MANAN MALECOT BASKET DRAINAGE CATHETER

K981258 · Medical Device Technologies, Inc. · FEW · Apr 22, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K981258
• Device Name: MANAN MALECOT BASKET DRAINAGE CATHETER
• Applicant: Medical Device Technologies, Inc.
• Product Code: FEW · Gastroenterology, Urology
• Decision Date: Apr 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5090
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Manan™ Malecot Basket Drainage Catheter is for percutaneous nephrostomy and abcess drainage.

Device Story

Manan Malecot Basket Drainage Catheter is a urological device used for percutaneous nephrostomy and abscess drainage. Constructed from biocompatible Tecoflex urethane, the catheter softens at body temperature to minimize tissue trauma. The device features a Malecot end configuration and includes a flexible stiffening cannula to assist with insertion. It is intended for use by clinicians in a medical setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Tecoflex (biocompatible urethane). Configuration: Malecot end. Accessories: Flexible stiffening cannula. Softens at body temperature.

Indications for Use

Indicated for patients requiring percutaneous nephrostomy or abscess drainage.

Regulatory Classification

Identification

A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.

Predicate Devices

• Malecot Basket Drainage Catheter (K954147)

Submission Summary (Full Text)

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MDTECH
MEDICAL DEVICE TECHNOLOGIES INC

## APR 22 1998

# P / 9 /

1981258

4445-310 S.W. 35th Terrace Gainesville, Florida 32608 TEL: [phone] FAX: [phone]

#### 510(k) SUMMARY

| APPLICANT: | Medical Device Technologies, Inc.<br>4445-310 SW 35th Terrace<br>Gainesville, FL 32608 |
|----------------------|----------------------------------------------------------------------------------------|
| CONTACT: | Karl Swartz<br>Quality Assurance Manager |
| TELEPHONE: | [phone]<br>fax [phone] |
| TRADE NAMES: | Manan™™ Malecot Basket Drainage Catheter |
| COMMON NAME: | Suprapubic urological catheter |
| CLASSIFICATION NAME: | §876.509-Suprapubic Urological Catheter and Accessories |

## SUBSTANTIAL EQUIVALENCE:

| Company Name | Product Name | 510(k) No. |
|------------------------|----------------------------------|------------|
| Manan Medical Products | Malecot Basket Drainage Catheter | K954147 |

### DESCRIPTION OF DEVICE:

Manan drainage catheters are made from a biocompatible urethane (Tecoflex) that has been used extensively in both short and long term implantable medical devices. This material softens at body temperature thus minimizing tissue trauma. The catheters come in malecot end configuration. Also included with the catheters are flexible stiffening cannula.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 22 1998

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

Re: K981258 Manan™ Malecot Basket Drainage Catheter Dated: December 29, 1997 Received: April 6, 1998 Regulatory Class: II 21 CFR 876.5090/Procode: 78 FEW

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 ether 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 (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 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/odrh/dsmaldsmamain.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

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Image /page/2/Picture/0 description: The image shows the logo for MDTECH Medical Device Technologies Inc. The logo is black and white and features the letters "MDTECH" in a bold, sans-serif font. Below the letters is the text "MEDICAL DEVICE TECHNOLOGIES INC" in a smaller font. The logo is simple and modern, and it conveys a sense of professionalism and innovation.

4445-310 S.W. 35th Te Gainesville, Florida 32608 TEL: [phone] FAX: [phone]

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Manan™ Malecot Basket Drainage Catheter

Indications for Use:

The Manan™ Malecot Basket Drainage Catheter is for percutaneous nephrostomy and abcess drainage.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert P. Rathbun
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K981258

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)