(50 days)
Indicated for CP Stent / Covered CP Stent placement in vessels over 8mm in diameter.
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.
The provided text describes a medical device, the NuMED BIB® Stent Placement Catheter, and its substantial equivalence to a predicate device. It includes performance data from in vitro testing and a clinical trial. However, the document does not explicitly state acceptance criteria in a quantitative format, nor does it present the study results specifically framed as meeting such criteria. Instead, it leverages prior testing and a clinical trial to demonstrate substantial equivalence.
Based on the provided text, here's an attempt to extract and infer the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
As explicit acceptance criteria with numerical targets are not stated, this table will present the key performance indicators from the leveraged studies, which implicitly served as the basis for performance evaluation for substantial equivalence.
| Acceptance Criterion (Inferred from study objectives) | Reported Device Performance |
|---|---|
| Bench Testing (In Vitro) | |
| Visual inspection | Leveraged from K050857 and P150028; assumed to have passed. |
| Balloon Preparation Test | Leveraged from K050857 and P150028; assumed to have passed. |
| Diameter and Profile Test | Leveraged from K050857 and P150028; assumed to have passed. |
| Balloon Distensibility | Leveraged from K050857 and P150028; assumed to have passed. |
| Balloon Minimum Burst Strength / Volume | Leveraged from K050857 and P150028; assumed to have passed. |
| Repeated Balloon Inflation (Balloon Fatigue) Test | Leveraged from K050857 and P150028; assumed to have passed. |
| Balloon Inflation/Deflation Test | Leveraged from K050857 and P150028; assumed to have passed. |
| Balloon Deflatability Test | Leveraged from K050857 and P150028; assumed to have passed. |
| Tip Pull and Torque Test | Leveraged from K050857 and P150028; assumed to have passed. |
| Bond Strength Test | Leveraged from K050857 and P150028; assumed to have passed. |
| Catheter Body Maximum Pressure Test | Leveraged from K050857 and P150028; assumed to have passed. |
| Biocompatibility Testing | |
| Cytotoxicity (L929) | Leveraged from K050857 and P150028; assumed to have passed. |
| Sensitization (ISO Guinea Pig Maximization Test) | Leveraged from K050857 and P150028; assumed to have passed. |
| Irritation (ISO Rabbit Intracutaneous Reactivity) | Leveraged from K050857 and P150028; assumed to have passed. |
| Systemic Toxicity (ISO Mouse Systemic Injection) | Leveraged from K050857 and P150028; assumed to have passed. |
| Material-Mediated Pyrogenicity (USP Rabbit Pyrogenicity) | Leveraged from K050857 and P150028; assumed to have passed. |
| Hemocompatibility (Hemolysis) | Leveraged from K050857 and P150028; assumed to have passed. |
| Clinical Performance (Primary Safety Endpoints) | |
| Rate of serious adverse events within 30 days | 8.9% |
| Rate of post-procedure paradoxical hypertension | 7.5% |
| Clinical Performance (Primary Effectiveness Endpoints) | |
| Reduction in arm-leg systolic blood pressure gradient from baseline to 12 months | 30 ± 22 mmHg |
| Length of hospital stay | 1.1 ± 0.3 days |
| CP Stent successfully mounted and implanted with acceptable rate of procedure-related adverse events and clinically acceptable systolic blood pressure gradients | Demonstrated |
2. Sample size used for the test set and the data provenance
- Test Set Description: The clinical study is referred to as the COAST trial.
- Sample Size: 112 patients were enrolled.
- Data Provenance: The COAST trial was a "prospective, multi-center, single arm study." While the specific country of origin is not explicitly stated, "multi-center" implies data from several locations, typically within a regulatory region (e.g., USA for FDA approval).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The provided text only refers to clinical trial data (COAST study) for safety and effectiveness. It does not mention the use of experts to establish a "ground truth" for the test set in the context of diagnostic performance or image interpretation often associated with AI/ML devices. Therefore, this question is not applicable to the submitted document. The clinical outcomes served as the definitive measure of device performance.
