The Removal System Large Bore 60 cc Syringe is used with the Removal Catheters to inject fluids into or withdraw fluids and/or tissues from the body. It can be used for aspiration removal of fluid and/or tissue in the form of abscess fluid, infected materials, etc.

Device Description

The Removal System Large Bore 60 cc Syringe is a general piston syringe constructed using a barrel, plunger, plunger seal, and large bore Toomey tip adapter that acts as a quick-release connector. The quick-release connector is compatible with the Removal System Catheters' sideport connector to establish an airtight seal. The twist-to-lock plunger with barrel tabs maintains the retracted position of the plunger.

AI/ML Overview

The provided text describes information about the Inari Medical, Inc. Removal System Large Bore 60 cc Syringe (K233069).

Based on the provided document, this device is a simple piston syringe. The information about "acceptance criteria" and "study that proves the device meets the acceptance criteria" refers to non-clinical performance testing for mechanical integrity, biocompatibility, and sterilization, rather than a clinical study involving human patients or complex AI algorithms. Therefore, many of the requested categories (like MRMC studies, expert ground truth for imaging, training/test set sample sizes for AI, etc.) are not applicable to this type of device submission.

Here's the breakdown of the relevant information from the document:

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

The document does not provide a direct table of specific numerical acceptance criteria alongside quantitative performance results for each test. Instead, it lists the types of tests conducted and states that "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." This indicates a qualitative summary of successful performance against predefined criteria internally established by the manufacturer, rather than reportable numerical results for public review.

Here's a summary of the types of performance tests mentioned:

Type of Test	Description (from document)	Reported Performance
Biocompatibility Tests	- Cytotoxicity - Sensitization - Acute Systemic Toxicity - Intracutaneous Reactivity - Material-Mediated Pyrogenicity	"The passing results demonstrate that the subject device meets the biological safety requirements per ISO 10993-1."
Sterilization Validation	EtO sterilization to achieve a Sterility Assurance Level (SAL) of 10^-6 in accordance with ISO 11135:2014/Amd 1:2018 and AAMI TIR 28:2016.	"The Removal System is sterilized using EtO to achieve a sterility assurance level (SAL) of 10^-6 using a validated sterilization process..."
Non-Clinical Performance Tests	- Packaging Inspection - Leak Testing Syringe to Quick-Connect Adapter - Vacuum Testing Syringe to Quick-Connect Adapter - Air Leakage - Simulated Pus Analog Removal - Tensile Testing - Large Bore Syringe to Connector - General, ISO 7886-1, Clause 6.1 - Limits for Acidity or Alkalinity, ISO 7886-1, Clause 6.2 & Annex A - Limits for Extractable Metals, ISO 7886-1, Clause 6.3 & Annex A - Lubricant, ISO 7886-1, Clause 7 (Paragraph 1) - Tolerance on Graduated Capacity, ISO 7886-1, Clause 8 - Scale, ISO 7886-1, Clause 9.1 - Numbering of Scales, ISO 7886-1, Clause 9.2 - Overall Length of Scale, ISO 7886-1, Clause 9.3 - Position of Scale, ISO 7886-1, Clause 9.4 - Barrel Flanges, ISO 7886-1, Clause 10.2 - Design, ISO 7886-1, Clause 11.1 - Position of Nozzle on End of Barrel, ISO 7886-1, Clause 12.2 - Nozzle Lumen, ISO 7886-1, Clause 12.3 - Freedom from Liquid Leakage Past Plunger, guided by ISO 7886-1, Clause 13.2 & Annex D - Freedom from Air Leakage Past Plunger, ISO 7886-1, Clause 13.2 & Annex B - Force to Operate the Piston, ISO 7886-1, Clause 13.3 & Annex E - Fit of Stopper/Plunger in Barrel, ISO 7886-1, Clause 13.4 - Particulate Matter	"Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications."
Leveraged Performance Tests	- Pouch Seal Visual Inspection (from K191368 and K231848) - Bubble Leak (from K231848) - Dye Penetration (from K231848) - Pouch Peel, Seal Strength (from K231108) - Packaging Usability Evaluation for Aseptic Presentation (from K230494) - Vacuum Testing Large Bore Syringe (from K191710) - Simulated Use, Tensile Large Bore Syringe (from K191710)	"Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications."

