(306 days)
The Disposable Semi Automatic Biopsy Instrument is intended for obtaining percutaneous or surgical histological core samples from soft tissues such as breast, kidney, liver, lung and various soft tissue masses. The device is not intended for use in bone.
The extent of histological abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality (e.g. malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures
The disposable semi automatic biopsy instrument (hereinafter referred to as biopsy instrument) is divided into A and B in accordance with different configuration. A contains semi automatic biopsy needle. B contains semi automatic biopsy needle and coaxial biopsy needle.
The disposable semi automatic biopsy instrument consists of cannula, stylet, protecting sheath and mechanical powering parts. The coaxial biopsy needle consists of canular housing, canula, marker, stylet with sharping, stylet without sharping (option), stylet housing and protecting sheath.
It is available in several gauge sizes and lengths. Both the A and B of the device have printed gauge size indicator that is color coded according to the various gauge sizes (yellow= 20G, pink= 18G, purple= 16 G, and green= 14G). The needles have a protecting sheath.
The disposable semi automatic biopsy instrument is loaded a semi automatic biopsy needle that is visible in ultrasound. The device is equipped with a beveled needle with centimeter markings and an echogenic distal tip for visualization during ultrasound imaging. Centimeter markings on the cannula surface permits an easy identification of the insertion depth with the maximum safety for the patient.During use, the position of the device is monitored using technique. The inner stylet which has a triple face ultra-sharp tip to penetrate easily also into fibrous tissues is equipped with a slot/ groove (a 19mm specimen notch) to collect a biopsy specimen.
During use, the position of the device is monitored using imaging technique. The inner stylet is equipped with a slot (specimen notch) to collect a biopsy specimen.
The materials used for construction of disposable semi automatic biopsy instrument are typical for this type of medical device. The only material in direct patient contact is the stainless steel 06Cr19Ni10.
As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.
This document describes acceptance criteria and testing for the Disposable Semi Automatic Biopsy Instrument (K212820) by Suzhou Leapmed Healthcare Corporation.
Acceptance Criteria and Device Performance Study
The acceptance criteria for the Disposable Semi Automatic Biopsy Instrument are based on non-clinical testing, particularly bench testing, to assess performance and functionality against requirement specifications and recognized consensus standards. The study demonstrates that the device performs equivalently to its predicate device (SemiCut Semi-automatic Biopsy Needle, K160316) and meets safety and effectiveness requirements.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria / Standard Compliance | Reported Device Performance |
|---|---|---|
| Sterilization | ISO 11607-1 (for sterile barrier systems), SAL: 10-6 | Successfully tested, delivered sterile, shelf life of 3 years. |
| Biocompatibility | ISO 10993 (Cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, material-mediated pyrogenicity) | Test results verify that ISO 10993 criteria are fulfilled. Concluded as non-toxic and biocompatible. |
| Depth projection | Device will not extend over the stylet tip during use. | Conformity demonstrated. |
| Penetration force | Equivalent to predicate device. | Conformity demonstrated. |
| Stiffness | Per ISO 9626. | Conformity demonstrated. |
| Resistance to Breakage | Per ISO 9626. | Conformity demonstrated. |
| Bonding Strength | Per ISO 7864 (connection firmness). | Conformity demonstrated. |
| Biopsy Tissue Sample | Successfully retrieve biopsy specimen multiple times. | Conformity demonstrated. |
| Ultrasound Visibility | Invasive part visible in the area guided by puncture frame or within ultrasound range. | Conformity demonstrated. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each bench test. However, it indicates that "bench testing was performed" and "results from testing performed confirms that the design requirement specification and user needs have been met." The tests involved evaluating the subject device against technical specifications and sometimes comparing it directly with the predicate device.
The data provenance is non-clinical bench testing conducted by the manufacturer, Suzhou Leapmed Healthcare Corporation. No information regarding country of origin for the test data itself is given beyond the company's location in China. The testing is reported as retrospective in the sense that it evaluates the manufactured device against pre-defined specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of submission. The ground truth for the bench testing is established by compliance with international standards (ISO 9626, ISO 10993, ISO 11607, ISO 7864) and manufacturer's design specifications. No human expert "ground truth" in the diagnostic sense is required for these mechanical and material tests.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements against defined criteria in established international standards. There is no human interpretation or adjudication in the typical sense (e.g., 2+1, 3+1 consensus) as would be the case for clinical image interpretation.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical study is included in this submission." This device gained clearance based on non-clinical (bench) testing and substantial equivalence to a predicate device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical medical instrument (biopsy instrument), not an AI algorithm or software. Therefore, the concept of "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests is based on:
- Engineering specifications: The device's design requirements, such as depth projection and bonding strength.
- International Consensus Standards: ISO 9626 (Stiffness, Resistance to Breakage), ISO 10993 (Biocompatibility), ISO 11607-1 (Sterilization and Shelf Life), ISO 7864 (Bonding Strength).
- Functional requirements: The ability to successfully retrieve biopsy specimens and ultrasound visibility.
8. The Sample Size for the Training Set
Not applicable. This submission concerns a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.