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 Shears with Scissor Handle (ACE-S) is a sterile, single patient use, ultrasonic surgical instrument consisting of a scissor handle housing assembly with hand control buttons, a rotating shaft with a curved, ultrasonic blade and a clamp arm on a 14 cm length shaft. The handle housing has an integrated audible/tactile mechanism for indicating full closure. The instrument is designed for use in open or laparoscopic procedures. The Harmonic ACE instruments are used for the coagulation of vessels up to and including 5mm in diameter. The Harmonic ACE Curved Shears with Ergonomic Handle (ACE-E), Hand Control are sterile, single patient use, ultrasonic surgical instruments 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 instruments are designed for use in open or laparoscopic procedures and are available in various shaft lengths. The Harmonic ACE instruments are used for the coagulation of vessels up to and including 5mm in diameter.

AI/ML Overview

This is a submission for a 510(k) premarket notification for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive de novo clinical studies with detailed acceptance criteria and expert ground truth.

Based on the provided document, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Used for Preclinical Study)	Reported Device Performance (Following Handle Modifications)
Transection times	Equivalent performance achieved in preclinical porcine vessel sealing validation studies.
Hemostasis	Equivalent performance achieved in preclinical porcine vessel sealing validation studies.
Thermal spread measurements	Equivalent performance achieved in preclinical porcine vessel sealing validation studies.
Blood pressure challenges on sealed vessels	Equivalent performance achieved in preclinical porcine vessel sealing validation studies.
Meet design requirements (functionality and reliability)	Demonstrated through functionality and reliability testing for the subject devices.
Ability to seal vessels up to and including 5mm	Demonstrated that modified Harmonic Instruments seal vessels up to and including 5 mm.

Note: The document explicitly states, "The devices continue to meet predetermined acceptance criteria." The listed parameters were part of the "preclinical study criteria for success."

2. Sample Size and Data Provenance

Sample Size: Not explicitly stated for specific tests (e.g., number of vessels, number of animals). The document refers to "Preclinical porcine vessel sealing validation studies."
Data Provenance: Porcine (animal) model, preclinical.
Retrospective or Prospective: Prospective (validation studies conducted for this submission).

3. Number of Experts and Qualifications for Ground Truth

Not Applicable. This submission is for a physical surgical instrument, not an AI/software device that requires expert-established ground truth on diagnostic images or other data for its performance evaluation. The "ground truth" here is objective physiological and physical measurements.

4. Adjudication Method for the Test Set

Not Applicable. As this is not an AI/software device involving expert consensus on interpretations, there is no adjudication method for a test set in the traditional sense. The metrics are objective physiological measurements.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No. This is not a software/AI device, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or performed.

6. Standalone (Algorithm Only) Performance Study

Not Applicable. This is a physical surgical instrument; there is no standalone algorithm to evaluate.

7. Type of Ground Truth Used

Objective Physiological Measurements and Physical Device Performance Criteria. The ground truth for evaluating the device's performance relies on direct measurements of:
- Transection times
- Hemostasis (presumably evaluated visually and/or through blood loss)
- Thermal spread (measured physically)
- Vessel sealing integrity under blood pressure challenges
- Functionality and reliability against design requirements.

8. Sample Size for the Training Set

Not Applicable. This is a hardware modification submission, not an AI/machine learning model that typically requires a "training set." Device development involves iterative design, testing, and refinement, but not in the sense of an algorithm training on a dataset.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. There is no "training set" or corresponding ground truth establishment in the context of an AI/ML model for this device. The design control process involves verification and validation activities guided by engineering specifications and predicate device performance.

