(233 days)
No
The device description and performance studies focus on the mechanical and material properties of a balloon dilator and its accessories. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for ureteral dilation prior to ureteral stone manipulation or ureteroscopy and dilation of the intramural ureter, which directly addresses a medical condition to improve health.
No
The device is intended for ureteral dilation, a therapeutic or interventional procedure, not for identifying the presence, nature, or extent of a disease.
No
The device description clearly outlines physical components such as a balloon ureteral dilator, wire guide, syringe, endoscopic cap, and pin-vise handle, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "ureteral dilation prior to ureteral stone manipulation or ureteroscopy and dilation of the intramural ureter." This is a therapeutic or procedural use, not a diagnostic one. IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The device is a physical tool (a balloon catheter) used to mechanically dilate a part of the body. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of reagents, calibrators, controls, or any other components typically associated with in vitro diagnostic tests.
Therefore, this device falls under the category of a medical device used for a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Balloon Ureteral Dilator and Balloon Ureteral Dilator Set is intended for ureteral dilation prior to ureteral stone manipulation or ureteroscopy and dilation of the intramural ureter.
Product codes
EZN
Device Description
The Balloon Ureteral Dilator Set includes the balloon ureteral dilator, a wire guide, a 10 mL syringe, an endoscopic cap and a pin-vise handle. Balloon ureteral dilators can be purchased separately.
The balloon ureteral dilator is composed of a radiopaque dilator fitted with a polyethylene balloon. The balloon ureteral dilator is available in 5.0 or 7.0 French and is 65 centimeters in length. The balloon is located on the distal end of the dilator and has diameters of 5 or 6 millimeters with lengths of 4 or 10 centimeters when inflated. The balloon has a maximum inflation pressure of 40 or 60 psi, depending on the diameter and length of the balloon. Additionally, radiopaque marker bands are placed at the proximal and distal ends of the balloon to provide fluoroscopic visibility.
Additional set components in the Balloon Ureteral Dilator Set include a straight safety wire guide, endoscopic cap, pin-vise handle, and syringe. The wire guide has a diameter of 0.028 or 0.038 inches and a length of 145 centimeters. The endoscopic cap and a pin-vise handle are provided to stabilize the wire guide during introduction. The syringe is a 10 mL luer-lock syringe provided for balloon inflation.
The Balloon Ureteral Dilator and Balloon Ureteral Dilator Set is provided sterile for one-time use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ureteral / intramural 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)
The subject device, Balloon Ureteral Dilator and Balloon Ureteral Dilator Set, was subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests have been conducted to ensure reliable design and performance under the specified testing parameters:
-
- Radiopacity
-
- Pressure Resistance for Dilatation Balloons
-
- Kink Radius Testing
-
- Balloon Rated Burst Pressure (RBP)
-
- Dimensional Verification of Balloon upon inflation
-
- Balloon Deflation Testing
-
- Tensile Testing
-
- Dimensional Verification
-
- Biocompatibility
- o Cytotoxicity, Sensitization, and Irritation/Intracutaneous
The results of performance testing confirm that the Balloon Ureteral Dilator and Balloon Ureteral Dilator Set meets the design input requirements based on the intended use and support the conclusion that this device does not raise new questions of safety or effectiveness and is substantially equivalent to the predicate device, the Ascend™ Balloon Dilation Catheter (Cook Urological, Inc., K970041).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains two logos. On the left is the logo for the Department of Health & Human Services - USA, which features a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 19, 2018
Cook Incorporated Carly Powell Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404
Re: K172588
Trade/Device Name: Balloon Ureteral Dilator and Balloon Ureteral Dilator Set Regulation Number: 21 CFR§ 876.5470 Regulation Name: Ureteral Dilator Regulatory Class: II Product Code: EZN Dated: March 8, 2018 Received: March 9, 2018
Dear Carly Powell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit/tray have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice. labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Food and Drug Administration
Indications for Use
Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K172588
Device Name
Balloon Ureteral Dilator and Balloon Ureteral Dilator Set
Indications for Use (Describe)
The Balloon Ureteral Dilator and Balloon Ureteral Dilation prior to ureteral dilation prior to ureteral stone manipulation or ureteroscopy and dilation of the intramural ureter.
Type of Use (Select one or both, as applicable)
V Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda. hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in large, white, sans-serif letters, with a registered trademark symbol next to it. Below "COOK", the word "MEDICAL" is written in smaller, white, sans-serif letters.
COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM
2.0 510(k) SUMMARY
Balloon Ureteral Dilator and Balloon Ureteral Dilator Set 21 CFR §807.92 Date Prepared: April 19, 2018
Submitted By:
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Applicant: | Cook Incorporated |
| Contact: | Carly Powell |
| Karthik Pillai | |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact Phone Number: | (812) 335-3575 |
| Contact Fax Number: | (812) 332-0281 |
Device Information: Trade Name: Balloon Ureteral Dilator and Balloon Ureteral Dilator Set Common Name: Ureteral Dilator Regulation Number: 21 CFR §876.5470 Regulation Name: Ureteral Dilator Regulatory Class: Class II Product Code: EZN Classification Panel: Gastroenterology/Urology
Predicate Device:
- The Balloon Ureteral Dilator and Balloon Ureteral Dilator Set is substantially equivalent ● to the following device: Ascend™ Balloon Dilation Catheter (K970041, Cook Urological, Inc.) cleared on March 19, 1997.
