Who is the manufacturer of POWERSEAL Curved Jaw Sealer and Divider, Double Action?

Olympus Surgical Technologies America filed the 510(k) submission for POWERSEAL Curved Jaw Sealer and Divider, Double Action (K212643).

What is the FDA product code for POWERSEAL Curved Jaw Sealer and Divider, Double Action?

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 POWERSEAL Curved Jaw Sealer and Divider, Double Action?

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

Who can help prepare an FDA 510(k) submission like POWERSEAL Curved Jaw Sealer and Divider, Double Action?

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.

POWERSEAL Curved Jaw Sealer and Divider, Double Action

K212643 · Olympus Surgical Technologies America · GEI · Sep 27, 2021 · General, Plastic Surgery

Device Facts

Record ID	K212643
Device Name	POWERSEAL Curved Jaw Sealer and Divider, Double Action
Applicant	Olympus Surgical Technologies America
Product Code	GEI · General, Plastic Surgery
Decision Date	Sep 27, 2021
Decision	SESE
Submission Type	Special
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The POWERSEAL Sealer and Divider is a bipolar electrosurgical device intended for use in laparoscopic/minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The POWERSEAL devices can be used on vessels (arteries and veins, pulmonary arteries, pulmonary veins) up to and including 7 mm, lymphatics, and tissue bundles. POWERSEAL devices are indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to. Nissen fundoplication, colectomy, adhesiolysis, sleeve gastrectomy, hysterectomy, oophorectomy. The POWERSEAL Sealer and Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the POWERSEAL devices for these procedures.

Device Story

Bipolar electrosurgical instrument; pistol-grip handle; 5mm shaft (23, 37, 44 cm lengths); integral extending cutting blade. Used in OR for open/laparoscopic surgery. Physician operates hand-actuated mechanism to close jaws over tissue/vessels; initiates bipolar HF energy via generator to seal; activates blade via separate control to divide tissue. Compatible with Olympus electrosurgical generators (e.g., ESG-410). Provides hemostasis and tissue separation; benefits include reduced surgical time and controlled tissue management.

Clinical Evidence

Bench testing only. Non-clinical evaluation included electrical, mechanical, and functional testing, plus preclinical simulated use, tissue effects, thermal safety, vessel burst pressure, and vessel thermal margin testing to validate compatibility with the additional generator.

Technological Characteristics

Bipolar electrosurgical device; pistol-grip handle; 5mm shaft. Energy source: HF bipolar electrosurgical generator. Sterilization: Ethylene oxide (ISO 11135). Compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2. Materials unchanged from K203682 (biocompatibility per ISO 10993).

Indications for Use

Indicated for ligation and division of vessels (up to 7mm), lymphatics, and tissue bundles in laparoscopic/minimally invasive or open general, urologic, colorectal, bariatric, vascular, thoracic, and gynecologic surgeries. Contraindicated for tubal sterilization or tubal coagulation.

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

POWERSEAL Curved Jaw Sealer and Divider, Double Action (K203682)

Reference Devices

Olympus ESG-410 generator (K203277)

