(145 days)
Not Found.
No
The device description and performance summary focus on the mechanical aspects and clinical outcomes of a balloon catheter, with no mention of AI or ML capabilities.
Yes
The device is intended for the dilatation of stenosis in coronary arteries or bypass grafts, addressing a medical condition and providing a therapeutic effect.
No
The device is a dilatation catheter used for treatment (dilatation of stenosis), not for diagnosing conditions.
No
The device description clearly outlines a physical medical device consisting of a catheter with a balloon, shaft, and radiopaque marker band. It is a hardware device used for mechanical dilatation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the mechanical dilatation of stenosis in coronary arteries or bypass grafts. This is a direct intervention on the patient's anatomy.
- Device Description: The device is a catheter with a balloon designed for inflation within a blood vessel. This is a physical medical device used for treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. This device is used inside the body for a therapeutic procedure.
N/A
Intended Use / Indications for Use
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).
Product codes
LOX
Device Description
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.
Mentions image processing
Not Found.
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Not Found.
Anatomical Site
coronary arteries or bypass grafts
Indicated Patient Age Range
Not Found.
Intended User / Care Setting
Not Found.
Description of the training set, sample size, data source, and annotation protocol
Not Found.
Description of the test set, sample size, data source, and annotation protocol
Not Found.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The EMERGE study was a prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device procedural success of the Emerge 1.20 mm PTCA Dilatation Catheter in subjects with stenotic coronary arteries or bypass grafts during percutaneous coronary intervention (PCI).
Sample Size: Sixty (60) subjects were treated at 3 US sites with the Emerge 1.20 mm PTCA Dilatation Catheter to pre-dilate coronary arteries or bypass grafts during their index procedure. A total of 60 subjects with 67 target lesions were enrolled in the study at 3 US sites.
Key Results:
Primary Endpoint (Device Procedural Success): 98.3% (59/60) of subjects and 98.5% (66/67) of lesions achieved device procedural success including successful delivery, inflation, deflation, and withdrawal of the Emerge 1.20 mm PTCA Dilatation Catheter. Device procedural failure was observed in 1.7% (1/60) of subjects and 1.5% (1/67) of lesions and was related to unsuccessful delivery (i.e., failure to cross a lesion) of the study device. No procedural complications were observed in the intent-to-treat subject population. This included no vessel perforation, no flow-limiting dissection, and no reduction in TIMI flow from baseline. Furthermore, 100% (60/60) of subjects and 100% (67/67) of lesions had a final TIMI flow grade of 3 at the conclusion of the PCI procedure.
Secondary Clinical Endpoint (Safety Events): 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). 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found.
Predicate Device(s)
Reference Device(s)
Not Found.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found.
§ 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.
0
。
510(k) Summary per 21 CFR §807.92
JUL 1 0 2013
| Submitter's
Name and
Address | Boston Scientific Corporation
Cardiovascular, Rhythm & Vascular Division
One Scimed Place
Maple Grove, MN 55311
Phone: 763-494-1700
763-494-2222
Fax: | | |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Name
and
Information | Vicky L. Hagens
Principal Regulatory Affairs Specialist
Phone: 763-255-0303
763-494-2222
Fax:
e-mail: vicky.hagens@bsci.com | | |
| Date Prepared | February 12, 2013 | | |
| Proprietary
Name(s) | 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 | | |
| Common Name | Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation
Catheter | | |
| Product Code | LOX | | |
| Classification | Class II, 21 CFR Part 870.5100 | | |
| Predicate
Devices | Emerge™ PTCA Dilatation
March 22, 2012
K113220
Catheter (2.00 - 4.00 mm diameter
balloon models) | | |
| | Emerge™ PTCA Dilatation
K121196
August 31, 2012
Catheter (1.50 mm diameter
balloon models) | | |
| Device
Description | 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. | | |
| Intended Use
of Device | The Emerge™ PTCA Dilatation Catheter (1.20 mm diameter) is intended
for dilatation of stenosis in coronary arteries or bypass grafts. | | |
1
| 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). | | | | |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|--|--|--|
| Comparison of
Technological
