(29 days)
The Peripheral Cutting Balloon catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.
The 2cm PCB is an Over-The-Wire (OTW) catheter packaged as sterile and intended for single use in a radiology suite/catheterization laboratory/operating room in conjunction with radiologic equipment for fluoroscopic imaging. The device consists of a double-lumen catheter with a non-compliant balloon attached at the distal tip. One of the lumens connects the Y-Adaptor to the proximal end of the outer shaft and the other connects the Y-Adaptor wire port extending from the wire lumen to the distal end of the balloon. The outer lumen is the balloon inflation lumen and is used to inflate and deflate the balloon during the procedure. The inner lumen is used to pass the catheter over a guidewire. The product is intended to pass a 0.018" (0.46 mm) guidewire. The catheter useable length (effective length) is measured from the distal end of the strain relief to the tip and is available in three sizes - 50 cm, 90 cm and 135 cm. Radiopaque markers are placed on the guidewire tubing at the ends of the atherotomes to provide visual reference points for balloon positioning within the vessel. The device is coated with MDX 4-4159 silicone coating.
The provided document is a 510(k) Summary for the 2cm Peripheral Cutting Balloon® Microsurgical Dilatation Catheter (K151253) by Boston Scientific Corporation. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a new clinical trial to establish new safety and effectiveness.
Therefore, the acceptance criteria and study information requested in the prompt (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are typically not found in a 510(k) summary for a medical device cleared based on substantial equivalence to existing predicate devices. Such details are usually associated with novel devices requiring clinical trials, de novo submissions, or Pre-Market Approval (PMA) applications, especially for AI/ML-driven devices.
This 510(k) submission primarily relies on bench testing and biocompatibility testing to demonstrate that the proposed device performs as intended and is as safe and effective as its predicate devices.
Here's a breakdown of the information that is available in the document related to performance and acceptance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in a quantitative format for each test with corresponding performance metrics like one might find in a clinical study report. Instead, it states that the tests provide "reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use" and that "No new safety or performance issues were raised during the testing." This indicates that the device met its internal design specifications and safety requirements, which effectively serve as the acceptance criteria for a 510(k) submission focusing on substantial equivalence.
| Test Type | Reported Device Performance/Conclusion |
|---|---|
| In-Vitro Performance Tests | All performed tests ensured conformance to requirements. (Specific quantitative results or pass/fail thresholds are not detailed in this summary, but the conclusion states "No new safety or performance issues were raised.") |
| Balloon Compliance | Met requirements |
| Balloon Rated Burst Pressure | Met requirements |
| Balloon Multiple Inflation | Met requirements |
| Balloon Deflation Time | Met requirements |
| Introducer Sheath Compatibility | Met requirements |
| Bond Strength | Met requirements |
| Crossing Profile | Met requirements |
| Freedom from Leakage | Met requirements |
| Blade Attach | Met requirements |
| Guide Catheter Compatibility | Met requirements |
| Particulate Release | Met requirements |
| Biocompatibility Tests | All performed tests demonstrated biocompatibility. (The conclusion implies these tests confirm the materials are safe for their intended use and are substantially equivalent to the predicate devices.) |
| In Vitro Cytotoxicity | Met requirements |
| Guinea Pig Maximization Sensitization | Met requirements |
| Intracutaneous Reactivity | Met requirements |
| Acute Systemic Injection | Met requirements |
| Materials Mediated Rabbit Pyrogen | Met requirements |
| Ames Mutagenicity | Met requirements |
| Mouse Lymphoma Assay | Met requirements |
| Direct Contact Hemolysis | Met requirements |
| Complement Activation C3a and SC5b-9 Assay | Met requirements |
| Indirect Extract Hemolysis | Met requirements |
| Partial Thromboplastin Time | Met requirements |
| In Vitro Hemocompatibility | Met requirements |
| USP Physicochemical | Met requirements |
| Natural Rubber Latex | Confirmed absence or acceptable levels for the device, given it's a critical material property for medical devices. (The summary doesn't state "absence" but lists it as a completed test for biocompatibility). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the 510(k) summary. For bench testing, sample sizes would typically be determined by engineering standards or internal quality procedures, but these specific numbers are not publicly disclosed in this type of document.
- Data Provenance: The tests are described as "Bench testing" and "biocompatibility tests," which are conducted in a laboratory setting. There is no mention of country of origin for data; it's assumed to be from Boston Scientific's internal testing facilities or contracted labs. The data is retrospective in the sense that it was generated prior to the submission, but it's not clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This device is a physical medical device (catheter) and its substantial equivalence is demonstrated through engineering and material performance tests, not through interpretation of medical images or other data requiring clinical expert consensus for "ground truth." Ground truth, in this context, would be the known physical properties and performance characteristics of the predicate device, against which the new device is compared via testing.
4. Adjudication Method for the Test Set:
- Not Applicable. As noted above, this involves engineering and biocompatibility tests, not subjective assessments requiring adjudication by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. MRMC studies are specific to diagnostic devices, particularly those involving human interpretation of outputs (e.g., radiologists reading images). This 510(k) is for a therapeutic catheter, not an AI/ML diagnostic aid.
6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not Applicable. This is a physical medical device, not a software algorithm or an AI/ML product.
7. The Type of Ground Truth Used:
- The "ground truth" for demonstrating substantial equivalence for this device would be:
- Predicate Device Performance: The established safety and performance characteristics of the legally marketed predicate devices (K041993 and K070951).
- Engineering Specifications/Standards: The device must meet predefined engineering specifications, design inputs, and relevant industry standards (e.g., ISO standards for medical devices, specific test methods for balloon catheters).
