HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD

K992390 · Telemed Systems, Inc. · KGE · Dec 22, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K992390
• Device Name: HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD
• Applicant: Telemed Systems, Inc.
• Product Code: KGE · Gastroenterology, Urology
• Decision Date: Dec 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For Endoscopic removal of polyps and obtaining samples in the gastrointestinal tract.

Device Story

Hot Biopsy Forceps (Models 1592, 1594, 1596, 1598) are endoscopic instruments used for tissue sampling and polyp removal in the gastrointestinal tract. Operated by physicians during endoscopic procedures, the device functions by grasping tissue and applying electrosurgical energy to excise and cauterize the site simultaneously. The device facilitates biopsy collection and polyp resection, aiding in diagnostic and therapeutic gastrointestinal interventions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Electrosurgical endoscopic forceps; manual operation; intended for use with compatible electrosurgical generators.

Indications for Use

Indicated for endoscopic removal of polyps and tissue sampling within the gastrointestinal 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

DEC 22 1999

Mr. John A. Chaves President & CEO Telemed Systems, Inc. 19 Brigham Street, Unit 1 Marlborough, MA 01752 Re: K992390 Hot Biopsy Forceps, Models 1592, 1594, 1596 and 1598 Dated: October 26, 1999 Received: November 1, 1999 Regulatory Class: II 21 CFR §876.4300/Procode: 78 KGE

Dear Mr. Chaves:

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 requlations 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 Register. Please note: this response to your premarket notification 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)_K992390 K992390/S⁰⁰¹

Device Name: Hot Biopsy Forceps

Indications For Use: For Endoscopic removal of polyps and obtaining samples in the gastrointestinal tract.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
|----------------------|--|
| (Per 21 CFR 801.109) | |

OR

| Over-The Counter Use | |
|-------------------------|--|
| (Optional Format 1-2-9) | |

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices

| 510(k) Number | K992390/5 ⁰¹ |
|---------------|-------------------------|
|---------------|-------------------------|