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.

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. A hydrophilic coating has been applied on the distal portion of catheter i.e., up to the RX port, to improve catheter pushability. The balloon material expands to a known diameter at a specific pressure as defined in the compliance table supplied with the catheter.

The device is supplied sterile and intended for one-time use.

AI/ML Overview

This document is a 510(k) summary for the Tamarin Blue PTCA RX Dilatation Catheter (K210012). It details the device's comparison to predicate and reference devices and non-clinical testing performed to establish substantial equivalence.

Here's an analysis to extract the requested information, although it's important to note that this document pertains to a medical device (catheter) and not an AI/ML-driven diagnostic or image analysis device, which are typically the subject of the detailed acceptance criteria and study design questions you've posed. Therefore, many of the requested fields related to AI/ML performance, ground truth establishment by experts, MRMC studies, training sets, etc., will not be applicable or present in this type of submission.

The information consistently aligns with a submission for a physical medical device, not a software/AI device.

Here's the closest interpretation of your request based on the provided document:

Device Name: Tamarin Blue PTCA RX Dilatation Catheter

Device Type: Medical Device (PTCA Dilatation Catheter)

Acceptance Criteria and Device Performance:

The primary "acceptance criteria" for this device, as detailed in a 510(k) submission, revolve around demonstrating substantial equivalence to a previously cleared predicate device. This is typically achieved through non-clinical bench testing to ensure the device performs as intended and meets established safety and performance standards for its class. The document explicitly states that the technological characteristics (components, design, sterilization method, shelf life, operating principle) are identical to the predicate device, with the only notable difference being the addition of a hydrophilic coating, which was tested and shown not to raise new questions of safety or effectiveness.

1. A table of acceptance criteria and the reported device performance:

Since this is a physical medical device, "acceptance criteria" are not reported as classical sensitivity/specificity/AUC metrics for a diagnostic algorithm. Instead, they are engineering and performance benchmarks validated through bench testing. The document states that the device "met all acceptance criteria."

Acceptance Criteria Category	Reported Device Performance
Coating Performance	Hydrophilic coating performed as intended and did not impact functionality.
Coating Integrity & Durability	(Passed, implied by "performed as intended")
Balloon Preparation, Deployment, & Retraction	(Passed, implied by "met all acceptance criteria")
Balloon Rated Burst Pressure	Passed (Rated Burst Pressure: 16 atm - identical to predicate)
Balloon Fatigue	(Passed, implied by "met all acceptance criteria")
Balloon Compliance	Semi-compliant (identical to predicate)
Balloon Inflation/Deflation	(Passed, implied by "met all acceptance criteria")
Particulate	(Passed, implied by "met all acceptance criteria")
Biocompatibility	Verified to be the same as predicate/reference devices based on material similarities; subject device is biocompatible.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated as a "sample size" in the context of clinical studies for diagnostic accuracy. The non-clinical bench testing would involve a certain number of manufactured devices for each test (e.g., a specific batch size for burst pressure testing, a number of devices for fatigue testing). These numbers are not detailed in this summary.
Data Provenance: The testing is non-clinical bench testing, meaning it's performed in a laboratory, not from patient data. Therefore, "country of origin of the data" and "retrospective or prospective" are not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This concept is not applicable here as the "ground truth" for a physical device is its adherence to engineering specifications and performance standards, validated through objective bench testing. There are no "experts" establishing ground truth in the sense of medical image interpretation for diagnosis.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This is for objective bench testing, not subjective human interpretations that require adjudication.

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 is for an AI/ML-driven diagnostic/image analysis device. This product is a physical medical catheter.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device is based on engineering specifications, established performance standards (e.g., burst pressure limits), and material properties. Compliance is demonstrated through objective bench testing.

8. The sample size for the training set:

Not applicable. There is no AI/ML "training set" for this physical device.

9. How the ground truth for the training set was established:

Not applicable. There is no AI/ML "training set" for this physical device.

Summary of the Study:

The study proving the device meets acceptance criteria is a non-clinical bench testing program. The purpose of this testing was to demonstrate that the Tamarin Blue PTCA RX Dilatation Catheter (K210012), with the addition of a hydrophilic coating, is substantially equivalent to its predicate device (Tamarin Blue PTCA RX Dilatation Catheter, K112735) and equivalent to a reference device (Filao NC RX PTCA Dilatation Catheter, K141933) for the coating aspects.

The testing evaluated various performance characteristics, including:

Coating Inspection
Coating Integrity (Performance and Durability)
Balloon preparation, deployment and retraction
Balloon Rated Burst
Balloon Fatigue
Balloon compliance
Balloon inflation/deflation
Particulate

The conclusion from these tests was that the hydrophilic coating performed as intended, did not impact the functionality of the device, and that the subject device "met all acceptance criteria" and is biocompatible. The technological characteristics, intended use, and indications for use were found to be identical or substantially similar, with any differences not raising new questions of safety or effectiveness.

Summary

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July 20, 2021

Natec Medical Ltd. % Candace Cederman Principal Consultant CardioMed Device Consultants LLC 1783 Forest Drive, Suite 254 Annapolis, Maryland 21401

Re: K210012

Trade/Device Name: Tamarin Blue PTCA RX Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX

Dear Candace Cederman:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 9, 2021. Specifically, FDA is updating this SE Letter typo in the Company name as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, 301-796-6075, Gregory.Oconnell@fda.hhs.gov.

