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.

AI/ML Overview

The provided 510(k) summary for the Emerge™ Monorail (MR) and Over-The-Wire (OTW) PTCA Dilatation Catheter (K121196) describes the device, its intended use, and a comparison to predicate devices, along with performance data. However, it does not explicitly define specific acceptance criteria with numerical targets for each test, nor does it present the device's reported performance in a quantitative table against such criteria.

Instead, the document states: "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."

This indicates that the acceptance criteria are implicitly defined by the relevant FDA guidance document and the performance of the predicate devices. The "reported device performance" is summarized as having met these requirements without raising new safety or performance issues.

Given the information provided, it's not possible to create a table with quantitative acceptance criteria and reported device performance because these specific details are not outlined in the 510(k) summary. The summary refers to the types of tests performed and the overall conclusion that the device performed acceptably, rather than specifying numerical thresholds and results.

Below is an attempted reconstruction based on the available information, highlighting what is implicitly assumed from the text versus what is explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative acceptance criteria and reported device performance values are not provided in the 510(k) summary, the table below reflects what is implied by the document's general statements regarding testing and substantial equivalence. The acceptance criteria are implicitly those established by the FDA Guidance Document and the performance of predicate devices. The reported performance is a qualitative statement of compliance.

Acceptance Criterion (Implicit)	Reported Device Performance (Qualitative)
Biocompatibility Testing:	All tests passed:
Cytotoxicity	Demonstrated satisfactory results, confirming biocompatibility.
Sensitization	Demonstrated satisfactory results, indicating no sensitization risk.
Intracutaneous Reactivity	Demonstrated satisfactory results, indicating no intracutaneous reactivity.
Acute Systemic Toxicity	Demonstrated satisfactory results, confirming no acute systemic toxicity.
Materials Mediated Pyrogenicity	Demonstrated satisfactory results, confirming non-pyrogenic nature.
USP Physicochemical	Demonstrated satisfactory results.
Hemolysis (Direct Contact)	Demonstrated satisfactory results, confirming non-hemolytic properties.
Hemolysis (Extract Method)	Demonstrated satisfactory results, confirming non-hemolytic properties.
Complement Activation	Demonstrated satisfactory results.
Coagulation	Demonstrated satisfactory results.
In Vitro Hemocompatibility	Demonstrated satisfactory results.
FTIR Analysis	Demonstrated satisfactory results, confirming material composition.
Residual NPGDA Analysis	Demonstrated satisfactory results.
In-Vitro Performance Testing (Bench Testing):	All tests passed:
Effective Length (Conform to specifications)	Conforms to specified effective length.
Shaft Inner and Outer Diameter (Conform to specifications)	Conforms to specified shaft dimensions.
Balloon Crossing Profile (Equivalent to predicate)	Demonstrated an acceptable crossing profile, considered substantially equivalent to predicate.
Balloon Preparation, Deployment, and Retraction (Successful operation)	Successfully prepared, deployed, and retracted, meeting functional requirements.
Withdrawal into a Guide Catheter (Successful operation)	Successfully withdrawn into a guide catheter.
Shaft and Bond Burst Pressure (Meet safety specifications)	Met or exceeded required burst pressure specifications for shaft and bonds.
Balloon Rated Burst Pressure (Meet safety specifications)	Met or exceeded the rated burst pressure specifications for the balloon.
Balloon Fatigue (Repeat Inflations) (Withstand specified cycles)	Withstood the specified number of inflation cycles without failure.
Balloon Compliance (Within specified range)	Demonstrated compliance within the specified range.
Balloon Inflation/Deflation Time (Within specified limits)	Achieved inflation and deflation within specified time limits.
Catheter Bond Strength Tensile (Meet safety specifications)	Met tensile strength requirements for catheter bonds.
Tip Pull Test (Meet safety specifications)	Passed tip pull test, indicating adequate tip integrity.
Flexibility and Kink (Meet functional requirements)	Demonstrated acceptable flexibility and resistance to kinking, meeting functional requirements for navigation.
Torque Strength (Meet functional requirements)	Exhibited sufficient torque strength for intended use.
Radiopacity (Adequate visibility)	Exhibited adequate radiopacity to aid in positioning.
Coating Integrity (Maintain over use)	Maintained coating integrity throughout testing.
Particulate Evaluation (Below specified limits)	Evaluated for particulates, found to be within specified limits.
Overall Conclusion: Safe and effective, substantially equivalent to predicate devices, with no new safety or performance issues raised.	Overall Performance: 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.

