(90 days)
Not Found
Not Found
No
The device description focuses on a mechanical design with an added fiberoptic illumination fiber, with no mention of AI or ML capabilities.
No.
The device is used to collect tissue for histologic examination and provides adjunctive illumination, it does not directly treat or prevent a disease or condition.
No
The device is designed for collecting tissue samples and providing adjunctive illumination during endoscopic procedures. It does not perform any diagnostic function itself; the tissue collected would then be sent for histologic examination, which is where the diagnosis would take place.
No
The device description clearly details a physical biopsy forceps with mechanical components and a fiberoptic illumination fiber, indicating it is a hardware device.
Based on the provided information, the SpectraScience Biopsy Forceps is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide adjunctive illumination while collecting tissue endoscopically for histologic examination." This describes a tool used during a medical procedure to aid in tissue collection.
- Device Description: The device is a mechanical biopsy forceps with an added fiberoptic light source. It's designed to physically obtain a tissue sample.
- Lack of Diagnostic Function: The device itself does not perform any diagnostic testing on the tissue sample. The tissue is collected for subsequent histologic examination, which is where the diagnostic process occurs. IVD devices are designed to perform tests on biological samples to provide diagnostic information.
The SpectraScience Biopsy Forceps is a medical device used for tissue collection, which is a step that precedes in vitro diagnostic testing (histologic examination).
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
Device Description
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. 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 SpectraScience device is to enhance visualization and thus result in more accurate and precise identification and location of the tissue to be sampled.
The employment of an illumination fiber does not change the forceps' mechanism of action, performance, nor biopsy technique when compared to using standard biopsy forceps. The SpectraScience biopsy forceps illuminates automatically once the forceps jaws are opened. No additional movements, techniques, or steps will be required to deliver additional light to the targeted location. 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. Therefore, the application of adjunctive light via the SpectraScience biopsy forceps does not negatively affect the safety or effectiveness of performing endoscopic biopsy. On the contrary, adjunctive light is intended to enhance the endoscopist's view of the location to be biopsied.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal and urologic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
endoscopist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Device testing included:
- Sterilization: standard and defined methods, packaging materials identical to predicate devices.
- Biocompatibility: verified by vendor certifications and vendor biocompatibility testing.
- Mechanical mechanisms: Mechanical design, of action, materials, dimensions, workmanship, operation, light transmittance, and light source connections are identical to predicate devices.
Key Result: SpectraScience, Inc., believes that their biopsy forceps are substantially equivalent to the predicate products due to the use of identical design, materials, indications for use and packaging.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
U.S. Endoscopy Group Inc., Disposable Biopsy Forceps Model #00711206
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary | DEC - 2 1996 | 510(k) Number: K963517 | f172 |
---|---|---|---|
SpectraScience Biopsy Forceps | |||
Summary Prepared | November 22, 1996 | ||
Submitter's Name and | |||
Address | SpectraScience, Inc. | ||
3650 Annapolis Lane, Suite 101 | |||
Plymouth, MN 55447 | |||
Contact Person | Brian McMahon, President and CEO | ||
SpectraScience, Inc3650 Annapolis Lane, Suite 101 | |||
Plymouth, MN 55447 | |||
612-509-9999(telephone) | |||
612-509-9805 (fax) | |||
Device Name | |||
Proprietary Name: | SpectraScience Biopsy Forceps | ||
Common Name: | Biopsy Forceps | ||
Classification Name: | Gastroenterology-Urology Biopsy Instruments (21 CFR 876.1075) | ||
Predicate Device | U.S. Endoscopy Group Inc., Disposable Biopsy Forceps | ||
Model #00711206 | |||
Device Description | 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. | |||
In various anatomies under certain circumstances, the | |||
endoscope's light angle may not reveal critical structural |
1
contours which should be considered before a biopsy is The intent of the SpectraScience device is to performed. enhance visualization and thus result in more accurate and precise identification and location of the tissue to be sampled.
The employment of an illumination fiber does not change the forceps' mechanism of action, performance, nor biopsy technique when compared to using standard biopsy forceps. The SpectraScience biopsy forceps illuminates automatically once the forceps jaws are opened. No additional movements, techniques, or steps will be required to deliver additional light to the targeted location. 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. Therefore, the application of adjunctive light via the SpectraScience biopsy forceps does not negatively affect the safety or effectiveness of performing endoscopic biopsy. On the contrary, adjunctive light is intended to enhance the endoscopist's view of the location to be biopsied.
Product Testing
Sterilization
Intended Use
Biocompatibility Biocompatibility is verified by vendor certifications and vendor biocompatibility testing.
Sterilization methods are standard and defined. Packaging materials are identical to predicate devices.
-
Mechanical mechanisms Mechanical design, of action, materials, dimensions, workmanship, operation, light transmittance, and light source connections are identical to predicate devices and therefore substantially equivalent.
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. -
Conclusion SpectraScience, Inc., believes that their biopsy forceps are substantially equivalent to the predicate products due to the use of identical design, materials, indications for use and packaging.