(147 days)
Not Found
No
The description focuses on the mechanical and material properties of a physical catheter and does not mention any computational or algorithmic components.
No
The device is a microcatheter used to support guidewires, facilitate guide wire exchange, and deliver contrast media during PCI, which are procedural functions rather than direct therapeutic actions or treatments for a disease.
No
The device's intended use is to provide support to a guide wire, facilitate guide wire exchange, and deliver contrast media, all of which are interventional rather than diagnostic functions.
No
The device description clearly outlines physical components (catheter shaft, hypotube, hub, radiopaque marker) and materials (stainless steel, PTFE, Pebax, Makrolon, Pt/Ir alloy). The performance studies are bench tests evaluating physical characteristics and functionality of the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during a medical procedure (PCI) to assist with guide wire manipulation and contrast media delivery within the patient's body. This is an in vivo application.
- Device Description: The description details a physical catheter designed to be inserted into the coronary vasculature.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests on samples taken from the body, typically in a laboratory setting. This device is a tool used directly within the patient during a procedure.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DQY, KRA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The catheter should only be used by physicians trained in the performance of PCI.
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
Summery of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed on the M-CATH™ microcatheter to determine substantial equivalence. The following testing/assessments were performed:
-
- Dimensional Verification
-
- Ancillary Device Compatibility Test
- Pushability and Trackability Testing 3)
-
- Catheter Bond Strength
- Tip Pull Test 5)
- Flexibility and Kink Test
-
- Torque Strength Test
-
- Coating Lubricity
- a) Particulate Evaluation – Coating Integrity
-
- Particulate Evaluation - Coating Integrity (Coating Inspection)
- Radiopacity 11)
- Maximum Labeled Pressure 12)
-
- Media Flow Rate
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.
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.
Finecross® MG in K082519, Asahi Corsair in K083127
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
§ 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).
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
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
1
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
2
Indications for Use
510(k) Number (if known)
Device Name M-CATH Microcatheter
Indications for Use (Describe)
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.
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)
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."
3
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
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.
4
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.
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.
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:
-
- Dimensional Verification
-
- Ancillary Device Compatibility Test
- Pushability and Trackability Testing 3)
-
- Catheter Bond Strength
- Tip Pull Test 5)
- ର) Flexibility and Kink Test
-
- Torque Strength Test
-
- Coating Lubricity
- a) Particulate Evaluation – Coating Integrity
-
- Particulate Evaluation - Coating Integrity (Coating Inspection)
- Radiopacity 11)
- Maximum Labeled Pressure 12)
-
- Media Flow Rate
5
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) AG
Stegackerstrasse 14
CH-8409 Winterthur,
Switzerland
T.+41 22 347 68 70
F.+41 52 233 95 50 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Carmen Herraez
Clinical and Regulatory Affairs Manager
T.+41 (0)22 533 23 03
F.+41 52 233 95 50
carmen.herraez@acrostak.com |