(87 days)
No
The summary describes a standard electrosurgical device with mechanical and electrical components, and there is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device performs mono polar cutting and coagulation, grasping, bipolar coagulation, and sealing vessels during electrosurgery, which are all therapeutic actions.
No
The device is described as an electrosurgical tool for cutting, coagulation, and sealing tissues and vessels, not for diagnosing medical conditions.
No
The device description explicitly states it is comprised of a mixture of plastics, metals, heatshrink, and epoxy, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for surgical procedures (cutting, coagulation, grasping, and sealing vessels) on the patient's body.
- Device Description: The device is a surgical instrument (pencil-type handle, forceps) used directly in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not for direct surgical intervention on the body itself. This device is clearly a surgical tool.
N/A
Intended Use / Indications for Use
The PK AIM is intended for mono polar cutting & coagulation, grasping, bipolar coagulation of selected soft tissues and sealing vessels up to and including 3.0 mm in diameter during electro surgery. This device is not intended to be used for tubal ligation or female sterilization.
Product codes
GEI
Device Description
Both predicate and proposed PK AIM devices can be described as 2 in 1 devices with a pencil type handle that combines the technologies of a monopolar pencil and a bipolar forceps. The device has buttons that allow hand activation and a sliding toggle switch to allow the surgeon to switch between a forceps, and a pencil device. Foot pedals connected to the generator are also available to allow for foot pedal activation of the device. The proposed device plugs into the Olympus ESG-400 generator (K141225). The generator and device make up a medical electrical system. The instrument is to be used only with the Olympus ESG-400 Generator.
The proposed device is comprised of a mixture of plastics, metals heatshrink and epoxy. The predicate Olympus PK AIM passed all applicable biocompatibility testing and additional information was provided within in K152219 for any patient contacting materials that contain colorants. The subject Olympus PK AIM and predicate Olympus PK AIM are physically identical - no design or material changes whatsoever.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
selected soft tissues
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
Bench and animal testing performance tests were conducted to support the additional 3 mm vessel sealing claim which is the subject of this submission. Performance testing provided in this submission will demonstrate that the 3 mm vessel sealing performance of the proposed PK AIM is substantially equivalent to the predicate Gyrus ACMI PKS OMNI, K081766.
The vessel sealing performance of subject PK AIM and the predicate PKS OMNI were compared via ex vivo bench testing, acute animal testing, and chronic animal testing (porcine model). Protocols, reports and test data for this testing are provided in the appendices of Section 15 and 16.
Bench Testing ex vivo, confirmed that both devices:
- Sealed 1.00 mm to 3.49 mm size arteries.
- Burst pressures of sealed arteries were statistically equivalent.
- and burst pressure of sealed arteries exceeded 360 mmHg.
The Acute GLP Study evaluated thermal spread, qualitative sealing characteristics and provided collection of thermal imaging while sealing vessels with the Olympus PK AIM device in a swine model. The predicate Gyrus ACMI (PKS) OMNI device was used as the Control device. During the acute study, quantities of 11 and 12 blood vessels respectively were sealed by subject PK AIM and predicate PK OMNI. A Histopathology Report is attached to this study.
The Chronic GLP Study in a swine model evaluated thermal spread, qualitative sealing characteristics and provided a collection of thermal imaging while sealing vessels with the proposed Olympus PK AIM device. The predicate Gyrus ACMI (PKS) OMNI device was used as the Control device. The Chronic studies demonstrated that 11 animals survived a minimum of 21-days following the surgical procedure. Their health was deemed acceptable prior-to, during, and following the 21day survival period at which time they were euthanized and grossly examined. A necropsy pathology of post-splenectomy and ovariectomy sealed vessel sites showed no differences between sealing performed by test and control devices.
The test results concluded that the subject PK AIM test article demonstrated similar functionality to the control article (Gyrus ACMI (PKS) OMNI) for sealing arteries, veins and artery vein bundles up to 3mm in diameter.
Key Metrics
Not Found
Predicate Device(s)
Unlike Image /page/0/Picture/1, the image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 26, 2016
Gyrus ACMI Inc. Mr. Graham Baillie Regulatory Affairs Manager 136 Turnpike Road Southborough, Massachusetts 01772
Re: K161825
Trade/Device Name: PK AIM Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 12, 2016 Received: September 13, 2016
Dear Mr. Baillie:
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 devicerelated adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth
1
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 Parts 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Christopher J. Ronk -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161825
Device Name PK AIM
Indications for Use (Describe)
The PK AIM is intended for mono polar cutting & coagulation, grasping, bipolar coagulation of selected soft tissues and sealing vessels up to and including 3.0 mm in diameter during electro surgery. This device is not intended to be used for tubal ligation or female sterilization.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Traditional 510(k) Notification June 27, 2016
510(k) Summary Gyrus ACMI, Inc.
