(244 days)
Not Found
No
The description focuses on the electrosurgical technology, bipolar functionality, and mechanical features (shaft lengths, aspiration/irrigation). There is no mention of AI, ML, image processing, or data-driven decision making. The user controls the blend ratio, not an automated system.
No.
The device is used for surgical procedures (resection and coagulation of soft tissue and blood vessels), which are generally considered treatments rather than therapeutic processes according to the FDA's definition of "therapeutic device." Therapy aims to deliver a direct treatment, while resection and coagulation are surgical actions.
No
The device is indicated for surgical procedures (resection and coagulation of soft tissue and blood vessels), not for diagnosing conditions.
No
The device description clearly describes physical hardware components (electrodes, shaft, lumen, tubing, connectors) and their function in electrosurgical procedures. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Bipolar electrosurgical resection and coagulation of soft tissue and blood vessels in laparoscopic or general surgical procedures." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details a surgical instrument used for cutting and coagulating tissue during surgery. It interacts directly with the patient's body.
- 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 patient's health. This device does not perform any such analysis of specimens.
Therefore, the Plasmacision and Plasmablend Electrodes are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
The Plasmacision and Plasmablend Electrodes are indicated for Bipolar electrosurgical resection and coagulation of soft tissue and blood vessels in laparoscopic or general surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Gyrus PlasmaCision and PlasmaBlend electrodes are bipolar electrosurgical instruments with the capability to cut and coagulate soft tissue and blood vessels in laparoscopic surgery under carbon dioxide gas or air insufflation. The instrument will pass through a 5mm cannula or through an operating laparoscope working channel of 5mm or larger diameter. The PlasmaCision and PlasmaBlend electrodes may also be used in general surgical procedures. The instruments are to be used only with the Gyrus General Surgery RF Workstation. Activation of the instruments is achieved via footswitch control. The Instruments are available with and without aspiration (suction) / irrigation lines. On such equipped instruments, this provides additional functionality to the device by increasing its range of capabilities within the procedure. The suction / irrigation capable versions incorporate a lumen / Y connector and male connector with polymeric tubing for adaptation to suction / irrigation systems. The instruments are, like other Gyrus bipolar electrosurgical instruments, available in a number of different shaft lengths and diameters, chosen by the surgeon to be most appropriate for the procedure to be undertaken. The instruments have a multipole arrangement at the patient interface. The instruments consist of three individually isolated conductors that act as the tissue effectors. A PlasmaBlend output is a blended cut and coagulation output that is delivered to the L09 instrument. The ratio of cut to coagulation of this output is selectable by the user and this allows the user to select the amount of haemostasis created during cutting. This output is controlled by the Gyrus General Surgery RF Workstation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue and blood vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel trained in the use of electrosurgical equipment
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)
Performance testing has been done to validate the performance of the device. The comparison and validation results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to predicate devices and is safe and effective in its intended use.
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
510(k) Premarket Notification Plasmacision and Plasmablend Electrodes
OCT 24 2005
Page 1 of 2
K050460
510(k) Summary of Safety and Effectiveness Gyrus L09 Instrument
| Submitted by: | Gyrus Medical, Inc.
6655 Wedgwood Road, Suite 160.
Maple Grove, MN 55311-3602 |
|------------------------|--------------------------------------------------------------------------------------------|
| Contact Person: | Mark A. Jensen
Group Vice President Regulatory Affairs/Quality
Assurance |
| | Telephone: 763 416 3005 |
| | Facsimile: 763 416 3070 |
| Date Summary Prepared: | October 18, 2005 |
| Name of the Device: | |
| Proprietary Name: | Gyrus PlasmaCision and PlasmaBlend electrodes |
| Project Name: | L09 Instrument |
| Common/Usual Name: | Electrosurgical Accessory |
| Classification Name: | Electrosurgical Cutting & Coagulation Device
and Accessories (per 21 CFR 878.4400) |
| Brand Name: | Not yet assigned |
| Predicate Devices: | K031082 - PK Bipolar L Hook
K041285 - Gyrus G3 System (Generator
and
Accessories) |
Description
General:
The Gyrus PlasmaCision and PlasmaBlend electrodes are bipolar electrosurgical instruments with the capability to cut and coagulate soft tissue and blood vessels in laparoscopic surgery under carbon dioxide gas or air insufflation. The instrument will pass through a 5mm cannula or through an operating laparoscope working channel of 5mm or larger diameter. The PlasmaCision and PlasmaBlend electrodes may also be used in general surgical procedures.
The instruments are to be used only with the Gyrus General Surgery RF Workstation. Activation of the instruments is achieved via footswitch control.
Variants available:
1
510(k) Premarket Notification Plasmacision and Plasmablend Electrodes
K 050 460
Page 2 of 2
The Instruments are available with and without aspiration (suction) / irrigation lines. On such equipped instruments, this provides additional functionality to the device by increasing its range of capabilities within the procedure. The suction / irrigation capable versions incorporate a lumen / Y connector and male connector with polymeric tubing for adaptation to suction / irrigation systems.
The instruments are, like other Gyrus bipolar electrosurgical instruments, available in a number of different shaft lengths and diameters, chosen by the surgeon to be most appropriate for the procedure to be undertaken.
Indication:
The instruments are indicated for Bipolar electrosurgical resection and coagulation of soft tissue and blood vessels in laparoscopic or general surgical procedures.
Construction:
The instruments have a multipole arrangement at the patient interface. The instruments consist of three individually isolated conductors that act as the tissue effectors.
E07 Generator Output to the L09 Instrument
A PlasmaBlend output is a blended cut and coagulation output that is delivered to the L09 instrument. The ratio of cut to coagulation of this output is selectable by the user and this allows the user to select the amount of haemostasis created during cutting. This output is controlled by the Gyrus General Surgery RF Workstation.
Classification:
The instruments are Class II medical devices.
The system and therefore these instruments are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
Comparison to Predicate Devices:
The instruments are a development of a previously cleared electrosurgical instrument the PK Bipolar L Hook, cleared in 510(k) No. K031082. The instruments has the same intended use of Electrosurgical coagulation, cutting and dissection with aspiration (suction) and irrigation. Its functionality is the same as the previously cleared Gyrus ENT PlasmaCision Electrode, the OPI, cleared in 510(k) No. K041285 with suction (aspiration).
The instruments has been carefully compared to the legally marketed devices with respect to intended use and technological characteristics. In addition, performance testing has been done to validate the performance of the device. The comparison and validation results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to predicate devices and is safe and effective in its intended use,
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of four abstract human figures, arranged in a way that suggests movement or progress. The figures are depicted in black against a white background.
OCT 2 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mark A. Jensen Group Vice President Regulatory Affairs/Quality Assurance Gyrus Medical, Incorporate 6655 Wedgwood Road, Suite 160 Maple Grove, Minnesota 55311-3602
Re: K050460
Trade/Device Name: Plasmacision and Plasmablend Electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 22, 2005 Received: September 23, 2005
Dear Mr. Jensen:
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.
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 (2 l 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.
3
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,
Barbara Pruchus
tor
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K050460 510(k) Number (if known):
Plasmacision and Plasmablend Electrodes Device Name:
The Plasmacision and Plasmablend Electrodes are Indications For Use: indicated for Bipolar electrosurgical resection and coagulation of soft tissue and blood vessels in laparoscopic or general surgical procedures.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (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
ODE)
Laubara Buemud for MPM
Division Sign Off
Division of General, Restorative, and Neurological Devices
510(k) Numl
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