(145 days)
The Emerge™ PTCA Dilatation Catheter (1.20 mm diameter) is intended for dilatation of stenosis in coronary arteries or bypass grafts.
The Emerge™ Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (1.20 mm balloon models) are indicated as pre-dilatation catheters in the stenotic portion of a coronary artery or bypass graft stenosis (≥ 70% stenosis).
The Boston Scientific Emerge™ PTCA Dilatation Catheter (1.20 mm) 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 is a single radiopaque marker band 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 (1.20 mm diameter) will be available in balloon lengths from 8 mm to 20 mm.
The provided text describes the 510(k) summary for the Boston Scientific Emerge™ PTCA Dilatation Catheter (1.20 mm). This is a medical device, and the "acceptance criteria" and "study" refer to the performance goals and the clinical trial conducted to demonstrate the device's safety and effectiveness for its intended use. There is no mention of "AI" in this document.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Primary Endpoint) | Reported Device Performance (Emerge 1.20 mm PTCA Dilatation Catheter) |
|---|---|
| Device procedural success, defined as: - Successful delivery, inflation, deflation, and withdrawal of the study balloon. - No evidence of vessel perforation, flow limiting dissection (grade C or higher), or reduction in TIMI flow from baseline related to the study balloon. - Final TIMI flow grade of 3 at the conclusion of the PCI procedure. | Subjects: 98.3% (59/60) Lesions: 98.5% (66/67) Specifically: - Failure of delivery, inflation/deflation, and withdrawal: 1.7% (1/60 subjects, 1.5% (1/67) lesions) due to unsuccessful delivery (failure to cross a lesion). - Vessel perforation, flow limiting dissection, or reduction in TIMI flow: 0.0% (0/60 subjects, 0/67 lesions). - Failure of final TIMI flow: 0.0% (0/60 subjects, 0/67 lesions). |
| Secondary Clinical Endpoints (Safety Events): In-hospital MACE (cardiac and non-cardiac death, MI and TVR) In-hospital stent thrombosis within the target vessel Clinically significant arrhythmias requiring intervention | In-hospital MACE: 5.0% (3/60 subjects) - All Death or MI: 5.0% (3/60) - All Death: 0.0% (0/60) - MI: 5.0% (3/60) - Q-Wave MI: 0.0% (0/60) - Non-Q-Wave MI: 5.0% (3/60) - TVR, Overall: 0.0% (0/60) - In-hospital ARC Stent Thrombosis: 0.0% (0/60) - In-hospital Clinical Significant Arrhythmias: 0.0% (0/60) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Study) Sample Size: 60 subjects with 67 target lesions.
- Data Provenance: Prospective, open-label, multi-center, single-arm, observational study (called "EMERGE") conducted at 3 US sites.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not explicitly state the "number of experts" or their "qualifications" involved in establishing ground truth in the way one might for an AI model's test set. However, in a clinical trial setting for a medical device:
- The "ground truth" for success/failure, complications, and patient outcomes are typically determined by the treating physicians at the clinical sites based on their observations during the procedure and post-procedure follow-up.
- Adjudication committees (often composed of independent expert clinicians) are commonly used in clinical trials to ensure consistency and impartiality in evaluating clinical endpoints, especially adverse events. The "Secondary Endpoint Outcomes" table indicates "CEC adjudicated data" (Clinical Events Committee), suggesting that expert clinicians were involved in reviewing and determining the final classification of these events. The specific number and qualifications of these CEC members are not provided in this summary.
4. Adjudication Method for the Test Set
- The document states that "Secondary Endpoint Outcomes" are based on "site reported and CEC adjudicated data," indicating that a Clinical Events Committee (CEC) was involved in adjudicating safety endpoints. The specific method (e.g., 2+1, 3+1) is not detailed, but the use of a CEC implies a formal, expert-driven review process for critical events.
