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.

Device 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.

AI/ML Overview

The provided text is a 510(k) Summary for the Olympus POWERSEAL Curved Jaw Sealer and Divider, Double Action (K212643). It states that this submission is a modification to a previously cleared device (K203682) to add compatibility with an additional Olympus generator (ESG-410).

Crucially, the document explicitly states: "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."

Therefore, the study described in this document is not a de novo study proving the initial performance of the device, but rather a bridge study to demonstrate that the device's performance, when connected to a new, compatible generator, remains equivalent to its previously cleared performance. The focus is on demonstrating that the modification (new generator compatibility) does not adversely affect the device's established safety and effectiveness.

Because of this, the document does not contain the detailed information necessary to answer all aspects of your request, particularly regarding clinical studies, human-in-the-loop performance, and the specifics of generating ground truth for a completely new device evaluation. The information provided heavily relies on the previous clearance (K203682) and focuses on non-clinical testing to confirm continued equivalence.

However, I can extract the relevant information that is available from the document regarding the acceptance criteria and the study that proves the device meets them for this specific modification.

Here's a breakdown based on the provided text, addressing your points where information is available:

1. A table of acceptance criteria and the reported device performance:

The document states: "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)
Preclinical (simulated use) evaluation and testing of tissue effects and thermal safety and vessel burst pressure testing and vessel thermal margin"

The specific acceptance criteria (e.g., minimum burst pressure, maximum thermal spread) and the reported quantitative performance data for these tests are not detailed in this 510(k) Summary. The document relies on the fact that these tests were "performed on the subject device according to the methods and acceptance criteria established in the original clearance K203682" and that the results "met" those criteria, implying the performance is equivalent to the predicate.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated for specific tests. The tests mentioned are "non-clinical" and "preclinical (simulated use)", which would involve a certain number of devices or simulated tissue samples, but the exact quantities are not provided.
Data Provenance: The tests were conducted by the manufacturer, Gyrus ACMI, Inc., with some testing performed by Intertek (Fridely, MN, USA) and WuXi AppTec (St. Paul, MN, USA) for compliance to voluntary standards (e.g., biocompatibility). These are laboratory/bench tests, not clinical studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable to this type of submission. This document describes non-clinical and preclinical testing of a surgical device's physical and functional properties, not an AI or imaging device requiring expert interpretation for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This question is not applicable. Adjudication is typically associated with human-read studies or clinical trials involving subjective interpretation, which is not what this document describes. Test results for electrosurgical devices are typically quantitative measurements against defined engineering specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This question is not applicable. This submission is for a electrosurgical sealing and cutting device, not an AI-assisted diagnostic or imaging tool. Therefore, MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This question is not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical and preclinical tests, the "ground truth" would be established by the engineering specifications and scientific principles governing device performance. For example, for "vessel burst pressure testing," the ground truth is the actual measured burst pressure, and the acceptance criterion would be a predefined minimum required pressure. For "tissue effects and thermal safety," the ground truth is the measured extent of tissue damage or thermal spread, compared against a safe operating range. These are objective measures, not subjective interpretations.

8. The sample size for the training set:

This question is not applicable. This is not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established:

This question is not applicable. This is not an AI/machine learning device.

In summary, as per the provided text, the study proving the device meets acceptance criteria for this specific 510(k) (K212643) was primarily a non-clinical and preclinical validation that the addition of compatibility with a new generator did not alter the power seal device's performance characteristics established in its prior clearance (K203682). The detailed acceptance criteria and quantitative performance results for those tests are not provided in this summary, but the document states they were met.

Summary

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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

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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

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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 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)

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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 andDivider, Double Action (PS-0523CJDA,PS-0537CJDA, PS-0544CJDA)
Device Classification Name:	Electrosurgical Cutting and Coagulationdevice 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 Coagulationdevice 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

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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 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.

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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

StandardsNumber	Standard Title	FDARecognitionno + date	Testing Lab
AAMI/ANSI ES60601-1:2005/(R)2012andC1:2009/(R)2012and,A2:2010/(R)2012	Medical electrical equipment - Part 1:General requirements for basic safetyand essential performance (IEC 60601-1:2005, MOD)	19-407/09/2014	Intertek, Fridely, MN,USA
IEC 60601-1-2Ed. 4.0:2014-02	Medical electrical equipment - Part 1-2:General requirements for basic safetyand essential performance - CollateralStandard: Electromagnetic disturbances-Requirements and tests	19-809/17/2018	Intertek, Fridely, MN,USA
IEC 60601-2-2Ed. 6.0:2017-03	Medical electrical equipment - Part 2-2:Particular requirements for the basicsafety and essential performance of highfrequency surgical equipment and highfrequency surgical accessories	6-38908/21/2017	Intertek, Fridely, MN,USA
IEC 62366-1 Ed.1.0:2015-02	Medical devices - Part 1: Application ofusability engineering to medical devices[Including CORRIGENDUM 1 (2016)]	5-11412/23/2016	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:

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Second Edition2007-03-01	management to medical devices	06/27/2016
ISO 11135: 2014	Sterilization of health care products -Ethylene oxide - Requirements fordevelopment, validation and routinecontrol of a sterilization process formedical devices	14-52907/15/2019	N/A
ISO 11607-1Second Edition2019-2	Packaging for terminally sterilizedmedical devices - Part 1: Requirementsfor materials, sterile barrier systems andpackaging systems	14-53007/15/2019	N/A
ASTM F1980-16	Standard Guide for Accelerated Agingof Sterile Barrier Systems for MedicalDevices	14-49712/23/2016	N/A
ISO 10993-5:2009	Biological Evaluation of MedicalDevices, Part 5: Tests for In VitroCytotoxicity	2-24512/23/2016	WuXi AppTec in St. Paul,MN
ISO 10993-10:2010	Biological Evaluation of MedicalDevices, Part 10: Tests for Irritation andSkin Sensitization	2-17407/26/2016	WuXi AppTec in St. Paul,MN
ISO 10993-11Third Edition2019-09	Biological Evaluation of MedicalDevices, Part 11: Tests for SystemicToxicity	2-25509/17/2018	WuXi AppTec in St. Paul,MN
ISO 10993-7Second Edition2008-10-15	Biological evaluation of medical devices- Part 7: Ethylene oxide sterilizationresiduals	14-40801/30/2014	WuXi AppTec in St. Paul,MN
ISO 10993-18:2020	Biological evaluation of medical devices— Part 18: Chemical characterization ofmedical device materials within a riskmanagement process	2-27607/06/2020	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)

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. 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.

Regulation Number and Section

§ 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.