(29 days)
The Sterling ES Monorail and Over-the-Wire PTA Balloon Dilatation Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) in 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 post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Sterling™ ES MR and OTW PTA Balloon Dilatation Catheters:
Summary of Device and Performance Information:
The Sterling™ ES MR and OTW PTA Balloon Dilatation Catheters are Percutaneous Transluminal Angioplasty (PTA) catheters indicated for use in the peripheral vasculature and for treating obstructive lesions in arteriovenous dialysis fistulae. Smaller balloon sizes (2.00 mm - 4.00 mm) are also indicated for post-dilatation of stents. The device is a modification of a previously cleared device (K080982).
1. Table of Acceptance Criteria and Reported Device Performance
Unfortunately, the provided text does not explicitly state specific acceptance criteria or quantitative performance metrics for the Sterling™ ES MR and OTW PTA Balloon Dilatation Catheters.
The document mentions: "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."
This statement indicates that performance was assessed, but the details of what was measured, how well it performed, and what standards it had to meet are not included in the provided 510(k) summary and FDA letter.
Based on the available information, a table cannot be constructed with specific acceptance criteria and reported device performance.
Regarding the other requested information:
While the document confirms a study was done ("bench testing on file at Boston Scientific"), it does not provide any of the detailed information requested for points 2 through 9.
Here's why and what's missing:
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No Clinical Study Details: The provided text explicitly states "bench testing" and "design control activities" were used to demonstrate safety and effectiveness. This indicates that a clinical study (involving human subjects) was likely not the primary method for demonstrating substantial equivalence for this particular modification, at least not in the context of this 510(k) summary. If a clinical study were performed, details like sample size, data provenance, ground truth establishment, etc., would be crucial.
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Focus on Substantial Equivalence: The 510(k) submission process primarily focuses on demonstrating "substantial equivalence" to a predicate device. For modifications to existing devices, this often relies heavily on bench testing and comparisons of materials, design, and manufacturing processes, rather than extensive new clinical trials, unless the modification significantly alters safety or effectiveness.
Therefore, for aspects 2-9, the answer is that the information is not provided in the given text.
Detailed breakdown of missing information for points 2-9:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
* Information Not Provided. The document only refers to "bench testing." Details on sample size or data provenance for such testing are not given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
* Information Not Provided. This type of information would typically be relevant for studies involving image interpretation or clinical outcomes, which is not described here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
* Information Not Provided. This applies to clinical studies with expert reviewers, which is not detailed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
* Information Not Provided. This device is a physical medical device (catheter), not an AI-powered diagnostic or interpretive tool. An MRMC study is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
* Information Not Provided. As noted, this is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
* Information Not Provided. For physical device bench testing, "ground truth" would typically refer to known physical properties or specified performance parameters measured against accepted standards (e.g., burst pressure, inflation time, guidewire compatibility). The document does not specify these.
8. The sample size for the training set
* Information Not Provided. No training set for an algorithm is mentioned or implied.
9. How the ground truth for the training set was established
* Information Not Provided. No training set is mentioned.
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510(k) Summary
| Sponsor: | Boston Scientific CorporationOne Boston Scientific PlaceNatick 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: | LIT21 CFR 870.1250 | |
| Predicate Devices: | Sterling ES Monorail (MR) and Over-the-Wire (OTW) PTA Balloon DilatationCatheters (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.
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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 . . .
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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
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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
§ 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).