(505 days)
No
The document describes a standard electrosurgical generator and associated instruments. There is no mention of AI, ML, or any features that would suggest the use of such technologies. The controls and readouts described are typical for this type of device.
Yes
The device is indicated for medical procedures such as ablation, resection, coagulation, and hemostasis of soft tissue and blood vessels, which are explicit therapeutic actions.
No
The device is described as an electrosurgical generator used for ablation, resection, coagulation, and hemostasis of soft tissue and blood vessels, not for diagnosing conditions.
No
The device description clearly outlines hardware components including an electrosurgical generator, electrodes, connector cables, a return pad, and a footswitch. It is a physical medical device with software controlling its operation, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures (ablation, resection, coagulation, hemostasis) on soft tissue and blood vessels within the body (in vivo). IVDs are used to examine specimens from the body (in vitro) to provide information about a patient's health.
- Device Description: The description details an electrosurgical generator and instruments used for applying energy to tissue during surgery. This is consistent with a surgical device, not a diagnostic device that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, this device is a surgical electrosurgical system, not an IVD.
N/A
Intended Use / Indications for Use
The Bipolar Generator section of the G3 RF Workstation and accessories are indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (Head and Neck) surgery including:
Adenoidectomy, Papilloma Keloids, Cysts, Submucosal Palatal Shrinkage, Head, Neck, Oral, and Sinus Surgery, Tonsillectomy, Mastoidectomy, Traditional Uvulopalatoplasty (RAUP), Myringotomy with effective Hemorrhage Control, Tumors, Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates, Tissue in the Uvula/Soft Palate for the Treatment of Snoring, Nasopharyngeal / Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking, Uvulopalatopharyngoplasty (UPPP), Neck Dissection (Radical and Modified Neck Dissection), Parotidectomy, Neck Mass.
The Gyrus ACMI Dissector Plasma Knife is indicated for resection and coagulation of soft tissue and hemostasis of blood vessels in head and neck surgery including Neck Dissection, (Radical and Modified Neck Dissection), Tonsillectomy, Parotidectomy and UPPP when used with the bipolar generator section of the G3 Workstation.
Product codes
GEI
Device Description
The Gyrus ACMI® G3 Generator is an electrosurgical generator containing five key components: A dual output electrosurgical generator; Monopolar output side Bipolar output side Disposables; Monopolar electrodes (TCRF) Bipolar PlasmaCision Electrodes -Connector Cables Monopolar return pad; and Footswitch.
The Gyrus G3 System Generator has two principal modes of operation dependant on which no Of electrode is attached - The monopolar mode has controls for maximum temperature type of boor our is analers and has readouts for total energy delivered, impedance, temperature and chergy delivered. - 110 time of energy delivery. - The bipolar mode has controls for output for two mornocouples and power. The unit has readouts for set power and waveform. Connectors on wavelonin cype and power monopolar connector for active electrode and dispersive electrode the nom panel metude ar connectors for PlasmaCision electrodes and bipolar instruments. The device is operated by a foot pedal, connected on the back panel.
The Dissector Plasma Knife is a single use disposable bipolar instrument designed for use with the G3 generator within an ambient air environment. The instrument incorporates a which the SS generates which of fluids and gases during operative procedures when connected to an appropriate suction facility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, blood vessels in otorhinolaryngology (Head and Neck) surgery, Uvula/Soft Palate, Tracheal, Laryngeal, Neck.
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
Gyrus ACMI G3Generator- Dissector Plasma Knife Gyrus ACMI Inc. 136 Turnpike Road Southborough, MA 01772
KO80844
Page 1 of 2
510(k) Summary of Safcty and Effectiveness Gyrus ACMI Inc. Gyrus ACMI G3 Generator and Accessories - Dissector Plasma Knife
General Information
AUG 1 3 2009
Manufacturer:
Contact Person:
Date Prepared:
Device Description
Gyrus ACMI Inc. 136 Turnpike Rd. Southborough, MA 01772-2104
Lorraine Calzetta Regulatory Affairs Tel. #: 508-804-2752 Fax #: 508-804-2624
- Dissector Plasma Knife
devices and accessories
March 18, 2008
Classification Name: Electrosurgical cutting and coagulation devices and accessories (21CFR 878.4400, Class II)
Gyrus ACMI G3 Generator and Accessories
Electrosurgical cutting and coagulation
Trade Name:
Generic/Common Name:
including Tracheal Procedures, Laryngeal
Predicate Devices
Gyrus ACMI G3 Generator and Accessories - Dissector Plasma Knife K041285
Intended Uses
The Bipolar Generator section of the G3 RF Workstation and accessories are indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (Head and Neck) surgery including:
| Adenoidectomy | Papilloma Keloids |
|---|---|
| Cysts | Submucosal Palatal Shrinkage |
| Head, Neck, Oral, and Sinus Surgery | Tonsillectomy |
| Mastoidectomy | Traditional Uvulopalatoplasty (RAUP) |
| Myringotomy with effective Hemorrhage | |
| Control | Tumors |
| Nasal Airway Obstruction by Reduction of | |
| Hypertrophic Nasal Turbinates | Tissue in the Uvula/Soft Palate for the |
| Treatment of Snoring | |
| Nasopharyngeal / Laryngeal indications | Uvulopalatopharyngoplasty (UPPP) |
| Parotidectomy |
1
Gyrus ACMI® Gyrus ACMI Inc. 136 Turnpike Road Southborough, MA 01772
Traditional 510(k) Notification Statement of Intended Use
Page 2 of 2
රි
Polypectomy, and Laryngeal Lesion Debulking · Neck Mass · Neck Dissection (Radical and Modified Neck Dissection)
The Gyrus ACMI Dissector Plasma Knife is indicated for resection and coagulation of soft The Gyras From Discover Proceeds in head and neck surgery including Neck Dissection (Radical and Modified Neck Dissection), Tonsillectomy, Parotidectorny and UPPP when used with the bipolar generator section of the G3 Workstation.
