(142 days)
The Emerge™ Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. Emerge Over-The-Wire and Emerge Monorail PTCA Dilation Catheters are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).
The Boston Scientific Emerge™ PTCA Dilatation Catheter is a sterile, single-use, intravascular medical device. The catheter consists of a shaft with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The Emerge™ PTCA Dilatation Catheter is offered in both Monorail (MR) and Over-the-Wire (OTW) platforms. There are radiopaque marker bands located under the balloon to aid in positioning the system during the procedure. Coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance. The Emerge™ PTCA Dilatation Catheter will be available with balloon diameters 2.00 mm to 4.00 mm and balloon lengths 8 mm to 30 mm.
The provided document is a 510(k) summary for the Boston Scientific Emerge™ Monorail (MR) and Over-The-Wire (OTW) PTCA Dilatation Catheter. It outlines the device description, intended use, comparison to predicate devices, and performance data to demonstrate substantial equivalence.
This document does not contain information typically found in a study proving a device meets acceptance criteria related to AI/ML software performance. Instead, it focuses on the physical and biological performance of a medical device (a PTCA dilatation catheter), demonstrating its safety and effectiveness through bench testing and biocompatibility. Therefore, most of the questions you've asked, which are relevant to AI/ML software evaluation, cannot be answered from this document.
However, I can extract the information that is present and indicate where requested information is not applicable or not provided.
Device Acceptance Criteria and Performance (Physical Device)
The acceptance criteria for this medical device (a PTCA Dilatation Catheter) are derived from the "Guidance for Industry and FDA Staff - Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010." The reported device performance is based on successful completion of the listed tests, demonstrating conformance to these requirements.
| Acceptance Criteria (Implied by Test) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity | Completed successfully |
| Sensitization | Completed successfully |
| Intracutaneous Reactivity | Completed successfully |
| Acute Systemic Toxicity | Completed successfully |
| Materials Mediated Pyrogenicity | Completed successfully |
| USP Physicochemical | Completed successfully |
| Hemolysis (Direct Contact) | Completed successfully |
| Hemolysis (Extract Method) | Completed successfully |
| Complement Activation | Completed successfully |
| Coagulation | Completed successfully |
| In Vitro Hemocompatibility | Completed successfully |
| FTIR Analysis | Completed successfully |
| Residual NPGDA analysis | Completed successfully |
| In-vitro Performance: | |
| Effective Length | Completed successfully |
| Shaft Inner and Outer Diameter | Completed successfully |
| Balloon Crossing Profile | Completed successfully |
| Balloon Preparation, Deployment, and Retraction | Completed successfully |
| Withdrawal into a Guide Catheter | Completed successfully |
| Shaft and Bond Burst Pressure | Completed successfully |
| Balloon Rated Burst Pressure | Completed successfully |
| Balloon Fatigue (Repeat Inflations) | Completed successfully |
| Balloon Compliance | Completed successfully |
| Balloon Inflation/Deflation Time | Completed successfully |
| Catheter Bond Strength Tensile | Completed successfully |
| Tip Pull Test | Completed successfully |
| Flexibility and Kink | Completed successfully |
| Torque Strength | Completed successfully |
| Radiopacity | Completed successfully |
| Coating Integrity | Completed successfully |
| Particulate Evaluation | Completed successfully |
| Balloon Rated Burst Pressure in Stent | Completed successfully |
| Balloon Fatigue (Repeat Inflations) in Stent | Completed successfully |
The document states: "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 and, therefore, these devices may be considered substantially equivalent to the predicate devices."
Inapplicable/Not Provided Information for AI/ML Software Evaluation
Given that this is a submission for a physical medical device (a balloon catheter) and not an AI/ML software, the following requested information is not applicable or not provided in the document:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as testing was primarily bench testing and biocompatibility, not data-driven AI/ML performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device refers to its physical and biological properties.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 device does not involve human readers interpreting data enhanced by AI.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical device, "ground truth" would refer to the validated physical and chemical properties and biological responses, measured through standardized tests.
- The sample size for the training set: Not applicable. There is no training set for an AI/ML model for this device.
- How the ground truth for the training set was established: Not applicable.
