Ultrasonic Scalpel System

K212614 · Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · LFL · Jul 18, 2022 · SU

Device Facts

• Record ID: K212614
• Device Name: Ultrasonic Scalpel System
• Applicant: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
• Product Code: LFL · SU
• Decision Date: Jul 18, 2022
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Ultrasonic Scalpel System is intended 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.

Device Story

Ultrasonic Scalpel System comprises ultrasonic generator, transducer, foot switch, and single-use scalpel. Generator converts AC electrical energy to 55.5kHz signal; transducer converts signal to mechanical vibrations (50-100μm amplitude) at scalpel waveguide tip. Vibrations break hydrogen bonds in soft tissue proteins, creating viscous coagulum for hemostasis and cutting. Used in hospital surgical/imaging intervention rooms by surgeons. Surgeon controls energy via hand buttons or foot switch. Real-time impedance monitoring allows generator to auto-adjust power output. Provides audible feedback. Benefits include precise tissue dissection and vessel sealing with reduced thermal damage.

Clinical Evidence

No clinical data. Evidence consists of bench testing (electrical safety per IEC 60601-1, EMC per IEC 60601-1-2, output characteristics per IEC 61847) and porcine animal studies (in vitro burst pressure, acute, and 21-day chronic). Animal studies demonstrated no statistical difference in burst pressure, sealing time, or thermal damage compared to predicate. Chronic study showed normal postoperative recovery and acceptable tissue healing (mild necrosis/fibrosis).

Technological Characteristics

System uses ultrasonic energy (55.5kHz) for tissue coagulation/cutting. Components: SC100E generator, SC100T transducer, SC43C+/SC35C+/SC21C+/SC13C+ scalpels. Materials: biocompatible per ISO 10993-1. Scalpels are single-use (EO sterilized per ISO 11135); transducer is reusable (99 cycles). Connectivity: foot switch interface. Software: real-time impedance monitoring for power modulation. Complies with IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for patients undergoing open or endoscopic general surgical procedures requiring tissue transection, dissection, and coagulation with bleeding control and minimal thermal injury. Suitable for coagulation of veins and arteries up to 5 mm in diameter. Contraindicated for sterilization procedures or tubal coagulation.

Predicate Devices

• Generator G11 (K141122)
• HARMONICACE®+Shears with Advanced Hemostasis (K132612)

Submission Summary (Full Text)

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July 18, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Ms. Guofang Ma QARA Director No.1 XinXing Yilu Road. Emerging Industrial Cluster Area Zonghan Subdistrict Cixi, Zhejiang 315301 China

Re: K212614

Trade/Device Name: Ultrasonic Scalpel System Regulatory Class: Unclassified Product Code: LFL Dated: May 24, 2022 Received: June 15, 2022

Dear Ms. Ma:

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. 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 located 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.

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) for

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devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K212614

Device Name Ultrasonic Scalpel System

#### Indications for Use (Describe)

The Ultrasonic Scalpel System is intended 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 .

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92.

# 3.1 Submitter Information

#### 510(k) Submitter/Holder: ●

Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. No.1 Xinxing Yilu Road, Emerging Industrial Cluster Area, Zonghan Subdistrict, Cixi City, Zhejiang, China

- . Contact
- Ms. Guofang Ma QA&RA Director Telephone: [phone]-8108 Fax: [phone]-8167

Email: [e-mail]

- Date Prepared: July 15, 2022 ●
# 3.2 Proposed Device Information

Trade/Proprietary Name: Ultrasonic Scalpel System Common Name: Ultrasonic Scalpel System Model: SC100E Device Classification Names: Instrument, Ultrasonic Surgical Regulations Number: Unclassified Product Code: LFL Device Class: Unclassified Panel: General & Plastic Surgery

# 3.3 Predicate Device

| 510(k)<br>Number | K141122 | K132612 |
|------------------|---------|---------|
|------------------|---------|---------|

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| Device Name | Generator G11 | HARMONICACE®+Shears with<br>Advanced Hemostasis |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Classification<br>Name | Electrosurgical, Cutting & Coagulation &<br>Accessories;<br>Electrocautery, Gynecologic (and<br>Accessories);<br>Instrument, Ultrasonic Surgical. | Instrument, Ultrasonic Surgical |
| Product Code | GEI, HGI, LFL | LFL |
| Device Class | Class II | Unclassified |
| Panel | General & Plastic Surgery | General & Plastic Surgery |
| Manufacturer | ETHICONENDO-SURGERY.LLC | ETHICONENDO-SURGERY.LLC |

# 3.4 Device Description

The Ultrasonic Scalpel System is an ultrasonic dissection and coagulation system composed of four components: the single use Ultrasonic Scalpel including four shaft lengths; a multiple use transducer; a generator and a foot switch, details see following table:

| | Name | Model |
|---------------------------|-----------------------|--------------------------------|
| Ultrasonic Scalpel System | Ultrasonic Generator | SC100E |
| | Ultrasonic Transducer | SC100T |
| | Ultrasonic Scalpel | SC43C+, SC35C+, SC21C+, SC13C+ |
| | Foot Switch | TG-A |

Table III-1: Ultrasonic Scalpel System

The single-use Ultrasonic Scalpel with EO sterilization contains the waveguide, shaft, jaws, trigger and activation button. Trigger activation opens and closes the jaws against the distal tip of the waveguide where the tissue is clamped.

The Ultrasonic Generator provides AC electrical energy to drive the Ultrasonic Transducer. The Ultrasonic Transducer converts the electrical energy into mechanical vibrations, making the Ultrasonic Scalpel waveguide tip keep vibrating with amplitude between 50μm-100μm at frequency about 55.5kHz. When the vibrating Ultrasonic Scalpel waveguide tip contacts with soft tissues, the hydrogen bond in proteins of the soft tissues is broken apart. The proteins become viscous and coagulate so as to stop bleeding and reduce damage to soft tissues in cutting.

