(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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