(71 days)
The SpectraScience™ Reusable Biopsy Forceps are designed specifically to provide adjunctive illumination while collecting tissue endoscopically for bistological examination. The instruments are intended for endoscopic gastrointestinal and urologic biopsy and should not be used for any purpose other than their intended function.
The current biopsy forceps design has not changed during its long course of past clinical utility. The standard hinged design utilizes cup-shaped jaws to bite or pinch off tissue with minimal complications while providing a viable tissue sample. The cup-shaped jaws also serve to hold the biopsy sample within the forceps until the tissue can be transferred to a biopsy container. The proposed SpectraScience™ Reusable Biopsy Forceps uses the most basic of standard design. The mechanism of action of the SpectraScience™ design is identical to predicate devices in that the same standard mechanical design, materials and sizes are utilized. Using essentially identical mechanisms of action and materials results in identical clinical performance. The SpectraSciences design employs an adjunctive technological characteristic. The SpectraScience design incorporates an optical illumination fiber. The optical illumination fiber is intended to provide the endoscopist with additional light from a different angle compared to the endoscope's light source. In various anatomies under certain circumstances, the endoscope's light angle may not reveal critical structural contours which should be considered before a biopsy is performed. The intent of the SpectraSciences device is to enhance visualization and thus result in more accurate and precise identification and location of the tissue to be sampled.
The document provided is a 510(k) Notification for SpectraScience™ Reusable Biopsy Forceps, dated September 17, 1997. It describes the device, its intended use, and its substantial equivalence to predicate devices. The notification emphasizes the addition of an optical illumination fiber as an "adjunctive technological characteristic" to enhance visualization during endoscopic biopsy without changing the core mechanism of action.
Based on the provided information, here's an analysis of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Verified by vendor certifications and vendor biocompatibility testing. |
| Mechanical Performance | Mechanical design, mechanisms of action, materials, dimensions, workmanship, operation, light transmittance, and light source connections are identical to predicate devices. The employment of an optical illumination fiber does not change the forceps' mechanism of action, performance, nor biopsy technique. |
| Intended Use | Designed specifically to collect tissue endoscopically for histologic examination, intended for endoscopic gastrointestinal and urologic biopsy. |
| Safety and Effectiveness | The application of adjunctive (xenon or intensity equivalent) light will have no adverse effect on tissue. The proven biocompatibility, safety, and effectiveness, and clinical utility of fiberoptic illumination dates from prior to the 1976 amendments to present. The device does not negatively affect the safety or effectiveness of performing endoscopic biopsy. |
| Substantial Equivalence | Believed to be substantially equivalent to predicate products due to the use of identical design, materials, indications for use, and packaging, with the addition of an optical illumination fiber for enhanced visualization. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a test set or any specific clinical studies involving human subjects or collected data from a particular country. The approval is based on a claim of substantial equivalence to predicate devices, supported by bench testing and material specifications, not clinical trial data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as there was no test set or expert-established ground truth described in the submission. The assessment relies on a comparison to existing, already-approved medical devices.
4. Adjudication Method for the Test Set:
This information is not applicable as there was no test set described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
No MRMC comparative effectiveness study was described. The device's enhancement is qualitative (improved visualization) rather than a quantitative measure of performance that would typically be assessed in an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This device is a physical medical instrument, not an AI algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this submission is the established safety and effectiveness of the predicate devices and the accepted principles of medical device engineering and biocompatibility. For the enhanced visualization feature, the ground truth is the historical and accepted safety and utility of fiberoptic illumination in medical devices.
8. The Sample Size for the Training Set:
This information is not applicable as there is no mention of a training set for an AI algorithm.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no mention of a training set for an AI algorithm.
Summary of the Study and Device Proof:
The SpectraScience™ Reusable Biopsy Forceps gained clearance through a 510(k) submission, demonstrating substantial equivalence to existing predicate devices. The "study" described is primarily based on engineering analysis, material scientific data, and historical precedent. The manufacturer asserts that the new device shares the same fundamental design, materials, and mechanism of action as previously approved biopsy forceps. The key addition, an optical illumination fiber, is justified by its long history of safe and effective use in other medical contexts, and the claim is made that it enhances visualization without altering the core function or safety of the biopsy procedure. Therefore, the proof of meeting acceptance criteria is largely through comparison to established medical device standards and the known performance of predicate devices, rather than a novel clinical study with a specific test or training set.
§ 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.