K Number

Device Name

Ultrasonic Surgical System

Manufacturer

Hunan Handlike Minimally Invasive Surgery Co., Ltd.

Date Cleared

2024-06-18

(267 days)

Product Code

LFL

Regulation Number

N/A

Intended Use

The Ultrasonic System is intended to be used to transect, dissect, and coagulate tissue. The instruments are indicated for use in open and endoscopic general surgical procedures where bleeding control and minimal thermal injury to tissue are desired. The instruments allow for the coagulation of vessels (veins and arteries) up to 3 mm in diameter.

Device Description

Ultrasonic Surgical System is an ultrasonic dissection and coagulation system composed of four components: Ultrasonic Generator (HD-CSD01), Hand Piece (HD-CSH01), a disposable Ultrasonic Shears includes 4 shaft lengths (HD-CS-DJ45, HD-CS-DJ36, HD-CS-DJ22, HD-CS-DJ14) and foot switch (HRF-M52). A disposable Ultrasonic Shears is a sterile component that has undergone EO sterilization, including an ultrasonic horn, jaws, main shaft, axis rotation, handle, operating handle, and control switch. The operating handle is used to open and close the jaws that grip the tissue. The Ultrasonic Surgical System can simultaneously cut and coagulate tissues by setting different output power levels. The high-power range allows for faster tissue cutting, while the low-power range allows for better tissue closure. The ultrasonic frequency current in the ultrasonic generator is transmitted to the hand piece, which converts electrical energy into mechanical energy for forward and backward vibration. Through the transmission and release of the blade, the end of the blade vibrates at a certain frequency. The heat generated by friction causes water vaporization in the tissue cells that come into contact with the blade, protein hydrogen bonds break, cells collapse and the tissue is cut open after solidification; When cutting blood vessels, the knife head contacts with Histone and generates heat through mechanical vibration, leading to the destruction of the collagen structure in the tissue, causing the protein to coagulate, and then sealing the blood vessels to stop bleeding. The disposable ultrasonic shears are EO sterilized, but the other parts are non-sterilized packaging, and the hand piece must be cleaned and sterilized by the user before being used for surgery. This device is intended to be used in the hospital environment, such as surgical operation room and imaging intervention room.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K212614, K151136

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical and electrical aspects of ultrasonic tissue manipulation and coagulation. There is no mention of AI, ML, or any data-driven decision-making processes.

Therapeutic

Yes.
This device is used to transect, dissect, and coagulate tissue during surgical procedures for therapeutic outcomes.

Diagnostic

This device is an ultrasonic surgical system intended for transecting, dissecting, and coagulating tissue, which is a therapeutic function, not diagnostic.

SaMD (Software as a Medical Device)

The device description clearly outlines multiple hardware components (Generator, Hand Piece, Ultrasonic Shears, foot switch) and describes their physical functions and interactions. While software verification and validation are mentioned, the device is fundamentally a hardware system with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "transect, dissect, and coagulate tissue" during surgical procedures. This is a direct intervention on the patient's body for therapeutic purposes (cutting, sealing blood vessels).
Device Description: The description details a system that uses ultrasonic energy to physically interact with and alter tissue. This is a surgical tool, not a device used to examine specimens in vitro (outside the body).
Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. The device's function is purely procedural.

IVD devices are used to examine specimens obtained from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This Ultrasonic Surgical System does not fit that definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Ultrasonic Surgical System is intended to be used to transect, dissect, and coagulate tissue. The instruments are indicated for use in open and endoscopic general surgical procedures where bleeding control and minimal thermal injury to tissue are desired. The instruments allow for the coagulation of vessels (veins and arteries) up to 3 mm in diameter.

