(184 days)
This instrument has been designed to be used with endoscopes to collect tissue, cauterize, coagulate and perform hemostasis using high-frequency current within the digestive tract.
The subject device Disposable Hot Biopsy Forceps is a sterile, single-use endoscopic device, intended to be used with endoscopes to cut, coagulate and stop bleeding in the digestive tract by using high-frequency current.
The disposable Hot Biopsy Forceps consists of an insertion part and a handle part. The insertion part includes a jaw assembly and a spring tube; the handle part includes a handle, a finger ring, a conductive column, a rotating sleeve, a locking sleeve, and a sheath tube.
The subject device has 7 specifications. The differences among these models are the jaws type, Jaw O.D, and Working Length.
The subject device is EO sterilized to achieve the Sterility Assurance Level (SAL) of 10 ° and placed in a sterility maintenance package to ensure a shelf life of 3 years.
The materials used for construction of Disposable Hot Biopsy Forceps are typical for this type of medical device. Materials of Jaw and spring tube is stainless steel SUS304, the Sheath tube is made of HDPE, the Locking sleeve, Rotating sleeve and handle are made of ABS. The conductive column is made of H62.
Based on the provided text, the device in question is a "Disposable Hot Biopsy Forceps" and it is a Class II medical device. The document describes several non-clinical tests conducted to evaluate its performance and functionality against specific acceptance criteria.
However, it's crucial to note that the provided text explicitly states: "No clinical study is included in this submission." This means that the device's acceptance criteria and proven performance are based solely on non-clinical (bench) testing, not on human-in-the-loop (MRMC) or standalone (algorithm only) clinical performance studies.
Therefore, for the following points, I can only provide information based on the non-clinical test data presented. Information related to clinical studies, human expert involvement, or AI performance will be marked as "Not Applicable" or "Not Provided" as per the document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical thresholds for each test item in a clear "acceptance criteria" column. Instead, the "Description" column implies the criteria (e.g., "smooth rotation and without interference" for rotation performance). The reported performance is generally stated as "has been verified" or "fulfilled." For "Conduction resistance," a numerical acceptance criterion and result are provided.
| Test Item | Acceptance Criteria (Implied from Description) | Reported Device Performance |
|---|---|---|
| Appearance | Integrity, cleanliness, and hygiene | Confirmed |
| Dimension | Complied with company's requirements | Confirmed |
| Rotation performance | Smooth rotation and without interference | Verified (smooth rotation confirmed) |
| Pushability Testing | Ease and smoothness of advancement through endoscope working channel | Verified |
| Actuation Testing | Functional, proper opening/closing for effective tissue sampling | Verified |
| Hemostatic Performance Testing | Ability to achieve hemostasis effectively after tissue sampling | Verified |
| Compatibility testing with endoscopes | Free insertion into corresponding endoscope orifice, no distortion or resistance | Verified (can be freely inserted without distortion or resistance) |
| Conduction resistance | $\le 30 \Omega$ | Confirmed to be $\le 30 \Omega$ |
| Sterility | Sterile (Sterilized by ethylene oxide) | Confirmed to be sterile |
| EO residue | $\le 10 \mu g/g$ | Confirmed to be $\le 10 \mu g/g$ |
| Biocompatibility | Fulfilled ISO 10993 criteria (non-toxic and biocompatible) | Verified |
| Sterilization and shelf life | Sterility Assurance Level (SAL) of 10⁻⁶ and 3-year shelf life | Successfully tested according to ISO 11135 and ASTM 1980, 3-year shelf life. |
| Electromagnetic Compatibility and Electrical Safety | Conform to IEC 60601-1:2005+A1:2012 and IEC 60601-2-2:2017 | Performed in accordance with standards |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each non-clinical test (e.g., how many forceps were tested for pushability). It broadly states "Bench testing was performed."
- Sample Size: Not explicitly stated for individual tests. The phrasing "the subject device has been subjected to compliance testing" implies a sufficient number of units were tested to demonstrate compliance.
- Data Provenance: This is non-clinical bench test data, not patient data. The tests were performed in a lab setting by the manufacturer, Beijing ZKSK Technology Co., Ltd. (China). The document does not specify whether the data is retrospective or prospective, as this distinction typically applies to clinical studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. These are non-clinical bench tests; ground truth is established by objective measurements against engineering specifications and industry standards, not by human expert interpretation of medical images or conditions.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As these are non-clinical, objective bench tests, there is no need for expert adjudication. The results are based on direct measurement or observation against predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. The document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study comparing human readers with and without AI assistance was performed or reported.
- Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Study: No. The device is a physical medical instrument (forceps), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance evaluation is for the physical device itself.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the non-clinical tests is based on engineering specifications, industry standards (e.g., ISO, IEC), and predefined functional requirements. For example, the criterion for "Conduction resistance" ($\le 30 \Omega$) is an engineering specification. Biocompatibility is assessed against ISO 10993 standards.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI model. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as this is not an AI model requiring a training set. The design and validation of the device rely on established engineering principles and compliance with relevant medical device standards.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).