(39 days)
The Sterling™ Monorail™ PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, renal, and carotid 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™ Monorail™ PTA Balloon Dilatation Catheter is a Monorail brand rapid exchange 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 guidewires 0.014 in / 0.018 in (0.36 mm/ 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 to and through the stenosis. Two radiopaque marker bands, in conjunction with fluoroscopy, enable accurate positioning of the balloon. The working lengths of the balloon catheter are 80 cm and 135 cm. A needle with a luer port is included for flushing the distal inner lumen prior to the insertion of appropriate guidewires.
The provided text describes a 510(k) summary for the Boston Scientific Sterling™ Monorail™ PTA Balloon Dilatation Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than providing acceptance criteria and performance data from a specific study designed to meet those criteria.
Therefore, many of the requested details cannot be extracted from this document, particularly those related to a clinical study with detailed acceptance criteria, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance.
Here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document. The 510(k) summary reports "Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence." However, it does not elaborate on specific acceptance criteria for these tests nor provide detailed performance results against those criteria. The focus is on stating that the proposed device has been designed and tested to assure conformance to requirements.
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not provided. The document mentions "Bench testing and biocompatibility testing" but does not give sample sizes for these tests.
- Data provenance: Not provided. No information about country of origin or whether data was retrospective/prospective is given, as most of the testing was likely bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable/Not provided. As the described testing is primarily bench and biocompatibility, there is no mention of "ground truth" in the clinical sense established by experts.
4. Adjudication method for the test set:
Not applicable/Not provided. This is not relevant for the type of testing described (bench and biocompatibility).
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:
Not applicable/Not provided. This document describes a medical device (a balloon catheter), not an AI or imaging diagnostic device that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable/Not provided. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
Not applicable/Not provided. For bench testing, the "ground truth" would be engineering specifications and measurements. For biocompatibility, it would be established biological and toxicological endpoints. Clinical ground truth (e.g., pathology, outcomes data) is not discussed.
8. The sample size for the training set:
Not applicable/Not provided. As it's a physical device and not an AI algorithm, there is no "training set."
9. How the ground truth for the training set was established:
Not applicable/Not provided. As there is no "training set," this question is not applicable.
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DEC 16 2005
BSC Sterling™ Monorail™ PTA Balloon Dilatation ✆. ↓↓↓↓
510(k) Summary per 21 CFR §807.92
| Submitter's Name and Address | Boston Scientific CorporationTwo Scimed PlaceMaple Grove, MN 55311 |
|---|---|
| Contact Name and Information | Maureen MontbriandSpecialist, Regulatory AffairsPhone: 763-494-2903Fax: 763-494-2981e-mail: montbrim@bsci.com |
| Date Prepared | November 4, 2005 |
| Proprietary Name(s) | Sterling™ Monorail™ PTA Balloon Dilatation Catheter |
| Common Name | PTA Balloon Dilatation Catheter |
| Product Code | DQY |
| Classification of Device | Class II, 21 CFR Part 870.1250 |
| Predicate Device | Ultra-soft™ SV Balloon Dilatation CatheterK050389May 25, 2005 |
| Device Description | The Sterling™ Monorail™ PTA Balloon Dilatation Catheteris a Monorail brand rapid exchange catheter with a semi-compliant balloon fixed at the distal tip. The ballooncatheter has a coaxial shaft design. The outer lumen isused for inflation of the balloon, and the wire lumen permitsthe use of guidewires 0.014 in / 0.018 in (0.36 mm/ 0.46mm) to facilitate advancement of the catheter to andthrough the stenosis to be dilated.The balloon is designed to provide an inflatable segment ofknown diameter and length at recommended pressures toand through the stenosis. Two radiopaque marker bands,in conjunction with fluoroscopy, enable accurate positioningof the balloon.The working lengths of the balloon catheter are 80 cm and135 cm. A needle with a luer port is included for flushingthe distal inner lumen prior to the insertion of appropriateguidewires. |
{1}------------------------------------------------
| Intended Use ofDevice | The SterlingTM MonorailTM PTA Balloon Dilatation Catheteris indicated for Percutaneous Transluminal Angioplasty(PTA) in the peripheral vasculature, including iliac, femoral,ilio-femoral, popliteal, renal, and carotid arteries, and for thetreatment of obstructive lesions of native or syntheticarteriovenous dialysis fistulae. This device is also indicatedfor post-dilatation of balloon expandable and self-expandingstents in the peripheral vasculature. |
|---|---|
| Comparison ofTechnologicalCharacteristics | The SterlingTM MonorailTM catheter will incorporate asubstantially equivalent design, packaging, fundamentaltechnology, manufacturing, sterilization and intended use asthose featured 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, and safety and performance testing, theSterlingTM MonorailTM PTA Balloon Dilatation Catheter hasbeen shown to be appropriate for its intended use and isconsidered to be substantially equivalent to the Ultra-softSV Balloon Dilatation Catheter (K050389; cleared May 25,2005). |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of three human figures.
