(334 days)
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.
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. 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.
The provided document is a 510(k) Premarket Notification for a medical device, the "Ultrasonic Scalpel System," and as such, it does not describe an AI/ML-driven device. Therefore, the questions related to AI acceptance criteria, training/test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance are not applicable to this document.
The document discusses the regulatory review of a physical medical device (ultrasonic scalpel system) and its substantial equivalence to predicate devices, focusing on:
- Device Description: Components (generator, transducer, scalpel, foot switch), working principle.
- Indications for Use: Transect, dissect, coagulate tissue in open and endoscopic general surgical procedures, particularly for vessels up to 5mm.
- Performance Data: Bench testing, animal studies (acute and chronic), sterilization validation, biocompatibility, electrical safety/EMC, packaging, and shelf-life.
Since the request is specifically about "acceptance criteria and the study that proves the device meets the acceptance criteria" and many of the sub-questions are tailored to AI/ML devices, I will interpret "device" as the Ultrasonic Scalpel System described in the document and apply the relevant information provided.
Acceptance Criteria and Study for the Ultrasonic Scalpel System (Non-AI Device)
The document does not explicitly present a table of "acceptance criteria" in the format typically used for AI/ML performance metrics (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria for this medical device are implicitly derived from various performance tests conducted to demonstrate safety and effectiveness and substantial equivalence to predicate devices. The "reported device performance" is the successful outcome of these tests, satisfying the underlying safety and performance standards.
Here's an interpretation of the acceptance criteria and study findings based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Sterilization Efficacy(Device is sterile and safe for use) | Ultrasonic scalpel sterilized via ethylene oxide (EO). Validation per ISO 11135 (overkill, half-cycle). EO residuals met ISO 10993-7 requirements. (Met) |
| Biocompatibility(Device is not toxic, irritating, or sensitizing) | Biocompatibility testing per FDA guidance (ISO 10993-1) for direct tissue contact (<24h). 5 tests: in vitro cytotoxicity, intracutaneous reactivity, skin sensitization, acute systemic toxicity, pyrogen. (Result: Not toxic, irritating, sensitizing; free of acute systemic toxicity and pyrogen - Met) |
| Electrical Safety & EMC(Device operates safely in medical environment) | Complied with IEC 60601-1-2:2014 for electromagnetic compatibility and IEC 60601-1:2005/A1:2012 for electrical safety. (Met) |
| Functional Performance(Device performs according to design specifications) | Performance and functional tests conducted per product design specifications and IEC 61847:1998. (Result: Data met predetermined acceptance criteria - Met) |
| Vessel Sealing Strength (Burst Pressure)(Equivalent or better than predicate device) | In vitro burst pressure testing: No statistical difference or average burst pressure of test group (Surgnova) was higher than control (predicate). No errors/notes. (Met) |
| Acute Surgical Performance(Similar performance to predicate in terms of thermal damage and sealing integrity) | Acute animal study: Times and thermal damage range for test article (Surgnova) did not show statistical difference compared to control (predicate). No sealing failures after first activation or challenge. (Met) |
| Chronic Biocompatibility/Safety(No significant adverse tissue reactions over time) | 21-day chronic animal study: Postoperative observations showed no abnormal phenomena in animals. Gross examination of sealed sites showed no hematoma, bleeding, or other adverse conditions. Few tissues with moderate inflammatory cells, most with small numbers. Wide fibrosis and mild tissue necrosis at test site. (Met - deemed acceptable) |
| Packaging & Shelf Life Integrity(Package maintains sterility and device function over time) | Packaging validation per ISO 11607. Shelf life validation per ASTM F1980-16. (Met) |
| Software Verification & Validation(Software functions as intended and is safe) | Compliance with FDA Guidance for Software Contained in Medical Devices. (Met) |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Animal Testing: The document states "animal study was conducted on porcine model." It mentions "all animals" and "each animal" for observations but does not specify the exact number of pigs used for the acute and 21-day chronic animal studies.
