(474 days)
This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) for pulmonary applications.
- A patient with isolated stenosis. .
- A patient with valvular stenosis with other minor congenital heart disease that does not require surgical intervention.
The Tyshak™, and Z-MED™ PTV Catheters are coaxial over-the-wire catheters 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 Tyshak™, and Z-MED ™ models are all made of a noncompliant polyethylene, however the Z-MED™ balloon is manufactured with an increased wall thickness. The increased wall thickness allows the balloon to achieve a higher pressure before rupture occurs. 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 molded '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.
I am sorry, but the provided text does not contain information about the acceptance criteria, device performance, or any studies conducted for the NuMED, Inc. Tyshak™ PTV Catheter and Z-MED™ PTV Catheter.
The document is a 510(k) summary and an FDA clearance letter, which primarily focuses on establishing substantial equivalence to a predicate device for market approval. It describes the device, its intended use, and states that its technological characteristics are the same as an approved PTA catheter. However, it does not include details on formal performance studies, acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies as requested in your prompt.
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SECTION SIX: 510(K) Summary
| A. Trade Name: | NuMED, Inc. Tyshak TM PTV Catheter Z-MED TM PTV Catheter |
|---|---|
| B. Common Name: | PTV Catheter |
| C. Device Class: | II, 74MAD; 21 CFR 870.1250 |
| D. Predicate Devices: | This catheter is the same as the approved NuMED Tyshak TM , and Z-MED TM PTA Catheters, 510(K) 931009. |
- E. Description - The Tyshak™, and Z-MED™ PTV Catheters are coaxial over-the-wire catheters 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 Tyshak™, and Z-MED ™ models are all made of a noncompliant polyethylene, however the Z-MED™ balloon is manufactured with an increased wall thickness. The increased wall thickness allows the balloon to achieve a higher pressure before rupture occurs. 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 molded '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.
- F. Indication - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) for pulmonary applications.
- A patient with isolated stenosis. .
- A patient with valvular stenosis with other minor congenital heart disease that does not require surgical intervention.
- G. Technological Characteristics - The technological characteristics for the PTV catheter are the same as the approved PTA catheter, because it is the same catheter with a different intended use.
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SEP 2 7 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Nichelle LaFlesh Requlatory Affairs Manager NuMed, Inc. P.O. Box 129 Nicholville, NY 12965
K991977 Re: Tyshak™ PTV Catheter and Z-Med™ PTV Catheter Trade Name: Requlatory Class: II (two) Product Code: LIT Dated: June 28, 2000 Received: June 29, 2000
Dear Ms. LaFlesh:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Nichelle LaFlesh
This letter will allow you to begin marketing your device as described
ing the many in and ifination - The EDA finding of substantial This letter will allow you co begin mirket god finding of substantial
in your 510(k) premarket notification. www.based podicate device in your 510(K) premarket notification. I marketed predicate device equivalence of your device to a regarly mannual and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling If you desire specific advice for your additionally 809.10 for in vitro
regulation (21 CFR Part 801 and additionally 809 Compliance at regulation (21 Crk Part our and addressionaliance at (301)
diagnostic devices), please contact the Office promotion and devices), prease concessions on the promotion and 594-4586. 594-4586. Additionally, for quese contact the office of Compliance at
advertising of your device, please contact the officies on itled Also, please note the regulation entitled, (301) 594-4639. (301) 594-4639. "A1307 premarket notification" (21CFR 807.97).
"Misbranding by reference to premarket notifilities under the Art ma "Misbranding by reference to premarke nosibilities under the Act may Other general Information on your soul Manufacturers Assistance at its internet be obtained irom the bivision or binas in the bronnel its internet
toll-free number (800) 638-2041 or (301) 443-6597 htmll coll-free number (000)
address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Les Qan Till
Lester F. Dillard III
Dillard III 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):
NuMED, Inc. PTV Catheter Device Name:
Indications For Use:
Transluminal Percutaneous is recommended for catheter This Valvuloplasty (PTV) for pulmonary applications.
- A patient with isolated stenosis. ●
- A patient with valvular stenosis with other minor congenital heart disease that does not require surgical intervention.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER-PAGE/F NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
| 510(k) Number | K991977 |
|---|---|
| --------------- | --------- |
| Prescription Use | (Per 21 CFR 801.109) | OR | Over-The-Counter-Use |
|---|---|---|---|
| ------------------ | --------------------------------- | ---- | ---------------------- |
(Optional Format 1-2-96)
F:\FDA Submissions\PTV\510(k)\Indications
§ 870.1250 Percutaneous catheter.
(a)
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.(b)
Classification. Class II (performance standards).