(39 days)
The Sterling OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
The Sterling OTW PTA Balloon Dilatation Catheter is an Over-The-Wire catheter 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 balloon, and the wire lumen permits the use of 0.014 in/0.018 in (0.36 mm/0.46 mm) 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 catheter are 40 cm, 80 cm and 135 cm.
This document describes the Boston Scientific Corporation Sterling™ OTW PTA Balloon Dilatation Catheter (K053116).
1. Acceptance Criteria and Reported Device Performance
The submission relies on demonstrating substantial equivalence to predicate devices (Ultra-soft™ SV Balloon Dilatation Catheters K021735 and K050389) through bench testing and biocompatibility testing. The document states: "Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing regimen."
However, the provided text does not explicitly list specific quantitative acceptance criteria (e.g., specific thresholds for burst pressure, flexibility, etc.) nor does it report detailed quantitative performance data of the Sterling™ OTW PTA Balloon Dilatation Catheter against such criteria. The document states that the testing demonstrated conformance to requirements and raised no new safety or performance issues, implying satisfactory performance against internal or recognized standards for these types of devices.
Without specific performance metrics and acceptance thresholds, a table for this section cannot be fully populated from the given text.
2. Sample Size Used for the Test Set and Data Provenance
The document indicates that "Bench testing" was performed. This typically refers to laboratory testing of physical samples of the device.
- Sample Size for Test Set: The exact sample size used for the bench testing is not specified in the provided 510(k) summary.
- Data Provenance: The data is described as "Bench testing," meaning it was generated in a controlled laboratory environment, likely by the manufacturer (Boston Scientific Corporation). This is a form of prospective data collection for the purpose of demonstrating device performance. The country of origin of the data is not explicitly stated but can be inferred to be the United States, given the submitter's address and the FDA submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This submission describes a medical device (a balloon dilatation catheter), not a diagnostic algorithm that requires expert-established ground truth from medical images or clinical data. Therefore, the concept of "experts used to establish the ground truth for the test set" is not applicable in the context of this 510(k) submission for a physical device. Ground truth for a physical device is typically established through engineering specifications, material properties, and standardized functional performance tests.
4. Adjudication Method for the Test Set
As this is a physical medical device submission relying on bench testing, the concept of an "adjudication method" involving human experts (like 2+1 or 3+1 for diagnostic interpretations) is not applicable. Device performance is assessed against predefined engineering specifications and testing protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
The device is a physical medical device, not an AI or imaging diagnostic tool that would typically involve a MRMC study to assess human reader performance with and without AI assistance. The submission focuses on the safety and performance of the device itself, not on improving human diagnostic capabilities.
6. Standalone Performance Study (Algorithm Only)
No, a standalone performance study (algorithm only) was not done.
This is a physical medical device, not a software algorithm. Therefore, the concept of "standalone (i.e., algorithm only without human-in-the-loop performance)" is not applicable.
7. Type of Ground Truth Used
The "ground truth" for the performance of this physical medical device is established by:
- Engineering specifications: The device is designed to meet specific physical and functional parameters (e.g., balloon diameter, length, burst pressure, trackability, pushability, inflation/deflation times).
- Performance standards: Testing is conducted against recognized industry standards and regulatory requirements for PTA balloon catheters.
- Biocompatibility standards: Materials are tested to ensure they are safe for contact with the human body.
In this context, ground truth is based on objective physical and chemical measurements rather than expert consensus on medical conditions, pathology results, or clinical outcomes data in the traditional sense of a diagnostic study.
8. Sample Size for the Training Set
This submission is for a physical medical device. It does not involve machine learning algorithms or AI, and therefore, there is no "training set" in the context of data used to train an algorithm. Performance is assessed through physical testing of manufactured devices.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" for an algorithm, this question is not applicable.
{0}------------------------------------------------
510(k) Summary
per 21 CFR §807.92
| Submitter'sName andAddress | Boston Scientific CorporationTwo Scimed PlaceMaple Grove, MN 55311 |
|---|---|
| Contact Nameand Information | Maureen MontbriandSpecialist, Regulatory AffairsPhone: 763-494-2903Fax: 763-494-2981e-mail: montbrim@bsci.com |
| Date Prepared | November 4, 2005 |
| ProprietaryName(s) | Sterling ™ OTW PTA Balloon Dilatation Catheter |
| Common Name | PTA Balloon Dilatation Catheter |
| Product Code | DQY |
| Classification ofDevice | Class II, 21 CFR Part 870.1250 |
| Predicate Device | Ultra-soft™ SVBalloon DilatationCatheterK021735 August 8, 2002 |
| Ultra-soft™ SVBalloon DilatationCatheterK050389 May 25, 2005 | |
| DeviceDescription | The Sterling OTW PTA Balloon Dilatation Catheter is anOver-The-Wire catheter with a semi-compliant balloon fixedat the distal tip. The balloon catheter has a coaxial shaftdesign. The outer lumen is used for inflation of the balloon,and the wire lumen permits the use of 0.014 in/0.018 in(0.36 mm/0.46 mm) guidewires to facilitate advancement ofthe catheter to and through the stenosis to be dilated. Theballoon is designed to provide an inflatable segment ofknown diameter and length at recommended pressures.Two radiopaque marker bands (one proximal and onedistal), in conjunction with fluoroscopy, enable accuratepositioning of the balloon. The working lengths of theballoon catheter are 40 cm, 80 cm and 135 cm. |
| Intended Use ofDevice | The Sterling OTW PTA Balloon Dilatation Catheter isindicated for Percutaneous Transluminal Angioplasty(PTA) in the peripheral vasculature, including iliac, femoral,ilio-femoral, popliteal and renal arteries, and for thetreatment of obstructive lesions of native or syntheticarteriovenous dialysis fistulae. This device is alsoindicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. |
| Comparison ofTechnologicalCharacteristics | The Sterling OTW catheter will incorporate a substantiallyequivalent design, packaging, fundamental technology,manufacturing, sterilization and intended use as thosefeatured in the predicate BSC Ultra-soft SV BalloonDilatation Catheter. |
| Support ofSubstantialEquivalence | Bench testing and biocompatibility testing were performedto support a determination of substantial equivalence. Theresults of these tests provide reasonable assurance that theproposed device has been designed and tested to assureconformance to the requirements for its intended use. Nonew safety or performance issues were raised during thetesting regimen. |
| Conclusion | Based on the Indications for Use, technologicalcharacteristics, safety and performance testing, the SterlingOTW PTA Balloon Dilatation Catheter has been shown tobe appropriate for its intended use and is considered to besubstantially equivalent to the Ultra-soft SV BalloonDilatation Catheter (K050389; cleared May 25, 2005 andK021735; cleared August, 8 2002). |
{1}------------------------------------------------
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.
DEC 16 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific Corporattion c/o Ms. Maureen Montbriand Regulatory Affairs Specialist Two Scimed Place Maple Grove, MN 56311-1566
Re: K053116
Sterling™ OTW PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: DQY Dated: November 4, 2005 Received: November 7, 2005
Dear Ms. Montibriand:
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 such 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.
{3}------------------------------------------------
Page 2 - Ms. Maureen Montibriand
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); 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Duna R. Vachner
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use Statement
| 510(k) Number (if known) | K053116 |
|---|---|
| Device Name | Sterling TM OTW PTA Balloon Dilatation Catheter |
| Indications For Use | The Sterling OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. |
Prescription Use: ____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR §801 Subpart D) OR
Over-The-Counter Use: __ (21 CFR 807 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dune R. Vachner
Division Sign-Off)
Division of Cardiovascular Devices
ok) Number_K05311 (
§ 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).