Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical properties and physical characteristics of a balloon catheter, with no mention of AI or ML.

Therapeutic

Yes
The document describes the intended use of the ELM Extension PTA Balloon Dilatation Catheter for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions in arteries and dialysis fistulae, which is a therapeutic intervention.

Diagnostic

No

The device description indicates it is a therapeutic device used for Percutaneous Transluminal Angioplasty (PTA) to dilate vessels and treat obstructive lesions, rather than for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device is a physical catheter with a balloon, designed for mechanical dilation procedures. The description details hardware components, materials, and mechanical testing, indicating it is a hardware medical device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is for Percutaneous Transluminal Angioplasty (PTA) of blood vessels and treatment of obstructive lesions in dialysis fistulae. This is a therapeutic procedure performed directly on the patient's body.
Device Description: The device is a balloon catheter designed to be inserted into blood vessels to dilate them. This is a physical intervention, not a test performed on a sample taken from the body.
Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) to provide diagnostic information. There is no mention of reagents, assays, or any form of in vitro testing.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic tool used for a medical procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ELM Extension PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

Product codes

LIT, DOY

Device Description

The Creagh Medical ELM Balloon Dilatation Catheter is a coaxial catheter with a semi compliant balloon near the distal tip. It is an Over-the-Wire (OTW) PTA device with shaft lengths of 40cm & 75cm. The ELM PTA Balloon Dilatation Catheter is compatible with a 0.035" guide wire.

The balloon has two radiopaque markers at either end of the balloon body that aid in the placement of the balloon within the stenosis. These two radiopaque marker bands indicate the dilating section of the balloon and aid in the balloon placement. The marker bands also indicate the nominal length of the balloon. The catheter tip is designed to ease entry into the peripheral arteries and to facilitate the crossing of tight stenosis. The clearance between the inner and outer catheter shaft acts as the passage for the inflation medium for balloon expansion. The proximal end of the catheter has a bifurcated manifold and strain relief that allows for the use of the 0.035" guidewire and the attachment of a balloon inflation device via a standard luer connector. The inflation device is used to inflate and deflate the balloon with a contrast medium. The ELM PTA Balloon Dilatation Catheter is to be provided sterile (via ethylene oxide) and is intended for single use only.

The catheter is designed so that a specific balloon diameter can be reached depending on the Balloon size and defined pressure. A compliance chart is provided on the product label which provides the diameter of balloons at given pressures. Each product is packaged with a balloon protector which is positioned over the balloon for its protection prior to use. A re-wrap tool is also provided on the catheter shaft.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

femoral, iliac, and renal arteries; native or synthetic arteriovenous dialysis fistulae

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

This Traditional 510(k) submission aims to demonstrate substantial equivalence of the ELM Extension PTA Balloon Dilatation Catheter with extended range through comparison with the predicate device – ELM PTA Balloon Dilatation Catheter cleared in K102645. Substantial equivalence is demonstrated for the intended use of the ELM device. Where substantial equivalence is not directly demonstrated from the perspective of technology and performance, design verification testing provides evidence of the safety and effectiveness of the ELM Extension device.

Technological differences between the subject and predicate devices have been evaluated through mechanical tests to provide evidence the ELM Extension Catheter is safe and effective as the ELM PTA Balloon Dilatation Catheter. The ELM Extension is substantially equivalent to the specified predicate device based on comparisons of device functionality. technological characteristics and indications for use. The ELM Extension device design has been verified and validated through the following mechanical tests:

Working Length
Radiopacity
Tortuosity
Catheter profile
. Guidewire passage
. Fatigue Testing
Burst / Compliance Testing
Tensile
Inflation / Deflation
Shelf Life Testing
. Simulate Use Testing
. Sheath Compatibility Testing

This verification and validation testing shows substantial equivalence through compliance of the ELM Extension to standards and specifications which the ELM predicate device was previously verified against. The results were shown to meet the specified acceptance criteria and did not raise new questions of safety or effectiveness, therefore, Elm Extension catheter is substantially equivalent to the ELM PTA Balloon Dilatation Catheter.