Product codes

LFL

Device Description

A disposable Ultrasonic Shears is a sterile component that has undergone EO sterilization, including an ultrasonic horn, jaws, main shaft, axis rotation, handle, operating handle, and control switch. The operating handle is used to open and close the jaws that grip the tissue. The Ultrasonic Surgical System can simultaneously cut and coagulate tissues by setting different output power levels. The high-power range allows for faster tissue cutting, while the low-power range allows for better tissue closure. The ultrasonic frequency current in the ultrasonic generator is transmitted to the hand piece, which converts electrical energy into mechanical energy for forward and backward vibration. Through the transmission and release of the blade, the end of the blade vibrates at a certain frequency. The heat generated by friction causes water vaporization in the tissue cells that come into contact with the blade, protein hydrogen bonds break, cells collapse and the tissue is cut open after solidification; When cutting blood vessels, the knife head contacts with Histone and generates heat through mechanical vibration, leading to the destruction of the collagen structure in the tissue, causing the protein to coagulate, and then sealing the blood vessels to stop bleeding. The disposable ultrasonic shears are EO sterilized, but the other parts are non-sterilized packaging, and the hand piece must be cleaned and sterilized by the user before being used for surgery.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

For use in all patients

Intended User / Care Setting

Users: Healthcare professionals
Environment of Use: Hospital environment, such as surgical operation room and imaging intervention room.

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)

Summary of Non-Clinical Tests

Sterilization: The Ultrasonic Shears were sterilized via ethylene oxide. The process was validated as per ISO 11135 (overkill method). Ethylene oxide residuals met ISO 10993-7 requirements.
Biocompatibility Testing: Conducted on the shear for direct contact with body tissue (less than 24 hours). Tests included in vitro cytotoxicity, intracutaneous reactivity, skin sensitization, acute systemic toxicity, and pyrogen, as per FDA guidance ISO 10993-1. Results indicated the device was not toxic, irritating, or sensitizing, and was free of acute systemic toxicity and pyrogen.
Electrical safety and electromagnetic compatibility (EMC): Complied with IEC 60601-1-2:2020 for EMC, and IEC 60601-1:2020 and IEC 60601-2-18 for electrical safety.
Performance testing: Functional tests met predetermined acceptance criteria.
Animal testing: Conducted on porcine model with test articles (Ultrasonic Surgical System) and control article (predicate device Ethicon G11). It consisted of three experiments:
- In vitro burst pressure: Test results showed no statistical difference or higher average burst pressure in the test group compared to the control group. No error or notes observed.
- Acute animal study: Times and thermal damage range for each vessel diameter did not show statistical difference compared to the control article. No sealing failures were identified.
- Chronic Animal Testing: Postoperative observation showed no abnormal phenomena in animals. Gross examination of animals showed no hematoma, bleeding, or other adverse conditions at the sealed site. Few tissues showed moderate inflammatory cell infiltration, most showed few inflammatory cells. Wide fibrosis and mild tissue necrosis were observed at the test site.
Packaging & Shelf life: Study conducted to ensure package integrity throughout shelf life, including primary packaging validation as per ISO 11607 and shelf life validation as per ASTM F1980.
Software Verification and Validation: In compliance with FDA Guidance-Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Cleaning, Disinfection and Sterilization effectiveness: Methods for Hand Piece validated as per ISO 17664-1.
Cybersecurity: No cybersecurity evaluation needed as the device does not have external interfaces, according to FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K212614, K151136

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.

June 18, 2024

Hunan Handlike Minimally Invasive Surgery Co., Ltd. % Lee Cassie Official Correspondent Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, Guangdong 510700 China

Re: K233036

Trade/Device Name: Ultrasonic Surgical System Regulatory Class: Unclassified Product Code: LFL Dated: May 17, 2024 Received: May 17, 2024

Dear Lee Cassie:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.06.18 14:02:02 -04'00' Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality

Enclosure

Indications for Use

510(k) Number (if known) K233036

Device Name Ultrasonic Surgical System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

510(k) Summary for K233036

Prepared on: 2024-06-13

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 801.92.

