(109 days)
No
The device description and performance studies focus on the mechanical properties and performance of a balloon catheter for nephrostomy tract dilatation, with no mention of AI or ML technologies.
Yes
The device is described as a "Balloon Dilatation Catheter" used for "dilatation of the nephrostomy tract," which is a therapeutic intervention aimed at treating medical conditions.
No
Explanation: The device, the Nephromax™ High Pressure Balloon Dilatation Catheters, is used for "dilatation of the nephrostomy tract." This is a therapeutic action, not a diagnostic one. The device description and performance studies focus on physical characteristics and mechanical performance (e.g., dilatation, balloon burst pressure), not on detecting or identifying a medical condition.
No
The device description clearly describes a physical catheter with a balloon, sheath, and multiple lumens, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "dilatation of the nephrostomy tract." This is a therapeutic procedure performed directly on a patient's body.
- Device Description: The device is a balloon catheter designed to exert radial force to dilate a tract within the body. This is a physical intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, disease, or condition.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is used to physically modify a structure within the body.
N/A
Intended Use / Indications for Use
The Nephromax™ High Pressure Balloon Dilatation Catheters are recommended for dilatation of the nephrostomy tract.
Product codes
LJE
Device Description
The NephroMax Balloon Catheter, styled after the Gruntzig technique, is a multiple lumen catheter with a dilatation balloon mounted at the distal tip. Provided with the balloon catheter is a 24F (8 mm) or 30F (10 mm) renal sheath. Dilatation balloon catheters are used to exert radial force to dilate nephrostomy tracts. The balloon features a silicone coating to reduce friction between the balloon surface and renal sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nephrostomy 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 and additional size configurations. The following testing was completed to evaluate the effects of the design change and sizes:
- Effective Working Length .
- Catheter Tip Length/ RO Marker Location
- Deflation Time .
- Balloon Diameter/Length at Rated Burst Pressure .
- Balloon Compliance .
- Multiple Inflation .
- Balloon Burst .
- Proximal Balloon Bond Tensile .
- Balloon Protector Removal Force .
- . Guidewire Passability
The results of the performance testing demonstrate equivalence of the NephroMax Balloon Catheter to the predicate balloon dilatation catheter. The NephroMax Balloon Catheters are considered safe and effective for their intended use.
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
N/A
0
Nephromax Balloon Dilatation Catheter Traditional 510(k)
SECTION 5
:510(k) Summary for NephroMax™ High Pressure Balloon Dilatation Catheter
A. Sponsor
Boston Scientific Corporation Urology and Women's Health Division 100 Boston Scientific Way Marlborough, MA 01756
B. Contact
Lauren Anderson Senior Specialist, Regulatory Affairs 508-683-4707 lauren.anderson@bsci.com
or
Donna Gardner Director, Regulatory Affairs 508-683-4398 gardnerd@bsci.com
C. Device Name
NephroMax 116 High Pressure Balloon Dilatation Catheter Trade name: Common/usual name: Catheter, Nephrostomy Classification Name: LJE - Catheter, Nephrostomy Pre-Amendment
D. Predicate Device
Trade name: Nephrostomy Balloon Dilatation Catheter Common/usual name: Catheter, Nephrostomy Classification Name: LJE - Catheter, Nephrostomy Pre-Amendment
Premarket Notification: Boston Scientific, K952968
E. Device Description
The NephroMax Balloon Catheter, styled after the Gruntzig technique, is a multiple lumen catheter with a dilatation balloon mounted at the distal tip. Provided with the balloon catheter is a 24F (8 mm) or 30F (10 mm) renal sheath. Dilatation balloon catheters are used to exert radial force to dilate nephrostomy tracts. The balloon features a silicone coating to reduce friction between the balloon surface and renal sheath.
F. Intended Use
The NephroMax Balloon Catheters are recommended for dilatation of the nephrostomy tract.
