(147 days)
K-082568
Not Found
No
The 510(k) summary describes a standard electrosurgical device with mechanical and electrical components for delivering RF energy and saline. There is no mention of AI, ML, image processing, or any data-driven decision-making processes within the device's operation.
No
The device is used for cutting and coagulating soft tissue during laparoscopic procedures, which are surgical interventions, not therapeutic treatments.
No
The device is described as an electrosurgical device for cutting and coagulating soft tissue, which are therapeutic functions, 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 that delivers RF current and saline.
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 the "laparoscopic delivery of radiofrequency ("RF") current and sterile saline for cutting and coagulating soft tissue." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a surgical instrument with a handle, shaft, and electrode tip designed to deliver energy and saline directly to tissue during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for treatment.
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 laparoscopic delivery of radiofrequency ("RF") current and sterile saline for cutting and coagulating soft tissue.
The Laparoscopic Resection Device is a sterile, single use electrosurgical device intended to be used in conjunction with an electrosurgical generator for the laparoscopic 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 (comma separated list FDA assigned to the subject device)
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 laparoscopic 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. 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.
- Insulated Handle:
-
- 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. The electrode shaft measures 32 centimeters (12.6 inches) in length and is intended to be placed through a cannula with a minimum diameter of 10 millimeters.
This device use technology substantially equivalent to the Bovie Medical Resection Device (K-082568). Both consist of a sintered stainless steel electrode tip that is used to cut and coagulate tissue through the utilization of high frequency radiofrequency energy. The difference between the two devices is that the predicate device is used for open surgical procedures and the Laparoscopic Resection Device is used for laparoscopic procedures.
Laparoscopic Resection Devices are provided sterilized using ethylene oxide gas, and are for single use only.
The Laparoscopic Resection Device conforms to the requirements of safety standard IEC 60601-2-2.
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): 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.
K-082568
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.
Not Found
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).
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
KOSIYUO
510(k) SUMMARY (per CFR21 807.92(c))
GENERAL INFORMATION:
OCT - 9 2009
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
May 12, 2009
DEVICE DESCRIPTION:
Trade Name:
Common Name:
Classification Name:
Laparoscopic 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:
Bovie Medical Resection Device (K-082568)
1
510(k) SUMMARY (per CFR21 807.92(c))
INTENDED USE:
The Resection Device is a sterile, single use electrosurgical device intended to be used in conjunction with an electrosurgical generator for the laparoscopic 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.
The electrode shaft measures 32 centimeters (12.6 inches) in length and is intended to be placed through a cannula with a minimum diameter of 10 millimeters..
2
510(k) SUMMARY (per CFR21 807.92(c))
This device use technology substantially equivalent to the Bovie Medical Resection Device (K-082568). Both consist of a sintered stainless steel electrode tip that is used to cut and coagulate tissue through the utilization of high frequency radiofrequency energy. The difference between the two devices is that the predicate device is used for open surgical procedures and the Laparoscopic Resection Device is used for laparoscopic procedures.
Laparoscopic Resection Devices are provided sterilized using ethylene oxide gas, and are for single use only.
The Laparoscopic Resection Device conforms to the requirements of safety standard IEC 60601-2-2.
There are no significant differences in technology, intended use, or performance between the Laparoscopic 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 three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Bovie Medica Inc. % Mr. Richard Kozloff 7100 30th Avenue North Saint Petersburg, Florida 33710
OCT - 9 2009
Re: K091440
Trade/Device Name: Laparoscopic Resection Device, model sr326L Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 21, 2009 Received: August 25, 2009
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, 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 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-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.
4
Page 2- Mr. Richard Kozloff
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Laparoscopic Resection Device Device Name:
Indications for Use:
The Laparoscopic Resection Device is a sterile, single use electrosurgical device intended to be used in conjunction with an electrosurgical generator for the laparoscopic 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 (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)
Division Sign Off
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091440