Key Metrics

Not Found

Predicate Device(s)

K102645

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/1 description: The image is a black and white emblem for the Department of Health & Human Services - USA. The emblem features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing ribbon-like shape at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

May 19, 2015

Creagh Medical, Ltd. % Ms. Maureen O'Connell President O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, Massachusetts 01864

Re: K143561
Trade/Device Name: ELM PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: April 17, 2015 Received: April 20, 2015

Dear Ms. O'Connell,

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 device

1

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 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 yours,

Kenneth J. Cavanaugh -S

for

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

Enclosure

2

Indications for Use

510(k) Number (if known) K143561

Device Name ELM PTA Balloon Dilatation Catheter

Indications for Use (Describe)

The ELM Extension PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

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

	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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This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

1.	General Information
----	---------------------

| 510(k) Owner: | Creagh Medical
IDA Business Park,
Ballinasloe,
Co. Galway,
Ireland |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number: | 011 353 909 646300 |
| Fax Number: | 011 353 909 646330 |
| Contact Person: | Maureen O'Connell
Regulatory Consultant
Telephone: 978-207-1245
Fax: 978-824-2541
Email: Maureen@oconnellregulatory.com |
| Summary Preparation Date: | December 23, 2014 |
| Device Information | |
| Device Trade Names: | ELM PTA Balloon Dilatation Catheter |
| Common Name: | PTA Balloon Dilatation Catheter |
| Classification Name: | Catheter, Angioplasty, Peripheral, Transluminal
(21 CFR 870.1250, Product Code: DOY) |

3. Predicate Devices

ELM PTA Balloon Dilatation Catheter predicate

Device Name:	ELM PTA Balloon Dilatation Catheter
510(k) Clearance Number:	K102645

4. Device Description

The Creagh Medical ELM Balloon Dilatation Catheter is a coaxial catheter with a semi compliant balloon near the distal tip. It is an Over-the-Wire (OTW) PTA device with shaft lengths of 40cm & 75cm. The ELM PTA Balloon Dilatation Catheter is compatible with a 0.035" guide wire.

The balloon has two radiopaque markers at either end of the balloon body that aid in the placement of the balloon within the stenosis. These two radiopaque marker bands indicate the dilating section of the balloon and aid in the balloon placement. The marker bands also indicate the nominal length of the balloon. The catheter tip is designed to ease entry into the peripheral arteries and to facilitate the crossing of tight stenosis. The clearance between the inner and outer catheter shaft acts as the passage for the inflation medium for balloon expansion. The proximal end of the catheter has a bifurcated manifold and strain relief that allows for the use of the 0.035" guidewire and the attachment of a balloon inflation device via

4

a standard luer connector. The inflation device is used to inflate and deflate the balloon with a contrast medium. The ELM PTA Balloon Dilatation Catheter is to be provided sterile (via ethylene oxide) and is intended for single use only.

The catheter is designed so that a specific balloon diameter can be reached depending on the Balloon size and defined pressure. A compliance chart is provided on the product label which provides the diameter of balloons at given pressures. Each product is packaged with a balloon protector which is positioned over the balloon for its protection prior to use. A re-wrap tool is also provided on the catheter shaft.

The accessories required by the physician but not included in the packaging are detailed below.

=> Introducer sheath in appropriate size and configuration for the selected vasculature
=> Syringes (10 20 cc)
=> Inflation device with manometer
=> Contrast medium
=> 0.035" Guidewire

The modified ELM 0.035" PTA Balloon Dilatation Catheter, hereafter referred to as ELM Extension, introduces 3 additional product codes with reduced Rated Burst Pressure as detailed below in Table 1.

Table: 1: ELM Extension Matrix

| Balloon D x L
(mm) x (mm) | Shaft Length | Min Rated Burst Pressure | Nominal
Pressure | Sheath
Size | Guide wire
Size |
|------------------------------|--------------|--------------------------|---------------------|----------------|--------------------|
| 12.0 x 40 | 75cm | 18 ATM | 12 ATM | 7F | 0.035" |
| 14.0 x 40 | 75cm | 16 ATM | 10 ATM | 8F | 0.035" |
| 16.0 x 40 | 75cm | 14 ATM | 10 ATM | 8F | 0.035" |

The ELM 0.0035" PTA Balloon Dilatation Catheter matrix which was cleared in K102645 is detailed below in Table 2.

