(90 days)
The SpectraScience Biopsy Forceps are designed specifically to provide adjunctive illumination while collecting tissue endoscopically for histologic 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 design of biopsy forceps 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 biopsy forceps uses the most basic of standard designs in that no teeth or spikes will be employed in the 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 identical mechanisms of action and materials results in identical clinical performance. The SpectraScience design employs a different technological characteristic. The SpectraScience design incorporates a fiberoptic illumination fiber. The illumination fiber is intended to provide the endoscopist with adjunctive light directed at the tissue biopsy site in addition to the endoscope's light source.
This 510(k) summary describes a medical device, the SpectraScience Biopsy Forceps, for which the manufacturer is seeking clearance through a substantial equivalence pathway. As such, the document primarily focuses on establishing that the new device is as safe and effective as a legally marketed predicate device, rather than providing a detailed study proving performance against acceptance criteria in the way a novel device might.
Therefore, many of the typical elements of an AI/ML device study (like sample size for test sets, ground truth establishment, or human reader studies) are not present in this summary. The manufacturer's argument for substantial equivalence relies on the device sharing fundamental design, materials, and mechanisms with existing devices, with the addition of a fiberoptic illumination feature.
Here's an analysis based on the provided text, addressing the requested points where information is available or inferable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sterilization: Standard and effective sterilization. | "Sterilization methods are standard and defined." "Packaging materials are identical to predicate devices." |
| Intended Use: Consistent with current biopsy forceps. | "The SpectraScience Biopsy Forceps are designed specifically to provide adjunctive illumination while collecting tissue endoscopically for histologic examination. The instruments are intended for endoscopic gastrointestinal and urologic biopsy and should not be used for any purpose other than their intended function." |
| Biocompatibility: Non-toxic and safe for contact with tissue. | "Biocompatibility is verified by vendor certifications and vendor biocompatibility testing." |
| Mechanical Performance: Equivalent to predicate devices. | "Mechanical design, of action, materials, dimensions, workmanship, operation, light transmittance, and light source connections are identical to predicate devices and therefore substantially equivalent." |
| Illumination Safety & Effectiveness: Adjunctive light is safe and enhances visualization without adverse effects on tissue. | "The application of adjunctive cold (xenon or equivalent) light will have no adverse effect on tissue." "The proposed illumination technology is identical to the illumination provided by the endoscope." "The proven biocompatibility, safety and effectiveness, and clinical utility of fiberoptic illumination dates pre 1976 amendment to present." "On the contrary, adjunctive light is intended to enhance the endoscopist's view of the location to be biopsied." |
| Clinical Performance: Identical to predicate device in terms of tissue sampling. | "The SpectraScience design is identical to predicate devices in that the same standard mechanical design, materials and sizes are utilized. Using identical mechanisms of action and materials results in identical clinical performance." |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not applicable in the context of this 510(k) summary. This submission relies on demonstrating substantial equivalence to a predicate device through engineering and material comparisons, not a clinical trial with a "test set" of patient data for performance evaluation in the typical sense.
- Data Provenance: Not applicable. The "data" here primarily refers to engineering specifications, material certifications, and a comparison to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" derived from expert consensus on a test set of cases as this is not an AI/ML device requiring clinical validation against ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set requiring adjudication in this context.
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. This is not an AI/ML device, and no MRMC study was conducted or mentioned. The device's enhancement is a physical illumination feature, not an AI assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm, so a standalone performance study as described would not be relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" equivalent would be established engineering standards, material properties, and the known performance of the predicate device. The claim of "identical clinical performance" is based on having "identical mechanisms of action and materials," implying that if the fundamental physical aspects are identical, the outcome (tissue sampling) will be identical.
8. The sample size for the training set:
- Not applicable. This summary is not about an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set is involved.
§ 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.