Characteristics | The Emerge™ PTCA Dilatation Catheter (1.20 mm diameter) incorporates
substantially equivalent device materials and design, packaging materials
and design, fundamental technology, manufacturing processes,
sterilization process and intended use as those featured in the Boston
Scientific predicate devices, Emerge™ PTCA Dilatation Catheter
K113220 (cleared March 22, 2012) and Emerge™ PTCA Dilatation
Catheter K121196 (cleared August 31, 2012). | | | | |
| Performance
Data | The Emerge™ PTCA Dilatation Catheter was subjected to testing
according to the requirements of Guidance for Industry and FDA Staff -
Class II Special Controls for Certain Percutaneous Transluminal Coronary
Angioplasty (PTCA) Catheters, September 8, 2010. Bench testing and
biocompatibility testing were performed to support a determination of
substantial equivalence. 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. | | | | |
| | The following biocompatibility and chemical characterization tests were
completed 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 | | | |
| Performance
Data - Clinical | A clinical investigation was conducted for the Emerge PTCA Dilatation
Catheter (1.20 mm diameter), called "EMERGE: Evaluation of Coronary
Luminal Diameter Enlargement with Emerge™ 1.20 mm PTCA Dilatation
Catheter." | | | | |
. ´
2
| Clinical Study
Purpose | The objective of the EMERGE study was to evaluate the acute safety and
device procedural success of the Emerge 1.20 mm PTCA Dilatation
Catheter when used to initially treat the stenotic portion of coronary
arteries or bypass grafts. |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Study
Design | The EMERGE study was a prospective, open label, multi-center, single
arm, observational study designed to evaluate the acute safety and device
procedural success of the Emerge 1.20 mm PTCA Dilatation Catheter in
subjects with stenotic coronary arteries or bypass grafts during
percutaneous coronary intervention (PCI). |
| | Sixty (60) subjects were treated at 3 US sites with the Emerge 1.20 mm
PTCA Dilatation Catheter to pre-dilate coronary arteries or bypass grafts
during their index procedure. All subjects were to be screened according
to the protocol inclusion and exclusion criteria and were followed through
hospital discharge. |
| | The primary endpoint was device procedural success consisting of
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. |
| | The secondary clinical endpoints measured through hospital discharge
included in-hospital MACE (cardiac and non-cardiac death, MI and TVR);
in-hospital stent thrombosis within the target vessel; clinically significant
arrhythmias requiring intervention. |
| | Subjects were followed through hospital discharge. |
| Demographics
and Baseline
Lesion
Characteristics | Demographics: A total of 60 subjects with 67 target lesions were
enrolled in the study at 3 US sites. The subject population was
predominantly male (71.7%) and Caucasian (95.0%) with an average age
of 61 years. Most subjects had a history of medically treated
hyperlipidemia (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 the
subject population, of which 16.7% were insulin-requiring. |
| | Baseline Lesion Characteristics: The average reference vessel
diameter 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 average
lesion length was $15.5 \pm 14.7$ mm. Total occlusion was observed in
10.4% (7/67) of target lesions. |
| Clinical Study
Results | Primary Endpoint (Device Procedural Success): As illustrated in
Table 1, 98.3% (59/60) of subjects and 98.5% (66/67) of lesions achieved
device procedural success including successful delivery, inflation,
deflation, and withdrawal of the Emerge 1.20 mm PTCA Dilatation
Catheter. Device procedural failure was observed in 1.7% (1/60) of
subjects and 1.5% (1/67) of lesions and was related to unsuccessful
delivery (i.e., failure to cross a lesion) of the study device. No procedural
complications were observed in the intent-to-treat subject population.
This included no vessel perforation, no flow-limiting dissection, and no
reduction in TIMI flow from baseline. Furthermore, 100% (60/60) of
subjects and 100% (67/67) of lesions had a final TIMI flow grade of 3 at
the conclusion of the PCI procedure. |
.
.
.
.
3
Table 1: Primary Endpoint Outcomes
| | EMERGE
Subjects
(N=60) | EMERGE
Lesions
(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/deflation
and withdrawal | 1.7% (1/60) | 1.5% (1/67) |
| Vessel perforation, flow limiting
disection 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).
4
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).
5
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
6
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
7
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
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