(78 days)
Not Found
No
The description focuses on mechanical and electrical modifications, human factors, and standard performance testing. There is no mention of AI/ML terms, image processing, or data sets for training/testing.
Yes
The device is indicated for electrosurgical coagulation and mechanical cutting and grasping of tissue during surgical procedures, which are therapeutic actions.
No
The device is indicated for electrosurgical coagulation, mechanical cutting, grasping, transecting, dissecting, and retracting tissue. These are therapeutic actions, not diagnostic ones.
No
The device description clearly details a physical, electrosurgical instrument (forceps) with mechanical components (jaws, rotation wheel, trigger) and electrical components (hand switching, mode switch, LED). It is an accessory to a generator, which is also a hardware device. There is no indication that the device is solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "electrosurgical coagulation, mechanical cutting and grasping of tissue during the performance of laparoscopic and open general surgical procedures." This describes a surgical tool used directly on the patient's tissue in vivo.
- Device Description: The description details a "bipolar electrosurgical device" used to "grasp, coagulate, transect, dissect and retract tissue." This further reinforces its use as a surgical instrument for manipulating and treating tissue within the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device does not perform any such testing on samples.
The device is a surgical instrument used during a surgical procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Gyrus ACMI® HALO PKS Cutting Forceps is indicated for electrosurgical coagulation, mechanical cutting and grasping of tissue during the performance of laparoscopic and open general surgical procedures when used in conjunction with the Gyrus ACMI General Surgery Generator (G400).
The Gyrus ACMI® HALO PKS Cutting Forceps are indicated for electrosurgical coagulation, mechanical cutting and grasping of tissue during the performance of laparoscopic and open general surgical procedures when used in conjunction with the Gyrus ACMI General Surgery Generator (G400).
Product codes
GEI
Device Description
The Gyrus ACMI®HALO PKS Cutting Forceps is a bipolar electrosurgical device that may be utilized in minimally invasive surgery for general endoscopic use to grasp, coagulate, transect, dissect and retract tissue. The Gyrus ACMI®HALO PKS Cutting Forceps is a single use, sterile accessory, to be used in conjunction with the bipolar outputs of the Gyrus General Surgery Generator (G400).
The Gyrus ACMI®HALO PKS Cutting Forceps is a modification of the Gyrus Bipolar Cutting Forceps and includes hand switching capabilities and a redesigned handle based on human factors considerations. The device handle has been ergonomically redesigned with additional areas of soft polymer around the device where the user contacts it. Thumb tabs for advancing the blade that were present on the predicate have been replaced with a pistol like trigger for user comfort. The ratchet mechanism blade activation has been redesigned and the latch mechanism has been moved to a place that allows single hand use. The HALO Cutting Forceps includes new features including hand activation, and a mode switch (Select Button) on the handpiece that allows the user to select either of up to two devices attached to the G400 generator at any one time. Selection of either device is indicated by the illumination of a green LED on top of the handpiece showing that the device has been selected. The jaws are identical as those found on the predicate Gyrus Bipolar Cutting Forceps except that they are sclectively rotatable via a rotation wheel on the device which allows for rotation of the jaws about the device shaft.
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)
Performance testing was utilized to establish the performance characteristics of the modifications of the device and determine substantial equivalence to the predicate. Performance testing includes biocompatibility testing, sterility testing, shelf life testing, design verification and validation (non-clinical bench testing and preclinical testing)
The patient contact portions of the device have been evaluated for biocompatibility and comply with the requirements of ISO 10993-1.
The Gyrus ACMI® HALO PKS Cutting Forceps is a Single use, sterile device and has been tested to ensure a SAL of 10th and comply with the requirements of ISO 11135-1.
The device was tested to demonstrate compliance with the following electrical safety standards:
IEC 60601- Medical Electrical Equipment - Part 1: General Requirements for Safety.
IEC 60601-Medical Electrical Equipment - Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment.
IEC 60601 -- Medical Electrical Equipment Part 1-2: General Requirements for Safety: Electromagnetic Compatibility.
Non-clinical bench testing and preclinical performance testing show that the device performance is substantially equivalent to the predicate, and that the modifications raise no new issues of safety and effectiveness.
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 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
KC100896
Gyrus ACMI®HALO PKS Cutting Forceps Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772
Special 510(k) Notification
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510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. Gyrus ACMI® HALO PKS Cutting Forceps®
General Information
Manufacturer:
Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772-2104
Establishment Registration Number:
Contact Person:
Date Prepared: Device Description
Classification Name:
3003790304
Lorraine Calzetta Senior Regulatory Affairs Specialist
19 Apr 2010
Electrosurgical Cutting & Coagulation Device and Accessories (21 CFR 878.4400). Class II General& Restorative Surgery Panel
Trade Name:
Generic/Common Name:
Gyrus ACMI® HALO PKS Cutting Forceps®
Electrosurgical device for cutting and coagulation
Predicate Device
Gyrus Bipolar Cutting Forceps cleared under K023492 Gyrus General Surgery Generator cleared under K050550
Intended Uses
The Gyrus ACMI® HALO PKS Cutting Forceps is indicated for electrosurgical coagulation, mechanical cutting and grasping of tissue during the performance of laparoscopic and open general surgical procedures when used in conjunction with the Gyrus ACMI General Surgery Generator (G400).
