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 Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (balloon models 1.50-4.00 mm) 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.

The 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).

Device Description

The Boston Scientific Emerge™ PTCA Dilatation Catheter is a sterile (EO), single-use, intravascular medical device for use in coronary angioplasty procedures. The catheter consists of a dual-lumen polymeric shaft with a balloon near the distal tip. The outer lumen is used for inflation of the balloon, and the inner lumen permits the use of a guidewire to facilitate advancement of the catheter to the appropriate location. 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. Marks on the proximal portion of the catheter shaft (at 90 cm and 100 cm) indicate the exit of the balloon catheter tip out of the guide catheter. Radiopaque marker bands located under the balloon aid in positioning the system during the procedure. Hydrophilic and hydrophobic coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance. The Emerge™ PTCA Dilatation Catheters (1.20 mm and 1.50 mm balloon models) are available in balloon lengths from 8 mm to 20 mm. The Emerge™ PTCA Dilatation Catheters (2.00 - 4.00 mm balloon models) are available in balloon lengths from 8 mm to 30 mm.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Emerge PTCA Dilatation Catheter based on the provided document:

This document is a 510(k) summary for a medical device submitted to the FDA, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical study report for a new AI-powered diagnostic. Therefore, the information provided primarily relates to device performance testing (bench testing and biocompatibility) and does not include details about acceptance criteria or studies involving human readers, AI assistance, or complex ground truth establishment in the way typically seen for AI/ML-based diagnostic devices.

The "device" in this context is a physical medical device (a PTCA Dilatation Catheter), not an AI algorithm. As such, many of the requested points related to AI studies are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance tests and biocompatibility tests conducted to demonstrate substantial equivalence. It does not provide specific numerical acceptance criteria or detailed quantitative results in this summary. Instead, it states that the tests provide "reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."

Acceptance Criteria (General)	Reported Device Performance (General)
Conformance for intended use	Bench testing completed, providing reasonable assurance of design and testing conformance. No new safety or performance issues raised.
Biocompatibility requirements	Biocompatibility and chemical characterization tests completed.
Substantial equivalence to predicate devices	Tests support substantial equivalence to predicate devices (K113220, K121196, K130391) based on indications, characteristics, safety, and performance.

Specific Performance Tests (Bench Testing):

Corrosion Resistance
Proximal Mark Abrasion Resistance
Proximal Shaft Marks
Repeat Inflation
Midshaft Bond Tensile
Shaft and Bond Burst Pressure

Specific Biocompatibility and Chemical Characterization Tests:

Cytotoxicity
Partial Thromboplastin Time
Sensitization
In Vitro Hemocompatibility
Intracutaneous Reactivity
Complement Activation
Acute Systemic Injection
USP Physicochemical
Materials Mediated Pyrogenicity
Latex Assay
Mutagenicity
Nonvolatile Residue
Hemolysis
SEM

Regarding AI-Specific Criteria (Not Applicable to this Device):

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device, not an AI model evaluated on a data test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI-based diagnostic model is not relevant here. The "ground truth" for this catheter is its ability to perform its mechanical and biological functions safely.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI for human reader assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a physical medical device like this, "ground truth" relates to engineering specifications, material properties, and biological safety standards (e.g., ISO standards, FDA guidance documents). There isn't a "ground truth" in the diagnostic sense.
8. The sample size for the training set: Not applicable. This is a physical device; there is no "training set" in the AI sense.
9. How the ground truth for the training set was established: Not applicable.

