(334 days)
No
The description focuses on the mechanical and electrical principles of ultrasonic tissue dissection and coagulation. There is no mention of AI, ML, or any data-driven decision-making or image processing components.
No
The device is used for surgical procedures like transecting, dissecting, and coagulating tissue, which are operative functions rather than therapeutic ones aimed at healing or treating a disease.
No
The device is an ultrasonic scalpel system used for surgical procedures (transecting, dissecting, and coagulating tissue) indicating a therapeutic rather than a diagnostic function.
No
The device description clearly outlines multiple hardware components including a single-use scalpel, transducer, generator, and foot switch.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Ultrasonic Scalpel System is a surgical instrument used to physically cut, dissect, and coagulate tissue during a surgical procedure. It directly interacts with the patient's body.
- Intended Use: The intended use clearly states it's for "transect, dissect, and coagulate tissue" in "open and endoscopic general surgical procedures." This is a therapeutic and procedural use, not a diagnostic one based on analyzing specimens.
The device's function and intended use fall squarely within the realm of surgical instruments, not in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Product codes
LFL
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 Generator | SC100E |
Ultrasonic Transducer | SC100T |
Ultrasonic Scalpel | SC43C+, SC35C+, SC21C+, SC13C+ |
Foot Switch | TG-A |
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.
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
Not Found
Intended User / Care Setting
This device is intended to be used in the 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
Bench testing and laboratory evaluations in an animal model including acute and 21-day chronic studies were conducted to demonstrate that the Ultrasonic Scalpel System SC100E performs as intended.
Sterilization: The ultrasonic scalpel, which was single-use, was sterilized via ethylene oxide. The Ethylene oxide sterilization process is validated as per ISO 11135 using the overkill (half-cycle approach) method in a fixed chamber. Ethylene oxide residuals were tested and met ISO 10993-7 requirements.
Biocompatibility Testing: Conducted on the scalpel as it is in direct contact with body tissue for less than 24 hours. Tests performed include in vitro cytotoxicity, intracutaneous reactivity, skin sensitization, acute systemic toxicity and pyrogen as per FDA guidance Use of international Standard 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): The system was shown to comply with IEC 60601-1-2:2014 for electromagnetic compatibility and IEC 60601-1:2005/A1:2012 for electrical safety.
Performance testing: Conducted in accordance with product design specifications and IEC 61847:1998 Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics. Data met predetermined acceptance criteria.
Animal testing: Conducted on porcine model with test articles (SC43C+, SC35C+, SC21C+ and SC13C+) and control article (predicate device HARH36). It consisted of three experiments:
- In vitro burst pressure: Test results demonstrated either no statistical difference or higher average burst pressure in the test group compared to the control group. No error or note observed.
- Acute animal study: Test results demonstrated no statistical difference in times and thermal damage range of the test article for each vessel diameter compared to the control article. No failure of sealing identified 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. Gross examination showed no hematoma, bleeding or other adverse conditions at the sealed site. Few tissues showed moderate inflammatory cell infiltration, while most showed a small number of inflammatory cells. Wide fibrosis and mild tissue necrosis were observed at the test site.
Packaging & Shelf life: Study conducted to ensure package integrity throughout the shelf life, including primary packaging validation as per ISO 11607 and shelf life validation as per ASTM F1980-16.
Software Verification and Validation: In compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Clinical Study: Clinical studies were not required to demonstrate the substantial equivalence.
Key results: The bench testing and laboratory evaluations in an animal model demonstrated that the proposed device is as safe and effective, and performs as well as the predicate device under 5mm intended condition.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
---|---|
☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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: +86-010-64117355-8108 Fax: +86-010-64117355-8167
Email: QARA@surgnova.com
- 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)
Number | K141122 | K132612 |
---|---|---|
------------------ | --------- | --------- |
4
| Device Name | Generator G11 | HARMONICACE®+Shears with
Advanced Hemostasis |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Classification
Name | Electrosurgical, Cutting & Coagulation &
Accessories;
Electrocautery, Gynecologic (and
Accessories);
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.
