(245 days)
K-063639, K-052859
Not Found
No
The description focuses on electrosurgical energy delivery and saline flow, with no mention of AI or ML technologies.
Yes
The device is intended to deliver RF energy and saline for coagulation of soft tissue and bone, which is a therapeutic intervention.
No
Explanation: The device description states its purpose is to "deliver RF energy and saline for coagulation of soft tissue and bone at the operative site." This indicates it is a therapeutic device used for treatment (coagulation), not for diagnosis.
No
The device description explicitly details physical components such as an insulated handle, shaft, electrode tip, saline delivery tubing, and a power cord, indicating it is a hardware device that utilizes RF energy and saline.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue samples) to provide information about a person's health.
- Device Function: The BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation Device is an electrosurgical device used directly on soft tissue and bone during surgical procedures to coagulate them. It delivers RF energy and saline to the operative site.
- Lack of Specimen Analysis: The description does not mention the device being used to analyze any biological specimens taken from the patient. Its function is therapeutic (coagulation) rather than diagnostic (analyzing samples).
Therefore, this device falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation devices are sterile. single-use bipolar electrosurgical devices intended to deliver RF energy and saline for coagulation of soft tissue and bone at the operative site. It is intended for but not limited to orthopaedic, spine, endoscopic procedures, abdominal and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization.)
Product codes
GEI
Device Description
The BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation Device consists of an insulated handle that encases the shaft and tip, and contains one of the controlling mechanisms for saline flow. RF current activation is by footswitch. Saline flow can be regulated by the user within the sterile field via two flow control mechanisms: one directly on the handle and a roller clamp just proximal to the handle. The saline delivery tubing is approximately ten (10) feet in length and incorporates an I.V. spike for attachment 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 on the handle and power cord meets requirements for Dielectric Withstands of Accessories. The electrode tip delivers RF energy for coagulation and delivers gravity-fed saline from an intravenous bag to the tip. There are three handle shape configurations: straight shaft, angled shaft, and laparoscopic shaft, all constructed of the same materials. The devices are sterile and for single use only, sterilized using ethylene oxide gas.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue and bone at the operative site (orthopaedic, spine, endoscopic procedures, abdominal and thoracic surgery).
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)
K-063639, K-052859
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
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510(k) SUMMARY (per CFR21 807.92(c))
GENERAL INFORMATION:
MAR 1 8 2010
| 510k Owner's Name | Bovie Medical |
|---|---|
| Address | 5115 Ulmerton Road |
| Clearwater, Florida 33760-4004 | |
| Contact Person | Richard A. Kozloff |
| Vice-President; Quality Assurance/Regulatory Affairs | |
| Telephone #: (727) 384-2323 | |
| FAX Number: (727) 347-9144 | |
| Date Prepared: | March 9, 2010 |
DEVICE DESCRIPTION:
| Trade Name: | BOSS Bipolar Operative Saline-Enhanced Sintered Steel
Coagulation Device |
|----------------------|---------------------------------------------------------------------------------------------------------------------|
| Common Name: | Resection (Cutting and Coagulation) Device |
| Classification Name: | Electrosurgical Cutting and Coagulation Devices and
Accessories (21CFR 878.4400; Class II;
Product Code: GEI) |
DEVICE DESCRIPTION:
Predicate Devices:
TissueLink: Aquamantys 2.3 Bipolar Sealer
K-052859
TissueLink: Aquamantys 6.0 Bipolar Sealer K-052859
1
510(k) SUMMARY (per CFR21 807.92(c))
INTENDED USE:
BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation devices are sterile. single-use bipolar electrosurgical devices intended to deliver RF energy and saline for coagulation of soft tissue and bone at the operative site. It is intended for but not limited to orthopaedic, spine, endoscopic procedures, abdominal and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization.)
DEVICE COMPONENTS AND OPERATION:
-
- Insulated Handle:
The Insulated Handle encases the shaft and tip and one of the controlling mechanisms for the flow of saline. The activation of RF current is accomplished by footswitch.
- Insulated Handle:
There are two flow control mechanisms so the flow of saline (one directly on the handle and a roller clamp just proximal to the handle). Saline flow can be regulated by the user within the sterile field. The saline delivery tubing 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 on the Handle and Power Cord meets the requirements for Dielectric Withstands of Accessories.
-
- Shaft and Electrode Tip:
The electrode tip delivers RF energy for coagulation and delivers saline which is gravity-fed from an intravenous bag to the tip. There are three handle shape configurations: straight shaft, angled shaft, and laparoscopic shaft. Each is constructed of the same materials.
- Shaft and Electrode Tip:
5-3
2
510(k) SUMMARY (per CFR21 807.92(c))
These devices use technology substantially equivalent to the Aquamantys SS4.0 Bipolar Sealer (K-063639) and the Aquamantys 6.0 Bipolar Sealer (K-052859). Both consist of an electrode tip that is used to coagulate tissue through the utilization of high frequency radiofrequency energy and saline.
BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation devices are provided sterile, sterilized using ethylene oxide gas, and are for single use only.
These devices conform to the requirements of safety standard IEC 60601-2-2. There are no significant differences in technology, performance, or intended use between BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation devices and predicate devices. There are no new questions raised regarding safety or effectiveness.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. 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 Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 1 8 2010
Bovie Medical % Mr. Richard A. Kozloff Vice - President, Quality Assurance/Regulatory Affairs 5115 Ulmerton Road Clearwater, Florida 33760-4004
Re: K092149
Trade Name: BOSS Bipolar Operative Saline-Enhanced Sintered Steel) Coagulation Device
Regulation Number: 21 CFR 878.4400
Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: March 9, 2010 Received: March 10, 2010
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. 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
4
Page 2 - Mr. Richard A. Kozloff
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.
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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510(k) Number (if known):
Device Name: BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation Device
Indications for Use:
BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation Devices are sterile, single-use bipolar electrosurgical devices intended to deliver RF energy and saline for coagulation of soft tissue and bone at the operative site. It is intended for but not limited to orthopedic, spine, endoscopic procedures, abdominal and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
Prescription Use イ (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
FOR M. MELKERSON
Sien Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092149