(139 days)
The MediSISS Reprocessed Non-electric Biopsy Forceps are intended to be used to remove polyps, and obtain a specimen of tissue for microscopic examination.
MediSISS Reprocessed Non-electric GI Biopsy Forceps are designed for endoscopic use to retrieve tissue samples for microscopic inspection. Forceps outer diameters range from 2,2mm to 2.5mm and working lengths vary from 160cm. A syringe-like proximal handle opens and closes the distal instrument jaws, that are available in multiple design configurations such as Oval, Alligator, Smooth, or Fenestrated with and without a needle. The working length of the biopsy forceps is coated with a plastic sheath to decrease friction.
The provided document is a 510(k) summary for the MediSISS Reprocessed Non-electric GI Biopsy Forceps. This type of document is for a medical device that processes existing devices, rather than a diagnostic AI device. As such, the specific criteria for AI model performance (like sensitivity, specificity, MRMC studies, ground truth establishment for training/test sets) are not applicable.
Instead, the acceptance criteria and study information provided relate to the reprocessing of surgical instruments to ensure they are safe and effective for reuse, demonstrating substantial equivalence to new, unused predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Description | Reported Device Performance (Summary of Validation Data) |
|---|---|---|
| Cleaning | Processed device must be adequately cleaned to remove biological and other contaminants, adhering to established standards to ensure patient safety and prevent cross-contamination. | "MediSISS has validated its cleaning...processes Non-Electric GI Biopsy Forceps. Successful validation, and routine tests monitor the safety and effectiveness of our product post sterilization." The conclusion states, "MediSISS Reprocessed Non-electric GI Biopsy Forceps are substantially equivalent to the legally marketed predicate devices with respect to cleanliness..." |
| Sterilization | Reprocessed device must achieve and maintain sterility to eliminate microbial life, meeting specified Sterility Assurance Levels (SALs) as per regulatory standards. Ethylene Oxide sterilization residuals must also be within acceptable limits. | "MediSISS has validated its...sterilization...processes Non-Electric GI Biopsy Forceps. Successful validation, and routine tests monitor the safety and effectiveness of our product post sterilization." The conclusion states, "MediSISS Reprocessed Non-electric GI Biopsy Forceps are substantially equivalent to the legally marketed predicate devices with respect to...sterility..." |
| Functional Performance | Reprocessed device must perform its intended function (e.g., retrieving tissue samples) without degradation in performance compared to new devices, for the maximum number of intended uses. This includes mechanical integrity and operational effectiveness. | "MediSISS has validated its...functional performance...processes Non-Electric GI Biopsy Forceps. Successful validation, and routine tests monitor the safety and effectiveness of our product post sterilization. We have demonstrated with a high degree of assurance that MediSISS Reprocessed Non-Electric GI Biopsy Forceps...will continue to be safe and effective for the maximum number of intended uses." |
| Packaging and Distribution | Packaging must maintain sterility and protect the device during storage and transport. Packaging integrity and seal strength must be validated. | "MediSISS has validated its...packaging and distribution processes Non-Electric GI Biopsy Forceps. Successful validation, and routine tests monitor the safety and effectiveness of our product post sterilization." The conclusion states, "MediSISS Reprocessed Non-electric GI Biopsy Forceps are substantially equivalent to the legally marketed predicate devices with respect to...packaging..." |
| Biocompatibility | Materials in contact with patients after reprocessing should not cause adverse biological reactions due to residuals or material changes. (Implied by sterilization and cleaning standards, especially regarding ETO residuals). | ANSI/AAMI/ISO 10993:1995, Biological Evaluation-Part 7: Ethylene Oxide Sterilization Residuals, is listed as an applicable standard, indicating that residuals were evaluated to ensure biocompatibility. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the specific sample sizes for each validation test (cleaning, sterilization, functional performance, packaging). However, it refers to "validation data" and "routine tests" which implies a sampling methodology was used in accordance with the listed standards.
Data provenance refers to the origin and history of data. In this context, it relates to the devices that were reprocessed and tested. The predicate devices are from manufacturers like Bard, Esco Precision, Inc., and Olympus. The MediSISS device itself is a reprocessed version of various OEM models (e.g., Bard 385, Microvasive 1537, Olympus FB-240U, Wilson-Cook SDE 2.5-230). The testing would have been conducted on these reprocessed devices, likely in a controlled laboratory or testing facility ("retrospective" in the sense that the original devices are already manufactured, but "prospective" in the sense that the reprocessing and validation are performed afterward).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information (number and qualification of specific experts for ground truth) is typically not applicable to the validation of reprocessed surgical instruments. The "ground truth" here is adherence to established engineering, microbiological, and material science standards. These standards (e.g., ISO, AAMI, ASTM, USP) are developed and maintained by expert committees and are considered the "ground truth" for safe and effective reprocessing. Compliance with these standards is assessed through validated test methods, not by subjective expert consensus on 'cases'.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert disagreement in diagnostic image reading. For device reprocessing validation, objective measurements and adherence to performance specifications of the listed standards dictate acceptance or rejection.
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 device is a reprocessed surgical instrument, not an AI diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to AI algorithm performance without human intervention, which is not relevant to a reprocessed surgical instrument.
7. The Type of Ground Truth Used
The "ground truth" for the reprocessed non-electric GI biopsy forceps is defined by:
- Adherence to recognized industry standards: ANSI/AAMI/ISO 11737-1, AAMI TIR No. 12, ASTM D4164, ISO 11607, ANSI/AAMI/ISO 11135, ANSI/AAMI/ISO 10993, ASTM F88, ASTM F1980, United States Pharmacopeia 24, ASTM F2096-02. These standards specify acceptable limits for microbial load, sterility, residual levels, functional performance, and packaging integrity.
- Substantial equivalence to legally marketed predicate devices: The "ground truth" for safety and effectiveness is benchmarked against new, unused predicate devices (Bard K912549, Esco Precision K900015, Olympus K955065). Validation data confirmed that the reprocessed devices perform equivalently to these new devices.
8. The Sample Size for the Training Set
Not applicable. This concept is relevant for AI models, not for traditional medical device reprocessing validation.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the context of this device's validation.
§ 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.