MANAN MANTA CATHETER FIXATION DISK

K981229 · Medical Device Technologies, Inc. · KNY · Apr 22, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K981229
• Device Name: MANAN MANTA CATHETER FIXATION DISK
• Applicant: Medical Device Technologies, Inc.
• Product Code: KNY · Gastroenterology, Urology
• Decision Date: Apr 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Indications for Use

The Manan™ Manta Catheter Fixation Disk is intended for the fixation of percutaneous drainage catheters.

Device Story

Manan Manta Catheter Fixation Disk is a soft silicone device designed to secure percutaneous drainage catheters to a patient's skin. The device is sutured or adhered to the skin; a drainage catheter is then snapped into the disk and secured using a nylon tie-wrap. It is intended for use by healthcare professionals in clinical settings to prevent catheter dislodgement, thereby maintaining drainage efficacy and patient comfort.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Constructed of soft silicone. Mechanical fixation device utilizing a snap-in mechanism and nylon tie-wrap for catheter securement. Non-powered, manual operation.

Indications for Use

Indicated for the fixation of percutaneous drainage catheters in patients requiring such drainage.

Regulatory Classification

Identification

A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

Predicate Devices

• Manan Catheter Fixation Disk (K954132)

Submission Summary (Full Text)

{0}------------------------------------------------

**MDTECH**
MEDICAL DEVICE TECHNOLOGIES INC.

## APR 22 1998

510(k) SUMMARY

445-310 S.W. 35th Ter Gainesville, Florida 32608 TEL: [phone] FAX: [phone]

K981229

p l g l

K954132

## Medical Device Technologies, Inc. APPLICANT: 4445-310 SW 35th Terrace Gainesville, FL 32608 CONTACT: Karl Swartz Quality Assurance Manager TELEPHONE: [phone] fax [phone] Manan™ Manta Catheter Fixation Disk TRADE NAMES: COMMON NAME: Catheter anchoring or fixation device. CLASSIFICATION NAME: §846.5010-Biliary Catheter and Accessories SUBSTANTIAL EQUIVALENCE: Company Name Product Name 510(k) No.

## DESCRIPTION OF DEVICE:

Manan Medical Products

The Manan Manta Catheter Fixation Disk is made of soft silicone. It is sutured or adhered to the skin and a drainage catheter is snapped into the device. A nylon tie-wrap is used to secure the catheter into the device.

Manta Catheter Fixation Disk

Group of companies A member of The

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three human figures in profile. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 22 998

Mr. Karl Swartz Quality Manager Medical Device Technologies, Inc. 4445-310 S.W. 35th Terrace Gainesville, FL 32608

Re: K981229

Manan™ Manta Catheter Fixation Disk Dated: December 29, 1997 Received: April 3, 1998 Regulatory Class: II 21 CFR 876.5130/Procode: 78 KNY

Dear Mr. Swartz:

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, 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 (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 (OS) 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 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 tegally 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/dsmarain.html".

Sincerely yours

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

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for MDTECH Medical Device Technologies Inc. The logo is in a black box with rounded corners. The text "MDTECH" is in large, bold, white letters, and the text "MEDICAL DEVICE TECHNOLOGIES INC" is in smaller, white letters below the main text.

445-310 S.W. 35th Terrace Gainesville, Florida 32608 TEL: [phone] FAX: [phone]

Page_1_of_1_

510(k) Number (if known):_ K95 1209

Device Name: Manan™ Manta Catheter Fixation Disk

Indications for Use:

The Manan™ Manta Catheter Fixation Disk is intended for the fixation of percutaneous drainage catheters.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) な ber R D (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 481229 510(k) Number Prescription Use OR Over-The-Counter Use_

(Per 21 CFR 801.109)

(Optional Format 1-2-96)