(153 days)
The Unimicro Disposable Retrieval Endo-Pouch is intended for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.
The Unimicro Disposable Retrieval Endo-Pouch is a sterile and single-use specimen container designed for use in retrieving specimens during endoscopic surgery. The Unimicro Disposable Retrieval Endo-Pouch is supplied in a dispending tube for ease of insertion through a standard 10,11or 12mm trocar sheath.
The document is a 510(k) premarket notification for the Unimicro Disposable Retrieval Endo-Pouch. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical studies with acceptance criteria based on outcome measures.
Therefore, the information typically requested in your prompt (such as acceptance criteria for device performance in terms of accuracy, sensitivity, specificity, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and how ground truth for training data was established) is not applicable to this 510(k) submission for a medical device that retrieves tissues, organs, and calculi during surgical procedures.
Instead, the submission relies on demonstrating similarity in intended use, design, principles of operation, materials, performance, and sterilization to a predicate device. The "acceptance criteria" here refers to the successful completion of non-clinical (bench) testing to ensure the device performs as expected and meets safety requirements.
Here's a breakdown of the relevant information from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "A series of preclinical physical, mechanical and biocompatibility tests were performed to assess the safety and effectiveness of the Unimicro Disposable Retrieval Endo-Pouch. All the test results demonstrate the performance of Unimicro Disposable Retrieval Endo-Pouch meets the requirements of its predefined acceptance criteria and intended uses."
While the specific acceptance criteria and detailed quantitative results for each test are not provided in this summary document, the general categories of tests and the conclusion are stated.
| Category of Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Physical Tests | Device functions as intended without physical failure during simulated use or applicable stress. | Meets requirements of predefined acceptance criteria and intended uses. |
| Mechanical Tests | Device maintains structural integrity and performs mechanical actions (e.g., deployment, retrieval strength) as designed. | Meets requirements of predefined acceptance criteria and intended uses. |
| Biocompatibility Tests (ISO 10993 series) | Device materials are non-toxic, non-irritating, and non-sensitizing as per the specified ISO standards: | |
| ISO 10993-1:2009 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) | ||
| ISO 10993-5:2009 (Tests for in vitro cytotoxicity) | ||
| ISO 10993-10:2010 (Tests for irritation and skin sensitization) | ||
| ISO 10993-12:2012 (Sample preparation and reference materials) | Meets requirements of predefined acceptance criteria (by adhering to ISO standards) and intended uses. | |
| Sterilization (EO Sterilized) | Device achieves and maintains sterility. | EO Sterilized (implies successful sterilization validation). |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. Standard practice for non-clinical bench testing generally involves a sufficient number of units to demonstrate reproducibility and robustness, but specific numbers are not typically included in a 510(k) summary.
- Data Provenance: Not explicitly stated, but these are bench tests conducted by the manufacturer, Unimicro Medical Systems (ShenZhen) Co., Ltd., in China. The data would therefore be prospective in the sense that the tests were conducted specifically for this submission, but not in the clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a non-clinical device that collects specimens. There is no "ground truth" to be established by clinical experts in the context of the described bench tests. The tests evaluate physical, mechanical, and biological properties according to engineering and biocompatibility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As these are non-clinical bench tests evaluating device properties, there is no need for expert adjudication of results in the way it would be applied to a diagnostic imaging algorithm. Test results are typically objective measurements.
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:
- Not Applicable. This is a device for specimen retrieval, not a diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a medical device, not an algorithm. Bench testing evaluates the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. For non-clinical bench testing, the "ground truth" or reference standard would be the pre-defined engineering specifications, material properties, and biocompatibility standards (e.g., ISO 10993 suite). These are objective criteria.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established:
- Not Applicable. (See point 8).
Summary of Equivalence (rather than direct performance against clinical criteria):
The submission demonstrates substantial equivalence by comparing the Unimicro Disposable Retrieval Endo-Pouch to the predicate device, Unimax Specimen Retrieval System (K103510), across several parameters:
- Intended Use: Identical ("receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.")
- Design: Both consist of a flexible polymer bag and an introducer structure that fits through a trocar port.
- Principles of Operation: Implied to be identical given design and intended use.
- Materials: Both use "Various polymer Stainless."
- Performance: Supported by the statement "The result of bench testing indicates that the new device is as safe and effective as the predicate device" and that the non-clinical tests "demonstrate the performance... meets the requirements of its predefined acceptance criteria and intended uses."
- Sterilization: Both are EO Sterilized.
- Biocompatibility: Both adhere to ISO 10993 standards (with slightly updated versions for the proposed device, reflecting current standards).
In conclusion, this 510(k) submission establishes equivalence through non-clinical testing against predefined engineering and biocompatibility standards, rather than through clinical studies with performance metrics like sensitivity/specificity or expert-adjudicated ground truth.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes 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 (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.