Who is the manufacturer of Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle?

Gyrus Acmi, Inc. filed the 510(k) submission for Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle (K213831).

What is the FDA product code for Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle?

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 Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle?

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

What are the predicate devices for Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle?

PK Needle (K142154); PK Spatula (K142289); PK J-Hook (K142350).

Who can help prepare an FDA 510(k) submission like Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle?

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.

Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle

K213831 · Gyrus Acmi, Inc. · GEI · Jan 4, 2022 · General, Plastic Surgery

Device Facts

Record ID	K213831
Device Name	Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle
Applicant	Gyrus Acmi, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Jan 4, 2022
Decision	SESE
Submission Type	Special
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

1. The PK Needle is indicated for resection of soft tissue in laparoscopic and general surgical procedures. 2. The PK Spatula is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures. 3. The PK J-Hook is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures.

Device Story

Bipolar electrosurgical instruments (Needle, Spatula, J-Hook) for laparoscopic/general surgery; used to resect/coagulate soft tissue and blood vessels. Devices feature active tips (needle, spatula, or J-hook) and are activated via handle buttons or foot pedals. Instruments pass through 5mm cannulas or laparoscope working channels. Devices connect to Olympus ESG-400 or ESG-410 generators; generator/device form medical electrical system. Generator automatically presets output settings upon connection. Physician operates device during surgery; output affects tissue via high-frequency electrical energy. Benefits include precise tissue resection/coagulation.

Clinical Evidence

Bench testing only. Non-clinical testing included electrical, mechanical, functional, and generator compatibility assessments to verify performance with the additional ESG-410 generator. No clinical data provided.

Technological Characteristics

Bipolar electrosurgical instruments; 5mm diameter form factor. Materials unchanged from original clearance. Energy source: high-frequency electrical energy from compatible Olympus generators (ESG-400/ESG-410). Compliance with AAMI/ANSI ES 60601-1 and IEC 60601-2-2. Sterilization: Ethylene oxide (ISO 11135).

Indications for Use

Indicated for resection and/or coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures.

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

PK Needle (K142154)
PK Spatula (K142289)
PK J-Hook (K142350)

Reference Devices

Olympus ESG-400 generator (K141225)
Olympus ESG-410 generator (K203277)

Related Devices

K142350 — PK J-HOOK · Gyrus Acmi, Inc. · Jan 8, 2015
K082505 — KLS MARTIN ELECTROSURGICAL INSTRUMENTS · Kl Martin L.P. · Jun 12, 2009
K142154 — PK NEEDLE · Gyrus Acmi, Inc. · Dec 19, 2014
K142289 — PK Spatula · Gyrus Acmi, Inc. · Dec 31, 2014
K971677 — ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR CORD · Transamerican Technologies Intl. · Aug 20, 1997