Regarding the other points:

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify the exact sample sizes (number of syringes) used for each individual non-clinical performance test. This level of detail is typically found in the full test reports referenced by the submission, not the summary itself.
Data Provenance: The tests are performance tests of a physical medical device. "Data provenance" as in geographic origin or retrospective/prospective data collection is not applicable here, as it pertains to clinical data or AI data sets. These are laboratory-based engineering tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This question relates to studies establishing "ground truth" for clinical diagnoses, typically in the context of AI or diagnostic imaging. For a physical device like a syringe, "ground truth" is established by engineering specifications, international standards (e.g., ISO 7886-1, ISO 10993-1, ISO 11135), and successful outcomes of validated test methods performed by qualified personnel in a laboratory setting. Experts would logically be engineers, material scientists, and sterilization specialists.

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

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of clinical data (e.g., in radiology studies). This is not relevant for physical device performance testing. The "adjudication" for these tests would involve ensuring that the test methods are followed correctly and that results are objectively measured against predefined acceptance criteria.

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. MRMC studies are specific to evaluating diagnostic performance, particularly with AI assistance in clinical imaging. This device is a manual piston syringe and does not involve AI or human "readers" in its primary function or evaluation for this submission. The document explicitly states: "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 question relates to AI algorithm performance. This device is a physical, non-AI medical device.

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

Engineering Specifications and International Standards: The "ground truth" for this device's performance is whether it meets predefined engineering specifications (e.g., dimensions, materials, leak rates, force to operate) and complies with relevant international standards (e.g., ISO 7886-1 for sterile hypodermic syringes, ISO 10993 for biocompatibility, ISO 11135 for sterilization). The tests are designed to verify these physical and biological characteristics.

8. The sample size for the training set:

Not Applicable. This question relates to AI model training. This device does not use AI.

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

Not Applicable. This question relates to AI model training. This device does not use AI.

In summary: The provided FDA 510(k) summary is for a Class II manual medical device (piston syringe). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to a series of non-clinical, laboratory-based performance, biocompatibility, and sterilization validation tests conducted to demonstrate that the device meets established engineering specifications and international standards, thereby supporting its substantial equivalence to a predicate device. Clinical studies or AI-related evaluations were explicitly stated as "not required" for this submission.

Summary

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March 26, 2024

Inari Medical, Inc. Kaitlyn Weinkauf Sr. Regulatory Affairs Specialist 6001 Oak Canyon, Suite 100 Irvine, California 92618

Re: K233069

Trade/Device Name: Removal System Large Bore 60 cc Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: PUR Dated: February 22, 2024 Received: February 22, 2024

Dear Kaitlyn Weinkauf:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Shruti N. Mistry -S

Shruti Mistry Assistant Director Division of Drug Delivery and General Hospital Devices, and Human Factors Office of Gastrorenal, ObGyn,

General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K233069

Device Name

Removal System Large Bore 60 cc Syringe

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

Date prepared	March 25, 2024
Name	Inari Medical, Inc.6001 Oak Canyon, Suite 100Irvine, CA 92618877.923.4747
Contact person	Kaitlyn WeinkaufSr. Regulatory Affairs Specialist
Trade name	Removal System Large Bore 60 cc Syringe
Common name	Vacuum Syringe
Regulation name	Piston Syringe
Classification number	21 CFR 880.5860
Product code	PUR
Regulatory class	II
Predicate device(s)	Merit VacLok AT Vacuum Syringe (K163597)
Device description	The Removal System Large Bore 60 cc Syringe is a general piston syringeconstructed using a barrel, plunger, plunger seal, and large bore Toomey tipadapter that acts as a quick-release connector. The quick-release connector iscompatible with the Removal System Catheters' sideport connector toestablish an airtight seal. The twist-to-lock plunger with barrel tabs maintainsthe retracted position of the plunger.
Indications for Use	The Removal System Large Bore 60 cc Syringe is used with the RemovalCatheters to inject fluids into or withdraw fluids and/or tissues from the body.It can be used for aspiration removal of fluid and/or tissue in the form ofabscess fluid, infected materials, etc.
Summary of	A tabular comparison of the predicate and subject devices is provided below:

substantial equivalence

	Subject DeviceRemoval System LargeBore 60 cc Syringe	Primary Predicate DeviceMerit VacLok AT VacuumSyringe	Comments
510(k)Number	K233069	K163597	-
Manufacturer	Inari Medical, Inc.	Merit Medical Systems, Inc.	-
Regulation	21 CFR 880.5860 PistonSyringe	21 CFR 880.5860 PistonSyringe	Identical.
Product Code	PUR	PUR	Identical.
Intended Use	To inject fluids into orwithdraw fluids from the	To inject fluids into orwithdraw fluids from the	Identical.
	body.	body.
Indications forUse	The Removal System LargeBore 60 cc Syringe is usedwith the Removal Cathetersto inject fluids into orwithdraw fluids and/ortissues from the body. Itcan be used for aspirationremoval of fluid and/ortissue in the form ofabscess fluid, infectedmaterials, etc.	VacLok AT VacuumSyringe is used to injectfluids into, or withdrawfluids from the body. It canalso be used in cases where avacuum syringe is preferred(e.g. thrombus, abscessfluid, bile, urine, etc.).	Substantially equivalent.The indications for use forthe Removal System LargeBore 60 cc Syringe is notidentical to the predicatedevice; however, thedifferences do not alter theintended therapeutic use ofthe device, nor do theyaffect the performance ofthe device. The subject andpredicate device have thesame intended use.
Design	Standard piston syringeconstructed with a clearhollow barrel into which isinserted a closely fittingmoveable plunger andplunger seal. Containstwist-to-lock plunger tomaintain the retractedposition of the plunger.Fitted with a large boreToomey tip adapter thatacts as a quick-releaseconnector.	Standard piston syringeconstructed with a clearhollow barrel into which isinserted a closely fittingmoveable plunger andtip/seal. Variable camlocktechnology maintains theretracted position of theplunger. Fitted with maleluer lock connector.	Similar in design. Thesubject device met alldesign verification andvalidation acceptancecriteria. The minor designdifferences between thesubject and predicate devicedo not raise new or differentquestions of safety oreffectiveness.
DeviceDescription	The Removal System LargeBore 60 cc Syringe is ageneral piston syringeconstructed using a barrel,plunger, plunger seal, andlarge bore Toomey tipadapter that acts as a quick-release connector. Thequick-release connector iscompatible with theRemoval System Catheters'sideport connector toestablish an airtight seal.The twist-to-lock plungerwith barrel tabs maintainsthe retracted position of theplunger.	The VacLok AT VacuumSyringe is a general pistonsyringe constructed using abarrel, plunger, piston seal,and locking mechanism. It isdesigned to lock in anyposition along the length ofthe barrel with the capabilityof holding a vacuum whenthe cam locking mechanismis engaged.
BarrelMaterial	Clear polycarbonate	Clear polycarbonate	Identical.
PlungerMaterial	ABS	ABS	Identical.
Seal Material	EPDM Rubber	Silicone	The Removal System LargeBore 60 cc Syringematerials are establishedmedical device materials
			and have successfullypassed ISO 10993-1:2018biocompatibility testing aspart of the final, finisheddevice intended formarketing.
OperationalVolume	60 mL	20 mL and 30 mL	The subject device met alldesign verification andvalidation acceptancecriteria. The operatonalvolume difference betweenthe subject and predicatedevice do not raise new ordifferent questions of safetyor effectiveness.
Graduation	Printed with accurategraduation lines that arecompliant with ISO 7886-1	Printed with accurategraduation lines that arecompliant with ISO 7886-1	Identical.
Vacuum LockTechnology	Twist-to-lock plunger withbarrel tabs	Variable camlocktechnology	Similar locking mechanismfor vacuum source. Thesubject device and predicatedevice locking mechanismdiffers only in the numberof locking positions alongthe barrel. The subjectdevice contains one lockingposition at the operationalvolume of 60 mL, while thepredicate device containsninety locking positionsalong the barrel length.Both devices are locked andunlocked by twisting theplunger in the barrel. Thisdoes not raise new ordifferent questions of safetyor effectiveness.
Tip	Large bore Toomey tipadapter	Male luer lock	-
Principles ofOperation	Manually operated byadvancing and withdrawingthe plunger within thebarrel.	Manually operated byadvancing and withdrawingthe plunger within the barrel.	Identical.
Sterilization	EtO	EtO	Identical.
Shelf-life	6 months	Information not available	The subject device met allT=6 month acceleratedaging design verificationand validation acceptancecriteria.
Single-use	Yes	Yes	Identical.

