PBN DRAINAGE CATHETER GUIDEWIRES

K991097 · Medical Device Technologies, Inc. · KNY · Apr 23, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K991097
• Device Name: PBN DRAINAGE CATHETER GUIDEWIRES
• Applicant: Medical Device Technologies, Inc.
• Product Code: KNY · Gastroenterology, Urology
• Decision Date: Apr 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Intended Use

The PBN Drainage Catheter Guidewires are intended for use in the placement of non-vascular catheters for abscess drainage, nephrostomy, thoracentesis, and other fluid drainage.

Device Story

PBN Drainage Catheter Guidewires are mechanical devices used to facilitate the placement of non-vascular catheters. The guidewire is inserted into the body to provide a track for the subsequent placement of drainage catheters for procedures such as abscess drainage, nephrostomy, and thoracentesis. Used in clinical settings by physicians. The device assists in the navigation and positioning of drainage catheters, enabling fluid drainage from body cavities or organs. Benefits include improved accuracy and ease of catheter placement for therapeutic fluid removal.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical guidewire for non-vascular catheter placement. Materials and specifications not detailed in provided text. No software, energy source, or electronic components.

Indications for Use

Indicated for patients requiring non-vascular catheter placement for abscess drainage, nephrostomy, thoracentesis, and other fluid drainage. Prescription use only.

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).

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 1999

Mr. Karl Swartz Quality Manager Medical Device Technologies, Inc. 3600 S.W. 47th Avenue Gainesville, FL 32608

Re: K991097 PBN Drainage Catheter Guidewires Dated: March 30, 1999 Received: April 1, 1999 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 have have have have have have have have be have We nave reviews your occusive ifor the indications for use stated in the endosure) to legally marketed predicate devices marketed in interstate commerce pror to May 28, 1976, the enactment date of the manced prodocto do nove hambled in motion in accordance with the provisions of the specificated to the annorgi one Medical Device Anientanie, or to neviews that had nav therefore, market the device, subject to the general controls I edelan Food, Drug, and Oosments root, "Tou may f the Act include requirements for annual registration, listing of provident of the new active, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Special Controls) or class III (Prema Ker Approval), it may if your device is classifica (GCC doove) into dimorations affecting your device can be found in the Code of be dayson to battlerity of the 11, Parts 800 to 895. A substantially equivalent determination assumes on the compliance r Goldin Regulations, This 21, Tare over equirements, as set forth in the Quality System Regulation (QS) for the Current Good Manufacturing Practicents, as detern in the becinity of Sincertions, the Food and Meanal Devices. Ocheral roguently 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 Feceral regulatory action. In addition: 1971 may publicit notification submission does not affect any objection your register. Thease neces the roopense to your product to 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 This reter will and with to begin marketing your 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 labcling regulation (21 CFR Part 801 and additionally 809.10 or nin in diagnostic devices), please contact the Office of Compliance at [phone]. Additionaliy 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 predise the regalation onlines "Misallanen" and readly of 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, Nosc and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/1/Picture/0 description: The image shows a logo for MDTECH MEDICAL DEVICE TECHNOLOGIES INC. The logo is black and white and features the company name in a bold, sans-serif font. The letters "MDTECH" are stacked on top of the rest of the company name. The logo is simple and modern.

3600 SW 47th Avenue Gainesville, Florida 32608 EL: 352/338-0440 FAX: [phone]

Page 1_of_1_

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: PBN Guidewires

Indications for Use:

The PBN Drainage Catheter Guidewires are intended for use in the placement of non-vascular porculations The PBN Drainage Catheter Guider in use in the paccinent of Resident of Resident of Residentials and Submitted States is, the pleuracentcsis, and other fluid drainage.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_X (Per 21 CFR 801.109) OR

Over-The-Counter Use_

Signature

(Optional Format 1-2-96

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K991097

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