(102 days)
No
The provided text describes a mechanical thrombectomy system and its components. There is no mention of AI, ML, or any computational processing that would suggest the use of such technologies. The performance studies are focused on mechanical and simulated use testing.
Yes
The device is intended to remove thrombi and emboli from blood vessels, which directly treats a medical condition.
No
The device is indicated for the "non-surgical removal of thrombi and emboli from blood vessels," and for "injection, infusion, and/or aspiration of contrast media and other fluids." These are therapeutic or interventional actions, not diagnostic ones. While it mentions aiding "Sheath positioning under fluoroscopic visualization," this visualization is for guiding the therapeutic procedure, not for diagnosing a condition.
No
The device description explicitly states that the system consists of physical components: a sheath and a catheter, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The InThrill Thrombectomy System is a mechanical device designed to physically remove thrombi and emboli from blood vessels. It is used within the body (in vivo) to treat a condition, not to analyze samples outside the body (in vitro).
- Intended Use: The intended use clearly describes a therapeutic procedure (removal of thrombi and emboli) and the injection/aspiration of fluids within the blood vessel. This is not a diagnostic test performed on a specimen.
Therefore, the InThrill Thrombectomy System is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The InThrill Thrombectomy System is indicated for:
- The non-surgical removal of thrombi and emboli from blood vessels, including arteriovenous grafts for dialysis access, and synthetic grafts.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel/graff.
The InThrill Thrombectomy System is intended for use in the peripheral vasculature.
The InThrill Thrombectomy System is not intended for use in deep vein thrombosis (DVT) treatment.
Product codes
QEW, KRA
Device Description
The InThrill™ Thrombectomy System is a single-use, sterile medical device designed to remove thrombi and emboli from the peripheral vasculature. The InThrill™ Thrombectomy System consists of the InThrill Sheath ("Sheath") and the InThrill Thrombectomy Catheter ("Catheter"), each packaged separately.
The Sheath is an introducer sheath with a distal self-expanding funnel, proximal aspiration port, and proximal hub. A Dilator is provided to aid insertion and positioning of the Sheath.
Radiopaque markers aid Sheath positioning under fluoroscopic visualization.
The Sheath and Dilator tips are radiopaque, and there is a radiopaque marker band at the proximal end of the Sheath funnel.
The InThrill Thrombectomy System is a single-use, over-the-wire, catheter-based system for the minimally invasive treatment of thromboemboli (including organized thrombus and adherent thrombotic material) in the peripheral vasculature, including arteriovenous fistulae and arteriovenous grafts for dialysis access, and synthetic grafts. The system comprises two main components packaged separately:
• InThrill Sheath (8 Fr)
• InThrill Thrombectomy Catheter (8 Fr)
The InThrill Sheath is comprised of reinforced polymeric coaxial sheath shafts equipped with a self-expanding distal mesh funnel, a flush/aspiration port, and a proximal hemostatic valve. The InThrill Thrombectomy Catheter is comprised of reinforced polymeric coaxial shafts terminating in an expandable nitinol coring element (basket). Other accessories provided include a pre-dilator and dilator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral vasculature, peripheral vessels (4-10 mm) that include: native vessels, arteriovenous fistulae, arteriovenous grafts, synthetic grafts.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 InThrill Thrombectomy System to the predicate devices. These tests included:
Performance Tests:
- Graft Leak Testing (Pre-Simulated Use)
- In-Graft Simulated Use, InThrill Thrombectomy System
- Graft Leak Testing (Post-Simulated Use)
- Graft Visual Inspection (Post-Simulated Use)
- Radial Force Testing
- Prescale Contact Paper Pressure Testing
- Graft Abrasion Testing
- Comparative Adherent Clot Removal Testing
- Visual Inspection of Vein-to-Graft Anastomosis (Pre-Simulated Use)
- Simulated Use, InThrill Catheter through Vein-to-Graft Anastomosis
- Visual Inspection of Vein-to-Graft Anastomosis (Post-Simulated Use)
Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications.
Pre-Clinical Study:
A GLP Animal study was performed, which did not identify any new questions of safety or effectiveness for the InThrill Thrombectomy System in peripheral vessels within the indicated size range.
Clinical testing was not required for the determination of substantial equivalence.
Key results: Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications. The GLP Animal study did not identify any new questions of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
March 17, 2023
Inari Medical, Inc Ellen Nguyen Regulatory Affairs Specialist 6001 Oak Canyon, Suite 100 Irvine, California 92618
Re: K223613
Trade/Device Name: InThrill Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: February 14, 2023 Received: February 14, 2023
Dear Ellen Nguyen:
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. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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,
Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S O'connell -S Date: 2023.03.17
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223613
Device Name InThrill Thrombectomy System
Indications for Use (Describe) The InThrill Thrombectomy System is indicated for:
-
The non-surgical removal of thrombi and emboli from blood vessels, including arteriovenous grafts for dialysis access, and synthetic grafts.
