(50 days)
K050857, P150028
No
The device description and performance studies focus on the mechanical and material properties of a balloon catheter for stent placement, with no mention of AI or ML technologies.
Yes
The device is used for "CP Stent / Covered CP Stent placement" within blood vessels and "to apply an incremental inflation for the purpose of dilating a stent," which directly addresses or modifies a physiological condition (vessel narrowing) or structure (stent placement for vessel patency). In the clinical study, it contributed to a "reduction of arm-leg systolic blood pressure gradient."
No
This device is described as a stent placement catheter used to implant CP Stents, which is a therapeutic rather than a diagnostic function.
No
The device description clearly details a physical catheter with balloons, lumens, and radiopaque markers, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the NuMED BIB® Stent Placement Catheter Model 420 is a catheter used for the placement of a stent within blood vessels. It is an interventional device used inside the body.
- Intended Use: The intended use is for "CP Stent / Covered CP Stent placement in vessels over 8mm in diameter." This is a therapeutic procedure performed directly on the patient.
- Input Modality: The input modality is fluoroscopy, which is an imaging technique used during procedures performed on the patient.
- Anatomical Site: The anatomical site is "vessels over 8mm in diameter," which are internal structures of the body.
The device is a tool used in a medical procedure performed on a patient, not a device used to analyze samples taken from a patient.
N/A
Intended Use / Indications for Use
Indicated for CP Stent / Covered CP Stent placement in vessels over 8mm in diameter.
Product codes
NVM
Device Description
The NuMED BIB® Stent Placement Catheter Model 420 is indicated for CP Stent / Covered CP Stent placement in vessels over 8mm in diameter. The catheter is triaxial in construction with two lumens being used to inflate the balloons while one lumen is being used for tracking over a guidewire. The purpose of the double balloon catheter is to apply an incremental inflation for the purpose of dilating a stent. The inner balloon provides initial expansion of the stent and also acts as a tool to hold the stent on the catheter prior to the outer balloon being inflated. The outer balloon is then inflated providing the remainder of the expansion. There are radiopaque platinum marker bands under the balloon shoulders for placement using fluoroscopy. The balloon material is clear. The catheter balloon diameters are stamped onto the inflation extensions and are labeled with balloon diameter x balloon length and the catheter lot number.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
vessels over 8mm in diameter
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
In Vitro Testing
Bench and biocompatibility testing of the BIB Stent Placement Catheter was leveraged from testing previously completed under K050857 and P150028. Under K050857, in vitro testing was completed using the BIB PTA Catheter alone. Under P150028, in vitro testing was completed using the BIB PTA Catheter along with the CP stent. Leveraged bench testing included the following: Visual inspection, Balloon Preparation Test, Diameter and Profile Test, Balloon Distensibility, Balloon Minimum Burst Strength / Volume, Repeated Balloon Inflation (Balloon Fatigue) Test, Balloon Inflation/Deflation Test, Balloon Deflatability Test, Tip Pull and Torque Test, Bond Strength Test, Catheter Body Maximum Pressure Test. Leveraged biocompatibility testing included the following: Cytotoxicity (L929), Sensitization (ISO Guinea Pig Maximization Test), Irritation (ISO Rabbit Intracutaneous Reactivity), Systemic Toxicity (ISO Mouse Systemic Injection), Material-Mediated Pyrogenicity (USP Rabbit Pyrogenicity), Hemocompatibility (Hemolysis).
Clinical
The COAST trial was a prospective, multi-center, single arm study to evaluate the NuMed CP stent for the treatment of coarctation of the aorta (approved under P150028). The NuMED BIB® Stent Placement Catheter was used in the COAST trial to place the CP Stent during the implant procedure. The primary safety endpoints were the rate of serious adverse events within 30 days of the procedure and the rate of post-procedure paradoxical hypertension. The primary effectiveness endpoints were the reduction in arm-leg systolic blood pressure gradient from baseline to 12 months and length of hospital stay. A total of 112 patients were enrolled in the study. The rate of serious adverse events within 30 days of the procedure was 8.9% and the rate of post-procedure paradoxical hypertension was 7.5%. The reduction of arm-leg systolic blood pressure gradient at 12 months was 30 ±22mmHg and the length of hospital stay was 1.1±0.3 days. The results demonstrated that the CP Stent could be successfully mounted and implanted using the BiB Stent Placement Catheter with an acceptable rate of procedure-related adverse events and clinically acceptable systolic blood pressure gradients.
Key Metrics
Rate of serious adverse events within 30 days of the procedure: 8.9%
Rate of post-procedure paradoxical hypertension: 7.5%
Reduction of arm-leg systolic blood pressure gradient at 12 months: 30 ±22mmHg
Length of hospital stay: 1.1±0.3 days
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2016
NuMED, Inc. Ms. Nichelle LaFlesh Regulatory Affairs Manager/Compliance Officer 2880 Main St. Hopkinton, New York 12965
Re: K160889
Trade/Device Name: BiB Stent Placement Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NVM Dated: March 30, 2016 Received: March 31, 2016
Dear Ms. LaFlesh:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 contact the Division of Industry and Consumer Education 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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 vours.