5
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, | ||
Unclassified (LFL) | Unclassified (LFL) | ||
Classification | II | Unclassified | |
Product Code | GEI, HGI, LFL | LFL | |
Indications for Use | The Generator G11 provides radiofrequency power to | ||
drive Enseal electrosurgical instruments that are used | |||
during open or laparoscopic general and gynecological | |||
surgery to cut and seal vessels and to cut, grasp, and | |||
dissect tissues. In addition, the generator provides | |||
power to drive Harmonic ultrasonic surgical | |||
instruments that are indicated for soft tissue incisions | |||
when bleeding control and minimal thermal injury are | |||
desired. Enseal and Harmonic instruments when used | |||
with the Generator G11 have not been shown to be | |||
effective for sterilization procedures or tubal | |||
coagulation. Do not use these instruments for these | |||
procedures. | 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. | |||
Technological | |||
characteristics | Working | ||
Principle | The generator outputs the AC energy at a resonating frequency of 55.5KHz to the 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 | 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 | ||
transducer 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 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 | |||
frequency | 55.5KHz | 55.5KHz | |
Physicochemical | |||
Properties | Not contain any medications, animal tissues or blood | ||
components, especially in contact with human tissue | |||
does not contain the above substances. | Not contain any medications, animal tissues or blood | ||
components, especially in contact with human tissue | |||
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 | ||
transducers that convert electronic energy into | |||
ultrasonic vibration to power HARMONIC® Devices. | 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 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 | ||
control the energy output of the generator by the users | |||
stepping down the pedal. | 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 | Press the left foot pedal of the footswitch is equivalent | ||
to press the hand control MIN button. Press the right | |||
foot pedal of the footswitch is equivalent to press the | |||
hand control MAX button. | 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. | Cleaning and disinfection, if foot switch contaminated | ||
by blood or body fluid according to IFU or the hospital | |||
regulations. | |||
Table III-3 Comparison with predicate device (K132612) | |||
Comparison Elements | Predicate Device (K132612) | Proposed Device | |
Product Name | HARMONIC ACE®+ Shears with Advanced | ||
Hemostasis | Ultrasonic Scalpel | ||
Regulation No. | Unclassified | Unclassified | |
Classification | Unclassified | Unclassified | |
Product Code | LFL | LFL | |
Indications for Use | The HARMONIC ACE+7, 5 mm Diameter Shears | ||
with Advanced Hemostasis are indicated for soft tissue | |||
incisions when bleeding control and minimal thermal | |||
injury are desired. The instruments can be used as an | |||
adjunct to or substitute for electro-surgery, lasers and | |||
steel scalpels in general, plastic, pediatric, | |||
gynecologic, urologic, thoracic, exposure to orthopedic | |||
structures(such as spine and joint space), sealing and | |||
transection of lymphatic vessels, and other open and | |||
endoscopic procedures. The instruments allow for the | |||
coagulation of vessels up to and including 7 mm in | |||
diameter, using the Advanced Hemostasis hand control | |||
button. | 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. | |||
Technological | |||
characteristics | Model Number | HARH23 | |
HARH36 | |||
HARH45 | SC43C+ | ||
SC35C+ | |||
SC21C+ | |||
SC13C+ | |||
Shaft Length | |||
(cm) | HARH23: 23 cm | ||
HARH36: 36 cm | |||
HARH45: 45 cm | SC43C+: 43cm | ||
SC35C+: 35cm | |||
SC21C+: 21cm | |||
SC13C+: 13cm | |||
Working | |||
Principle | Utilize ultrasonic energy to enable hemostatic cutting | ||
and/or coagulation of soft tissue. All Blades are | |||
powered through a generator that outputs optimal | |||
power curves and communicates with the surgical | |||
instruments. | 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 | |||
Description of | |||
function | The HARMONIC ACE+7, 5 mm Diameter Shears | ||
(Product Codes HARH23 / HARH36 / HARH45) with | |||
Advanced Hemostasis are sterile, single patient use | |||
instruments consisting of an ergonomic grip housing | |||
assembly with hand control buttons (MIN for | |||
minimum power level, MAX for maximum power | |||
