(73 days)
Not Found
Not Found
No
The summary describes a physical medical device (balloon catheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is used for ureteral dilation, which is a therapeutic intervention aimed at treating medical conditions (ureteral stenosis prior to stone manipulation or ureteroscopy).
No
The device is described as a "Balloon Dilation Catheter" intended for "ureteral dilation prior to ureteral stone manipulation, ureteroscopy, and dilating the intramural ureter." Its purpose is to physically dilate an anatomical structure, not to diagnose a condition or disease.
No
The device description clearly outlines physical components like a catheter, balloon, and specific materials (nylon, polyethylene), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a procedure performed within the body (ureteral dilation) for therapeutic and diagnostic purposes related to the urinary tract. IVDs are used to examine specimens outside the body (in vitro) to provide information about a patient's health.
- Device Description: The description details a physical catheter with a balloon designed for insertion into the ureter. This is a medical device used for a procedure, not a reagent, instrument, or system intended for testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Pursuit Balloon Dilation Catheter is a medical device used for a surgical or interventional procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for ureteral dilation prior to ureteral stone manipulation, ureteroscopy, and dilating the intramural ureter.
Product codes (comma separated list FDA assigned to the subject device)
78 EZN
Device Description
The Pursuit Balloon Dilation Catheter is used for the ureteral dilation prior to ureteral stone manipulation or ureteroscopy, and dilating the intramural ureter. The materials used to construct the balloon is nylon and polyethylene. The Pursuit Balloon Dilation Catheter will be offered in a 5FR diameter and 40cm to 100cm long catheter with a 5mm to 10mm x 4cm to 10cm balloon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureter
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.
Balloon Catheters manufactured by Bard, High Pressure Ureteral Dilatation Balloon Catheter manufactured by Microvasive, Balloon Dilation Catheters from Cook Urological, Inc.
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
§ 876.5470 Ureteral dilator.
(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the date 3/25/99, followed by the text "510(k) Premarket Notification Pursuit Balloon Dilation Catheter Cook Urological". The text appears to be part of a document or label. The date is handwritten, while the rest of the text is printed in a formal font.
K 990072
I. 510(k) SUMMARY
Submitted By:
Debbie Schmitt Cook Urological 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 Date: January 8, 1999
Device
Trade Name: Proposed Classification Name: Pursuit Balloon Dilation Catheter Dilator, Catheter, Ureteral
Predicate Devices:
The Pursuit Balloon Dilation Catheter is substantially equivalent to predicate devices in terms of indications for use and design. Predicate devices include Balloon Catheters manufactured by Bard and High Pressure Ureteral Dilatation Balloon Catheter manufactured by Microvasive also a variety of Balloon Dilation Catheters from Cook Urological, Inc.
Device Description:
The Pursuit Balloon Dilation Catheter is used for the ureteral dilation prior to ureteral stone manipulation or ureteroscopy, and dilating the intramural ureter. The materials used to construct the balloon is nylon and polyethylene. The Pursuit Balloon Dilation Catheter will be offered in a 5FR diameter and 40cm to 100cm long catheter with a 5mm to 10mm x 4cm to 10cm balloon.
Substantial Equivalence:
The device will be manufactured by Cook Incorporated according to specified process controls and Quality Assurance Program. The device will undergo packaging and sterilization procedures similar to devices currently marketed and distributed by Cook Urological. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510 (k) substantial equivalence.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 1999
Ms. Debbie Schmitt Regulatory Affairs Manager Cook Urological, Inc. 1100 West Morgan Street Spencer. IN 47460
Re: K990072
Pursuit Balloon Ureteral Dilation Catheter Dated: March 16, 1999 Received: March 17, 1999 Regulatory Class: II 21 CFR 876.5470/Procode: 78 EZN
Dear Ms. Schmitt:
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 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 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 regulation may result in requlatory 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 vitro diagnostic devices), please contact the Office of Compliance 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,
Dan Setiz
APT 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
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | Unknown at this time K990072 |
|---|---|
| Device Name: | Pursuit Balloon Dilation Catheter |
| Indications for Use: | The device is intended for ureteral dilation prior to ureteral stone manipulation, ureteroscopy, and dilating the intramural ureter. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A
Prescription Use
(Per 21 CFR 801.109)
ﺒ
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Vhird h. Hlymm
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 990072 510(k) Number.