(71 days)
Not Found
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No
The description focuses on a mechanical biopsy forceps with an added optical illumination fiber for enhanced visualization. There is no mention of data processing, algorithms, or learning capabilities.
No
The device is described as biopsy forceps, used for collecting tissue samples for examination, which is a diagnostic purpose, not a therapeutic one. Its additional illumination feature also serves to enhance visualization for diagnostic sampling.
No
The device is designed to collect tissue for histological examination and to enhance visualization during a biopsy procedure, not to interpret or diagnose based on the collected tissue or visual information. While it aids in the process of obtaining a diagnostic sample, it does not perform the diagnostic function itself.
No
The device description clearly details a physical, reusable biopsy forceps with mechanical components (hinged design, cup-shaped jaws) and an optical illumination fiber. It is a hardware device, not software only.
Based on the provided information, the SpectraScience™ Reusable Biopsy Forceps is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment. The SpectraScience™ Reusable Biopsy Forceps is a tool used to collect the tissue sample, not to perform the diagnostic test on the sample itself.
- The intended use is for collecting tissue endoscopically for histological examination. The histological examination (the analysis of the tissue) is the diagnostic part, which would be performed using other IVD devices and procedures in a laboratory setting.
- The device's function is mechanical (biting off tissue) and provides adjunctive illumination. These are actions performed on the patient during the procedure, not on a specimen in vitro (outside the body).
The device is a surgical/endoscopic instrument used for tissue collection, which is a step prior to the in vitro diagnostic process.
N/A
Intended Use / Indications for Use
The SpectraScience™ Reusable Biopsy Forceps are designed specifically to collect 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 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.
Product codes (comma separated list FDA assigned to the subject device)
78 GCT, 78 FCL
Device Description
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 employment of an optical illumination fiber does not change the forceps' mechanism of action, performance, nor biopsy technique when compared to using standard biopsy forceps. The SpectraScience™ Reusable Biopsy Forceps illuminates automatically once the forceps jaws are opened. No additional movements, techniques, or steps are required to deliver additional light to the targeted location. 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. Therefore, the application of adjunctive light via the SpectraScience™ Reusable 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, 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
SpectraScience™ Single Use Biopsy Forceps
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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) Notification SpectraScience™, Inc. Reusable Biopsy Forceps
September 17, 1997
Ag 10f 2 X 9736 11 510(k) Summary SpectraScience™ Reusable Biopsy Forceps DEC - 2 1997 September 17, 1997 Summary Prepared SpectraScience™, Inc. Submitter's Name and 3650 Annapolis Lane, Suite 101 Address Minneapolis, MN 55447-5434 John G. Yager Contact Person Director, Quality Assurance and Regulatory Affairs SpectraScience™, Inc. 3650 Annapolis Lane, Suite 101 Minneapolis, MN 55447-5434 612-509-9999 (telephone) 612-509-9805 (fax) Device Name SpectraScience™ Reusable Biopsy Forceps Proprietary Name: Reusable Biopsy Forceps Common Name: Gastroenterology-Urology Biopsy Instruments (21 CFR 876.1075) Classification Name: (Class I exempt) SpectraScience™ Single Use Biopsy Forceps Predicate Device The current biopsy forceps design has not changed during its long course Device Description 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
1
K973611 Pg2gr
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 employment of an optical illumination fiber does not change the forceps' mechanism of action, performance, nor biopsy technique when compared to using standard biopsy forceps. The SpectraScience™ Reusable Biopsy Forceps illuminates automatically once the forceps jaws are opened. No additional movements, techniques, or steps are required to deliver additional light to the targeted location. 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. Therefore, the application of adjunctive light via the SpectraScience™ Reusable 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
Biocompatibility | Biocompatibility is verified by vendor certifications and vendor
biocompatibility testing. |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mechanical | Mechanical design, mechanisms of action, materials, dimensions,
workmanship, operation, light transmittance, and light source connections
are identical to predicate devices and therefore substantially equivalent. |
| Intended Use | The SpectraScience™ Reusable Biopsy Forceps are designed specifically
to collect 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 Reusable Biopsy Forceps are
substantially equivalent to the predicate products due to the use of
identical design, materials, indications for use and packaging. |
2
Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 2 1997
Mr. John G. Yager Director, Regulatory Affairs and Ouality Assurance Spectra Science Inc. 3650 Annapolis Lane, Suite 101 Minneapolis, Minnesota 55447
Re: K973611
Spectra Science™ Reusable Biopsy Forceps Dated: September 17, 1997 Received: September 22, 1997 Regulatory Class: II 21 CFR §876.1500/Product Code: 78 GCT 21 CFR 8876.1075/Product Code: 78 FCL
Dear Mr. Yager:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 5100k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
William Yui
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear. Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K97 3611 510(k) Number (if known):
Device Name:
SpectraScience™ Reusable Biopsy Forceps
Indications for Use:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dolar P. Sathing
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K973611
Prescription Use:
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use:
(Facsimile)
(Optional Format 1-2-96)