level, and Advanced Hemostasis for large vessel | Ultrasonic Scalpel is sterile, single patient use | ||
instruments consisting of an ergonomic grip housing | |||
assembly with hand control buttons (MIN for | |||
minimum power level, MAX for maximum power | |||
level, and power level 1 of MIN button for large vessel | |||
sealing). | |||
Description of | |||
power level | sealing). | ||
The MAX button is typically used for smaller vessels | |||
where cutting speed is fastest. The MIN button is | |||
typically used in slightly larger vessels and has | |||
reduced cutting speed. It is indicated for vessels up to | |||
5 mm in size. | |||
The Advanced Hemostasis button is designed for | |||
larger vessels and is indicated for vessels up to 7 mm | |||
in size. In this mode, cutting speed is further reduced | |||
and hemostasis is maximized. | 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. | |||
Tissue self- | |||
adjustment | |||
technology | The instruments utilize Adaptive Tissue Technology. | ||
This provides the generator with the ability to identify | |||
and monitor the instrument during use, which enables | |||
the generator to modulate and adjust its power output | |||
as well as provide audible feedback to the user as | |||
appropriate. | 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. | |||
Outer Diameter | |||
(mm) | 5.5 mm | 5.5 mm | |
Blade frequency | 55.5KHz | 55.5KHz | |
Blade amplitude | 50~100 µm | 50~100 µm | |
Blade | |||
design/geometry | Multi-purpose shears | Multi-purpose shears | |
Handle type | Pistol Grip | Pistol Grip | |
Energy | |||
activation | |||
method | Press Max/Min button | Press Max/Min button | |
Indicated vessel | |||
type | Veins and arteries | Veins and arteries | |
Energy buttons | Max/Min | Max/Min | |
Design | The device utilizes ultrasonic energy to enable | ||
hemostatic cutting and/or coagulation of soft tissue. | The device utilizes ultrasonic energy to enable | ||
hemostatic cutting and/or coagulation of soft tissue. | |||
Human Tissue or | |||
Body Fluids in | |||
Contact with the | |||
Device | Tissue | Tissue |
Table III-2 Comparison with predicate device (K141122)
6
Table III-3 Comparison with predicate device (K132612)
7
8
9
3.6 Indications for use
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.
3.7 Performance data
Bench testing and laboratory evaluations in an animal model including acute and 21-day chronic studies were conducted to demonstrate that the Ultrasonic Scalpel System SC100E performs as intended.
Sterilization
The ultrasonic scalpel, 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 proposed scalpel is in direct contact with body tissue, with contact duration of less than 24 hours. Biocompatibility testing was conducted on the scalpel in question on 5 tests of in vitro cytotoxicity, intracutaneous reactivity, skin sensitization, acute systemic toxicity and pyrogen as per FDA guidance 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.
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 60601-1-2:2014 for electromagnetic compatibility and IEC 60601-1:2005/A1:2012 for electrical safety.
Performance testing
Performance test and functional tests were conducted on the proposed device in accordance with product design specifications and IEC 61847:1998 Ultrasonics - Surgical systems -Measurement and declaration of the basic output characteristics. Data generated from the test met the predetermined acceptance criteria.
Animal testing
The animal study was conducted on porcine model with test articles (SC43C+, SC35C+, SC21C+ and SC13C+) and control article (predicate device HARH36). It consisted of three experiments,
10
in vitro burst pressure, acute animal experiment and 21-day chronic animals 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.
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 F1980-16.
Software Verification and Validation
The Software verification and validation is in compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Clinical Study
Clinical studies were not required to demonstrate the substantial equivalence of the Ultrasonic Scalpel System and the predicated device.
3.8 Conclusion
The proposed device is similar to the predicate device; although the intended vessel sealing diameter is up to 5mm for the proposed device while 7mm for the predicate device, however, the substantial equivalence with the predicate is supported by the results of the bench testing and laboratory evaluations in an animal model, which demonstrates that the proposed device is as safe and effective, and performs as well as the predicate device under 5mm intended condition.