(64 days)
This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.
The NuMED, Inc. MULLINS™ PTA Catheter is a co-axial over-the-wire catheter with a balloon near the distal tip. It is available in sizes of 12-20mm diameter and 3-4cm in length. One lumen permits guidewire insertion to facilitate advancement of the catheter, while the other lumen is for balloon inflation and deflation. The balloons of the NuMED, Inc. MULLINS™ PTA Catheter is made of a noncompliant polymeric material and are the same balloons that are used on the approved Z-MED Catheter (K931009, K991977, and K011557). The two laminate balloon system is designed to inflate to a specific diameter at a given pressure. The change in diameter is minimal over the range of inflation pressures. The balloons are heat bonded to the shaft. The outer body and inner body tubing are made of polymeric tubing. The area under the balloon is enhanced with five radiopaque platinum image bands. Two that are 5mm on each side of the balloon center and two more under the balloon shoulders. An additional image band is imbedded into the tip of the catheter as an additional safety measure.
This document is a 510(k) premarket notification for the NuMED Mullins PTA Catheter. It claims substantial equivalence to the NuMED Z-MED PTA Catheter. The information provided is primarily focused on the device description, biocompatibility, and bench testing, rather than explicit acceptance criteria and a detailed study report with performance metrics.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the document, direct, quantifiable acceptance criteria with corresponding performance results are not explicitly stated in a table format. The submission relies on demonstrating substantial equivalence to a predicate device by comparing design, materials, and intended use. The "acceptance criteria" can be inferred as meeting the standards and performance of the predicate device and relevant biocompatibility/bench testing.
| Feature/Test | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate (PTA of femoral, iliac, renal arteries) | Same as predicate (PTA of femoral, iliac, renal arteries) |
| Biocompatibility | Compliance with Tripartite Biocompatibility Guidance for Medical Devices | "Test results indicate that all materials demonstrate the biocompatibility of the NuMED catheter and are on file at NuMED, Inc." |
| Laboratory (Bench) Testing | Performed in accordance with GMP's | "All bench testing was performed in accordance with GMP's and the results are kept on file at NuMED, Inc." |
| Materials | Same as predicate (Shaft: PES3, Balloon: PES2, Image Band: Platinum) | Same as predicate (Shaft: PES3, Balloon: PES2, Image Band: Platinum) |
| Construction | Same as predicate (Coaxial, distally mounted non-compliant balloons) | Same as predicate (Coaxial, distally mounted non-compliant balloons) |
| Balloon Performance (Diameter/Pressure) | Maintain specific diameter at given pressure with minimal change | "The two laminate balloon system is designed to inflate to a specific diameter at a given pressure. The change in diameter is minimal over the range of inflation pressures." (This is a design characteristic, not a direct test result proving it met a specific deviation tolerance) |
Missing specific quantifiable acceptance criteria and performance data. The document states that test results are "on file at NuMED, Inc.", indicating that the detailed data was submitted to the FDA but is not included in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document only mentions "Biocompatibility Testing" and "Laboratory (Bench) Testing" without indicating the number of devices or components tested.
- Data Provenance: The tests were conducted internally by NuMED, Inc. ("on file at NuMED, Inc."). The document does not specify the country of origin of the data beyond "NuMED, Inc.", which is based in Hopkinton, NY, USA. The testing appears to be retrospective in the sense that the results were submitted for a premarket notification for a device that has undergone testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The device is a medical catheter, and its evaluation relies on physical and material properties, mechanical testing, and biocompatibility, not on expert interpretation of medical images or clinical data to establish a ground truth for a diagnostic output.
4. Adjudication Method for the Test Set
This is not applicable for the reasons stated above. There's no "ground truth" established by experts or adjudication involved in the type of testing described (biocompatibility, bench testing).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. The device is a medical catheter, not an AI-powered diagnostic tool requiring human readability or interpretation. Therefore, there's no comparison of human readers with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable. The device is a physical medical instrument, not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for this device's safety and effectiveness relies on:
- Biocompatibility Standards: Compliance with the "Tripartite Biocompatibility Guidance for Medical Devices."
- Engineering Standards: Meeting the device's design specifications for dimensions, material integrity, and functionality (e.g., balloon inflation properties).
- Good Manufacturing Practices (GMPs): Adherence to quality system requirements during testing.
There is no "ground truth" derived from expert consensus, pathology, or outcomes data in the context of diagnostic interpretation, as this is an interventional device.
