The Aspiron(TM) Aspiration Catheter is used for removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature system.

Device Description

The Aspiron™ Aspiration Catheter is a dual lumen, rapid exchange catheter consisting of a distal tip, distal shaft, and proximal shaft with luer hub at the proximal end. The smaller of the two lumens is the Guide wire lumen (distal tip) and is compatible with 0.014" (0.36mm) guide wires. The larger diameter lumen is the extraction lumen and when used with the Aspiron™ accessories, allows for removal of thrombus. The extraction lumen is provided pre-loaded with a stylet that resists kinking during delivery. A hydrophilic coating is applied to the distal shaft. The Aspiron™ is compatible with 6F guide catheters and has a working length of 140cm. The Aspiron™ accessories include 30ml suction syringes, a one way stopcock, an extension tube, a flushing needle and 70μm filter caps.

AI/ML Overview

The provided text describes the Aspiron™ Aspiration Catheter and its 510(k) summary, which outlines the device's comparison to a predicate device and its non-clinical performance data. It does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria based on human-in-the-loop performance or diagnostic accuracy metrics.

Here's a breakdown of the information that is available, and what is missing based on your request:

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

The document states: "The Aspiron™ Aspiration catheter met all predetermined acceptance criteria as specified by applicable standards, FDA guidance documents and test protocols." However, it does not provide a table with specific acceptance criteria (e.g., numerical thresholds for performance like extraction rate or tensile strength) or their corresponding individual reported device performance values. It only lists the types of tests performed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The non-clinical performance data describes bench testing, not a clinical test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as the document details non-clinical, bench testing, not studies requiring expert interpretation of medical images or patient data.

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

This information is not provided as the document details non-clinical, bench testing.

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 provided. The document describes a medical device (aspiration catheter) and its non-clinical performance, not an AI or imaging device that would typically undergo MRMC studies.

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

This information is not provided. The device described is a physical catheter, not an algorithm.

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

For the non-clinical performance tests, the "ground truth" would be the established engineering specifications, standards (like ISO 10993-1 for biocompatibility), and test protocols. The document states the device "met all predetermined acceptance criteria as specified by applicable standards, FDA guidance documents and test protocols."

8. The sample size for the training set

This information is not provided as the document details non-clinical, bench testing, not a machine learning model requiring a training set.

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

This information is not provided as the document details non-clinical, bench testing, not a machine learning model.

Summary of available information related to acceptance criteria and study:

The device is the Aspiron™ Aspiration Catheter. The study described is a series of non-clinical, bench performance tests and biocompatibility tests.

Acceptance Criteria (General Statement):
"The Aspiron™ Aspiration catheter met all predetermined acceptance criteria as specified by applicable standards, FDA guidance documents and test protocols."

Reported Device Performance (General Statement):
"Comparative testing between the Aspiron™ Aspiration Catheter and Export Advance™ Aspiration Catheter found similar performance characteristics with respect to Catheter Extraction Rate, Tensile strength and Radiopacity."

List of Non-Clinical Performance Tests Performed:

Dimensional verification
Tensile Strength
Flexibility and kink
Torque strength
Radiopacity
Catheter Preparation, Extraction and Removal
Catheter Extraction Rate (Aspiration Rate)
Aspiration Catheter Leak
Coating Integrity & Acute Particulate Evaluation

Biocompatibility Testing (in compliance with ISO 10993-1):

In Vitro Cytotoxicity Study
Skin Sensitization Study
Intracutaneous reactivity test
Acute Systemic Toxicity Study
In vitro Hemolysis test Study
Material Mediated Pyrogen Test
In vitro C3a and SC5b-9 complement activation Test
In Vivo Thromboresistance

Biocompatibility Testing for Accessories:

In Vitro Cytotoxicity Study
Skin Sensitization Study
Intracutaneous reactivity test
Acute Systemic Toxicity Study
In vitro Hemolysis test Study
Material Mediated Pyrogen Test

Conclusion of the study: The Aspiron™ Aspiration catheter met all predetermined acceptance criteria and no safety and efficacy issues were raised. It was found substantially equivalent to the predicate Export Advance™ Aspiration Catheter.

