(101 days)
No
The description focuses on the mechanical and material properties of a balloon catheter and does not mention any computational or analytical functions that would suggest the use of AI or ML. The "image bands" are radiopaque markers for visualization, not for image processing or analysis.
Yes.
The device is a dilatation catheter used for percutaneous transluminal valvuloplasty and angioplasty, which are procedures to treat narrowed or obstructed blood vessels and valves, thus providing a therapeutic effect on the patient.
No
The device description indicates it is a dilation catheter used for procedures like valvuloplasty and angioplasty, which are therapeutic interventions, not diagnostic ones. The use of radiopaque bands is for imaging during the procedure, not for diagnosis.
No
The device description clearly details a physical catheter with a balloon, lumens, polymeric tubing, stainless steel braid, and radiopaque bands. This is a hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for Percutaneous Transluminal Valvuloplasty (PTV) and Percutaneous Transluminal Angioplasty (PTA). These are procedures performed within the body to treat conditions affecting blood vessels and heart valves.
- Device Description: The description details a catheter with a balloon designed for mechanical dilation. This is a physical intervention, not a test performed on samples taken from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests in vitro (in glass, or outside the living organism) on samples from the human body. This device is used in vivo (within the living organism) for therapeutic purposes.
N/A
Intended Use / Indications for Use
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.
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
OMZ
Device Description
The Mullins-X catheter is an Ultra High Pressure Dilatation catheter recommended for Percutaneous Transluminal Valvuloplasty of the Pulmonary Valve. The catheter is a coaxial over the wire catheter with a balloon near the distal tip. One lumen is for balloon inflation and deflation. The balloons of the Mullins-X 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 on 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pulmonary valve, femoral arteries, iliac arteries, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
In-Vitro Testing
- Visual Inspection: All catheters were visually inspected without any anomalies.
- Balloon Preparation Test: All catheters tested were without functional difficulties or anomalies.
- Diameter and Profile Test: All catheters met the acceptance criteria.
- Balloon Distensibility: All data obtained demonstrates that the balloon diameter is within +/- 10% of the labeled diameter at the RBP. All data obtained demonstrates that the diameter of the balloons will not be significantly increased at increasingly higher pressures.
- Balloon Minimum Burst Strength: All catheters met the established acceptance criteria.
- Repeated Balloon Inflation (Balloon Fatigue) Test: No Breaks.
- Balloon Inflation/Deflation Test: All catheters met the established acceptance criteria.
- Balloon Deflatability Test: All catheters met the established acceptance criteria.
- Tip Pull and Torque Test: No breaks.
- Bond Strength Test: All bonds met the established acceptance criteria.
- Catheter Body Maximum Pressure Test: >30 ATM
Summary of Safety and Effectiveness: The Mullins-X Catheter has been tested and compared to the predicate device listed herein. All data gathered demonstrate the Mullins-X Catheter is substantially equivalent. No new issues of safety or efficacy have been raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Appendix D
·
DEC - 9 2010
510(k) Summary
| General
| Provisions | Trade Name: Mullins-X PTV Catheter |
|---|---|
| Classification Name: Catheter, Percutaneous (Valvuloplasty) | |
| Name of | |
| Predicate | |
| Device | Z-MED-X PTV Catheter – K022722 |
| Classification | Class II, 21 CFR 870.1250 - Product Code OMZ |
| Performance | |
| Standards | Performance Standards have not been established by FDA under Section 514 of the Food, Drug and Cosmetic Act. |
| Intended Use | 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. | |
| Original Indication: Recommended for Percutaneous Transluminal 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. |
Continued on next page
365
1
510(k) Summary, Continued
Device The Mullins-X catheter is an Ultra High Pressure Dilatation catheter Description recommended for Percutaneous Transluminal Valvuloplasty of the Pulmonary Valve. The catheter is a coaxial over the wire catheter with a balloon near the distal tip. One lumen is for balloon inflation and deflation. The balloons of the Mullins-X 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 on 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 All materials used to manufacture the Mullins-X Catheter are available on other commercially available NuMED, Inc. devices (K022722, K081680, and K014124) and have passed all relevant biocompatibility tests. No additional biocompatibility testing was conducted for the Mullins-X Balloon Catheter. In-Vitro A complete list of tests performed and the results are provided in the table Testing below. Continued on next page
