The Harmonic Shears are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space), and other open and endoscopic procedures.

Device Description

The Harmonic ACE Curved Shear with Ergonomic Handle (ACE45E), Hand Control is a sterile, single patient use, ultrasonic surgical instrument consisting of an ergonomic housing assembly with hand control buttons, a rotating shaft with curved, ultrasonic blades and clamp arms. The handle housing has an integrated audible/tactile mechanism for indicating full closure. The instrument is designed for use in open or laparoscopic procedures and is available in the 45 centimeter shaft length. The Harmonic ACE instrument is used for the coagulation of vessels up to and including 5 mm in diameter.

AI/ML Overview

This submission describes a medical device, the HARMONIC ACE Curved Shears with Ergonomic Handle, which is an ultrasonic surgical instrument. The submission is for a 510(k) premarket notification, indicating that the manufacturer is demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" and "study" described are focused on showing that the modified device performs equivalently to the existing predicate device, not necessarily against a specific clinical performance metric for a novel AI system.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Parameter for Success)	Reported Device Performance
Transection times (Preclinical)	Demonstrated equivalent performance to predicate.
Hemostasis (Preclinical)	Demonstrated equivalent performance to predicate. Specifically, "seals vessels up to and including 5 mm".
Thermal spread measurements (Preclinical)	Demonstrated equivalent performance to predicate.
Blood pressure challenges on sealed vessels (Preclinical)	Demonstrated equivalent performance to predicate.
Functionality and reliability (Testing)	Meets design requirements following device modifications.

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

Sample Size: Not explicitly stated. The text mentions "Preclinical porcine vessel sealing validation studies," implying animal testing. No specific number of animals or vessels is provided.
Data Provenance: Preclinical studies, specifically "porcine vessel sealing validation studies." This indicates animal (swine) data. The studies were conducted by Ethicon Endo-Surgery, LLC. There is no mention of country of origin for the data other than the company's location in Cincinnati, OH. The studies are by nature prospective as they are validation studies for a modified device.

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

This section is not applicable as this describes a physical surgical instrument, not an AI/ML device that requires expert ground truth for image or data interpretation. The performance assessment would typically be based on objective physiological measurements (e.g., burst pressure, thermal damage area) and direct observation of surgical outcomes in the animal model by research personnel, not expert panel consensus as would be used for diagnostic AI.

4. Adjudication method for the test set

This section is not applicable for the same reason as point 3. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labeling or interpretation, which is not relevant for the performance testing of this physical surgical instrument.

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 section is not applicable. The device is a surgical instrument, not an AI diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

This section is not applicable. This is a physical surgical instrument, not an AI algorithm. Its performance is inherent to the device itself, operated by a surgeon.

7. The type of ground truth used

The "ground truth" for the device's performance was established through objective physiological measurements and direct observation in preclinical porcine vessel sealing validation studies. This includes measurements for transection times, hemostasis, thermal spread, and the ability of sealed vessels to withstand blood pressure challenges.

8. The sample size for the training set

This section is not applicable. This is a physical surgical instrument, not an AI/ML device that requires a training set. The device was developed and then tested against its design criteria.

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

This section is not applicable for the same reason as point 8.

Summary

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Ethicon Endo-Surgery, LLC

510(k) Summary

CompanyInformation	Ethicon Endo-Surgery, LLC4545 Creek RoadCincinnati, OH 45242	DEC 1 6 2013
ContactInformation	David M. LockeRegulatory Affairs Associate, EnergyEthicon Endo-Surgery(419) 233 - 2611 ext. 1281dlocke1@its.jnj.com
Date Prepared	August 07, 2013
Device Name	Trade Names:HARMONIC ACE Curved Shears with Ergonomic Handle
	Classification Name:Instrument, Ultrasonic SurgicalCommon Name:Ultrasonic scalpel
Device Class	Unclassified
Panel	General & Plastic Surgery
Product Code	LFL
ClassificationRegulation	Unclassified

