5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH

K992402 · Telemed Systems, Inc. · KNS · Dec 22, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K992402
• Device Name: 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH
• Applicant: Telemed Systems, Inc.
• Product Code: KNS · 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

Cannulation of the biliary ductal system with infusion of contrast and sphincterotomy.

Device Story

Three Lumen Papillotome/Sphincterotome (Models 5102, 5104, 5106, 5108, 5110) used for biliary ductal system cannulation, contrast infusion, and sphincterotomy. Device operated by clinicians in clinical settings. Facilitates diagnostic and therapeutic endoscopic procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Three-lumen catheter design for cannulation, contrast delivery, and sphincterotomy. Class II device (21 CFR 876.4300).

Indications for Use

Indicated for patients requiring cannulation of the biliary ductal system for contrast infusion and sphincterotomy.

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

HES 22 1936

Mr. John A. Chaves President & CEO Telemed Systems, Inc. 19 Brigham Street. Unit 1 Marlborough, MA 01752 Re: K992402 Three Lumen Papillotome/Sphincterotome Models 5102, 5104, 5106, 5108 and 5110 Dated: November 1. 1999 Received: November 1, 1999 Requlatory Class: II 21 CFR 876.4300/Procodes: 78 KNS and FDI

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. 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 vour 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 requlation (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 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 requlations.

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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ATTAchment IT

Page 1

510(k) Number (If known)_K992402

Device Name: Three Lumen Papillotome/Sphincterotome

Indications For Use:Cannulation of the biliary ductal system with infusion of contrast and sphincterotomy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON
ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use <div>(Per 21 CFR 801.109)</div> | <div>OR Over-The Counter Use</div> <div>(Optional Format 1-2-9)</div> |
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(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

| 510(k) Number | K992402 |
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