K Number
K121196
Device Name
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
Date Cleared
2012-08-31

(134 days)

Product Code
Regulation Number
870.5100
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 (balloon models 2.00 - 4.00 mm) are also indicated for the postdelivery expansion of balloon expandable stents (bare metal and drug-eluting).
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 of 1.50 mm and balloon lengths 8 mm to 20 mm.
More Information

K113220, P860019 /S208

Not Found

No
The 510(k) summary describes a standard balloon catheter for angioplasty and stent expansion. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of these technologies. The performance studies described are standard bench and biocompatibility tests for this type of device.

Yes
The device is indicated for balloon catheter dilatation of stenotic portions of coronary arteries or bypass grafts to improve myocardial perfusion, directly addressing a health condition.

No
The device is a PTCA dilatation catheter, which is used for the mechanical dilatation of stenotic coronary arteries or bypass grafts. Its primary function is therapeutic (improving myocardial perfusion and expanding stents) rather than diagnostic (identifying or characterizing a disease).

No

The device description clearly outlines a physical medical device (catheter with a balloon) and its components, indicating it is not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes a device used in vivo (within the body) for a therapeutic procedure (dilatation of coronary arteries/bypass grafts and stent expansion). IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
  • Device Description: The description details a catheter with a balloon, designed for insertion into blood vessels. This is consistent with an in vivo medical device, not an in vitro diagnostic.
  • Anatomical Site: The anatomical site is the coronary artery or bypass graft, which is an internal part of the body.
  • Performance Studies: The performance studies mentioned are bench testing and biocompatibility testing, which are typical for in vivo medical devices. There is no mention of studies involving the analysis of biological specimens.

Therefore, the Emerge™ PTCA Dilatation Catheter is an in vivo therapeutic medical device, not an IVD.

N/A

Intended Use / Indications for Use

The Emerge™ PTCA Dilatation Catheter (1.50 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 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 (balloon models 2.00 - 4.00 mm) 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 of 1.50 mm and balloon lengths 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™ 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
Sensitization
Intracutaneous Reactivity
Acute Systemic Toxicity
Materials Mediated Pyrogenicity
USP Physicochemical
(Additional Characterization Tests - residual NPGDA analysis)
Hemolysis (Direct Contact)
Hemolysis (Extract Method)
Complement Activation
Coagulation
In Vitro Hemocompatibility
FTIR Analysis

The following in-vitro performance tests were completed on the Emerge™ PTCA Dilatation Catheter:
Effective Length
Shaft Inner and Outer Diameter
Balloon Crossing Profile
Balloon Preparation, Deployment, and Retraction
Withdrawal into a Guide Catheter
Shaft and Bond Burst Pressure
Balloon Rated Burst Pressure
Balloon Fatigue (Repeat Inflations)
Balloon Compliance
Balloon Inflation/Deflation Time
Catheter Bond Strength Tensile
Tip Pull Test
Flexibility and Kink
Torque Strength
Radiopacity
Coating Integrity
Particulate Evaluation

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.

K113220, P860019 /S208

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

K121196

. .

AUG 3 1 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 | 16 April 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 | Emerge™ PTCA Dilatation Catheter K113220 22 March 2012
Apex™ PTCA Dilatation Catheter P860019 /S208 07 November 2008 | |
| 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 of 1.50 mm and balloon lengths 8 mm to 20 mm. | |
| Intended Use of Device | The Emerge™ PTCA Dilatation Catheter (1.50 mm diameter) is intended for dilatation of stenosis in coronary arteries or bypass grafts. | |
| 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 (balloon models 2.00 - 4.00 mm) 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 (1.50 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 Apex™ PTCA Dilatation Catheter
P860019/S208 (approved November 7, 2008) | |
| 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 |
| | Shaft and Bond Burst Pressure | Radiopacity |
| | Balloon Rated Burst Pressure | Coating Integrity |
| | Balloon Fatigue (Repeat Inflations) | Particulate Evaluation |
| | Balloon Compliance | |
| 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. | |

:

1

:

. . .

Emerge™ and Apex™ PTCA Dilatation Catheters.

:

,

·

:

:

.

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG 3 1 2012

Boston Scientific Corporation c/o Ms. Vicky Hagens Principal Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311

Re: K121196

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: August 16, 2012 Received: August 17, 2012

Dear Ms. Hagens:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bocares in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) ve the enactment date of the Medical Device Amendments, or to conninered prior to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Act (110.) that do novice, subject to the general controls provisions of the Act. The r ou may, dierelors, manus are act include requirements for annual registration, listing of general controls provisions of the I 100 labeling, and prohibitions against misbranding and devices, good manimatianing praction in exaluate information related to contract liability adulteration. Tease note: CDICP does not evaluate 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 If your device is classified (500 acove). Existing major regulations affecting your device can be may be subject to additional combiness, 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 Please be advised hat I DA s issualted or a sualies with other requirements of the Act
that FDA has made a determination that your device complies with other must that I DA has made a decornmancir as administered by other Federal agencies. You must of any Federal statutes and regulations daminding, but not limited to: registration and listing (21
comply with all the Act's requirements, including, but not section (consec comply with an the Act 3 requirements, including in the reporting (reporting of medical

3

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/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,

Mig Heller

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

Indications for Use

510(k) Number (if known):

Device Name: Emerge ™ 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 Dilatation Catheters (balloon models 2.00 - 4.00 mm) are also indicated for the postdelivery 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)

Tm.g. Hillman

ision Sign-Off) Division of Cardiovascular Devices

510(k) Number