1. Submitter's Information

510(k) Owner's Name: Hunan Handlike Minimally Invasive Surgery Co., Ltd. Establishment Registration Number: 3010594949 Address: A4, Lugu Yuyuan, #27, Wenxuan Rd, High-tech Zone Changsha Hunan 410205 China Tel: +(86) 731 89727780 Contact Person: Mr. Yang Bihong E-mail: yang_bh@handlike.cn

Application Correspondent:

Contact Person: Cassie Lee Company: Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8266 2446 E-mail: 382198657@qq.com

2. Subject Device Information

Type of 510(k): Traditional Trade Name: Ultrasonic Surgical System Model: HD-CSXT-001 Common Name: Ultrasonic Shears Classification name: Instrument, Ultrasonic Surgical Product Code: LFL Regulation Number: Unclassified

3. Predicate Device Information

Predicate Device 1:

Sponsor: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Trade Name: Ultrasonic Scalpel System 510(K) Number: K212614 Classification name: Instrument, Ultrasonic Surgical Product Code: LFL

Review Panel: General & Plastic Surgery Requlation Class: Unclassified

Predicate Device 2:

Sponsor: Ethicon Endo-Surgery, LLC Trade Name: HARMONIC Hook 510(K) Number: K151136 Classification name: Instrument, Ultrasonic Surgical Product Code: LFL Review Panel: General & Plastic Surgery Requlation Class: Unclassified

4. Device Description

This device is intended to be used in the hospital environment, such as surgical operation room and imaging intervention room.

5. Intended Use / Indications for Use

The Ultrasonic Surgical System is intended to be used to transect, dissect, and coagulate tissue. The instruments are indicated for use in open and endoscopic general surgical

procedures where bleeding control and minimal thermal injury to tissue are desired. The instruments allow for the coagulation of vessels (veins and arteries) up to 3 mm in diameter.

