(176 days)
Not Found
No
The summary describes a standard electrosurgical device with a programmable memory device for compatibility, but no mention of AI or ML for decision-making, image analysis, or adaptive control.
Yes
The device is described as an electrosurgical device for cutting and coagulation of soft tissue, which directly indicates a therapeutic function.
No
The device description states its intended use is for "cutting and coagulation of soft tissue," which are treatment functions, not diagnostic.
No
The device description clearly details physical hardware components including a handpiece, retractable cutting blade, and compatibility with a generator and cable. While it mentions a "programmable memory device," this is part of the physical handpiece and not a standalone software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cutting and coagulation of soft tissue for use during both open and laparoscopic surgical procedures." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details an electrosurgical device that uses helium gas and a retractable blade for surgical manipulation of tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are specifically designed to perform tests on biological samples to provide information about a person's health status. This device is a surgical instrument used for direct intervention on tissue.
N/A
Intended Use / Indications for Use
The Bovie J-Plasma Handpiece with Retractable Cutting Blade is an electrosurgical device that utilizes helium gas plasma for coagulation of soft tissue during both open and laparoscopic surgical procedures.
The Bovie® J-Plasma Handpiece with Retractable Cutting Blade is an electrosurgical device that utilizes a retractable blade for cutting of soft tissue during both open and laparoscopic surgical procedures.
Indications for Use:
The Bovie® J-Plasma Handpiece with Retractable Cutting Blade is an electrosurgical device that utilizes helium gas and a retractable blade for cutting and coagulation of soft tissue for use during both open and laparoscopic surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Bovie® J-Plasma Handpiece with Retractable Cutting Tip are single use devices designed to be compatible only with the ICON GS generator (GS100) and reusable cable (GS-807-RC) cleared under 510k K-090586. There are device models for both open and laparoscopic surgical procedures (GS-018C and GS-270C respectively). These handpieces contain a programmable memory device that requires a unique code for the generator to operate. Each handpiece has a button for finger activation of the generator. Once activated, helium gas flows out the distal end of the device where gas molecules are excited by the high electric field resulting in a plasma stream. The handpiece that is intended for open procedures does not have an extended shaft. The handpiece intended for laparoscopic procedures has a 27 cm extended tip. Both handpieces contain a retractable cutting blade that can be extended manually for excising tissue.
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.
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
P
JAN 2 7 2012
K 112233 PAGE LOF 3
510(k) SUMMARY
(As Required per 21 CFR 807.92(c))
GENERAL INFORMATION:
| 510k Owner's Name | Bovie Medical Corporation | |
|---|---|---|
| Address | 5115 Ulmerton Road | |
| Clearwater, Florida 33760-4004 | ||
| Telephone Number: | (727) 384-2323 | |
| FAX Number: | (727) 322-4465 | |
| Contact Person | Richard A. Kozloff | |
| Vice-President; Quality Assurance/Regulatory Affairs | ||
| Date Prepared: | August 2, 2011 |
DEVICE DESCRIPTION:
| Trade Name: | Bovie® J-Plasma Handpiece with Retractable Cutting Blade |
|---|---|
| Common Name: | Cutting and Coagulation Electrosurgical Device |
| Classification Name: | Electrosurgical Cutting and Coagulation Devices and |
| Accessories | |
| Classification: | 21CFR 878.4400; Class II; Product Code GEI |
| Legally Marketed | |
| Predicate Device(s): | Bovie® ICON GS Electrosurgical Handpiece (K090586) |
Included Accessories:
| | J-Plasma Handpiece with Retractable Cutting Blade | Bovie® ICON GS Electrosurgical Handpiece
(Predicate Device) |
|--------------------------|---------------------------------------------------|----------------------------------------------------------------|
| Reusable Handpiece Cable | GS807-RC
(510k K090586) | GS807-RC
(510k K090586) |
1
510(k) SUMMARY
(As Required per 21 CFR 807.92(c))
DEVICE FUNCTION, TECHNOLOGY, AND INTENDED USE:
The Bovie® J-Plasma Handpiece with Retractable Cutting Tip are single use devices designed to be compatible only with the ICON GS generator (GS100) and reusable cable (GS-807-RC) cleared under 510k K-090586. There are device models for both open and laparoscopic surgical procedures (GS-018C and GS-270C respectively). These handpieces contain a programmable memory device that requires a unique code for the generator to operate. Each handpiece has a button for finger activation of the generator. Once activated, helium gas flows out the distal end of the device where gas molecules are excited by the high electric field resulting in a plasma stream. The handpiece that is intended for open procedures does not have an extended shaft. The handpiece intended for laparoscopic procedures has a 27 cm extended tip. Both handpieces contain a retractable cutting blade that can be extended manually for excising tissue.