- Other tests (Sterilization, Biocompatibility, Electrical Safety, Performance, Packaging): Standard validation numbers for these tests are not explicitly stated (e.g., number of units tested for electrical safety or sterility assurance level).
- Data Provenance: The document implies that the studies were conducted by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. in China.
- Retrospective/Prospective: All described studies (in vitro, animal studies, bench testing) are inherently prospective studies designed specifically to test the performance and safety of the proposed device.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. This is a non-AI/ML medical device. Ground truth, in the context of device performance, is established through direct measurements, observations, and histological analyses in controlled laboratory and animal settings, not through expert consensus on diagnostic images.
- The "experts" involved would be qualified laboratory technicians, veterinarians, pathologists, and engineers conducting the tests, but their role is not "establishing ground truth for a test set" in the sense of image interpretation for AI.
4. Adjudication Method for the Test Set
- Not Applicable. As this is a physical device and not an AI/ML system requiring human interpretation for "ground truth," adjudication methods like 2+1 or 3+1 are not relevant. Test results are based on objective measurements and established protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This type of study is specific to diagnostic imaging AI, evaluating how human reader performance changes with AI assistance. The Ultrasonic Scalpel System is a surgical instrument, not an imaging AI; thus, an MRMC study was not performed.
6. Standalone (Algorithm Only) Performance
- Not Applicable. There is no standalone algorithm for this physical ultrasonic scalpel system. The device functions physically as an instrument.
7. Type of Ground Truth Used
- For this device, "ground truth" refers to direct, objective measurements and observations of the device's physical and biological effects:
- Sterility: Absence of viable microorganisms, EO residuals within limits.
- Biocompatibility: Absence of toxic, irritating, or sensitizing reactions in biological assays.
- Electrical Safety/EMC: Compliance with international safety standards (e.g., leakage current, electromagnetic interference).
- Performance/Functional Tests: Meeting pre-defined engineering specifications for frequency, amplitude, power output, etc.
- Burst Pressure: Measured pressure required to burst a sealed vessel.
- Acute Animal Study: Direct observation of thermal damage and visual confirmation of sealing integrity.
- Chronic Animal Study: Gross pathological examination of sealed sites, histological analysis of tissue for inflammatory cells, fibrosis, etc. (performed by pathologists).
8. Sample Size for the Training Set
- Not Applicable. This is a physical medical device, not an AI/ML system that undergoes a "training phase" on a dataset. The development of the device would involve engineering design, prototyping, and iterative testing, not "training" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no "training set" for an AI algorithm in this context, the concept of establishing ground truth for it does not apply.
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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 (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
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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: +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 |
|---|---|---|
| ------------------ | --------- | --------- |
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| Device Name | Generator G11 | HARMONICACE®+Shears withAdvanced Hemostasis |
|---|---|---|
| ClassificationName | Electrosurgical, Cutting & Coagulation &Accessories;Electrocautery, Gynecologic (andAccessories);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,Unclassified (LFL) | Unclassified (LFL) | |
| Classification | II | Unclassified | |
| Product Code | GEI, HGI, LFL | LFL | |
