(267 days)
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.
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.
The provided text is a 510(k) Summary for a medical device called "Ultrasonic Surgical System." It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain details about specific acceptance criteria for performance tests or the detailed study results that would typically prove a device meets those criteria in a format directly applicable to the table requested.
The document mentions "Performance test and functional tests were conducted on the proposed device in accordance with product design specifications. Data generated from the test met the predetermined acceptance criteria." but does not list those criteria or the specific performance data against them.
It also includes results from animal testing (burst pressure, acute, and chronic animal studies) but these are comparative to a predicate device rather than against predefined, quantitative acceptance criteria for the subject device itself.
Therefore, many of the requested fields cannot be filled directly from the provided text.
Based on the information provided, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly detailed in the provided document. The document states that "Data generated from the test met the predetermined acceptance criteria" but does not list the specific criteria or the exact performance data against them for each test.
| Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (as per non-clinical tests summary) |
|---|---|
| Sterilization: (Presumed: Sterility Assurance Level [SAL] compliance, EO residuals within limits) | Ultrasonic Shears: Sterilized via ethylene oxide as per ISO 11135 (overkill method). Ethylene oxide residuals met ISO 10993-7 requirements. |
| Biocompatibility: (Presumed: No toxicity, irritation, sensitization, acute systemic toxicity, pyrogenicity) | Ultrasonic Shears: Not toxic, irritating, or sensitizing; free of acute systemic toxicity and pyrogen, as per FDA guidance Use of International Standard ISO 10993-1. |
| Electrical Safety & EMC: (Presumed: Compliance with relevant standards) | System: Complied with IEC 60601-1-2:2020 for electromagnetic compatibility, IEC 60601-1:2020 and IEC 60601-2-18 for electrical safety. |
| Overall Performance & Functional Tests: (Presumed: Met product design specifications) | Device: "Data generated from the test met the predetermined acceptance criteria." (Specifics not provided). |
| Burst Pressure Testing (Animal Study): (Presumed: Equivalent or superior burst pressure compared to predicate) | Animal Study: "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." No error/note observed. |
| Acute Animal Study: (Presumed: Equivalent times/thermal damage, no sealing failures) | Animal Study: Times and thermal damage range did not have statistical difference compared to predicate. No failure of sealing identified after first activation and after challenge. |
| Chronic Animal Study: (Presumed: No abnormal phenomena, no adverse conditions at sealed site, acceptable tissue response) | Animal Study: Postoperative observation showed no abnormal phenomena. Gross examination showed no hematoma, bleeding, or other adverse conditions at the sealed site. Few tissues showed moderate inflammatory cell infiltration, most showed few inflammatory cells. Wide fibrosis and mild tissue necrosis at the test site. |
| Packaging & Shelf Life: (Presumed: Package integrity throughout shelf life) | Packaging: Primary packaging validated as per ISO 11607. Shelf Life: Validated as per ASTM F1980. |
| Software V&V: (Presumed: Compliance with FDA Guidance) | Software: In compliance with FDA Guidance-Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. |
| Cleaning, Disinfection, Sterilization effectiveness (Hand Piece): (Presumed: Effectiveness validated as per ISO) | Hand Piece: Methods validated as per ISO 17664-1. |
| Cybersecurity: (Presumed: No external interfaces requiring evaluation) | Device: No external interfaces, no need for cybersecurity evaluation per FDA guidance. |
2. Sample Size Used for the Test Set and Data Provenance
- The document specifies a "porcine model" for animal testing.
- It does not specify the sample size for the burst pressure, acute, or chronic animal studies (e.g., number of animals or number of vessels tested per animal/group).
- The data is prospective, generated from the animal study using the subject device and a predicate device.
- The country of origin of the data is not specified, but the applicant (Hunan Handlike Minimally Invasive Surgery Co., Ltd.) is from China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The animal studies would typically involve veterinarians and potentially pathologists, but their number and specific qualifications are not mentioned.