Device Description:
The Balloon Ureteral Dilator Set includes the balloon ureteral dilator, a wire guide, a 10 mL syringe, an endoscopic cap and a pin-vise handle. Balloon ureteral dilators can be purchased separately.
4
The balloon ureteral dilator is composed of a radiopaque dilator fitted with a polyethylene balloon. The balloon ureteral dilator is available in 5.0 or 7.0 French and is 65 centimeters in length. The balloon is located on the distal end of the dilator and has diameters of 5 or 6 millimeters with lengths of 4 or 10 centimeters when inflated. The balloon has a maximum inflation pressure of 40 or 60 psi, depending on the diameter and length of the balloon. Additionally, radiopaque marker bands are placed at the proximal and distal ends of the balloon to provide fluoroscopic visibility.
Additional set components in the Balloon Ureteral Dilator Set include a straight safety wire guide, endoscopic cap, pin-vise handle, and syringe. The wire guide has a diameter of 0.028 or 0.038 inches and a length of 145 centimeters. The endoscopic cap and a pin-vise handle are provided to stabilize the wire guide during introduction. The syringe is a 10 mL luer-lock syringe provided for balloon inflation.
The Balloon Ureteral Dilator and Balloon Ureteral Dilator Set is provided sterile for one-time use.
Intended Use:
The Balloon Ureteral Dilator and Balloon Ureteral Dilator Set is intended for ureteral dilation prior to ureteral stone manipulation or ureteroscopy and dilation of the intramural ureter.
Comparison to Predicate:
The Balloon Ureteral Dilator and Balloon Ureteral Dilator Set and the predicate device, the Ascend" Balloon Dilation Catheter (K970041), are substantially equivalent in that these devices are identical in indications for use and method of placement. Additionally, the subject device has a similar design and technological characteristics as the predicate device. The differences between the subject device and the predicate device include materials, dimensions, and balloon characteristics. The differences between the dimensions and balloon characteristics of the subject and predicate devices are dimensions, material, and balloon characteristics. Characteristics of the subject device that differ from the predicate device are supported by testing and do not raise any new questions of safety and effectiveness.
5
| | Balloon Ureteral Dilator and Balloon Ureteral Dilator Set Substantial Equivalence Comparison
PREDICATE DEVICE | SUBJECT DEVICE |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| | Ascend™ Balloon Dilation Catheter | Balloon Ureteral Dilator and Balloon
Ureteral Dilator Set |
| Manufacturer | Cook Incorporated (formerly Cook Urological,
Inc.) | Cook Incorporated |
| 510(k) | K970041 | Subject of this submission |
| Regulation | 21 CFR §876.5470 | Identical to the predicate device |
| Product Code | EZN | Identical to the predicate device |
| Classification | II | Identical to the predicate device |
| Indications for
Use | Used for ureteral dilation prior to ureteral stone
manipulation or ureteroscopy, and dilation of
the intramural ureter. | Identical to the predicate device |
| Catheter/Dilator
O.D. (Fr) | 7.0 | 5.0, 7.0 |
| Catheter/Dilator
Length (cm) | 40-65 | 65 |
| Catheter/Dilator
Material | Polyurethane | Radiopaque Polyethylene, clear polyethylene |
| Inflated Balloon
O.D. (mm) | 5.0, 6.0, 7.0, 8.0, 10.0 | 5.0, 6.0 |
| Inflated Balloon
Length (cm) | 4.0, 6.0, 10.0, 12.0 | 4.0, 10.0 |
| Balloon Material | Polyethylene terephthalate (PET) | Polyethylene |
| Maximum Balloon
Inflation Pressure | 14, 16, 17, 19, 22 atm | 40 psi, 60 psi
(2.72 atm, 4.08 atm) |
| Wire Guide O.D.
(inch) | 0.038 | 0.028, 0.038 |
| Wire Guide
Length (cm) | 145 | Identical to the predicate device |
| Wire Guide
Material | Stainless Steel | Identical to the predicate device |
| Markerbands | Not applicable | 5 Fr - Stainless Steel
7 Fr - Tungsten |
| Sterilization
Method | Ethylene Oxide | Identical to the predicate device |
Balloon Ureteral Dilator and Balloon Ureteral Dilator Set Substantial Equivalence Comparison
Performance Data:
The subject device, Balloon Ureteral Dilator and Balloon Ureteral Dilator Set, was subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests have been conducted to ensure reliable design and performance under the specified testing parameters:
-
- Radiopacity
-
- Pressure Resistance for Dilatation Balloons
-
- Kink Radius Testing
-
- Balloon Rated Burst Pressure (RBP)
-
- Dimensional Verification of Balloon upon inflation
6
-
- Balloon Deflation Testing
-
- Tensile Testing
-
- Dimensional Verification
-
- Biocompatibility
- o Cytotoxicity, Sensitization, and Irritation/Intracutaneous
Conclusion:
The results of performance testing confirm that the Balloon Ureteral Dilator and Balloon Ureteral Dilator Set meets the design input requirements based on the intended use and support the conclusion that this device does not raise new questions of safety or effectiveness and is substantially equivalent to the predicate device, the Ascend™ Balloon Dilation Catheter (Cook Urological, Inc., K970041).