(101 days)
Recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.
- A patient with isolated pulmonary stenosis.
- A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.
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 Mullins-X catheter is an Ultra High Pressure Dilatation catheter recommended for Percutaneous Transluminal Valvuloplasty of the Pulmonary Valve. The catheter is a coaxial over the wire catheter with a balloon near the distal tip. One lumen is for balloon inflation and deflation. The balloons of the Mullins-X catheter are made of a non-compliant polymeric material. 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 is made of polymeric tubing, and the inner tubing is comprised of a multi layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. The area under the balloon is enhanced with four radiopaque platinum image bands. Two are 5mm on each side of the balloon center and two more under the balloon shoulders. The catheter is white in color and the balloon material is clear. The catheter balloon diameter and name is stamped on the Y sleeve and the balloon extension is labeled with balloon diameter x balloon length x introducer size x shaft size x usable length x guidewire size and the catheter lot number. The catheter is packaged in a polyethylene sheath and is double packed in two heat sealed Tyvek pouches.
The provided text describes the Mullins-X PTV Catheter, a medical device. Here's an analysis of its acceptance criteria and the study proving it meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Mullins-X Results |
|---|---|---|
| Visual Inspection | The catheters shall be free from contamination, discoloration, and any form of damage that could impact the proper functioning of the device. | All catheters were visually inspected without any anomalies. |
| Balloon Preparation Test | Each catheter shall be prepped per the procedure without functional difficulties or anomalies. | All catheters tested were without functional difficulties or anomalies. |
| Diameter and Profile Test | The balloon diameter at rated burst pressure shall be within +/- 10% of the labeled balloon diameter and the samples should fit through the selected introducer with no problems. | All catheters met the acceptance criteria. |
| Balloon Distensibility | The results must demonstrate that the balloon diameter is within +/- 10% of the labeled diameter at the RBP and will not be significantly increased at increasingly higher pressures. | All data obtained demonstrates that the balloon diameter is within +/- 10% of the labeled diameter at the RBP. All data obtained demonstrates that the diameter of the balloons will not be significantly increased at increasingly higher pressures. |
| Balloon Minimum Burst Strength | The results must show statistically that with at least 95% confidence, 99.9% of the balloons will not burst at or below the maximum recommended rated burst pressure. | All catheters met the established acceptance criteria. |
| Repeated Balloon Inflation (Balloon Fatigue) Test | No breaks allowed. | No Breaks. |
| Balloon Inflation/Deflation Test | Inflation achieved in less than 12 seconds and deflation achieved in less than 20 seconds. | All catheters met the established acceptance criteria. |
| Balloon Deflatability Test | There should be no interference with balloon deflation. | All catheters met the established acceptance criteria. |
| Tip Pull and Torque Test | Must withstand at least 10 turns without breaking. | No breaks. |
| Bond Strength Test | All bonds must withstand at least 3 lbs. of pull strength. | All bonds met the established acceptance criteria. |
| Catheter Body Maximum Pressure Test | All samples must withstand 30 ATM (400psi). | >30 ATM |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size for each in-vitro test. Instead, it refers to "all catheters tested" or "all samples," implying that a sufficient number of units were tested to demonstrate compliance with the acceptance criteria. The data provenance is not mentioned, but as this is an in-vitro study, it is likely conducted in a controlled laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The study described is an in-vitro performance test of a medical device (a catheter), not a diagnostic algorithm that relies on expert interpretation of data. The "ground truth" for these tests is based on objective measurements against engineering specifications and industry standards.
4. Adjudication Method for the Test Set
Not applicable, as this is an in-vitro performance test, not a study requiring human adjudication of results.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the scope of this device's testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The "Mullins-X PTV Catheter" is a physical medical device, not a software algorithm. The tests performed are standalone performance tests of the physical catheter itself.
7. The Type of Ground Truth Used
The "ground truth" for these tests is based on:
- Objective Measurements and Specifications: For criteria like diameter, pressure ratings, and time for inflation/deflation, the ground truth is the predefined numerical specification.
- Absence of Defects: For visual inspection and balloon fatigue tests, the ground truth is the absence of anomalies or breaks.
- Statistical Assurance: For balloon burst strength, the ground truth is a statistical confidence level that a certain percentage of balloons will not burst below the rated pressure.
These are established engineering standards and performance requirements for the device.
8. The Sample Size for the Training Set
Not applicable. This is an in-vitro performance test for a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained above, this device does not involve a training set or AI algorithm.
