(28 days)
Tyshak, Tyshak II, Z-MED, Z-MED II, Mullins
Not Found
No
The 510(k) summary describes a mechanical catheter with a change in inner tubing material and configuration. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies are focused on physical characteristics and functionality of the catheter.
Yes
The devices are catheters used for medical procedures (Percutaneous Transluminal Valvuloplasty and Angioplasty) which inherently aim to treat or alleviate a medical condition.
No
The "Intended Use / Indications for Use" section describes the catheters' use for Percutaneous Transluminal Valvuloplasty (PTV) and Percutaneous Transluminal Angioplasty (PTA), which are therapeutic procedures to open narrowed vessels or valves, not to diagnose a condition.
No
The device description clearly details physical components of a catheter, including tubing, braid, and radiopaque bands. This indicates a hardware device, not software only.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of these catheters is for Percutaneous Transluminal Valvuloplasty (PTV) and Percutaneous Transluminal Angioplasty (PTA). These are procedures performed within the body to treat conditions like pulmonary stenosis and arterial blockages.
- The device description focuses on the physical characteristics and performance of the catheter itself. It describes the materials, tubing configuration, and how it interacts with a guidewire. This is consistent with a medical device used for interventional procedures, not for analyzing biological samples.
- The performance studies are bench tests evaluating the physical properties and functionality of the catheter. They assess things like balloon deflation, bond integrity, and guidewire compatibility. These are not studies related to the accuracy or reliability of a diagnostic test performed on a specimen.
In summary, these catheters are designed for therapeutic interventions within the body, not for diagnostic testing of samples taken from the body. Therefore, they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Z-MED-X Catheter - 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. And;
This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, illiac, and renal arteries. These catheters are not designed to be used in the coronary arteries.
Tyshak-X Catheter - 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. And;
This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.
Tyshak II-X Catheter - 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. And;
Z-MED II-X Catheter - 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. And;
Mullins-X PTA - This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The only change from the current catheter configuration to the new X line is the inner tubing configuration. The current inner tubing on all catheter models is composed of Pebax polyamide material. The tubing is sized to accept a 0.035" guidewire and provide adequate guidewire movement and catheter trackability. This tubing is also fitted with radiopaque image bands of platinum/iridium. This tubing is common to all catheters in NuMED's product lines.
The proposed tubing is comprised of a multi layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. This tubing is loaded with 20% BaSO4 and is Colored blue with Pantone 295C. All materials have been certified as biocompatible. This tubing is designed to enhance guidewire movement and also to avoid any stretching of the catheter body during a tougher than normal catheter removal.
The proposed inner tubing is a nylon (polyamide) tubing that is very similar to the current material. There will be no significant material changes in the tubing or the image bands. The only change will be the construction of the inner tubing in changing from a polyamide tubing to a braided polyamide tubing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pulmonary valve, femoral arteries, iliac arteries, renal arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing Performed:
2. Balloon Deflatability: Deflation achieved in less than 20 seconds.
3. Inflation/ Deflation Times Test: Inflation and deflation achieved in less than 20 seconds.
5. Maximum Luminal Injection Pressure Test: Must withstand 400 psi.
6. Bond Integrity: Minimum of 2 lbs. at all test points.
7. Diameter/ Profile Test and Introducer Test: Must fit through rated introducer size.
9. Guidewire Compatibility: Minimal resistance while pushing catheter over guidewire. Force may not be great enough to bend guidewire.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Tyshak, Tyshak II, Z-MED, Z-MED II, Mullins
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
SEP 1 3 2002
August 14, 2002
Submitted By: NuMED, Inc., 2880 Main St., Hopkinton, NY 12965 (Ph) 315-328-4491 (F) 315-328-4941
Contact Person: Nichelle LaFlesh
Device Name: Tyshak-X, Tyshak II-X, Z-MED-X, Z-MED II-X, Mullins-X
Predicate Devices: Tyshak, Tyshak II, Z-MED, Z-MED II, Mullins
The only material that has changed is the material in the inner Biocompatibility Testing: tubing. It has gone from being Pebax to Vestamid with stainless steel braiding. The testing that was done on this new material in enclosed in the biocompatibility section of this submission as well as the data for the other materials that have not changed.
| Bench Testing Performed | Acceptance Criteria |
|---|---|
| 2. Balloon Deflatability | Deflation achieved in less than 20 seconds. |
| 3. Inflation/ Deflation Times Test | Inflation and deflation achieved in less than 20 |
| seconds. | |
| 5. Maximum Luminal Injection Pressure Test | Must withstand 400 psi. |
| 6. Bond Integrity | Minimum of 2 lbs. at all test points. |
| 7. Diameter/ Profile Test and Introducer Test | Must fit through rated introducer size. |
| 9. Guidewire Compatibility | Minimal resistance while pushing catheter over |
| guidewire. Force may not be great enough to | |
| bend guidewire. |
Laboratory (Bench) Testing:
Comparison Information:
Change Description:
The only change from the current catheter configuration to the new X line is the inner tubing configuration. The current inner tubing on all catheter models is composed of Pebax
1
polyamide material. The tubing is sized to accept a 0.035" guidewire and provide adequate guidewire movement and catheter trackability. This tubing is also fitted with radiopaque image bands of platinum/iridium. This tubing is common to all catheters in NuMED's product lines.
The proposed tubing is comprised of a multi layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. This tubing is loaded with 20% BaSO4 and is Colored blue with Pantone 295C. All materials have been certified as biocompatible. This tubing is designed to enhance guidewire movement and also to avoid any stretching of the catheter body during a tougher than normal catheter removal.
Important Considerations:
The proposed inner tubing is a nylon (polyamide) tubing that is very similar to the current material. There will be no significant material changes in the tubing or the image bands. The only change will be the construction of the inner tubing in changing from a polyamide tubing to a braided polyamide tubing.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
SEP 1 3 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Numed, Inc. c/o Ms. Nichelle R. LaFlesh Regulatory Affairs Manager P.O. Box 129 Nicholville, NY 12965
Re: K022722
Trade Name: PTA and PTV Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DQY Dated: August 15, 2002 Received: August 16, 2002
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
3
Page 2 – Ms. Nichelle R. LaFlesh
forth in the quality systems (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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.
Delguth
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use
510(k) Number (if known):
Device Names: Z-MED-X Catheter, Tyshak-X Catheter, Tyshak II-X Catheter, Z-MED II-X Catheter, and Mullins-X PTA Catheter
Indications For Use:
Z-MED-X Catheter - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.
- A patient with isolated pulmonary stenosis י
- A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not l require surgical intervention. And;
This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, illiac, and renal arteries. These catheters are not designed to be used in the coronary arteries.
Tyshak-X Catheter - 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. And;
This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.
Tyshak II-X Catheter - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.
- A patient with isolated pulmonary stenosis B
- A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention. And;
Z-MED II-X Catheter - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.
- A patient with isolated pulmonary stenosis 트
- I A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention. And;
Mullins-X PTA - This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.
(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 | K022722 |
|---|---|
| --------------- | --------- |