(118 days)
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.
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.
The provided text describes the Merit ASAPLP Aspiration Catheter and its substantial equivalence to a predicate device, the ASAP Aspiration Catheter. It lists numerous safety and performance tests conducted to demonstrate this equivalence. However, it does not detail specific acceptance criteria with quantitative thresholds or reported device performance in the format of a table. While it states that "All testing was successfully completed" and "the device met the acceptance criteria necessary to demonstrate the safety and efficacy of the device," the document does not provide the specific numerical acceptance criteria or the actual measured performance data for each test.
Furthermore, the document does not contain information about:
- Sample sizes used for a test set for diagnostic performance, as this is a medical device for physical aspiration, not a diagnostic AI.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts and their qualifications for establishing ground truth for a test set.
- Adjudication method for a test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done involving human readers and AI, or if an effect size of human readers improving with AI vs. without AI assistance was calculated.
- Whether a standalone (algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (pathology, outcomes data, etc.) beyond stating testing was based on industry standards and risk analysis.
- The sample size for the training set.
- How the ground truth for the training set was established.
This document focuses on the mechanical, material, and biological safety and performance of a physical medical device (catheter) rather than the diagnostic performance of an AI algorithm. Therefore, the questions related to AI-specific evaluation metrics (like MRMC studies, ground truth establishment for training/test sets in diagnostic contexts, and sample sizes for diagnostic performance evaluation) are not applicable or addressed in this submission.
Summary of what can be extracted/inferred regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "the device met the acceptance criteria necessary to demonstrate the safety and efficacy of the device." and "All testing was successfully completed." However, it does not provide a specific table with quantitative acceptance criteria and corresponding reported device performance values for each test. Instead, it lists the types of tests performed.
| Test Category | Specific Test | Acceptance Criteria (General Statement) | Reported Device Performance (General Statement) |
|---|---|---|---|
| Physical/Mechanical | Surface Condition / Visual | Based on industry standards, device risk analysis | "Successfully completed," "met acceptance criteria" |
| Corrosion Resistance | Based on industry standards, device risk analysis | "Successfully completed," "met acceptance criteria" | |
| Force at Break | Based on industry standards, device risk analysis | "Successfully completed," "met acceptance criteria" | |
| Catheter Liquid Leak under Pressure | Based on industry standards, device risk analysis | "Successfully completed," "met acceptance criteria" | |
| Catheter Air Aspiration Leak | Based on industry standards, device risk analysis | "Successfully completed," "met acceptance criteria" | |
| Dimensions | Based on industry standards, device risk analysis | "Successfully completed," "met acceptance criteria" | |
| Luer Gauging Test | Based on ISO 594-1:1986, ISO 594-2:1998 | "Successfully completed," "met acceptance criteria" | |
| Luer Liquid Leak Test | Based on ISO 594-1:1986, ISO 594-2:1998 | "Successfully completed," "met acceptance criteria" | |
| Luer Air Aspiration Leak Test | Based on ISO 594-1:1986, ISO 594-2:1998 | "Successfully completed," "met acceptance criteria" | |
| Luer Separation Force Test | Based on ISO 594-1:1986, ISO 594-2:1998 | "Successfully completed," "met acceptance criteria" | |
| Luer Unscrewing Torque Test | Based on ISO 594-1:1986, ISO 594-2:1998 | "Successfully completed," "met acceptance criteria" | |
| Luer Ease of Assembly Test | Based on ISO 594-1:1986, ISO 594-2:1998 | "Successfully completed," "met acceptance criteria" | |
| Luer Resistance to Overriding Test | Based on ISO 594-1:1986, ISO 594-2:1998 | "Successfully completed," "met acceptance criteria" | |
| Luer Stress Cracking Test | Based on ISO 594-1:1986, ISO 594-2:1998 | "Successfully completed," "met acceptance criteria" | |
| Radio-Detectability | Based on ASTM F640-12 | "Successfully completed," "met acceptance criteria" | |
| Kink | Based on EN 13868:2002 | "Successfully completed," "met acceptance criteria" | |
| Stiffness | Based on industry standards, device risk analysis | "Successfully completed," "met acceptance criteria" | |