4. Adjudication Method for the Test Set
- This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done, as this is a surgical device, not an imaging/diagnostic AI device that would typically involve human readers interpreting cases. The comparative effectiveness assessment was against a predicate device in animal models.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Not applicable, as this is a physical surgical device, not a standalone algorithm. The device itself is evaluated.
7. The Type of Ground Truth Used
- For the animal studies, the "ground truth" would be established through direct observation during the procedures, histological examination of tissue samples, and measurements (e.g., burst pressure). These are effectively pathology and direct physiological measurements/observations.
8. The Sample Size for the Training Set
- Not applicable, as this is a physical surgical device, not an AI/ML algorithm that requires a training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as this is a physical surgical device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
June 18, 2024
Hunan Handlike Minimally Invasive Surgery Co., Ltd. % Lee Cassie Official Correspondent Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, Guangdong 510700 China
Re: K233036
Trade/Device Name: Ultrasonic Surgical System Regulatory Class: Unclassified Product Code: LFL Dated: May 17, 2024 Received: May 17, 2024
Dear Lee Cassie:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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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 ofComparison | Subject Device | Predicate Device 1 |
|---|---|---|
| Manufacturer | Hunan Handlike MinimallyInvasive Surgery Co., Ltd. | Surgnova HealthcareTechnologies (Zhejiang) Co.,Ltd. |
| Trade Name | Ultrasonic Surgical System | Ultrasonic Scalpel System |
| 510(k) Number | K233036 | K212614 |
| Classification Name | Instrument, UltrasonicSurgical | Instrument, UltrasonicSurgical |
| Classification ProductCode | LFL | LFL |
| Indications for Use | The Ultrasonic SurgicalSystem is intended to beused to transect, dissect, andcoagulate tissue. Theinstruments are indicated foruse in open and endoscopicgeneral surgical procedureswhere bleeding control andminimal thermal injury totissue are desired. Theinstruments allow for thecoagulation of vessels (veinsand arteries) up to 3 mm indiameter. | The Ultrasonic ScalpelSystem is intended to beused to transect, dissect, andcoagulate tissue. Theinstruments are indicated foruse in open and endoscopicgeneral surgical procedureswhere bleeding control andminimal thermal injury totissue are desired. Theinstruments allow for thecoagulation of vessels (veinsand arteries) up to 5 mm indiameter while using thepower level 1. Device havenot been shown to beeffective for sterilizationprocedures or tubalcoagulation. Do not usethese instruments for theseprocedures. |
| Working Principle | The Ultrasonic Generatoroutputs the AC energy at aresonating frequency of | The generator outputs the ACenergy at a resonatingfrequency of 55.5KHz to the |
| Elements ofComparison | Subject Device | Predicate Device 1 |
| 55.5KHz to the hand piece,which transforms it tomechanical vibrations toreach the clamped tissue atthe blade tip of the ultrasonicshears' waveguide. Vibratingat high frequency, the bladetip denatures protein in thetissue to form a stickycoagulum, with the pressureexerted on tissue with theblade surface collapses bloodvessels and allows thecoagulum to form ahemostatic seal. Theprecision of cutting andcoagulation is controlled bythe surgeon's technique andadjusting the power level,blade edge, tissue tractionand blade pressure. | ultrasonic transducer, whichtransforms it to mechanicalvibrations to reach theclamped tissue at the bladetip of the ultrasonic scalpel'swaveguide. Vibrating at highfrequency, the blade tipdenatures protein in thetissue to form a stickycoagulum, with the pressureexerted on tissue with theblade surface collapses bloodvessels and allows thecoagulum to form ahemostatic seal. Theprecision of cutting andcoagulation is controlled bythe surgeon's technique andadjusting the power level,blade edge, tissue tractionand blade pressure. | |