Clarification:

The provided document is an FDA 510(k) clearance letter and summary for a PTCA Dilatation Catheter, which is a physical medical device used in coronary angioplasty. It is not an AI/ML-based diagnostic system. Therefore, the questions related to AI studies, test sets, training sets, ground truth establishment by experts, and reader studies are not relevant to the information presented in this document. The "study" described is a series of non-clinical bench tests and biocompatibility evaluations confirming the physical and biological properties of the catheter.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

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

December 14, 2016

Boston Scientific Corporation Jane Horan Senior Regulatory Affairs Specialist Three Scimed Place Maple Grove, Minnesota 55311

Re: K163174

Trade/Device Name: Emerge PTCA Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: November 10, 2016 Received: November 14, 2016

Dear Jane Horan:

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 devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Brian D. Pullin -S

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

510(k) Number (if known) K163174

Device Name Emerge PTCA Dilatation Catheter

Indications for Use (Describe)

The 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).

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510k Summary

Per 21 CFR §807.92

Common orUsual Name	PTCA Dilatation Catheter
Trade Name(s)	Emerge™ Monorail PTCA Dilatation CatheterEmerge™ Push Monorail PTCA Dilatation CatheterEmerge™ Over-The-Wire Monorail PTCA Dilatation CatheterEmerge™ Push Over-The-Wire Monorail PTCA Dilatation Catheter
Product Code	LOX - Percutaneous Transluminal Coronary Angioplasty(PTCA) Catheter
Classification ofDevice	Class II, 21 CFR 870.5100
Submitter's Nameand Address	Boston Scientific CorporationThree Scimed PlaceMaple Grove, MN 55311-1566
Contact Nameand Information	Jane HoranSenior Regulatory Affairs SpecialistPhone: 763-494-2572Fax: 763-494-2222Email: Jane.Horan@bsci.com
Date Prepared	7 Dec. 2016
Section 514 of theAct PerformanceStandards	No performance standards have been established underSection 514 of the Food, Drug and Cosmetic Act forpercutaneous catheters.

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EstablishmentRegistrationNumbers	Owner/Operator:	Boston Scientific Corporation300 Boston Scientific WayMarlborough, MA 01752ERN: 9912058
	ManufacturingFacility:	Boston Scientific CorporationTwo Scimed PlaceMaple Grove, MN 55311ERN: 2134265
	SterilizationFacilities:	Boston Scientific Corporation –Coventry8 Industrial DriveCoventry, RI 02816ERN: 1000121056
		STERIS Isomedix Services3459 South Clinton AvenueSouth Plainfield, NJ 07080ERN: 2246552
		Synergy Health Ireland Ltd.(Tullamore)IDA Business & Technology ParkTullamore, County OffalyIrelandERN: 3002807314
		Synergy Health AST, SRLB13. 1 Street 4, Avenue 1El Coyol Free ZoneEl Coyol, Alajeula 20102Costa RicaERN: 3010273872
		Synergy Health VenloFaunalaan 38Venlo Limburg, Netherlands5928 RZERN: 3009337401

