(16 days)
No
The description focuses on the electrosurgical generator's hardware, waveform technology, and accessory additions. There is no mention of AI, ML, or any related concepts like image processing, training data, or performance metrics associated with AI/ML algorithms. The "automatic instrument detection" is described as a simple system based on a capacitor, not an AI/ML algorithm.
No
The device is described as an electrosurgical generator used for ablation, removal, resection, and coagulation of soft tissue, primarily during surgical procedures. While it performs a medical function, its role is not directly therapeutic but rather for surgical intervention.
No
Explanation: The device is described as an electrosurgical generator intended for ablation, removal, resection, and coagulation of soft tissue, which are therapeutic actions, not diagnostic ones.
No
The device description clearly describes a bipolar RF generator, disposable hand pieces, a power cable, and a foot switch, all of which are hardware components. The proposed change is an additional hardware accessory (Dual Footswitch Connector Cable).
Based on the provided information, the Gyrus ACMI PlasmaKinetic SuperPulse System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the "ablation, removal, resection, and coagulation of soft tissue" during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The device is a bipolar RF generator used with disposable handpieces for electrosurgery. This is a surgical tool.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is used to perform surgical procedures directly on the patient.
N/A
Intended Use / Indications for Use
The Gyrus ACMI PK (PlasmaKinctic) SuperPulse System is intended for use for the ablation, removal, resection, and coagulation of soft tissue, and where associated hemostasis is required in open, endoscopic, and laparoscopic surgical procedures.
Product codes
GEI
Device Description
The currently marketed Gyrus ACMI PK SuperPulse System is a bipolar RF generator that accepts a variety of disposable hand pieces that utilize a PlasmaKinetic (PK) 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 PK SuperPulse System General Purpose Electrosurgical Generator employs a system of automatic instrument detection, through a capacitor 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 PK SuperPulse System include a power cable and a foot switch. It should be noted that this footswitch is also used with the Gyrus ACMI General Surgery Workstation generator (cleared under K050550).
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 PK SuperPulse System 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 PK SuperPulse System with the Dual Footswitch Connector Cable accessory remain the same as the currently marketed Gyrus ACMI PK SuperPulse System.
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
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)
Not Found
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
AUG - 6 2008
Special 510(k) Notification 510(k) Summary of Safety and Effectiveness July 18, 2008
Gyrus ACMI PK SuperPulse System Gyrus ACMI, Inc. 136 Turnpike Rd. Southborough, MA 01772
Date
July
K082054 510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. Gyrus ACMI Y-Connector
Page 1 of ②
General Information
Manufacturer:
ﺔ ﺍﻟ
Establishment Registration Number:
Submitter:
Establishment Registration Number:
Contact Person:
Date Prepared:
Device Description
Classification Name:
Gyrus Medical Ltd. Fortran Road, St. Mellons Cardiff, United Kingdom
9617070
Gyrus ACMI, Inc. 136 Turnpike Rd. Southborough, MA 01772-2104
3003790304
Terrence E. Sullivan Vice President, Regulatory Affairs
July 18, 2008
Electrosurgical Cutting & Coagulation Device and Accessories (21 CFR 878.4400), Class II General & Plastic Surgery Panel
Gyrus ACMI PK (PlasmaKinetic) SuperPulse System
Electrosurgical Generator and Accessories
Predicate Device
Generic/Common Name:
Trade Name:
Gyrus PlasmaKinetic SuperPulse System Generator and Accessories
1
Gyrus ACMI PK SuperPulse System Gyrus ACMI, Inc. 136 Turnpike Rd. Southborough, MA 01772
Intended Uses
t
Special 510(k) Notification 510(k) Summary of Safety and Effectiveness July 18, 2008
KO 82054
Page 2 of 2
The State of ILLINOIS Needs You!
The Gyrus ACMI PK (PlasmaKinctic) SuperPulse System is intended for use for the ablation, removal, resection, and coagulation of soft tissue, and where associated hemostasis is required in open, endoscopic, and laparoscopic surgical procedures.
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 PK SuperPulse System is a bipolar RF generator that accepts a variety of disposable hand pieces that utilize a PlasmaKinetic (PK) 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 PK SuperPulse System General Purpose Electrosurgical Generator employs a system of automatic instrument detection, through a capacitor 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 PK SuperPulse System include a power cable and a foot switch. It should be noted that this footswitch is also used with the Gyrus ACMI General Surgery Workstation generator (cleared under K050550).
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 PK SuperPulse System 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 PK SuperPulse System with the Dual Footswitch Connector Cable accessory remain the same as the currently marketed Gyrus ACMI PK SuperPulse System.
Summary of Safety and Effectiveness
The proposed modifications for the Gyrus ACMI PK SuperPulse System, 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle symbol on the right and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion on the left. The eagle symbol is composed of thick, curved lines, giving it a modern and abstract appearance. The text is written in uppercase letters and is evenly spaced around the circle.
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
Re: K082054
Trade/Device Name: Gyrus ACMI PK SuperPulse System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 18, 2008 Received: July 21, 2008
AUG - 6 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, labcling, 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 (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 the reporting 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 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 M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Gyrus ACMI PK SuperPulse System Gyrus ACMI, Inc. 136 Turnpike Rd. Southborough, MA 01772
Special 510(k) Notification Statement of Intended Use July 18, 2008
Device Name: Gyrus ACMI PK SuperPulse System
510(k) Number: K08
K0882054
Intended use:
The Gyrus ACMI PlasmaKinetic SuperPulse System is intended for use for the ablation, removal, resection, and coagulation of soft tissue, and where associated hemostasis is required in open, endoscopic, and laparoscopic surgical procedures.
The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
(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:
(Per 21 CFR 801.109)
Mark A. Milham
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
7