6. Comparison to predicate device

6.1 Comparison table for Ultrasonic Generator, transducer and pedal

| Elements of

Comparison	Subject Device	Predicate Device 1
Manufacturer	Hunan Handlike Minimally
Invasive Surgery Co., Ltd.	Surgnova Healthcare
Technologies (Zhejiang) Co.,
Ltd.
Trade Name	Ultrasonic Surgical System	Ultrasonic Scalpel System
510(k) Number	K233036	K212614
Classification Name	Instrument, Ultrasonic
Surgical	Instrument, Ultrasonic
Surgical
Classification Product
Code	LFL	LFL
Indications for Use	The Ultrasonic Surgical
System is intended to be
used to transect, dissect, and
coagulate tissue. The
instruments are indicated for
use in open and endoscopic
general surgical procedures
where bleeding control and
minimal thermal injury to
tissue are desired. The
instruments allow for the
coagulation of vessels (veins
and arteries) up to 3 mm in
diameter.	The Ultrasonic Scalpel
System is intended to be
used to transect, dissect, and
coagulate tissue. The
instruments are indicated for
use in open and endoscopic
general surgical procedures
where bleeding control and
minimal thermal injury to
tissue are desired. The
instruments allow for the
coagulation of vessels (veins
and arteries) up to 5 mm in
diameter while using the
power level 1. Device have
not been shown to be
effective for sterilization
procedures or tubal
coagulation. Do not use
these instruments for these
procedures.
Working Principle	The Ultrasonic Generator
outputs the AC energy at a
resonating frequency of	The generator outputs the AC
energy at a resonating
frequency of 55.5KHz to the
Elements of
Comparison	Subject Device	Predicate Device 1
	55.5KHz to the hand piece,
which transforms it to
mechanical vibrations to
reach the clamped tissue at
the blade tip of the ultrasonic
shears' waveguide. Vibrating
at high frequency, the blade
tip denatures protein in the
tissue to form a sticky
coagulum, with the pressure
exerted on tissue with the
blade surface collapses blood
vessels and allows the
coagulum to form a
hemostatic seal. The
precision of cutting and
coagulation is controlled by
the surgeon's technique and
adjusting the power level,
blade edge, tissue traction
and blade pressure.	ultrasonic transducer, which
transforms it to mechanical
vibrations to reach the
clamped tissue at the blade
tip of the ultrasonic scalpel's
waveguide. Vibrating at high
frequency, the blade tip
denatures protein in the
tissue to form a sticky
coagulum, with the pressure
exerted on tissue with the
blade surface collapses blood
vessels and allows the
coagulum to form a
hemostatic seal. The
precision of cutting and
coagulation is controlled by
the surgeon's technique and
adjusting the power level,
blade edge, tissue traction
and blade pressure.
Size (Width x Height x
Depth)	Ultrasonic Generator: 37.0cm
x 39.0cm x 16.3cm	Generator: 40.0cm x 40.0cm
x 12.0cm
Design	The ultrasonic generator is
configured to resonate with
the Hand Piece and scalpel at
a resonant frequency to drive
the scalpel's distal tip to
vibrate at a high frequency.	The generator is configured
to resonate with the
transducer and scalpel at a
resonant frequency to drive
the scalpel's distal tip to
vibrate at a high frequency.
Power Source	110-240V AC, 50/60Hz, 500
VA	100-240V AC, 50/60Hz, 200
VA
Output Frequency	55.5KHz	55.5KHz
Environment of Use	Hospital environment	Hospital environment
Patient Population	For use in all patients	For use in all patients
Users	Healthcare professionals	Healthcare professionals
Transducer
Product Name	Hand Piece	Ultrasonic Transducer
Model	HD-CSH01	SC100T
Elements of
Comparison	Subject Device	Predicate Device 1
Working Principle	The Hand Piece which
contains piezoelectric Hand
Pieces that converts
electronic energy into
ultrasonic vibration to power
ultrasonic Shears.	The Ultrasonic Transducer
which contains piezoelectric
transducers that converts
electronic energy into
ultrasonic vibration to power
Ultrasonic Scalpel.
Reusable /Single-use
Device	Reusable device	Reusable device
Reusable times	95 times	99 times
Supply	It is supplied non-sterilize,
sterilize prior to use.	It is supplied non-sterilize,
sterilize prior to use.
Sterilization method	Low temperature plasma	Pulsation vacuum/Low
temperature plasma
Foot Switch
Product Name	Foot Switch	Foot Switch
Model	HRF-M52	TG-A
Working Principle	It is connected to the
Ultrasonic Generator, can be
used to control the energy
output of the generator by the
users stepping down the foot
switch.	It is connected to the
Ultrasonic Generator, can be
used to control the energy
output of the generator by the
users stepping down the foot
switch.
Design features	The left foot switch is used to
control the cutting mode; The
right foot switch is used to
control the coagulation mode	Press the left foot pedal of
the foot switch is equivalent
to press the hand control MIN
button. Press the right foot
pedal of the foot switch is
equivalent to press the hand
control MAX button.
Reusable /Single-use
Device	Reusable	Reusable
Sterility	Non-sterile	Non-sterile
Cleaning and disinfection	Cleaning and disinfection, if
foot switch contaminated by
blood or body fluid according
to IFU or the hospital
regulations	Cleaning and disinfection, if
foot switch contaminated by
blood or body fluid according
to IFU or the hospital
regulations

