(28 days)
No
The description focuses on a mechanical, hand-lever operated device for aspiration and retraction, with no mention of AI, ML, image processing, or data-driven decision making.
No
Explanation: The device is described as facilitating simultaneous aspiration and withdrawal for a catheter, not directly treating a disease or condition. It is an accessory to a larger system.
No
The device description clearly states its purpose is to "facilitate the simultaneous aspiration and withdrawal of the FlowTriever Catheter into the Guide Catheter," which is a therapeutic or procedural action, not a diagnostic one. There is no mention of it being used to detect, diagnose, treat, or prevent disease, injury, or other conditions.
No
The device description clearly details a hand-lever operated mechanical device with a vacuum syringe and collection container, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a procedure performed within the body (simultaneous aspiration and withdrawal of a catheter). IVDs are used to examine specimens outside the body (in vitro).
- Device Description: The description details a mechanical device used for aspiration and retraction during a medical procedure. This is consistent with an in-vivo device, not an in-vitro diagnostic.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in-vitro diagnostics.
The device is clearly intended for use during a medical procedure on a patient, which is the definition of an in-vivo device.
N/A
Intended Use / 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.
Product codes
DXE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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. Clinical testing was not required for the determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Inari Medical Infusion Aspiration Catheter System (K143563)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
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
1
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)
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):
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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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. |
| 9272 Jeronimo Road, Suite 124 | |
| Irvine, CA 92618 | |
| 949.600.8433 x114 | |
| Contact person | Eben Gordon |
| 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 |
| 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. | |
| 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. | |
| Summary of | |
| substantial equivalence | 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. | |
| Non-Clinical Testing | |
| 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. | |
| 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.