| Size (Width x Height xDepth) | Ultrasonic Generator: 37.0cmx 39.0cm x 16.3cm | Generator: 40.0cm x 40.0cmx 12.0cm |
| Design | The ultrasonic generator isconfigured to resonate withthe Hand Piece and scalpel ata resonant frequency to drivethe scalpel's distal tip tovibrate at a high frequency. | The generator is configuredto resonate with thetransducer and scalpel at aresonant frequency to drivethe scalpel's distal tip tovibrate at a high frequency. |
| Power Source | 110-240V AC, 50/60Hz, 500VA | 100-240V AC, 50/60Hz, 200VA |
| 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 ofComparison | Subject Device | Predicate Device 1 |
| Working Principle | The Hand Piece whichcontains piezoelectric HandPieces that convertselectronic energy intoultrasonic vibration to powerultrasonic Shears. | The Ultrasonic Transducerwhich contains piezoelectrictransducers that convertselectronic energy intoultrasonic vibration to powerUltrasonic Scalpel. |
| Reusable /Single-useDevice | 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/Lowtemperature plasma |
| Foot Switch | ||
| Product Name | Foot Switch | Foot Switch |
| Model | HRF-M52 | TG-A |
| Working Principle | It is connected to theUltrasonic Generator, can beused to control the energyoutput of the generator by theusers stepping down the footswitch. | It is connected to theUltrasonic Generator, can beused to control the energyoutput of the generator by theusers stepping down the footswitch. |
| Design features | The left foot switch is used tocontrol the cutting mode; Theright foot switch is used tocontrol the coagulation mode | Press the left foot pedal ofthe foot switch is equivalentto press the hand control MINbutton. Press the right footpedal of the foot switch isequivalent to press the handcontrol MAX button. |
| Reusable /Single-useDevice | Reusable | Reusable |
| Sterility | Non-sterile | Non-sterile |
| Cleaning and disinfection | Cleaning and disinfection, iffoot switch contaminated byblood or body fluid accordingto IFU or the hospitalregulations | Cleaning and disinfection, iffoot switch contaminated byblood or body fluid accordingto IFU or the hospitalregulations |
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6.2 Comparison table for Ultrasonic Scalpel
| Elements ofComparison | Subject Device | Predicate Device 1 | Predicate Device 2 |
|---|---|---|---|
| Manufacturer | Hunan HandlikeMinimally InvasiveSurgery Co., Ltd. | Surgnova HealthcareTechnologies (Zhejiang)Co., Ltd. | Ethicon Endo-Surgery, LLC |
| Trade Name | Ultrasonic SurgicalSystem | Ultrasonic ScalpelSystem | HARMONIC Hook |
| 510(k) Number | Applying | K212614 | K151136 |
| Classification Name | Instrument, UltrasonicSurgical | Instrument, UltrasonicSurgical | Instrument,Ultrasonic Surgical |
| ClassificationProductCode | LFL | LFL | LFL |
| Indications for Use | The UltrasonicSurgical System isintended to be used totransect, dissect, andcoagulate tissue. Theinstruments areindicated for use inopen and endoscopicgeneral surgicalprocedures wherebleeding control andminimal thermal injuryto tissue are desired.The instruments allowfor the coagulation ofvessels (veins andarteries) up to 3 mm indiameter. | The Ultrasonic ScalpelSystem is intended to beused to transect,dissect, and coagulatetissue. The instrumentsare indicated for use inopen and endoscopicgeneral surgicalprocedures wherebleeding control andminimal thermal injury totissue are desired. Theinstruments allow for thecoagulation of vessels(veins and arteries) upto 5 mm in diameterwhile using the powerlevel 1. Device have notbeen shown to beeffective for sterilizationprocedures or tubalcoagulation. Do not usethese instruments forthese procedures. | The HARMONICHook instrument isindicated for softtissue incisions whenbleeding control andminimal thermalinjury are desired.The instrument canbe used as anadjunct to orsubstitute forelectrosurgery,lasers, and steelscalpels in general,plastic, gynecologic,exposure toorthopedic structures(such as spine andjoint space), andthoracic surgery,including mobilizationof the InternalMammary Artery(IMA). |
| Product Name | Ultrasonic Shears | Ultrasonic Scalpel | HARMONIC Hook |
| Model | HD-CS-DJ14 | SC43C+ | -- |
| Elements ofComparison | Subject Device | Predicate Device 1 | Predicate Device 2 |
