Who is the manufacturer of Thunderbeat Open Fine Jaw Type X Hand Instrument?

Olympus Medical Systems Corp. filed the 510(k) submission for Thunderbeat Open Fine Jaw Type X Hand Instrument (K192103).

What is the FDA product code for Thunderbeat Open Fine Jaw Type X Hand Instrument?

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 Thunderbeat Open Fine Jaw Type X Hand Instrument?

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

What are the predicate devices for Thunderbeat Open Fine Jaw Type X Hand Instrument?

THUNDERBEAT Open Fine Jaw (TB-0009OF) (K151743); LigaSure Curved, Small Jaw, Open Sealer/Divider (K113572).

Who can help prepare an FDA 510(k) submission like Thunderbeat Open Fine Jaw Type X Hand Instrument?

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.

Thunderbeat Open Fine Jaw Type X Hand Instrument

K192103 · Olympus Medical Systems Corp. · GEI · May 11, 2020 · General, Plastic Surgery

Device Facts

Record ID	K192103
Device Name	Thunderbeat Open Fine Jaw Type X Hand Instrument
Applicant	Olympus Medical Systems Corp.
Product Code	GEI · General, Plastic Surgery
Decision Date	May 11, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The THUNDERBEAT Open Fine Jaw Type X hand instrument is intended to be used for open surgery to cut, seal, coagulate, grasp, and dissect. Seal & Cut mode: The THUNDERBEAT Open Fine Jaw Type X hand instrument when used in combination with the Seal & Cut mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. The device has been designed to seal and cut vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics. This mode is also indicated for open ENT procedure in adults (thyroidectomy, parathyroidectomy, parotidectomy, radical neck dissection, and tonsillectomy) for only ligation (sealing and cutting) of vessels, lymphatics and tissue bundles greater than 3 mm away from unintended thermally sensitive structures such as nerves and parathyroid glands. Seal mode: The THUNDERBEAT Open Fine Jaw Type X hand instrument when used in combination with the Seal mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which vessel sealing, coagulation, grasping is performed. The device has been designed to seal vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics. This mode is also indicated for open ENT procedure in adults (thyroidectomy, parathyroidectomy, parotidectomy, radical neck dissection, and tonsillectomy) for sealing of vessels, lymphatics and tissue bundles greater than 3 mm away from unintended thermally sensitive structures such as nerves and parathyroid glands. The THUNDERBEAT Open Fine Jaw Type X hand instrument has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

Device Story

Sterile, single-use electrosurgical/ultrasonic hand instrument; used in open surgery for cutting, sealing, coagulating, grasping, and dissecting. Operates via connection to ESG-400 Electrosurgical Generator and USG-400 Ultrasonic Generator. Employs combined HF bipolar and ultrasonic energy (Seal & Cut mode) or HF bipolar energy only (Seal mode). Physician-operated; used in OR. Provides mechanical grasping and energy delivery to tissue bundles/vessels up to 7mm. Output allows for vessel ligation and tissue division; aids in hemostasis. Benefits include efficient tissue management and reduced surgical time.

Clinical Evidence

No clinical data. Evidence consists of bench testing (ex-vivo porcine vessel burst pressure, temperature-time history) and chronic/acute animal studies (porcine/Beagle dogs) evaluating seal maintenance, thermal spread, and healing progression.

Technological Characteristics

Materials: Polycarbonate, ADC12, PEEK, PTFE, SUS630, SUS304, SUS303, Ti-6Al-4V. Sensing/Actuation: Ultrasonic transducer and HF bipolar electrodes. Energy: Ultrasonic and HF bipolar. Form factor: Hemostat-style hand instrument. Connectivity: Connects to ESG-400/USG-400 generators. Sterilization: Sterile, single-use. Standards: ANSI AAMI ES60601-1, IEC60601-1-2, IEC60601-2-2, ISO 10993, ISO 11135, ISO 11607, ASTM F1980.

Indications for Use

Indicated for open general surgery (including plastic/reconstructive) and open ENT procedures in adults (thyroidectomy, parathyroidectomy, parotidectomy, radical neck dissection, tonsillectomy) for cutting, sealing, coagulating, grasping, and dissecting vessels up to 7mm, tissue bundles, and lymphatics. Contraindicated for tubal sterilization/coagulation. ENT procedures require >3mm distance from thermally sensitive structures (nerves, parathyroid glands).

