(9 days)
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.
The Mullins X™ catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac and renal arteries. The catheter is a coaxial over the wire catheter with a balloon near the distal tip. 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 MULLINS X™ PTA Catheter are made of a non-compliant polymeric material. 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 is made of polymeric tubing, and the inner tubing is comprised of a multi layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. 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.
The catheter is white in color and the balloon material is clear. The catheter balloon diameter and name is stamped onto the Y sleeve and the balloon 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 sheath and is double packed in two heat sealed Tyvek pouches.
The provided document is a 510(k) premarket notification for a medical device (NuMED Mullins X PTA Catheter), which primarily focuses on demonstrating substantial equivalence to a predicate device based on manufacturing specifications, materials, and intended use. It does not contain information about clinical studies, device performance in terms of efficacy or diagnostic accuracy, or specific acceptance criteria and their achievement through studies in the way a diagnostic AI device submission would.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth adjudication, MRMC studies, standalone performance, or training set details. This document describes a medical device for a physical intervention (PTA catheter), not a diagnostic algorithm or AI system.
I reiterate that the provided text does not contain any information about acceptance criteria or studies proving device performance related to diagnostic accuracy, AI, or human reader improvement.
The document does mention:
- Biocompatibility Testing: Materials used are the same as previously approved devices (K931009, K991977) which were tested for biocompatibility in compliance with the Tripartite Biocompatibility Guidance for Medical Devices. Test results are on file at NuMED, Inc.
- Laboratory (Bench) Testing: All bench testing was performed in accordance with GMP's and results are kept on file at NuMED, Inc.
However, these are general statements about compliance and are not the type of detailed performance studies asked for in the user's prompt (which implies a diagnostic or AI-driven device context).
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SUMMARY OF SAFETY AND EFFECTIVENESS DATA
April 23, 2004
Submitted By: NuMED, Inc. , 2880 Main St., Hopkinton, NY 12965 (Ph) 315-328-4491
Contact Person: Nichelle LaFlesh
Device Name: NuMED Mullins X PTA Catheter; 21 CFR 870.1250 -- Percutaneous Catheter
Predicate Devices: NuMED Mullins X PTA Catheter
Device Description: The Mullins X™ catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac and renal arteries. The catheter is a coaxial over the wire catheter with a balloon near the distal tip. 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 MULLINS X™ PTA Catheter are made of a non-compliant polymeric material. 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 is made of polymeric tubing, and the inner tubing is comprised of a multi layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. 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.
The catheter is white in color and the balloon material is clear. The catheter balloon diameter and name is stamped onto the Y sleeve and the balloon 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 sheath and is double packed in two heat sealed Tyvek pouches.
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.
There have been no changes in material from the original Mullins X approval (K022722).
Test results indicate that all materials demonstrate the biocompatibility of the NuMED catheter and are on file at NuMED, Inc.
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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 artcries.
| MODEL: | NUMED MULLINS X | NUMED MULLINS X – WITH THEADDITIONAL SIZES |
|---|---|---|
| Indications: | This catheter is recommendedfor Percutaneous TransluminalAngioplasty (PTA) of thefemoral, iliac, and renalarteries. These catheters arenot designed to be used in thecoronary arteries. | This catheter is recommendedfor Percutaneous TransluminalAngioplasty (PTA) of thefemoral, iliac, and renalarteries. These catheters arenot designed to be used in thecoronary arteries. |
| Introducer: | 9 Fr - 13 Fr | 9 Fr - 16 Fr |
| Shaft Size: | 7 Fr - 8 Fr | 7 Fr - 9 Fr |
| Guidewire Size: | 0.035" | 0.035" |
| Usable Length: | 100 cm | 100 cm |
| Balloon Diameter: | 12 mm – 20 mm | 12 mm – 25 mm |
| Balloon Length: | 3 cm – 4 cm | 3 cm – 4 cm |
| Materials: | Shaft: PebaxBalloon: PES2Image Band: Platinum | Shaft: PebaxBalloon: PES2Image Band: Platinum |
| Construction: | Coaxial construction withdistally mounted non-compliantballoons. | Coaxial construction withdistally mounted non-compliantballoon. |
Comparison Information:
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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 6 2004
NuMED Inc. c/o Ms. Nichelle LaFlesh Regulatory Affairs Manager 2880 Main Street Hopkinton, NY 12965
Re: K041093 NuMED Mullins X PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II (two) Product Code: DQY Dated: April 23, 2004 Received: April 27, 2004
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.
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Page 2 - Ms. Nichelie LaFlesh
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 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) 594-4648. 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 yours,
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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Indications for Use
510(k) Number (if known): K041093
Device Name: Mullins X PTA Catheter
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) :
:
Concurrence of CDRH, Office of Device Evaluation (ODE)
Q.Mee
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K041093
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§ 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).