- For the primary endpoint, the data appears to be based on site-reported observations of procedural success, with definitions provided in the protocol.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This was a single-arm observational study evaluating the performance of the Emerge 1.20 mm PTCA Dilatation Catheter alone. It did not involve comparing human readers (clinicians) with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This document is about a physical medical device (a catheter), not an algorithm or AI.
7. The Type of Ground Truth Used
- The ground truth for the clinical study was based on clinical observations, procedural outcomes, and patient follow-up data collected during hospitalization.
- This includes direct measurements and assessments made by interventional cardiologists (e.g., TIMI flow grade, presence of dissection/perforation), as well as clinical event reporting and subsequent adjudication by a Clinical Events Committee (CEC) for safety endpoints (e.g., MI, death, stent thrombosis).
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI/machine learning model, so there is no concept of a "training set" in this context. The device was evaluated in a clinical study to assess its performance in real-world use.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See #8)
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510(k) Summary per 21 CFR §807.92
JUL 1 0 2013
| Submitter'sName andAddress | Boston Scientific CorporationCardiovascular, Rhythm & Vascular DivisionOne Scimed PlaceMaple Grove, MN 55311Phone: 763-494-1700763-494-2222Fax: | ||
|---|---|---|---|
| Contact NameandInformation | Vicky L. HagensPrincipal Regulatory Affairs SpecialistPhone: 763-255-0303763-494-2222Fax:e-mail: vicky.hagens@bsci.com | ||
| Date Prepared | February 12, 2013 | ||
| ProprietaryName(s) | Emerge™ Monorail PTCA Dilatation CatheterEmerge™ Push Monorail PTCA Dilatation CatheterEmerge™ Over-The-Wire PTCA Dilatation CatheterEmerge™ Push Over-The-Wire PTCA Dilatation Catheter | ||
| Common Name | Percutaneous Transluminal Coronary Angioplasty (PTCA) DilatationCatheter | ||
| Product Code | LOX | ||
| Classification | Class II, 21 CFR Part 870.5100 | ||
| PredicateDevices | Emerge™ PTCA DilatationMarch 22, 2012K113220Catheter (2.00 - 4.00 mm diameterballoon models) | ||
| Emerge™ PTCA DilatationK121196August 31, 2012Catheter (1.50 mm diameterballoon models) | |||
| DeviceDescription | The Boston Scientific Emerge™ PTCA Dilatation Catheter (1.20 mm) is asterile, single-use, intravascular medical device. The catheter consists ofa shaft with a balloon near the distal tip. The balloon is designed toprovide an inflatable segment of known diameter and length atrecommended pressures. The Emerge™ PTCA Dilatation Catheter isoffered in both Monorail (MR) and Over-The-Wire (OTW) platforms.There is a single radiopaque marker band located under the balloon to aidin positioning the system during the procedure. Coatings are applied tothe balloon and catheter to enhance insertion and withdrawalperformance. | ||
| The Emerge™ PTCA Dilatation Catheter (1.20 mm diameter) will beavailable in balloon lengths from 8 mm to 20 mm. | |||
| Intended Useof Device | The Emerge™ PTCA Dilatation Catheter (1.20 mm diameter) is intendedfor dilatation of stenosis in coronary arteries or bypass grafts. |
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| Indications forUse | The Emerge™ Over-The-Wire and Emerge Monorail PTCA DilatationCatheters (1.20 mm balloon models) are indicated as pre-dilatationcatheters in the stenotic portion of a coronary artery or bypass graftstenosis (≥ 70% stenosis). | ||||
|---|---|---|---|---|---|
| Comparison ofTechnologicalCharacteristics | The Emerge™ PTCA Dilatation Catheter (1.20 mm diameter) incorporatessubstantially equivalent device materials and design, packaging materialsand design, fundamental technology, manufacturing processes,sterilization process and intended use as those featured in the BostonScientific predicate devices, Emerge™ PTCA Dilatation CatheterK113220 (cleared March 22, 2012) and Emerge™ PTCA DilatationCatheter K121196 (cleared August 31, 2012). | ||||
| 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) | |||||
| 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 | ||||
| Balloon Rated Burst Pressure | Radiopacity | ||||
