(89 days)
No
The summary describes a surgical instrument that uses ultrasonic energy for cutting and coagulation. While it mentions "Adaptive Tissue Technology" and an EEPROM chip for storing parameters, there is no mention of AI, ML, or any learning or adaptive algorithms based on data analysis. The "adaptive" aspect likely refers to the device's ability to adjust energy delivery based on tissue impedance or other physical properties, which is a common feature in electrosurgical and ultrasonic devices and does not necessarily involve AI/ML.
Yes
The device is used to make incisions and coagulate tissue, which are direct interventions for treating medical conditions or performing surgical procedures.
No
The device is described as surgical shears used for cutting and coagulating soft tissue, indicating its therapeutic function rather than a diagnostic one.
No
The device description clearly outlines a physical instrument with a handle, shaft, tissue effector, blade, and an EEPROM memory chip. While it contains software on the chip, it is fundamentally a hardware device for surgical procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device for soft tissue incisions during surgical procedures (general, plastic, pediatric, gynecologic, urologic, thoracic, orthopedic). This is a surgical device used directly on the patient's body.
- Device Description: The description details a surgical instrument used for coagulation and mechanical transection of soft tissue during laparoscopic and open procedures. It involves grasping, coagulating, and transecting tissue.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a person's health. This device does not perform any such analysis on specimens.
The device is a surgical instrument used for cutting and coagulating tissue during surgery, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The HARMONIC ACE® Shears + Adaptive Tissue Technology 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) and other open and endoscopic procedures.
Product codes
LFL
Device Description
The Ethicon Endo-Surgery HARMONIC ACE® Shears + Adaptive Tissue Technology 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, orthopedic structures (spine and joint space)
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 of thoracic procedures in an animal model including acute and 30-day chronic survival studies were conducted to demonstrate that the HARMONIC ACE® Shears + Adaptive Tissue Technology 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
Page 1 of 3
AUG 222 2012
510(k) Summary of Safety and Effectiveness
Company
Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969
Contact Marcia Arentz Regulatory Affairs Portfolio Leader Ethicon Endo-Surgery. Inc. Telephone: (513) 337-1066 Fax: (513) 337-2016 Email: marentz5@its.jnj.com
Date Prepared: May 24, 2012
Device Name:
Trade Name: HARMONIC ACE® Shears + Adaptive Tissue Technology Common Name: Instrument, Ultrasonic Surgical
Classification Name:
Instrument, Ultrasonic Surgical (Unassigned, Product Code LFL)
Predicate Devices:
| K120729: HARMONIC ACE® Shears + Adaptive Tissue Technology |
|---|
| K050885: SonoSurg Short Curved Scissors 5 mm O.D., HF Series, Pistol |
| and Inline Grip submitted as part of the Olympus Ultrasonic |
| Surgical System SonoSurg |
| K060245: HARMONIC Scalpel 5 mm Instruments by Ethicon Endo- |
- Surgery
Device Description:
The Ethicon Endo-Surgery HARMONIC ACE® Shears + Adaptive Tissue Technology 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 Statement:
The HARMONIC ACE® Shears + Adaptive Tissue Technology 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) and other open and endoscopic procedures.
1
Page 2 of 3
Technological Characteristics: Both the Ethicon Endo-Surgery HARMONIC ACE® Shears + Adaptive Tissue Technology and the predicate devices operate using ultrasonic technology to cut and coagulate soft tissues. The Ethicon Endo-Surgery HARMONIC ACE® Shears + Adaptive Tissue Technology incorporate an ergonomic handle and tapered blade geometry. The instruments have a coated ultrasonic blade and 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 + Adaptive Tissue Technology.
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 when there is little or no tissue between the instrument blade and tissue pads. To do this the generator monitors the frequency of the instrument blade and determines when there is a change in the thermal condition of the blade during device activation. This thermal condition of the blade is compared to the values stored on the EEPROM to determine when this minimal tissue condition is present and the Adaptive Tissue Technology features are activated.
| Device
Characteristic | HARMONIC ACE
Shears + Adaptive
Tissue Technology
(subject devices) | SonoSurg Short Curved
Scissors 5 mm O.D.,
(predicate K050885) | Ethicon Endo-surgery
HARMONIC Scalpel
5 mm Instruments
(predicate K060245) |
|----------------------------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Technology | Ultrasonic | Ultrasonic | Ultrasonic |
| Procedures | Open and laparoscopic | Open and laparoscopic | Open and laparoscopic |
| Patient Use | Single Use | Reusable | Single Use |
| Sterilization
Method | Ethylene Oxide
sterilized
(provided sterile to
customer) | Steam
(autoclave by end user) | Ethylene Oxide
sterilized
(provided sterile to
customer) |
| SAL | $10^{-6}$ | n/a | $10^{-6}$ |
| Shaft Diameter | 5.5 mm | 5.5 mm | 5.5 mm |
| Shaft Length | 23 & 36 cm | 19 cm | 32 cm |
| Blade Frequency | 55.5 kHz | 47 kHz | 55.5 kHz |
| Maximum Blade
Amplitude
(MAX Power
Level) | 91.2 microns (HAR36)
85.9 microns (HAR23) | 81 microns | 100 microns |
| Blade Shape | Curved | Curved | Curved |
| Energy
Activation
Method | Foot or Hand Switch | Footswitch | Foot or Hand Switch |
| Seals vessels up
to diameter of | 5 mm | 5 mm | 3 mm |
Technological Comparison:
2
Page 3 of 3
Performance Data: Bench testing and laboratory evaluations of thoracic procedures in an animal model including acute and 30-day chronic survival studies were conducted to demonstrate that the HARMONIC ACE® Shears + Adaptive Tissue Technology perform as intended.
Conclusion: The results of the bench top and animal model testing demonstrate that the HARMONIC ACE® Shears + Adaptive Tissue Technology are as safe and as effective as the predicate device in cutting and coagulating soft tissue and sealing vessels up to 5 mm in diameter, as measured in situ, in thoracic surgical procedures. This testing supports the substantial equivalence of the HARMONIC ACE® Shears + Adaptive Tissue Technology to the legally marketed predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines representing its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ethicon Endo-Surgery, LLC % Ethicon Endo-Surgery, Incorporated Ms. Marcia Arentz Regulatory Affairs Portfolio Leader 4545 Creek Road Cincinnati, Ohio 45242
AUG 222 2012
Re: K121550
Trade/Device Name: HARMONIC ACE® Shears + Adaptive Technology Regulatory Class: Unclassified Product Code: LFL Dated: July 18, 2012 Received: July 19, 2012
Dear Ms. Arentz:
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
4
Page 2 - Ms. Marcia Arentz
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.goy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
yours,
Melkerson
Mark N. Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Ethicon Endo-Surgery, LLC
Premarket Notification (Traditional) HARMONIC ACE Shears + Adaptive Tissue Technology - Thoracic Indication
Indications for Use
510(k) Number (if known): K121550
Device Name: HARMONIC ACE® Shears + Adaptive Tissue Technology
Indications for Use:
The HARMONIC ACE® Shears + Adaptive Tissue Technology 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, thoracic, 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)
Nil R.P. Ogden
(Division Sign-Off) (Division Sign Sign Sical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K121550
14