Olympus PK AIM
General Information
| Manufacturer: | Gyrus ACMI, Inc.
9600 Louisiana Ave North
Brooklyn Park, MN 55445
Phone: 508-804-2690 |
|------------------------------------|----------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 3011050570 |
| 510(k) Submitter: | Gyrus ACMI, Inc.
136 Turnpike Rd.
Southborough, MA 01772-2104 |
| Establishment Registration Number: | 3003790304 |
| Contact Person: | Graham A. L. Baillie MS
Regulatory Affairs Manager
508-804-2738
Graham.baillie@olympus-osta.com |
| Date Prepared: | June 27, 2016 |
| Device Description | |
| Classification Name: | Electrosurgical cutting and coagulation
device and accessories |
| Regulation number | 21 CFR 878.4400 |
| Product code | GEI |
| Regulatory class | Class II |
| Review Panel | General and Plastic Surgery |
| Trade Name: | Olympus - PK AIM |
| Generic/Common Name: | Electrosurgical cutting and coagulation
device |
4
Predicate Devices
| K152219 | Olympus PK AIM |
|---|---|
| K081766 | (Gyrus ACMI, Inc.) PKS OMNI Instrument |
Comparison to Predicate Devices:
The Olympus PK AIM has been compared to predicate Olympus PK AIM and PKS OMNI with respect to intended use, design, and fundamental scientific technology. The comparisons and testing results presented in this 510(k) notification to FDA show this device to be substantially equivalent to predicate devices and raises no new concerns or safety or effectiveness.
Like the predicate PK AIM, the proposed PK AIM is intended for mono polar cutting and coagulation, grasping, bipolar coagulation of selected soft tissues, and like its predicate PKS OMNI the proposed PK AIM is also intended to seal vessels up to and including 3.0 mm in diameter during electro surgery. Both predicate and proposed PK AIM devices are not intended to be used for tubal ligation or female sterilization.
Product Description
Both predicate and proposed PK AIM devices can be described as 2 in 1 devices with a pencil type handle that combines the technologies of a monopolar pencil and a bipolar forceps. The device has buttons that allow hand activation and a sliding toggle switch to allow the surgeon to switch between a forceps, and a pencil device. Foot pedals connected to the generator are also available to allow for foot pedal activation of the device. The proposed device plugs into the Olympus ESG-400 generator (K141225). The generator and device make up a medical electrical system. The instrument is to be used only with the Olympus ESG-400 Generator.
The proposed device is comprised of a mixture of plastics, metals heatshrink and epoxy. The predicate Olympus PK AIM passed all applicable biocompatibility testing and additional information was provided within in K152219 for any patient contacting materials that contain colorants. The subject Olympus PK AIM and predicate Olympus PK AIM are physically identical - no design or material changes whatsoever.
Technological Characteristics
The proposed Olympus PK AIM uses monopolar energy in order to cut and bipolar energy in order to coagulate soft tissue in general surgical procedures. For safety and convenience the ESG-400 generator recognizes the proposed Olympus PK AIM when it is connected and limits generator settings to those dedicated for use with the proposed Olympus PK AIM device. These settings are called out in the IFU.
The Olympus PK AIM can be activated using buttons located on the device handle, or via a foot pedals which are sold separately. The hand activation allows the physician to activate either cut or coagulation (coag) mode without taking their eyes off the surgical site. A sliding toggle switch located on the handle allows the user to switch between using the device as a pencil or forceps.
5
Material
No material changes were made to the predicate PK AIM cleared under K152219.
Indications for Use
The PK AIM is intended for mono polar cutting & coagulation, grasping, bipolar coagulation of selected soft tissues and sealing vessels up to and including 3.0 mm in diameter during electro surgery. This device is not intended to be used for tubal ligation or female sterilization.
Compliance to Voluntary Standards
The design of the proposed device complies with the following standards:
ISO 10993-1. 2009 ISO 10993-5, 2009 ISO 10993-7 2008 ISO 10993-10, 2010 ANSI/AAMI/ISO 11607-1, 2006 ANSI/AAMI/ISO 11135-1, 2007 ISO 14971, 2007 ISO 15223-1; 2012 IEC 60601-1: 2005 IEC 60601-2-2: 2009
Summary of Sterilization and Shelf Life Discussion
Like the predicate Olympus PK AIM, (K152219), the proposed Olympus PK AIM will be distributed in a sterile state and is intended for single patient use only. The sterilization method used is ethylene oxide and has a shelf life of 1 year.
