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510(k) Data Aggregation
(184 days)
This device is used for endoscopic histological sampling or electrocoagulation of various tissues, within the gastrointestinal and bronchial tracts, via the operating channel of endoscopic instruments.
The proposed device Disposable Hot Biopsy Forceps is a sterile, single-use endoscopic device, intended to be used for endoscopic histological sampling or electrocoagulation of various tissues, within the gastrointestinal and bronchial tracts, via the operating channel of endoscopic instruments. It consists of a flexible wire cable and jaws which can be opened and closed by a handle. When passed through an endoscope the forceps can be activated to deliver a monopolar electrical current for histological sampling or electrocoagulation with the jaws.
The main component of the proposed device is jaws, spring sheath and handle.
The proposed device has four (4) models, HBF55-11023180 and HBF55-11023230, HBF65-11023180 and HBF65-11023230. HBF65-11023180 and HBF65-11023230 are two new models added. The differences between the two new models and the two approved models (predicate device) are the color of Handle and the jaws. The news models are White-blue Handle and Alligator Forceps; the two approved models are Grey-blue Handle and oval forceps.
The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10 to the power of -6 and placed in a sterility maintenance package to ensure a shelf life of 3 years.
The provided FDA 510(k) summary (K180018) for the "Disposable Hot Biopsy Forceps" describes the acceptance criteria and the studies performed to demonstrate that the device meets those criteria.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
The document states that "Non clinical tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment, the non-clinical tests verify that the proposed device met all acceptance criteria." However, it does not provide a specific table detailing each acceptance criterion with a corresponding reported performance outcome. Instead, it lists the standards that the device complies with, implying that meeting these standards constitutes the acceptance criteria.
| Acceptance Criteria (Implied by Standards Met) | Reported Device Performance (Implied by Compliance) |
|---|---|
| Seal Strength of Flexible Barrier Materials (ASTM F88/F88M-15) | Complies with standard |
| Detecting Seal Leaks in Porous Medical Packaging By Dye Penetration (ASTM F1929-15) | Complies with standard |
| Internal Pressurization Failure Resistance Of Unrestrained Packages (ASTM F1140/F1140M-13) | Complies with standard |
| Integrity of Seals for Flexible Packaging by Visual Inspection (ASTM F1886/F1886M–16) | Complies with standard |
| Sterility (USP 40 - NF35:2017 <71>) | Complies with standard (Sterility Assurance Level: $10^{-6}$) |
| Accelerated Aging of Sterile Barrier Systems for Medical Devices (ASTM F1980-16) | Complies with standard |
| Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process (ISO 10993-1:2009) | Complies with standard |
| Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity (ISO 10993-5: 2009) | Complies with standard |
| Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10: 2010) | Complies with standard |
| Biological evaluation of medical devices-Part 11: Tests for systemic toxicity (ISO 10993-11: 2006) | Complies with standard |
| Pyrogen Test (USP 40 NF 35:2017 <151>) | Complies with standard |
| Sterilization of health care products - Ethylene oxide -Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135 Second Edition 2014) | Complies with standard |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for each of the non-clinical tests listed. It also does not explicitly state the provenance (country of origin, retrospective/prospective) of the data beyond the fact that Micro-Tech (Nanjing) Co., Ltd. is located in Nanjing, Jiangsu, China. The tests are described as "Non-Clinical Tests," implying laboratory or bench testing rather than human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The studies conducted are non-clinical (bench/laboratory tests) and do not involve human subject interpretation or expert ground truth establishment in the medical sense (e.g., radiologists interpreting images).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the studies are non-clinical and do not involve human interpretation or adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. The submission explicitly states: "No clinical study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical instrument (Disposable Hot Biopsy Forceps), not a software algorithm, so the concept of standalone performance for an algorithm does not apply. The "performance" here refers to the physical and biological properties of the device meeting established standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" is established by the specifications and measurement techniques outlined in the referenced international and national standards (e.g., ASTM, ISO, USP). For example, a "sealed" package must pass specific dye penetration or burst strength tests as defined by the ASTM standards, and "sterility" is defined by the absence of microbial growth as per USP <71> criteria.
8. The sample size for the training set
This is not applicable. This device is a physical medical device and does not involve machine learning algorithms that require a "training set."
9. How the ground truth for the training set was established
This is not applicable as there is no "training set" for this type of medical device submission.
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