(98 days)
The Sterling ES MR and OTW PTA Balloon Dilatation Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, iliofemoral, popliteal, infrapopliteal 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 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 (0.39 mm) guide wires 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 143 cm.
This document describes the 510(k) summary for the Sterling ES MR and OTW PTA Balloon Dilatation Catheters. It's important to note that this is a submission for a medical device (a physical product), not an AI/software device. Therefore, many of the typical AI/software acceptance criteria and study components you've requested (like MRMC studies, ground truth establishment for algorithms, training sets, and expert adjudication of AI performance) are not applicable to this type of device.
This submission focuses on demonstrating substantial equivalence to a predicate device through bench testing and biocompatibility.
Here's an attempt to fill in the requested information based on the provided text, with clarifications where the concepts are not applicable:
- Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Substantial Equivalence Basis) | Reported Device Performance |
|---|---|
| Technological Characteristics: Substantially equivalent design, packaging, fundamental technology, manufacturing, sterilization, and intended use as the predicate device (Sterling OTW PTA Balloon Dilatation Catheter, K053116). This would implicitly include aspects like balloon diameter, length, working pressures, shaft design, guide wire compatibility, radiopacity. | The Sterling ES MR and OTW catheters incorporate a substantially equivalent design, packaging, fundamental technology, manufacturing, sterilization and intended use as those featured in the predicate BSC Sterling OTW PTA Balloon Dilatation Catheter. Specific performance metrics are not detailed, but the conclusion states that based on testing, it's appropriate for intended use. |
| Safety and Performance: No new safety or performance issues identified during device testing. This implies the device performs as safely and effectively as the predicate for its intended use. | "No new safety or performance issues were identified during device testing." "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." |
| Biocompatibility: The device materials must be biocompatible for their intended use. | "biocompatibility testing were performed to support a determination of substantial equivalence." (Specific results not detailed, but implied as acceptable). |
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Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated. For a physical device, "test set" would refer to the number of devices or components tested during bench testing. This information is typically detailed in the full 510(k) submission, not the summary.
- Data Provenance: The testing was "bench testing" and "biocompatibility testing." This implies laboratory testing on physical device samples, not patient data from a specific country. It's prospective in the sense that the testing was performed on the device candidates to support the submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical medical device. "Ground truth" in the context of AI/software devices typically refers to the confirmed diagnosis or measurement used to evaluate an algorithm's performance. For a balloon catheter, "ground truth" might loosely refer to validated measurements of its physical properties against specifications, but this isn't established by external "experts" in the clinical diagnostic sense. The device's performance is measured against engineering specifications and predicate device performance.
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Adjudication method for the test set
- Not Applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations of medical data (e.g., images for AI performance evaluation). For a physical device, performance is typically measured against objective criteria and specifications established during design and verified during testing.
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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
- No. This is a physical medical device, not an AI/software product. MRMC studies are used to evaluate diagnostic performance of imaging systems or AI algorithms with human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm or software. There is no "standalone" algorithm performance to evaluate.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable (in the AI/clinical sense). For this device, the "ground truth" is implied to be engineering specifications, validated test methods for mechanical properties (e.g., burst pressure, balloon diameter at pressure), and established biocompatibility standards. The predicate device's performance also serves as a benchmark for "ground truth" performance expectations.
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The sample size for the training set
- Not Applicable. This is a physical medical device. There is no "training set" in the context of machine learning. The "training" for such a device is its design and manufacturing process, optimized through engineering principles.
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How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/software device, this question is not relevant.
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510(k) Summary
per 21 CFR §807.92
JUL 1 4 2008
| Submitter'sName andAddress | Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311 | ||
|---|---|---|---|
| Contact Nameand Information | Mark MurphySr. Regulatory Affairs SpecialistPhone: 763-494-2377Fax: 763-494-2981e-mail: mark.murphy2@bsci.com | ||
| Date Prepared | April 4, 2008 | ||
| ProprietaryName(s) | Sterling TM ES MR and OTW PTA Balloon DilatationCatheters | ||
| Common Name | PTA Balloon Dilatation Catheter | ||
| Product Code | LIT | ||
| Classification ofDevice | Class II, 21 CFR Part 870.1250 | ||
| Predicate Device | Sterling OTW PTABalloon DilatationCatheter | K053116 | December 16, 2005 |
| DeviceDescription | The Sterling ES PTA Balloon Dilatation Catheters consist ofa Monorail and an Over-The-Wire catheter with a semi-compliant balloon fixed at the distal tip. The balloon catheterhas a coaxial shaft design. The outer lumen is used forinflation of the balloon, and the wire lumen permits the useof 0.014 in (0.39 mm) guide wires to facilitate advancementof the catheter to and through the stenosis to be dilated.The balloon 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 catheters are 143 cm. |
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| Intended Use ofDevice | The Sterling ES MR and OTW PTA Balloon DilatationCatheters are indicated for PercutaneousTransluminal Angioplasty (PTA) in the peripheralvasculature, including iliac, femoral, ilio-femoral, popliteal,infra-popliteal and renal arteries, and for the treatmentof obstructive lesions of native or synthetic arteriovenousdialysis fistulae. The 2.00 mm - 4.00 mm balloondevices are also indicated for post-dilatation of balloonexpandable and self-expanding stents in the peripheralvasculature. |
|---|---|
| Comparison ofTechnologicalCharacteristics | The Sterling ES MR and OTW catheters incorporate asubstantially equivalent design, packaging, fundamentaltechnology, manufacturing, sterilization and intended use asthose featured in the predicate BSC Sterling OTW PTABalloon Dilatation 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 identified duringdevice testing. |
| Conclusion | Based on the Indications for Use, technologicalcharacteristics, safety and performance testing, the SterlingES MR and OTW PTA Balloon Dilatation Catheters havebeen shown to be appropriate for its intended use and isconsidered to be substantially equivalent to the SterlingOTW PTA Balloon Dilatation Catheter (K053116; clearedDecember 16, 2005). |
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and the comments of the comments of
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like design with three curved lines representing the bird's wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 4 2008
Boston Scientific Corp. c/o Mr. Mark Murphy Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311-1566
Re: K080982
Trade Name: Sterling ES Monorail and Over-The-Wire PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: LIT Dated: June 25, 2008 Received: June 26, 2008
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 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.
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Page 2 -- Mr. Mark 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 complics 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.
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) | K080982 | |
| Device Name | Sterling™ ES Monorail™ and Over-the-Wire PTA BalloonDilatation Catheters | |
| Indications For Use | The Sterling ES MR and OTW PTA Balloon DilatationCatheters are indicated for Percutaneous TransluminalAngioplasty (PTA) in the peripheral vasculature, includingiliac, femoral, iliofemoral, popliteal, infrapopliteal and renalarteries, and for the treatment of obstructive lesions of nativeor synthetic arteriovenous dialysis fistulae.The 2.00 mm - 4.00 mm balloon devices are also indicatedfor post-dilatation of balloon expandable and self-expandingstents in the peripheral vasculature. | |
| Prescription Use: X(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) |
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(Division Sign-Off)
Division of Cardiovascular Devices
K080982 510(k) Number_
§ 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).