MULLINS-X PTV CATHETER

K102473 · NuMED, Inc. · OMZ · Dec 9, 2010 · Cardiovascular

Device Facts

• Record ID: K102473
• Device Name: MULLINS-X PTV CATHETER
• Applicant: NuMED, Inc.
• Product Code: OMZ · Cardiovascular
• Decision Date: Dec 9, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

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. 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.

Device Story

Mullins-X PTV Catheter is an ultra-high-pressure, coaxial, over-the-wire dilatation catheter. Features non-compliant, two-laminate polymeric balloon at distal tip; inner tubing composed of polyamide (Vestamid PA12) surrounding 304 LV stainless steel braid; four radiopaque platinum image bands for positioning. Operated by physicians in clinical settings for pulmonary valve valvuloplasty and peripheral artery angioplasty. Device uses inflation/deflation lumen to expand balloon to specific diameter at controlled pressure; minimal diameter change over pressure range. Radiopaque markers assist physician in visualization under fluoroscopy to ensure accurate placement. Benefits include effective stenosis dilation with controlled balloon expansion. Device is supplied sterile.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included visual inspection, balloon preparation, diameter/profile, distensibility, minimum burst strength, fatigue (repeated inflation), inflation/deflation timing, deflatability, tip pull/torque, bond strength, and catheter body pressure testing. All results met established acceptance criteria and were comparable to the predicate device.

Technological Characteristics

Coaxial over-the-wire catheter; non-compliant polymeric balloon; inner shaft: polyamide (Vestamid PA12) with 304 LV stainless steel braid; radiopaque platinum markers. Energy source: external inflation device (manual/mechanical). Connectivity: none. Sterilization: not specified (double-packed in Tyvek).

Indications for Use

Indicated for patients with isolated pulmonary stenosis or valvular pulmonary stenosis with minor congenital heart disease not requiring surgery, undergoing PTV of the pulmonary valve. Also indicated for PTA of femoral, iliac, and renal arteries. Contraindicated for use in coronary arteries.

Regulatory Classification

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.

Predicate Devices

• Z-MED-X PTV Catheter (K022722)

Reference Devices

• NuMED, Inc. device (K081680)
• NuMED, Inc. device (K014124)

Submission Summary (Full Text)

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K102473

# Appendix D

·

DEC - 9 2010

# 510(k) Summary

| General<br>Provisions | Trade Name: Mullins-X PTV Catheter |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Classification Name: Catheter, Percutaneous (Valvuloplasty) |
| Name of<br>Predicate<br>Device | Z-MED-X PTV Catheter – K022722 |
| Classification | Class II, 21 CFR 870.1250 - Product Code OMZ |
| Performance<br>Standards | 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

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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

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| Test<br>Performed | Acceptance<br>Criteria | Mullins-X<br>Results | Predicate<br>Device –<br>Z-MED-X Results |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Visual<br>Inspection | The catheters shall be<br>free from<br>contamination,<br>discoloration, and<br>any form of damage<br>that could impact the<br>proper functioning of<br>the device. | All catheters were<br>visually inspected<br>without any<br>anomalies. | All catheters were visually inspected<br>without any anomalies. |
| Balloon Preparation<br>Test | Each catheter shall<br>be prepped per the<br>procedure without<br>functional difficulties<br>or anomalies. | All catheters tested<br>were without<br>functional<br>difficulties or<br>anomalies. | All catheters tested were without<br>functional difficulties or anomalies. |
| Diameter and Profile<br>Test | The balloon diameter<br>at rated burst<br>pressure shall be<br>within +/- 10% of the<br>labeled balloon<br>diameter and the<br>samples should fit<br>through the selected<br>introducer with no<br>problems. | All catheters met the<br>acceptance criteria. | All catheters met the acceptance criteria. |
| Balloon<br>Distensibility | The results must<br>demonstrate that the<br>balloon diameter are<br>within +/- 10% of the<br>labeled diameter at<br>the RBP and will not<br>be significantly<br>increased at<br>increasingly higher<br>pressures. | All data obtained<br>demonstrates that the<br>balloon diameter is within<br>+/- 10% of the labeled<br>diameter at the RBP. All<br>data obtained<br>demonstrates that the<br>diameter of the balloons<br>will not be significantly<br>increased at increasingly<br>higher pressures. | All data obtained demonstrates that the balloon<br>diameter is within +/- 10% of the labeled diameter<br>at the RBP. All data obtained demonstrates that<br>the diameter of the balloons will not be<br>significantly increased at increasingly higher<br>pressures. |
| Balloon Minimum<br>Burst Strength | The results must<br>show statistically that<br>with at least 95%<br>confidence, 99.9% of<br>the balloons will not<br>burst at or below the<br>maximum<br>recommended rated<br>burst pressure. | All catheters met the<br>established<br>acceptance criteria. | All catheters met the established<br>acceptance criteria. |
| Repeated Balloon<br>Inflation (Balloon<br>Fatigue) Test | No breaks allowed | No Breaks. | No breaks. |
| Balloon<br>Inflation/Deflation<br>Test | Inflation achieved in<br>less than 12 seconds<br>and deflation<br>achieved in less than<br>20 seconds | All catheters met the<br>established<br>acceptance criteria. | All catheters met the established<br>acceptance criteria. |
| Test<br>Performed | Acceptance<br>Criteria | Mullins-X<br>Results | Predicate<br>Device -<br>Z-MED-X Results |
| Balloon Deflatability<br>Test | There should be no<br>interference with<br>balloon deflation | All catheters met the<br>established<br>acceptance criteria. | All catheters met the established<br>acceptance criteria. |
| Tip Pull and Torque<br>Test | Must withstand at<br>least 10 turns without<br>breaking | No breaks | No breaks |
| Bond Strength Test | All bonds must<br>withstand at least 3<br>lbs. of pull strength. | All bonds met the<br>established<br>acceptance criteria. | All bonds met the established acceptance<br>criteria. |
| Catheter Body<br>Maximum Pressure<br>Test | All samples must<br>withstand 30 ATM<br>(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.

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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 [phone] or [phone] 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

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