CYSTIC DUCT BALLOON DILATING CATHETER

K983154 · Applied Medical Resources · FGE · May 5, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K983154
• Device Name: CYSTIC DUCT BALLOON DILATING CATHETER
• Applicant: Applied Medical Resources
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: May 5, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Applied Medical Cystic Duct Balloon Dilating Catheter is indicated for dilating narrowed or obstructed ducts in the biliary tree to allow access for diagnostic or surgical procedures.

Device Story

The Applied Medical Cystic Duct Balloon Dilating Catheter is a medical device used to dilate narrowed or obstructed ducts within the biliary tree. It features a non-distensible balloon with a 15 French inflation profile. The device is operated by clinicians during diagnostic or surgical procedures to improve access to the biliary system. By inflating the balloon, the catheter mechanically expands the ductal lumen, facilitating subsequent medical interventions. The device is intended for prescription use.

Clinical Evidence

Bench testing only.

Technological Characteristics

Non-distensible balloon dilating catheter; 15 French inflation profile. Mechanical dilation principle. Class II device.

Indications for Use

Indicated for patients requiring dilation of narrowed or obstructed biliary tree ducts to facilitate diagnostic or surgical access.

Regulatory Classification

Identification

A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

Special Controls

*Classification.* Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• Applied Medical Obturator (dilator) (K929224/A)
• Cook Guided Biliary Dilator Set (preamendment device)

Submission Summary (Full Text)

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MAY り いず

K983154
Page 1 of 1

## 510(k) SUMMARY

| 510(k) NUMBER: | K983154 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------|
| SUBMITTED BY: | Applied Medical Resources Corporation<br>26051 Merit Circle, Unit # 103<br>Laguna Hills, California 92653<br>[phone] |
| CONTACT PERSON: | Anil Bhalani |
| DATE OF PREPARATION: | February 1 1999 |
| NAME OF DEVICE: | Applied Medical Cystic Duct Balloon Dilating Catheter |
| CLASSIFICATION NAME: | Endoscope and Accessories, 21 CFR 876.1500 |
| TRADE NAME: | Not Determined |

SUMMARY STATEMENT: The Applied Medical Cystic Duct Balloon Dilating Catheter is indicated for dilating narrowed or obstructed ducts in the biliary tree to allow access for diagnostic or surgical procedures. The Applied Medical Cystic Duct Balloon Dilating Catheter is substantially equivalent to predicate devices cleared for marketing inclusive of the Applied Medical Obturator (dilator) which is a component of the Cystic Duct Access Kit K929224/A and the Cook Guided Biliary Dilator Set which is a preamendment device. The Applied Cystic Duct Dilator consists of a non-distensible dilating balloon with a inflation profile of 15 French.

The Applied Medical Cystic Duct Balloon Dilating Catheter passed all testing to demonstrate substantial equivalence to the predicate devices and introduces no new safety and effectiveness issues when used as instructed.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling an emblem. The emblem is a stylized representation of a human figure, with three profiles merging to form a single, abstract shape.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 5 1999

Mr. Anil Bhalani Director of Regulatory Affairs and Clinical Programs Applied Medical Resources 26051 Merit Circle, Building 104 Laguna Hills, California 92653

Re: K983154

Cystic Duct Balloon Dilating Catheter Regulatory Class: II 21 CFR 876.5010/Product Code: 78 FGE Dated: February 3, 1999 Received: February 4, 1999

Dear Mr. Bhalani:

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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish

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Page 2 - Mr. Anil Bhalani

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 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 the 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,

[signature]

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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## INDICATIONS FOR USE

Applied Medical Resources is providing this revised separate cover page for the Applied Medical Cystic Duct Balloon Dilating Catheter "Indications for Use" as required.

510(k) Number: K983154

Applied Medical Cystic Duct Balloon Dilating Catheter Device Name:

Indications for Use: The Applied Medical Cystic Duct Balloon Dilating Catheter is indicated for dilating narrowed or obstructed ducts in the biliary tree to allow access for diagnostic or surgical procedures.

Signature:

ANIL BHALANI

Title: Director of RA
and Clinical Programs

Date: 2-3-99

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | |
|------------------------------------------|--|
|------------------------------------------|--|

OR

| Over -The -Counter Use | |
|------------------------|--|
|------------------------|--|

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

| 510(k) Number | K983154/S001 |
|---------------|--------------|
|---------------|--------------|