M.A. Hillebrenner
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Appendix C
Indications for Use
510(k) Number (if known): K160889
Device Name: BIB Stent Placement Catheter
Indications For Use:
Indicated for CP Stent / Covered CP Stent placement in vessels over 8mm in diameter.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
3
510(k) Summary
Date Prepared May 17, 2016
| Submitter | NuMED, Inc.
2880 Main Street
Hopkinton, NY 12965
Telephone - (315) 328-4491
Fax - (315) 328-4941
Contact - Nichelle LaFlesh, RAC
Email - nlaflesh@numedusa.com |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Trade Name: BIB Stent Placement Catheter
Common Name: Catheter, Percutaneous |
| | Classification Name: Catheter, Percutaneous
Class II, 21 CFR 870.1250 – Product Code NVM |
| Predicate
Device | BIB PTA Catheter, Model 420- K050857 |
| Device
Description | The NuMED BIB® Stent Placement Catheter Model 420 is indicated for CP
Stent / Covered CP Stent placement in vessels over 8mm in diameter. The
catheter is triaxial in construction with two lumens being used to inflate the
balloons while one lumen is being used for tracking over a guidewire. The
purpose of the double balloon catheter is to apply an incremental inflation for
the purpose of dilating a stent. The inner balloon provides initial expansion
of the stent and also acts as a tool to hold the stent on the catheter prior to the
outer balloon being inflated. The outer balloon is then inflated providing the
remainder of the expansion. There are radiopaque platinum marker bands
under the balloon shoulders for placement using fluoroscopy. The balloon
material is clear. The catheter balloon diameters are stamped onto the
inflation extensions and are labeled with balloon diameter x balloon length
and the catheter lot number. |
| Indications for
Use | Indicated for CP Stent / Covered CP Stent placement in vessels over 8mm in
diameter. |
| Comparison of
Technological
Characteristics | The BiB Stent Placement Catheter is identical to the predicate in design,
materials and technological characteristics. A new indication for use is being |
4
Date Prepared May 17, 2016, Continued
| with the
predicate
Device | added to allow the use of the BiB Catheter for placement of the CP stent
within a vessel. |
| --------------------------------- | ---------------------------------------------------------------------------------------------- |
|---|
| Performance
| Data | In Vitro Testing |
|---|---|
| Bench and biocompatibility testing of the BIB Stent Placement Catheter was | |
| leveraged from testing previously completed under K050857 and P150028. | |
| Under K050857, in vitro testing was completed using the BIB PTA Catheter | |
| alone. Under P150028, in vitro testing was completed using the BIB PTA | |
| Catheter along with the CP stent. Leveraged bench testing included the | |
| following: | |
| Visual inspection Balloon Preparation Test Diameter and Profile Test Balloon Distensibility Balloon Minimum Burst Strength / Volume Repeated Balloon Inflation (Balloon Fatigue) Test Balloon Inflation/Deflation Test Balloon Deflatability Test Tip Pull and Torque Test Bond Strength Test Catheter Body Maximum Pressure Test Leveraged biocompatibility testing included the following: Cytotoxicity (L929) Sensitization (ISO Guinea Pig Maximization Test) Irritation (ISO Rabbit Intracutaneous Reactivity) Systemic Toxicity (ISO Mouse Systemic Injection) Material-Mediated Pyrogenicity (USP Rabbit Pyrogenicity) Hemocompatibility (Hemolysis) Clinical | |
| The COAST trial was a prospective, multi-center, single arm study to evaluate | |
| the NuMed CP stent for the treatment of coarctation of the aorta (approved |
under P150028). The NuMED BIB® Stent Placement Catheter was used in the COAST trial to place the CP Stent during the implant procedure. The primary safety endpoints were the rate of serious adverse events within 30 days of the procedure and the rate of post-procedure paradoxical hypertension. The primary effectiveness endpoints were the reduction in arm-leg systolic blood pressure gradient from baseline to 12 months and
5
length of hospital stay. A total of 112 patients were enrolled in the study. The rate of serious adverse events within 30 days of the procedure was 8.9% and the rate of post-procedure paradoxical hypertension was 7.5%. The reduction of arm-leg systolic blood pressure gradient at 12 months was 30 ±22mmHg and the length of hospital stay was 1.1±0.3 days. The results demonstrated that the CP Stent could be successfully mounted and implanted using the BiB Stent Placement Catheter with an acceptable rate of procedurerelated adverse events and clinically acceptable systolic blood pressure gradients.
- Conclusions The BIB Stent Placement Catheter has been tested and compared to the predicate device, the BIB PTA Balloon Catheter (K050857). All nonclinical and clinical data gathered demonstrate the BIB Stent Placement Catheter is substantially equivalent to the BIB PTA Catheter.