(142 days)
P860019/S208, P860019/S179, P860019/S162
Not Found
No
The device description and performance studies focus on the mechanical aspects of a balloon catheter and do not mention any AI/ML components or capabilities.
Yes
The device is used for "balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion," which is a therapeutic intervention.
No
The device is a treatment device (PTCA Dilatation Catheter) used for dilating stenotic coronary arteries or bypass grafts, not for diagnosing conditions.
No
The device description clearly describes a physical catheter with a balloon, shaft, and radiopaque markers, indicating it is a hardware medical device.
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 coronary arteries and bypass grafts using a balloon catheter. This is a direct intervention on the patient's body.
- Device Description: The device is a physical catheter with a balloon designed for inflation within a blood vessel.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for a therapeutic procedure.
N/A
Intended Use / Indications for Use
The Emerge™ PTCA Dilatation Catheter is intended for dilatation of stenosis in coronary arteries or bypass grafts and for the post-delivery expansion of bare metal and drug-eluting stents.
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 Dilatation Catheters are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).
Product codes (comma separated list FDA assigned to the subject device)
LOX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary arteries, 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™ 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, Shaft and Bond Burst Pressure, Radiopacity, Balloon Rated Burst Pressure, Coating Integrity, Balloon Fatigue (Repeat Inflations), Particulate Evaluation, Balloon Compliance, Balloon Rated Burst Pressure in Stent, Balloon Fatigue (Repeat Inflations) in Stent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
P860019/S208, P860019/S179, P860019/S162
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KI1322-0
1983
MAR 2 2 2012
510(k) Summary
per 21 CFR §807.92
| Submitter's
Name and
Address | Boston Scientific Corporation
Cardiovascular, Rhythm & Vascular Division
One Scimed Place
Maple Grove, MN 55311
Phone: 763-494-1700
Fax: 763-494-2222 | | |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|------------------|
| Contact Name
and
Information | Vicky L. Hagens
Principal Regulatory Affairs Specialist
Phone: 763-255-0303
Fax: 763-494-2222
e-mail: vicky.hagens@bsci.com | | |
| Date Prepared | 21 March 2012 | | |
| Proprietary
Name | Emerge™ Monorail (MR) and Over-The-Wire (OTW) 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 | Apex™ PTCA Dilatation Catheter | P860019
/S208 | 07 November 2008 |
| | Maverick2™ MR PTCA Dilatation
Catheter | P860019
/S179 | 20 November 2002 |
| | Maverick™ OTW MR PTCA
Dilatation Catheter | P860019
/S162 | 05 October 2000 |
| Device
Description | 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. | | |
| Intended Use
of Device | The Emerge™ PTCA Dilatation Catheter is intended for dilatation of
stenosis in coronary arteries or bypass grafts and for the post-delivery
expansion of bare metal and drug-eluting stents. | | |
1
| 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 Dilatation Catheters are also indicated for the post-
delivery expansion of balloon expandable stents (bare metal and drug-
eluting). |
|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of
Technological
Characteristics | The Emerge™ PTCA Dilatation Catheter 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, Apex™ PTCA Dilatation Catheter P860019/S208 (approved
November 7, 2008), Maverick²™ MR PTCA Dilatation Catheter
(P860019/S179, approved November 20, 2002), and Maverick™ OTW
PTCA Dilatation Catheter (P860019/S162, approved October 05, 2000). |
| 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) | |
2
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 in |
| Stent | |
| 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.
3
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
4
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
5
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
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