(260 days)
Not Found
No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, or image processing.
No.
The device facilitates the introduction and placement of guidewires and catheters for drainage and fluid collection, which are diagnostic or interventional procedures, not therapeutic actions in themselves.
No
Explanation: The device, PBN Dilators, is intended for the introduction and placement of guidewires and catheters for fluid collection and drainage, which is a therapeutic or interventional purpose, not a diagnostic one.
No
The device description explicitly states it is comprised of tubing and a hub made of physical materials (polyethylene and polyxymethylene), indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- PBN Dilator Function: The description clearly states the PBN Dilators are used for the "introduction and placement of guidewires and catheters for biliary, nephrostomy, and general percutaneous fluid collection and drainage." This is a procedure performed within the body (in vivo) to facilitate other medical interventions.
- No Specimen Testing: There is no mention of the device being used to test or analyze any biological specimens.
The PBN Dilator is a surgical or interventional device used to create or enlarge a passage within the body, not to perform diagnostic tests on samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
78 FGE, 79 GCC, 78 LJE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary, nephrostomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/2 description: The image contains three distinct symbols arranged horizontally. The first symbol is a musical sharp sign. The second symbol appears to be the number 2 with a curved line above it. The third symbol is the number 3 with a curved line above it.
Image /page/0/Picture/3 description: The image shows a logo for MD Tech Medical Device Innovation Company. The logo is in black and white and features the letters "MD TECH" in a bold, sans-serif font. The letters "MD" are stacked on top of each other, and the word "TECH" is to the right of the letters "MD". Below the letters is the text "MEDICAL DEVICE INNOVATION COMPANY".
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, Inc
3600 SW 47th Avenue
Gainesville, FL 32608 |
| ---------- | ---------------------------------------------------------------------------------- |
|---|
- 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:
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.
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.
1
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
2
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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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)