Summary of Performance Testing
The predicate PK AIM (K152219) and proposed PK AIM, are identical in every respect. No physical design changes were made that would require the repeat of performance testing already provided in K152219. Bench and animal testing performance tests were conducted to support the additional 3 mm vessel sealing claim which is the subject of this submission. Performance testing provided in this submission will demonstrate that the 3 mm vessel sealing performance of the proposed PK AIM is substantially equivalent to the predicate Gyrus ACMI PKS OMNI, K081766.
The vessel sealing performance of subject PK AIM and the predicate PKS OMNI were compared via ex vivo bench testing, acute animal testing, and chronic animal testing (porcine model). Protocols, reports and test data for this testing are provided in the appendices of Section 15 and 16 and include:
Bench Testing ex vivo, confirmed that both devices:
- Sealed 1.00 mm to 3.49 mm size arteries.
- Burst pressures of sealed arteries were statistically equivalent. ●
6
- and burst pressure of sealed arteries exceeded 360 mmHg. ●
The Acute GLP Study evaluated thermal spread, qualitative sealing characteristics and provided collection of thermal imaging while sealing vessels with the Olympus PK AIM device in a swine model. The predicate Gyrus ACMI (PKS) OMNI device was used as the Control device. During the acute study, quantities of 11 and 12 blood vessels respectively were sealed by subject PK AIM and predicate PK OMNI. A Histopathology Report is attached to this study.
The Chronic GLP Study in a swine model evaluated thermal spread, qualitative sealing characteristics and provided a collection of thermal imaging while sealing vessels with the proposed Olympus PK AIM device. The predicate Gyrus ACMI (PKS) OMNI device was used as the Control device. The Chronic studies demonstrated that 11 animals survived a minimum of 21-days following the surgical procedure. Their health was deemed acceptable prior-to, during, and following the 21day survival period at which time they were euthanized and grossly examined. A necropsy pathology of post-splenectomy and ovariectomy sealed vessel sites showed no differences between sealing performed by test and control devices.
The test results concluded that the subject PK AIM test article demonstrated similar functionality to the control article (Gyrus ACMI (PKS) OMNI) for sealing arteries, veins and artery vein bundles up to 3mm in diameter.
An Animal Health Report and Pathology Report were attached in the appendices of this report.
Substantial Equivalence
The proposed Olympus PK AIM has the same intended use, design, and scientific technology as its predicate Olympus PK AIM device combined into one device. The predicate PK AIM and proposed PK AIM device are both a pencil and a forceps device with a dual cord. The proposed and predicate devices were shown to perform substantially equivalent in bench testing. There were no new issues of safety or effectiveness with the proposed device. Please see the following Substantial
| Design
Feature | Proposed
Olympus PK AIM | Predicate
Olympus PK AIM
K152219 | Predicate
PKS OMNI
K081766 | Comments |
|-----------------------|-----------------------------------------------|-----------------------------------------------|----------------------------------|--------------------------------|
| Function of
Device | Forceps/Pencil | Forceps/Pencil | Forceps | Same as
predicate PK
AIM |
| Tip Size | Forceps
1mm tip, 2mm base
Pencil
2mm | Forceps
1mm tip, 2mm base
Pencil
2mm | | Same |
| Energy | Monopolar/Bipolar | Monopolar/Bipolar | Bipolar | Same |
Equivalence Comparison Table:
7
| Activation | Hand / Footpedal | Hand / Footpedal | Same |
|---|---|---|---|
| Plug | Dual (mono/bi) | Dual (mono/bi) | Same |
| Electrode | |||
| Materials | Stainless Steel | Stainless Steel | Same |
| Sterility | $10^{-6}$ | ||
| EtO | $10^{-6}$ | ||
| EtO | $10^{-6}$ (Same) | ||
| Single Use | Yes | Yes | Same |
| Intended Use | The PK AIM is intended for mono polar cutting & coagulation, grasping, bipolar coagulation of selected soft tissues and sealing vessels up to and including 3.0 mm in diameter during electro surgery. This device is not intended to be used for tubal ligation or female sterilization. | The PK AIM device is intended for monopolar cutting as well as grasping, manipulating and bipolar coagulation of selected soft tissues during electrosurgery. This device is not intended to be used for tubal ligation or female sterilization. | The Gyrus ACMI Inc. PKS OMNI Instruments 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 |
| Predicate and proposed PK AIM devices are the same except for the addition of 3 mm vessel sealing to the proposed PK AIM. The PKS OMNI was included as predicate because of its 3 mm vessel sealing. |
Conclusion:
In summary, the proposed Olympus PK AIM is substantially equivalent to the predicate Olympus PK AIM and Gyrus ACMI PKS OMNI devices and presents no new questions of safety or efficacy.