INTENDED USE:
Plasma:
The Bovie J-Plasma Handpiece with Retractable Cutting Blade is an electrosurgical device that utilizes helium gas plasma for coagulation of soft tissue during both open and laparoscopic surgical procedures.
Blade:
The Bovie® J-Plasma Handpiece with Retractable Cutting Blade is an electrosurgical device that utilizes a retractable blade for cutting of soft tissue during both open and laparoscopic surgical procedures.
ELECTRICAL STANDARDS:
Both named devices and the predicate are designed to comply with the following electrical standards:
| IEC 60601-1: | Standard for Safety Medical Electrical Equipment, Part 1: General
Requirements for Safety (2005) |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-2-2: | Medical Electrical Equipment - Part 2-2: Particular Requirements for the
Basic Safety and Essential Performance of High Frequency Surgical
Equipment and High Frequency Surgical Accessories (2009) |
2
510(k) SUMMARY
(As Required per 21 CFR 807.92(c))
| Characteristics | Bovie® J-Plasma Handpiece
with Retractable Cutting
Blade
(This Submission) | Bovie® ICON GS
Electrosurgical Handpiece
(K-090586) |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Plasma:
The Bovie® J-Plasma
Handpiece with Retractable
Cutting Blade is an
electrosurgical device that
utilizes helium gas plasma
for coagulation of soft tissue
during both open and
laparoscopic surgical
procedures.
Blade:
The Bovie® J-Plasma
Handpiece with Retractable
Cutting Blade is an
electrosurgical device that
utilizes a retractable blade
for cutting of soft tissue
during both open and
laparoscopic surgical
procedures. | An electrosurgical device
that utilizes Helium gas for
the coagulation of soft
tissues during open soft
tissue surgery. |
| Electrical Safety
Standards | IEC60601-2-2, IEC60601-1 | IEC60601-2-2, IEC60601-1 |
| Output Energy | | |
| Coagulation | 40 Watts (100% Setting on
ICON GS Generator) | 40 Watts (100% Setting on
ICON GS Generator) |
| Delivery System | Monopolar | Monopolar |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 bodies, representing the department's commitment to health, human services, and well-being. The eagle is positioned to the right of the department's name, which is written in a circular fashion around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Bovie Medical Corporation % Mr. Richard A. Kozloff Vice President; Quality Assurance/Regulatory Affairs 5115 Ulmerton Road Clearwater, Florida 33760
JAN 2 7 2012
Re: K112233
Trade/Device Name: BOVIE® J-Plasma Handpiece with Retraceable Cutting Blade Regulation Number: 21 CFR 878.4400
Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI
Dated: January 19, 2012
Received: January 20, 2012
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 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 A. 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/defaultshtm./
Sincerely vours,
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):
Device Name: Bovie® J-Plasma Handpiece with Retractable Cutting Blade
Indications for Use:
The Bovie® J-Plasma Handpiece with Retractable Cutting Blade is an electrosurgical device that utilizes helium gas and a retractable blade for cutting and coagulation of soft tissue for use during both open and laparoscopic surgical procedures.
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)
Sign-
(Division (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112233
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