(58 days)
Not Found
No
The summary describes a mechanical device (balloon catheter) and does not mention any AI/ML components or image processing.
Yes
The device is used for dilatation of the urinary tract to address narrow ureteral segments, which is a therapeutic intervention.
No
Explanation: The device is a balloon dilatation catheter used for therapeutic purposes (dilatation of the urinary tract) and does not perform any diagnostic functions like detection or analysis of a medical condition.
No
The device description clearly describes a physical catheter with a balloon, which is a hardware component. The performance studies also focus on physical characteristics and testing of the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "dilatation of the urinary tract." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a catheter with a balloon used to exert force to dilate narrow segments of the urinary tract. This is a physical intervention.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on sample analysis
- Reagents, calibrators, or controls
IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for a therapeutic intervention within the body.
N/A
Intended Use / Indications for Use
The Uromax Ultra Balloon Catheters are recommended for dilatation of the urinary tract.
Product codes
EZN, KOE
Device Description
The Balloon Dilatation Catheter, styled after the Gruntzig technique, is a multiple lumen catheter with a dilatation balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow ureteral segments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract
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
Boston Scientific has conducted performance testing with samples aged at T=0 and T=7 months accelerated aging in support of the balloon design change. The following testing was completed to evaluate the effects of the design change:
- Effective Working Length
- Catheter Tip Length
- Deflated Profile
- Coating
- Deflation Time
- Balloon Diameter at RBP
- Balloon Dilatation Length at RBP
- Radiopaque Markerband to Balloon Alignment
- Balloon Compliance
- Multiple Inflation
- Balloon Burst
- Proximal Balloon Bond
- Surface Finish
- Scope Compatibility
- Guidewire Compatibility/Passability
- Balloon Protector (Wingtool) Removal Force
Performance data for biocompatibility provided in K121614 for the Nephromax High Pressure Balloon Dilatation Catheter supports the Uromax Ultra Balloon Dilatation Catheter. The results of the performance testing demonstrate equivalence of the Uromax Ultra Balloon Catheter to the predicate balloon dilatation catheter (K980795).
Key Metrics
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
K 130804
Boston Scientific page 1 of 3
SECTION 5
510K SUMMARY
510(k) Summary for Uromax Ultra™ Balloon Dilatation Catheter
MAY 2 2 2013
A. Sponsor
Boston Scientific Corporation Urology and Women's Health Division 100 Boston Scientific Way Marlborough, MA 01756
B. Contact
Lauren Russo Principal Specialist, Regulatory Affairs 508-683-4707 lauren.russo@bsci.com or
Donna Gardner Director, Regulatory Affairs 508-683-4398 gardnerd@bsci.com
C. Device Name
Trade name: Uromax Ultra . High Pressure Balloon Dilatation Catheter Device Type: Dilator, Catheter, Ureteral Classification: 21 CFR 876.5470, 21CFR 876.5520 Product Code: EZN, KOE
D. Predicate Devices
Trade name: Urological Balloon Dilatation Catheter Device Type: Dilator, Catheter, Ureteral Classification: 21 CFR 876.5470, 21CFR 876.5520 Product Code: EZN, KOE
Premarket Notification: Boston Scientific, K980795
Nephromax™ High Pressure Balloon Dilatation Catheter Trade name: Common usual/name: Catheter, Nephrostomy Classification: LJE- Catheter, Nephrostomy Pre-Amendment
Premarket Notification: Boston Scientific, K121614
1
K130 8.04
Boston Scientific page 2 of 3
| SECTION 5 | 510K SUMMARY |
|---|---|
| ----------- | -------------- |
E. Device Description
The Balloon Dilatation Catheter, styled after the Gruntzig technique, is a multiple lumen catheter with a dilatation balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow ureteral segments.
F. Intended Use
The Uromax Ultra Balloon Catheters are recommended for dilatation of the urinary tract.
G. Technological Characteristics
The proposed Uromax Ultra Balloon Catheter has the same technological characteristics and fundamental multi-lumen balloon dilatation catheter design as the predicate device (K980795). The proposed Uromax Ultra Balloon Catheter is . available in the same existing sixteen single and kit configurations.
H. Substantial Equivalence
A direct comparison of key characteristics demonstrates that the proposed balloon dilatation catheter is substantially equivalent to the predicate devices in terms of intended use, technological characteristics, and performance characteristics. The Uromax Ultra Balloon Catheter is as safe, as effective, and performs as well as the predicate devices.
I. Performance Testing (Bench Evaluation)
Boston Scientific has conducted performance testing with samples aged at T=0 and T=7 months accelerated aging in support of the balloon design change. The following testing was completed to evaluate the effects of the design change:
- Effective Working Length �
- Catheter Tip Length �
- Deflated Profile .
- Coating .
- . Deflation Time
- Balloon Diameter at RBP .
- Balloon Dilatation Length at RBP .
- Radiopaque Markerband to Balloon Alignment �
- . Balloon Compliance
- Multiple Inflation .
- Balloon Burst ♥
- Proximal Balloon Bond .
- . Surface Finish
- Scope Compatibility �
- 9 Guidewire Compatibility/Passability
- Balloon Protector (Wingtool) Removal Force ●
Page 26 of 219
2
page 3 of 3
Boston Scientific
SECTION 5
510K SUMMARY
ي والي والي ويوري
Page 27 of 219
Performance data for biocompatibility provided in K121614 for the Nephromax High Pressure Balloon Dilatation Catheter supports the Uromax Ultra Balloon Dilatation Catheter. The results of the performance testing demonstrate equivalence of the Uromax Ultra Balloon Catheter to the predicate balloon dilatation catheter (K980795).
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 22, 2013
· Boston Scientific Corporation Urology/Women's Health % Ms. Lauren B. Russo Principal Regulatory Affairs Specialist 100 Boston Scientific Way MARLBOROUGH MA 01752
Re: K130804
Trade/Device Name: Uromax Ultra™ Balloon Dilatation Catheter Regulation Number: 21 CFR& 876.5470 Regulation Name: Ureteral dilator Regulatory Class: II Product Code: EZN, KOE Dated: March 22, 2013 Received: March 25, 2013
Dear Ms. Russo:
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. 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. 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.
4
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Glenn B. Bell -S
Acting Director for: 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
5
Boston Scientific
SECTION 4 INDICATIONS FOR USE
Indications for Use Statement
510(k) Number
Uromax Ultra™ Balloon Dilatation Catheter
Indications For Use
Device Name
Uromax Ultra™ Balloon Dilatation Catheters are recommended for dilatation of the urinary tract.
Prescription Use X (21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
To be determined.
Glenn B. Bell -S
for BRF
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number K130804
Proprietary and Confidential Information of Boston Scientific Corporation
Page 23 of 219