current and sterile saline for cutting and coagulating soft tissue.
DEVICE COMPONENTS AND OPERATION:
-
- Insulated Handle:
The Insulated Handle encases the controlling mechanism for the flow of saline, and activation of the RF current for the device.
- Insulated Handle:
The activation of RF current is accomplished by a single push button on the top of the handle.
The Handle has a flow control mechanism so the flow of saline can be regulated by the user within the sterile field. The tubing length is approximately ten (10) feet in length and incorporates an I.V. spike on the end to attach directly to a hanging IV (saline) bag.
The Handle power cord is approximately ten (10) feet in length and incorporates a 3-prong electrical plug.
The insulation of the Insulated Handle and Power Cord meets the requirements for Dielectric Withstands of Accessories.
-
- Shaft and Electrode Tip:
The electrode tip delivers RF energy for cutting and coagulation and delivers saline which is gravity-fed from an Intravenous bag to the tip.
- Shaft and Electrode Tip:
2
KO82568
510(k) SUMMARY (per CFR21 807.92(c)}
Page 3 of 3
These devices use technology substantially equivalent to the TissueLink Solid Cylinder Monopolar Device (K014260). Both consist of an electrode tip that is used to cut and coagulate tissue through the utilization of high frequency radiofrequency energy.
Resection Devices are provided sterile, sterilized using ethylene oxide gas, and are for single use only.
The Resection Device conforms to the requirements of safety standard IEC 60601-2-2.
There are no significant differences in technology, performance, or intended use between the Resection Device and the given predicate device. There are no new questions raised regarding safety or effectiveness.
3
Image /page/3/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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 7 2008
Bovic Medical % Mr. Richard Kozloff VP, Quality Assurance/Regulatory Affairs 7100 30th Avenue North St. Petersburg, Florida 33710-2902
Re: K082568
Trade/Device Name: Resection Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 6, 2008 Received: November 7, 2008
Dear Mr. Kozloff:
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. Iisting 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.
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 (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.
4
Page 2 - Mr. Richard Kozloff
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Prosmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse vents (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K082568
Device Name: Resection Device
Indications for Use:
The Resection Device is a sterile, single use electrosurgical device intended to be used in conjunction with an electrosurgical generator for the delivery of radiofrequency ("RF") current and sterile saline for cutting and coagulating soft tissue. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
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)
Neil ReOphm formxm
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number K082568