(118 days)
Not Found
No
The summary describes a mechanical aspiration catheter and its physical characteristics and performance testing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is intended for the removal of emboli and thrombi from vessels, which is a therapeutic intervention to treat blockages in the arterial system.
No
Explanation: The device is described as an aspiration catheter intended for the removal of emboli and thrombi, which is a therapeutic function, not a diagnostic one. The performance studies focus on mechanical and biological safety and efficacy, not on diagnostic accuracy.
No
The device description clearly outlines a physical catheter with lumens, a stylet, and other hardware components. The performance studies also focus on physical properties and simulated use in anatomical models, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Merit ASAPLP Aspiration Catheter is a device used inside the body (in vivo) to physically remove emboli and thrombi from blood vessels. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states its purpose is for the "removal of fresh, soft emboli and thrombi from vessels of the arterial system." This is a treatment, not a diagnostic test.
The description and testing performed also align with an in-vivo medical device, focusing on physical properties, performance within a simulated anatomical model, and biocompatibility.
N/A
Intended Use / Indications for Use
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
QEZ, DXE
Device Description
The ASAPLP Aspiration Catheter is a dual lumen rapid exchange catheter, compatible with 0.014”/0.36mm guide wires. It is packaged with related accessories including a stiffening stylet. The catheter has a maximum outer diameter of 0.055"/0.140cm and a working length of 145cm. The catheter has a radiopaque marker band located approximately 2mm proximal to the distal tip. The catheter has three (3) non-radiopaque positioning marks located approximately 90cm, 100cm and 110cm proximal of the distal tip. The distal region has a hydrophilic coating. The rapid exchange lumen is 20cm in length.
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
No applicable mandatory performance standards or special controls have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, a battery of tests was performed according to protocols based on the requirements of industry standards and the device risk analysis and the device met the acceptance criteria necessary to demonstrate the safety and efficacy of the device. Where appropriate, the tests were based on the requirements of the following documents: ISO 10555-1: 1995. Sterile, single-use intravascular catheters - Part 1: General requirements, ISO 594-1:1986, Conical Fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment - Part 1: General Requirements, ISO 594-2:1998, Conical Fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment - Part 2: Lock fittings, EN 13868: 2002, Test methods for kinking of single lumen catheters and medical tubing, ISO 11135-1: 2007, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, ASTM F640-12, Standard Test Methods for Determining Radiopacity for Medical Use, ASTM F756-08, Standard Practice for Assessment of Hemolytic Properties of Materials, ISO 10993-1: 2009, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing within a risk management process, ISO 10993-3: 2003, Biological Evaluation of Medical Devices Part-3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity, ISO 10993-4: 2002, Biological Evaluation of Medical Devices Part-4: Selection of Tests for Interactions with Blood, as amended 2006, ISO 10993-5: 2009, Biological Evaluation of Medical Devices Part-5 Tests for In Vitro Cytotoxicity, ISO 10993-7: 2008, Biological Evaluation of Medical Devices Part-7 Ethylene Oxide Sterilization Residuals, ISO 10993-10: 2010, Biological Evaluation of Medical Devices Part-10 Tests for Irritation and Skin Sensitization, ISO 10993-11: 2006, Biological Evaluation of Medical Devices Part-11 Tests for Systemic Toxicity, USP 35-151: 2012, United States Pharmacopeia 35, National Formulary 30, 2012 Pyrogen Test. The following is a list of all significant testing performed on the ASAPLP. All testing was successfully completed: Surface Condition / Visual, Corrosion Resistance, Force at Break, Catheter Liquid Leak under Pressure, Catheter Air Aspiration Leak, Dimensions, Luer Gauging Test, Luer Liquid Leak Test, Luer Air Aspiration Leak Test, Luer Separation Force Test, Luer Unscrewing Torque Test, Luer Ease of Assembly Test, Luer Resistance to Overriding Test, Luer Stress Cracking Test, Radio-Detectability, Kink, Stiffness, Aspiration, Flow, Coating Lubricity and Coverage, Marker Band Retention, Guide Wire Friction Test, Simulated Use Test in Anatomical Model, Simulated Aspiration and Use Test in Tortuous Path Model. Biocompatibility Tests: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Rabbit Pyrogen Test, Genotoxicity, Hemocompatibility, Physicochemical Tests.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 27, 2020
Merit Medical Systems, Inc. Susan Christensen Principal Regulatory Affairs Specialist 1600 West Merit Pkwy. South Jordan, Utah 84095
Re: K132155
Trade/Device Name: Merit ASAPLP Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ
Dear Susan Christensen:
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 November 7, 2013. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.
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.
Gregory W.
