(112 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of the catheter, with no mention of AI, ML, or image processing.
Yes
The device is intended for the "removal of thrombi and thrombi from vessels of the arterial system," which is a treatment action directed at a pathological condition.
No
This device is intended for the removal of thrombi and emboli from vessels, which is a therapeutic action, not a diagnostic one. It does not provide information about a medical condition.
No
The device description clearly details physical components such as catheters, guide wires, syringes, and other accessories, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the removal of thrombi and emboli from blood vessels. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description details a catheter designed for insertion into blood vessels and the physical removal of material. This is consistent with an interventional medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing biological samples like blood, urine, or tissue.
Therefore, the Merit ASAP® and ASAPLP™ Aspiration Catheters are not IVD devices. They are interventional medical devices used for therapeutic purposes.
N/A
Intended Use / Indications for Use
The Merit ASAP® Aspiration Catheter is intended for the removal and thrombi and thrombi from vessels of the arterial system. Not for use in cerebral vasculature.
The Merit ASAPLP™ Aspiration Catheter is intended for the removal of fresh, soft emboli and thrombi from vessels of the arterial system. Not for use in cerebral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
QEZ
Device Description
The Merit ASAP aspiration Catheter is a dual lumen rapid exchange catheter, compatible with 0.014"/0.36 mm quide wires with related accessories. The catheter has a maximum outer diameter of 0.068"/1.73mm and a working length of 140 cm. The catheter has a radiopaque marker band located approximately 2 mm proximal to the distal tip. The catheter has three (3) non-radiopaque positioning marks located approximately 90 cm, 100 cm, and 110 cm proximal of the distal tip. The distal reqion has a hydrophilic coating. The rapid exchange lumen is 12cm in length. The ASAPLP Aspiration Catheter is a dual lumen rapid exchange catheter, compatible with 0.014"/0.36 mm guide wires. It is packaged Device with related accessories including a stiffening stylet. The catheter has Description a maximum outer diameter of 0.055"/0.140 cm and a working length of 145cm. The catheter has a radiopaque marker band located approximately 2 mm proximal to the distal tip. The catheter has three (3) non-radiopaque positioning marks located approximately 90 cm. 100 cm and 110 cm proximal of the distal tip. The distal region has a hydrophilic coating. The rapid exchange lumen is 20 cm in length. The associated accessories packaged with the device include: Tubing Connector Set with (1) Large Bore Stopcock ● RXP® Rapid Exchange Prep Syringe ● (2) 30 mL VacLok™ syringes ● Microstop Waste Basin with Lid and (2) 70 Micron Pore Filter . Baskets
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vessels of the arterial system. Not for use in cerebral vasculature.
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)
Performance testing of the subject ASAP® and ASAPLP™ Aspiration Catheters was conducted based on the risk analysis and based on the requirements of the following international standards:
ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters – Part 1: General requirements
ISO 80369-7:2021 Small Bore Connectors for liquids and gases in healthcare applications – Part 7: Connectors for intravascular or hypodermic applications
ISO 10993-1:2018, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” (2020).
ISO 10993-4: 2017, Biological Evaluation of Medical Devices Part- 4: Selection of Tests for Interactions with Blood
ISO 10993-5:2009 (Amd, 2017), Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2013, Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2017, Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
United States Pharmacopeia (USP) 43-National Formulary (NF) 37: 2019 Pyrogen Test.
Biocompatibility testing:
The biocompatibility evaluation for the ASAP® and ASAPLP™ Aspiration Catheters was conducted in accordance with ISO 10993-1 (2018), Biological Evaluation of Medical Devices- Part 1: Evaluation and testing within a risk management process and the FDA guidance document, Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” (2020). The battery of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Pyrogenicity
- Hemolysis
Performance Testing-Bench:
- Force at break
- ISO 80369-7 Dimensional and functional testing
Key Results: The results of the testing demonstrated that the subject ASAP® and ASAPLP™ Aspiration Catheters met the predetermined acceptance criteria applicable to the safety and efficacy of the device.
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.
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
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 3, 2021
Merit Medical Systems, Inc. Kirk McIntosh Regulatory Affairs Specialist II 1600 West Merit Parkway South Jordan, Utah 84095
Re: K212199
Trade/Device Name: ASAP® Aspiration Catheter, ASAPLP™ Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEZ Dated: October 4, 2021 Received: October 5, 2021
Dear Kirk Mcintosh:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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,
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
2
Indications for Use
510(k) Number (if known) K212199
Device Name ASAP® Aspiration Catheter (ASAP100); ASAPLPTM Aspiration Catheter (ASAPLP)
Indications for Use (Describe)
The Merit ASAP® Aspiration Catheter is intended for the removal and thrombi and thrombi from vessels of the arterial system. Not for use in cerebral vasculature.