3ldo
2
| Test
Performed | Acceptance
Criteria | Mullins-X
Results | Predicate
Device –
Z-MED-X Results |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Visual
Inspection | The catheters shall be
free from
contamination,
discoloration, and
any form of damage
that could impact the
proper functioning of
the device. | All catheters were
visually inspected
without any
anomalies. | All catheters were visually inspected
without any anomalies. |
| Balloon Preparation
Test | Each catheter shall
be prepped per the
procedure without
functional difficulties
or anomalies. | All catheters tested
were without
functional
difficulties or
anomalies. | All catheters tested were without
functional difficulties or anomalies. |
| Diameter and Profile
Test | The balloon diameter
at rated burst
pressure shall be
within +/- 10% of the
labeled balloon
diameter and the
samples should fit
through the selected
introducer with no
problems. | All catheters met the
acceptance criteria. | All catheters met the acceptance criteria. |
| Balloon
Distensibility | The results must
demonstrate that the
balloon diameter are
within +/- 10% of the
labeled diameter at
the RBP and will not
be significantly
increased at
increasingly higher
pressures. | All data obtained
demonstrates that the
balloon diameter is within
+/- 10% of the labeled
diameter at the RBP. All
data obtained
demonstrates that the
diameter of the balloons
will not be significantly
increased at increasingly
higher pressures. | All data obtained demonstrates that the balloon
diameter is within +/- 10% of the labeled diameter
at the RBP. All data obtained demonstrates that
the diameter of the balloons will not be
significantly increased at increasingly higher
pressures. |
| Balloon Minimum
Burst Strength | The results must
show statistically that
with at least 95%
confidence, 99.9% of
the balloons will not
burst at or below the
maximum
recommended rated
burst pressure. | All catheters met the
established
acceptance criteria. | All catheters met the established
acceptance criteria. |
| Repeated Balloon
Inflation (Balloon
Fatigue) Test | No breaks allowed | No Breaks. | No breaks. |
| Balloon
Inflation/Deflation
Test | Inflation achieved in
less than 12 seconds
and deflation
achieved in less than
20 seconds | All catheters met the
established
acceptance criteria. | All catheters met the established
acceptance criteria. |
| Test
Performed | Acceptance
Criteria | Mullins-X
Results | Predicate
Device -
Z-MED-X Results |
| Balloon Deflatability
Test | There should be no
interference with
balloon deflation | All catheters met the
established
acceptance criteria. | All catheters met the established
acceptance criteria. |
| Tip Pull and Torque
Test | Must withstand at
least 10 turns without
breaking | No breaks | No breaks |
| Bond Strength Test | All bonds must
withstand at least 3
lbs. of pull strength. | All bonds met the
established
acceptance criteria. | All bonds met the established acceptance
criteria. |
| Catheter Body
Maximum Pressure
Test | All samples must
withstand 30 ATM
(400psi). | >30 ATM | > 400 psi |
366-A
3
Summary of The Mullins-X Catheter has been tested and compared to the predicate device Safety and listed herein. All data gathered demonstrate the Mullins-X Catheter is Effectiveness substantially equivalent. No new issues of safety or efficacy have been raised.
3lolo-B
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name encircling a stylized emblem. The emblem consists of a stylized eagle or bird-like figure with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NuMED Inc. c/o Nichelle LaFlesh, RAC Regulatory Affairs Manager/Compliance Officer 2880 Main Street Hopkinton, NY 12965
DEC - 9 2010
Re: K102473 Mullins-X PTV Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: OMZ
Dated: December 6, 2010 Received: December 7, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
5
Page 2 - Nichelle LaFlesh, RAC
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set . forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Appendix E
Indications for Use
510(k) Number (if known): K102473
DEC - 9 2010
Device Name: Mullins-X Catheter
Indications For Use:
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.
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.
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)
(Division Sign-Off) Division of Cardiovascular Devices 6102475 510(k) Number
Page 1 of 1
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