| Balloon Fatigue (Repeat Inflations) | Coating Integrity | ||||
| Balloon Compliance | Particulate Evaluation | ||||
| PerformanceData - Clinical | A clinical investigation was conducted for the Emerge PTCA DilatationCatheter (1.20 mm diameter), called "EMERGE: Evaluation of CoronaryLuminal Diameter Enlargement with Emerge™ 1.20 mm PTCA DilatationCatheter." |
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| Clinical StudyPurpose | The objective of the EMERGE study was to evaluate the acute safety anddevice procedural success of the Emerge 1.20 mm PTCA DilatationCatheter when used to initially treat the stenotic portion of coronaryarteries or bypass grafts. |
|---|---|
| Clinical StudyDesign | The EMERGE study was a prospective, open label, multi-center, singlearm, observational study designed to evaluate the acute safety and deviceprocedural success of the Emerge 1.20 mm PTCA Dilatation Catheter insubjects with stenotic coronary arteries or bypass grafts duringpercutaneous coronary intervention (PCI). |
| Sixty (60) subjects were treated at 3 US sites with the Emerge 1.20 mmPTCA Dilatation Catheter to pre-dilate coronary arteries or bypass graftsduring their index procedure. All subjects were to be screened accordingto the protocol inclusion and exclusion criteria and were followed throughhospital discharge. | |
| The primary endpoint was device procedural success consisting ofsuccessful delivery, inflation, deflation and withdrawal of the studyballoon; no evidence of vessel perforation, flow limiting dissection (gradeC or higher) or reduction in TIMI flow from baseline related to the studyballoon; final TIMI flow grade of 3 at the conclusion of the PCI procedure. | |
| The secondary clinical endpoints measured through hospital dischargeincluded in-hospital MACE (cardiac and non-cardiac death, MI and TVR);in-hospital stent thrombosis within the target vessel; clinically significantarrhythmias requiring intervention. | |
| Subjects were followed through hospital discharge. | |
| Demographicsand BaselineLesionCharacteristics | Demographics: A total of 60 subjects with 67 target lesions wereenrolled in the study at 3 US sites. The subject population waspredominantly male (71.7%) and Caucasian (95.0%) with an average ageof 61 years. Most subjects had a history of medically treatedhyperlipidemia (85.0%) and hypertension (93.3%) with a history of PCI(61.7%); myocardial infarction (23.3%), and coronary bypass surgery(18.3%). Medically-treated diabetic subjects accounted for 35% of thesubject population, of which 16.7% were insulin-requiring. |
| Baseline Lesion Characteristics: The average reference vesseldiameter was $2.6 \pm 0.5$ mm, average minimum lumen diameter was $0.7 \pm$0.4 mm, average diameter stenosis was $73.0% \pm 12.6%$ , and averagelesion length was $15.5 \pm 14.7$ mm. Total occlusion was observed in10.4% (7/67) of target lesions. | |
| Clinical StudyResults | Primary Endpoint (Device Procedural Success): As illustrated inTable 1, 98.3% (59/60) of subjects and 98.5% (66/67) of lesions achieveddevice procedural success including successful delivery, inflation,deflation, and withdrawal of the Emerge 1.20 mm PTCA DilatationCatheter. Device procedural failure was observed in 1.7% (1/60) ofsubjects and 1.5% (1/67) of lesions and was related to unsuccessfuldelivery (i.e., failure to cross a lesion) of the study device. No proceduralcomplications were observed in the intent-to-treat subject population.This included no vessel perforation, no flow-limiting dissection, and noreduction in TIMI flow from baseline. Furthermore, 100% (60/60) ofsubjects and 100% (67/67) of lesions had a final TIMI flow grade of 3 atthe conclusion of the PCI procedure. |
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Table 1: Primary Endpoint Outcomes
| EMERGESubjects(N=60) | EMERGELesions(N=67) | |
|---|---|---|
| Device Procedural Success | 98.3% (59/60) | 98.5% (66/67) |
| Device Procedural Failure | 1.7% (1/60) | 1.5% (1/67) |
| Failure of delivery, inflation/deflationand withdrawal | 1.7% (1/60) | 1.5% (1/67) |
| Vessel perforation, flow limitingdisection or reduction in TIMI flow | 0.0% (0/60) | 0.0% (0/67) |
| Failure of final TIMI flow | 0.0% (0/60) | 0.0% (0/67) |
Numbers are % (Count/Sample Size), and based on number of subjects and lesions with site reported data.
