SPECTRASCIENCE REUSABLE BIOPSY FORCEPS

K973611 · Spectrascience, Inc. · FCL · Dec 2, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K973611
• Device Name: SPECTRASCIENCE REUSABLE BIOPSY FORCEPS
• Applicant: Spectrascience, Inc.
• Product Code: FCL · Gastroenterology, Urology
• Decision Date: Dec 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 1

Intended 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.

Device Story

Reusable biopsy forceps featuring cup-shaped jaws for tissue sampling. Device incorporates an integrated optical illumination fiber to provide supplemental light from an angle distinct from the endoscope's primary light source. Illumination activates automatically upon opening the forceps jaws. Used by endoscopists in clinical settings (gastrointestinal/urologic) to enhance visualization of structural contours during biopsy. Supplemental light aids in precise identification and location of target tissue. Mechanical operation, materials, and biopsy technique remain identical to standard forceps; no additional procedural steps required. Benefit includes improved visualization for more accurate tissue sampling.

Clinical Evidence

Bench testing only. Biocompatibility verified via vendor certifications and testing. Mechanical design, light transmittance, and operational performance compared to predicate devices.

Technological Characteristics

Reusable biopsy forceps with cup-shaped jaws. Features integrated optical illumination fiber for supplemental lighting. Materials, dimensions, and mechanical design are identical to standard predicate biopsy forceps. Light source connection compatible with standard endoscopic illumination systems (xenon or equivalent).

Indications for Use

Indicated for endoscopic gastrointestinal and urologic biopsy procedures requiring tissue collection for histological examination.

Regulatory Classification

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.

Predicate Devices

• SpectraScience™ Single Use Biopsy Forceps (K973611)

Submission Summary (Full Text)

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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

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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<br>Biocompatibility | Biocompatibility is verified by vendor certifications and vendor<br>biocompatibility testing. |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mechanical | Mechanical design, mechanisms of action, materials, dimensions,<br>workmanship, operation, light transmittance, and light source connections<br>are identical to predicate devices and therefore substantially equivalent. |
| Intended Use | The SpectraScience™ Reusable Biopsy Forceps are designed specifically<br>to collect tissue endoscopically for histologic examination. The<br>instruments are intended for endoscopic gastrointestinal and urologic<br>biopsy and should not be used for any purpose other than their intended<br>function. |
| Conclusion | SpectraScience™, Inc., believes that their Reusable Biopsy Forceps are<br>substantially equivalent to the predicate products due to the use of<br>identical design, materials, indications for use and packaging. |

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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 [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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.

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## 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)