Summary

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Ethicon Endo-Surgery, LLC

្រី

Special 510(k) Summary

CompanyInformation	Ethicon Endo-Surgery, LLC4545 Creek RoadCincinnati, OH 45242	OCT 24 2013
ContactInformation	David M. LockeRegulatory Affairs Associate, EnergyEthicon Endo-Surgery(419) 233 - 2611 ext. 1281dlocke1@its.jnj.com
Date Prepared	Aug 09, 2013
Device Name	Trade Names:○ HARMONIC ACE Curved Shears with Scissor○ HARMONIC ACE Curved Shears with Ergonomic Handle
	Classification Name:Instrument, Ultrasonic Surgical
	Common Name:Ultrasonic scalpel
Device Class	Unclassified
Panel	General & Plastic Surgery
Product Code ·	LFL
ClassificationRegulation	Unclassified

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Page 2 of 3 K132512 Ethicon Endo-Surgery, LLC 510(k) Premarket Notification (Special) for Harmonic ACE14S, ACE23E and ACE36E The Predicate devices are: Predicate O Harmonic ACE curved Shears with Scissor Handle and Hand Device Information Control cleared under K051036 & K060245 Harmonic ACE Curved Shears with Pistol Handle and Hand o Control cleared under K051036 & K060245 The Harmonic ACE Curved Shears with Scissor Handle (ACE-S) is Device Description a sterile, single patient use, ultrasonic surgical instrument consisting of a scissor handle housing assembly with hand control buttons, a rotating shaft with a curved, ultrasonic blade and a clamp arm on a 14 cm length shaft. The handle housing has an integrated audible/tactile mechanism for indicating full closure. The instrument is designed for use in open or laparoscopic procedures. The Harmonic ACE instruments are used for the coagulation of vessels up to and including 5mm in diameter. The Harmonic ACE Curved Shears with Ergonomic Handle (ACE-E), Hand Control are sterile, single patient use, ultrasonic surgical instruments 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 instruments are designed for use in open or laparoscopic procedures and are available in various shaft lengths. The Harmonic ACE instruments are used for the coagulation of vessels up to and including 5mm in diameter. Description of There have been minor design and labeling changes to the ACE-S Changes to and the ACE-E Harmonic instruments since the clearance of K051036 and K060245 respectively. None of these changes the Device required notification to the agency per FDA guidance document: Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1). These changes are being incorporated in this submission to provide the Agency with information for the most current version of these devices. The Harmonic ACE-E instruments were changed from a pistol grip handle design to a handle with a more ergonomic design with activation buttons positioned in a more accessible location. The 14 cm length shaft continues to use the ACE-S scissors handle. Additional minor design changes for manufacturability and user ease of assembly were implemented. Changes were verified and validated in accordance with design control requirements. Labeling for the ACE-E and ACE-S instruments was updated to show the device with the ergonomic handle and to enhance warnings and precautions. There has been no change in intended use.

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Ethicon Endo-Surgery, LLC		K132512 Page 3 of
	510(k) Premarket Notification (Special) for HarmonicACE14S, ACE23E and ACE36E
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 devices continue 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 modifications. Preclinicalstudy criteria for success included the following parameters:transection times, hemostasis, thermal spread measurements andblood pressure challenges on sealed vessels. Additionally,functionality and reliability testing was performed to demonstratethat the subject devices meet design requirements following devicemodifications. No clinical studies were required to support a findingof substantial equivalence. In conclusion, the testing resultsdemonstrate that the ACE-E and ACE-S devices are as safe andeffective as the predicate devices. The results from testing supportthe substantial equivalence of the ACE-E and the ACE-S devices tothe predicate devices.
SubstantialEquivalence	The modified devices are substantially equivalent to the unmodifiedpredicate devices in that they have the same intended use as thepredicate devices and the same technological characteristics that donot raise different types of questions of safety and effectiveness. Themodification to a more ergonomic handle does not adversely affectthe hemostatic capability of the devices. Testing shows the modifiedHarmonic Instruments seal vessels up to and including 5 mm as didthe predicate Harmonic devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic element resembling a human figure embracing the world, positioned to the right of the department's name. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" is arranged in a circular fashion around the graphic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 24, 2013

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

Re: K132512

Trade/Device Name: HARMONIC ACE Curved Shears Regulatory Class: Unclassified Product Code: LFL Dated: October 18, 2013 Received: October 21, 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 (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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small 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/McdicalDevices/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,

Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K132512 510(k) Number (if known):.

Device Names:

o HARMONIC ACE Curved Shears with Scissor Handle
HARMONIC ACE Curved Shears with Ergonomic Handle o

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use ______________ AND/OR (21 CFR 801 Subpart C)

(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
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for MXM

(Division Sign-off)
Division of Surgical Devices
510(k) Number:	K132512

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Regulation Number and Section

N/A