Summary

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April 29, 2019

Meril Life Sciences Private Limited % H. Semih Oktay President CardioMed Device Consultants, LLC 1783 Forest Drive, #254 Annapolis, Maryland 21401

Re: K190619

Trade/Device Name: Aspiron(TM) Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEZ Dated: March 8, 2019 Received: March 11, 2019

Dear Mr. Oktay:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

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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Indications for Use

510(k) Number (if known) K190619

Device Name Aspiron(TM) Aspiration Catheter

Indications for Use (Describe)

The Aspiron(TM) Aspiration Catheter is used for removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature system.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

510(k) Summary

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807.92.

5.1 Applicant:

Meril Life Sciences Private Limited Bilakhia house, Survey No. 135/139 Muktanand Marg, Chala, Vapi Gujarat 396191 INDIA Phone: +91 - 2603052100 Mobile: +91 – 9601260306

5.2 Contact Person:

Utpal Thakor Director Meril Life Sciences Private Limited Bilakhia house, Survey No. 135/139 Muktanand Marg, Chala, Vapi Gujarat 396 191 INDIA Phone: +91 - 2603052100 Mobile: +91 – 9601260306 E mail: utpal.thakor@merillife.com

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5.3 Date prepared: Jan 11, 2019

5.4 Device information:

Proprietary Name: Aspiron™ Aspiration Catheter Common / Usual Name: Aspiration Thrombectomy Catheter Classification Name: Embolectomy Catheter (21 CFR 870.5150, Product Code QEZ) Device Class: Class II

5.5 Predicate device:

. Export Advance™ Aspiration Catheter (K152335)

5.6 Device description:

5.7 Indication for use:

The Aspiron™ Aspiration Catheter is used for removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature system.

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5.8 Comparison of Technological characteristics:

The Aspiron™ Aspiration Catheter is similar to the predicate devices with respect to device design, materials and method of sterilization.

Comparative testing between the Aspiron™ Aspiration Catheter and Export Advance™ Aspiration Catheter found similar performance characteristics with respect to Catheter Extraction Rate, Tensile strength and Radiopacity.

The Aspiron™ Aspiration Catheter indication differs from the predicate Export Advance™ Aspiration Catheter in that the Aspiron™ Aspiration Catheter is limited to removal of fresh, soft emboli and thrombi from vessels. This difference does not raise new concerns because the more limited use of the Aspiron™ Aspiration Catheter is a more conservative indication.

5.9 Non clinical Performance data:

To ensure that the device design and construction are suitable for the intended use, the Aspiron™ Aspiration Catheter was subjected to the following performance testing:

. Dimensional verification
Tensile Strength ●
Flexibility and kink ●
Torque strength
Radiopacity ●
. Catheter Preparation, Extraction and Removal
. Catheter Extraction Rate (Aspiration Rate )
. Aspiration Catheter Leak
Coating Integrity & Acute Particulate Evaluation ●
Biocompatibility testing of Aspiron™ Aspiration Catheter and its accessories ● are in compliance with the ISO 10993-1. Aspiron "" was subjected to following tests.
- In Vitro Cytotoxicity Study o
- Skin Sensitization Study o
- Intracutaneous reactivity test o
- Acute Systemic Toxicity Study O
- In vitro Hemolysis test Study O

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K190619 Page 4

Material Mediated Pyrogen Test o
In vitro C3a and SC5b-9 complement activation Test O
In Vivo Thromboresistance O

The Accessories of Aspiron™ Aspiration Catheter were subjected to the following tests.

O In Vitro Cytotoxicity Study
Skin Sensitization Study O
Intracutaneous reactivity test O
Acute Systemic Toxicity Study O
In vitro Hemolysis test Study O
Material Mediated Pyrogen Test O

5.10 Conclusion

The Aspiron™ Aspiration catheter met all predetermined acceptance criteria as specified by applicable standards, FDA guidance documents and test protocols. No safety and efficacy issues were raised during the testing program.

The Aspiron™ Aspiration catheter is substantially equivalent to the predicate Export Advance™ Aspiration Catheter

Regulation Number and Section

§ 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).