Retraction Aspirator

K152097 · Inari Medical · QEW · Aug 25, 2015 · Cardiovascular

Device Facts

• Record ID: K152097
• Device Name: Retraction Aspirator
• Applicant: Inari Medical
• Product Code: QEW · Cardiovascular
• Decision Date: Aug 25, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Retraction Aspirator is intended to be used with the FlowTriever Retrieval/Aspiration System to facilitate the simultaneous aspiration and withdrawal of the FlowTriever Catheter into the Guide Catheter.

Device Story

Retraction Aspirator is a hand-lever operated device used as a component of the FlowTriever Retrieval/Aspiration System; facilitates simultaneous aspiration and withdrawal of FlowTriever Catheter into Guide Catheter. Device features integrated clutch, vacuum syringe, and collection container. Operated by clinician; lever actuation retracts catheter while aspirating fluid. Benefits include streamlined retrieval process during aspiration procedures.

Clinical Evidence

No clinical data was required for this determination of substantial equivalence. Non-clinical testing was previously submitted under K143563; no new testing was necessary as the device remains unchanged.

Technological Characteristics

Hand-lever operated aspiration device; includes integrated clutch, vacuum syringe, and collection container. Mechanical design remains identical to predicate K143563.

Indications for Use

Indicated for use with the FlowTriever Retrieval/Aspiration System to facilitate simultaneous aspiration and withdrawal of the FlowTriever Catheter into the Guide Catheter.

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

• Inari Medical Infusion Aspiration Catheter System (K143563)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 25, 2015

Inari Medical, Inc. c/o Mr. Eben Gordon Vice President, Regulatory Affairs & Quality Assurance 9272 Jeronimo Road, Suite 124 Irvine, CA 92618

Re: K152097

Trade/Device Name: Retraction Aspirator Regulation Number: 21 CFR 870.5150 Regulation Name: Embelectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: July 26, 2015 Received: July 28, 2015

Dear Mr. Gordon:

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 (QS) 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kenneth J. Cavanaugh -S

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

Pg. 1 of 1

510(k) Number (if known) K152097

Device Name Retraction Aspirator

Indications for Use (Describe)

The Retraction Aspirator is intended to be used with the FlowTriever Retrieval/Aspiration System to facilitate the simultaneous aspiration and withdrawal of the FlowTriever Catheter into the Guide Catheter.

Type of Use (Select one or both, as applicable):

| <span style="font-size:10pt">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|------------------------------------------------------------------------------------|
| <span style="font-size:10pt">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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Image /page/3/Picture/0 description: The image shows the logo for Inari Medical. The logo consists of a circular graphic on the left and the word "INARI" in large, bold, purple letters on the right. Below "INARI" is the word "MEDICAL" in smaller, lighter letters. The circular graphic is made up of several concentric circles in purple, with orange lines running through the center.

## 510(K) SUMMARY 6

| Date prepared | August 24, 2015 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Inari Medical, Inc.<br>9272 Jeronimo Road, Suite 124<br>Irvine, CA 92618<br>949.600.8433 x114 |
| Contact person | Eben Gordon<br>Vice President, Regulatory Affairs & Quality Assurance |
| Trade name | Retraction Aspirator |
| Common name | Embolectomy catheter |
| Regulation Name | Embolectomy catheter |
| Classification number | 21 CFR 870.5150 |
| Product code | DXE |
| Regulatory class | II |
| Predicate devices | Inari Medical Infusion Aspiration Catheter System (K143563) |
| Description | The Retraction Aspirator facilitates the simultaneous aspiration and withdrawal of<br>the FlowTriever Catheter into the Guide Catheter. The hand-lever operated<br>Retraction Aspirator, with its integrated clutch, is fitted with a vacuum syringe<br>and collection container. Operating the Retraction Aspirator lever simultaneously<br>retracts the FlowTriever Catheter into the Guide Catheter and aspirates fluid. |
| Indications for Use | The Retraction Aspirator is intended to be used with the FlowTriever<br>Retrieval/Aspiration System to facilitate the simultaneous aspiration and<br>withdrawal of the FlowTriever Catheter into the Guide Catheter. |
| Summary of<br>substantial equivalence | No changes have been made to the Retraction Aspirator since the original<br>clearance on February 3, 2015 (K143563). The device design, technology,<br>materials, processes, etc. have not been changed with this application. |
| | <b>Non-Clinical Testing</b> |
| | Non-clinical test results for the Retraction Aspirator were submitted in premarket<br>notification K143563. No changes have been made to the device therefore<br>additional testing was not necessary. |
| | Clinical testing was not required for the determination of substantial equivalence. |
| | <b>Conclusion</b> |
| | The Retraction Aspirator is a component of the FlowTriever System and has not |

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been modified from the device cleared under premarket notification (510(k)) number K143563. The Retraction Aspirator will be commercially distributed individually with the same intended use apart from the FlowTriever System. The information that the Retraction Aspirator that is the subject of this 510(k) is substantially equivalent to the legally marketed predicate device.