The EMPIRA Rx PTCA Catheter and EMPIRA NC Rx PTCA Dilatation Catheter are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

The EMPIRA NC Rx PTCA Dilatation Catheter is also indicated for post-delivery expansion of balloon expandable stents.

Device Description

The EMPIRA and EMPIRA NC Rx PTCA Dilatation Catheters, hereafter referred to as the EMPIRA Catheter, are similar in design. The catheters differ in available configurations (diameter versus balloon working length). The EMPIRA Catheter is a sterile, single-use rapid exchange catheter with a nylon-blend balloon near the distal tip. The distal section of the catheter is dual lumen and coaxial. The outer lumen is used for inflation of the balloon and the inner lumen permits the use of a guide wire (≤ 0.014 in. / 0.36 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated. The proximal section of the catheter is a single lumen stainless steel PTFE coated hypotube with a single luer port for the inflation of the balloon. The balloon is designed to provide an inflatable segment of specified diameter and length at recommended pressures. The balloon is folded to achieve a low crossing profile and is connected to a tapered, soft tip. The tapered tip facilitates advancement of the catheter to and through the stenosis. A hydrophilic coating is applied from the distal tip to the guide wire port and over the balloon for increased lubricity. All models have two radiopaque marker bands that aid in the placement of the catheter's balloon segment under fluoroscopy. A balloon protector is placed over the balloon to maintain a low profile and a mandrel is placed in the lumen to maintain patency. The proximal end of the catheter is comprised of a hypotube connected to a plastic hub. The hub can be connected to a standard inflation device and is used to inflate/deflate the balloon. A needle with a luer port is included for flushing the distal lumen prior to the insertion of a guide wire.

The EMPIRA Catheter is compatible with standard 0.014" coronary guide wires and 5F guiding catheters. The catheter length is approximately 139 cm. The EMPIRA and EMPIRA NC Rx PTCA Catheters are offered in diameters of 1.5- 4.0 mm and 2.0-4.0, respectively. The working lengths of the treatment balloon are offered in lengths from 6.0 to 30mm. The EMPIRA and EMPIRA NC Rx PTCA Balloon Dilatation Catheter product family consists of multiple sizes.

AI/ML Overview

The provided text describes non-clinical testing performed on the EMPIRA and EMPIRA NC Rx PTCA Dilatation Catheters to demonstrate their substantial equivalence to predicate devices, rather than a study proving the device meets specific performance acceptance criteria for a diagnostic or AI-driven device.

The document lists various tests conducted, primarily focusing on biocompatibility, physical device characteristics, and packaging/sterilization. For most of these, the "Results" column simply states "PASS," indicating that the device met the criteria for each specific test. However, the specific acceptance criteria themselves are not explicitly detailed in a standalone table within the provided text. Instead, the document notes that testing was performed "in accordance with applicable requirements of FDA Guidance Document - Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters" and ISO standards.

Therefore, a table of acceptance criteria and reported device performance as typically expected for diagnostic devices is not directly extractable in the requested format. Instead, the document presents a summary of non-clinical tests and their pass/fail outcomes against established standards for PTCA catheters.

Given this context, here's an attempt to address your request based on the available information, noting the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria for each test are not listed in the document, and only a "PASS" result is provided, a direct fulfillment of this table with detailed criteria is not possible. The table below lists the tests performed and their reported results against the implicit acceptance criteria of the referenced FDA Guidance and ISO standards.

