(182 days)
No
The device description and performance studies focus on the mechanical function of a syringe and do not mention any AI or ML components or capabilities.
Yes
The device is used to inject or withdraw fluids/tissues from the body, including the aspiration removal of abscess fluid and infected materials, which are therapeutic actions.
No
The device is described as a syringe used for injecting or withdrawing fluids and tissues, which is a therapeutic or procedural function, not a diagnostic one. There is no mention of it being used to identify or analyze medical conditions.
No
The device description clearly outlines a physical syringe with a barrel, plunger, and seals, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "inject fluids into or withdraw fluids and/or tissues from the body." This is a direct interaction with the patient's body for therapeutic or diagnostic purposes in vivo.
- Device Description: The description details a syringe, which is a tool for manipulating fluids and tissues within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., in a laboratory or clinical setting to diagnose or monitor conditions. This syringe is used for direct patient intervention.
N/A
Intended Use / Indications for Use
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.
Product codes
PUR
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.
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
Not Found
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 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: 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.
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).
Key results: 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K191368, K231848, K231108, K230494, K191710
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
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).
1
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
2
Indications for Use
Submission Number (if known)
Device Name
Removal System Large Bore 60 cc Syringe
Indications for Use (Describe)
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.
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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PAGE 1 OF 5
510(K) SUMMARY
| Date prepared | March 25, 2024 | |
|---|---|---|
| Name | Inari Medical, Inc. | |
| 6001 Oak Canyon, Suite 100 | ||
| Irvine, CA 92618 | ||
| 877.923.4747 | ||
| Contact person | Kaitlyn Weinkauf | |
| Sr. 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 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. | ||
| Indications for Use | 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. | ||
| Summary of | A tabular comparison of the predicate and subject devices is provided below: |
substantial equivalence
| | Subject Device
Removal System Large
Bore 60 cc Syringe | Primary Predicate Device
Merit VacLok AT Vacuum
Syringe | Comments |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Number | K233069 | K163597 | - |
| Manufacturer | Inari Medical, Inc. | Merit Medical Systems, Inc. | - |
| Regulation | 21 CFR 880.5860 Piston
Syringe | 21 CFR 880.5860 Piston
Syringe | Identical. |
| Product Code | PUR | PUR | Identical. |
| Intended Use | To inject fluids into or
withdraw fluids from the | To inject fluids into or
withdraw fluids from the | Identical. |
| | body. | body. | |
| Indications for
Use | 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. | VacLok AT Vacuum
Syringe is used to inject
fluids into, or withdraw
fluids from the body. It can
also be used in cases where a
vacuum syringe is preferred
(e.g. thrombus, abscess
fluid, bile, urine, etc.). | Substantially equivalent.
The indications for use for
the Removal System Large
Bore 60 cc Syringe is not
identical to the predicate
device; however, the
differences do not alter the
intended therapeutic use of
the device, nor do they
affect the performance of
the device. The subject and
predicate device have the
same intended use. |
| Design | Standard piston syringe
constructed with a clear
hollow barrel into which is
inserted a closely fitting
moveable plunger and
plunger seal. Contains
twist-to-lock plunger to
maintain the retracted
position of the plunger.
Fitted with a large bore
Toomey tip adapter that
acts as a quick-release
connector. | Standard piston syringe
constructed with a clear
hollow barrel into which is
inserted a closely fitting
moveable plunger and
tip/seal. Variable camlock
technology maintains the
retracted position of the
plunger. Fitted with male
luer lock connector. | Similar in design. The
subject device met all
design verification and
validation acceptance
criteria. The minor design
differences between the
subject and predicate device
do not raise new or different
questions of safety or
effectiveness. |
| 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. | The VacLok AT Vacuum
Syringe is a general piston
syringe constructed using a
barrel, plunger, piston seal,
and locking mechanism. It is
designed to lock in any
position along the length of
the barrel with the capability
of holding a vacuum when
the cam locking mechanism
is engaged. | |
| Barrel
Material | Clear polycarbonate | Clear polycarbonate | Identical. |
| Plunger
Material | ABS | ABS | Identical. |
| Seal Material | EPDM Rubber | Silicone | The Removal System Large
Bore 60 cc Syringe
materials are established
medical device materials |
| | | | and have successfully
passed ISO 10993-1:2018
biocompatibility testing as
part of the final, finished
device intended for
marketing. |
| Operational
Volume | 60 mL | 20 mL and 30 mL | The subject device met all
design verification and
validation acceptance
criteria. The operatonal
volume difference between
the subject and predicate
device do not raise new or
different questions of safety
or effectiveness. |
| Graduation | Printed with accurate
graduation lines that are
compliant with ISO 7886-1 | Printed with accurate
graduation lines that are
compliant with ISO 7886-1 | Identical. |
| Vacuum Lock
Technology | Twist-to-lock plunger with
barrel tabs | Variable camlock
technology | Similar locking mechanism
for vacuum source. The
subject device and predicate
device locking mechanism
differs only in the number
of locking positions along
the barrel. The subject
device contains one locking
position at the operational
volume of 60 mL, while the
predicate device contains
ninety locking positions
along the barrel length.
Both devices are locked and
unlocked by twisting the
plunger in the barrel. This
does not raise new or
different questions of safety
or effectiveness. |
| Tip | Large bore Toomey tip
adapter | Male luer lock | - |
| Principles of
Operation | Manually operated by
advancing and withdrawing
the plunger within the
barrel. | Manually operated by
advancing and withdrawing
the plunger within the barrel. | Identical. |
| Sterilization | EtO | EtO | Identical. |
| Shelf-life | 6 months | Information not available | The subject device met all
T=6 month accelerated
aging design verification
and validation acceptance
criteria. |
| Single-use | Yes | Yes | Identical. |
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PAGE 2 OF 5
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PAGE 4 OF 5
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
7
PAGE 5 OF 5
- 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.