NUMED MULLINS PTA CATHETER

K013601 · NuMED, Inc. · DQY · Jan 3, 2002 · Cardiovascular

Device Facts

• Record ID: K013601
• Device Name: NUMED MULLINS PTA CATHETER
• Applicant: NuMED, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jan 3, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

NuMED Mullins PTA Catheter is a co-axial over-the-wire balloon catheter; used for percutaneous transluminal angioplasty of femoral, iliac, and renal arteries. Device features non-compliant polymeric balloon; two-lumen design (one for guidewire, one for inflation/deflation); five radiopaque platinum image bands for visualization. Operated by physicians in clinical settings. Balloon inflation to specific diameter at given pressure facilitates vessel dilation; diameter change is minimal over pressure range. Radiopaque bands assist in accurate positioning under fluoroscopy. Benefits include effective vessel dilation for patients with arterial stenosis.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing performed in accordance with GMPs and biocompatibility testing compliant with Tripartite Biocompatibility Guidance.

Technological Characteristics

Coaxial over-the-wire catheter; non-compliant polymeric balloon; platinum radiopaque image bands; PES3 shaft material; PES2 balloon material. Dimensions: 12-20mm diameter, 3-4cm length. Manual inflation/deflation via lumen. No software or electronic components.

Indications for Use

Indicated for Percutaneous Transluminal Angioplasty (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

• NuMED Z-MED PTA Catheter (K931009, K991977, K011557)

Submission Summary (Full Text)

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## SUMMARY OF SAFETY AND EFFECTIVENESS DATA

K013601

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 recommended<br>for Percutaneous Transluminal<br>Angioplasty (PTA) of the<br>femoral, iliac, and renal<br>arteries. These catheters are<br>not designed to be used in the<br>coronary arteries. | 1) This catheter is recommended for<br>Percutaneous Transluminal<br>Angioplasty (PTA) of the femoral,<br>iliac, and renal arteries. These<br>catheters are not designed to be<br>used in the coronary arteries.<br>----AND----<br><br>2) This catheter is recommended<br>for Percutaneous Transluminal<br>Valvuloplasty (PTV) of the<br>pulmonary valve.<br>A patient with isolated<br>pulmonary stenosis.A patient with valvular<br>pulmonary stenosis with other<br>minor congenital heart disease<br>that does not require surgical<br>intervention. |
| 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: PES3<br>Balloon: PES2<br>Image Band: Platinum | Shaft: PES3<br>Balloon: PES2<br>Image Band: Platinum |
| Construction: | Coaxial construction with<br>distally mounted non-compliant<br>balloons | Coaxial construction with<br>distally mounted non-compliant<br>balloon. |

Comparison Information:

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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)

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