Related Devices

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K201212 — Voyant Open Fusion Device · Applied Medical Resources Corp. · Jun 5, 2020
K223158 — LigaSure XP Maryland Jaw Sealer/Divider · Covidien, LLC · Jan 23, 2023
K230387 — ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S) · Ethicon Endo-Surgery, LLC · Apr 13, 2023
K222284 — Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) · Applied Medical Resources Corporation · Oct 14, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. September 27. 2021 Olympus Surgical Technologies America Christina Flores Manager, Regulatory Affairs 9600 Louisiana Blvd North Brooklyn Park, Minnesota 55455 #### Re: K212643 Trade/Device Name: POWERSEAL Curved Jaw Sealer and Divider, Double Action Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: August 18, 2021 Received: August 20, 2021 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 {1}------------------------------------------------ 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 mediation-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/cdrl-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) K212643 #### Device Name POWERSEAL Curved Jaw Sealer and Divider, Double Action (PS-0523CJDA, PS-0537CJDA, PS-0544CJDA) #### Indications for Use (Describe) The POWERSEAL Sealer and Divider is a bipolar electrosurgical device intended for use in laparoscopic/minimally invasive or open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. POWERSEAL devices can be used on vessels (arteries and veins, pulmonary veins) up to and including 7 mm, lymphatics, and tissue bundles. POWERSEAL devices are indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, adhesiolysis, sleeve gastrectomy, hysterectomy, oophorectomy. The POWERSEAL Sealer and Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the POWERSEAL devices for these procedures. 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}------------------------------------------------ ### 510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. POWERSEAL Curved Jaw Sealer and Divider, Double Action Date Prepared: August 16, 2021 #### General Information Manufacturer: Gyrus ACMI, Inc. 9600 Louisiana Blvd. North Brooklyn Park, MN 55455 USA Establishment Registration Number: Contact Person: 3011050570 Christina Flores Manager, Regulatory Affairs ### Device Description | Proprietary names: | POWERSEAL Curved Jaw Sealer and Divider, Double Action (PS-0523CJDA, PS-0537CJDA, PS-0544CJDA) | |-------------------------------|------------------------------------------------------------------------------------------------------| | 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 POWERSEAL Curved Jaw Sealer and Divider, Double Action (PS-0523CJDA, PS-0537CJDA, and PS-0544CJDA) were cleared under K203682. This submission is {4}------------------------------------------------ a modification to the device that intends to add compatibility with an Olympus generator, ESG-410 cleared under K203277. The predicate device has not been subject to any recalls. #### Product Description The POWERSEAL 5mm laparoscopic curved jaw sealer divider is an electrosurgical bipolar device with an integral extending cutting blade. It features a pistol grip handle and will be provided in shaft lengths of 23, 37, and 44 cm. The subject POWERSEAL devices will be provided as sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with Olympus electrosurgical generators to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics. The jaws of the POWERSEAL are designed to seal vessels, and grasp and dissect tissue during open and minimally invasive general surgical procedures using high frequency (HF) energy. A hand actuated mechanism allows the user to open and close the instrument jaws. When the instrument jaws are correctly placed over tissue or vessel to be sealed, the user operates a second control to initiate delivery of bipolar energy, which seals the tissue. When the sealing is complete, the user operates a third control to activate a blade, which divides the tissue along the seal line. The subject device. POWERSEAL Sealer and Divider is a class II medical devices under the regulation number 878.4400 and the product code GEI - "Electrosurgical cutting and coagulation device and accessories". Regulation Medical Specialty: General & Plastic Surgery. The device is compliant with FDA recognized consensus safety standards as listed in Appendix 13B. #### Technological Characteristics The POWERSEAL Curved Jaw Sealer and Divider, Double Action (PS-0523CJDA, PS-0537CJDA, and PS-0544CJDA) is unchanged from the predicate device as cleared under K203682 in terms of intended use, design, performance, and technological characteristics. The only difference is in the labeling that identifies an additional compatible Olympus generator. ### Material The materials have not changed for these devices since their original clearance under K203682, in which full biocompatibility information was provided. {5}------------------------------------------------ ## Indications for Use The intended use of the modified device, as described in its labeling, has not changed as a result of the modification. The indications for use are as follows: The POWERSEAL Sealer and Divider is a bipolar electrosurgical device intended for use in laparoscopic/minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The POWERSEAL devices can be used on vessels (arteries and veins, pulmonary arteries, pulmonary veins) up to and including 7 mm, lymphatics, and tissue bundles. POWERSEAL devices are indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to. Nissen fundoplication, colectomy, adhesiolysis, sleeve gastrectomy, hysterectomy, oophorectomy. The POWERSEAL Sealer and Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the POWERSEAL devices for these procedures. ## Compliance to Voluntary Standards | Standards Number | Standard Title | FDA Recognition no + date | Testing Lab | |-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|-------------------------------| | 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 | Intertek, Fridely, MN, USA | | IEC 60601-1-2 Ed. 4.0:2014-02 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests | 19-8 09/17/2018 | Intertek, Fridely, MN, USA | | IEC 60601-2-2 Ed. 6.0:2017-03 | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories | 6-389 08/21/2017 | Intertek, Fridely, MN, USA | | IEC 62366-1 Ed. 1.0:2015-02 | Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)] | 5-114 12/23/2016 | N/A | | ISO 14971 | Medical devices – Application of risk | 5-40 | N/A | The design of the POWERSEAL Curved Jaw Sealer and Divider, Double Action complies with the following standards: {6}------------------------------------------------ | Second Edition 2007-03-01 | management to medical devices | 06/27/2016 | | |---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|--------------------------------| | 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 | N/A | | 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 | N/A | | ASTM F1980-16 | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices | 14-497 12/23/2016 | N/A | | ISO 10993- 5:2009 | Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity | 2-245 12/23/2016 | WuXi AppTec in St. Paul, MN | | ISO 10993- 10:2010 | Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Skin Sensitization | 2-174 07/26/2016 | WuXi AppTec in St. Paul, MN | | ISO 10993-11 Third Edition 2019-09 | Biological Evaluation of Medical Devices, Part 11: Tests for Systemic Toxicity | 2-255 09/17/2018 | WuXi AppTec in St. Paul, MN | | ISO 10993-7 Second Edition 2008-10-15 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals | 14-408 01/30/2014 | WuXi AppTec in St. Paul, MN | | ISO 10993- 18:2020 | Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process | 2-276 07/06/2020 | WuXi AppTec in St. Paul, MN | ### 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 in K203682, 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 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 modification to the POWERSEAL Curved Jaw Sealer and Divider, Double Action. 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 clearance K203682: - . Non-clinical (electrical, mechanical, functional) {7}------------------------------------------------ - . Preclinical (simulated use) evaluation and testing of tissue effects and thermal safety and vessel burst pressure testing and vessel thermal margin #### Substantial Equivalence Discussion The POWERSEAL Curved Jaw Sealer and Divider, Double Action has identical indications for use as the previously cleared POWERSEAL Curved Jaw Sealer and Divider, Double Action. There have been no changes in the device compared to the previously cleared device in K203682. The 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 Gyrus ACMI POWERSEAL Curved Jaw Sealer and Divider, Double Action is substantially equivalent to the predicate devices and presents no new questions of safety or effectiveness.