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

THUNDERBEAT Open Fine Jaw (TB-0009OF) (K151743)
LigaSure Curved, Small Jaw, Open Sealer/Divider (K113572)

Related Devices

K132703 — THUNDERBEAT · Olympus Medical Systems Corp. · May 19, 2014
K131435 — ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW, · Ethicon Endo-Surgery, LLC · Oct 3, 2013
K201066 — ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length · Ethicon Endo-Surgery, LLC · Jan 22, 2021
K173281 — LigaSure Exact Dissector, Nano-coated · Covidien · Mar 2, 2018
K112033 — ENSEAL G2 TISSUS SEALERS · Ethicon Endo-Sugery, LLC · Nov 8, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 11, 2020 Olympus Medical Systems Corp. Christina Flores Manager, Regulatory Affairs Gyrus ACMI inc. 136 Turnpike Road Southborough, Massachusetts 01772 ### Re: K192103 Trade/Device Name: Thunderbeat Open Fine Jaw Type X Hand Instrument Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, LFL Dated: May 6, 2020 Received: May 7, 2020 ### Dear Christina Flores: 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. 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/cdrh/cfdocs/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. 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 {1}------------------------------------------------ 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 Advice (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, for Michael J. Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192103 #### Device Name THUNDERBEAT Open Fine Jaw Type X hand instrument #### Indications for Use (Describe) The THUNDERBEAT Open Fine Jaw Type X hand instrument is intended to be used for open surgery to cut, seal, coagulate, grasp, and dissect. #### Seal & Cut mode: The THUNDERBEAT Open Fine Jaw Type X hand instrument when used in combination with the Seal & Cut mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. The device has been designed to seal and cut vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics. This mode is also indicated for open ENT procedure in adults (thyroidectomy, parotidectomy, partical neck dissection, and tonsillectory) for only ligation (sealing and cutting) of vessels, lymphatics and tissue bundles greater than 3 mm away from unintended thermally sensitive structures such as nerves and parathyroid glands. Seal mode: The THUNDERBEAT Open Fine Jaw Type X hand instrument when used in combination with the Seal mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which vessel sealing, coagulation, grasping is performed. The device has been designed to seal vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics. This mode is also indicated for open ENT procedure in adults (thyroidectomy, parotidectomy, radical neck dissection, and tonsillectomy) for sealing of vessels, lymphatics and tissue bundles greater than 3 mm away from unintended thermally sensitive structures such as nerves and parathyroid glands. The THUNDERBEAT Open Fine Jaw Type X hand instrument has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures. | Type of Use (Select one or both, as applicable) | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | <table><tr><td><div style="display:inline-block;"></div>Prescription Use (Part 21 CFR 801 Subpart D)</td></tr><tr><td><div style="display:inline-block;"></div>Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | <div style="display:inline-block;"></div> Prescription Use (Part 21 CFR 801 Subpart D) | <div style="display:inline-block;"></div> Over-The-Counter Use (21 CFR 801 Subpart C) | | <div style="display:inline-block;"></div> Prescription Use (Part 21 CFR 801 Subpart D) | | | | <div style="display:inline-block;"></div> 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly rounded and have a glossy appearance. There is a thin, horizontal, yellow line underneath the word. The registered trademark symbol is located to the right of the letter "S". ## 510(k) Summary Gyrus ACMI, Inc. THUNDERBEAT Open Fine Jaw Type X hand instrument ### General Information | Applicant: | OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Phone: (+81) 42-642-2694 Fax: (+81) 42-642-2307 | |------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------| | Establishment Registration Number: | 8010047 | | Manufacturer: | Aomori Olympus 2-248-1 okkonoki kuroishi-shi aomori, Japan 036-0357 Phone: (+81) 172-52-8543 Fax: (+81) 172-52-8515 | | Establishment Registration Number: | 9614641 | | 510(k) Submitter: | Gyrus ACMI, Inc. 136 Turnpike Rd. Southborough, MA 01772-2104 | | Establishment Registration Number: | 3003790304 | | Contact Person: | Christina Flores, RAC Manager, Regulatory Affairs | | Date Prepared: | May 10, 2020 | ### Device Description Classification Name: Electrosurgical cutting and coagulation device and accessories Regulation Number: 21 CFR 878.4400 Regulatory Class: Class II, Product Codes: GEI, LFL Review Panel: General & Plastic Surgery {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. A