| BalloonD x L
(mm) x (mm) | Shaft Length | Rated Burst Pressure | Nominal
Pressure | Sheath
Size | Guide wire
Size |
|-----------------------------|--------------|----------------------|---------------------|----------------|--------------------|
| 3.0 x 40 | 40cm 75cm | 27 ATM | 14 ATM | 6F | 0.035" |
| 4.0 x 20 | 40cm 75cm | 27 ATM | 14 ATM | 6F | 0.035" |
| 4.0 x 40 | 40cm 75cm | 27 ATM | 14 ATM | 6F | 0.035" |
| 5.0 x 20 | 40cm 75cm | 27 ATM | 14 ATM | 6F | 0.035" |
| 5.0 x 40 | 40cm 75cm | 27 ATM | 14 ATM | 6F | 0.035" |
| 5.0 x 60 | 40cm 75cm | 27 ATM | 14 ATM | 6F | 0.035" |
| 6.0 x 20 | 40cm 75cm | 25 ATM | 14 ATM | 6F | 0.035" |
| 6.0 x 40 | 40cm 75cm | 25 ATM | 14 ATM | 6F | 0.035" |
| 6.0 x 60 | 40cm 75cm | 25 ATM | 14 ATM | 6F | 0.035" |
| 6.0 x 100 | 40cm 75cm | 25 ATM | 14 ATM | 6F | 0.035" |
| 7.0 x 20 | 40cm 75cm | 25 ATM | 14 ATM | 6F | 0.035" |
| 7.0 x 40 | 40cm 75cm | 25 ATM | 14 ATM | 6F | 0.035" |
| 7.0 x 60 | 40cm 75cm | 25 ATM | 14 ATM | 6F | 0.035" |
| 7.0 x 100 | 40cm 75cm | 25 ATM | 14 ATM | 6F | 0.035" |
| 8.0 x 20 | 40cm 75cm | 24 ATM | 14 ATM | 6F | 0.035" |
| 8.0 x 40 | 40cm 75cm | 24 ATM | 14 ATM | 6F | 0.035" |
| 8.0 x 60 | 40cm 75cm | 23 ATM | 14 ATM | 6F | 0.035" |

Table 2: ELM 0.0035" Catheter Matrix

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8.0 x 80	40cm	75cm	23 ATM	14 ATM	6F	0.035"
9.0 x 40	40cm	75cm	20 ATM	12 ATM	7F	0.035"
10.0 x 40	40cm	75cm	20 ATM	12 ATM	7F	0.035"
12.0 x 40	40cm	75cm	18 ATM	12 ATM	8F	0.035"

The 12.0x40 catheter size has a lower sheath compatibility than the previously approved ELM 12.0 * 40. The 14.0 X 40 and 16.0 x 40 are 2 new sizes with an increased balloon diameter.

5. Indications for Use

The ELM Extension PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

6. Substantial Equivalence

This Traditional 510(k) submission aims to demonstrate substantial equivalence of the ELM Extension PTA Balloon Dilatation Catheter with extended range through comparison with the predicate device – ELM PTA Balloon Dilatation Catheter cleared in K102645. Substantial equivalence is demonstrated for the intended use of the ELM device. Where substantial equivalence is not directly demonstrated from the perspective of technology and performance, design verification testing provides evidence of the safety and effectiveness of the ELM Extension device.

Technological differences between the subject and predicate devices have been evaluated through mechanical tests to provide evidence the ELM Extension Catheter is safe and effective as the ELM PTA Balloon Dilatation Catheter. The ELM Extension is substantially equivalent to the specified predicate device based on comparisons of device functionality. technological characteristics and indications for use. The ELM Extension device design has been verified and validated through the following mechanical tests:

Working Length
Radiopacity
Tortuosity ●
Catheter profile ●
. Guidewire passage
. Fatigue Testing
Burst / Compliance Testing
Tensile
Inflation / Deflation
Shelf Life Testing
. Simulate Use Testing
. Sheath Compatibility Testing

This verification and validation testing shows substantial equivalence through compliance of the ELM Extension to standards and specifications which the ELM predicate device was previously verified against. The results were shown to meet the specified acceptance criteria and did not raise new questions of safety or effectiveness, therefore, Elm Extension catheter is substantially equivalent to the ELM PTA Balloon Dilatation Catheter.