-
Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel/graff.
The InThrill Thrombectomy System is intended for use in the peripheral vasculature.
The InThrill Thrombectomy System is not intended for use in deep vein thrombosis (DVT) treatment.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
PAGE 1 OF 6
510(K) SUMMARY
| Date prepared | March 16, 2023 |
|---|---|
| Name | Inari Medical, Inc. |
| 6001 Oak Canyon, Suite 100 | |
| Irvine, CA 92618 | |
| 877.923.4747 | |
| Contact person | Ellen Nguyen |
| Regulatory Affairs Specialist | |
| Trade name | InThrill Thrombectomy System |
| Common name | Embolectomy catheter |
| Regulation name | Embolectomy catheter |
| Classification number | 21 CFR 870.5150 |
| Product code | QEW |
| Secondary product code | KRA |
| Regulatory class | II |
| Predicate device(s) | Capture Vascular, MegaVac Mechanical Thrombectomy System (K171493) |
| Hotspur Technologies, Inc., PTA-Plus PTA Balloon Catheter (K100842) | |
| Inari Medical, Mini-ClotTriever Thrombectomy System (K220887) | |
| Reference device(s) | Intramed Laboratories, Inc., Graft Thrombectomy Instruments (K942457) |
| Rex Medical, Cleaner Rotational Thrombectomy System (K141617) | |
| Description | The InThrill™ Thrombectomy System is a single-use, sterile medical device |
| designed to remove thrombi and emboli from the peripheral vasculature. The | |
| InThrill™ Thrombectomy System consists of the InThrill Sheath ("Sheath") | |
| and the InThrill Thrombectomy Catheter ("Catheter"), each packaged | |
| separately. | |
| The Sheath is an introducer sheath with a distal self-expanding funnel, | |
| proximal aspiration port, and proximal hub. A Dilator is provided to aid | |
| insertion and positioning of the Sheath. | |
| Radiopaque markers aid Sheath positioning under fluoroscopic visualization. | |
| The Sheath and Dilator tips are radiopaque, and there is a radiopaque marker | |
| band at the proximal end of the Sheath funnel. | |
| Indications for Use | The InThrill Thrombectomy System is indicated for: |
| The non-surgical removal of thrombi and emboli from blood vessels, including arteriovenous fistulae and arteriovenous grafts for dialysis access, and synthetic grafts. Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel/graft. |
4
PAGE 2 OF 6
The InThrill Thrombectomy System is intended for use in the peripheral vasculature.
The InThrill Thrombectomy System is not intended for use in deep vein thrombosis (DVT) treatment.
Summary of substantial
A tabular comparison of the predicate and subject devices is provided below:
equivalence
| | Subject Device
InThrill
Thrombectomy
System | Primary Predicate
MegaVac Mechanical
Thrombectomy
System | Predicate
PTA-Plus PTA
Balloon Cather 5mm
X 4cm, PTA-Plus
PTA Balloon
Catheter 6mm X 4cm | Predicate
Mini-ClotTriever
Thrombectomy
System | |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| K Number | K223613 | K171493 | K100842 | K220887 | |
| Manufacturer | Inari Medical, Inc. | Capture Vascular, Inc. | Hotspur
Technologies, Inc. | Inari Medical, Inc. | |
| Regulations | 21 CFR 870.5150
Embolectomy
catheter | 21 CFR 870.5150
Embolectomy
catheter | 21 CFR 870.5150
Embolectomy
catheter
21 CFR 870.1250
Percutaneous catheter | 21 CFR 870.5150
Embolectomy
catheter | |
| Product Code | QEW
KRA | QEW
QEX
DXE | DXE
LIT | QEW | |
| Indications for
Use | The InThrill
Thrombectomy
System is indicated
for:
• The non-surgical
removal of thrombi
and emboli from
blood vessels,
including
arteriovenous
fistulae and
arteriovenous grafts
for dialysis access,
and synthetic grafts.
• Injection, infusion,
and/or aspiration of
contrast media and
other fluids into or
from a blood
vessel/graft.
The InThrill
Thrombectomy
System is intended
for use in the
peripheral
vasculature. | The MegaVac
Mechanical
Thrombectomy
System is indicated
for:
• The non-surgical
removal of emboli
and thrombi from
blood vessels.
• The non-surgical
removal of thrombi
from synthetic
grafts.
• Use in temporary
blood vessel/graft
occlusion.