Product Description
The Gyrus ACMI® G3 Generator is an electrosurgical generator containing five key components: A dual output electrosurgical generator; Monopolar output side Bipolar output side Disposables; Monopolar electrodes (TCRF) Bipolar PlasmaCision Electrodes -Connector Cables Monopolar return pad; and Footswitch.
The Gyrus G3 System Generator has two principal modes of operation dependant on which 1 no Of electrode is attached - The monopolar mode has controls for maximum temperature type of boor our is analers and has readouts for total energy delivered, impedance, temperature and chergy delivered. - 110 time of energy delivery. - The bipolar mode has controls for output for two mornocouples and power. The unit has readouts for set power and waveform. Connectors on wavelonin cype and power monopolar connector for active electrode and dispersive electrode the nom panel metude ar connectors for PlasmaCision electrodes and bipolar instruments. The device is operated by a foot pedal, connected on the back panel.
The Dissector Plasma Knife is a single use disposable bipolar instrument designed for use with the G3 generator within an ambient air environment. The instrument incorporates a which the SS generates which of fluids and gases during operative procedures when connected to an appropriate suction facility.
Technological Characteristics and Substantial Equivalence
The Gyrus ACMI® G3 Generator and Accessories - Dissector Plasma Knife are The Oyrus Town® 05 Generals and identical features of the predicate. There are no changes to the design of the generator or instrument pursuant to this aronission. Therefore In summary, the Gyrus ACMI is substantially equivalent to the predicate device and presents no new questions of safety or efficacy
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Gyrus ACMI, Inc. % Ms. Lorraine Calzetta Regulatory Affairs 136 Turnpike Road Southborough, Massachusetts 01772-2104
AUG 1 3 2009
Re: K080844
Trade/Device Name: Gyrus ACMI® G3 Generator and Accessories – Dissector Plasma Knife
Regulation Number: 21 CFR 878.4400
Regulation Name: Electrosurgical cutting and coagulation device and accessories
Regulatory Class: Class II Product Code: GEI Dated: July 12, 2009
Received: July 23, 2009
Dear Ms. Calzetta:
-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
3
Page 2 - Ms. Lorraine Calzetta
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milburn
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Gyrus ACMI G3Generator- Dissector Plasma Knife Gyrus ACMI Inc. 136 Turnpike Road Southborough, MA 01772
Device Name: Gyrus ACMI® G3 Generator and Accessories - Dissector Plasma Knife
510(k) Number:
Indications for use:
The Bipolar Generator section of the G3 RF Workstation and accessories are indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (Head and Neck) surgery including:
| • Adenoidectomy | • Papilloma Keloids |
|---|---|
| • Cysts | • Submucosal Palatal Shrinkage |
| • Head, Neck, Oral, and Sinus Surgery | • Tonsillectomy |
| • Mastoidectomy | • Traditional Uvulopalatoplasty (RAUP) |
| • Myringotomy with effective Hemorrhage Control | • Tumors |
| • Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates | • Tissue in the Uvula/Soft Palate for the Treatment of Snoring |
| • Nasopharyngeal / Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking | • Uvulopalatopharyngoplasty (UPPP) |
| • Neck Dissection (Radical and Modified Neck Dissection) | • Parotidectomy |
| • Neck Mass |
The Gyrus ACMI Dissector Plasma Knife is indicated for resection and coagulation of soft tissue and hemostasis of blood vessels in head and neck surgery including Neck Dissection, (Radical and Modified Neck Dissection), Tonsillectomy, Parotidectorny and UPPP when used with the bipolar generator section of the G3 Workstation.
Prescription Use: x
OR Over-the-Counter Use:
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nil R. Patel, Mxm
vision Sign-C Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number.
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