(64 days)
No
The device description and performance studies focus on the physical characteristics and material biocompatibility of a balloon catheter, with no mention of AI or ML.
Yes
The device is a PUA catheter, which is used in Percutaneous Transluminal Angioplasty (PTA) to open narrowed arteries, thus directly treating a medical condition.
No
The device is a Percutaneous Transluminal Angioplasty (PTA) catheter, which is used for therapeutic procedures to open narrowed arteries, not for diagnosing conditions.
No
The device description clearly details a physical catheter with a balloon, lumens, and radiopaque bands, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body. They are used to diagnose diseases, conditions, or to monitor health.
- This device is a catheter used for Percutaneous Transluminal Angioplasty (PTA). This is a procedure performed inside the body to widen narrowed arteries.
The description clearly indicates it's a medical device used for a therapeutic procedure within the patient's body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
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
DQY
Device Description
The NuMED, Inc. MULLINS™ PTA Catheter is a co-axial over-the-wire catheter with a balloon near the distal tip. It is available in sizes of 12-20mm diameter and 3-4cm in length. One lumen permits guidewire insertion to facilitate advancement of the catheter, while the other lumen is for balloon inflation and deflation.
The balloons of the NuMED, Inc. MULLINS™ PTA Catheter is made of a noncompliant polymeric material and are the same balloons that are used on the approved Z-MED Catheter (K931009, K991977, and K011557). The two laminate balloon system is designed to inflate to a specific diameter at a given pressure. The change in diameter is minimal over the range of inflation pressures. The balloons are heat bonded to the shaft.
The outer body and inner body tubing are made of polymeric tubing. The area under the balloon is enhanced with five radiopaque platinum image bands. Two that are 5mm on each side of the balloon center and two more under the balloon shoulders. An additional image band is imbedded into the tip of the catheter as an additional safety measure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral, iliac, and 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
Biocompatibility Testing: The materials used in the NuMED Mullins PTA Catheter is the same as those used in our other 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.
Key Metrics
Not Found
Predicate Device(s)
NuMED Z-MED PTA Catheter
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
December 11, 2001
Submitted By: NuMED, Inc. , 2880 Main St., Hopkinton, NY 12965 (Ph) 315-328-4491
Contact Person: Nichelle LaFlesh
NuMED Mullins PTA Catheter; 21 CFR 870.1250 - Percutaneous Device Name: Catheter
Predicate Devices: NuMED Z-MED PTA Catheter
The NuMED, Inc. MULLINS™ PTA Catheter is a co-axial over-Device Description : the-wire catheter with a balloon near the distal tip. It is available in sizes of 12-20mm diameter and 3-4cm in length. One lumen permits guidewire insertion to facilitate advancement of the catheter, while the other lumen is for balloon inflation and deflation.
The balloons of the NuMED, Inc. MULLINS™ PTA Catheter is made of a noncompliant polymeric material and are the same balloons that are used on the approved Z-MED Catheter (K931009, K991977, and K011557). The two laminate balloon system is designed to inflate to a specific diameter at a given pressure. The change in diameter is minimal over the range of inflation pressures. The balloons are heat bonded to the shaft.
The outer body and inner body tubing are made of polymeric tubing. The area under the balloon is enhanced with five radiopaque platinum image bands. Two that are 5mm on each side of the balloon center and two more under the balloon shoulders. An additional image band is imbedded into the tip of the catheter as an additional safety measure.
Biocompatibility Testing:
The materials used in the NuMED Mullins PTA Catheter is the same as those used in our other 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 Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.
1
| Comparison Information: | ||
|---|---|---|
| MODEL: | NUMED MULLINS | NUMED Z-MED PTA |
| Indications: | 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. | 1) 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. | ||
| ----AND---- |
- 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: | 9 Fr - 14 Fr | 6 Fr - 14 Fr |
| Shaft Size: | 7 Fr - 8 Fr | 5 Fr - 9Fr |
| Guidewire Size: | 0.035" | 0.025" and 0.035" |
| Usable Length: | 90cm and 100cm | 85cm, 100cm, 110cm, 120cm |
| Balloon Diameter: | 12mm - 20mm | 2mm - 25mm |
| Balloon Length: | 3cm - 4cm | 1cm - 15cm |
| Materials: | Shaft: PES3
Balloon: PES2
Image Band: Platinum | Shaft: PES3
Balloon: PES2
Image Band: Platinum |
| Construction: | Coaxial construction with
distally mounted non-compliant
balloons | Coaxial construction with
distally mounted non-compliant
balloon. |
Comparison Information:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized chevrons, which are meant to represent the department's mission of providing essential human services and protecting the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 3 2002
NuMED, Inc. c/o Ms. Nichelle R. LaFlesh 2880 Main St Hopkinton, NY 12965
Re: K013601
NuMED Mullins PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: December 3, 2001 Received: December 4, 2001
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
3
Page 2 - Ms. Nichelle R. LaFlesh
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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,
Dela Till
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use
510(k) Number (if known):
Device Name: NuMED Mullins PTA Catheter
Indications For Use:
- This catheter is recommended for Percutaneous Transluminal Angioplasty 트 (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_
Division of Cardiovascular & Bespiratory Devices
510(k) Number R013600
(Optional Format 1-2-96)
: