(126 days)
Not Found
No
The description focuses on the mechanical and ultrasonic functions of the device for tissue cutting and coagulation, with no mention of AI or ML technologies.
Yes
The device is used for soft tissue incisions and coagulation of vessels, indicating its direct application in treating medical conditions.
No
This device is an ultrasonic surgical instrument used for cutting and coagulating tissue during surgical procedures. It is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines a physical surgical instrument with a handle, shaft, blades, and clamp arms, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical instrument used for cutting and coagulating soft tissue and vessels during surgical procedures. This is an in vivo (within a living organism) application.
- Device Description: The description details a surgical instrument with blades and clamp arms, designed for use in open or laparoscopic procedures. This aligns with a surgical tool, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition. The device's function is purely procedural.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LFL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
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
・
·
:
.
| 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
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