The single-use Ultrasonic Scalpel with EO sterilization, the Ultrasonic Generator and Ultrasonic Transducer are of non-sterile package, the transducer has to be sterilized by users before being used in surgery.

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

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# 3.5 Comparison list of the technological characteristics

| Table III-2 Comparison with predicate device (K141122) | | | |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison Elements | Predicate Device (K141122) | Proposed Device | |
| Generator | | | |
| Product Name | Generator G11 | Ultrasonic Generator | |
| Regulation No. | 21 CFR 878.4400, 21 CFR 878.4120,<br>Unclassified (LFL) | Unclassified (LFL) | |
| Classification | II | Unclassified | |
| Product Code | GEI, HGI, LFL | LFL | |
| Indications for Use | The Generator G11 provides radiofrequency power to<br>drive Enseal electrosurgical instruments that are used<br>during open or laparoscopic general and gynecological<br>surgery to cut and seal vessels and to cut, grasp, and<br>dissect tissues. In addition, the generator provides<br>power to drive Harmonic ultrasonic surgical<br>instruments that are indicated for soft tissue incisions<br>when bleeding control and minimal thermal injury are<br>desired. Enseal and Harmonic instruments when used<br>with the Generator G11 have not been shown to be<br>effective for sterilization procedures or tubal<br>coagulation. Do not use these instruments for these<br>procedures. | The Ultrasonic Scalpel System is intended to be used<br>to transect, dissect, and coagulate tissue. The<br>instruments are indicated for use in open and<br>endoscopic general surgical procedures where bleeding<br>control and minimal thermal injury to tissue are<br>desired. The instruments allow for the coagulation of<br>vessels (veins and arteries) up to 5 mm in diameter<br>while using the power level 1. Device have not been<br>shown to be effective for sterilization procedures or<br>tubal coagulation. Do not use these instruments for<br>these procedures. | |
| Technological<br>characteristics | Working<br>Principle | The generator outputs the AC energy at a resonating frequency of 55.5KHz to the ultrasonic transducer, which<br>transforms it to mechanical vibrations to reach the clamped tissue at the blade tip of the ultrasonic scalpel's<br>waveguide. Vibrating at high frequency, the blade tip denatures protein in the tissue to form a sticky coagulum,<br>with the pressure exerted on tissue with the blade surface collapses blood vessels and allows the coagulum to<br>form a hemostatic seal. The precision of cutting and coagulation is controlled by the surgeon's technique and<br>adjusting the power level, blade edge, tissue traction and blade pressure. | |
| | Size: Width x<br>Height x Depth | Generator: 35.0cm x 35.5cm x 13.6cm | Generator: 40.0cm x 40.0cm x 12.0cm |
| | Design | The generator is configured to resonate with the<br>transducer and scalpel at a resonant frequency to drive<br>the scalpel's distal tip to vibrate at a high frequency. | The generator is configured to resonate with the<br>transducer and scalpel at a resonant frequency to drive<br>the scalpel's distal tip to vibrate at a high frequency. |
| | Power supply: | 100-240 V, 50/60 Hz, 500 VA | 100-240V AC, 50/60Hz, 200 VA |
| | Voltage output | Inconstant voltage | Inconstant voltage |
| | Power Output | Maximum electric power: 60W | Maximum electric power: 45W |
| | Output<br>frequency | 55.5KHz | 55.5KHz |
| | Physicochemical<br>Properties | Not contain any medications, animal tissues or blood<br>components, especially in contact with human tissue<br>does not contain the above substances. | Not contain any medications, animal tissues or blood<br>components, especially in contact with human tissue<br>does not contain the above substances. |
| Transducer | | | |
| Product Name | | HARMONIC Hand Piece | Ultrasonic Transducer |
| Device Model | | HP054 | SC100T |
| Working Principle | | The hand pieces which contain piezoelectric<br>transducers that convert electronic energy into<br>ultrasonic vibration to power HARMONIC® Devices. | The Ultrasonic Transducer which contains<br>piezoelectric transducers that converts electronic<br>energy into ultrasonic vibration to power Ultrasonic<br>Scalpel. |
| Reusable /Single-use Device | | Reusable device | Reusable device |
| Reusable times | | 95 times | 99 times. |
| Supply | | It supplied non-sterilize, sterilize prior to use. | It is supplied non-sterilize, sterilize prior to use. |
| Sterilization method | | Gravity /Prevacuum | Pulsation vacuum/Low temperature plasma |
| Foot Switch | | | |
| Product Name | | Foot Switch | Foot Switch |
| Device Model | | FSW11 | TG-A |
| Working Principle | | It connected to the Generator G11, can be used to<br>control the energy output of the generator by the users<br>stepping down the pedal. | It is connected to the Ultrasonic Generator, can be<br>used to control the energy output of the generator by<br>the users stepping down the foot switch. |
| Design features | | Press the left foot pedal of the footswitch is equivalent<br>to press the hand control MIN button. Press the right<br>foot pedal of the footswitch is equivalent to press the<br>hand control MAX button. | Press the left foot pedal of the foot switch is equivalent<br>to press the hand control MIN button. Press the right<br>foot pedal of the foot switch is equivalent to press the<br>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<br>by blood or body fluid according to IFU. | Cleaning and disinfection, if foot switch contaminated<br>by blood or body fluid according to IFU or the hospital<br>regulations. |
| Table III-3 Comparison with predicate device (K132612) | | | |
| Comparison Elements | Predicate Device (K132612) | Proposed Device…