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Predicate Devices	Emerge™ PTCA Dilatation Catheter, K113220, cleared 22March 2012.
	Emerge™ PTCA Dilatation Catheter, K121196, cleared 31August 2012.
	Emerge™ PTCA Dilatation Catheter, K130391, cleared 10July 2013.
ReferenceDevice	NC Emerge™ PTCA Dilatation Catheter, K141236,cleared 7 August 2014
DeviceDescription	The Boston Scientific Emerge™ PTCA Dilatation Catheter is a sterile (EO), single-use, intravascular medical device for use in coronary angioplasty procedures. The catheter consists of a dual-lumen polymeric shaft with a balloon near the distal tip. The outer lumen is used for inflation of the balloon, and the inner lumen permits the use of a guidewire to facilitate advancement of the catheter to the appropriate location. 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. Marks on the proximal portion of the catheter shaft (at 90 cm and 100 cm) indicate the exit of the balloon catheter tip out of the guide catheter. Radiopaque marker bands located under the balloon aid in positioning the system during the procedure. Hydrophilic and hydrophobic coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance. The Emerge™ PTCA Dilatation Catheters (1.20 mm and 1.50 mm balloon models) are available in balloon lengths from 8 mm to 20 mm. The Emerge™ PTCA Dilatation Catheters (2.00 - 4.00 mm balloon models) are available in balloon lengths from 8 mm to 30 mm.
Intended Use/Indications forUse	The Emerge Over-The-Wire and Emerge Monorail PTCADilatation Catheters (1.20 mm balloon models) areindicated as pre-dilatation catheters in the stenotic portionof a coronary artery or bypass graft stenosis (≥ 70%stenosis).
	The Emerge Over-The-Wire and Emerge Monorail PTCADilatation Catheters (balloon models 1.50-4.00 mm) areindicated for the balloon catheter dilatation of the stenoticportion of a coronary artery or bypass graft stenosis forthe purpose of improving myocardial perfusion.
	The Emerge Over-The-Wire and Emerge Monorail PTCADilatation Catheters (balloon models 2.00 - 4.00 mm) arealso indicated for the post-delivery expansion of balloonexpandable stents (bare metal and drug-eluting).
Comparison ofRequiredTechnologicalCharacteristics	The proposed Emerge™ PTCA Dilatation Catheterincorporates substantially equivalent device materials anddesign, packaging materials and design, fundamentaltechnology, manufacturing processes, sterilizationprocess and intended use as those featured in the BostonScientific predicate devices, Emerge™ PTCA DilatationCatheter K113220 (cleared March 22, 2012); Emerge™PTCA Dilatation Catheter K121196 (cleared August 31,2012); and Emerge™ PTCA Dilatation Catheter K130391(cleared July 10, 2013).
	The proposed and predicate devices share the followingtechnological characteristics:
	Fundamental catheter design and intended use Shaft, balloon, marker band, and coating materials Packaging materials and design Sterilization method Fundamental manufacturing processes
	The proposed and predicate devices differ in the followingtechnological characteristic:
	Method of making proximal marks on the shaft

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Summary of Non-Clinical Test Summary	Bench testing was 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 device testing.
	The following performance tests were completed on the Emerge™ PTCA Dilatation Catheter:
	Corrosion ResistanceProximal Mark Abrasion ResistanceProximal Shaft MarksRepeat InflationMidshaft Bond TensileShaft and Bond Burst Pressure	Corrosion Resistance	Proximal Mark Abrasion Resistance	Proximal Shaft Marks	Repeat Inflation	Midshaft Bond Tensile	Shaft and Bond Burst Pressure
Corrosion Resistance	Proximal Mark Abrasion Resistance
Proximal Shaft Marks	Repeat Inflation
Midshaft Bond Tensile	Shaft and Bond Burst Pressure
	The following biocompatibility and chemical characterization tests were completed on the Emerge™ PTCA Dilatation Catheter:
	CytotoxicityPartial Thromboplastin TimeSensitizationIn Vitro HemocompatibilityIntracutaneous ReactivityComplement ActivationAcute Systemic InjectionUSP PhysicochemicalMaterials Mediated PyrogenicityLatex AssayMutagenicityNonvolatile ResidueHemolysisSEM	Cytotoxicity	Partial Thromboplastin Time	Sensitization	In Vitro Hemocompatibility	Intracutaneous Reactivity	Complement Activation	Acute Systemic Injection	USP Physicochemical	Materials Mediated Pyrogenicity	Latex Assay	Mutagenicity	Nonvolatile Residue	Hemolysis	SEM
Cytotoxicity	Partial Thromboplastin Time
Sensitization	In Vitro Hemocompatibility
Intracutaneous Reactivity	Complement Activation
Acute Systemic Injection	USP Physicochemical
Materials Mediated Pyrogenicity	Latex Assay
Mutagenicity	Nonvolatile Residue
Hemolysis	SEM
Conclusion	Based on the indications for use, technological characteristics, and safety and performance testing, the proposed Emerge™ PTCA Dilatation Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to Emerge™ PTCA Dilatation Catheter (K113220), (K121196) and (K130391).

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.