(260 days)
Symmetry™ and Symmetry Stiff Shaft Balloon Dilatation Catheters are indicated for Percutaneous Transluminal Angioplasty of narrowed or obstructed iliac, femoral, or renal vessels in the peripheral vasculature.
The proposed Symmetry Balloon Dilatation Catheter is substantially equivalent to the existing Symmetry Balloon Dilatation Catheter cleared by FDA under premarket notification K060959 (April 12, 2006). Symmetry has the same intended use, scientific technology, design, materials (with the exception of the Pebax resin used in the shaft), sterilization method, and packaging materials as the applicable predicate device.
The vendor is discontinuing the supply of the current Pebax resin, which is used in the shaft of the device; therefore a new resin is being supplied.
This document is a 510(k) summary for a medical device called the "Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheter" from Boston Scientific. It is a submission to the FDA seeking clearance to market this device as substantially equivalent to a predicate device.
The study presented here is focused on demonstrating the substantial equivalence of a modified version of an existing device to its predicate. The primary change is the material used for the shaft (a new Pebax resin). This is not an AI/algorithm-driven device, so many of the requested criteria related to AI studies (like sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable.
Here's an analysis based on the provided text, focusing on the device's technical performance and regulatory acceptance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit from Bench Testing) | Reported Device Performance |
|---|---|---|
| Material Equivalence | The new Pebax resin used in the shaft must perform equivalent to the previous resin. | The non-clinical tests ensure that the new resin does not introduce new safety or performance issues. (Specific metrics not detailed in this summary). |
| Biocompatibility | Device materials must be biocompatible. | Biocompatibility testing was performed, providing reasonable assurance of conformance. |
| Functional Performance | The device must meet the functional requirements for its intended use (Percutaneous Transluminal Angioplasty of narrowed or obstructed vessels). | Bench testing was performed to assure conformance to the requirements for its intended use. (Specific functional metrics like burst pressure, inflation/deflation times, guidewire compatibility are implied but not detailed in this summary). |
| Sterilization | Validated sterilization method. | Same sterilization method as the predicate device. |
| Packaging | Validated packaging materials and integrity. | Same packaging materials as the predicate device. |
| Overall Safety & Performance | No new safety or performance issues introduced by the change. | No new safety or performance issues were raised during the device testing. |
2. Sample Size Used for the Test Set and the Data Provenance
This document does not specify sample sizes for "test sets" in the context of image analysis or algorithm validation, as this is a physical medical device. The "testing" mentioned refers to bench testing and biocompatibility studies of the physical device. The provenance of this data is from internal testing conducted by Boston Scientific.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is not an AI/algorithm-driven device requiring expert ground truth for image analysis.
4. Adjudication Method for the Test Set
Not applicable. This is not an AI/algorithm-driven device requiring ground truth adjudication.
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. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-only device.
7. The Type of Ground Truth Used
Not applicable in the context of AI studies. For the physical device, the "ground truth" would be established through engineering specifications, validated test methods, and compliance with relevant industry standards for material properties, functional performance, and biocompatibility.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/algorithm-driven device with a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/algorithm-driven device with a training set.
Summary of the Study and Acceptance:
The study described here is purely focused on demonstrating substantial equivalence for a minor material change in the shaft of an existing balloon dilatation catheter.
- Acceptance Criteria for Substantial Equivalence: The primary acceptance criterion for this 510(k) submission is that the modified device (Symmetry™ and Symmetry Stiff Shaft Balloon Dilatation Catheters with the new Pebax resin) is as safe and effective as the predicate device (Symmetry Balloon Dilatation Catheter K060959 cleared April 12, 2006). This is demonstrated by showing that the indications for use, scientific technology, design, materials (except for the specified resin change), sterilization method, and packaging materials are essentially the same or that any differences do not raise new questions of safety or effectiveness.
- Study Proving Acceptance: Boston Scientific conducted bench testing and biocompatibility testing. The results of these tests indicated that the changes (specifically the new Pebax resin in the shaft) did not introduce any new safety or performance issues. The report explicitly states, "No new safety or performance issues were raised during the device testing." This positive outcome of the non-clinical tests allowed the FDA to determine that the device is substantially equivalent to the predicate. The FDA's letter states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices."
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24, 2015
Boston Scientific Ms. Anna Deraney Regulatory Affairs Specialist One Scimed Place Maple Grove, Minnesota 55311
Re: K143193
Trade/Device Name: Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: June 5, 2015 Received: June 8, 2015
Dear Ms. Deraney:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 801and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
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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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kenneth J. Cavanaugh -S
for
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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510k Summary
Per 21 CFR §807.92
| Common or UsualName | Balloon Dilatation Catheter | |
|---|---|---|
| Trade Name(s) | Boston Scientific Symmetry™ and Symmetry Stiff Shaft BalloonDilatation Catheter | |
| Product Code | LIT - Catheter, Angioplasty, Peripheral, Transluminal | |
| Classification ofDevice | Symmetry Balloon Dilatation catheters and accessories have beenclassified as Class II devices according to 21 CFR 870.1250 -Percutaneous Catheter. | |
| Submitter's Nameand Address | Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311-1566 | |
| Contact Name andInformation | Anna DeraneyRegulatory Affairs SpecialistPhone: 763-494-1683Fax: 763-494-2222Email: anna.deraney@bsci.com | |
| Section 514 of theAct PerformanceStandards | Currently no FDA mandated or voluntary performance standards existfor this device. | |
| EstablishmentRegistrationNumbers | Owner /Operator: | Boston Scientific Corporation300 Boston Scientific WayMarlborough, MA 01752 |
| ManufacturingFacility: | Boston Scientific Ireland Ltd. (BSIL) | |
| Ballybrit Business ParkGalway, Ireland | ||
| ERN: 9681260 | ||
| SterilizationFacilities: | Synergy Health Ireland LimitedIDA Business & Technology ParkTullamore, County Offaly, Ireland | |
| Predicate Devices | Symmetry Balloon Dilatation Catheter K060959 cleared April 12,2006. | |
| Intended Use/Indications for Use | Symmetry™ and Symmetry Stiff Shaft Balloon Dilatation Cathetersare indicated for Percutaneous Transluminal Angioplasty of narrowedor obstructed iliac, femoral, or renal vessels in the peripheralvasculature. | |
| Comparison ofRequiredTechnologicalCharacteristics | The proposed Symmetry Balloon Dilatation Catheter is substantiallyequivalent to the existing Symmetry Balloon Dilatation Cathetercleared by FDA under premarket notification K060959 (April 12,2006). Symmetry has the same intended use, scientific technology,design, materials (with the exception of the Pebax resin used in theshaft), sterilization method, and packaging materials as the applicablepredicate device.The vendor is discontinuing the supply of the current Pebax resin,which is used in the shaft of the device; therefore a new resin is beingsupplied. | |
| Summary of Non-Clinical TestSummary | Bench testing and biocompatibility testing were performed to support adetermination of substantial equivalence. The results of these testsprovide reasonable assurance that the proposed device has beendesigned and tested to assure conformance to the requirements for itsintended use. No new safety or performance issues were raisedduring the device testing. | |
| Conclusion | Based on the indications for use, technological characteristics, andsafety and performance testing, the proposed Symmetry BalloonDilatation Catheter has been shown to be appropriate for its intendeduse and is considered to be substantially equivalent to the SymmetryBalloon Dilatation Catheter (K060959). |
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§ 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).