8. Sample Size for the Training Set
This is not applicable. The device is a physical medical instrument, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
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SUMMARY OF SAFETY AND EFFECTIVENESS DATA
December 11, 2001
Submitted By: NuMED, Inc. , 2880 Main St., Hopkinton, NY 12965 (Ph) 315-328-4491
Contact Person: Nichelle LaFlesh
NuMED Mullins PTA Catheter; 21 CFR 870.1250 - Percutaneous Device Name: Catheter
Predicate Devices: NuMED Z-MED PTA Catheter
The NuMED, Inc. MULLINS™ PTA Catheter is a co-axial over-Device Description : the-wire catheter with a balloon near the distal tip. It is available in sizes of 12-20mm diameter and 3-4cm in length. One lumen permits guidewire insertion to facilitate advancement of the catheter, while the other lumen is for balloon inflation and deflation.
The balloons of the NuMED, Inc. MULLINS™ PTA Catheter is made of a noncompliant polymeric material and are the same balloons that are used on the approved Z-MED Catheter (K931009, K991977, and K011557). The two laminate balloon system is designed to inflate to a specific diameter at a given pressure. The change in diameter is minimal over the range of inflation pressures. The balloons are heat bonded to the shaft.
The outer body and inner body tubing are made of polymeric tubing. The area under the balloon is enhanced with five radiopaque platinum image bands. Two that are 5mm on each side of the balloon center and two more under the balloon shoulders. An additional image band is imbedded into the tip of the catheter as an additional safety measure.
Biocompatibility Testing:
The materials used in the NuMED Mullins PTA Catheter is the same as those used in our other PTA Catheters (510(k) #K931009) and PTV Catheters (510(k) #K991977) which were tested for biocompatibility in compliance with the Tripartite Biocompatibility Guidance for Medical Devices.
Test results indicate that all materials demonstrate the biocompatibility of the NuMED catheter and are on file at NuMED, Inc.
Laboratory (Bench) Testing: All bench testing was performed in accordance with GMP's and the results are kept on file at NuMED, Inc.
Intended Use: This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.
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| Comparison Information: | ||
|---|---|---|
| MODEL: | NUMED MULLINS | NUMED Z-MED PTA |
| Indications: | This catheter is recommendedfor Percutaneous TransluminalAngioplasty (PTA) of thefemoral, iliac, and renalarteries. These catheters arenot designed to be used in thecoronary arteries. | 1) This catheter is recommended forPercutaneous TransluminalAngioplasty (PTA) of the femoral,iliac, and renal arteries. Thesecatheters are not designed to beused in the coronary arteries.----AND----2) This catheter is recommendedfor Percutaneous TransluminalValvuloplasty (PTV) of thepulmonary valve.A patient with isolatedpulmonary stenosis.A patient with valvularpulmonary stenosis with otherminor congenital heart diseasethat does not require surgicalintervention. |
| Introducer: | 9 Fr - 14 Fr | 6 Fr - 14 Fr |
| Shaft Size: | 7 Fr - 8 Fr | 5 Fr - 9Fr |
| Guidewire Size: | 0.035" | 0.025" and 0.035" |
| Usable Length: | 90cm and 100cm | 85cm, 100cm, 110cm, 120cm |
| Balloon Diameter: | 12mm - 20mm | 2mm - 25mm |
| Balloon Length: | 3cm - 4cm | 1cm - 15cm |
| Materials: | Shaft: PES3Balloon: PES2Image Band: Platinum | Shaft: PES3Balloon: PES2Image Band: Platinum |
| Construction: | Coaxial construction withdistally mounted non-compliantballoons | Coaxial construction withdistally mounted non-compliantballoon. |
Comparison Information:
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Image /page/2/Picture/1 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 emblem featuring three stylized chevrons, which are meant to represent the department's mission of providing essential human services and protecting the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 3 2002
NuMED, Inc. c/o Ms. Nichelle R. LaFlesh 2880 Main St Hopkinton, NY 12965
Re: K013601
NuMED Mullins PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: December 3, 2001 Received: December 4, 2001
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
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Page 2 - Ms. Nichelle R. LaFlesh
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dela Till
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
510(k) Number (if known):
Device Name: NuMED Mullins PTA Catheter
Indications For Use:
- This catheter is recommended for Percutaneous Transluminal Angioplasty 트 (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use_
Division of Cardiovascular & Bespiratory Devices
510(k) Number R013600
(Optional Format 1-2-96)
:
§ 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).