Who is the manufacturer of HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE?

Ethicon Endo-Surgery, LLC filed the 510(k) submission for HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE (K132522).

What is the FDA product code for HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE?

LFL. as a Class U device in the SU panel.

What is the regulatory pathway for HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE?

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

What are the predicate devices for HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE?

HARMONIC ACE Curved Shears with Pistol Handle and Hand Control (K051036); HARMONIC ACE Curved Shears with Pistol Handle and Hand Control (K060245).

Who can help prepare an FDA 510(k) submission like HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE?

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.

HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE

K132522 · Ethicon Endo-Surgery, LLC · LFL · Dec 16, 2013 · SU

Device Facts

Record ID	K132522
Device Name	HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE
Applicant	Ethicon Endo-Surgery, LLC
Product Code	LFL · SU
Decision Date	Dec 16, 2013
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic, Pediatric

Intended Use

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 Story

Ultrasonic surgical instrument for soft tissue incision and coagulation; utilizes ultrasonic energy to seal vessels up to 5 mm in diameter. Device consists of ergonomic housing with hand control buttons, rotating shaft, curved ultrasonic blades, and clamp arms. Features integrated audible/tactile mechanism for indicating full closure. Used in open or laparoscopic procedures by surgeons. Provides hemostasis with minimal thermal spread; serves as adjunct or substitute for electrosurgery, lasers, or steel scalpels. Benefits include precise tissue transection and reduced thermal injury to surrounding structures.

Clinical Evidence

Bench testing only. Preclinical porcine vessel sealing validation studies performed to assess transection times, hemostasis, thermal spread, and blood pressure challenges on sealed vessels. Functionality and reliability testing confirmed design requirements met. No clinical studies required.

Technological Characteristics

Ultrasonic surgical scalpel; utilizes ultrasonic energy for tissue coagulation and transection. Features ergonomic handle with hand control buttons, rotating shaft, and curved blades. Sterile, single-patient-use device. No software or electronic processing algorithms described.

Indications for Use

Indicated for patients requiring soft tissue incisions where hemostasis and minimal thermal injury are required. Applicable across general, plastic, pediatric, gynecologic, urologic, and orthopedic surgical procedures in both open and endoscopic settings.

Predicate Devices

HARMONIC ACE Curved Shears with Pistol Handle and Hand Control (K051036)
HARMONIC ACE Curved Shears with Pistol Handle and Hand Control (K060245)

Related Devices

K161693 — Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis · Stryker Sustainability Solutions · Feb 23, 2017
K132612 — HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE · Ethicon Endo-Surgery, LLC · Oct 17, 2013
K062000 — HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCH · Ethicon Endo-Surgery, Inc. · Sep 25, 2006
K151340 — HARMONIC Focus Long Shears + Adaptive Tissue Technology · Ethicon Endo-Surgery, LLC · Jul 10, 2015
K121550 — HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY · Ethicon Endo-Surgery, LLC · Aug 22, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ Ethicon Endo-Surgery, LLC . ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ______________________________________________________________________________________________________________________________________________________________________________ ## 510(k) Summary | Company Information | Ethicon Endo-Surgery, LLC 4545 Creek Road Cincinnati, OH 45242 | DEC 1 6 2013 | |------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|--------------| | Contact Information | David M. Locke Regulatory Affairs Associate, Energy Ethicon Endo-Surgery (419) 233 - 2611 ext. 1281 dlocke1@its.jnj.com | | | Date Prepared | August 07, 2013 | | | Device Name | Trade Names: 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 | | | Classification Regulation | Unclassified | | . {1}------------------------------------------------ Ethicon Endo-Surgery, LLC K132522 ・ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ · : . | Predicate Device Information | The Predicate device is: HARMONIC ACE Curved Shears with Pistol Handle and Hand Control (23 & 36cm length) cleared under K051036 & K060245 | |--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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. | | Description of Changes to the Device | There have been minor design and labeling changes to the ACE45E Harmonic instrument since the clearance of K051036 and K060245 respectively. None of these changes 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 ACE45E Shear incorporates a more ergonomic design with activation buttons positioned in a more accessible location than the predicate pistol grip device. Minor design changes for manufacturability and user ease of assembly are also included. The ACE45E device is offered in a 45cm length. Changes were verified and validated in accordance with design control requirements. Labeling for the ACE45E Shear was updated to show the device with the ergonomic handle and to enhance warnings and precautions. There has been no change in intended use. | | | | | Intended Use | 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. | | Completion of Design Control Activities | The Ethicon Endo-Surgery design control procedures were followed to develop and test the minor modifications. The device continues to meet predetermined acceptance criteria. Design verification and validation testing revealed no new issues of safety and efficacy related to the changes. | | Performance Data | Preclinical porcine vessel sealing validation studies demonstrated equivalent performance following handle and shaft modifications. Preclinical study criteria for success included the following parameters: transection times, hemostasis , thermal spread measurements and blood pressure challenges on sealed vessels. Additionally, functionality and reliability testing was performed to demonstrate that the subject device meets design requirements following device modifications. No clinical studies were required to support a finding of substantial equivalence. In conclusion, the testing results demonstrate that the ACE45E is as safe and effective as the predicate devices. The results from testing support the substantial equivalence of the ACE45E to the predicate devices. | | Substantial Equivalence | The modified device is substantially equivalent to the unmodified predicate device in that it has the same intended use as the predicate device and the same technological characteristics that do not raise different types of questions of safety and effectiveness. The modification to a longer shaft does not adversely affect the hemostatic capability of the device. Testing shows the modified Harmonic instrument seals vessels up to and including 5 mm as did the unmodified Harmonic device. | {2}------------------------------------------------ Ethicon Endo-Surgery, LLC : {3}------------------------------------------------ #### 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. {4}------------------------------------------------ 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 {5}------------------------------------------------ #### Indications for Use 510(k) Number (if known): __ K 132522 Device Names: O HARMONIC ACE Curved Shear with Ergonomic Handle Indications for Use: 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. 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 Page 1 of 1 (Division Sign-off) Division of Surgical Devices 510(k) Number: K132522 15 of 48