WILTEK HOT BIOPSY FORCEPS

K990231 · Wiltek Medical, Inc. · KGE · Apr 13, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990231
• Device Name: WILTEK HOT BIOPSY FORCEPS
• Applicant: Wiltek Medical, Inc.
• Product Code: KGE · Gastroenterology, Urology
• Decision Date: Apr 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Wiltek Hot Biopsy Forcep is intended for transendoscopic biopsy of the GI tract.

Device Story

The Wiltek Hot Biopsy Forcep is a surgical instrument used during endoscopic procedures to obtain tissue samples from the gastrointestinal (GI) tract. It is designed for use by physicians in a clinical or hospital setting. The device functions as a biopsy forceps capable of delivering electrical current (hot biopsy) to cauterize tissue during the sampling process, aiding in hemostasis. The physician operates the device through an endoscope, using it to grasp and excise tissue. The output is a tissue specimen for pathological examination. The device benefits patients by allowing for minimally invasive tissue collection for diagnostic purposes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Transendoscopic biopsy forceps with integrated electrosurgical (hot) capability for tissue cauterization. Form factor designed for passage through endoscope working channels. Class II device under 21 CFR 876.4300.

Indications for Use

Indicated for patients undergoing transendoscopic biopsy of the GI tract.

Regulatory Classification

Identification

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 3 1999

Mr. Jon S. Wilson President WILTEK Medical, Inc. 101 North Chestnut Street Suite 300 Winston-Salem, NC 27101 Re: K990231

Wiltek Hot Biopsy Forceps Dated: January 20, 1999 Received: January 25, 1999 Regulatory Class: II 21 CFR876.4300/Procode: 78 KGE

Dear Mr. Wilson:

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 legally marketed predicate 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, market the device, 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 II (Special Controls) or 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 requirements, 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 rogation your in adation - or and your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting 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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| 510(k) Number (if known): | K990231 |
|---------------------------|---------|
| Wiltek Hot Biopsy Forcep | |
| Device Name: | |

Indications for Use:

The Wiltek Hot Biopsy Forcep is intended for transendoscopic biopsy of the GI tract.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 1

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| (Division Sign-Off) |

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_K 99022

Prescription Use_ (Per 21 CFR 801.109)

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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________