registered trademark symbol is located to the right of the letter "S". Trade Name: THUNDERBEAT Open Fine Jaw Type | | | X hand instrument | |--|----------------------|--------------------------------------------------| | | Model Name | Device Name | | | TB-0009OFX | THUNDERBEAT Open Fine Jaw Type X hand instrument | | | Generic/Common Name: | Ultrasonic and electrosurgical devices | Ultrasonic and electrosurgical devices ### Primary Predicate Device | Device name | 510(k) Submitter | 510(k) No. | |------------------------------------------|----------------------------------|------------| | THUNDERBEAT Open Fine Jaw (TB-0009OF) | OLYMPUS MEDICAL SYSTEMS CORP. | K151743 | ### Secondary Predicate Device | Device name | 510(k) Submitter | 510(k) No. | |----------------------------------------------------|------------------|------------| | LigaSure Curved, Small Jaw, Open Sealer/Divider | COVIDIEN | K113572 | # Product Description THUNDERBEAT Open Fine Jaw Type X hand instrument is intended to be used for open surgery to cut, seal, coagulate, grasp, and dissect. The THUNDERBEAT Open Fine Jaw Type X hand instrument is provided as a sterile, single use device. The subject device is functional device capable of vessel sealing & cutting, tissue coagulating & cutting, grasping, and dissecting. This device has been designed to seal and cut vessels up to and including 7 mm in diameter, tissue bundles, and lymphatics. This device also has been designed for open ENT procedures in adults. # Comparison of Technological Characteristics The basic principle and operational characteristics of the subject device are identical to the predicate device. The proposed THUNDERBEAT Open Fine Jaw Type X Hand Instrument is equivalent to the predicate device in that each device is connected to Surgical Tissue Management System, specifically the ESG-400 Electrosurgical Generator, USG-400 Ultrasonic Generator and THUNDERBEAT Transducer (TD-TB400). Like the predicate device, the subject device activates combined HF Bipolar (FineCoag) output and Ultrasonic output [Seal & Cut mode] simultaneously or only the HF Bipolar output (Seal mode) while grasping vessels, tissue bundles and lymphatics between the Probe and the H electrode in the Grasping section. {5}------------------------------------------------ In terms of the design concept of the subject device, the differences from the predicate device are as follows: - Addition of the Radical Neck Dissection indication - Removal of generator specific information from indications for use - Adding resin cover (PEEK) on the H electrode - Changing a material of H electrode in the grasping section and Sheath cover A side by side comparison of the subject device and the predicate device is provided below. | Item | Subject Device | Primary Predicate Device (PD) K151743 | Secondary Predicate Device (PD2) K113572 | Discussion | |--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | TB-0009OFX | TB-0009OF | LigaSure Curved, Small Jaw, Open Sealer/Divider | | | Indicatio ns for Use | The THUNDERBEAT Open Fine Jaw Type X hand instrument is intended to be used for open surgery to cut, seal, coagulate, grasp, and dissect. Seal & Cut mode: The THUNDERBEAT Open Fine Jaw Type X hand instrument when used in combination with the Seal & Cut mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. The device has been designed to seal and cut vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics. This mode is also indicated for open ENT procedure in adults (thyroidectomy | The THUNDERBEAT Open Fine Jaw hand instrument is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer, (TD- TB400). Seal & Cut mode: The THUNDERBEAT Open Fine Jaw hand instrument when used in combination with the Seal & Cut mode is indicated for open, general surgery (including plastic and reconstructive, etc) or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. The device has been designed to seal and cut vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics. | The LigaSure™ Curved, Small Jaw, Open Sealer / Divider is a bipolar electrosurgical instrument intended to be used with the ForceTriad™ energy platform. The instrument is indicated for use in open general surgical procedures where ligation and division of vessels (up to 7 mm in diameter), tissue bundles, and lymphatics is performed, such as urologic, thoracic, plastic, and reconstructive, and including such procedures as bowel resections, gall bladder procedures, Nissen fundoplication, adhesiolysis, etc. The device is also indicated for open ENT procedures in adults | The differences between SD and PD are the removal of the specific generator information and the addition of the Radical Neck Dissection indication. The Radical Neck Dissection indication is carried by the PD2. | | Item | Subject Device | Primary Predicate Device (PD) K151743 | Secondary Predicate Device (PD2) K113572 | Discussion | | | TB-0009OFX parathyroidectomy, parotidectomy, radical neck dissection, and