| Indications for Use | The Generator G11 provides radiofrequency power todrive Enseal electrosurgical instruments that are usedduring open or laparoscopic general and gynecologicalsurgery to cut and seal vessels and to cut, grasp, anddissect tissues. In addition, the generator providespower to drive Harmonic ultrasonic surgicalinstruments that are indicated for soft tissue incisionswhen bleeding control and minimal thermal injury aredesired. Enseal and Harmonic instruments when usedwith the Generator G11 have not been shown to beeffective for sterilization procedures or tubalcoagulation. Do not use these instruments for theseprocedures. | The Ultrasonic Scalpel System is intended to be usedto transect, dissect, and coagulate tissue. Theinstruments are indicated for use in open andendoscopic general surgical procedures where bleedingcontrol and minimal thermal injury to tissue aredesired. The instruments allow for the coagulation ofvessels (veins and arteries) up to 5 mm in diameterwhile using the power level 1. Device have not beenshown to be effective for sterilization procedures ortubal coagulation. Do not use these instruments forthese procedures. | |
| Technologicalcharacteristics | WorkingPrinciple | The generator outputs the AC energy at a resonating frequency of 55.5KHz to the ultrasonic transducer, whichtransforms it to mechanical vibrations to reach the clamped tissue at the blade tip of the ultrasonic scalpel'swaveguide. 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 toform a hemostatic seal. The precision of cutting and coagulation is controlled by the surgeon's technique andadjusting the power level, blade edge, tissue traction and blade pressure. | |
| Size: Width xHeight 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 thetransducer and scalpel at a resonant frequency to drivethe scalpel's distal tip to vibrate at a high frequency. | The generator is configured to resonate with thetransducer and scalpel at a resonant frequency to drivethe 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 | |
| Outputfrequency | 55.5KHz | 55.5KHz | |
| PhysicochemicalProperties | Not contain any medications, animal tissues or bloodcomponents, especially in contact with human tissuedoes not contain the above substances. | Not contain any medications, animal tissues or bloodcomponents, especially in contact with human tissuedoes not contain the above substances. | |
| Transducer | |||
| Product Name | HARMONIC Hand Piece | Ultrasonic Transducer | |
| Device Model | HP054 | SC100T | |
| Working Principle | The hand pieces which contain piezoelectrictransducers that convert electronic energy intoultrasonic vibration to power HARMONIC® Devices. | The Ultrasonic Transducer which containspiezoelectric transducers that converts electronicenergy into ultrasonic vibration to power UltrasonicScalpel. | |
| 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 tocontrol the energy output of the generator by the usersstepping down the pedal. | It is connected to the Ultrasonic Generator, can beused to control the energy output of the generator bythe users stepping down the foot switch. | |
| Design features | Press the left foot pedal of the footswitch is equivalentto press the hand control MIN button. Press the rightfoot pedal of the footswitch is equivalent to press thehand control MAX button. | Press the left foot pedal of the foot switch is equivalentto press the hand control MIN button. Press the rightfoot pedal of the foot switch is equivalent to press thehand control MAX button. | |
| Reusable /Single-use Device | Reusable | Reusable | |
| Sterility | Non-sterile | Non-sterile | |
| Cleaning and disinfection | Cleaning and disinfection, if foot switch contaminatedby blood or body fluid according to IFU. | Cleaning and disinfection, if foot switch contaminatedby blood or body fluid according to IFU or the hospitalregulations. | |
| Table III-3 Comparison with predicate device (K132612) | |||
| Comparison Elements | Predicate Device (K132612) | Proposed Device | |
| Product Name | HARMONIC ACE®+ Shears with AdvancedHemostasis | Ultrasonic Scalpel | |
| Regulation No. | Unclassified | Unclassified | |
| Classification | Unclassified | Unclassified | |
| Product Code | LFL | LFL | |
