(22 days)
No
The document describes a standard electrosurgical generator with automatic instrument detection based on a resistor, and a new accessory for connecting a second footswitch. There is no mention of AI or ML technologies.
No.
Explanation: The device is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in surgery, which are surgical procedures, not therapeutic ones.
No
This device is a surgical tool used for ablation, resection, and coagulation of tissue, not for diagnosis. It is an electrosurgical generator.
No
The device description clearly outlines a physical RF generator, disposable hand pieces, and accessories like a power cable and footswitch. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in surgery." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a "bipolar RF generator" used with "disposable hand pieces" for surgical procedures. This aligns with surgical equipment, not diagnostic equipment.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly described as a surgical tool used for therapeutic purposes (ablation, resection, coagulation, hemostasis) during surgery.
N/A
Intended Use / Indications for Use
The Gyrus ACMI General Surgery Workstation is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in surgery.
Product codes
GEI
Device Description
The currently marketed Gyrus ACMI General Surgery Workstation is a bipolar RF generator that accepts a variety of disposable hand pieces that utilize a PlasmaKinetic (PK) or PlasmaCision (PC) waveform. The generator face includes two sockets that allow a range of hand pieces to be utilized in a dry field environment, although only one socket may be active at any given time.
The Gyrus ACMI General Surgery Workstation General Purpose Electrosurgical Generator employs a system of automatic instrument detection, through a resistor located in the hand piece connector plug. This ensures that only the allowable range of waveform output and power level can only be applied to the instrument irrespective of the output socket. Accessories presently provided with the Gyrus ACMI General Surgery Workstation include a power cable and a foot switch. It should be noted that this footswitch is also used with the Gyrus ACMI SuperPulse generator (cleared under K031085).
This Special 510(k) proposes the addition of a new optional accessory, the Dual Footswitch Connector Cable. The Dual Footswitch Connector Cable allows for easier use of the Gyrus ACMI General Surgery Workstation when multiple surgeons are present. This is achieved by allowing the connection and use of two footswitches on the same generator. The indications for use, principles of operation, energy waveform outputs, and accessories of the Gyrus ACMI General Surgery Workstation with the Dual Footswitch Connector Cable accessory remain the same as the currently marketed Gyrus ACMI General Surgery Workstation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The proposed modifications for the Gyrus ACMI General Surgery Workstation, as described in this submission, are substantially equivalent to the predicate device. The proposed addition of the Dual Footswitch Connector Cable as an accessory is not a substantial change or modification, and do not significantly affect the safety or efficacy of the devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 General Surgery Workstation ? Gyrus ACMI, Inc. 136 Turnpike Rd. Southborough, MA 01772
Special 510(k) Notification 510(k) Summary of Safety and Effectiveness July 2, 2008
JUL 3 1 2008
510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. Gyrus ACMI Y-Connector
K 081954
General Information
Manufacturer:
જ
Gyrus Medical Ltd. Fortran Road, St. Mellons Cardiff, United Kingdom
Establishment Registration Number:
Submitter:
Establishment Registration Number:
Contact Person:
Date Prepared:
Trade Name:
Device Description
Classification Name:
9617070
Gyrus ACMI, Inc. 136 Turnpike Rd. Southborough, MA 01772-2104
3003790304
Terrence E. Sullivan Vice President, Regulatory Affairs
July 2, 2008
Electrosurgical Cutting & Coagulation Device and Accessories (21 CFR 878.4400), Class II General & Plastic Surgery Panel
Gyrus ACMI General Surgery (G400) Workstation
Electrosurgical Generator and Accessories
Predicate Device
Generic/Common Name:
Gyrus General Purpose Electrosurgical System
1
Special 510(k) Notification 510(k) Summary of afety and Effectiveness Inly 2, 2008
Intended Uses
Page 2 of (2)
The Gyrus ACMI General Surgery Workstation is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in surgery.
These devices are marketed as reusable devices; methods for cleaning, disinfecting and sterilization are included in latter sections of this submission under Section 12.0, "Cleaning".
Product Description
The currently marketed Gyrus ACMI General Surgery Workstation is a bipolar RF generator that accepts a variety of disposable hand pieces that utilize a PlasmaKinetic (PK) or PlasmaCision (PC) waveform. The generator face includes two sockets that allow a range of hand pieces to be utilized in a dry field environment, although only one socket may be active at any given time.
The Gyrus ACMI General Surgery Workstation General Purpose Electrosurgical Generator employs a system of automatic instrument detection, through a resistor located in the hand piece connector plug. This ensures that only the allowable range of waveform output and power level can only be applied to the instrument irrespective of the output socket. Accessories presently provided with the Gyrus ACMI General Surgery Workstation include a power cable and a foot switch. It should be noted that this footswitch is also used with the Gyrus ACMI SuperPulse generator (cleared under K031085).
This Special 510(k) proposes the addition of a new optional accessory, the Dual Footswitch Connector Cable. The Dual Footswitch Connector Cable allows for easier use of the Gyrus ACMI General Surgery Workstation when multiple surgeons are present. This is achieved by allowing the connection and use of two footswitches on the same generator. The indications for use, principles of operation, energy waveform outputs, and accessories of the Gyrus ACMI General Surgery Workstation with the Dual Footswitch Connector Cable accessory remain the same as the currently marketed Gyrus ACMI General Surgery Workstation.
Summary of Safety and Effectiveness
The proposed modifications for the Gyrus ACMI General Surgery Workstation, as described in this submission, are substantially equivalent to the predicate device. The proposed addition of the Dual Footswitch Connector Cable as an accessory is not a substantial change or modification, and do not significantly affect the safety or efficacy of the devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Gyrus ACMI, Inc. % Mr. Terrence E. Sullivan VP, Regulatory Affairs 136 Turnpike Road Southborough, Massachusetts, 01772
JUL 3 1 2008
Re: K081954
Trade/Device Name: Gyrus ACMI General Surgery (G400) Workstation Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 02, 2008 Received: July 09, 2008
Dear Mr. Sullivan:
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 adultcration.
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 (21 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
Page 2 - Mr. Terrence E. Sullivan
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilitics 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 M Wilkinson
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Device Name: Gyrus ACMI General Surgery (G400) Workstation
510(k) Number:
Intended use:
The generator is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: X
OR Over-the-Counter Use:
7
(Per 21 CFR 801.109)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K081957