Who is the manufacturer of PK AIM?

Gyrus Acmi, Inc. filed the 510(k) submission for PK AIM (K163373).

What is the FDA product code for PK AIM?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for PK AIM?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like PK AIM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PK AIM

K163373 · Gyrus Acmi, Inc. · GEI · Dec 12, 2016 · General, Plastic Surgery

Device Facts

Record ID	K163373
Device Name	PK AIM
Applicant	Gyrus Acmi, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Dec 12, 2016
Decision	SESE
Submission Type	Special
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

PK AIM is a 2-in-1 electrosurgical instrument combining a monopolar pencil and bipolar forceps in a single handle. Used in general surgery, it allows surgeons to switch between monopolar cutting/coagulation and bipolar coagulation via a sliding toggle switch on the handle. Activation occurs through hand-held buttons or an optional foot pedal. The device connects to the Olympus ESG-400 generator, which automatically recognizes the instrument and limits settings to appropriate parameters. The device is intended for single-patient use. By integrating two modalities into one tool, it enables surgeons to perform multiple tasks—grasping, cutting, and vessel sealing—without switching instruments, potentially reducing surgical time and improving workflow efficiency. The current submission implements a cable design modification to address capacitive coupling concerns.

Clinical Evidence

No clinical testing was conducted. Substantial equivalence is supported by bench testing, including electrical functionality, continuity, Hi-Pot, HF leakage, and electrical characterization, all of which met prescribed acceptance criteria.

Technological Characteristics

Materials: stainless steel electrodes, plastics, heatshrink, epoxy. Energy: monopolar and bipolar electrosurgery. Connectivity: proprietary connection to Olympus ESG-400 generator. Form factor: pencil-type handle with sliding toggle switch. Sterilization: Ethylene Oxide (EtO). Standards: ISO 10993, ISO 14971, IEC 60601-1, IEC 60601-2-2, ASTM-F2906-11, ISTA-2A, ASTMD4169-09.

Indications for Use

Indicated for monopolar cutting/coagulation, grasping, and bipolar coagulation of soft tissues and vessel sealing up to 3.0 mm in diameter during electrosurgery. Contraindicated for tubal ligation or female sterilization.

Regulatory Classification

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.

Predicate Devices

Olympus PK AIM (K161825)

Reference Devices

Olympus ESG-400 Generator (K141225)
Olympus PK AIM (K152219)

Related Devices

K152219 — PK AIM · Gyrus Acmi, Inc. · Dec 17, 2015
K161825 — PK AIM · Gyrus Acmi, Inc. · Sep 26, 2016
K170908 — PK AIM · Gyrus Acmi, Inc. · May 19, 2017
K142350 — PK J-HOOK · Gyrus Acmi, Inc. · Jan 8, 2015
K100896 — GYRUS ACMI HALO PKS CUTTING FORCEPS · Gyrus Acmi, Inc. · Jun 17, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines connecting them. The symbol is black, and the background is white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 12, 2016 Gyrus ACMI, Inc. Mr. Graham Baillie Regulatory Affairs Manager 136 Turnpike Road Southborough, Massachusetts 01772 Re: K163373 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: November 29, 2016 Received: December 1, 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 of medical devicerelated adverse events) (21 CFR 803); 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. {1}------------------------------------------------ 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, Jennifer R. Stevenson -A 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) K163373 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) | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <input type="checkbox"/> 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}------------------------------------------------ ## 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 Contact Person: Graham A. L. Baillie Manager, Regulatory Affairs 508-804-2738 Graham.baillie@olympus-osta.com Date Prepared: November 29, 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 Trade Name: Olympus PK Aim Generic/Common Name: Electrosurgical cutting and coagulation device Predicate Device K161825 Olympus PK AIM ## Comparison to Predicate Device: The Olympus PK AIM has been compared to the predicate Olympus PK AIM with respect to intended use, design and fundamental scientific technology. The comparisons and summary of testing results presented in this Special 510(k) Notification show this device to be substantially equivalent to the predicate PK AIM and raises no new concerns of safety or effectiveness. Like the predicate PK AIM, the proposed PK AIM is intended for monopolar cutting and coagulation, grasping, bipolar coagulation of selected soft tissue, and like its predicate PK AIM the proposed device is also intended to seal vessels up to and including 3.0 mm in diameter during electrosurgery. Both predicate and proposed PK AIM devices are not intended to be used for tubal ligation or female sterilization. {4}------------------------------------------------ ## 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 electrosurgical system. The instrument is to be used only with the Olympus ESG-400 Generator. As a result of the PK AIM cable modifications which are the subject of this submission, no modifications were required or made to the 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 the original PK AIM K152219 for any patient contacting materials that contain colorants. Except for the cable design modification that is being implemented to address a capacitive coupling concern, the subject Olympus PK AIM and predicate Olympus PK AIM are physically identical no other design or material changes. ## 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 monopolar pencil or bipolar forceps. # Material No material or packaging changes were made to the predicate PK AIM cleared under K161825. ## Indications for Use The intended use of the modified/proposed PK AIM device, as described in its labeling, has not changed as a result of the cable modification. 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. {5}------------------------------------------------ ## Compliance to Voluntary Standards The design of the Olympus PK AIM 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, (K161825), the proposed Olympus PK AIM will be distributed in a sterile state and is intended for single patient use only. The sterilization method used continues to be ethylene oxide and will now be labeled with a shelf life of 3 years. | Description | Specification/objective | |-----------------------------|------------------------------------------------------| | Cable/Cord Length | Meet length specification | | Electrical Functionality | Generator confirmation | | Package Testing | ISTA-2A, ASTMD4169-09 | | IEC 60601 | Meet relevant requirements | | Label/Package damage | Visual inspection | | Bubble Leak | ASTM-F2906-11 | | Continuity | Meet specification | | Hi-Pot | Meet specification | | HF Leakage | Meet monopolar HF leakage from bipolar electrodes | | Electrical Characterization | Meet internal comparable power outputs | #### Summary of bench, Performance Testing (no clinical testing was conducted) All performance testing passed or met prescribed acceptance criteria ## Substantial Equivalence The proposed Olympus PK AIM has the same intended use, scientific technology and similar design as its predicate Olympus PK AIM 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 equivalence comparison table. {6}------------------------------------------------ | Design Feature | Proposed Olympus PK AIM | Predicate Olympus PK AIM K161825 | Comments | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | Function of Device | Forceps/Pencil | Forceps/Pencil | 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 | Same | | 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 | 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 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. | Predicate and proposed PK AIM devices have identical intended uses. | # Equivalence Comparison Table: ## Conclusion: In summary, the Olympus PK AIM is substantially equivalent to its predicate device and presents no new questions of safety or efficacy.