NUMED TYSHAK MINI PEDIATRIC PTV CATHETER

K032591 · NuMED, Inc. · DQY · Sep 25, 2003 · Cardiovascular

Device Facts

• Record ID: K032591
• Device Name: NUMED TYSHAK MINI PEDIATRIC PTV CATHETER
• Applicant: NuMED, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Sep 25, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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

Coaxial catheter for pediatric Percutaneous Transluminal Valvuloplasty (PTV); features distally mounted non-compliant balloon and dual-lumen shaft. Input: guidewire (0.014") for placement; fluoroscopic guidance via radiopaque platinum marker bands. Operation: physician-operated in clinical setting; balloon inflated to dilate pulmonary valve. Output: mechanical dilation of stenotic valve. Benefits: minimally invasive treatment for pulmonary stenosis in pediatric patients requiring small introduction sites.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in compliance with Tripartite Biocompatibility Guidance for Medical Devices. All materials demonstrated biocompatibility. Bench testing conducted in accordance with GMPs.

Technological Characteristics

Coaxial catheter; Pebax shaft; PES2 non-compliant balloon; platinum radiopaque marker bands. Dimensions: 2.5Fr-3.5Fr shaft; 0.014" guidewire compatibility; 3mm-10mm balloon diameter; 0.8cm-4cm balloon length. Sterilization: Tyvek pouch packaging.

Indications for Use

Indicated for pediatric patients with isolated pulmonary stenosis or valvular pulmonary stenosis with minor congenital heart disease not requiring surgery, undergoing Percutaneous Transluminal Valvuloplasty (PTV).

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 Tyshak Mini Pediatric PTV Catheter (K003276)

Submission Summary (Full Text)

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## SUMMARY OF SAFETY AND EFFECTIVENESS DATA

August 21, 2003

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

Contact Person: Nichelle LaFlesh

NuMED Tyshak Mini Pediatric PTV Catheter; 21 CFR 870.1250 -Device Name: Percutaneous Catheter

Predicate Devices: NuMED Tyshak Mini Pediatric PTV Catheter

#### Device Description :

The NuMED, Inc. Tyshak Mini Pediatric PTV catheter is a coaxial catheter for use in PTV applications where a small introduction site is necessary. The catheters inner and outer shafts are constructed of polymeric tubing. The catheter features a molded proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon made of polymeric material. This balloon is of the non-compliant variety. This balloon is designed to insert through the smallest possible introduction sleeve. The distal lumen terminates at the tip of the catheter and will accept the passage of the appropriate guidewire. This lumen has radiopaque platinum marker bands under the balloon shoulders for placement using fluoroscopy. The catheter is blue in color and the balloon material is clear. The catheter balloon diameter is stamped onto the Y connector and the inflation extension is labeled with balloon diameter x balloon length x introducer size x usable length x guidewire size and the catheter lot number. The catheter is packaged in a polyethylene loop and is double packed in two heat sealed Tyvek pouches. The Tyshak Mini catheter is available in standard diameters from 3mm to 10mm. The lengths available will be 0.8cm - 4cm. The Guidewire size will be 0.014'', and the shaft size will be 2.5Fr and 3.5Fr.

#### Biocompatibility Testing:

The materials used in the NuMED Tyshak Mini Pediatric PTV Catheter are the same as those used in the already approved Tyshak Mini Catheter (510/k) #K003276) 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. Copies are included in this section.

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 Valvuloplasty (PTV) of the pulmonary valve in Pediatric applications.

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

#### Comparison Information:

| MODEL: | NUMED TYSHAK MINI | NUMED TYSHAK MINI WITH<br>ADDITIONAL SIZES |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications: | This catheter is recommended<br>for Percutaneous Transluminal<br>Valvuloplasty (PTV) of the<br>pulmonary valve in Pediatric<br>applications.<br>A patient with isolated<br>pulmonary stenosis. A patient with valvular<br>pulmonary stenosis with<br>other minor congenital<br>heart disease that does<br>not require surgical<br>intervention. | This catheter is recommended<br>for Percutaneous Transluminal<br>Valvuloplasty (PTV) of the<br>pulmonary valve in Pediatric<br>applications.<br>A patient with isolated<br>pulmonary stenosis. A patient with valvular<br>pulmonary stenosis with<br>other minor congenital<br>heart disease that does<br>not require surgical<br>intervention. |
| Introducer: | 2.5Fr - 3.5Fr | 2.5Fr - 3.5Fr |
| Shaft Size: | 3Fr - 4Fr | 3Fr - 4Fr |
| Guidewire Size: | 0.014" | 0.014" |
| Usable Length: | 65cm | 20cm - 65cm |
| Balloon Diameter: | 4mm - 10mm | 3mm - 10mm |
| Balloon Length: | 2cm - 4cm | 0.8cm - 4cm |
| 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>balloons. | Coaxial construction with<br>distally mounted non-compliant<br>balloon. |

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Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing left and appears to be in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

SEP 2 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NuMED. Inc. c/o Ms. Nichelle R. LaFlesh Regulatory Affairs Manager 2880 Main Street Hopkinton, NY 12965

Re: K032591

Trade Name: NuMED, Inc. Tyshak Mini Pediatric PTV Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DQY Dated: August 21, 2003 Received: August 22, 2003

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

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#### Page 2 - Ms. Nichelle R. LaFlesh

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 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely vours.

Bran 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):

# Device Name: NuMED Tyshak Mini Pediatric PTV Catheter

Indications For Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

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