Acceptance Criteria (Implicit from reference standards)	Reported Device Performance (Result)
Biocompatibility (In accordance with ISO 10993):
Cytotoxicity	PASS
Hemolysis	PASS
Platelet and Leukocyte Counts	PASS
Partial Thromboplastin Time (PTT)	PASS
Complement Activation	PASS
Thromboresistance	PASS
Bacterial Mutagenicity Test	PASS
Intracutaneous Reactivity	PASS
Materials Mediated Pyrogen	PASS
Sensitization	PASS
Acute Systemic Toxicity	PASS
USP Physico-chemical	PASS
Physical and Mechanical Characteristics (In accordance with FDA Guidance Document - Class II Special Controls Guidance Document for Certain PTCA Catheters):
Dimensional Verification	PASS
Balloon Preparation, Deployment and Retraction	PASS
Balloon Rated Burst Pressure	PASS
Balloon Fatigue	PASS
Balloon Compliance (diameter vs. Pressure)	PASS
Balloon Inflation and Deflation Time	PASS
Catheter Bond Strength(s)	PASS
Tip Pull	PASS
Flexibility and Kink	PASS
Torque Strength	PASS
Radiopacity	PASS
Coating Integrity	PASS
Particulate Evaluation	PASS
Catheter Body Burst Pressure	PASS
Catheter Body Burst Pressure (In-Stent) (*for EMPIRA NC only)	PASS
Balloon Rated Burst Pressure (In-Stent) (*for EMPIRA NC only)	PASS
Balloon Fatigue (repeat balloon inflations; In-stent) (*for EMPIRA NC only)	PASS
Packaging and Sterilization:
Packaging Integrity Testing (In accordance with ISO 11607-1 and ISO 11607-2)	PASS
Sterilization (In accordance with ISO 11135-1 and ISO 10993-7)	PASS
Shelf Life (In accordance with FDA Guidance Document - Class II Special Controls Guidance Document for Certain PTCA Catheters)	PASS
Animal Study:
Comparative testing to currently legally marketed devices (in compliance with 21 CFR 58 - GLP)	PASS

2. Sample Size and Data Provenance

Test Set Sample Size: The document does not specify the sample sizes used for each non-clinical test (e.g., number of catheters tested for burst pressure, fatigue, etc.).
Data Provenance: The data provenance is not specified in terms of country of origin or whether it's retrospective or prospective. These are non-clinical (laboratory/animal) studies, not human clinical trials.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable to the provided document. The studies described are non-clinical, involving laboratory testing and an animal study, not human expert interpretation to establish ground truth for a diagnostic device.

4. Adjudication Method

This information is not applicable. The studies are non-clinical laboratory and animal tests, not studies requiring expert adjudication for a diagnostic output.

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

No MRMC study was done, as this is a medical device (PTCA catheter), not an AI-driven diagnostic tool involving human readers.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

No standalone algorithm performance was done, as this is a medical device (PTCA catheter), not an AI algorithm.

7. Type of Ground Truth Used

For the non-clinical tests, the "ground truth" implicitly refers to the known physical, chemical, and biological properties of the materials and device and their performance under predetermined test conditions as defined by the referenced ISO standards and FDA guidance documents. For the animal study, the ground truth would be the observed physiological responses and device performance in the animal model.

8. Sample Size for the Training Set

This is not applicable. The document describes non-clinical testing for a PTCA catheter, not an AI model that would require a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable, as no AI model training was involved.

Summary

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K110133

Image /page/0/Picture/1 description: The image shows the text "CREGANNA" in large, bold, sans-serif font. Below this, in a smaller font size, is the text "TACTX MEDICAL". The text appears to be slightly distressed or textured, giving it a somewhat vintage or weathered look.

JUN 1 0 2011

1353 Dell Avenue Campbell, California 95008, USA Tel: +1 408 364 7100 Fax: +1 408 871 2425 www.cregannatactx.com

General Information:

Submitter:	Creganna Tactx Medical, Inc.
	1353 Dell Avenue
	Campbell, Ca 95008
	Ph: (408) 364-7100
	Fax: (408) 871-2425
Contact Person:	Dennis Wong
	Director of Quality
Date Prepared:	January 17, 2011
Device Trade	EMPIRA Rx PTCA Dilatation Catheter and
name(s):	EMPIRA NC Rx PTCA Dilatation Catheter
Device Common	PTCA Catheter
name:
Class:	II
Classification	Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
Name:	(21 CFR 870.5100)
Product Code:	LOX

Predicate Device(s):

Device Name	Reference(s)
EMPIRA Rx PTCA Dilatation Catheter
Standard PTCA Catheter	21 CFR 870.5100
Cordis Fire Star	P880003
Boston Scientific's Maverick2 Monorail	P860019
EMPIRA NC Rx PTCA Dilatation Catheter
Standard PTCA Catheter	21 CFR 870.5100
Cordis Dura Star	P880003
Boston Scientific's Quantum Maverick Monorail	P860019

Note: Recently, PTCA Catheters were reclassified by the agency from Class II with Special Controls per FDA Guidance Document - Class II Special Controls Guidance Document for Certain Perculaneous Transluminal Coronary Angioplasty (PTCA) Catheters issued September 8, 2010.

Intended Use:

The EMPIRA NC Rx PTCA Dilatation Catheter is also indicated for post-delivery expansion of balloon expandable stents.