| Aspiration Flow | Based on industry standards, device risk analysis | "Successfully completed," "met acceptance criteria" | |
| Coating Lubricity and Coverage | Based on industry standards, device risk analysis | "Successfully completed," "met acceptance criteria" | |
| Marker Band Retention | Based on industry standards, device risk analysis | "Successfully completed," "met acceptance criteria" | |
| Guide Wire Friction Test | Based on industry standards, device risk analysis | "Successfully completed," "met acceptance criteria" | |
| Simulated Use Test in Anatomical Model | Clinical simulation of intended use | "Successfully completed," "met acceptance criteria" | |
| Simulated Aspiration and Use Test in Tortuous Path Model | Clinical simulation of intended use, specific challenging scenario | "Successfully completed," "met acceptance criteria" | |
| Biocompatibility | Cytotoxicity | Based on ISO 10993-5:2009 | "Successfully completed," "met acceptance criteria" |
| Sensitization | Based on ISO 10993-10:2010 | "Successfully completed," "met acceptance criteria" | |
| Irritation | Based on ISO 10993-10:2010 | "Successfully completed," "met acceptance criteria" | |
| Acute Systemic Toxicity | Based on ISO 10993-11:2006 | "Successfully completed," "met acceptance criteria" | |
| Rabbit Pyrogen Test | Based on USP 35-151:2012 | "Successfully completed," "met acceptance criteria" | |
| Genotoxicity | Based on ISO 10993-3:2003 | "Successfully completed," "met acceptance criteria" | |
| Hemocompatibility | Based on ISO 10993-4:2002 | "Successfully completed," "met acceptance criteria" | |
| Physicochemical Tests | Based on ISO 10993-7:2008 | "Successfully completed," "met acceptance criteria" | |
| Sterilization | Ethylene Oxide Sterilization (Residuals) | Based on ISO 11135-1:2007, ISO 10993-7:2008 (Residuals) | "Successfully completed," "met acceptance criteria" |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document lists the types of tests performed but does not quantify the number of devices or iterations per test. This is typically found in the full test reports, not a 510(k) summary.
- Data Provenance: Not specified. Likely conducted in a laboratory setting by the manufacturer, Merit Medical Systems, Inc. The nature of the device (physical catheter) points to in-vitro and ex-vivo testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI diagnostic device. Ground truth for device performance tests would be based on validated measurement methods and instrumentation, not expert consensus on diagnostic images.
4. Adjudication method for the test set:
- Not applicable for the types of tests described (physical, chemical, biological testing of a catheter).
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:
- Not applicable. This is a medical device (catheter) for physical intervention, not an AI diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
7. The type of ground truth used:
- For the physical and mechanical tests, the "ground truth" is defined by established international and national standards (e.g., ISO, ASTM, USP) and the device's design specifications. Measurements are compared against these predetermined standards and specifications.
- For biocompatibility, the "ground truth" is defined by the toxicological profiles and acceptable limits set forth in the ISO 10993 series and USP standards.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI system that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable.
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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
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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
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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
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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
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Section 5
510(k) Summary
| GeneralProvisions | Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date of Preparation:Registration Number: | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 208-4789(801) 253-6919Susan ChristensenJuly 11, 20131721504 | |
|---|---|---|---|
| SubjectDevice | Trade Name:Common/Usual Name:Classification Name: | Merit ASAPLP™ Aspiration CatheterEmbolectomy CatheterEmbolectomy Catheter | |
| PredicateDevice | Trade Name:Classification Name:Premarket Notification:Manufacturer: | ASAP® Aspiration CatheterEmbolectomy CatheterK100569Merit Medical Systems, Inc. | |
| Classification | Class II21 CFR § 870.5150FDA Product Code: DXEReview Panel: Cardiovascular | ||
| Intended Use | The Merit ASAPLP Aspiration Catheter is intended for the removal offresh, soft emboli and thrombi from vessels of the arterial system.Not for use in cerebral vasculature. | ||
