The PBN Dilators are intended for use in the introduction and placement of guidewires and catheters for biliary, nephrostomy, and general percutaneous fluid collection and drainage.

Device Description

The PBN Dilator is comprised of tubing that is either a hard or soft polyethylene and a hub that is made of polyxymethylene. The dilators will be provided in the following French sizes of 4 through 30 Fr., and in lengths from 20 to 35 cm.

AI/ML Overview

The provided text describes a 510(k) summary for the "PBN Dilators" and an FDA letter confirming substantial equivalence. It does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the context of performance metrics like sensitivity, specificity, accuracy, or reader improvement with AI assistance. This document is a regulatory submission for a physical medical device (dilators) and not a software-driven device requiring performance studies based on algorithms or human reading.

Therefore, I cannot extract the requested information. The document focuses on:

Device Description: Polyethylene tubing dilators with a polyoxymethylene hub, available in Fr sizes 4-30 and lengths 20-35 cm.
Intended Use: Introduction and placement of guidewires and catheters for biliary, nephrostomy, and general percutaneous fluid collection and drainage.
Substantial Equivalence: Claimed against Cook Urological, Inc.'s AQ Hydrophilic Dilator (K961904).
Regulatory Clearance: FDA's confirmation of substantial equivalence for marketing.

None of the points in your request (1-9) are addressed in the provided text as they pertain to performance studies typically required for diagnostic or AI-powered devices.

Summary

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NOV 26 1999

00 SW 47th Aver Gainesville, Florida 326 TEL: 352/338-0440 FAX: 352/338-0662

长990808

510(k) SUMMARY

PLICANT:	Medical Device Technologies, Inc3600 SW 47th AvenueGainesville, FL 32608
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Karl Swartz CONTACT: Quality Assurance Manager
(352)338-0440 TELEPHONE: fax (352)338-0662
TRADE NAMES: PBN Dilators
Catheter dilators COMMON NAME:
CLASSIFICATION NAME: $870.1310 - Dilator, Vessel, for Percutaneous Catheterization

SUBSTANTIAL EQUIVALENCE:

Company Name	Product Name	510(k) No.
Cook Urological, Inc.	AQ Hydrophilic Dilator	K961904

DESCRIPTION OF DEVICE:

INDICATIONS FOR USE:

The PBN Dilators are intended for use in the introduction and placement of guidewires and catheters for biliary, nephrostomy, and general percutaneous fluid collection and drainage.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the left side of the logo.

NOV 26 1999

Mr. Karl Swartz Qualitv Manager Medical Device Technologies, Inc. 3600 SW 47th Avenue Gainesville, FL 32608

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K990808 PBN Dilators Dated: September 2, 1999 Received: September 3, 1999 Requiatory Class: II 21 CFR §876.5010/Procode: 78 FGE 21 CFR §878.4200/Procode: 79 GCC Regulatory Class: Unclassified 78 LJE

Dear Mr. Swartz:

We have reviewed vour 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. 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 (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, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regult 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 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 vitto diagnostic devices), please contact the Office of Compilance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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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Image /page/2/Picture/3 description: The image shows the logo for MDTech Medical Device Technologies Inc. The logo is in black and white, with the letters "MDTECH" in large, bold font. Below the letters is the text "MEDICAL DEVICE TECHNOLOGIES INC." in a smaller font. The logo is simple and modern, and it effectively communicates the company's name and industry.

3600 SW 47th Avenue Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662

Page 1 of 1

510(k) Number (if known):___ K99 0808

Device Name: PBN Dilators

Indications for Use:

The PBN Dilators are intended for use in the introduction and placement of guidewires and catheters for biliary, nephrostomy, and general percutaneous fluid collection and drainage .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vainit C. Segnern

Division of Reproductive, Abdominal, ENT, and Radiological Devices

S10(k) Numbe

Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
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.(b)
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.