K Number

Device Name

TAMARIN BLUE PTCA RX DILATATION CATHETER

Manufacturer

NATEC MEDICAL LTD

Date Cleared

2012-11-02

(409 days)

Product Code

LOX

Regulation Number

870.5100

Intended Use

The Tamarin Blue® RX PTCA Dilatation Catheters are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion.

Device Description

The Tamarin Blue® PTCA RX Dilatation Catheter is a standard Rapid Exchange (RX) PTCA catheter with a single lumen proximally, a dual lumen distally, a semi-compliant inflatable balloon and a soft, tapered distal tip to aid in crossing tight stenoses. One lumen of the catheter's dual lumen is used for inflation and deflation of the balloon, and the other lumen allows guide wire access through the distal part of the catheter. The maximum recommended guide wire diameter is 0.014". A luer lock fitting (Hub) allows connection with an inflation device. Two radiopaque markers on the guide wire lumen tubing provide visual reference points for balloon positioning across the stenosis. The balloon material expands to a known diameter at specific pressure as defined in the compliance table supplied with the catheter.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

P860019,P790017,K103110

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

Yes

The device is indicated for "balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion," which describes a therapeutic intervention to treat a medical condition.

Diagnostic

Explanation: The device is indicated for "balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion," which is a therapeutic intervention, not a diagnostic one. It is used to treat a condition, not to identify or characterize it.

SaMD (Software as a Medical Device)

The device description clearly details a physical catheter with a balloon, lumens, and other hardware components, indicating it is not a software-only device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The Tamarin Blue® RX PTCA Dilatation Catheter is a device used directly within the body (in vivo) to physically dilate a narrowed coronary artery or bypass graft. It does not analyze samples taken from the body.
Intended Use: The intended use clearly states it's for "balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion." This is a therapeutic procedure performed inside the patient.

Therefore, based on the provided information, the Tamarin Blue® RX PTCA Dilatation Catheter is a therapeutic medical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Tamarin Blue® PTCA RX Dilatation Catheters are indicated for Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion.

Product codes (comma separated list FDA assigned to the subject device)

LOX

Device Description

	Diameter (mm)
	1.50	2.00	2.25	2.50	2.75	3.00	3.25	3.50	4.00
Length (mm)
8	✓	✓	✓	✓	✓	✓	✓	✓	✓
12	✓	✓	✓	✓	✓	✓	✓	✓	✓
15	✓	✓	✓	✓	✓	✓	✓	✓	✓
20	✓	✓	✓	✓	✓	✓	✓	✓	✓
25	✓	✓	✓	✓	✓	✓	✓	✓	✓
30	✓	✓	✓	✓	✓	✓	✓	✓	✓

It will be supplied sterile and is intended for one time use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

coronary artery or bypass graft

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 safety and effectiveness of the Tamarin Blue® PTCA RX Dilatation Catheter has been evaluated in the following non-clinical tests:

· Biocompatibility
· Balloon compliance
· Balloon burst pressure
· Balloon fatigue (repeated balloon inflation) endurance
= Balloon inflation/deflation performance
· Bond strengths
· Catheter dimensions and balloon profile
Catheter body minimum burst strength
· Device preparation (guide wire and introducer compatibility)
Flexibility and Kink
· Torque
· Radiopacity
· Coating integrity
· Particulate evaluation

The Tamarin Blue® PTCA RX Dilatation Catheter met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, and test protocols.

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.

Maverick 2 PTCA Catheter Boston Scientific Corporation P860019, Sprinter Legend Rapid Exchange Balloon Dilatation Catheter Medtronic Ireland -P790017, Trek ™ RX Coronary Dilatation Catheter Abbott Vascular Inc. K103110

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

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.

Summary

510(k) SUMMARY 807.92(c)

K112735

NOV - 2 2012

SPONSOR

Fax:

Natec Medical Ltd. Company Name: Maeva Centre Building - Ebene Business Park Company Address: Reduit, Mauritius +230 466 30 54 Telephone: +230 466 67 70

Xavier De Buchere Contact Person: Quality Manager info@natec-medical.com

Summary Preparation Date: October 08, 2012

DEVICE NAME

Trade Name:	Tamarin Blue® PTCA RX Dilatation Catheter
Common/Usual Name:	PTCA RX Catheter
Classification Name:	Catheters, transluminal coronary angioplasty, percutaneous
Regulation Number:	870.5100
Product Code:	LOX
Device Class:	Class II