Proprietary and Confidential Information of Boston Scientific Corporation
SEP 18 2012
510K SUMMARY
Boston Scientific
1
K121614 page 2 of 2
Nephromax Balloon Dilatation Catheter Traditional 510(k)
Boston Scientific
| SECTION 5 | 510K SUMMARY | |
|---|---|---|
| ----------- | -- | -------------- |
G. Technological Characteristics
The NephroMax Balloon Catheter has the same technological characteristics and fundamental multi-lumen balloon dilatation catheter design as the predicate device. The proposed NephroMax Balloon Catheter is available in four configurations with three balloon sizes.
H. Substantial Equivalence
A direct comparison of key characteristics demonstrates that the proposed balloon dilatation catheter is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and performance characteristics. The NephroMax Balloon Catheter is as safe, as effective, and performs as well as the predicate device.
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 and additional size configurations. The following testing was completed to evaluate the effects of the design change and sizes:
- Effective Working Length .
- 0 Catheter Tip Length/ RO Marker Location
- Deflation Time .
- Balloon Diameter/Length at Rated Burst Pressure .
- Balloon Compliance .
- Multiple Inflation .
- Balloon Burst .
- Proximal Balloon Bond Tensile .
- Balloon Protector Removal Force .
- . Guidewire Passability
The results of the performance testing demonstrate equivalence of the NephroMax Balloon Catheter to the predicate balloon dilatation catheter. The NephroMax Balloon Catheters are considered safe and effective for their intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle, with its wings spread and its head turned to the left.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP
18
2012
Ms. Lauren Anderson Senior Regulatory Affairs Specialist. Boston Scientific Corporation 100 Boston Scientific Way MARLBOROUGH MA 01752
Re: K121614
Trade/Device Name: Nephromax™ High Pressure Balloon Dilatation Catheter Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LJE Dated: July 30, 2012 Received: August 22, 2012
Dear Ms. Anderson :
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) premation is ubstantially equivalent (for the indications referenced above and nave determined the act roo sevedicate devices marketed in interstate for use stated in the enclosure) to regarly manotes province Amendments, or to commerce prior to May 20, 1970, the chaofficial with the provisions of the Federal Food, Drug, devices that have been reciassified in accordance with are preval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act. The and Cosment Act (Act) that do not require approval controls provisions of the Act. The Y ou may, therefore, market the device, basics to the gentration, listing of
general controls provisions of the Act include requirements for annual registration, includers an general controls of the fict increase a and prohibitions against misteraling and adulteration. Please note: CDRH does not evaluate in trutting related to contract liability.
adulteration. Please note: CDRH does not evaluate in truturely and not mislea adulteration. Please note: CDNT does not Cranado miconnation in and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) mo cation major regulations affecting your device can be
it may be subject to additional controls. it may be subject to additional controls. LAIsung mayors 800 to 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Paris 800 to 898. In additio found in the Code of I edelar Rogations) concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a succession other requirements of the Act
that FDA has made a determination that your device complies with of the Act that FDA has made a decemmation that your are research agencies. You must or any Federal statules and regulations administed to: registration and listing and listing of medi comply with all the Act s requirements, incruding, occhior manufactures
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 -
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set device-related adverse events) (21 OFF 009), good in applicable, the electronic a forum in the quality systems (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 II you desire specific advice tor your control so more offices/CDRH/CDRHOffices/ucm115809.htm for go to http://www.ida.gov.it.badiological Health's (CDRH's) Office of Compliance. Also, please the Center for Devilocs and Radiotegrounding by reference to premarket notification" (21CFR Patt note the regulation emilion, "informating 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 I ou may obtain other general mormanional 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin R. Civiletti
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
4
Nephromax Balloon Dilatation Catheter Traditional 510(k)
INDICATIONS FOR USE SECTION 4 2 3 1 1 1 1 1 1 1
Indications for Use Statement
| 510(k) Number | To be determined. K121614 |
|---|---|
| Device Name | Nephromax™ High Pressure Balloon Dilatation Catheter |
| Indications For Use | The Nephromax™ High Pressure Balloon Dilatation Catheters are recommended for dilatation of the nephrostomy 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)
loymmhm
Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K121614
Proprietary and Confidential Information of Boston Scientific Corporation