tonsillectomy) for only ligation (sealing and cutting) of vessels, lymphatics and tissue bundles greater than 3mm away from unintended thermally sensitive structures such as nerves and parathyroid glands. Seal mode: The THUNDERBEAT Open Fine Jaw Type X hand instrument when used in combination with the Seal mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which vessel sealing, coagulation, grasping is performed. The device has been designed to seal vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics. This mode is also indicated for open ENT procedure in adults (thyroidectomy, parathyroidectomy, parotidectomy, radical neck dissection, and tonsillectomy) for sealing of vessels, lymphatics and tissue bundles greater than 3mm away from | TB-0009OF This mode is also indicated for open ENT procedure in adults (thyroidectomy, parathyroidectomy, parotidectomy, and tonsillectomy) for only ligation (sealing and cutting) of vessels, lymphatics and tissue bundles 2-3 mm*1 away from unintended thermally sensitive structures such as nerves and parathyroid glands. Seal mode: The THUNDERBEAT Open Fine Jaw hand instrument when used in combination with the Seal mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which vessel sealing, coagulation, grasping is performed. The device has been designed to seal vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics. This mode is also indicated for open ENT procedure in adults (thyroidectomy, parathyroidectomy, parotidectomy, and tonsillectomy) for sealing of vessels, | LigaSure Curved, Small Jaw, Open Sealer/Divider (thyroidectomy, radical neck dissection, parotidectomy, and tonsillectomy) for ligation and division of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally sensitive structures such as nerves and parathyroid glands. The LigaSure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures. | | | Item | Subject Device | Primary Predicate Device (PD) K151743 | Secondary Predicate Device (PD2) K113572 | Discussion | | | TB-00090FX unintended thermally sensitive structures such as nerves and parathyroid glands. The THUNDERBEAT Open Fine Jaw Type X hand instrument has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures. | TB-0009OF lymphatics and tissue bundles 2-3mm*1 away from unintended thermally sensitive structures such as nerves and parathyroid glands. The THUNDERBEAT Open Fine Jaw hand instrument has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures. *1 It should be extended appropriately depending on the operation situation. | LigaSure Curved, Small Jaw, Open Sealer/Divider | | | Regulati on Number | 878.4400 | 878.4400 | 878.4400 | Same as PD | | Regulati on Name | Electrosurgical, cutting & coagulation & accessories | Electrosurgical, cutting & coagulation & accessories | Electrosurgical, cutting & coagulation & accessories | | | Regulato ry Class | II | II | II | | | Product Code | GEI, LFL | GEI, LFL | GEI | | | Classific ation Panel | General & Plastic Surgery | General & Plastic Surgery | General & Plastic Surgery | | | Basic principle | Seal and Cut mode: Activating the Ultrasonic output (generated by the USG-400, Ultrasonic Generator) and the HF Bipolar output (generated by the ESG-400) | Seal and Cut mode: Activating the Ultrasonic output (generated by the USG-400, Ultrasonic Generator) and the HF Bipolar output (generated by the ESG-400) | High-frequency current generated by Covidien's Electrosurgical Generators (such as Force Triad) is delivered to the jaw (electrodes), and coagulate (seal) vessels, | Same as PD | | Item | Subject Device TB-0009OFX | Primary Predicate Device (PD) K151743 TB-0009OF | Secondary Predicate Device (PD2) K113572 LigaSure Curved, Small Jaw, Open Sealer/Divider | Discussion | | | sealing and cutting of vessels, tissue bundles, and lymphatics and cutting and coagulation soft tissue. Seal mode: Uses only the HF Bipolar (ESG- 400) energy output which enables vessel, tissue bundle and lymphatic sealing and | sealing and cutting of vessels, tissue bundles, and lymphatics and cutting and coagulation soft tissue. Seal mode: Uses only the HF Bipolar (ESG- 400) energy output which enables vessel, tissue bundle and lymphatic sealing and | tissue bundles, lymphatics clamped by the jaw. The internal mechanical blade in the jaw makes the soft tissues divided | | | Handle shape | hemostasis. hemostat-style body | hemostasis. hemostat-style body | hemostat-style body | Same as PD | | Tip shape | Probe and H electrode | Probe and H electrode | Jaw | Same as PD | | Resin cover on the tip of grasping section | Equipped | N/A | Unknown | The resin cover is added on the H electrode. | | Grasping section | PTFE/SUS630 | PTFE/Aluminum alloy | SUS | The material of the H electrode was changed from aluminum alloy to SUS63. | | Device performa nce | Performance testing including Bench and Animal testing was conducted in support of the substantial equivalence determination. | | | | | Reproce ssing | Sterile, for single use…