(34 days)
NuMED Tyshak Mini Pediatric PTV Catheter
No
The device description focuses on the physical components and mechanical function of a catheter for valvuloplasty, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is a PTV catheter used for valvuloplasty of the pulmonary valve, which is a therapeutic intervention to treat pulmonary stenosis.
No
The device is a therapeutic catheter used for Percutaneous Transluminal Valvuloplasty (PTV) to treat pulmonary stenosis, not to diagnose a condition.
No
The device description clearly details a physical catheter with polymeric tubing, a balloon, marker bands, and packaging, indicating it is a hardware medical device. There is no mention of software as the primary component or function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The provided description clearly describes a catheter designed for a medical procedure performed inside the body (Percutaneous Transluminal Valvuloplasty of the pulmonary valve). It's a physical tool used to treat a condition directly.
- Intended Use: The intended use is to treat pulmonary stenosis by dilating the pulmonary valve, which is an in-vivo procedure.
- No Mention of Specimens: There is no mention of analyzing any biological specimens.
This device is a therapeutic medical device used for an interventional procedure, not an in vitro diagnostic device.
N/A
Intended Use / 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.
- A patient with valvular pulmonary stenosis with other minor congenital heart disease ■ that does not require surgical intervention.
Product codes (comma separated list FDA assigned to the subject device)
DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
pulmonary valve
Indicated Patient Age Range
Pediatric
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)
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.
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.
NuMED Tyshak Mini Pediatric PTV Catheter
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.
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
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.
1
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
ADDITIONAL SIZES |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications: | 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. | 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. |
| 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
Balloon: PES2
Image Band: Platinum | Shaft: Pebax
Balloon: PES2
Image Band: Platinum |
| Construction: | Coaxial construction with
distally mounted non-compliant
balloons. | Coaxial construction with
distally mounted non-compliant
balloon. |
2
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
3
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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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
4
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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