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: K053118
KUS3118
Sterling™ Monorail™ PTA Balloon Dilatation Catheter
Sterling™ Monorail™ PTA 1959 Sterling - Homber: 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
ty the indication we can in the device is substantially equivalent (for the indicat We have reviewed your Section > IQK ) premiums.illy equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and have deemined the usedicate devices marketed in interstate
for use stated in the enclosure) to legally marketed predical Device Amendments, for use stated in the enclosure) to the enatment date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food, Drug, commerce prior to May 28, 1976, the enaculient with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance while he views of the Art (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act. The and Cosmetic Act (Act) that do not require approval or a potherns of the Act. The Act. The
You may, therefore, market the device, subject to the general controls of listing You may, therefore, market the device, subject to the general or annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act theilude requirements in the many of the management misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into entire) and may be subjections affecting your device can
may be subject to such additional controls. Existing major regulations may be subject to such additional controls. Existing mays to 898. In addition, I'DA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. I be found in the Code of Federal Regulations, Frid 20, in the Federal Register.
{3}------------------------------------------------
Page 2 - Ms. Maureen Montbriand
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a subscribed with other requirements of the Act
that FDA has made a determination that your device complies. You must that FDA has made a decemmanon that your ac-roo be roo someph .
or any Federal statutes and regulations administered by other Federal and listing or any Federal statutes and regulations administers of registration and listing (21)
comply with all the Act's requirements, including, but not researches requirements as set comply with an the Act 3 requirements; me; good manufacturing practice requirements as set CFK Part 807); labeling (21 CFR Part 807); good and 10 pplicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1400, 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Decions 991 - 12 decribed in your Section 510(k)
This letter will allow you to begin marketing your device of way davice to legs) This letter will anow you to begin markemig your article equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of thus, premarket notification. The PDA Inding of substantal equive 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 If you desire specific advice for your do not of the of any please note the regulation entitled, whitely contact the Office of Comphalled at (210) 276 of 807.97). You may obtain "Misbranding by reference to premance noutheation" (= " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = other general information on your responsion.com its toll-free number (800) 638-2041 or 191 Manufacturers, International and Consultion in the Marcel of Constitutions try/support/index.html.
Sincerely yours,
Dunna R. Vochner
A 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 | |
|---|---|
| K053118 |
| 510(k) Number(if known) | |
|---|---|
| Device Name | Sterling™ Monorail™ PTA Balloon Dilatation Catheter |
| Indications For Use | The Sterling™ Monorail™ PTA Balloon Dilatation Catheter isindicated for Percutaneous Transluminal Angioplasty (PTA)in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, renal, and carotid arteries, and for thetreatment of obstructive lesions of native or syntheticarteriovenous dialysis fistulae. This device is also indicatedfor post-dilatation of balloon expandable and self-expandingstents in the peripheral vasculature. |
Prescription Use:_____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR §801 Subpart D) Over-The-Counter Use: __ (21 CFR 807 Subpart C)
(Please do not write below this line - continue on another Page if needed)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
une R. de huer
(Division Sign-Off) (Division Sign-on)
Division of Cardiovascular Devices
510(k) Number kor 311 8
§ 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).