Partners from Idea to Reality

Creganna. Registered in Dublin, Ireland: · Reg No 324172

Creganna Medical Devices Inc.

Drectors: - In Quinn, Endrac Clarke, Beenard Collers, Helen Ryan, Benard E. Lyons, Daniel G. Tully, George Altien-Daves

{1}------------------------------------------------

Device Description:

Partners from Idea to Reality

Creganna. Registered in Dublin, Ireland: Reg No 324177.

Creganna Mecical Davires Inc

Drectors: Jan Quinn, Enda Quinn, Patrair Collins, Helen Ryan, Banard E. I yoos, Caniel G. Tully, George Atlen-Daves

{2}------------------------------------------------

Device Comparison:

Below is a comparison of the EMPIRA and EMPIRA NC Rx PTCA Dilatation Catheters with Standard PTCA Catheter as defined by 21 CFR 870.5100:

1. Like Standard PTCA Catheters, the EMPIRA and EMPIRA NC Rx PTCA Dilatation Catheters operate on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end of the catheter.
1. Like Standard PTCA Catheters, the EMPIRA and EMPIRA NC Rx PTCA Dilatation Catheters have a double-lumen coaxial shaft.
1. Like Standard PTCA Catheters, the balloons on the EMPIRA and EMPIRA NC Rx PTCA Dilatation Catheters are constructed from a polymer (nylon) and have nominal rated pressures of 8 and 14atm, respectively.
1. Like Standard PTCA Catheters, the balloon on the EMPIRA and EMPIRA NC Rx PTCA Dilatation Catheters are available in different diameters and lengths.
1. Like Standard PTCA Catheters, the EMPIRA and EMPIRA NC Rx PTCA Dilatation Catheters have radiopaque marker bands to allow for visualization under fluoroscopy.
1. Like Standard PTCA Catheters, the EMPIRA and EMPIRA NC Rx PTCA Dilatation Catheters have the same intended use - indicated for the balloon dilatation of stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. In addition, the EMPIRA NC Rx PTCA Balloon Dilatation Catheter is also indicated for the post-delivery expansion of balloon expandable stents.

Partners from Idea to Reality

Registered in Dublin, Treland .- Reg No 324172

reganna Medical Devices Inc.

Directurs: Jan Quinn, Enda Quan, Padrac Callins, Helen Ryan, Bernard E. Lyons, Daniel G. Tully, George Arken-Davies

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CREGANNA
TACTX MEDICAL

		Pre-Dilatation Catheters			Post-Dilatation Catheters
		EMPIRA	Fire Star	Maverick Monorail	EMPIRA NC	Dura Star	Quantum Maverick Monorail
Item
Manufacturer		Creganna-TACTX Medical	Cordis-Johnson & Johnson	Boston Scientific	Creganna-TACTX Medical	Cordis-Johnson & Johnson	Boston Scientific
Submission Reference		Current Submission	P880003	P860019	Current Submission	P880003	P860019
Intended Use		Note 1	Same	Same	Note 1	Same	Same
Principle of Operation		Note 2	Same	Same	Note 2	Same	Same
CatheterCharacteristics	Configuration	Rapid Exchange	Same	Same	Rapid Exchange	Same	Same
	Effective Length (cm)	139	145	143	139	145	143
BalloonCharacteristics	Balloon Lengths (mm)	6.0-30mm	10-30mm	9.0-30mm	6.0-30mm	10-30mm	8.0-30mm
	Balloon Diameters (mm)	1.5-4.0mm	1.5-3.5mm	1.5-4.0mm	2.0 - 4.0mm	2.25-4.0mm	2.0-5.0mm
	Nominal Pressure (atm)	8	8	6	14	14	12
	Rated Burst Pressure (atm)	14	14	12-14	20	20	16-18
OtherCharacteristics	Guidewire compatibility	≤0.014in	Same	Same	≤0.014in	Same	same
	Sterilization Method	Ethylene Oxide	Same	Same	Ethylene Oxide	Same	same
	Single-Use?	Yes	Same	Same	Same	Same	Same
	Hydrophilic Coating	Yes	Yes	Yes	Yes	Yes	Yes

The table below also provides a comparison to other legally marketed devices.

Note 1: Indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. Also, indicated for post-delivery stent expansion.

Note 2: Operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.

