(57 days)
Not Found
No
The summary describes a surgical instrument for cutting and coagulating tissue using ultrasonic energy, with no mention of AI or ML capabilities.
Yes
The device is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired, and can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in various surgical procedures. This directly describes therapeutic intervention.
No
The device is described as an instrument for coagulation and mechanical transection of soft tissue during surgical procedures, not for identifying or diagnosing a condition or disease.
No
The device description clearly indicates it is a physical instrument used for surgical procedures, involving mechanical transection and energy delivery, which are hardware functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states that the HARMONIC ACE + Shears are used for "soft tissue incisions," "coagulation and mechanical transection of soft tissue," and "grasp, coagulate, and transect soft tissue" during surgical procedures (laparoscopic and open). This is an in vivo (within the body) application.
- No Specimen Analysis: There is no mention of the device being used to analyze any biological specimens taken from the patient.
Therefore, the HARMONIC ACE + Shears with Advanced Hemostasis is a surgical device used directly on tissue within the body, not an IVD.
N/A
Intended Use / Indications for Use
The HARMONIC ACE+ with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter using the Advanced Hemostasis hand control button.
Product codes
LFL
Device Description
The Ethicon Endo-Surgery HARMONIC ACE+Shears with Advanced Hemostasis are used for coagulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices allow the surgeon to grasp, coagulate, and transect soft tissue with a single instrument. The devices are hand-actuated with a shaft and tissue effector that can be rotated. The energy delivery can be activated with hand activation or with an optional generator foot switch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue incisions, lymphatic vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Bench testing and laboratory evaluations in an animal model including acute and 30-day chronic survival studies were conducted to demonstrate that the HARMONIC ACE+ Shears with Advanced Hemostasis perform as intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510(k) Summary
Company Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969
Contact Brian Godwin, RAC Senior Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. Telephone: (513) 337-3623 Fax: (513) 337-4366 Email: bgodwin@its.jnj.com
OCT 17 2013
Date Prepared 20 August 2013
Device Name
Trade Name: HARMONIC ACE+ Shears with Advanced Hemostasis Common Name: Instrument, Ultrasonic Surgical
Classification Name
Instrument, Ultrasonic Surgical (Unassigned, Product Code LFL)
Predicate Device
- HARMONIC ACE® Shears + Adaptive Tissue Technology, cleared under K120729 on . 17 May 2012
- ENSEAL® G2 Tissue Sealers, cleared under K112033 on 08 Nov 2011 .
Device Description
The Ethicon Endo-Surgery HARMONIC ACE+Shears with Advanced Hemostasis are used for coagulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices allow the surgeon to grasp, coagulate, and transect soft tissue with a single instrument. The devices are hand-actuated with a shaft and tissue effector that can be rotated. The energy delivery can be activated with hand activation or with an optional generator foot switch.
Indications for Use
The HARMONIC ACE+ with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter using the Advanced Hemostasis hand control button.
1
Technological Characteristics
.
The Ethicon Endo-Surgery HARMONIC ACE+ Shears with Advanced Hemostasis incorporate the same technological characteristics as that of the ultrasonic predicate device. HARMONIC ACE Shears + Adaptive Tissue Technology. The subject devices use an EEPROM memory chip that stores device identification, usage tracking, and operating parameters for use by the Generator G11 that provides power for the HARMONIC ACE+ Shears with Advanced Hemostasis. The devices have an ergonomic grip housing assembly with hand control buttons (MIN for minimum power level, MAX for maximum power level, and Advanced Hemostasis for large vessel [up to 7 mm] sealing).
Adaptive Tissue Technology refers to the power output algorithm that is utilized by the devices. During use, the Adaptive Tissue Technology algorithm parameters stored on the device EEPROM are read by the generator and used to reduce the power (current) to the instrument and provide a secondary, higher pitched generator activation tone as Adaptive Tissue Technology regulates the delivery of energy. To do this the generator monitors the thermal condition of the blade during device activation. The Advanced Hemostasis mode utilizes a unique algorithm within Adaptive Tissue Technology that modulates the power delivery from the Generator G11 to the blade of the device maximizing hemostasis.
Performance Data
Bench testing and laboratory evaluations in an animal model including acute and 30-day chronic survival studies were conducted to demonstrate that the HARMONIC ACE+ Shears with Advanced Hemostasis perform as intended.
Conclusion
The results of the bench testing and laboratory evaluations in an animal model demonstrate that the HARMONIC ACE+ Shears with Advanced Hemostasis are as safe and effective and perform as well as the identified legally marketed predicate devices for cutting and coagulating soft tissue and sealing vessels up to 7 mm in diameter, as measured in situ.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name, "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA," arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with healthcare, with a single staff entwined by a serpent.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Ethicon Endo-Surgery, LI.C Ethicon Endo-Surgery, Inc. Brian Godwin, RAC Senior Regulatory Affairs Associate 4545 Creek Road Cincinnati, Ohio 45242
October 17, 2013
Re: K132612
Trade/Device Name: HARMONIC ACE* + Shears with Advanced Hemostasis Regulatory Class: Unclassified Product Code: LFL Dated: August 29, 2013 Received: August 30, 2013
Dear Mr. Godwin:
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
3
Page 2 - Brian Godwin
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm I 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Neil R Ogden Neil K Ogden
2013.10.17 09:22:43 -04'00'
- For 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
510(k) Number (if known): K132612
Device Name:
HARMONIC ACE + Shears with Advanced Hemostasis
Indications for Use:
The HARMONIC ACE + Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and ioint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter using the Advanced Hemostasis hand control button.
Prescription Use __ × (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 | Digitally signed by Long H. Chen -A |
|---|---|
| A | Dir: c=US, o=U.S. Government, ou=HHS, |
| ou=FDA, ou=People, cn=Long H. Chen -A, | |
| 0.9.2342.19200300.100.1.1=1300369056 | |
| Date: 2013.10.16 15:22:24 -04'00 |
For MXM
(Division Sign-off) Division of Surgical Devices 510(k) Number K132612