- Biocompatibility Standards: Compliance with established standards for biological evaluation of medical devices (e.g., ISO 10993 series).
8. The Sample Size for the Training Set:
- Not Applicable. There is no "training set" in the context of an AI/ML algorithm for this physical device.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As above, no training set for an AI/ML algorithm is involved.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 31, 2016
Boston Scientific Limited Ms. Lisa Mee Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311
Re: K151253
Trade/Device Name: 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: May 8, 2015 Received: May 12, 2015
Dear Ms. Mee,
This letter corrects our substantially equivalent letter of June 10, 2015.
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 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
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Page 2 - Ms. Lisa Mee
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 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 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" (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 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,
Misti L. Malone -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K151253
Device Name
2cm Peripheral Cutting Balloon® Microsurgical Dilatation Catheter
Indications for Use (Describe)
The Peripheral Cutting Balloon catheters are indicated for Perculaneous Transluminal Angioplasty (PTA) of obstructive lessions of synthetic or native arteriovenous dialysis fistulae.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
[] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510k Summary
Per 21 CFR §807.92
| Submitter'sName andAddress | Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311 |
|---|---|
| Contact Nameand Information | Lisa MeeSenior Specialist, Regulatory AffairsPhone: +353 91 406184Fax: 763-494-2222e-mail: Meel@bsci.comOrMelissa SommerfeldPrincipal Specialist, Regulatory AffairsPhone : 763-494-1219Fax: 763-494-2222e-mail: Melissa.Sommerfeld@bsci.com |
| Date Prepared | 8 May 2015 |
| ProprietaryName | 2cm Peripheral Cutting Balloon® Microsurgical Dilatation Catheter |
| Common Name | Percutaneous Transluminal Angioplasty Dilatation Catheter |
| Product Code | LIT - Catheter, Angioplasty, Peripheral, Transluminal |
| Classification | Class II, 21 CFR Part 870.1250 |
| PredicateDevice(s) | 2cm Peripheral Cutting Balloon® Microsurgical Dilatation Catheter K041993 Aug 16, 20042cm Peripheral Cutting Balloon® Microsurgical Dilatation Catheter K070951 June 04, 2007 |
| DeviceDescription | The 2cm PCB is an Over-The-Wire (OTW) catheter packaged as sterile andintended for single use in a radiology suite/catheterization laboratory/operatingroom in conjunction with radiologic equipment for fluoroscopic imaging.The device consists of a double-lumen catheter with a non-compliant balloonattached at the distal tip. One of the lumens connects the Y-Adaptor to theproximal end of the outer shaft and the other connects the Y-Adaptor wire portextending from the wire lumen to the distal end of the balloon. The outerlumen is the balloon inflation lumen and is used to inflate and deflate theballoon during the procedure. The inner lumen is used to pass the catheterover a guidewire. The product is intended to pass a 0.018" (0.46 mm)guidewire. The catheter useable length (effective length) is measured from thedistal end of the strain relief to the tip and is available in three sizes - 50 cm,90 cm and 135 cm. Radiopaque markers are placed on the guidewire tubingat the ends of the atherotomes to provide visual reference points for balloonpositioning within the vessel. The device is coated with MDX 4-4159 siliconecoating. |
| Intended Use ofDevice | The Peripheral Cutting Balloon catheters are indicated for PercutaneousTransluminal Angioplasty (PTA) of obstructive lesions of synthetic or nativearteriovenous dialysis fistulae. |
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| Indications for Use | The Peripheral Cutting Balloon catheters are indicated for PercutaneousTransluminal Angioplasty (PTA) of obstructive lesions of synthetic or nativearteriovenous dialysis fistulae | ||
|---|---|---|---|
| Comparison ofTechnologicalCharacteristics | The 2cm PCB incorporates substantially equivalent device materials, design,packaging, catheter configuration, fundamental technology, manufacturingprocesses, sterilization process, and intended use/indication for use as thosein the Boston Scientific predicate devices, K041993 and K070951. | ||
| PerformanceData | Bench testing was performed to support a determination of substantialequivalence. The results of these tests provide reasonable assurance that theproposed device has been designed and tested to assure conformance to therequirements for its intended use. No new safety or performance issues wereraised during the testing and therefore, these devices may be consideredsubstantially equivalent to the predicate devices. The following in-vitroperformance tests were completed: | ||
| Balloon Compliance | Freedom from Leakage | ||
| Balloon Rated Burst Pressure | Blade Attach | ||
| Balloon Multiple Inflation | Guide Catheter Compatibility | ||
| Balloon Deflation Time | Particulate Release | ||
| Introducer Sheath Compatibility | |||
| Bond Strength | |||
| Crossing Profile | |||
| The following biocompatibility tests were completed: | |||
| In Vitro Cytotoxicity | Direct Contact Hemolysis | ||
| Guinea Pig MaximizationSensitization | Complement Activation C3a andSC5b-9 Assay | ||
| Intracutaneous Reactivity | Indirect Extract Hemolysis | ||
| Acute Systemic Injection | Partial Thromboplastin Time | ||
| Materials Mediated Rabbit Pyrogen | In Vitro Hemocompatibility | ||
| Ames Mutagenicity | USP Physicochemical | ||
| Mouse Lymphoma Assay | Natural Rubber Latex | ||
| Conclusion | Based on the indications for use, technological characteristics, and safety andperformance testing, the proposed 2cm PCB Dilatation Catheter has beenshown to be appropriate for its intended use and is considered to besubstantially equivalent to the Boston Scientific predicate 2cm PCB DilatationCatheter. |
§ 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).