O'connell -S
Digitally signed by
Gregory W. O'connell -S
Date: 2020.07.27 08:18:30
-04'00'
Gregory O'Connell Assistant Director Plaque Modification Devices Team 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
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing. The overall design is simple and conveys a sense of government authority and public service.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 7, 2013
Merit Medical Systems, Inc. % Susan Christensen Principal Regulatory Affairs Specialist 1600 West Merit Pkwy. South Jordan, UT 84095 US
Re: K132155
Trade/Device Name: Merit ASAPLP™ Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: October 9, 2013 Received: October 10, 2013
Dear Ms. Christensen:
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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
2
forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance 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 yours,
M.A. Hillebrand
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K132155 Indications for Use Page 1 of 1
Section 4
Indications for Use
K132155 510(k) Number (if known):
Device Name: Merit ASAPLP™ Aspiration Catheter
Indications for Use:
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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.A. Hilleman
4
Section 5
510(k) Summary
| General
Provisions | Submitter Name:
Address:
Telephone Number:
Fax Number:
Contact Person:
Date of Preparation:
Registration Number: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
(801) 208-4789
(801) 253-6919
Susan Christensen
July 11, 2013
1721504 | |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Subject
Device | Trade Name:
Common/Usual Name:
Classification Name: | Merit ASAPLP™ Aspiration Catheter
Embolectomy Catheter
Embolectomy Catheter | |
| Predicate
Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | ASAP® Aspiration Catheter
Embolectomy Catheter
K100569
Merit Medical Systems, Inc. | |
| Classification | Class II
21 CFR § 870.5150
FDA Product Code: DXE
Review Panel: Cardiovascular | | |
| Intended Use | 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. | | |
| Device
Description | The ASAPLP Aspiration Catheter is a dual lumen rapid exchange
catheter, compatible with 0.014”/0.36mm guide wires. It is packaged
with related accessories including a stiffening stylet. The catheter
has a maximum outer diameter of 0.055"/0.140cm and a working
length of 145cm. The catheter has a radiopaque marker band
located approximately 2mm proximal to the distal tip. The catheter
has three (3) non-radiopaque positioning marks located
approximately 90cm, 100cm and 110cm proximal of the distal tip.
The distal region has a hydrophilic coating. The rapid exchange
lumen is 20cm in length. | | |
| Comparison to
Predicate
Device | The technological characteristics of the subject Merit ASAPLP
Aspiration Catheter are substantially equivalent to those of the
predicate device. The Merit ASAPLP Aspiration Catheter has a
smaller outer diameter than the predicate ASAP Aspiration Catheter.
In addition, the design of the Merit ASAPLP Aspiration Catheter is
slightly different and includes a round aspiration lumen instead of "U"
channel aspiration lumen with several material changes. Also, the
length of the Rapid Exchange Lumen is increased, and a stiffening
stylet is added which can be used during insertion of the catheter. | | |
| Safety &
Performance
Tests | No applicable mandatory performance standards or special controls
have been established under Section 514 of the Food, Drug and
Cosmetic Act for these devices. However, a battery of tests was
performed according to protocols based on the requirements of
industry standards and the device risk analysis and the device met
the acceptance criteria necessary to demonstrate the safety and
efficacy of the device.
Where appropriate, the tests were based on the requirements of the
following documents:
ISO 10555-1: 1995. Sterile, single-use intravascular catheters -
●
Part 1: General requirements
ISO 594-1:1986, Conical Fittings with a 6% (Luer) taper for
●
syringes, needles, and certain other medical equipment - Part 1:
General Requirements
ISO 594-2:1998, Conical Fittings with a 6% (Luer) taper for
●
syringes, needles, and certain other medical equipment - Part 2:
Lock fittings
EN 13868: 2002, Test methods for kinking of single lumen
0
catheters and medical tubing
ISO 11135-1: 2007, Sterilization of health care products -
●
Ethylene oxide - Part 1: Requirements for development,
validation and routine control of a sterilization process for
medical devices
ASTM F640-12, Standard Test Methods for Determining
●
Radiopacity for Medical Use
ASTM F756-08, Standard Practice for Assessment of Hemolvtic
●
Properties of Materials
ISO 10993-1: 2009, Biological Evaluation of Medical Devices
●
Part-1: Evaluation and Testing within a risk management
process
ISO 10993-3: 2003, Biological Evaluation of Medical Devices
●
Part-3: Tests for Genotoxicity, Carcinogenicity and Reproductive
Toxicity
ISO 10993-4: 2002, Biological Evaluation of Medical Devices
●
Part-4: Selection of Tests for Interactions with Blood, as
amended 2006
ISO 10993-5: 2009, Biological Evaluation of Medical Devices
● | | |
| | | | |
5
6
| Safety &
Performance
Tests
(Continued) | Part-5 Tests for In Vitro Cytotoxicity ISO 10993-7: 2008, Biological Evaluation of Medical Devices
Part-7 Ethylene Oxide Sterilization Residuals ISO 10993-10: 2010, Biological Evaluation of Medical Devices
Part-10 Tests for Irritation and Skin Sensitization ISO 10993-11: 2006, Biological Evaluation of Medical Devices
Part-11 Tests for Systemic Toxicity USP 35-151: 2012, United States Pharmacopeia 35, National
Formulary 30, 2012 Pyrogen Test The following is a list of all significant testing performed on the
ASAPLP. All testing was successfully completed.
Surface Condition / Visual
Corrosion Resistance
Force at Break
Catheter Liquid Leak under Pressure
Catheter Air Aspiration Leak
Dimensions
Luer Gauging Test
Luer Liquid Leak Test
Luer Air Aspiration Leak Test
Luer Separation Force Test
Luer Unscrewing Torque Test
Luer Ease of Assembly Test
Luer Resistance to Overriding Test
Luer Stress Cracking Test
Radio-Detectability
Kink
Stiffness
Aspiration
Flow
Coating Lubricity and Coverage
Marker Band Retention
Guide Wire Friction Test
Simulated Use Test in Anatomical Model
Simulated Aspiration and Use Test in Tortuous Path Model
Biocompatibility Tests
Cytotoxicity
Sensitization
Irritation
Acute Systemic Toxicity
Rabbit Pyrogen Test
Genotoxicity
Hemocompatibility
Physicochemical Tests |
| ------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
7
| Summary of
Substantial
Equivalence | Based on the indications for use, design, and safety and
performance testing, the subject Merit ASAPLP Aspiration Catheter
meets the requirements that are considered essential for its intended
use and is substantially equivalent to the predicate device, the ASAP
Aspiration Catheter (K100569), manufactured by Merit Medical
Systems, Inc. |
| ------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|