• Injection, infusion,
and/or aspiration of
contrast media and
other fluids into or
from a vessel/graft
• Catheter placement
over a guidewire | The PTA-Plus PTA
Balloon Catheter is
indicated for use
within synthetic
arteriovenous dialysis
fistulae to remove
embolic material
(thrombus/debris)
and dilate stenosis for
treatment of
obstructive lesions. | The Mini-ClotTriever
Thrombectomy
System is indicated
for:
• The non-surgical
removal of emboli
and thrombi from
blood vessels.
Injection, infusion,
and/or aspiration of
contrast media and
other fluids into or
from a blood vessel.
The Mini-ClotTriever
Thrombectomy
System is intended
for use in the
peripheral
vasculature.
The Mini-ClotTriever
Thrombectomy
System is not
intended for use in
deep vein thrombosis
(DVT) treatment. | |
| | The InThrill | The MegaVac | The PTA-Plus PTA | The Mini-ClotTriever | |
| | Thrombectomy | Mechanical | Balloon Catheter is | Thrombectomy | |
| | System is not | Thrombectomy | designed for de- | System is a single- | |
| | intended for use in | System is a single- | clotting and treating | use, over-the-wire, | |
| | deep vein thrombosis | use, over-the-wire, | stenosis in synthetic | catheter-based system | |
| | (DVT) treatment. | catheter-based system | dialysis fistulae. It is | for the minimally | |
| Device | The InThrill | for intravascular | an .035" guide-wire | invasive treatment of | |
| Description | Thrombectomy | mechanical | compatible, PTA | thromboemboli in the | |
| | System is a single- | thrombectomy, | balloon catheter with | peripheral | |
| | use, over-the-wire, | occlusion, aspiration | a proprietary valve | vasculature. The | |
| | catheter-based system | and embolectomy in | system which allows | system comprises | |
| | for the minimally | the peripheral | injection of contrast | two main | |
| | invasive treatment of | vasculature, | and an embolectomy | components | |
| | thromboemboli | including grafts. The | coil for mechanical | packaged separately: | |
| | (including organized | system comprises | removal of thrombus. | • Mini-ClotTriever | |
| | thrombus and | two main | | Sheath (8 Fr) | |
| | adherent thrombotic | components: | | • Mini-ClotTriever | |
| | material) in the | • MegaVac Catheter | | Catheter (8 Fr) | |
| | peripheral | • ThromboWire clot | | The Mini-ClotTriever | |
| | vasculature, | retractor | | Sheath is comprised | |
| | including | The MegaVac | | of reinforced | |
| | arteriovenous fistulae | Catheter with | | polymeric coaxial | |
| | and arteriovenous | SafeSeal technology | | sheath shafts | |
| | grafts for dialysis | utilizes a silicone | | equipped with a self- | |
| | access, and synthetic | coated nitinol braided | | expanding distal | |
| | grafts. The system | funnel that expands | | mesh funnel, a | |
| | comprises two main | to occlude antegrade | | flush/aspiration port, | |
| | components | blood flow proximal | | and a proximal | |
| | packaged separately: | to the target work | | hemostatic valve. The | |
| | • InThrill Sheath (8 | zone creating a static | | Mini-ClotTriever | |
| | Fr) | environment in which | | Catheter is comprised | |
| | • InThrill | to perform the | | of reinforced | |
| | Thrombectomy | intervention, while | | polymeric coaxial | |
| | Catheter (8 Fr) | also centering and | | shafts terminating in | |
| | The InThrill Sheath is | securing the catheter | | an expandable nitinol | |
| | comprised of | tip position within the | | coring element | |
| | reinforced polymeric | vessel. The MegaVac | | (basket). Other | |
| | coaxial sheath shafts | catheter's large- | | accessories provided | |
| | equipped with a self- | mouth funnel and | | include a pre-dilator | |
| | expanding distal | inner diameter allows | | and dilator. | |
| | mesh funnel, a | for strong aspiration | | | |
| | flush/aspiration port, | while easily being | | | |
| | and a proximal | able to pass the | | | |
| | hemostatic valve. The | ThromboWire and | | | |
| | InThrill | other lesion | | | |
| | Thrombectomy | disruptive or | | | |
