Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature including iliac, femoral, popliteal, tibial, peroneal, subclavian, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature

Device Description

The Amethyst HP PTA OTW 0.035 catheter is a balloon catheter consisting of an over the wire catheter with a non-compliant inflatable balloon fixed at the distal end of the tip. The balloons are designed to provide consistent balloon diameters and lengths at high pressures. A radiopaque tapered tip positioned at distal of the balloon facilitates the advancement of the catheter to and through the stenosis. A Luer lock fitting (Y hub) at the proximal end allows connection with an inflation device. The catheter is a co-axial catheter with a balloon at the distal tip. One lumen is used for the inflation of the balloon and is accessed via the lateral port of the Y hub. The second lumen, start at the straight entry port of the Y hub, allows access to the distal tip of the catheter for guide wire insertion. The balloon has two radiopaque markers to aid in positioning the balloon relative to stenosis. The balloon is dilated using the lateral port, at which the balloon opens to a known diameter at a specific pressure. The maximum recommended guide wire diameter is 0.035". The catheter is supplied sterile and is intended for single use.

AI/ML Overview

The provided text describes the Amethyst HP PTA OTW 0.035" Catheter, a medical device for Percutaneous Transluminal Angioplasty (PTA). This document is a 510(k) Summary, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

However, the information provided does not contain details about acceptance criteria or a study that proves the device meets the acceptance criteria in the context of an AI/ML model for medical image analysis, which your request implies. The document focuses on the physical and performance characteristics of a catheter, and the "performance data" listed are standard non-clinical tests for such a device.

Here's an analysis based on the information available in the document, with a clear statement that the requested AI/ML specific information is not present:

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

The document lists various performance tests carried out on the catheter, and states that the "subject device... met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, FDA guidance documents and test protocols." However, it does not provide a table specifying the quantitative acceptance criteria for each test or the reported numerical performance outcomes.

Instead, it lists the types of tests performed. To illustrate the concept of such a table based on the provided test types for a physical device, it would generally look like this (but the actual data is missing from the document):

Test Category	Specific Test Parameter	Acceptance Criteria	Reported Device Performance
Dimensional	Catheter Dimensions	Within X% of nominal dimensions	All met
Mechanical	Balloon Rated Burst Pressure	> Y atm	All met
	Balloon Fatigue (Repeat Infl.)	> Z cycles without failure	All met
	Catheter Torque Strength	> A N*cm	All met
Material	Biocompatibility	Negative for toxicity, etc.	All biocompatibility tests passed
Packaging & Sterility	Package Integrity	No leaks, seals intact	All met
	Product Sterility	Sterile	Sterile

Please note: The actual numerical acceptance criteria and reported performance values are not detailed in the provided text. The document only states that "all the predetermined acceptance criteria" were met.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document relates to a physical medical device (catheter), not an AI/ML system. Therefore, the concepts of "test set," "data provenance," "country of origin," "retrospective or prospective" for data, and "number of experts" are not applicable in the way they would be for an AI/ML study.

For the non-clinical performance tests described (e.g., Catheter Torque Strength, Balloon Rated Burst Pressure), the sample sizes are not explicitly stated. The testing would typically involve a specific number of devices or components to statistically ensure reliability, but these details are not in the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to the type of device and study described. The document is about a physical catheter, not an AI/ML system requiring expert-established ground truth from a test set.

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

This question is not applicable to the type of device and study described.

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

This question is not applicable to the type of device and study described. The document does not describe an AI-assisted diagnostic or interpretive system.

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

This question is not applicable to the type of device and study described.

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

This question is not applicable to the type of device described. The "truth" for this device's performance is determined by meeting physical and mechanical specifications through direct measurement and testing against established engineering standards and regulatory guidance, not by medical ground truth as in a diagnostic study.

8. The sample size for the training set

This question is not applicable as this is not an AI/ML device.

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

This question is not applicable as this is not an AI/ML device.

In summary: The provided FDA 510(k) summary pertains to a physical medical device (a catheter) and outlines non-clinical performance testing (e.g., mechanical, material, packaging tests) to demonstrate substantial equivalence. It does not describe an AI/ML-based device or a study involving data sets, ground truth establishment by experts, or metrics like sensitivity/specificity, which are associated with AI/ML performance evaluations. Therefore, most of the questions related to AI/ML study specifics cannot be answered from the provided text.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol on the left is a stylized image of a bird or eagle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 18, 2024

Roy Devassy Pallippatt Head of Quality and Regulatory Affairs Maeva Centra Building, Silicon Avenue, Ebene Business Park Reduit, 72201 Mauritius

Re: K241040

Trade/Device Name: Amethyst HP PTA OTW 0.035" Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: November 4, 2024 Received: November 15, 2024

Dear Roy Devassy Pallippatt:

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 (the 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. 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Gregory W. O'connell -S Digitally signed by Gregory W. O'connell -S Date: 2024.12.18 15:09:03 -05'00'

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

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241040

Device Name

Amethyst HP PTA OTW 0.035" Catheter

Indications for Use (Describe)

The Amethyst HP PTA OTW 0.035" catheter is indicated for:

Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature including iliac, femoral, popliteal, tibial, peroneal, subclavian, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) SUMMARY

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807.92.

