(73 days)
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No
The provided text describes a balloon dilatation catheter and its intended use for angioplasty. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities that would suggest the use of AI/ML.
Yes
The device is used for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions in arteries and dialysis fistulae, which is a therapeutic intervention.
No
The provided text describes the Mustang and Charger Balloon Dilatation Catheters as tools for Percutaneous Transluminal Angioplasty (PTA) and post-dilatation of stents. These are therapeutic procedures aimed at treating obstructive lesions, not diagnosing them.
No
The device is described as a "Balloon Dilatation Catheter," which is a physical medical device used in angioplasty procedures. The description of its intended use clearly indicates a hardware component.
Based on the provided information, the Mustang and Charger Balloon Dilatation Catheters are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use clearly describes a procedure performed within the body (Percutaneous Transluminal Angioplasty) to treat obstructive lesions in blood vessels. This is an in vivo procedure, not an in vitro (outside the body) diagnostic test.
- Device Description (though not found): Balloon dilatation catheters are physical devices used to mechanically open narrowed blood vessels. This function is entirely different from the reagents, instruments, and software used for analyzing biological samples in vitro.
- Lack of IVD characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), diagnostic testing, or the generation of diagnostic information from samples.
Therefore, these devices are therapeutic medical devices used for interventional procedures, not IVD devices.
N/A
Intended Use / Indications for Use
The Mustang Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The Mustang Balloon Dilatation Catheter is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
The Charger Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The Charger Balloon Dilatation Catheter is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
LIT
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries; native or synthetic arteriovenous dialysis fistulae.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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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).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing right, with flowing lines beneath them. The image is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2014
Boston Scientific Corporation Ms. Melanie Raska Director, Regulatory Affairs One Scimed Place Maple Grove, MN 55311
Re: K141521
Trade/Device Name: Mustang PTA Balloon Dilatation Catheter Charger PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: July 28, 2014 Received: July 29, 2014
Dear Ms. Raska,
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.
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
1
related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
for
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 Statement
(if known) Device Name Mustang ™ PTA Balloon Dilatation Catheters The Mustang Balloon Dilatation Catheter is indicated for Indications for Use Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The Mustang Balloon Dilatation Catheter is also indicated for post-
510(k) Number
dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
Prescription Use × (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Boston Scientific Corporation
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3
Indications for Use Statement
| 510(k) Number
| (if known) | K141521 |
|---|---|
| Device Name | Charger TM PTA Balloon Dilatation Catheters |
| Indications for | |
| Use | The Charger Balloon Dilatation Catheter is indicated for |
| Percutaneous Transluminal Angioplasty (PTA) in the peripheral | |
| vasculature, including iliac, femoral, popliteal, tibial, peroneal, | |
| subclavian, and renal arteries and for the treatment of obstructive | |
| lesions of native or synthetic arteriovenous dialysis fistulae. |
The Charger Balloon Dilatation Catheter is also indicated for post-
dilatation of balloon expandable and self-expanding stents in the
peripheral vasculature. |
Prescription Use X (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Boston Scientific Corporation
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