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Appendix D
·
DEC - 9 2010
510(k) Summary
| GeneralProvisions | Trade Name: Mullins-X PTV Catheter |
|---|---|
| Classification Name: Catheter, Percutaneous (Valvuloplasty) | |
| Name ofPredicateDevice | Z-MED-X PTV Catheter – K022722 |
| Classification | Class II, 21 CFR 870.1250 - Product Code OMZ |
| PerformanceStandards | Performance Standards have not been established by FDA under Section 514 of the Food, Drug and Cosmetic Act. |
| Intended Use | Recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve. |
| A patient with isolated pulmonary stenosis. | |
| A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention. | |
| Original Indication: Recommended for Percutaneous Transluminal 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. |
Continued on next page
365
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510(k) Summary, Continued
Device The Mullins-X catheter is an Ultra High Pressure Dilatation catheter Description recommended for Percutaneous Transluminal Valvuloplasty of the Pulmonary Valve. The catheter is a coaxial over the wire catheter with a balloon near the distal tip. One lumen is for balloon inflation and deflation. The balloons of the Mullins-X catheter are made of a non-compliant polymeric material. 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 is made of polymeric tubing, and the inner tubing is comprised of a multi layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. The area under the balloon is enhanced with four radiopaque platinum image bands. Two are 5mm on each side of the balloon center and two more under the balloon shoulders. The catheter is white in color and the balloon material is clear. The catheter balloon diameter and name is stamped on the Y sleeve and the balloon extension is labeled with balloon diameter x balloon length x introducer size x shaft size x usable length x guidewire size and the catheter lot number. The catheter is packaged in a polyethylene sheath and is double packed in two heat sealed Tyvek pouches. Biocompatibility All materials used to manufacture the Mullins-X Catheter are available on other commercially available NuMED, Inc. devices (K022722, K081680, and K014124) and have passed all relevant biocompatibility tests. No additional biocompatibility testing was conducted for the Mullins-X Balloon Catheter. In-Vitro A complete list of tests performed and the results are provided in the table Testing below. Continued on next page
3ldo
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| TestPerformed | AcceptanceCriteria | Mullins-XResults | PredicateDevice –Z-MED-X Results |
|---|---|---|---|
| VisualInspection | The catheters shall befree fromcontamination,discoloration, andany form of damagethat could impact theproper functioning ofthe device. | All catheters werevisually inspectedwithout anyanomalies. | All catheters were visually inspectedwithout any anomalies. |
| Balloon PreparationTest | Each catheter shallbe prepped per theprocedure withoutfunctional difficultiesor anomalies. | All catheters testedwere withoutfunctionaldifficulties oranomalies. | All catheters tested were withoutfunctional difficulties or anomalies. |
| Diameter and ProfileTest | The balloon diameterat rated burstpressure shall bewithin +/- 10% of thelabeled balloondiameter and thesamples should fitthrough the selectedintroducer with noproblems. | All catheters met theacceptance criteria. | All catheters met the acceptance criteria. |
| BalloonDistensibility | The results mustdemonstrate that theballoon diameter arewithin +/- 10% of thelabeled diameter atthe RBP and will notbe significantlyincreased atincreasingly higherpressures. | All data obtaineddemonstrates that theballoon diameter is within+/- 10% of the labeleddiameter at the RBP. Alldata obtaineddemonstrates that thediameter of the balloonswill not be significantlyincreased at increasinglyhigher pressures. | All data obtained demonstrates that the balloondiameter is within +/- 10% of the labeled diameterat the RBP. All data obtained demonstrates thatthe diameter of the balloons will not besignificantly increased at increasingly higherpressures. |
| Balloon MinimumBurst Strength | The results mustshow statistically thatwith at least 95%confidence, 99.9% ofthe balloons will notburst at or below themaximumrecommended ratedburst pressure. | All catheters met theestablishedacceptance criteria. | All catheters met the establishedacceptance criteria. |
| Repeated BalloonInflation (BalloonFatigue) Test | No breaks allowed | No Breaks. | No breaks. |
| BalloonInflation/DeflationTest | Inflation achieved inless than 12 secondsand deflationachieved in less than20 seconds | All catheters met theestablishedacceptance criteria. | All catheters met the establishedacceptance criteria. |
| TestPerformed | AcceptanceCriteria | Mullins-XResults | PredicateDevice -Z-MED-X Results |
| Balloon DeflatabilityTest | There should be nointerference withballoon deflation | All catheters met theestablishedacceptance criteria. | All catheters met the establishedacceptance criteria. |
| Tip Pull and TorqueTest | Must withstand atleast 10 turns withoutbreaking | No breaks | No breaks |
| Bond Strength Test | All bonds mustwithstand at least 3lbs. of pull strength. | All bonds met theestablishedacceptance criteria. | All bonds met the established acceptancecriteria. |
| Catheter BodyMaximum PressureTest | All samples mustwithstand 30 ATM(400psi). | >30 ATM | > 400 psi |
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Summary of The Mullins-X Catheter has been tested and compared to the predicate device Safety and listed herein. All data gathered demonstrate the Mullins-X Catheter is Effectiveness substantially equivalent. No new issues of safety or efficacy have been raised.
3lolo-B
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name encircling a stylized emblem. The emblem consists of a stylized eagle or bird-like figure with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NuMED Inc. c/o Nichelle LaFlesh, RAC Regulatory Affairs Manager/Compliance Officer 2880 Main Street Hopkinton, NY 12965
DEC - 9 2010
Re: K102473 Mullins-X PTV Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: OMZ
Dated: December 6, 2010 Received: December 7, 2010
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.
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Page 2 - Nichelle LaFlesh, RAC
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 (OS) 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/CDRH/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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 E
Indications for Use
510(k) Number (if known): K102473
DEC - 9 2010
Device Name: Mullins-X Catheter
Indications For Use:
Recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.
- A patient with isolated pulmonary stenosis .
- A patient with valvular pulmonary stenosis with other minor congenital heart disease that . does not require surgical intervention.
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.
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)
(Division Sign-Off) Division of Cardiovascular Devices 6102475 510(k) Number
Page 1 of 1
367
§ 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).