6.2 Comparison table for Ultrasonic Scalpel

| Elements of

Comparison	Subject Device	Predicate Device 1	Predicate Device 2
Manufacturer	Hunan Handlike
Minimally Invasive
Surgery Co., Ltd.	Surgnova Healthcare
Technologies (Zhejiang)
Co., Ltd.	Ethicon Endo-
Surgery, LLC
Trade Name	Ultrasonic Surgical
System	Ultrasonic Scalpel
System	HARMONIC Hook
510(k) Number	Applying	K212614	K151136
Classification Name	Instrument, Ultrasonic
Surgical	Instrument, Ultrasonic
Surgical	Instrument,
Ultrasonic Surgical
Classification
Product
Code	LFL	LFL	LFL
Indications for Use	The Ultrasonic
Surgical System is
intended to be used to
transect, dissect, and
coagulate tissue. The
instruments are
indicated for use in
open and endoscopic
general surgical
procedures where
bleeding control and
minimal thermal injury
to tissue are desired.
The instruments allow
for the coagulation of
vessels (veins and
arteries) up to 3 mm in
diameter.	The Ultrasonic Scalpel
System is intended to be
used to transect,
dissect, and coagulate
tissue. The instruments
are indicated for use in
open and endoscopic
general surgical
procedures where
bleeding control and
minimal thermal injury to
tissue are desired. The
instruments allow for the
coagulation of vessels
(veins and arteries) up
to 5 mm in diameter
while using the power
level 1. Device have not
been shown to be
effective for sterilization
procedures or tubal
coagulation. Do not use
these instruments for
these procedures.	The HARMONIC
Hook instrument is
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, gynecologic,
exposure to
orthopedic structures
(such as spine and
joint space), and
thoracic surgery,
including mobilization
of the Internal
Mammary Artery
(IMA).
Product Name	Ultrasonic Shears	Ultrasonic Scalpel	HARMONIC Hook
Model	HD-CS-DJ14	SC43C+	--
Elements of
Comparison	Subject Device	Predicate Device 1	Predicate Device 2
	HD-CS-DJ22
HD-CS-DJ36
HD-CS-DJ45	SC35C+
SC21C+
SC13C+
Shaft Length (cm)	HD-CS-DJ14: 14cm
±10%
HD-CS-DJ22: 23cm
±10%
HD-CS-DJ36: 36 cm
±10%
HD-CS-DJ45:45 cm
±10%	SC43C+: 43cm
SC35C+: 35cm
SC21C+: 21cm
SC13C+: 13cm	32 cm
Working Principle	The Hand Piece
connects the
Ultrasonic Generator
and the Disposable
Ultrasonic Shears
together. It converts
electrical energy from
the ultrasonic
Generator into
mechanical vibrations
and transmits them to
the waveguide of the
scalpel. The scalpel
transmits the
vibrations from the
Ultrasonic Hand Piece
to the clamped soft
tissues for dissection
and coagulation	The Ultrasonic
Transducer connects
the Ultrasonic Generator
and the Ultrasonic
Scalpel together. It
converts electrical
energy from the
generator into
mechanical vibrations
and transmits them to
the waveguide of the
scalpel. The scalpel
transmits the vibrations
from the Ultrasonic
Transducer to the
clamped soft tissues for
dissection and
coagulation	The HPBLUE
handpiece connects
the HARMONIC
Hook device to the
Generator G11, and
converts electrical
energy into
mechanical motion
(ultrasonic energy).
The high-frequency
mechanical vibration
at 55.5 kHz of the
HARMONIC Hook
blade transects,
dissects, and
coagulates tissue,
sealing vessels up to
2 mm
Description of
function	Ultrasonic Shears is
sterile, single patient
use instruments
consisting of an
ergonomic grip
housing assembly with
hand control buttons	Ultrasonic Scalpel is
sterile, single patient
use instruments
consisting of an
ergonomic grip housing
assembly with hand
control buttons	Not public
Elements of
Comparison	Subject Device	Predicate Device 1	Predicate Device 2
Description of
power level	The MAX button is
typically used for
smaller vessels where
cutting speed is
fastest. The MIN
button at power level 1
is typically used in
larger vessels and has
reduced cutting speed.
It is indicated for
vessels up to 3 mm in
diameter.	The MAX button is
typically used for smaller
vessels where cutting
speed is fastest. The
MIN button at power
level 1 is typically used
in larger vessels and
has reduced cutting
speed. It is indicated for
vessels up to 5 mm in
diameter.	The instrument
allows for the cutting
of soft tissue and
coagulation of
vessels up to and
including 2 mm in
diameter.
Tissue self-
adjustment
technology	Energy timely
adjustment technology
provides the generator
with the ability to
monitor the real-time
impedance during use
so that the generator
auto adjusts the power
output and delivers it
to the Ultrasonic
Shears, as well as
provides audible
feedback to the user.	Energy timely
adjustment technology
provides the generator
with the ability to
monitor the real-time
impedance during use
so that the generator
auto adjusts the power
output and delivers it to
the ultrasonic scalpel, as
well as provides audible
feedback to the user.	Not public
Outer Diameter
(mm)	5.5 mm	5.5 mm	Not public
Blade frequency	55.5KHz	55.5KHz	55.5KHz
Blade amplitude	(50-70) ±15μm	50~100 μm	Not public
Blade
design/geometry	Multi-purpose shears	Multi-purpose shears	Not public
Handle type	Pistol Grip	Pistol Grip	Not public
Energy activation
method	Press Max/Min button	Press Max/Min button	Not public
Indicated vessel type	Veins and arteries	Veins and arteries	Not public
Energy buttons	Max/Min	Max/Min	Not public
Design	The device utilizes
ultrasonic energy to	The device utilizes
ultrasonic energy to	The device utilizes
ultrasonic energy to
Elements of
Comparison	Subject Device	Predicate Device 1	Predicate Device 2
enable hemostatic
cutting and/or
coagulation of soft
tissue	enable hemostatic
cutting and/or
coagulation of soft
tissue	enable hemostatic
cutting and/or
coagulation of soft
tissue
Human Tissue or
Body Fluids in
Contact with the
Device	Tissue	Tissue	Tissue

