The M-CATH Microcatheter is intended to provide support to the guide wire while performing PCI (percutaneous coronary intervention) and to facilitate the exchange of guide wires while maintaining access to distal vasculature. The device is also intended to deliver radiopaque contrast media into the coronary vasculature.

Device Description

M-CATH™ consists of a catheter shaft, a hypotube and a hub. The catheter shaft has reinforcing braided mesh with high torquability. The outer surface of the catheter is coated with a hydrophilic polymer with a high lubricity upon moistening, hence, enhancing maneuverability and patient comfort.

The microcatheter has one distal radiopaque marker proximal at the distal tip.

The shaft has a central guidewire lumen which permits the use of a guide wire with maximum diameter of 0.014" (0.36 mm). The guidewire lumen begins at the proximal luer port and ends at the distal tip. At the proximal end the catheter has a hub with one port. The catheter is compatible with any 5F guiding catheter.

The main materials are stainless steel, PTFE and Pebax (braided shaft), stainless steel and Teflon (hypotube), Makrolon (luer), and Pt/Ir alloy (radiopaque marker). The coating is hydrophilic, based on hyaluronic acid.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the M-CATH Microcatheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's absolute safety and effectiveness through extensive clinical trials. Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, expert involvement, and ground truth establishment, especially in the context of AI/ML performance, is not directly applicable to this document.

However, I can extract the information that is present and indicate where certain details are not provided due to the nature of a 510(k) submission for this type of device.

Here's a breakdown based on the provided document:

Acceptance Criteria and Device Performance

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

The document does not provide a table with specific quantitative acceptance criteria or a direct comparison of the M-CATH Microcatheter's performance against numerical targets. Instead, it states that "The in vitro bench tests demonstrated that M-CATH™ microcatheter met all acceptance criteria and performed similarly to the predicate devices."

The performance data mentioned relates to a series of bench tests. These tests are implicitly the basis for demonstrating that the device meets its design specifications and functional requirements for safe and effective use, thereby meeting "acceptance criteria" through a demonstration of substantial equivalence.

General Bench Test Categories Performed:

Acceptance Criteria Category	Reported Device Performance (Summary Statement)
Dimensional Verification	Met all acceptance criteria and performed similarly to predicate devices.
Ancillary Device Compatibility Test	Met all acceptance criteria and performed similarly to predicate devices.
Pushability and Trackability Testing	Met all acceptance criteria and performed similarly to predicate devices.
Catheter Bond Strength	Met all acceptance criteria and performed similarly to predicate devices.
Tip Pull Test	Met all acceptance criteria and performed similarly to predicate devices.
Flexibility and Kink Test	Met all acceptance criteria and performed similarly to predicate devices.
Torque Strength Test	Met all acceptance criteria and performed similarly to predicate devices.
Coating Lubricity	Met all acceptance criteria and performed similarly to predicate devices.
Particulate Evaluation – Coating Integrity	Met all acceptance criteria and performed similarly to predicate devices.
Particulate Evaluation - Coating Integrity (Coating Inspection)	Met all acceptance criteria and performed similarly to predicate devices.
Radiopacity	Met all acceptance criteria and performed similarly to predicate devices.
Maximum Labeled Pressure	Met all acceptance criteria and performed similarly to predicate devices.
Media Flow Rate	Met all acceptance criteria and performed similarly to predicate devices.
Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity/Irritation, Acute Systemic Toxicity, Hemocompatibility, Hematology: ASTM Hemolysis, Complement Activation Assay (Sc5b9), In vivo thromboresistance, Chemical Characterization)	Blood contacting materials were found to be biocompatible in accordance with ISO 10993 recommendations.

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

The document states that "Bench testing was performed on the M-CATH™ microcatheter." However, it does not specify the sample size for each bench test performed. Given that these are bench tests for a physical medical device (a microcatheter) and not an AI/ML model, the concept of "data provenance" (country of origin, retrospective/prospective) in the context of clinical data is not applicable here. The data would have been generated from laboratory testing of manufactured catheter samples.

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

This information is not applicable to this 510(k) submission. The "ground truth" for the performance of a physical medical device like a microcatheter in bench testing is typically established by engineering specifications, accepted industry standards, and comparisons to legally marketed predicate devices, not by expert interpretation of data in the way one would assess AI/ML diagnostic performance. There is no mention of expert radiologists or similar qualifications being used to establish "ground truth" for these engineering tests.

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

This information is not applicable to this 510(k) submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or interpretations, especially when establishing ground truth for AI/ML validation. The document describes bench testing of a physical device.

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 information is not applicable to this 510(k) submission. The M-CATH Microcatheter is a physical medical device (a microcatheter), not an AI/ML diagnostic or assistive device. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance would have been conducted or reported here.

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

This information is not applicable to this 510(k) submission. As mentioned, this is a physical medical device, not an algorithm or AI system.

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

For the M-CATH Microcatheter, the "ground truth" for its performance is established through adherence to engineering specifications, recognized national/international standards (e.g., ISO 10993 for biocompatibility), and comparability to the established performance characteristics of the predicate devices. This is demonstrated through objective bench testing. The concepts of expert consensus, pathology, or outcomes data related to diagnostic accuracy are not relevant here.

8. The sample size for the training set

This information is not applicable to this 510(k) submission. There is no "training set" in the context of a physical medical device. This term is relevant for AI/ML models.

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

This information is not applicable to this 510(k) submission. (See response for #8).