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Ethicon Endo-Surgery, LLC

K132522

・

PredicateDeviceInformation	The Predicate device is:HARMONIC ACE Curved Shears with Pistol Handle andHand Control (23 & 36cm length) cleared under K051036 &K060245
DeviceDescription	The Harmonic ACE Curved Shear with Ergonomic Handle(ACE45E), Hand Control is a sterile, single patient use, ultrasonicsurgical instrument consisting of an ergonomic housing assemblywith hand control buttons, a rotating shaft with curved, ultrasonicblades and clamp arms. The handle housing has an integratedaudible/tactile mechanism for indicating full closure. The instrumentis designed for use in open or laparoscopic procedures and isavailable in the 45 centimeter shaft length. The Harmonic ACEinstrument is used for the coagulation of vessels up to and including5 mm in diameter.
Description ofChanges tothe Device	There have been minor design and labeling changes to the ACE45EHarmonic instrument since the clearance of K051036 and K060245respectively. None of these changes required notification to theagency per FDA guidance document: Deciding When to Submit a510(k) for a Change to an Existing Device (K97-1). These changesare being incorporated in this submission to provide the Agency withinformation for the most current version of these devices.The Harmonic ACE45E Shear incorporates a more ergonomicdesign with activation buttons positioned in a more accessiblelocation than the predicate pistol grip device. Minor design changesfor manufacturability and user ease of assembly are also included.The ACE45E device is offered in a 45cm length. Changes wereverified and validated in accordance with design controlrequirements. Labeling for the ACE45E Shear was updated to showthe device with the ergonomic handle and to enhance warnings andprecautions. There has been no change in intended use.

Intended Use	The Harmonic Shears are indicated for soft tissue incisions whenbleeding control and minimal thermal injury are desired. Theinstrument can be used as an adjunct to or substitute forelectrosurgery, lasers, and steel scalpels in general, plastic, pediatric,gynecologic, urologic, exposure to orthopedic structures (such asspine and joint space), and other open and endoscopic procedures.
Completion ofDesignControlActivities	The Ethicon Endo-Surgery design control procedures were followedto develop and test the minor modifications. The device continues tomeet predetermined acceptance criteria. Design verification andvalidation testing revealed no new issues of safety and efficacyrelated to the changes.
PerformanceData	Preclinical porcine vessel sealing validation studies demonstratedequivalent performance following handle and shaft modifications.Preclinical study criteria for success included the followingparameters: transection times, hemostasis , thermal spreadmeasurements and blood pressure challenges on sealed vessels.Additionally, functionality and reliability testing was performed todemonstrate that the subject device meets design requirementsfollowing device modifications. No clinical studies were required tosupport a finding of substantial equivalence. In conclusion, thetesting results demonstrate that the ACE45E is as safe and effectiveas the predicate devices. The results from testing support thesubstantial equivalence of the ACE45E to the predicate devices.
SubstantialEquivalence	The modified device is substantially equivalent to the unmodifiedpredicate device in that it has the same intended use as the predicatedevice and the same technological characteristics that do not raisedifferent types of questions of safety and effectiveness. Themodification to a longer shaft does not adversely affect thehemostatic capability of the device. Testing shows the modifiedHarmonic instrument seals vessels up to and including 5 mm as didthe unmodified Harmonic device.

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Ethicon Endo-Surgery, LLC

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

Ethicon Endo-Surgery, LLC Mr. David Locke Regulatory Affairs Associate 4545 Creek Road Cincinnati, Ohio 45242

December 16, 2013

Re: K132522

Trade/Device Name: HARMONIC ACE Curved Shear with Ergonomic Handle Regulatory Class: Unclassified Product Code: LFL Dated: October 21, 2013 Received: October 22, 2013

Dear Mr. Locke:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. David Locke

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you usen's operio act Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): __ K 132522

Device Names:

O HARMONIC ACE Curved Shear with Ergonomic Handle

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Long H. Chen -A

for BSA

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(Division Sign-off) Division of Surgical Devices 510(k) Number: K132522

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Regulation Number and Section

N/A