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 4, 2022 Dolan Mills Program Manager, Regulatory Affairs Gyrus ACMI, Inc. 9600 Louisiana Ave. North Brooklyn Park, MN 55445 USA Re: K213831 Trade/Device Name: Olympus PK Electrosurgical Instruments: PK Needle, PK J-hook Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: December 7, 2021 Received: December 8, 2021 Dear Dolan Mills: We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrb/ofdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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. {1}------------------------------------------------ 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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213831 Device Name Olympus PK Electrosurgical Instruments: PK Needle, PK Spatula, PK J-Hook #### Indications for Use (Describe) 1. The PK Needle is indicated for resection of soft tissue in laparoscopic and general surgical procedures. 2. The PK Spatula is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures. 3. The PK J-Hook is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures. Type of Use (Select one or both, as applicable) X 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}------------------------------------------------ ## K213831 510(k) Summary Gyrus ACMI, Inc. Olympus PK Electrosurgical Instruments Date Prepared: Dec 22, 2021 #### General Information Manufacturer: Gyrus ACMI, Inc. 9600 Louisiana Blvd. North Brooklyn Park, MN 55455 USA Establishment Registration Number: Contact Person: 3011050570 Dolan Mills Program Manager, Regulatory Affairs 901-355-0007 Dolan.mills@olympus.com ### Device Description | Proprietary names: | Olympus PK Electrosurgical Instruments: PK Needle, PK Spatula, PK J-Hook | |-------------------------------|--------------------------------------------------------------------------| | Device Classification Name: | Electrosurgical Cutting and Coagulation device and Accessories | | Regulations number: | 21 CFR 878.4400 | | Regulation Medical Specialty: | General and Plastic Surgery | | Regulatory Class: | Class II | | Product Code: | GEI | | Generic/Common Name: | Electrosurgical Cutting and Coagulation device and Accessories | #### Predicate Devices The Olympus PK Electrosurgical Instruments: PK Needle (model # PK-NE0533), PK Spatula (model # PK-SP0533), and PK J-Hook (model # PK-JH0533), were cleared under K142154 (PK Needle), K142289 (PK Spatula), and K142350 (PK J-Hook). This submission is a modification to the device labeling to add compatibility with an Olympus generator, ESG-410 cleared under K203277. {4}------------------------------------------------ The predicate device has not been subject to any recalls. ### Product Description PK-NE0533: The PK Needle is a bipolar electrosurgical instrument with the capability to resect soft tissue and blood vessels in laparoscopic and general surgical procedures. The instrument will pass through a 5mm cannula or through an operating laparoscope working channel of 5mm or larger diameter. The device has an active blunt needle shaped tip and is activated via a button on the handle, or by a foot pedal. The device plugs into the Olympus ESG-400 generator (K141225), and the Olympus ESG-410 generator (K203277). The generator and device make up a medical electrical system. The instrument is to be used only with the compatible Generators. PK-SP0533: The PK Spatula is a bipolar electrosurgical instrument with the capability to cut and coagulate soft tissue and blood vessels in laparoscopic and general surgery. The instrument will pass through a 5mm cannula or through an operating laparoscope working channel of 5mm or larger diameter. The instrument is used with a 5 way connector cable. The device is intended for use in a non-irrigated (dry) environment. The device plugs into the Olympus ESG-400 generator (K141225), and the Olympus ESG-410 generator (K203277). The generator and device make up a medical electrical system. The instrument is to be used only with the compatible Generators. PK-JH0533: The PK J-Hook is a bipolar electrosurgical instrument with the capability to cut and coagulate soft tissue and blood vessels in laparoscopic and general surgery. The instrument will pass through a 5mm cannula or through an operating laparoscope working channel of 5mm or larger diameter. The device has an active "J" shaped tip and is activated via buttons on the handle, or by a foot pedal. The device plugs into the Olympus ESG-400 generator (K141225), and the Olympus ESG-410 generator (K203277). The generator and device make up a medical electrical system. The instrument is to be used only with the compatible Generators. The device is compliant with FDA recognized consensus safety standards as listed below. ### Technological Characteristics The Olympus PK Electrosurgical Instruments are unchanged from the original clearance in terms of intended use, design, performance, and technological characteristics. The only difference is in the labeling that identifies an additional compatible Olympus generator. For safety and convenience the compatible generator recognizes and automatically presets the default output settings once the instrument is connected. {5}------------------------------------------------ The PK Needle is activated using a button located on the device handle, or via a foot pedal. The device is a bipolar electrosurgical instrument with the capability to resect soft tissue and blood vessels in laparoscopic and general surgical procedures. The active tip is exposed in a blunt "needle" like electrode tip which is the active portion of the device allowing for cutting. The PK Spatula is activated using buttons located on the device handle. This allows the physician to activate either cut or coagulation (coag) mode without taking their eyes off the surgical site. Historically foot pedals have been used for such devices and are also available for the proposed device. A nosecone located at the distal end of the handle and at the proximal end of the device shaft allows the physician to alter the orientation of the electrode tip without altering the orientation of the handle. The PK J-Hook is activated using buttons located on the device handle, or via a foot pedal. This allows the physician to activate either cut or coagulation (coag) mode without taking their eyes off the surgical site. A nosecone located at the distal end of the handle and at the proximal end of the device shaft allows the physician to alter the orientation of the electrode tip without altering the orientation of the handle. # Material The materials have not changed for these devices since their original clearance, in which full biocompatibility information was provided. # Indications for Use - 1. The PK Needle is indicated for resection of soft tissue in laparoscopic and general surgical procedures. - 2. The PK Spatula is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures. - 3. The PK J-Hook is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures. | The design of the subject device complies with the following standards: | | | |-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | Standards Number | Standard Title | FDA Recognition no + date | | AAMI/ANSI ES 60601-1:2005/(R)2012 and C1:2009/(R)2012 and, A2:2010/(R)2012 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) | 19-4 07/09/2014 | | IEC 60601-2-2 Ed. | Medical electrical equipment - Part 2-2: Particular | 6-389 | # Compliance to Voluntary Standards {6}------------------------------------------------ | 6.0:2017-03 | requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories | 08/21/2017 | |------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------| | ANSI AAMI ISO 14971 2019 | Medical devices – Application of risk management to medical devices | 5-125 12/23/2019 | | ISO 11135: 2014 | Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices | 14-529 07/15/2019 | | ISO 15223-1:2016 | Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1 General requirements | 5-117 08/21/2017 | | ISO 11607-1 Second Edition 2019-2 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems | 14-530 07/15/2019 | | ISO 10993-1:2018 | Biological Evaluation of Medical Devices, Part 1: Evaluation and testing within a risk management process | 2-258 01/14/2019 | | ISO 10993-5:2009 | Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity | 2-245 12/23/2016 | | ISO 10993-10:2010 | Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Skin Sensitization | 2-174 07/26/2016 | | ISO 10993-7 Second Edition 2008-10-15 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals | 14-408 01/30/2014 | #### Summary of Sterilization and Shelf Life Discussion The product and packaging materials as well as the sterilization mode has not changed since the original clearance, therefore no additional testing was needed. #### Summary of Performance Testing Non-clinical testing was conducted as part of demonstrating substantial equivalence to the predicate device and to ensure that the performance criteria was met when used with the additional compatible generator. A risk analysis was completed to identify any new risks associated with the update. The following tests associated with the device modification were performed on the subject device according to the methods and acceptance criteria established in the original clearances noted above: - . Non-clinical (electrical, mechanical, functional, generator compatibility, cutting equivalency to predicate) #### Comparison to Predicate Discussion The Olympus PK Electrosurgical Instruments have identical indications for use as the previously cleared devices. There have been no changes in the devices as compared to the previously cleared devices in K142154, K142289, and K142350. The {7}------------------------------------------------ only difference is the compatibility with an additional cleared Olympus generator, ESG-410. The labeling has been updated to reflect this additional compatible generator. # Conclusion: In summary, the Olympus PK Electrosurgical Instruments are equivalent to the predicate devices and present no new questions of safety or effectiveness.