(85 days)
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.
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 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 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.
The provided document describes a 510(k) premarket notification for the NuMED Tyshak II and Z-Med II PTV Catheters, which modifies previously approved devices by introducing new lengths. Since this is a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical trial or extensive standalone algorithm testing.
Therefore, many of the typical sections you'd expect for AI/algorithm performance studies (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance with metrics like sensitivity/specificity, or training set details) are not applicable or explicitly mentioned in this type of submission. The focus is on demonstrating that the new device (with extended lengths) is as safe and effective as the predicate device already on the market.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission focused on modifications to an existing device, "acceptance criteria" are typically related to maintaining the same performance characteristics as the predicate device. The document states that the new models are "very similar in construction" to the predicate devices, with specific differences (thinner balloon for Tyshak II, thicker balloon material for Z-MED II) and new lengths.
The primary "performance" demonstrated here is the meeting of biocompatibility and bench testing standards, implying that the modified devices perform equivalently to the predicate devices in these aspects. There are no explicit performance metrics (e.g., success rates in procedures) measured against numerical acceptance criteria presented in this specific document.
| Feature/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with Tripartite Biocompatibility Guidance for Medical Devices (as per predicate devices) | All materials demonstrate biocompatibility |
| Bench Testing | Performed in accordance with GMPs (similar to predicate devices) | Performed in accordance with GMPs; results on file |
| Indications for Use | Identical to predicate devices | Identical to predicate devices |
| Materials | Unchanged from previously approved devices | Materials used have not changed |
| Construction | Coaxial construction with distally mounted non-compliant balloon | Coaxial construction with distally mounted non-compliant balloon |
| Balloon Length | Expanded range (2cm-10cm) while maintaining safety/effectiveness of predicate | Tyshak II: 2cm-10cm; Z-MED II: 2cm-10cm |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for this type of submission. There is no mention of a "test set" in the context of clinical data for AI/algorithm performance. The biocompatibility and bench testing are presumably performed on a sample of the manufactured devices, but specific sample sizes for these tests are not provided and are internal to NuMED, Inc. The document states "Test results indicate that all materials demonstrate the biocompatibility... and are on file at NuMED, Inc." and "All bench testing was performed in accordance with GMP's and the results are kept on file at NuMED, Inc." This indicates the provenance is internal data from NuMED's labs from their testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This device is a catheter, not an AI or diagnostic algorithm requiring expert-established ground truth from medical images or clinical outcomes in a test set.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" in the context of clinical data requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical catheter, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used
For biocompatibility, the "ground truth" is compliance with established biological safety standards for medical device materials. For bench testing, the "ground truth" is adherence to engineering specifications and performance parameters demonstrated as safe and effective for the predicate device. These are established through standardized testing protocols (e.g., ISO, ASTM).
8. The Sample Size for the Training Set
Not applicable. There is no AI algorithm involved, thus no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable.
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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
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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.
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16030589
| Comparison Information: | ||
|---|---|---|
| MODEL: | NUMED TYSHAK IIAND Z-MED II | NUMED TYSHAK IIAND Z-MED II - NEW LENGTHS |
| Indications: | This catheter is recommended forPercutaneous TransluminalValvuloplasty (PTV) of thepulmonary valve.A patient with isolatedpulmonary stenosis.A patient with valvularpulmonary stenosis withother minor congenitalheart disease that does notrequire surgicalintervention. | This catheter is recommended forPercutaneous TransluminalValvuloplasty (PTV) of thepulmonary valve.A patient with isolatedpulmonary stenosis.A patient with valvularpulmonary stenosis withother minor congenitalheart disease that does notrequire surgicalintervention. |
| Introducer: | Tyshak II - 4Fr-10FrZ-MED II - 5Fr-16Fr | Tyshak II - 4Fr-10FrZ-MED II - 5Fr-16Fr |
| Shaft Size: | Tyshak II - 4Fr-9FrZ-MED II - 5Fr-11Fr | Tyshak II - 4Fr-9FrZ-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 - 30mmZ-MED II - 4mm - 30 mm | Tyshak II - 4mm - 30mmZ-MED II - 4mm - 30mm |
| Balloon Length: | Tyshak II - 2cm-8cmZ-MED II - 2cm-6cm | Tyshak II- 2cm-10cmZ-MED II-2cm-10cm |
| Materials: | Shaft: PebaxBalloon: PES2Image Band: Platinum | Shaft: PebaxBalloon: PES2Image Band: Platinum |
| Construction: | Coaxial construction withdistally mounted non-compliantballoon | Coaxial construction withdistally mounted non-compliantballoon |
Comparison Information:
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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
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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
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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)
§ 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).