Retraction Aspirator by INARI MEDICAL

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 Description

The Retraction Aspirator facilitates the simultaneous aspiration and withdrawal of the FlowTriever Catheter into the Guide Catheter. The hand-lever operated Retraction Aspirator, with its integrated clutch, is fitted with a vacuum syringe and collection container. Operating the Retraction Aspirator lever simultaneously retracts the FlowTriever Catheter into the Guide Catheter and aspirates fluid.

AI/ML Overview

The provided text is a 510(k) summary for the Inari Medical Retraction Aspirator, stating that it is substantially equivalent to a previously cleared device (K143563) and that no changes have been made to the device, its design, technology, materials, or manufacturing processes. Therefore, no new performance data or acceptance criteria are presented for this specific 510(k) (K152097). Instead, it refers back to the non-clinical test results submitted for K143563.

Based on the provided document, the following information can be extracted regarding the device and its assessment:

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

Since the current submission (K152097) explicitly states "No changes have been made to the Retraction Aspirator since the original clearance on February 3, 2015 (K143563). The device design, technology, materials, processes, etc. have not been changed with this application," and "Non-clinical test results for the Retraction Aspirator were submitted in premarket notification K143563. No changes have been made to the device therefore additional testing was not necessary," no new acceptance criteria or reported performance is included in this document. The assessment relies on the prior clearance.

Acceptance Criteria	Reported Device Performance
Not specified in this document due to reliance on prior clearance (K143563).	Not specified in this document due to reliance on prior clearance (K143563).

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

Sample Size for Test Set: Not specified in this document. The document refers to non-clinical test results from the original clearance (K143563).
Data Provenance: Not specified in this document. The document refers to non-clinical test results from the original clearance (K143563).

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):

Not applicable/Not specified. The assessment for this device relies on non-clinical testing rather than expert-based ground truth from clinical studies.

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

Not applicable/Not specified. The assessment for this device relies on non-clinical 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:

Not applicable. This device is an embolectomy catheter, a physical medical device, not an AI-powered diagnostic or assistive tool for human readers. "Clinical testing was not required for the determination of substantial equivalence."

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

Not applicable. This is a physical medical device, not an algorithm.

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

For the non-clinical testing referenced from K143563, the ground truth would typically be based on established engineering and material science metrics, such as mechanical strength, fluid dynamics, biocompatibility, and manufacturing quality control. Specific types are not detailed in this document.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

Not applicable. This is a physical medical device, not an AI model.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY 6

Date prepared	August 24, 2015
Name	Inari Medical, Inc.9272 Jeronimo Road, Suite 124Irvine, CA 92618949.600.8433 x114
Contact person	Eben GordonVice 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 ofthe FlowTriever Catheter into the Guide Catheter. The hand-lever operatedRetraction Aspirator, with its integrated clutch, is fitted with a vacuum syringeand collection container. Operating the Retraction Aspirator lever simultaneouslyretracts the FlowTriever Catheter into the Guide Catheter and aspirates fluid.
Indications for Use	The Retraction Aspirator is intended to be used with the FlowTrieverRetrieval/Aspiration System to facilitate the simultaneous aspiration andwithdrawal of the FlowTriever Catheter into the Guide Catheter.
Summary ofsubstantial equivalence	No changes have been made to the Retraction Aspirator since the originalclearance on February 3, 2015 (K143563). The device design, technology,materials, processes, etc. have not been changed with this application.
	Non-Clinical Testing
	Non-clinical test results for the Retraction Aspirator were submitted in premarketnotification K143563. No changes have been made to the device thereforeadditional testing was not necessary.
	Clinical testing was not required for the determination of substantial equivalence.
	Conclusion
	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.

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).