(29 days)
Not Found
No
The document describes a mechanical device (balloon catheter) and does not mention any AI or ML components or functions.
Yes
The device is indicated for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions in the peripheral vasculature and dialysis fistulae, which are therapeutic medical procedures.
No
The device is a therapeutic device (balloon dilatation catheter) used for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions, not to diagnose a condition.
No
The device description clearly details physical components like a catheter, balloon, shaft, lumens, and marker bands, indicating it is a hardware device.
Based on the provided information, 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.
- Device Function: The Sterling ES Monorail and Over-the-Wire PTA Balloon Dilatation Catheters are used for Percutaneous Transluminal Angioplasty (PTA). This is a procedure performed inside the body to widen narrowed or blocked blood vessels.
- Intended Use: The intended use clearly describes a therapeutic procedure performed directly on the patient's vasculature, not a diagnostic test on a sample.
- Device Description: The description details a catheter with a balloon designed for inflation within a blood vessel, not for analyzing a biological sample.
Therefore, this device falls under the category of therapeutic medical devices used for interventional procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Sterling ES MR and OTW PTA Balloon Dilatation Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, illo-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The 2.00 mm - 4.00 mm balloon devices are 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
The Sterling ES PTA Balloon Dilatation Catheters consist of a Monorail and an Over-The-Wire catheter designs with a semi-compliant balloon fixed at the distal tip. The balloon catheter has a coaxial shaft design. The outer lumen is used for inflation of the wire lumen permits the use of 0.014" guidewires 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.
Two radiopaque marker bands (one proximal and one distal), in conjunction with fluoroscopy, enable accurate positioning of the balloon. The working lengths of the balloon catheters are approximately 143 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature, including iliac, femoral, illo-femoral, popliteal, infra-popliteal and 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)
The safety and effectiveness of the modified Sterling ES MR and OTW PTA Balloon Dilatation Catheter 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) Summary
| Sponsor: | Boston Scientific Corporation
One Boston Scientific Place
Natick MA 01760 | DEC 2 3 2009 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Shannon Pettit | |
| Phone Number: | 763-494-2833 | |
| Fax Number: | 763-494-2981 | |
| Prepared: | November 23, 2009 | |
| Trade Name: | Sterling™ ES MR and OTW PTA Balloon Dilatation Catheters | |
| Common Name: | Percutaneous Transluminal Angioplasty Catheter | |
| Classification: | II | |
| Product Code: | LIT
21 CFR 870.1250 | |
| Predicate Devices: | Sterling ES Monorail (MR) and Over-the-Wire (OTW) PTA Balloon Dilatation
Catheters (K080982; clearance date July 14, 2008) | |
Device Description
The Sterling ES PTA Balloon Dilatation Catheters consist of a Monorail and an Over-The-Wire catheter designs with a semi-compliant balloon fixed at the distal tip. The balloon catheter has a coaxial shaft design. The outer lumen is used for inflation of the wire lumen permits the use of 0.014" guidewires 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.
Two radiopaque marker bands (one proximal and one distal), in conjunction with fluoroscopy, enable accurate positioning of the balloon. The working lengths of the balloon catheters are approximately 143 cm.
Indications for Use
The Sterling ES MR and OTW PTA Balloon Dilatation Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, illo-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The 2.00 mm - 4.00 mm balloon devices are also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
Substantial Equivalence
The Sterling ES MR and OTW PTA Balloon Dilatation Catheter design, materials, manufacturing process and intended use are substantially equivalent to the predicate device and other marketed PTA catheters.
Performance Data
The safety and effectiveness of the modified Sterling ES MR and OTW PTA Balloon Dilatation Catheter 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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three human figures or faces, resembling a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Boston Scientific Corporation c/o Ms. Shannon Pettit Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311
DEC 2 3 2009
Re: K093636
Trade/Device Name: Sterling ES Monorail & Over-the-Wire PTA Balloon Dilatation Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: LIT Dated: November 23, 2009 Received: November 24, 2009
Dear Ms. Pettit:
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.
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
and the country of the county of and the country of the county of the county of and the state of the same . . .
2
Page 2 - Ms. Shannon Pettit
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/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 (240) 276-3150 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
3
Indications for Use Statement
510(k) Number (if known)
Device Name Sterling™ ES Monorail® and Over-the-Wire PTA Balloon Dilatation Catheters
Indications for The Sterling ES Monorail and Over-the-Wire PTA Balloon Dilatation Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) in Use the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The 2.00 mm - 4.00 mm balloon devices are also indicated for postdilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
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. W
ardiovascular Devices
510(k) Number L013636