| DeviceDescription | The ASAPLP Aspiration Catheter is a dual lumen rapid exchangecatheter, compatible with 0.014”/0.36mm guide wires. It is packagedwith related accessories including a stiffening stylet. The catheterhas a maximum outer diameter of 0.055"/0.140cm and a workinglength of 145cm. The catheter has a radiopaque marker bandlocated approximately 2mm proximal to the distal tip. The catheterhas three (3) non-radiopaque positioning marks locatedapproximately 90cm, 100cm and 110cm proximal of the distal tip.The distal region has a hydrophilic coating. The rapid exchangelumen is 20cm in length. | ||
| Comparison toPredicateDevice | The technological characteristics of the subject Merit ASAPLPAspiration Catheter are substantially equivalent to those of thepredicate device. The Merit ASAPLP Aspiration Catheter has asmaller outer diameter than the predicate ASAP Aspiration Catheter.In addition, the design of the Merit ASAPLP Aspiration Catheter isslightly different and includes a round aspiration lumen instead of "U"channel aspiration lumen with several material changes. Also, thelength of the Rapid Exchange Lumen is increased, and a stiffeningstylet is added which can be used during insertion of the catheter. | ||
| Safety &PerformanceTests | No applicable mandatory performance standards or special controlshave been established under Section 514 of the Food, Drug andCosmetic Act for these devices. However, a battery of tests wasperformed according to protocols based on the requirements ofindustry standards and the device risk analysis and the device metthe acceptance criteria necessary to demonstrate the safety andefficacy of the device.Where appropriate, the tests were based on the requirements of thefollowing documents:ISO 10555-1: 1995. Sterile, single-use intravascular catheters -●Part 1: General requirementsISO 594-1:1986, Conical Fittings with a 6% (Luer) taper for●syringes, needles, and certain other medical equipment - Part 1:General RequirementsISO 594-2:1998, Conical Fittings with a 6% (Luer) taper for●syringes, needles, and certain other medical equipment - Part 2:Lock fittingsEN 13868: 2002, Test methods for kinking of single lumen0catheters and medical tubingISO 11135-1: 2007, Sterilization of health care products -●Ethylene oxide - Part 1: Requirements for development,validation and routine control of a sterilization process formedical devicesASTM F640-12, Standard Test Methods for Determining●Radiopacity for Medical UseASTM F756-08, Standard Practice for Assessment of Hemolvtic●Properties of MaterialsISO 10993-1: 2009, Biological Evaluation of Medical Devices●Part-1: Evaluation and Testing within a risk managementprocessISO 10993-3: 2003, Biological Evaluation of Medical Devices●Part-3: Tests for Genotoxicity, Carcinogenicity and ReproductiveToxicityISO 10993-4: 2002, Biological Evaluation of Medical Devices●Part-4: Selection of Tests for Interactions with Blood, asamended 2006ISO 10993-5: 2009, Biological Evaluation of Medical Devices● | ||
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| Safety &PerformanceTests(Continued) | Part-5 Tests for In Vitro Cytotoxicity ISO 10993-7: 2008, Biological Evaluation of Medical DevicesPart-7 Ethylene Oxide Sterilization Residuals ISO 10993-10: 2010, Biological Evaluation of Medical DevicesPart-10 Tests for Irritation and Skin Sensitization ISO 10993-11: 2006, Biological Evaluation of Medical DevicesPart-11 Tests for Systemic Toxicity USP 35-151: 2012, United States Pharmacopeia 35, NationalFormulary 30, 2012 <151> Pyrogen Test The following is a list of all significant testing performed on theASAPLP. All testing was successfully completed.Surface Condition / VisualCorrosion ResistanceForce at BreakCatheter Liquid Leak under PressureCatheter Air Aspiration LeakDimensionsLuer Gauging TestLuer Liquid Leak TestLuer Air Aspiration Leak TestLuer Separation Force TestLuer Unscrewing Torque TestLuer Ease of Assembly TestLuer Resistance to Overriding TestLuer Stress Cracking TestRadio-DetectabilityKinkStiffnessAspirationFlowCoating Lubricity and CoverageMarker Band RetentionGuide Wire Friction TestSimulated Use Test in Anatomical ModelSimulated Aspiration and Use Test in Tortuous Path ModelBiocompatibility TestsCytotoxicitySensitizationIrritationAcute Systemic ToxicityRabbit Pyrogen TestGenotoxicityHemocompatibilityPhysicochemical Tests |
|---|---|
| ------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| Summary ofSubstantialEquivalence | Based on the indications for use, design, and safety andperformance testing, the subject Merit ASAPLP Aspiration Cathetermeets the requirements that are considered essential for its intendeduse and is substantially equivalent to the predicate device, the ASAPAspiration Catheter (K100569), manufactured by Merit MedicalSystems, Inc. |
|---|---|
| ------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
§ 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).