| Indications for Use | The HARMONIC ACE+7, 5 mm Diameter Shearswith Advanced Hemostasis are indicated for soft tissueincisions when bleeding control and minimal thermalinjury are desired. The instruments can be used as anadjunct to or substitute for electro-surgery, lasers andsteel scalpels in general, plastic, pediatric,gynecologic, urologic, thoracic, exposure to orthopedicstructures(such as spine and joint space), sealing andtransection of lymphatic vessels, and other open andendoscopic procedures. The instruments allow for thecoagulation of vessels up to and including 7 mm indiameter, using the Advanced Hemostasis hand controlbutton. | The Ultrasonic Scalpel System is intended to be usedto transect, dissect, and coagulate tissue. Theinstruments are indicated for use in open andendoscopic general surgical procedures where bleedingcontrol and minimal thermal injury to tissue aredesired. The instruments allow for the coagulation ofvessels (veins and arteries) up to 5 mm in diameterwhile using the power level 1. Device have not beenshown to be effective for sterilization procedures ortubal coagulation. Do not use these instruments forthese procedures. | |
| Technologicalcharacteristics | Model Number | HARH23HARH36HARH45 | SC43C+SC35C+SC21C+SC13C+ |
| Shaft Length(cm) | HARH23: 23 cmHARH36: 36 cmHARH45: 45 cm | SC43C+: 43cmSC35C+: 35cmSC21C+: 21cmSC13C+: 13cm | |
| WorkingPrinciple | Utilize ultrasonic energy to enable hemostatic cuttingand/or coagulation of soft tissue. All Blades arepowered through a generator that outputs optimalpower curves and communicates with the surgicalinstruments. | The Ultrasonic Transducer connects the UltrasonicGenerator and the Ultrasonic Scalpel together. Itconverts electrical energy from the generator intomechanical vibrations and transmits them to thewaveguide of the scalpel. The scalpel transmits thevibrations from the Ultrasonic Transducer to theclamped soft tissues for dissection and coagulation | |
| Description offunction | The HARMONIC ACE+7, 5 mm Diameter Shears(Product Codes HARH23 / HARH36 / HARH45) withAdvanced Hemostasis are sterile, single patient useinstruments consisting of an ergonomic grip housingassembly with hand control buttons (MIN forminimum power level, MAX for maximum powerlevel, and Advanced Hemostasis for large vessel | Ultrasonic Scalpel is sterile, single patient useinstruments consisting of an ergonomic grip housingassembly with hand control buttons (MIN forminimum power level, MAX for maximum powerlevel, and power level 1 of MIN button for large vesselsealing). | |
| Description ofpower level | sealing).The MAX button is typically used for smaller vesselswhere cutting speed is fastest. The MIN button istypically used in slightly larger vessels and hasreduced cutting speed. It is indicated for vessels up to5 mm in size.The Advanced Hemostasis button is designed forlarger vessels and is indicated for vessels up to 7 mmin size. In this mode, cutting speed is further reducedand hemostasis is maximized. | The MAX button is typically used for smaller vesselswhere cutting speed is fastest. The MIN button atpower level 1 is typically used in larger vessels and hasreduced cutting speed. It is indicated for vessels up to5 mm in diameter. | |
| Tissue self-adjustmenttechnology | The instruments utilize Adaptive Tissue Technology.This provides the generator with the ability to identifyand monitor the instrument during use, which enablesthe generator to modulate and adjust its power outputas well as provide audible feedback to the user asappropriate. | Energy timely adjustment technology provides thegenerator with the ability to monitor the real-timeimpedance during use so that the generator auto adjuststhe power output and delivers it to the ultrasonicscalpel, as well as provides audible feedback to theuser. | |
| Outer Diameter(mm) | 5.5 mm | 5.5 mm | |
| Blade frequency | 55.5KHz | 55.5KHz | |
| Blade amplitude | 50~100 µm | 50~100 µm | |
| Bladedesign/geometry | Multi-purpose shears | Multi-purpose shears | |
| Handle type | Pistol Grip | Pistol Grip | |
| Energyactivationmethod | Press Max/Min button | Press Max/Min button | |
| Indicated vesseltype | Veins and arteries | Veins and arteries | |
| Energy buttons | Max/Min | Max/Min | |
| Design | The device utilizes ultrasonic energy to enablehemostatic cutting and/or coagulation of soft tissue. | The device utilizes ultrasonic energy to enablehemostatic cutting and/or coagulation of soft tissue. | |
| Human Tissue orBody Fluids inContact with theDevice | Tissue | Tissue |
Table III-2 Comparison with predicate device (K141122)
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Table III-3 Comparison with predicate device (K132612)
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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,
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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.
N/A