NUMED COEFFICIENT PTV CATHETERS

K014124 · NuMED, Inc. · OMZ · Jan 16, 2002 · Cardiovascular

Device Facts

• Record ID: K014124
• Device Name: NUMED COEFFICIENT PTV CATHETERS
• Applicant: NuMED, Inc.
• Product Code: OMZ · Cardiovascular
• Decision Date: Jan 16, 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 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.

Device Story

The NuMED COEfficient PTV Catheter is a coaxial over-the-wire balloon catheter used for pulmonary valvuloplasty. It features a non-compliant polyethylene balloon at the distal tip, designed to maintain a specific diameter across various inflation pressures. The catheter includes two lumens: one for guidewire advancement and one for balloon inflation/deflation. Radiopaque platinum bands are positioned at the balloon midpoint or shoulders to assist in fluoroscopic visualization. The device is operated by a physician in a clinical setting. By inflating the balloon within the pulmonary valve, the device mechanically dilates the stenotic valve to improve blood flow. The COEfficient model offers a lower profile, smaller shaft, and higher rated burst pressure compared to previous designs, facilitating easier navigation through the vasculature.

Clinical Evidence

Bench testing only. No clinical data provided. Biocompatibility testing was performed in compliance with Tripartite Biocompatibility Guidance for Medical Devices.

Technological Characteristics

Coaxial over-the-wire catheter; non-compliant polyethylene balloon; Pebax shaft; platinum radiopaque image bands. Dimensions: 4-12 mm balloon diameter, 2-4 cm balloon length, 3.5 Fr shaft, 0.018" guidewire compatibility. Energy source: manual hydraulic inflation. Sterilization: not specified.

Indications for Use

Indicated for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in patients with isolated pulmonary stenosis or valvular pulmonary stenosis with minor congenital heart disease not requiring surgery.

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 PTV Catheter

Submission Summary (Full Text)

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### SUMMARY OF SAFETY AND EFFECTIVENESS DATA

December 14, 2001

K014124

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

Contact Person: Nichelle LaFlesh

Device Name: NuMED COEfficient PTV Catheter; Class II

Predicate Devices: NuMED Z-MED PTV Catheter

Device Description: The COEfficient PTV 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 into the pulmonary valve while the other lumen is for balloon inflation and deflation. The balloon of the COEfficient model is made of a non-compliant polyethylene. The balloons are designed to inflate to a specific diameter at a given pressure. The change in diameter is minimal over the range of inflation pressures. The catheter body ends proximally in a bifurcated 'Y' connector with a guidewire port and a balloon extension. The balloon extension is marked with the product lot number and the balloon size. The outer body and inner body tubing is made of pebax. The area under the balloon is enhanced with either one or two radiopaque platinum image bands depending on the model. If marked with one image band, it is centered under the midpoint of the balloon. If it is marked with two image bands, they are located under the shoulders of the balloon. This catheter is of the same design and construction as the NuMED PTV catheters for which the 510(K) has been approved. The differences are lower profile, smaller shaft, and higher rated burst pressure.

Biocompatibility Testing: The materials used in the NuMED COEfficient Catheter are 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 Tripatite 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 Valvuloplasty (PTV) of the pulmonary valve.

- 에 A patient with isolated pulmonary stenosis
- A patient with valvular pulmonary stenosis with other minor congenital heart disease 미 that does not require surgical intervention.

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#### SPECIAL 510(K) - Confidential NuMED COEFFICIENT PTV Catheters

| Comparison Information:<br>MODEL: | NUMED COEFFICIENT PTV | NUMED Z-MED PTV |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications: | This catheter is recommended for<br>Percutaneous Transluminal<br>Valvuloplasty (PTV) of the pulmonary<br>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. | This catheter is recommended for<br>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<br>other minor congenital heart<br>disease that does not require<br>surgical intervention. |
| Introducer: | 4 Fr - 7 Fr | 6 Fr - 14 Fr |
| Shaft Size: | 3.5 Fr | 5 Fr - 11 Fr |
| Guidewire Size: | 0.018" | 0.018", 0.021", 0.025", and<br>0.035" |
| Usable Length: | 75 cm | 85 cm, 100 cm, 110 cm, and<br>120cm |
| Balloon Diameter: | 4 mm - 12 mm | 2 mm - 20 mm, 22 mm - 26<br>mm, 28 mm, 30 mm, 33 mm,<br>35 mm, 35 mm, 40 mm. |
| Balloon Length: | 2 cm - 4 cm | 1 cm - 15 cm |
| Materials: | Shaft: Pebax<br>Balloon: PES2<br>Image Band: Platinum | Shaft: Pebax<br>Balloon: PES2<br>Image Band: Platinum |
| 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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APR 28 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Nichelle LaFlesh Regulatory Affairs Manager NuMED, Inc. 2880 Main St. Hopkinton, NY 12965

Re: K014124 COEfficient PTV Catheter Regulation Number: 21 CFR §870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: OMZ Dated: December 14, 2001 Received: December 17, 2001

Dear Ms. LaFlesh:

This letter corrects our substantially equivalent letter of January 16, 2002.

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 (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 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

una R. lochner

- Bram D. Zuckerman, M.D. Division 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): Device Name: NuMED COEfficient PTV Catheter

Indications For Use:

This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

- A patient with isolated pulmonary stenosis 트
- A patient with valvular pulmonary stenosis with other minor congenital I heart disease that does not require surgical intervention.

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

(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number K014184