7. Test Summary

7.1 Summary of Non-Clinical Tests

Ultrasonic Surgical System has been evaluated the safety and performance by lab bench testing as following:

Sterilization
The Ultrasonic Shears, which was single use, was sterilized via ethylene oxide. The Ethylene oxide sterilization process is validated as per ISO 11135. The method used for ethylene oxide sterilization validation was overkill (half-cycle approach) method in a fixed chamber. Ethylene oxide residuals were tested and met ISO 10993-7 requirements.

Biocompatibility Testing

The Ultrasonic Shears is in direct contact with body tissue, with contact duration of less than 24 hours. Biocompatibility testing was conducted on the shear in question on 5 tests of in vitro cytotoxicity, intracutaneous reactivity, skin sensitization, acute systemic toxicity and pyrogen as per FDA quidance Use of international Standard ISO 10993-1, which indicated that the device was not toxic, irritating or sensitizing, and was free of acute systemic toxicity and pyrogen.

A Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the proposed device. The system was shown to comply with IEC 60601-1-2:2020 for electromagnetic compatibility, IEC 60601-1:2020 and IEC 60601-2-18 for electrical safety.

A Performance testing

Performance test and functional tests were conducted on the proposed device in accordance with product design specifications. Data generated from the test met the predetermined acceptance criteria.

A Animal testing

The animal study was conducted on porcine model with test articles (Ultrasonic Surgical System) and control article (predicate device Ethicon G11). It consisted of three experiments, in vitro burst pressure, acute animal experiment and 21-day chronic animal's experiment. The

experiments results show that the safety and efficacy of the tested articles are similar to those of the control articles.

■ Burst pressure testing

The test results demonstrated that either there was no statistical difference of burst pressure between test group and control group or the average burst pressure of test group was higher than that of the control group where there was statistical difference. There was no error or note observed during the in vitro burst experiment. Therefore, the results were deemed as acceptable.

Acute animal study
The test results demonstrated the times and thermal damage range of test article of each vessel diameter range did not have statistical difference compared with those of control article. There was no failure of sealing identified during all sealings after first activation and after challenge.
. Chronic Animal Testing
Postoperative observation showed no abnormal phenomena in respiration, muscle movement,spasm, reflex, eye symptoms, salivation, hair standing, pain loss, muscle state, gastrointestinal condition, and skin condition in all animals. The gross examination of each animal demonstrated that there was no hematoma, bleeding or any other adverse condition of the sealed site. Few tissues showed moderate inflammatory cell infiltration, while most tissues showed a small number of inflammatory cells. There was wide fibrosis and mild tissue necrosis at the test site.

A Packaging & Shelf life

The packaging and shelf life study was also conducted to ensure package integrity throughout the shelf life, including primary packaging validation as per ISO 11607 and shelf life validation as per ASTM F1980.

♪ Software Verification and Validation
The Software verification and validation is in compliance with FDA Guidance-Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
♪ Cleaning, Disinfection and Sterilization effectiveness
The methods for cleaning, disinfection, and sterilization of Hand Piece have been validated as per ISO 17664-1.

A Cybersecurity

The subject device does not have any external interfaces, according to FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", no need cybersecurity evaluation.

8. Final Conclusion:

The subject device Ultrasonic Surgical System has technological characteristics similar to the predicate device. Performance testing demonstrated that the differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially

equivalent to the predicate devices K212614 and K151136 in terms of safety and effectiveness for requested indications for use.