Summary

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Public Health Service

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

Acrostak (Schweiz) AG Carmen Herraez Clinical and Regulatory Affairs Manager Stegackerstrasse 14 CH-8409 Winterthur Switzerland

Re: K171176

Trade/Device Name: M-CATH Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, KRA Dated: August 9, 2017 Received: August 17, 2017

Dear Carmen Herraez:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 (DICE) 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 (DICE) 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.

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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Indications for Use

510(k) Number (if known)

K171176

Device Name M-CATH Microcatheter

Indications for Use (Describe)

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

☑ Depreciative Use (Part 21 CFR 601, Subpart D)
☐ Over-The-Counter Use (21 CFR 201.66)

Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image contains the logo for Acrostak. The logo features a red plus sign on the left, followed by the word "Acrostak" in a dark gray, sans-serif font. Below "Acrostak" is the text "Devices for interventional applications" in a smaller, lighter gray font, underlined with a red line.

8409 Winterthur Switzerland Phone +41 (0)52 233 95 51 Fax+41 (0)52 233 95 50

510(k) Summary [as required by 21 CFR 807.92] M-CATH™ Microcatheter

DATE PREPARED	August 30th, 2017
TRADE NAME	M-CATH™ microcatheter
COMMON NAME	Microcatheter
DEVICE CLASSIFICATION	Class II per 21 CFR §870.1250
PRODUCT CODE	DQY, Percutaneous Catheter

1. PREDICATE DEVICE

The predicate devices are Finecross® MG and Asahi Corsair, which are manufactured by Terumo Corporation and Asahi Intecc Co LTD, respectfully. The predicate devices have been cleared through the premarket notification process (Finecross® MG in K082519 and Asahi Corsair in K083127).

2. INTENDED USE

The M-CATH microcatheter is intended to provide support to the guide wire while performing PCI (percutaneous coronary intervention) and to facilitate the exchange of guide wires while maintaining access to distal vasculature. The device is also intended to deliver radiopaque contrast media into the coronary vasculature.

3. DEVICE DESCRIPTION

The microcatheter has one distal radiopaque marker proximal at the distal tip.

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Image /page/4/Picture/0 description: The image contains the logo for Acrostak. The logo features a red plus sign on the left, followed by the word "Acrostak" in gray, bold font. Underneath the word "Acrostak" is a thin red line, and below that is the text "Devices for interventional applications" in a smaller, lighter gray font.

4. PRINCIPLE OF OPERATION / TECHNOLOGY

M-CATH™ microcatheter is operated manually or by a manual process. The catheter should only be used by physicians trained in the performance of PCI.

5. SPECIFICATIONS

Usable length of catheter:	135 cm
Outer diameter of catheter (distal end):	2.25 Fr (0.75mm)
Outer diameter of catheter (middle):	3.30 Fr (1.10mm)
Outer diameter of catheter (proximal end):	2.10 Fr (0.70mm)
Inner diameter of catheter (distal end):	0.016" (0.40mm)
Inner diameter of catheter (proximal end):	0.018" (0.45mm)
Radiopaque markers:	1

6. PERFORMANCE DATA

Bench testing was performed on the M-CATH™ microcatheter to determine substantial equivalence. The following testing/assessments were performed:

1. Dimensional Verification
1. Ancillary Device Compatibility Test
Pushability and Trackability Testing 3)
1. Catheter Bond Strength
Tip Pull Test 5)
ର) Flexibility and Kink Test
1. Torque Strength Test
1. Coating Lubricity
a) Particulate Evaluation – Coating Integrity
1. Particulate Evaluation - Coating Integrity (Coating Inspection)
Radiopacity 11)
Maximum Labeled Pressure 12)
1. Media Flow Rate

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Image /page/5/Picture/1 description: The image shows the logo for Acrostak. The logo consists of a red plus sign on the left, followed by the word "Acrostak" in gray. A red line is underneath the word "Acrostak", and below the line is the text "Devices for interventional applications" in gray.

The in vitro bench tests demonstrated that M-CATH™ microcatheter met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrates that the device functions as intended, and is substantially equivalent to the predicate devices. The M-CATH™ microcatheter shelf life will be 3 years.

7. BIOCOMPATIBILITY TESTING

Blood contacting materials were tested in accordance with the test recommendations in International Standard ISO 10993, "Biological Evaluation of Medical Devices - Part I: Evaluation and Testing." The blood contacting materials were found to be biocompatible. The following biocompatibility and chemical characterization tests were performed:

Cytotoxicity .
트 Sensitization
트 Intracutaneous Reactivity/Irritation
Acute Systemic Toxicity
. Hemocompatibility
. Hematology: ASTM Hemolysis
Complement Activation Assay (Sc5b9)
I In vivo thromboresistance
트 Chemical Characterization

8. SUBSTANTIAL EQUIVALENCE

M-CATH™ microcatheter is substantially equivalent in intended use, principle of operation, technological characteristics, materials and performance to the Finecross® MG and Asahi Corsair, which are manufactured by Terumo Corporation and Asahi Intecc Co LTD, respectfully.

The submitted data demonstrates that the device is substantially equivalent as the legally marketed devices, and that the minor differences in materials and design do not raise different questions of substantial equivalence to the predicate devices.

Submitter Name and Address:	Acrostak (Schweiz) AGStegackerstrasse 14CH-8409 Winterthur,SwitzerlandT.+41 22 347 68 70F.+41 52 233 95 50
Contact Person:	Carmen HerraezClinical and Regulatory Affairs ManagerT.+41 (0)22 533 23 03F.+41 52 233 95 50carmen.herraez@acrostak.com

9. SUBMITTER INFORMATION

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).