4. Adjudication method for the test set
The document does not describe an adjudication method for the test set, as no "ground truth" establishment by multiple experts is discussed for diagnostic purposes. Clinical trial outcomes are typically assessed by study investigators and monitored, but not through an adjudication process in the sense of resolving discrepancies between expert opinions on a data point.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such MRMC comparative effectiveness study is mentioned. The device is a physical medical device (stent placement catheter), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical medical device; it does not have a standalone algorithm or AI component.
7. The type of ground truth used
For the clinical study (COAST trial), the "ground truth" for evaluating the device's performance was:
- Clinical Outcomes/Events:
- Rates of serious adverse events within 30 days.
- Rates of post-procedure paradoxical hypertension.
- Reduction in arm-leg systolic blood pressure gradient from baseline to 12 months.
- Length of hospital stay.
- Successful implantation: The text states, "The results demonstrated that the CP Stent could be successfully mounted and implanted using the BiB Stent Placement Catheter..."
For the bench and biocompatibility testing, the "ground truth" was established based on pre-defined engineering specifications, material standards, and biological safety guidelines, which the device components were expected to meet.
8. The sample size for the training set
The document does not describe a "training set" in the context of AI/ML. The device is a physical medical device. The "leveraged" data from K050857 and P150028 could be considered as prior performance data used for development and comparison, but not a "training set" in the AI sense.
9. How the ground truth for the training set was established
As there is no "training set" for an AI/ML algorithm described, this question is not applicable. The prior performance data from K050857 and P150028 were established through engineering tests, biocompatibility assessments, and clinical evaluation as per regulatory requirements for medical devices.
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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
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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
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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
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510(k) Summary
Date Prepared May 17, 2016
| Submitter | NuMED, Inc.2880 Main StreetHopkinton, NY 12965Telephone - (315) 328-4491Fax - (315) 328-4941Contact - Nichelle LaFlesh, RACEmail - nlaflesh@numedusa.com |
|---|---|
| Device | Trade Name: BIB Stent Placement CatheterCommon Name: Catheter, Percutaneous |
| Classification Name: Catheter, PercutaneousClass II, 21 CFR 870.1250 – Product Code NVM | |
| PredicateDevice | BIB PTA Catheter, Model 420- K050857 |
| DeviceDescription | The NuMED BIB® Stent Placement Catheter Model 420 is indicated for CPStent / Covered CP Stent placement in vessels over 8mm in diameter. Thecatheter is triaxial in construction with two lumens being used to inflate theballoons while one lumen is being used for tracking over a guidewire. Thepurpose of the double balloon catheter is to apply an incremental inflation forthe purpose of dilating a stent. The inner balloon provides initial expansionof the stent and also acts as a tool to hold the stent on the catheter prior to theouter balloon being inflated. The outer balloon is then inflated providing theremainder of the expansion. There are radiopaque platinum marker bandsunder the balloon shoulders for placement using fluoroscopy. The balloonmaterial is clear. The catheter balloon diameters are stamped onto theinflation extensions and are labeled with balloon diameter x balloon lengthand the catheter lot number. |
| Indications forUse | Indicated for CP Stent / Covered CP Stent placement in vessels over 8mm indiameter. |
| Comparison ofTechnologicalCharacteristics | The BiB Stent Placement Catheter is identical to the predicate in design,materials and technological characteristics. A new indication for use is being |
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Date Prepared May 17, 2016, Continued
| with thepredicateDevice | added to allow the use of the BiB Catheter for placement of the CP stentwithin a vessel. |
|---|---|
| --------------------------------- | ---------------------------------------------------------------------------------------------- |
| PerformanceData | In Vitro Testing |
|---|---|
| Bench and biocompatibility testing of the BIB Stent Placement Catheter wasleveraged from testing previously completed under K050857 and P150028.Under K050857, in vitro testing was completed using the BIB PTA Catheteralone. Under P150028, in vitro testing was completed using the BIB PTACatheter along with the CP stent. Leveraged bench testing included thefollowing: | |
| 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 evaluatethe 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
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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.
§ 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).