MULLINS-X, MODEL 250X

K082868 · NuMED, Inc. · DQY · Oct 24, 2008 · Cardiovascular

Device Facts

• Record ID: K082868
• Device Name: MULLINS-X, MODEL 250X
• Applicant: NuMED, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Oct 24, 2008
• 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. This catheter is not indicated for use in the coronary arteries, stent placement or stent redilation.

Device Story

Mullins-X PTA Catheter is a coaxial over-the-wire dilatation catheter used for percutaneous transluminal angioplasty. It features a non-compliant polymeric balloon at the distal tip, designed to inflate to specific diameters with minimal change over pressure ranges. The device includes two lumens: one for guidewire insertion and one for balloon inflation/deflation. Radiopaque platinum image bands are positioned under the balloon shoulders and center to assist physician visualization under fluoroscopy. Used in clinical settings by physicians to dilate femoral, iliac, and renal arteries. The device provides mechanical dilatation to improve vessel patency.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Coaxial catheter design; non-compliant polymeric balloon (PES2); inner shaft: Pebax with 304 LV stainless steel braid; outer shaft: Pebax; radiopaque platinum-iridium image bands. Dimensions: 7-9 Fr shaft, 0.035" guidewire compatibility, 12-25mm balloon diameters, 3-4cm balloon lengths. Sterilization via heat-sealed Tyvek packaging.

Indications for Use

Indicated for Percutaneous Transluminal Angioplasty (PTA) of femoral, iliac, and renal arteries. Contraindicated for coronary artery use, stent placement, or stent redilation.

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 Mullins-X PTA Catheter (K041093)

Reference Devices

• Z-MED Catheter (K931009)

Submission Summary (Full Text)

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KC422864 page 1 of 2

## 510(K) SUMMARY

OCT 2 4 2008

October 22, 2008

Submitted By: NuMED, Inc., 2880 Main St., Hopkinton, NY 12965 (Ph) 315-328-4491

Contact Person: Nichelle LaFlesh

Device Name: Nullins-X PTA Catheter; 21 CFR 870.1250 - Percutaneous Catheter

Predicate Devices: NuMED Mullins-X PTA Catheter

Device Description: The Mullins X™ catheter is an Ultra High Pressure Dilatation catheter recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac and renal arteries. The catheter is a coaxial over the wire catheter with a balloon near the distal tip. 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 MULLINS X™ PTA 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 onto 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 Testing: The materials used in the NuMED Mullins-X PTA Catheter are the same as those used in the already cleared Mullins-X PTA Catheter (510(k) #K041093) and Z-MED Catheter (K931009) 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.

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Intended Use: This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. This catheter is not indicated for use in the coronary arteries, stent placement or stent redilation.

| Comparison Information: | | |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MODEL: | NUMED MULLINS-X PTA<br>CATHETER | NUMED MULLINS-X PTA<br>CATHETER - ADDITIONAL<br>BALLOON DIAMETER |
| Indications: | This catheter is recommended<br>for Percutaneous Transluminal<br>Angioplasty (PTA) of the<br>femoral, iliac, and renal arteries.<br>These catheters are not<br>designed to be used in the<br>coronary arteries. | This catheter is recommended<br>for Percutaneous Transluminal<br>Angioplasty (PTA) of the<br>femoral, iliac, and renal arteries.<br>This catheter is not indicated<br>for use in the coronary<br>arteries, stent placement or<br>stent redilation. |
| Shaft Size: | 7 – 9 Fr | 7 – 9 Fr |
| Guidewire Size: | 0.035" | 0.035" |
| Balloon Diameter: | 12, 14, 15, 16, 18, 20, 22, and<br>25mm | 12, 14, 15, 16, 18, 20, 22, 23<br>and 25mm |
| Balloon Length: | 3 - 4 cm | 3 - 4 cm |
| Materials: | Inner Shaft: Pebax w/stainless<br>steel | Inner Shaft: Pebax w/stainless<br>steel |
| | Outer Shaft: Pebax<br>Balloon: PES2<br>Image Band: Platinum Iridium | Outer Shaft: Pebax<br>Balloon: PES2<br>Image Band: Platinum Iridium |
| Construction: | Coaxial construction with<br>distally mounted non-compliant<br>balloon. | Coaxial construction with<br>distally mounted non-compliant<br>balloon. |

Comparison Information:

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 2008

NuMED. Inc. c/o Nichelle R. LaFlesh, RAC 2880 Main Street Hopkinton, NY 12965

Re: K082868

Trade/Device Name: Mullins-X PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 26, 2008 Received: September 29, 2008

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 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

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Page 2 -- Ms. Nichelle R. LaFlesh

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

unea R. V. hmer

A 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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## Indications for Use

510(k) Number (if known): K082868

Device Name: Mullins-X PTA Catheter

Indications For Use:

- This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) . Fifth Catheter is reaching the . This catheter is not indicated for use in the coronary arteries, stent placement or stent redilation.
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)

una R. bohus

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_ko82868

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