← Product Code LFL · K233036
# Ultrasonic Surgical System (K233036)
_Hunan Handlike Minimally Invasive Surgery Co., Ltd. · LFL · Jun 18, 2024 · SU · SESE_
**Canonical URL:** https://fda.innolitics.com/device/K233036
## Device Facts
- **Applicant:** Hunan Handlike Minimally Invasive Surgery Co., Ltd.
- **Product Code:** LFL
- **Decision Date:** Jun 18, 2024
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU
- **Attributes:** Therapeutic
## Intended 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.
## Device Story
Ultrasonic Surgical System comprises an ultrasonic generator, handpiece, disposable ultrasonic shears, and foot switch. System converts electrical energy from generator into mechanical energy via piezoelectric handpiece; blade tip vibrates at 55.5 kHz. Friction-induced heat causes protein denaturation and water vaporization, enabling simultaneous tissue cutting and hemostatic coagulation. Used in hospital surgical/imaging intervention rooms by healthcare professionals. Surgeon controls power levels (high for cutting, low for coagulation) via hand buttons or foot switch. Real-time impedance monitoring allows generator to auto-adjust power output. System provides audible feedback to user. Benefits include precise tissue dissection and effective vessel sealing with minimal thermal injury.
## Clinical Evidence
No human clinical data. Evidence includes bench testing (electrical safety, EMC, biocompatibility, sterilization, packaging/shelf-life) and animal studies (porcine model). Animal testing compared subject device to predicate (Ethicon G11) via in vitro burst pressure, acute, and 21-day chronic experiments. Results showed no statistical difference in burst pressure or thermal damage range. Chronic study showed no adverse clinical signs or abnormal gross pathology at sealed sites.
## Technological Characteristics
Ultrasonic dissection/coagulation system. Components: Generator (HD-CSD01), Handpiece (HD-CSH01), Shears (HD-CS-DJ series), Foot switch (HRF-M52). Energy: 55.5 kHz ultrasonic vibration. Materials: Biocompatible per ISO 10993. Sterilization: EO (shears), user-cleaned/sterilized (handpiece). Connectivity: Standalone, no external interfaces. Software: Embedded control logic for impedance monitoring and power adjustment.
## Predicate Devices
- Ultrasonic Scalpel System ([K212614](/device/K212614.md))
- HARMONIC Hook ([K151136](/device/K151136.md))
## Submission Summary (Full Text)
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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"
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(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
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Enclosure
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# Indications for Use
510(k) Number (if known) K233036
Device Name Ultrasonic Surgical System
## Indications for Use (Describe)
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.
| 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) |
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# 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
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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
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.
### 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
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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 |
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# 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…
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**Source:** [https://fda.innolitics.com/device/K233036](https://fda.innolitics.com/device/K233036)
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