(21 days)
Not Found
No
The description focuses on the mechanical design and function of a balloon catheter and does not mention any AI or ML components.
Yes
The device is clearly indicated for "Percutaneous Transluminal Angioplasty (PTA)" and acts directly on the body by dilating vessels to treat "obstructive lesions," which are therapeutic actions.
No
The device is described as a "PTA Balloon Dilatation Catheter" used for Percutaneous Transluminal Angioplasty, which is a therapeutic procedure to dilate obstructive lesions. It is not designed to diagnose a condition.
No
The device description clearly details a physical catheter with a balloon, shaft, and guidewire lumen, 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 Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Description and Intended Use: The Sterling SL PTA Balloon Dilatation Catheter is a device used inside the body (in vivo) for a therapeutic procedure (angioplasty) to open narrowed blood vessels. It is a physical device used to directly treat a condition, not to analyze samples for diagnostic purposes.
The information provided clearly describes a device used for a surgical/interventional procedure within the peripheral vasculature, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Sterling SL PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including illac, femoral, ilio-femoral, infrapopliteal, renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes (comma separated list FDA assigned to the subject device)
LIT, DQY
Device Description
The Sterling SL PTA Balloon Dilatation Catheters has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guidewires 0.014 in (0.36 mm) or 0.018 in (0.46 mm) to facilitate advancement of the . catheter to and through the stenosis to be dilated. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The catheter includes a tapered tip to facilitate advancement of the catheter. The working lengths of the balloon catheter are 90 cm and 150 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature, including illac, femoral, ilio-femoral, infrapopliteal, renal arteries, native or synthetic arteriovenous dialysis fistulae
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 substantial equivalence of the modified Sterling PTA Balloon Dilatation Catheters is demonstrated with design control activities and bench testing on file at Boston Scientific.
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.
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
510(k) Summarv
| Submitter: | Boston Scientific Corporation
One Scimed Place Maple Grove, MN 55311 | DEC 23 2009 |
|------------------------|-------------------------------------------------------------------------|-------------|
| Contact Person: | Mark Murphy | |
| Phone Number: | 763-494-2377 | |
| Fax Number: | 763-494-2981 | |
| Date Prepared: | November 25, 2009 | |
| Device Trade Name: | Sterling SL Monorail and OTW PTA Balloon Dilatation Catheters | |
| Common Name: | Percutaneous Transluminal Angioplasty Dilatation Catheter | |
| Device Classification: | Class II 21 CFR 870.1250 Product Code: LIT | |
Predicate Devices
Sterling ES PTA Balloon Dilatation Catheters, Sterling Monorail and OTW PTA Balloon Dilatation Catheters and Polarcath Peripheral Dillatation System.
Device Description
The Sterling SL PTA Balloon Dilatation Catheters has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guidewires 0.014 in (0.36 mm) or 0.018 in (0.46 mm) to facilitate advancement of the . catheter to and through the stenosis to be dilated. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The catheter includes a tapered tip to facilitate advancement of the catheter. The working lengths of the balloon catheter are 90 cm and 150 cm.
Indications for Use
The Sterling SL PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including illac, femoral, ilio-femoral, infrapopliteal, renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Substantial Equivalence
The Sterling SL PTA Balloon Dilatation Catheters line extension design, materials, manufacturing process and intended use are substantially equivalent to predicate devices Sterling ES (K080982), Sterling Monorail (K053118), Sterling OTW (K053116)
Performance Data
The substantial equivalence of the modified Sterling PTA Balloon Dilatation Catheters is demonstrated with design control activities and bench testing on file at Boston Scientific.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, depicted with flowing lines to represent its wings and body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Boston Scientific Corporation c/o Mark Murphy Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311
DEC 2 3 2009
Re: K093720
Trade/Device Name: Sterling SL Monorail and Over-the-Wire Dilatation Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: LIT, DQY Dated: December 1, 2009 Received: December 2, 2009
Dear Mr. Murphy:
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 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.
2
Page 2 – Mr. Murphy
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 of medical device-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 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
3
Premarket Notification - Special 510(k) 1 Tomanton Notinodaon - Openal OTW PTA Balloon Dilatation Catheters
Indications for Use Statement
12093720 510(k) Number (if known) Sterling SL MR & OTW PTA Balloon Dilatation Catheters Device Name Sterling SL PTA Balloon Dilatation Catheter is indicated for Percutaneous Indications for Transluminal Angioplasty (PTA) in the peripheral vasculature, including Use iliac, femoral, ilio-femoral, infrapopliteal, popliteal, renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
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
OR
Over-The-Counter Use
W.M.
Division of Cardiovascular Devices
510(k) Number K093726