(49 days)
No
The summary describes a standard electrosurgical instrument and makes no mention of AI or ML capabilities.
No
The device is used for surgical procedures like coagulation, grasping, dissection, and vessel sealing, which are interventional rather than therapeutic.
No
Explanation: The device is intended for electrosurgical coagulation, mechanical grasping, dissection of tissue, and sealing of vessels during surgical procedures. These are therapeutic and surgical functions, not diagnostic ones.
No
The device description clearly states it is a single-use hardware instrument with a shaft, jaws, and electrosurgical elements, intended for physical manipulation and electrosurgery.
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 grasping, and dissection of tissue, and sealing of vessels... during the performance of laparoscopic and general (open) surgical procedures". This describes a device used on the patient during surgery, not a device used to test samples from the patient in a laboratory setting.
- Device Description: The description details a surgical instrument with a shaft, jaws, and electrosurgical elements. This is consistent with a surgical tool, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical instrument used for therapeutic and procedural purposes directly on the patient.
N/A
Intended Use / Indications for Use
The Gyrus ACMI Inc. PKS Omni Instrument is intended for electrosurgical coagulation, mechanical grasping and dissection of tissue, and sealing of vessels up to 3mm, during the performance of laparoscopic and general (open) surgical procedures. It is intended for use with the Gyrus ACMI G400 workstation cleared under K050550.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The PKS Omni Instrument is a single-use device with a classic laparoscopic so layout, with a 5mm shaft available in several lengths from 15 to 45cm, supporting symmetrically opening steel jaws. These are curved in a manner similar to Maryland forceps and other laparoscopic graspers, and contain bipolar electrosurgical elements that allow coagulation, cutting and vessel sealing. It is intended for use with the Gyrus ACMI G400 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)
Not Found
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.
K023493, K024286, K061975, K050460, K031011, K050550
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
Gyrus ACMI Inc. PKS Omni Instrument Gyrus ACMI Inc 136 Turnpike Road Southborough, MA 01772
8 1746
Traditional 510(k) Notification Summary of Safety and Effectiveness June 12, 2008
510(k) Summary of Safety and Effectiveness Gyrus ACMI Incorporated Gyrus ACMI Inc. PKS Omni Instrument
Page 1 of 2
AUG - 8 2008
General Information
Manufacturer:
Southborough, MA 01772-2104
Contact Person:
Date Prepared:
Device Description
Classification Name:
Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400), Class II General and Plastic Surgery Panel
Trade Name:
Gyrus ACMI Inc. PKS Omni Instrument
Generic/Common Name:
Electrosurgical Instruments
Gyrus ACMI Incorporated
136 Turnpike Rd.
Lorraine Calzetta
June 12, 2008
Predicate Device
Gyrus Medical Inc. Zip Wing Cutting Dissector K023493 Gyrus Medical Open Forceps K024286 Gyrus Medical Plasma Seal K061975 Gyrus Medical Plasmacision and Plasmablend Electrodes K050460 Valleylab Ligasure Sealing System/ Ligasure V K031011 Gyrus General Purpose Electrosurgical Generator K050550
Intended Uses
The Gyrus ACMI Inc.PKS Omni Instrument is intended for electrosurgical coagulation, mechanical grasping and dissection of tissue, and sealing of vessels up to 3mm, during the performance of laparoscopic and general (open) surgical procedures. It is intended for use with the Gyrus ACMI G400 workstation cleared under K050550.
1
Gyrus ACMI Inc. PKS Omni Instrument Gyrus ACMI Inc 136 Turnpike Road Southborough, MA 01772
Traditional 510(k) Notification Summary of Safety and Effectiveness June 12, 2008
Device Description
Page 2 of 2
The PKS Omni Instrument is a single-use device with a classic laparoscopic so layout, with a 5mm shaft available in several lengths from 15 to 45cm, supporting symmetrically opening steel jaws. These are curved in a manner similar to Maryland forceps and other laparoscopic graspers, and contain bipolar electrosurgical elements that allow coagulation, cutting and vessel sealing. It is intended for use with the Gyrus ACMI G400 workstation
Technological Characteristics and Substantial Equivalence
Like the predicate Zip Wing cleared under K023493, the upper and lower jaws contain the electrical elements that when placed at the desired tissue site, induce the cutting or coagulating/sealing tissue effect as the applicable generator mode is actuated.
The device is a refinement of already proven existing technology, Gyrus's PlasmaKinetic (PK) technology developed for dry field surgery (K050460). It relies upon simultaneous contact of both active and return electrodes of the bipolar device with the tissue. Other Gyrus devices use this principle in two modes to achieve cutting and coagulation effects. The Device is constructed of similar materials as other Gyrus ACMI electrosurgical devices.
The PKS Omni is intended to offer cutting and coagulation using bipolar electrosurgical energy application in a manner similar to other devices on the market (such as Gyrus ACMI Open Forceps (K024286,) and Valley Lab Ligasure V (K031011) for coagulation of vessels, and Plasmacision electrodes (K050460) for bipolar cutting and surface coagulation of tissue).
Summary of Safety and Effectiveness
The Gyrus ACMI Inc. PKS Omni Instrument, as described in this submission, is substantially equivalent to the predicates in intended use, principles of operation and fundamental scientific technology and raises no new issues of safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text component and an abstract symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The symbol itself is an abstract representation, possibly of a stylized eagle or a similar bird-like form.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
Gyrus ACMI, Inc. % Ms. Lorraine Calzetta Regulatory Affairs 136 Turnpike Road Southborough, Massachusetts 01772
Re: K081766
Trade/Device Name: Gyrus ACMI Inc. PKS Instrument Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 12, 2008 Received: June 20, 2008
AUG - 8 2008
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 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 - Ms. Lorraine Calzetta
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 N. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Traditional 510(k) Notification Statement of Intended Use June 12, 2008
Device Name: Gyrus ACMI Inc. PKS Omni Instrument
510(k) Number:
081766
Indications for use:
The Gyrus ACMI Inc. PKS Omni Instrument is intended for electrosurgical coagulation, mechanical grasping, and dissection of tissue, and sealing of vessels up to 3mm, during the performance of laparoscopic and general (open) surgical procedures when used in conjunction with the Gyrus ACMI G400 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)
Sign Off
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number 1081261