The Merit ASAPLP™ Aspiration Catheter is intended for the removal of fresh, soft emboli and thrombi from vessels of the arterial system. Not for use in cerebral 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) |
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3
Merit Medical ASAP® and ASAPLP™ 510(k) Summary K212199
| General
Provisions | Submitter Name:
Address:
Telephone Number:
Contact Person:
Date Prepared:
Registration Number: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
(801) 316-3695
Kirk McIntosh
July 13, 2021
1721504 |
|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:
Common/Usual Name:
Classification Name:
Regulatory Class:
Product Code:
21 CFR §:
Review Panel: | ASAP® and ASAPLP™ Aspiration Catheters
Embolectomy Catheter
Embolectomy Catheter
2
QEZ
870.5150
Cardiovascular |
| Primary
Predicate | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | ASAP® Aspiration Catheter
Embolectomy Catheter
K100569
Merit Medical Systems, Inc. |
| This predicate has not been subject to a design-related recall | | |
| Secondary
Predicate | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | ASAPLP™ Aspiration Catheter
Embolectomy Catheter
K132155
Merit Medical Systems, Inc. |
| This predicate has not been subject to a design-related recall | | |
4
The Merit ASAP aspiration Catheter is a dual lumen rapid exchange catheter, compatible with 0.014"/0.36 mm quide wires with related accessories. The catheter has a maximum outer diameter of 0.068"/1.73mm and a working length of 140 cm. The catheter has a radiopaque marker band located approximately 2 mm proximal to the distal tip. The catheter has three (3) non-radiopaque positioning marks located approximately 90 cm, 100 cm, and 110 cm proximal of the distal tip. The distal reqion has a hydrophilic coating. The rapid exchange lumen is 12cm in length. The ASAPLP Aspiration Catheter is a dual lumen rapid exchange catheter, compatible with 0.014"/0.36 mm guide wires. It is packaged Device with related accessories including a stiffening stylet. The catheter has Description a maximum outer diameter of 0.055"/0.140 cm and a working length of 145cm. The catheter has a radiopaque marker band located approximately 2 mm proximal to the distal tip. The catheter has three (3) non-radiopaque positioning marks located approximately 90 cm. 100 cm and 110 cm proximal of the distal tip. The distal region has a hydrophilic coating. The rapid exchange lumen is 20 cm in length. The associated accessories packaged with the device include: Tubing Connector Set with (1) Large Bore Stopcock ● RXP® Rapid Exchange Prep Syringe ● (2) 30 mL VacLok™ syringes ● Microstop Waste Basin with Lid and (2) 70 Micron Pore Filter . Baskets The Merit ASAP® Aspiration Catheter is intended for the removal of
fresh, soft emboli and thrombi from vessels of the arterial system. Not for use in cerebral vasculature.
- The Merit ASAPLP™ Aspiration Catheter is intended for the removal of Indications for Use fresh, soft emboli and thrombi from vessels of the arterial system. Not for use in cerebral vasculature.
Note: There is no change in the Indications for Use statement from the predicate to the subject devices.
5
| Comparison to
Predicate
Device | The subject devices are substantially equivalent to the predicate
devices based on an identical Indications for Use statement, the same
basic performance and safety profile, principle of operation,
fundamental design principles, and manufacturing technology.
The primary reason for submitting this Special 510(k) is the change to
the Luer hub material formulation for both the ASAP and ASAPLP
catheter configurations and update to the new ISO 80369-7 Luer
standard.
There are no changes to the associated accessories. |
|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance
Data | No performance standards have been established under Section 514 of
the Food, Drug and Cosmetic Act for these devices. Performance
testing of the subject ASAP® and ASAPLP™ Aspiration Catheters was
conducted based on the risk analysis and based on the requirements of
the following international standards:
ISO 10555-1:2013 Intravascular catheters - Sterile and single-use
catheters – Part 1: General requirements ISO 80369-7:2021 Small Bore Connectors for liquids and gases in
healthcare applications – Part 7: Connectors for intravascular or
hypodermic applications ISO 10993-1:2018, Biological Evaluation of Medical Devices Part
1: Evaluation and Testing within a risk management process, and
FDA guidance Use of International Standard ISO 10993-1,
"Biological evaluation of medical devices – Part 1: Evaluation and
testing within a risk management process” (2020). ISO 10993-4: 2017, Biological Evaluation of Medical Devices Part-
4: Selection of Tests for Interactions with Blood ISO 10993-5:2009 (Amd, 2017), Biological evaluation of medical
devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2013, Biological evaluation of medical devices –
Part 10: Tests for irritation and skin sensitization ISO 10993-11:2017, Biological evaluation of medical devices –
Part 11: Tests for systemic toxicity United States Pharmacopeia (USP) 43-National Formulary (NF)
37: 2019 Pyrogen Test. |
| Safety &
Performance
Tests cont. | The following performance data were provided in support of the
substantial equivalence determination.
Biocompatibility testing |
| and testing within a risk management process and the FDA guidance | |
| document, Use of International Standard ISO 10993-1, “Biological | |
| evaluation of medical devices – Part 1: Evaluation and testing within a | |
| risk management process” (2020). The battery of testing included the | |
| following tests: | |
The biocompatibility evaluation for the ASAP® and ASAPLP™
Aspiration Catheters was conducted in accordance with ISO 10993-1 (2018), Biological Evaluation of Medical Devices- Part 1: Evaluation
6
- Cytotoxicity
- Sensitization ●
- Irritation ●
- Acute Systemic Toxicity ●
- Pyrogenicity ●
- . Hemolysis
The ASAP® and ASAPLP™ Aspiration Catheters are considered tissue contacting for a duration of less than 24 hours.
Performance Testing-Bench
- Force at break ●
- . ISO 80369-7 Dimensional and functional testing
The results of the testing demonstrated that the subject ASAP® and ASAPLP™ Aspiration Catheters met the predetermined acceptance criteria applicable to the safety and efficacy of the device.
Summary of Substantial Equivalence
Based on the indications for use, design, safety and performance testing, the subject ASAP® and ASAPLP™ Aspiration Catheters meet the requirements that are considered essential for their intended use and are substantially equivalent to their predicate devices, the ASAP® and ASAPLP™ Aspiration Catheters, K100569 and K132155, manufactured by Merit Medical Systems, Inc.