(311 days)
Not Found
No
The summary describes a mechanical balloon catheter and its performance testing, with no mention of AI or ML capabilities.
Yes
The device is used for percutaneous transluminal angioplasty (PTA) to treat obstructed iliac and femoral vessels, which is a therapeutic intervention.
No
This device is a therapeutic device (a balloon dilatation catheter) used for percutaneous transluminal angioplasty, not for diagnosing conditions.
No
The device description clearly outlines a physical catheter with a balloon, lumens, and marker bands, indicating it is a hardware device, not software-only.
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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The Megabello Balloon Dilatation Catheter is a medical device used directly within the patient's body (in vivo) to physically treat blockages in blood vessels. It does not analyze samples taken from the body.
The description clearly indicates it's a device for a surgical procedure (percutaneous transluminal angioplasty) performed inside the patient.
N/A
Intended Use / Indications for Use
Megabello Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty (PTA) of the iliac and femoral vessels whose lumens are obstructed by atherosclerotic plaque. Megabello catheters are not indicated for use in coronary arteries nor in the neurovasculature. Any other use than those indicated is not recommended.
Product codes
LIT
Device Description
The Megabello Percutaneous Transluminal Angioplasty (PTA) Catheter consists of a multilumen catheter with a controlled-compliance balloon mounted at the distal tip. The balloon is designed to inflate to a known diameter and length at a specific pressure and is inflated and deflated via the side port. A second lumen allows access to the distal tip of the catheter for guidewire insertion. Two marker bands are positioned under the balloon at the proximal and distal tapers to aid in accurate placement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac and femoral vessels
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)
The Megabello Percutaneous Transluminal Angioplasty (PTA) Catheter had non-clinical performance testing, as did the predicate device, the SMASH™M Percutaneous Transluminal Angioplasty (PTA) Catheter.
Testing of the Megabello Percutaneous Transluminal Angioplasty (PTA) Catheter generally followed the PTCA Balloon Catheters section in Part II of the "Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices", May 1994. The following types of tests were performed similar to those in the guidance:
Balloon Minimum Burst Strength Balloon Compliance (Distensibility) Balloon Inflation/Deflation Performance Balloon Fatigue (Repeated Balloon Inflation) Bond Strength Catheter Diameter and Balloon Profile Catheter Body Burst Pressure
The following additional evaluations were also performed:
Sheath Removal Profile
The biocompatibility of the catheter was also tested and found acceptable.
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.
SMASH TM Percutaneous Transluminal Angioplasty (PTA) Catheter - K972512
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.
Not Found
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
MAY 1 8 2000
| 510(k) Summary |
|---|
| ---------------- |
Date Prepared
February 18, 2000
Submitter
| Submitter | Address: | Boston Scientific Corporation
Schneider (USA) Inc
5905 Nathan Lane
Minneapolis, MN 55442 |
|----------------|--------------------------------|---------------------------------------------------------------------------------------------------|
| | Phone :
Fax : | (612) 694-5500
(612) 694-5858 |
| Contact Person | | Ronald W. Bennett
Regulatory Affairs Project Manager |
| | Device Name and Classification | |
| | Trade Name | Megabello Percutaneous Transluminal Angioplasty
(PTA) Catheter |
Catheter
Class II
Device Description
Predicate Device
Common Name
Classification
The Megabello Percutaneous Transluminal Angioplasty (PTA) Catheter consists of a multilumen catheter with a controlled-compliance balloon mounted at the distal tip. The balloon is designed to inflate to a known diameter and length at a specific pressure and is inflated and deflated via the side port. A second lumen allows access to the distal tip of the catheter for guidewire insertion. Two marker bands are positioned under the balloon at the proximal and distal tapers to aid in accurate placement.
Percutaneous Transluminal Angioplasty (PTA)
SMASH TM Percutaneous Transluminal
Angioplasty (PTA) Catheter - K972512
Intended Use
Megabello Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty (PTA) of the iliac and femoral vessels whose lumens are obstructed by atherosclerotic plaque. Megabello catheters are not indicated for use in coronary arteries nor in the neurovasculature. Any other use than those indicated is not recommended.
1
Technical Characteristic Comparison to Predicate
The Megabello Percutaneous Transluminal Angioplasty (PTA) Catheter has the same intended use and basic construction as the predicate device, the SMASH™ Percutaneous Transluminal Angioplasty (PTA) Catheter. The following table compares the technical characteristics of the two devices:
| Feature | MEGABELLO
Percutaneous Transluminal
Angioplasty (PTA) Catheter | Smash™ Percutaneous
Transluminal Angioplasty
(PTA) Catheter |
|----------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------|
| Configuration | Multilumen | Multilumen |
| Shaft Length (cm) | 75-120 | 60-120 |
| Shaft French Size | 7 | 5 |
| Balloon Length (mm) | 20-40 | 20-80 |
| Balloon Diameter (mm) | 12, 14 | 3-12 |
| Rated Burst Pressure (atm) | 7 | 7-15 |
| Guidewire Size (inches) | 0.035 | 0.035 |
| Balloon Markers | 2 (90/10 Platinum/ Iridium) | 2 (Gold) |
| Balloon Material | Nylon | Nylon |
| Manifold Material | Pebax | ABS |
| Shaft Material | Pebax 6333 | Nylon |
Performance Data
The Megabello Percutaneous Transluminal Angioplasty (PTA) Catheter had non-clinical performance testing, as did the predicate device, the SMASH™M Percutaneous Transluminal Angioplasty (PTA) Catheter.
Testing of the Megabello Percutaneous Transluminal Angioplasty (PTA) Catheter generally followed the PTCA Balloon Catheters section in Part II of the "Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices", May 1994. The following types of tests were performed similar to those in the guidance:
Balloon Minimum Burst Strength Balloon Compliance (Distensibility) Balloon Inflation/Deflation Performance Balloon Fatigue (Repeated Balloon Inflation) Bond Strength Catheter Diameter and Balloon Profile Catheter Body Burst Pressure
2
The following additional evaluations were also performed:
Sheath Removal Profile
The biocompatibility of the catheter was also tested and found acceptable.
Summary
In summary, Boston Scientific Corporation has demonstrated the Megabello Percutaneous Transluminal Angioplasty (PTA) Catheter is substantially equivalent to the SMASHIM Percutaneous Transluminal Angioplasty (PTA) Catheter based on design and test results for the indications for use given, and is therefore acceptable for commercialization.
3
Image /page/3/Picture/1 description: The image is a black and white circular logo. The logo contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. Inside the circle is a stylized emblem consisting of three curved lines that resemble a person with outstretched arms.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 8 2000
Mr. Ronald W. Bennett Regulatory Affairs Project Manager Boston Scientific Corporation Scneider (USA) Inc. 5905 Nathan Lane Minneapolis, MN 55442
K992320 Re: Megabello Balloon Dilatation Catheter Regulatory Class: II (two) Product Code: LIT February 18, 2000 Dated: February 22, 2000 Received:
Dear Mr. Bennett:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
4
Page 2 - Mr. Ronald W. Bennett
This letter will allow you to begin marketing your device as described in your 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 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Bin E. Hawr
James E. Dillard III
Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
Device Name:
Megabello Percutaneous Transluminal Angioplasty (PTA) Catheter
Indications for Use:
Megabello Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty (PTA) of the iliac and femoral vessels whose lumens are obstructed by atherosclerotic plaque. Megabello catheters are not indicated for use in coronary arteries nor in the neurovasculature. Any other use than those indicated is not recommended.
Tom E. Harvey
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
5/11/10
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)
and Neurological Devi
510(k) Number
OR
Over-The-Counter Use