(25 days)
This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. This catheter is not indicated for use in the coronary arteries, stent placement or stent redilation.
The Mullins X™ catheter is an Ultra High Pressure Dilatation catheter 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 four radiopaque platinum image bands. Two are 5mm on each side of the balloon center and two more under the balloon shoulders.
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.
This document is a 510(k) Pre-market Notification for a medical device, specifically a PTA catheter. It is a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission relies on comparisons to existing devices and bench testing, rather than extensive clinical studies with human subjects or AI algorithms as would be required for the information requested.
Therefore, many of the requested categories related to clinical studies, AI algorithms, and ground truth establishment are not applicable to this particular document.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal "acceptance criteria" with numerical targets for clinical performance in the way an AI study would. Instead, it demonstrates performance through bench testing and comparison to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Materials are the same as previously cleared devices (510(k) #K041093, K931009) and tested in compliance with Tripartite Biocompatibility Guidance. Test results indicate biocompatibility (on file at NuMED, Inc.). |
| Functional Performance | All bench testing performed in accordance with GMP's and results are kept on file at NuMED, Inc. (Specific performance metrics are not detailed in this summary). |
| Substantial Equivalence | Device is substantially equivalent to the predicate device (NuMED Mullins-X PTA Catheter) in terms of indications, shaft size, guidewire size, balloon diameter, balloon length, materials, and construction. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This document refers to bench testing and comparison to a predicate device. It does not involve a "test set" of patient data for evaluating an AI algorithm.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in the context of expert consensus is not relevant for this type of device submission. The "ground truth" for a medical device in this context would be its physical and mechanical properties, and its safety and efficacy, demonstrated through bench testing and clinical equivalence to a known predicate.
4. Adjudication method for the test set
Not applicable. There is no "test set" of 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 device approval for a physical catheter, not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device approval for a physical catheter, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The closest concept to "ground truth" here would be:
- Bench Test Results: Objective measurements of the catheter's physical and mechanical properties (e.g., inflation diameter at a given pressure, material strength, radiopacity). These results, which are "on file at NuMED, Inc.", serve as the factual basis for its performance claims.
- Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate device (NuMED Mullins-X PTA Catheter, K041093, and Z-MED Catheter, K931009) provides the "ground truth" for comparison to establish substantial equivalence.
8. The sample size for the training set
Not applicable. This is a medical device approval for a physical catheter, not an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. This is a medical device approval for a physical catheter, not an AI algorithm.
Summary of what the document focuses on:
This 510(k) summary focuses on demonstrating the substantial equivalence of the new Mullins-X PTA Catheter to previously cleared predicate devices by:
- Stating identical materials for biocompatibility.
- Indicating that bench testing was performed according to GMPs, with results on file (though specifics are not in this summary).
- Directly comparing the device's characteristics (indications, size, materials, construction) to a predicate device, showing minimal differences, with the primary difference being an additional balloon diameter.
The content is typical for a 510(k) submission for a non-AI medical device and does not contain the information requested about AI performance or clinical study details.
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KC422864 page 1 of 2
510(K) SUMMARY
OCT 2 4 2008
October 22, 2008
Submitted By: NuMED, Inc., 2880 Main St., Hopkinton, NY 12965 (Ph) 315-328-4491
Contact Person: Nichelle LaFlesh
Device Name: Nullins-X PTA Catheter; 21 CFR 870.1250 - Percutaneous Catheter
Predicate Devices: NuMED Mullins-X PTA Catheter
Device Description: The Mullins X™ catheter is an Ultra High Pressure Dilatation catheter 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 four radiopaque platinum image bands. Two are 5mm on each side of the balloon center and two more under the balloon shoulders.
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-X PTA Catheter are the same as those used in the already cleared Mullins-X PTA Catheter (510(k) #K041093) and Z-MED Catheter (K931009) 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.
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Intended Use: This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. This catheter is not indicated for use in the coronary arteries, stent placement or stent redilation.
| Comparison Information: | ||
|---|---|---|
| MODEL: | NUMED MULLINS-X PTACATHETER | NUMED MULLINS-X PTACATHETER - ADDITIONALBALLOON DIAMETER |
| Indications: | This catheter is recommendedfor Percutaneous TransluminalAngioplasty (PTA) of thefemoral, iliac, and renal arteries.These catheters are notdesigned to be used in thecoronary arteries. | This catheter is recommendedfor Percutaneous TransluminalAngioplasty (PTA) of thefemoral, iliac, and renal arteries.This catheter is not indicatedfor use in the coronaryarteries, stent placement orstent redilation. |
| Shaft Size: | 7 – 9 Fr | 7 – 9 Fr |
| Guidewire Size: | 0.035" | 0.035" |
| Balloon Diameter: | 12, 14, 15, 16, 18, 20, 22, and25mm | 12, 14, 15, 16, 18, 20, 22, 23and 25mm |
| Balloon Length: | 3 - 4 cm | 3 - 4 cm |
| Materials: | Inner Shaft: Pebax w/stainlesssteel | Inner Shaft: Pebax w/stainlesssteel |
| Outer Shaft: PebaxBalloon: PES2Image Band: Platinum Iridium | Outer Shaft: PebaxBalloon: PES2Image Band: Platinum Iridium | |
| Construction: | Coaxial construction withdistally mounted non-compliantballoon. | Coaxial construction withdistally mounted non-compliantballoon. |
Comparison Information:
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 2008
NuMED. Inc. c/o Nichelle R. LaFlesh, RAC 2880 Main Street Hopkinton, NY 12965
Re: K082868
Trade/Device Name: Mullins-X PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 26, 2008 Received: September 29, 2008
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 forth in the quality
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Page 2 -- Ms. Nichelle R. LaFlesh
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
unea R. V. hmer
A 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): K082868
Device Name: Mullins-X PTA Catheter
Indications For Use:
- This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) . Fifth Catheter is reaching the . This catheter is not indicated for use in the coronary arteries, stent placement or stent redilation.
Prescription Use X (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)
una R. bohus
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_ko82868
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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).