← Product Code [DQY](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY) · K030589 # MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS (K030589) _NuMED, Inc. · DQY · May 21, 2003 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K030589 ## Device Facts - **Applicant:** NuMED, Inc. - **Product Code:** [DQY](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY.md) - **Decision Date:** May 21, 2003 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 870.1250 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## Indications for 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 Coaxial PTV catheter for pulmonary valve dilation; features polymeric inner/outer shafts and distally mounted non-compliant balloon. Radiopaque platinum marker bands under balloon shoulders facilitate fluoroscopic placement. Available in various diameters (4-30mm) and lengths (2-10cm). Used by physicians in clinical settings for percutaneous transluminal valvuloplasty. Device inserted via introducer sleeve over guidewire; inflation lumen allows balloon expansion to treat stenosis. Benefits include minimally invasive access to pulmonary valve, reducing need for surgical intervention in indicated patients. ## Clinical Evidence Bench testing only. No clinical data provided. Biocompatibility testing performed in compliance with Tripartite Biocompatibility Guidance for Medical Devices. Bench testing conducted in accordance with GMP standards. ## Technological Characteristics Coaxial catheter construction; polymeric tubing (Pebax shaft, PES2 balloon); platinum radiopaque marker bands. Non-compliant balloon design. Dimensions: 4F-9F (Tyshak II) or 5F-11F (Z-MED II) shaft sizes; 4mm-30mm balloon diameters; 2cm-10cm balloon lengths. Sterilization via heat-sealed Tyvek pouches. ## Regulatory 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 PTV Catheters ([K003052](/device/K003052.md)) - NuMED Z-MED PTV Catheters ([K003052](/device/K003052.md)) ## Reference Devices - NuMED PTA Catheters ([K931009](/device/K931009.md)) - NuMED PTV Catheters ([K991977](/device/K991977.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # SUMMARY OF SAFETY AND EFFECTIVENESS DATA February 20, 2003 Submitted By: NuMED, Inc., 2880 Main St., Hopkinton, NY 12965 (Ph) 315-328-4491 Contact Person: Nichelle LaFlesh Device Name: NuMED Tyshak II and Z-Med II PTV Catheters; Class II Predicate Devices: NuMED Tyshak and Z-MED PTV Catheters Device Description: The NuMED, Inc. Tyshak II PTV catheter is a coaxial catheter for use in PTV applications where a small introduction site is necessary. The catheter 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 and will have a typical single wall thickness of 0.0004". This balloon is designed to insert through the smallest possible introduction sleeve. Both the shaft size and the guidewire size varies according to balloon diameter with the Tyshak II catheter. 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 white 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 shaft 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. This catheter is very similar in construction to the Tyshak PTV catheters except for the thinner balloon and lower profile. The Tyshak II catheter is available in standard diameters from 4mm to 30mm in standard lengths of 2cm, 3cm, 4cm, 5cm, 6cm, 8cm and 10cm. Guidewire sizes will vary from 0.021" to 0.035" and shaft sizes from 4F to 9F. The NuMED, Inc. Z-MED II PTV catheter is a coaxial catheter for use in PTV applications. The catheter 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. Both the shaft size and the guidewire size varies according to balloon diameter with the Z-MED II catheter. The distal Jumen 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 white 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 {1}------------------------------------------------ ### Special 510(k) - Confidential NUMED TYSHAK II & Z-MED II PTV CATHETERS shaft 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. This catheter is very similar in construction to the Z-MED PTV catheter except for the thicker balloon material. The Z-MED II catheter is available in standard diameters from 4 mm to 30 mm in standard lengths of 2 cm to 10 cm. Guidewire sizes will vary from 0.025" to 0.035" and shaft sizes will vary from 5F to 9F. ## Biocompatibility Testing: The materials used in the NuMED Tyshak II and Z-MED II PTV have not changed from the previously approved Tyshak II and Z-MED II Catheters (K003052). These catheters have the same materials as those used in our 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 Valvuloplasty (PTV) of the pulmonary valve. - 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. {2}------------------------------------------------ 16030589 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Comparison Information: | | | |-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | MODEL: | NUMED TYSHAK II
AND Z-MED II | NUMED TYSHAK II
AND Z-MED II - NEW LENGTHS | | Indications: | 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. | 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. | | Introducer: | Tyshak II - 4Fr-10Fr
Z-MED II - 5Fr-16Fr | Tyshak II - 4Fr-10Fr
Z-MED II - 5Fr-16Fr | | Shaft Size: | Tyshak II - 4Fr-9Fr
Z-MED II - 5Fr-11Fr | Tyshak II - 4Fr-9Fr
Z-MED II - 5Fr-11Fr | | Guidewire Size: | Tyshak II - 0.021"-0.035"
Z-MED II - 0.025"-0.035" | Tyshak II - 0.021"-0.035"
Z-MED II - 0.025"-0.035" | | Balloon Diameter: | Tyshak II - 4mm - 30mm
Z-MED II - 4mm - 30 mm | Tyshak II - 4mm - 30mm
Z-MED II - 4mm - 30mm | | Balloon Length: | Tyshak II - 2cm-8cm
Z-MED II - 2cm-6cm | Tyshak II- 2cm-10cm
Z-MED II-2cm-10cm | | Materials: | Shaft: Pebax
Balloon: PES2
Image Band: Platinum | Shaft: Pebax
Balloon: PES2
Image Band: Platinum | | Construction: | Coaxial construction with
distally mounted non-compliant
balloon | Coaxial construction with
distally mounted non-compliant
balloon | Comparison Information: {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings and body. The eagle is facing to the right. Public Health Service MAY 21 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Nichelle R. LaFlesh Regulatory Affairs Manager NuMed, Inc. P.O. Box 129 Nicholville, NY 12965 Re: K030589 > Trade/Device Name: NuMed Tyshak II and Z-Med II PTV Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter. Regulatory Class: II Product Code: DQY Dated: April 30, 2003 Received: May, 1, 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 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 {4}------------------------------------------------ Page 2 - Ms. Nichelle R. LaFlesh 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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. Koder Teh Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ #### SPECIAL 510(K) - CONFIDENTIAL NUMED TYSHAK II & Z-MED II PTV CATHETERS # Indications For Use 510(k) Number (if known): # Device Name: NuMED Tyshak II and Z-MED II PTV Catheters Indications For Use: This catheter is recommnded for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve. - A patient with isolated pulmonary stenosis 를 - A patient with valvular pulmonary stenosis with other minor I congenital heart disease that does not requrie 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 | X | |------------------------------------|-------| | (Per 21 CFR 801.109) | OR | | | Odatu | | (Division Sign-Off) | | | Division of Cardiovascular Devices | | 510(k) Number Over-The-Counter-Use___________ (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K030589](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K030589) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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