Aspiron(TM) Aspiration Catheter

K190619 · Meril Life Sciences Private Limited · QEZ · Apr 29, 2019 · Cardiovascular

Device Facts

• Record ID: K190619
• Device Name: Aspiron(TM) Aspiration Catheter
• Applicant: Meril Life Sciences Private Limited
• Product Code: QEZ · Cardiovascular
• Decision Date: Apr 29, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Aspiron Aspiration Catheter is a dual-lumen, rapid-exchange catheter designed for mechanical thrombectomy. It features a guide wire lumen (compatible with 0.014" wires) and a larger extraction lumen for thrombus removal. The device is delivered via 6F guide catheters; a pre-loaded stylet prevents kinking during navigation. A hydrophilic coating on the distal shaft facilitates tracking. Used in clinical settings by physicians, the device is operated with accessories including 30ml suction syringes, a one-way stopcock, extension tubing, and 70μm filter caps. By applying manual suction, the clinician aspirates emboli/thrombi through the extraction lumen. This process restores blood flow in occluded vessels, providing a therapeutic benefit for patients suffering from acute vascular blockages.

Clinical Evidence

Bench testing only. Performance testing included dimensional verification, tensile strength, flexibility/kink resistance, torque strength, radiopacity, extraction rate, leak testing, and coating integrity. Biocompatibility testing (ISO 10993-1) included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemolysis, pyrogenicity, complement activation, and thromboresistance for both the catheter and accessories. All predetermined acceptance criteria were met.

Technological Characteristics

Dual-lumen, rapid-exchange catheter; 140cm working length; 6F guide catheter compatible; 0.014" guide wire compatibility. Features hydrophilic coating on distal shaft. Includes stylet for kink resistance. Accessories: 30ml suction syringes, stopcock, extension tube, flushing needle, 70μm filter caps. Sterilization method not specified.

Indications for Use

Indicated for removal of fresh, soft emboli and thrombi from coronary and peripheral vasculature.

Regulatory Classification

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.

Predicate Devices

• Export Advance™ Aspiration Catheter (K152335)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the word "Meril" in a sans-serif font against a light blue background. The letters are white, except for a small orange dot above the "i". The logo is simple and clean, with a focus on the brand name.

## 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: [e-mail]

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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:

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.

## 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