| HD-CS-DJ22HD-CS-DJ36HD-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+: 43cmSC35C+: 35cmSC21C+: 21cmSC13C+: 13cm | 32 cm |
| Working Principle | The Hand Piececonnects theUltrasonic Generatorand the DisposableUltrasonic Shearstogether. It convertselectrical energy fromthe ultrasonicGenerator intomechanical vibrationsand transmits them tothe waveguide of thescalpel. The scalpeltransmits thevibrations from theUltrasonic Hand Pieceto the clamped softtissues for dissectionand coagulation | The UltrasonicTransducer connectsthe Ultrasonic Generatorand the UltrasonicScalpel together. Itconverts electricalenergy from thegenerator intomechanical vibrationsand transmits them tothe waveguide of thescalpel. The scalpeltransmits the vibrationsfrom the UltrasonicTransducer to theclamped soft tissues fordissection andcoagulation | The HPBLUEhandpiece connectsthe HARMONICHook device to theGenerator G11, andconverts electricalenergy intomechanical motion(ultrasonic energy).The high-frequencymechanical vibrationat 55.5 kHz of theHARMONIC Hookblade transects,dissects, andcoagulates tissue,sealing vessels up to2 mm |
| Description offunction | Ultrasonic Shears issterile, single patientuse instrumentsconsisting of anergonomic griphousing assembly withhand control buttons | Ultrasonic Scalpel issterile, single patientuse instrumentsconsisting of anergonomic grip housingassembly with handcontrol buttons | Not public |
| Elements ofComparison | Subject Device | Predicate Device 1 | Predicate Device 2 |
| Description ofpower level | The MAX button istypically used forsmaller vessels wherecutting speed isfastest. The MINbutton at power level 1is typically used inlarger vessels and hasreduced cutting speed.It is indicated forvessels up to 3 mm indiameter. | The MAX button istypically used for smallervessels where cuttingspeed is fastest. TheMIN button at powerlevel 1 is typically usedin larger vessels andhas reduced cuttingspeed. It is indicated forvessels up to 5 mm indiameter. | The instrumentallows for the cuttingof soft tissue andcoagulation ofvessels up to andincluding 2 mm indiameter. |
| Tissue self-adjustmenttechnology | Energy timelyadjustment technologyprovides the generatorwith the ability tomonitor the real-timeimpedance during useso that the generatorauto adjusts the poweroutput and delivers itto the UltrasonicShears, as well asprovides audiblefeedback to the user. | Energy timelyadjustment technologyprovides the generatorwith the ability tomonitor the real-timeimpedance during useso that the generatorauto adjusts the poweroutput and delivers it tothe ultrasonic scalpel, aswell as provides audiblefeedback to the user. | Not public |
| Outer Diameter(mm) | 5.5 mm | 5.5 mm | Not public |
| Blade frequency | 55.5KHz | 55.5KHz | 55.5KHz |
| Blade amplitude | (50-70) ±15μm | 50~100 μm | Not public |
| Bladedesign/geometry | Multi-purpose shears | Multi-purpose shears | Not public |
| Handle type | Pistol Grip | Pistol Grip | Not public |
| Energy activationmethod | Press Max/Min button | Press Max/Min button | Not public |
| Indicated vessel type | Veins and arteries | Veins and arteries | Not public |
| Energy buttons | Max/Min | Max/Min | Not public |
| Design | The device utilizesultrasonic energy to | The device utilizesultrasonic energy to | The device utilizesultrasonic energy to |
| Elements ofComparison | Subject Device | Predicate Device 1 | Predicate Device 2 |
| enable hemostaticcutting and/orcoagulation of softtissue | enable hemostaticcutting and/orcoagulation of softtissue | enable hemostaticcutting and/orcoagulation of softtissue | |
| Human Tissue orBody Fluids inContact with theDevice | Tissue | Tissue | Tissue |
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7. Test Summary
7.1 Summary of Non-Clinical Tests
Ultrasonic Surgical System has been evaluated the safety and performance by lab bench testing as following:
-
Sterilization
The Ultrasonic Shears, which was single use, was sterilized via ethylene oxide. The Ethylene oxide sterilization process is validated as per ISO 11135. The method used for ethylene oxide sterilization validation was overkill (half-cycle approach) method in a fixed chamber. Ethylene oxide residuals were tested and met ISO 10993-7 requirements.