Applicant:	Natec Medical Ltd.AVA technopark,MedTech road,Cote D'Or Technopole,Minissy, Cote D'orMoka - 80829, Mauritius
Official Correspondent:	Roy Devassy PallippattHead of Quality & Regulatory AffairsNatec Medical Ltd.AVA technopark,MedTech road,Cote D'Or Technopole,Minissy, Cote D'orMoka - 80829, MauritiusTel: +230 466 30 54Fax: +230 466 67 70Email: rdpallippatt@natec-medical.com
Preparation Date:	Dec 17, 2024
Device Name:
Trade Name:	Amethyst HP PTA OTW 0.035" Catheter
Common/Regulatory name:	Percutaneous catheter
Classification Name:	Percutaneous transluminal angioplasty catheter
Generic name:	PTA Catheter
Regulation Number:	21 CFR 870.1250
Product Code:	LIT
Device Class:	Class II

Conquest™ 40 PTA Dilatation Catheter - K212588/ K120660 Predicate Devices:

Device Description:

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tapered tip positioned at distal of the balloon facilitates the advancement of the catheter to and through the stenosis. A Luer lock fitting (Y hub) at the proximal end allows connection with an inflation device. The catheter is a co-axial catheter with a balloon at the distal tip. One lumen is used for the inflation of the balloon and is accessed via the lateral port of the Y hub. The second lumen, start at the straight entry port of the Y hub, allows access to the distal tip of the catheter for guide wire insertion. The balloon has two radiopaque markers to aid in positioning the balloon relative to stenosis. The balloon is dilated using the lateral port, at which the balloon opens to a known diameter at a specific pressure. The maximum recommended guide wire diameter is 0.035". The catheter is supplied sterile and is intended for single use.

The Amethyst HP PTA OTW 0.035" catheter is available in following sizes:

Catheter Usable lengths 50, 75 & 135 cm
Balloon Size	Balloon Length (mm)
	20	40	60	80	100
BalloonDiameter (mm)	7.00	✓	✓	✓	✓	✓
	8.00	✓	✓	✓	✓	✓
	9.00	✓	✓	✓	✓
	10.00	✓	✓	✓	✓

Table 1: Balloon Size Matrix

Device Indication for Use:

The Amethyst HP PTA OTW 0.035" Catheter is indicated for:

. Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature including iliac, femoral, popliteal, tibial, peroneal, subclavian, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

Comparison of Technical Characteristics:

The design, materials and manufacturing of the Amethyst HP PTA OTW 0.035" Catheter is same or similar to those used for the predicate devices. The intended use for the Amethyst HP PTA OTW 0.035" Catheter is also comparable to the predicate devices.

Biocompatibility:

All materials used in the Amethyst HP PTA OTW 0.035" Catheter are biocompatible based on biocompatibility testing results. The device has been tested according to "ISO 10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing' and 21 CFR 58 (GLP regulations).

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The following biocompatibility tests were completed on the Amethyst HP PTA OTW 0.035" Catheter:

. Acute Systemic Toxicity Study
. Cytotoxicity Study
트 Hemolysis Test
Sc5b-9 Complement Activation
트 Intracutaneous Reactivity Test
트 Material Mediated Pyrogen Test
I Skin Sensitization Study
I Thromboresistance evaluation test
I Partial Thromboplastin Time (PTT) Assay test
Heparinized Blood Platelet and Leukocyte Count Assay 트

Performance Data:

Substantial equivalence has been demonstrated based on the results of non-clinical testing on the Amethyst HP PTA OTW 0.035" Catheter which addressed the following considerations:

Dimensional Verification
I Balloon Fatigue test (Repeat Balloon Inflations)
Catheter Torque Strength evaluation
트 Balloon Fatigue in stent (Repeat Balloon Inflations)
트 Balloon Inflation and Deflation Time
트 Balloon Rated Burst Pressure (RBP) and compliance test
I Balloon Rated Burst Pressure (RBP in Stent)
트 Catheter Bond (sleeve, hub and tip) Strength
Balloon Preparation, Deployment and Retraction ■
트 PTA Catheter Performance test
Flexibility and kink test
트 SEM analysis
트 Simulated shipping and climatic conditioning (shipping) study
I Package integrity testing
- Packaging box and label visual inspection o
- Seal & Peelable pouch Visual Inspection O
- Seal width (Dimensional) Verification O
- Seal tensile strength O
- Peeled pouch Seal Visual Inspection O
- Seal Dye Penetration O
- Bubble leak test O
- Product Sterility test O

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Conclusion:

The subject device, the Amethyst HP PTA OTW 0.035" Catheter met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, FDA guidance documents and test protocols. No new safety and effectiveness questions were raised based on the testing program.

Based on the similarities in the indication for use, device design, materials and the results of the non-clinical testing and analysis, the Amethyst HP PTA OTW 0.035" Catheter is considered substantially equivalent to the aforementioned predicate devices.

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).