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Product Description
The Gyrus ACMI®HALO PKS Cutting Forceps is a bipolar electrosurgical device that may be utilized in minimally invasive surgery for general endoscopic use to grasp, coagulate, transect, dissect and retract tissue. The Gyrus ACMI® HALO PKS Cutting Forceps is a single use, sterile accessory, to be used in conjunction with the bipolar outputs of the Gyrus General Surgery Generator (G400).
The Gyrus ACMI®HALO PKS Cutting Forceps is a modification of the Gyrus Bipolar Cutting Forceps and includes hand switching capabilities and a redesigned handle based on human factors considerations. The device handle has been ergonomically redesigned with additional areas of soft polymer around the device where the user contacts it. Thumb tabs for advancing the blade that were present on the predicate have been replaced with a pistol like trigger for user comfort. The ratchet mechanism blade activation has been redesigned and the latch mechanism has been moved to a place that allows single hand use. The HALO Cutting Forceps includes new features including hand activation, and a mode switch (Select Button) on the handpiece that allows the user to select either of up to two devices attached to the G400 generator at any one time. Selection of either device is indicated by the illumination of a green LED on top of the handpiece showing that the device has been selected. The jaws are identical as those found on the predicate Gyrus Bipolar Cutting Forceps except that they are sclectively rotatable via a rotation wheel on the device which allows for rotation of the jaws about the device shaft.
Comparison of Technological Characteristics of Device to Predicate Device
The Gyrus ACMI® HALO PKS Cutting Forceps is a single use, sterile accessory for use with the G400 Generator only, and is intended to provide the same performance as the predicate Gyrus Bipolar Cutting Forceps, but with the added utility of hand switching, rotation and attention given to user comfort The modified device and the currently marketed device share the same intended use, same operating principle, same radiofrequency generator (G400), similar patient contacting materials and same processes of packaging and sterilization. The distal end of the device has not changed. The jaws are identical as those found on the predicate Gyrus Bipolar Cutting Forceps, except that they are selectively rotatable via a rotation wheel on the device which allows for rotation of the jaws about the device shaft. The Gyrus ACMI® HALO PKS Cutting Forceps may be activated via the handpiece switch or footswitch, whereas the predicate could only be activated via a footswitch.
Summary of Performance data
Performance testing was utilized to establish the performance characteristics of the modifications of the device and determine substantial equivalence to the predicate. Performance testing includes biocompatibility testing, sterility testing, shelf life testing, design verification and validation (non-clinical bench testing and preclinical testing)
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The patient contact portions of the device have been evaluated for biocompatibility and comply with the requirements of ISO 10993-1.
The Gyrus ACMI® HALO PKS Cutting Forceps is a Single use, sterile device and has been tested to ensure a SAL of 10th and comply with the requirements of ISO 11135-1.
The device was tested to demonstrate compliance with the following electrical safety standards:
IEC 60601- Medical Electrical Equipment - Part 1: General Requirements for Safety.
IEC 60601-Medical Electrical Equipment - Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment.
IEC 60601 -- Medical Electrical Equipment Part 1-2: General Requirements for Safety: Electromagnetic Compatibility.
Non-clinical bench testing and preclinical performance testing show that the device performance is substantially equivalent to the predicate, and that the modifications raise no new issues of safety and effectiveness.
Summary of Safety and Effectiveness
The proposed modified Gyrus ACMI® HALO PKS Cutting Forceps®, as described in this submission, is substantially equivalent to the predicate device. The intended use and basic scientific technology of the device are not changed, nor is the intended user or distal end design. The proposed modifications in design do not significantly affect the safety or efficacy of the device.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Gyrus Acmi, Inc. % Ms. Lorraine Calzetta Senior Regulatory Affairs Specialist 136 Turnpike Road Southborough, Massachusetts 01772
JUN 1 7 2010
Re: K100896
Trade/Device Name: Gyrus ACMI® HALO PKS Cutting Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 18, 2010 Received: May 18, 2010
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. 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
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Page 2 - Ms. Lorraine Calzetta
forth in the quality systems (OS) 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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Gyrus ACMI® HALO PKS Cutting Forceps Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772
Special 510(k) Notification Intended Use Statement
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Indications for Use
510(k) Number:
Device Name: Gyrus ACMI® HALO PKS Cutting Forceps
Indications for Use:
The Gyrus ACMI® HALO PKS Cutting Forceps are indicated for electrosurgical coagulation, mechanical cutting and grasping of tissue during the performance of laparoscopic and open general surgical procedures when used in conjunction with the Gyrus ACMI General Surgery Generator (G400).
Prescription Use: X = (Per 21 CFR 801.109)
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)
Vanderlyly
(Dision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100896