PREDICATE DEVICE

Legally Marketed Equivalent Devices:

· Maverick 2 PTCA Catheter Boston Scientific Corporation P860019
· Sprinter Legend Rapid Exchange Balloon Dilatation Catheter Medtronic Ireland -P790017
= Trek ™ RX Coronary Dilatation Catheter Abbott Vascular Inc. K103110

DEVICE DESCRIPTION

connection with an inflation device. Two radiopaque markers on the guide wire lumen tubing provide visual reference points for balloon positioning across the stenosis. The balloon material expands to a known diameter at specific pressure as defined in the compliance table supplied with the catheter. The device is available in the balloon diameters and lengths shown in the table below:

	Diameter (mm)
	1.50	2.00	2.25	2.50	2.75	3.00	3.25	3.50	4.00
Length (mm)
8	✓	✓	✓	✓	✓	✓	✓	✓	✓
12	✓	✓	✓	✓	✓	✓	✓	✓	✓
15	✓	✓	✓	✓	✓	✓	✓	✓	✓
20	✓	✓	✓	✓	✓	✓	✓	✓	✓
25	✓	✓	✓	✓	✓	✓	✓	✓	✓
30	✓	✓	✓	✓	✓	✓	✓	✓	✓

It will be supplied sterile and is intended for one time use.

DEVICE INTENDED USE

COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)

The Tamarin Blue® PTCA RX Dilatation Catheter uses similar technology, materials and methods of operation as the approved predicates: Maverick2 PTCA Catheter (P860019), Sprinter Legend RX (P790017/S096 & K103095) and Trek ™ RX device (K103110). The properties of the Tamarin Blue® PTCA RX Catheter to treat disease are identical to predicate PTCA balloon dilatation catheters.

Additionally, the Tamarin Blue® PTCA RX Dilatation Catheter incorporates substantially equivalent indications for use, design and dimensional and performance specifications as those found with the aforementioned predicate devices.

NONCLINICAL TESTS

SAFETY and EFFECTIVENESS

BIOCOMPATIBILITY

All materials used in the Tamarin Blue® PTCA RX Dilatation Catheter are biocompatible based on biocompatibility testing results. The device has been tested according to ISO 10993 Part 1, 2, 4, 5, 10, 11, 12, ASTM F756-00 and 21 CFR 58 (GLP regulations).

PERFORMANCE DATA

The safety and effectiveness of the Tamarin Blue® PTCA RX Dilatation Catheter has been evaluated in the following non-clinical tests:

· Biocompatibility
· Balloon compliance
· Balloon burst pressure
· Balloon fatigue (repeated balloon inflation) endurance
= Balloon inflation/deflation performance
· Bond strengths
· Catheter dimensions and balloon profile
Catheter body minimum burst strength
· Device preparation (guide wire and introducer compatibility)
Flexibility and Kink
· Torque
· Radiopacity
· Coating integrity
· Particulate evaluation

CONCLUSION

The Tamarin Blue® PTCA RX Dilatation Catheter met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, and test protocols.

The Tamarin Blue® PTCA RX Dilatation Catheter has the same intended use, similar design and technological characteristics, equivalent performance properties, identical sterilization and packaging, same mode of operation, and no new safety or effectiveness issues. Therefore, the Tamarin Blue® PTCA RX Dilatation Catheter is considered substantially equivalent to the aforementioned predicate devices.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

NOV 2 0 2012

Natec Medical Ltd c/o Judy Danielson Senior Regulatory Consultant CardioMed Device Consultants, LLC 5523 Research Park Drive, Suite 360 Baltimore, MD 21228

Re: K112735

Trade/Device Name: Tamarin Blue® PTCA RX Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Catheters, transluminal coronary angioplasty, percutaneous Regulatory Class: Class II Product Code: LOX Dated (Date on orig SE letter): October 11, 2012 Received (Date on orig SE letter): October 15, 2012

Dear Ms. Danielson:

This letter corrects our substantially equivalent letter of November 2, 2012.

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 (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.

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ReportalProblem/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/Industry/default.htm.

Sincerely yours,

Matthew G. 201 Hillebrenner """,""","","","","","","","","","","","","","","","","","","","","","","","","","","","","","","","","","","","","","","","","","","","","","","","","","","","",

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

Indications for Use Statement

510(k) Number:	K112735
Device Name:	Tamarin Blue® RX PTCA Dilatation Catheter
Indications for Use:	The Tamarin Blue® RX PTCA Dilatation Catheters are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

TUS. Killelu

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number KL12735