Biocompatibility Testing
The Ultrasonic Shears is in direct contact with body tissue, with contact duration of less than 24 hours. Biocompatibility testing was conducted on the shear in question on 5 tests of in vitro cytotoxicity, intracutaneous reactivity, skin sensitization, acute systemic toxicity and pyrogen as per FDA quidance Use of international Standard ISO 10993-1, which indicated that the device was not toxic, irritating or sensitizing, and was free of acute systemic toxicity and pyrogen.
- A Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the proposed device. The system was shown to comply with IEC 60601-1-2:2020 for electromagnetic compatibility, IEC 60601-1:2020 and IEC 60601-2-18 for electrical safety.
A Performance testing
Performance test and functional tests were conducted on the proposed device in accordance with product design specifications. Data generated from the test met the predetermined acceptance criteria.
A Animal testing
The animal study was conducted on porcine model with test articles (Ultrasonic Surgical System) and control article (predicate device Ethicon G11). It consisted of three experiments, in vitro burst pressure, acute animal experiment and 21-day chronic animal's experiment. The
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experiments results show that the safety and efficacy of the tested articles are similar to those of the control articles.
■ Burst pressure testing
The test results demonstrated that either there was no statistical difference of burst pressure between test group and control group or the average burst pressure of test group was higher than that of the control group where there was statistical difference. There was no error or note observed during the in vitro burst experiment. Therefore, the results were deemed as acceptable.
-
Acute animal study
The test results demonstrated the times and thermal damage range of test article of each vessel diameter range did not have statistical difference compared with those of control article. There was no failure of sealing identified during all sealings after first activation and after challenge. -
. Chronic Animal Testing
Postoperative observation showed no abnormal phenomena in respiration, muscle movement,spasm, reflex, eye symptoms, salivation, hair standing, pain loss, muscle state, gastrointestinal condition, and skin condition in all animals. The gross examination of each animal demonstrated that there was no hematoma, bleeding or any other adverse condition of the sealed site. Few tissues showed moderate inflammatory cell infiltration, while most tissues showed a small number of inflammatory cells. There was wide fibrosis and mild tissue necrosis at the test site.
A Packaging & Shelf life
The packaging and shelf life study was also conducted to ensure package integrity throughout the shelf life, including primary packaging validation as per ISO 11607 and shelf life validation as per ASTM F1980.
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♪ Software Verification and Validation
The Software verification and validation is in compliance with FDA Guidance-Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. -
♪ Cleaning, Disinfection and Sterilization effectiveness
The methods for cleaning, disinfection, and sterilization of Hand Piece have been validated as per ISO 17664-1.
A Cybersecurity
The subject device does not have any external interfaces, according to FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", no need cybersecurity evaluation.
8. Final Conclusion:
The subject device Ultrasonic Surgical System has technological characteristics similar to the predicate device. Performance testing demonstrated that the differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially
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equivalent to the predicate devices K212614 and K151136 in terms of safety and effectiveness for requested indications for use.
N/A