Detailed Study Information:

The 510(k) summary provides limited details regarding the specifics of each test (e.g., sample sizes for individual tests, specific numerical thresholds, raw data). The description focuses on the types of tests performed and the overarching conclusion of substantial equivalence.

2. Sample Size for the Test Set and Data Provenance:

The document mentions "Bench testing and biocompatibility testing were performed." However, it does not specify the sample sizes (n) used for each of the listed performance and biocompatibility tests.

Sample Size: Not specified for individual bench or biocompatibility tests.
Data Provenance: Implied to be laboratory bench testing and in vitro biocompatibility testing, likely conducted by the manufacturer (Boston Scientific Corporation) or its contracted labs. The country of origin for the data is not specified but is typically within the country of manufacture or a region with certified testing facilities for medical devices. Given Boston Scientific's location in Minnesota, USA, the testing was likely performed in the USA or by labs adhering to US standards. The studies were likely prospective in the sense that they were designed and executed specifically to evaluate the new device for this premarket notification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This device is a physical medical device (catheter) and the testing described is primarily mechanical/functional bench testing and laboratory-based biocompatibility testing. These types of studies do not typically involve "experts" establishing a clinical ground truth in the way image analysis or diagnostic AI algorithms do.

Number of Experts: Not applicable in the context of clinical ground truth establishment. The "ground truth" for these tests relates to engineering specifications, material properties, and biological safety standards.
Qualifications of Experts: The "experts" would be the engineers, scientists, and technicians who designed the tests, conducted the experiments, and analyzed the results according to recognized standards (e.g., ISO, ASTM, FDA guidance). Their qualifications would include relevant scientific and engineering degrees and experience in medical device testing.

4. Adjudication Method for the Test Set:

Not applicable. The tests performed are objective measurements (e.g., burst pressure, dimensions, chemical analysis, cell viability) against pre-defined engineering and safety specifications, not subjective assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This is a physical medical device, not a diagnostic imaging or AI-driven system that would involve human readers interpreting cases with and without AI assistance. Therefore, an MRMC comparative effectiveness study is not relevant to this device.

6. Standalone (Algorithm only without human-in-the-loop performance) Study:

Not applicable. This device is a physical product, not a software algorithm. The "standalone performance" refers to the device's functionality as tested on the bench and in biocompatibility labs, without a human user directly influencing the measurement of that performance during the specified tests. The tests themselves inherently assess the device's intrinsic mechanical and material properties.

7. Type of Ground Truth Used:

The "ground truth" for this medical device's evaluation is based on a combination of:

Engineering Specifications: Defined by the manufacturer and aligned with industry standards (e.g., for dimensions, pressures, fatigue).
Regulatory Standards/Guidance: Adherence to FDA's "Guidance for Industry and FDA Staff - Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010" and relevant ISO/ASTM standards for medical device materials and performance.
Predicate Device Performance: The performance of the predicate devices (Emerge™ PTCA Dilatation Catheter K113220 and Apex™ PTCA Dilatation Catheter P860019/S208) serves as the benchmark for substantial equivalence.
Biocompatibility Standards: Established limits for various biological responses (e.g., cytotoxicity, hemolysis) as defined by ISO 10993 series and other relevant standards.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no "training set" for a physical medical device.

Summary

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K121196

. .

AUG 3 1 2012

510(k) Summary

per 21 CFR §807.92

Submitter's Name and Address	Boston Scientific CorporationCardiovascular, Rhythm & Vascular DivisionOne Scimed PlaceMaple Grove, MN 55311Phone: 763-494-1700Fax: 763-494-2222
Contact Name and Information	Vicky L. HagensPrincipal Regulatory Affairs SpecialistPhone: 763-255-0303Fax: 763-494-2222e-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 2012Apex™ 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 ofTechnologicalCharacteristics	The Emerge™ PTCA Dilatation Catheter (1.50 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 Apex™ PTCA Dilatation CatheterP860019/S208 (approved November 7, 2008)
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
	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 safetyand performance testing, the Emerge™ PTCA Dilatation Catheter hasbeen shown to be appropriate for its intended use and is considered to besubstantially equivalent to the Boston Scientific predicate devices.

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. . .

Emerge™ and Apex™ PTCA Dilatation Catheters.

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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

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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/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

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Indications for Use

510(k) Number (if known):

Device Name: Emerge ™ Monorail (MR) and Over-The-Wire (OTW) PTCA Dilatation Catheter

Indications for Use:

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

Regulation Number and Section

§ 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.