(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.
{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 TestingBiocompatibility | Biocompatibility is verified by vendor certifications and vendorbiocompatibility testing. |
|---|---|
| Mechanical | Mechanical design, mechanisms of action, materials, dimensions,workmanship, operation, light transmittance, and light source connectionsare identical to predicate devices and therefore substantially equivalent. |
| Intended Use | The SpectraScience™ Reusable Biopsy Forceps are designed specificallyto collect tissue endoscopically for histologic examination. Theinstruments are intended for endoscopic gastrointestinal and urologicbiopsy and should not be used for any purpose other than their intendedfunction. |
| Conclusion | SpectraScience™, Inc., believes that their Reusable Biopsy Forceps aresubstantially equivalent to the predicate products due to the use ofidentical 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)
§ 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.