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KI1322-0
1983
MAR 2 2 2012
510(k) Summary
per 21 CFR §807.92
| Submitter'sName andAddress | Boston Scientific CorporationCardiovascular, Rhythm & Vascular DivisionOne Scimed PlaceMaple Grove, MN 55311Phone: 763-494-1700Fax: 763-494-2222 | ||
|---|---|---|---|
| Contact NameandInformation | Vicky L. HagensPrincipal Regulatory Affairs SpecialistPhone: 763-255-0303Fax: 763-494-2222e-mail: vicky.hagens@bsci.com | ||
| Date Prepared | 21 March 2012 | ||
| ProprietaryName | Emerge™ Monorail (MR) and Over-The-Wire (OTW) PTCA DilatationCatheter | ||
| Common Name | Percutaneous Transluminal Coronary Angioplasty (PTCA) DilatationCatheter | ||
| Product Code | LOX | ||
| Classification | Class II, 21 CFR Part 870.5100 | ||
| PredicateDevices | Apex™ PTCA Dilatation Catheter | P860019/S208 | 07 November 2008 |
| Maverick2™ MR PTCA DilatationCatheter | P860019/S179 | 20 November 2002 | |
| Maverick™ OTW MR PTCADilatation Catheter | P860019/S162 | 05 October 2000 | |
| DeviceDescription | The Boston Scientific Emerge™ PTCA Dilatation Catheter is a sterile,single-use, intravascular medical device. The catheter consists of a shaftwith a balloon near the distal tip. The balloon is designed to provide aninflatable segment of known diameter and length at recommendedpressures. The Emerge™ PTCA Dilatation Catheter is offered in bothMonorail (MR) and Over-the-Wire (OTW) platforms. There areradiopaque marker bands located under the balloon to aid in positioningthe system during the procedure. Coatings are applied to the balloon andcatheter to enhance insertion and withdrawal performance.The Emerge™ PTCA Dilatation Catheter will be available with balloondiameters 2.00 mm to 4.00 mm and balloon lengths 8 mm to 30 mm. | ||
| Intended Useof Device | The Emerge™ PTCA Dilatation Catheter is intended for dilatation ofstenosis in coronary arteries or bypass grafts and for the post-deliveryexpansion of bare metal and drug-eluting stents. |
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| Indications forUse | The Emerge™ Over-The-Wire and Emerge Monorail PTCA DilatationCatheters are indicated for the balloon catheter dilatation of the stenoticportion of a coronary artery or bypass graft stenosis for the purpose ofimproving myocardial perfusion. Emerge Over-The-Wire and EmergeMonorail PTCA Dilatation Catheters are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting). |
|---|---|
| Comparison ofTechnologicalCharacteristics | The Emerge™ PTCA Dilatation Catheter incorporates substantiallyequivalent device materials and design, packaging materials and design,fundamental technology, manufacturing processes, sterilization processand intended use as those featured in the Boston Scientific predicatedevices, Apex™ PTCA Dilatation Catheter P860019/S208 (approvedNovember 7, 2008), Maverick²™ MR PTCA Dilatation Catheter(P860019/S179, approved November 20, 2002), and Maverick™ OTWPTCA Dilatation Catheter (P860019/S162, approved October 05, 2000). |
| PerformanceData | The Emerge™ PTCA Dilatation Catheter was subjected to testingaccording to the requirements of Guidance for Industry and FDA Staff -Class II Special Controls for Certain Percutaneous Transluminal CoronaryAngioplasty (PTCA) Catheters, September 8, 2010. Bench testing andbiocompatibility testing were performed to support a determination ofsubstantial equivalence. The results of these tests provide reasonableassurance that the proposed device has been designed and tested toassure conformance to the requirements for its intended use. No newsafety or performance issues were raised during the testing and,therefore, these devices may be considered substantially equivalent to thepredicate devices. |
| The following biocompatibility and chemical characterization tests werecompleted on the Emerge™ PTCA Dilatation Catheter: | |
| Cytotoxicity | Hemolysis (Direct Contact) |
| Sensitization | Hemolysis (Extract Method) |
| Intracutaneous Reactivity | Complement Activation |
| Acute Systemic Toxicity | Coagulation |
| Materials Mediated Pyrogenicity | In Vitro Hemocompatibility |
| USP Physicochemical | FTIR Analysis |
| (Additional Characterization Tests - residual NPGDA analysis) |
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The following in-vitro performance tests were completed on the Emerge™ PTCA Dilatation Catheter:
| Effective Length | Balloon Inflation/Deflation Time |
|---|---|
| Shaft Inner and Outer Diameter | Catheter Bond Strength Tensile |
| Balloon Crossing Profile | Tip Pull Test |
| Balloon Preparation, Deployment,and Retraction | Flexibility and Kink |
| Withdrawal into a Guide Catheter | Torque Strength |
| Shaft and Bond Burst Pressure | Radiopacity |
| Balloon Rated Burst Pressure | Coating Integrity |
| Balloon Fatigue (Repeat Inflations) | Particulate Evaluation |
| Balloon Compliance | Balloon Rated Burst Pressure inStent |
| Balloon Fatigue (Repeat Inflations)in Stent |
Conclusion
Based on the indications for use, technological characteristics, and safety and performance testing, the Emerge™ PTCA Dilatation Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Boston Scientific predicate devices, Apex™, Maverick2TM MR, and Maverick™ OTW PTCA Dilatation Catheters.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design, resembling a person with outstretched arms. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the design.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Boston Scientific Corporation c/o Ms. Vicky Hagens Principal Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311
Re: K113220
Trade Name: Emerge™ PTCA Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: PTCA Catheter Regulatory Class: Class II Product Code: LOX Dated: March 16, 2012 Received: March 19, 2012
Dear Ms. Hagens:
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 801); medical device reporting (reporting of medical
MAR 2 2 2012
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Page 2 - Ms. Vicky Hagens
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
M. A. Hillemann
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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Indications for Use
510(k) Number (if known):
Device Name: Emerge TM Monorail (MR) and Over-The-Wire (OTW) PTCA Dilatation Catheter
Indications for Use:
The Emerge™ Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. Emerge Over-The-Wire and Emerge Monorail PTCA Dilation Catheters are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.S. Alleben
(Division Sign-Off) Division of Cardiovascular Devices
KII 3220 510(k) Number
Page 1 of 1
§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.