Sincerely,

For

Digitally signed by Sara M. Sara M. Royce -S · Date: 2021.07.20 ROYCE -S Date: 2021.07.2

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.

July 9, 2021

Nantec Medical Ltd. c/o Candace Cederman Principal Consultant CardioMed Device Consultants LLC 1783 Forest Drive, Suite 254 Annapolis, Maryland 21401

Re: K210012

Dear Candace Cederman:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sara M. Digitally signed by
Sara M. Royce -S
Date: 2021.07.09
Royce -S 16:46:28 -04'00'

For

Enclosure

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Indications for Use

510(k) Number (if known) K210012

Device Name Tamarin Blue PTCA RX Dilatation Catheter

Indications for Use (Describe)

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)

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510(k) Summa [as required by 21 CFR 807.92(c)]

Tamarin Blue PTCA RX Dilatation Catheter 510(k) K210012

DATE PREPARED:	July 9, 2021
APPLICANT:	Natec Medical Ltd.Maeva Centre Building – Ebene Business ParkReduit 72201, Mauritius
CONTACT:	Roy Devassy Pallippatt, Regulatory Affairs Manager
TRADE NAME:	Tamarin Blue PTCA RX Dilatation Catheter
COMMON NAME:	PTCA RX Catheter
CLASSIFICATION	Catheters, transluminal coronary angioplasty, percutaneous
REGULATION:	(21 CFR §870.5100, Product Code LOX)
DEVICE CLASS:	Class II
PANEL CODE:	Cardiovascular
PREDICATE DEVICE:	Tamarin Blue PTCA RX Dilatation Catheter, K112735
REFERENCE DEVICES:	Filao NC RX PTCA Dilatation Catheter, K141933

INTENDED USE/INDICATIONS FOR USE:

DEVICE DESCRIPTION:

The device is supplied sterile and intended for one-time use.

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COMPARISON WITH PREDICATE DEVICE:

Comparisons of the Tamarin Blue PTCA RX Dilatation Catheter and the predicate device shows that the technological characteristics of the subject device such as components, design, sterilization method, shelf life and operating principle are identical to the currently marketed predicate device. Comparison of the subject device to the reference device show that the material, specifically the hydrophilic coating, are identical. Therefore, the addition of a hydrophilic coating to the subject device does not raise any new questions of safety or effectiveness.

The intended use/indications for use between the subject device and the predicate device are identical.

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becial 510(k) Premarket Notification – Tamarin Blue PTCA RX Dilatation Cathet

Device Name	Subject	Predicate	Reference
Manufacturer	Natec Medical Ltd	Natec Medical Ltd	Natec Medical Ltd
510(k)		K112735	K141933
Intended Use/IndicationFor Use	• balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion	• balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion	• balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion• balloon dilatation of a stent after implantation (balloon models 2.00mm – 4.50mm)
Regulation	21 CFR 870.5100	21 CFR 870.5100	21 CFR 870.5100
Regulation Name	Catheters, transluminal coronary angioplasty, percutaneous	Catheters, transluminal coronary angioplasty, percutaneous	Catheters, transluminal coronary angioplasty, percutaneous
Regulation Class	Class II	Class II	Class II
Product Code	LOX	LOX	LOX
Prescription/OTC	Prescription	Prescription	Prescription
Device Design/Processing
Catheter Design	Rapid Exchange	Rapid Exchange	Rapid Exchange
Balloon diameter (mm)	1.5-4.0	1.5-4.0	2.0-4.5
Balloon length (mm)	8 to 30	8 to 30	8 to 30
Effective Length (mm)	1400	1400	1400
Balloon Compliance	Semi-compliant	Semi-compliant	Non-compliant
Coating	Hydrophilic	None	Hydrophilic
Sterilization Method	EO	EO	EO
Performance Specifications
Nominal Pressure	8 atm	8 atm	12 atm
Rated Burst Pressure	16 atm	16 atm	20 atm

COMPARISON WITH PREDICATE AND REFERENCE DEVICES:

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NON-CLINICAL TESTING/PERFORMANCE DATA:

Non-clinical bench testing was performed on the subject device to determine substantial equivalence. The testing performed is as follows:

Coating Inspection
Coating Integrity (Performance and Durability)
Balloon preparation, deployment and retraction
Balloon Rated Burst
Balloon Fatigue ●
Balloon compliance
Balloon inflation/deflation
Particulate ●

In vitro bench testing demonstrated that the hydrophilic coating performed as intended and did not impact the functionality of the device.

BIOCOMPATIBILITY:

The Tamarin Blue PTCA RX Dilatation Catheter was compared to the predicate and reference devices, Based on similarities of the materials used in the subject device to its predicates / reference devices, the biocompatibility of the Tamarin Blue PTCA RX Dilatation Catheter was verified to be the same as those of the predicates / reference devices.

The results are being leveraged due to the similarities in the underlying materials to which the hydrophilic coating is applied.

The results of the testing show that the subject device in this submission met all acceptance criteria and the subject device is biocompatible.

CONCLUSION:

The Tamarin Blue PTCA RX Dilatation Catheter included in this notification is identical to the previously cleared predicate device in terms of intended use and technological characteristics. Any differences that exist between the Tamarin Blue PTCA RX Dilatation Catheter and the predicate did not raise any new questions of safety or effectiveness,

The Tamarin Blue PTCA RX Dilatation Catheter is substantially equivalent to the reference product cleared in the US in terms of biocompatibility.

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.