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Summary of substantial equivalence

Biocompatibility

The following biocompatibility tests were completed to satisfy ISO 10993-1 requirements for the subject device:

Cytotoxicity
Sensitization

Acute Systemic Toxicity

Intracutaneous Reactivity
- Material-Mediated Pyrogenicity

The passing results demonstrate that the subject device meets the biological safety requirements per ISO 10993-1.

Sterilization

The Removal System is sterilized using EtO to achieve a sterility assurance level (SAL) of 106 using a validated sterilization process in accordance with the principles of ISO 11135:2014/Amd 1:2018 and AAMI TIR 28:2016.

Non-Clinical Testing

In accordance with the design failure modes and effects analysis, verification and validation testing were identified to support the substantial equivalence of the Removal System Large Bore 60 cc Syringe to the predicate device and to support the indications for use. These tests included:

Performance Tests

Packaging Inspection
Leak Testing Syringe to Quick-Connect Adapter ●
Vacuum Testing Syringe to Quick-Connect Adapter ●
Air Leakage ●
Simulated Pus Analog Removal ●
Tensile Testing - Large Bore Syringe to Connector
General, ISO 7886-1, Clause 6.1 ●
Limits for Acidity or Alkalinity, ISO 7886-1, Clause 6.2 & Annex A
Limits for Extractable Metals, ISO 7886-1, Clause 6.3 & Annex A ●
Lubricant, ISO 7886-1, Clause 7 (Paragraph 1) ●
Tolerance on Graduated Capacity, ISO 7886-1, Clause 8 ●
Scale, ISO 7886-1, Clause 9.1
Numbering of Scales, ISO 7886-1, Clause 9.2 ●
Overall Length of Scale, ISO 7886-1, Clause 9.3 ●
Position of Scale, ISO 7886-1, Clause 9.4
Barrel Flanges, ISO 7886-1, Clause 10.2 ●
Design, ISO 7886-1, Clause 11.1
Position of Nozzle on End of Barrel, ISO 7886-1, Clause 12.2 ●
Nozzle Lumen, ISO 7886-1, Clause 12.3
Freedom from Liquid Leakage Past Plunger, guided by ISO 7886-1, ● Clause 13.2 & Annex D
Freedom from Air Leakage Past Plunger, ISO 7886-1, Clause 13.2 . & Annex B

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Force to Operate the Piston, ISO 7886-1, Clause 13.3 & Annex E
Fit of Stopper/Plunger in Barrel, ISO 7886-1, Clause 13.4
Particulate Matter

Leveraged Performance Tests

Pouch Seal Visual Inspection (K191368 and K231848)
Bubble Leak (K231848)
Dye Penetration (K231848) ●
Pouch Peel, Seal Strength (K231108)
Packaging Usability Evaluation for Aseptic Presentation (K230494) ●
Vacuum Testing Large Bore Syringe (K191710) ●
Simulated Use, Tensile Large Bore Syringe (K191710) ●

Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications.

Animal testing was not required for the determination of substantial equivalence.

Clinical testing was not required for the determination of substantial equivalence.

Conclusion

The Removal System Large Bore 60 cc Syringe has the same intended use as the predicate. Non-clinical performance data show that the different technological characteristics between the devices do not raise any new or different questions of safety or effectiveness and support the Removal System Large Bore 60 cc Syringe's substantial equivalence to the predicate device.

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).