Secondary Clinical Endpoint (Safety Events): As illustrated in Table 2, the in-hospital major adverse cardiac events were observed in 5.0% (3/60) of the subjects. The non-Q-wave MI rate was 5.0% (3/60), characterized by elevation of post-procedure creatine kinase-myoglobin band (CK-MB) levels to > 3.0 times upper limit of normal (ULN). The Qwave MI rate was 0% (0/60). The all-cause death and TVR rates were 0% (0/60). The in-hospital stent thrombosis rate, per Academic Research Consortium (ARC), was 0% (0/60). No clinically significant arrhythmias requiring intervention were observed in this study.
Table 2: Secondary Endpoint Outcomes
| EMERGE Subjects | |
|---|---|
| (N=60) | |
| In-hospital MACE | 5.0% (3/60) |
| All Death or MI | 5.0% (3/60) |
| All Death | 0.0% (0/60) |
| MI | 5.0% (3/60) |
| Q-Wave MI | 0.0% (0/60) |
| Non-Q-Wave MI | 5.0% (3/60) |
| TVR, Overall | 0.0% (0/60) |
| TVR, PCI | 0.0% (0/60) |
| TVR, CABG | 0.0% (0/60) |
| TLR, Overall | 0.0% (0/60) |
| TLR, PCI | 0.0% (0/60) |
| TLR, CABG | 0.0% (0/60) |
| TVR Remote, Overall | 0.0% (0/60) |
| TVR Remote, PCI | 0.0% (0/60) |
| TVR Remote, CABG | 0.0% (0/60) |
| In-hospital ARC Stent Thrombosis | 0.0% (0/60) |
| In-hospital Clinical Significant Arrhythmias | 0.0% (0/60) |
| Numbers are % (Count/Sample Size) and based on number of subjects with site |
reported and CEC adjudicated data.
Clinical Study Conclusion
The results of the EMERGE study support the acute safety and device procedural success of the Emerge 1.20 mm PTCA Dilatation Catheter and its intended use as a pre-dilatation catheter in the stenotic portion of a coronary artery or bypass graft stenosis (≥ 70% stenosis).
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Conclusion
Based on the indications for use, technological characteristics, and safety and performance testing, the Emerge™ PTCA Dilatation Catheter (1.20 mm diameter) has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Boston Scientific predicate devices, Emerge™ PTCA Dilatation Catheters (1.50 mm and 2.00 – 4.00 mm diameter).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 10, 2013
Boston Scientific Corporation c/o Ms. Vicky Hagens Principal Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311
Re: K130391
Trade Name: Emerge™ PTCA Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Standard PTCA Catheter Regulatory Class: Class II Product Code: LOX Dated: June 7, 2013 Received: June 10, 2013
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 device-related adverse events} (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Vicky Hagens
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/ReportalProblem/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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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
51D(k) Number (if known): K130391
Device Name: Emerge™ Monorail PTCA Dilatation Catheter Emerge™ Push Monorail PTCA Dilatation Catheter Emerge™ Over-The-Wire PTCA Dilatation Catheter Emerge™ Push Over-The-Wire PTCA Dilatation Catheter
Indications for Use:
The Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (1.20 mm balloon models) are indicated as pre-dilatation catheters in the stenotic portion of a coronary artery or bypass graft stenosis (≥ 70% stenosis).
Prescription Use X (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.A. Hillemann
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.