Partners from Idea to Reality

Creganna. Registered in Oublin, Treland:- Reg No 324172

Creganna Medical Devices Inc.

Drectors - Isn Quinn, Enda Quinn, Padrair Collins, Helen Ryan, Benaud E. Lyons, Datiel G. Tully, George Altien-Daves

{4}------------------------------------------------

Summary of Non-Clinical Testing:

The EMPIRA and EMPIRA NC Rx PTCA Dilatation Catheters were tested in accordance of FDA Guidance Document - Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. The following testing was completed:

Test	Method	Results
Cytotoxicity	In accordance with ISO 10993	PASS
Hemolysis
Platelet and Leukocyte Counts
Partial Thromboplastin Time (PTT)
Complement Activation
Thromboresistance
Bacterial Mutagenicity Test
Intracutaneous Reactivity
Materials Mediated Pyrogen
Sensitization
Acute Systemic Toxicity
USP Physico-chemical
Dimensional Verification	In accordance with applicable	PASS
Balloon Preparation, Deployment and Retraction	requirements of FDA GuidanceDocument - Class II SpecialControls Guidance Document forCertain Percutaneous TransluminalCoronary Angioplasty (PTCA)Catheters
Balloon Rated Burst Pressure
Balloon Fatigue
Balloon Compliance (diameter vs. Pressure)
Balloon Inflation and Deflation Time
Catheter Bond Strength(s)
Tip Pull
Flexibility and Kink
Torque Strength
Radiopacity
Coating Integrity
Particulate Evaluation
Catheter Body Burst Pressure
*Catheter Body Burst Pressure (In-Stent)
*Balloon Rated Burst Pressure (In-Stent)
*Balloon Fatigue (repeat balloon inflations; In-stent)
Packaging Integrity Testing	In accordance with ISO 11607-1and ISO 11607-2	PASS
Sterilization	In accordance with ISO 11135-1and ISO 10993-7	PASS

Partners from Idea to Reality

Creganna. Registerad in Dublin, Ireland: - Reg No 324172

Creganna Medical Devices Inc.

Drectors: Jan Quinn, Ende Quinn, Padract Collins, Helmi Ryan, Bernard E. Lyons, Daniel G. Titly, George Airken-Davies

{5}------------------------------------------------

Test	Method	Results
Shelf Life	In accordance with applicablerequirements of FDA GuidanceDocument - Class II SpecialControls Guidance Document forCertain Percutaneous TransluminalCoronary Angioplasty (PTCA)Catheters	PASS
Animal Study	Comparative testing to currentlylegally marketed devices incompliance with 21 CFR 58 - GLP	PASS

*This testing is not applicable to the EMPIRA Rx PTCA Dilatation Catheter because it is not intended for use In Stents.

Conclusion:

The EMPIRA and EMPIRA NC Rx PTCA Catheters are substantially equivalent to a Standard PTCA Catheter as defined in 21 CFR 870.5100 and other legally marketed devices with respect to intended use, principle of operation, technological characteristics and safety features.

Partners from Idea to Reality

Creganna. Registered in Dublin, Treland: - Reg No 324172 Creganna Medical Devices Inc.

Drectors: - Inn Quinn, Enda Quinn, Patrare Collins, Helen Ryan, Benard !!. I,yons, Damel G. Tolly, George Arken-Daves

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three wing strokes, representing health, services, and human aspects. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

JUN 1 0 2011

Creganna Tactx Medical, Inc. c/o Mr. Dennis Wong Director of Quality 1353 Dell Avenue Campbell, CA 95008

Re: K110133

EMPIRA™ Rx PTCA Dilatation Catheter Trade/Device Name: EMPIRA™ NC Rx 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: May 23, 2011 Received: May 24, 2011

Dear Mr. Wong:

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

{7}------------------------------------------------

Page 2 – Mr. Dennis Wong

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 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/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

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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4. Indications for Use Statement 510(k) Number (if known): _ K |(0133

Device Name: _ EMPIRA and EMPIRA NC Rx PTCA Dilatation Catheters

Indications for Use:

"The EMPIRA Rx PTCA Catheter and EMPIRA NC Rx PTCA Dilatation Catheter are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

The EMPIRA NC Rx PTCA Dilatation Catheter is also indicated for post-delivery expansion of balloon expandable stents."

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

Page of of

Traditional 510(k)	23
	(Division Sign-Off)
	Division of Cardiovascular Devices
510(k) Number	K110133

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.