| | Catheter is comprised | therapeutic devices | | | |
| | of reinforced | through it. The | | | |
| | polymeric coaxial | | | | |
| | shafts terminating in | | | | |
| | an expandable nitinol | | | | |
| | coring element | | | | |
| | (basket). Other | | | | |
| | accessories provided | | | | |
| | include a pre-dilator
and dilator. | ThromboWire
consists of a nitinol
embolectomy
element that when
expanded by the
proximal actuation
handle can serve to
gather and pull matter
towards and through
the MegaVac catheter
during aspiration. | | | |
| Target Vessel | Peripheral vessels (4-
10 mm) that include:
• native vessels
• arteriovenous
fistulae
• arteriovenous grafts
• synthetic grafts | Peripheral vessels
that include:
• native vessels
• synthetic grafts | Peripheral vessels
that include:
• arteriovenous
fistulae
• arteriovenous grafts
• synthetic grafts | Peripheral vessels (4-
10 mm) that include:
• native vessels | |
| Sterility | SAL 10-6, EO | SAL 10-6, EO | SAL 10-6, EO | SAL 10-6, EO | |
| Shelf-life | 2 years | Unknown | Unknown | 2 years * | |
| Guidewire
compatibility | 0.035" | Up to 0.044" OD | 0.035" | 0.035" | |
| Sheath
Dimensions | Outer shaft: 0.154"
OD/0.137" ID
Inner shaft: 0.137"
OD/0.110" ID
Length: 6 cm | Up to 9 Fr OD
Length: up to 300 cm | Unknown | Outer shaft: 0.154"
OD/0.137" ID
Inner shaft: 0.137"
OD/0.110" ID
Length: 6 cm | |
| Shaft Materials | Inner: Pebax 55D,
ProPell, PTFE Liner,
Stainless steel coil,
Radiopaque marker
band
Outer: Pebax 63D,
ProPell, PTFE Liner | Unknown | Unknown | Inner: Pebax 55D,
ProPell, PTFE Liner,
Stainless steel coil,
Radiopaque marker
band
Outer: Pebax 40D
and 25D, ProPell,
PTFE Liner | |
| Hemostasis
Valve | 8 Fr Garrote valve
Rotating swivel hub
with side port | Unknown | Unknown | 8 Fr Garrote valve
Rotating swivel hub
with side port | |
| Handle | Yes; Slide actuator
enclosed within
handle housings | Yes; Operator
controlled – linear
actuation | Unknown | Yes; Slide actuator
enclosed within
handle housings | |
| Braided Funnel | OD: 10 mm
Length: 0.70"
Braided nitinol
funnel | OD: 2-12 mm
Silicone coated
braided nitinol funnel | Unknown | OD: 10 mm
Length: 0.70"
Braided nitinol
funnel | |
| Side Port | Tygon tubing with
Loctite adhesive
1-way stopcock with
female Luer
connector | Unknown | Unknown | Tygon tubing with
Loctite adhesive
1-way stopcock with
female Luer
connector | |
| | Dilator | Unknown | Unknown | Dilator | |
| | OD: 0.110" | | | OD: 0.110" | |
| | Total length: 8.8" | | | Total length: 8.3" | |
| | Tipped LDPE/HDPE | | | Tipped LDPE/HDPE | |
| | extrusion | | | extrusion | |
| | Dilator cap | | | Dilator cap | |
| | Proximal flush port | | | Proximal flush port | |
| | Pre-Dilator | Unknown | Unknown | OD: 0.13" (10 Fr) | |
| | OD: 0.13" (10 Fr) | | | Polypropylene, | |
| | Polypropylene, | | | HDPE | |
| | HDPE | | | Length: 10.2 cm | |
| | Length: 10.2 cm | | | OD: 0.111" | |
| | Catheter | Nitinol | Unknown | OD: 0.111" | |
| | Proximal hub with | | | Proximal hub with | |
| | Tuohy Borst | | | Tuohy Borst | |
| | hemostasis Y-valve | | | hemostasis Y-valve | |
| | and 1-way stopcock | | | and 1-way stopcock | |
| | Materials: | | | Materials: | |
| | Outer: PTFE | | | Outer: PTFE | |
| | Liner, SS304V | | | Liner, SS304V | |
| | Braid, Radiopaque | | | Braid, | |
| | marker band, 63D | | | Radiopaque | |
| | Pebax Jacket, 63D | | | marker band, 63D | |
| | Pebax Fluoro-safe | | | Pebax Jacket, 63D | |
| | marker band | | | Pebax Fluoro-safe | |
| | Middle: Braided | | | marker band | |
| | polyimide, | | | Middle: Braided | |
| | Radiopaque | | | polyimide, | |
| | marker band, | | | Radiopaque | |
| | Pebax 72D | | | marker band, | |
| | Inner: Braided | | | Loctite 3942 | |
| | polyimide, | | | Inner: Braided | |
| | Radiopaque 55D | | | polyimide, | |
| | Pebax tip with | | | Radiopaque 55D | |
| | ProPell | | | Pebax tip with | |
| | | | | ProPell | |
| | Length | 65 cm | Up to 300 cm | 55 cm | 65 cm |
| | Coring Element | Laser-cut nitinol | Woven nitinol | Unknown | Laser-cut nitinol |
| | | OD: 18 mm | OD: 2-9 mm | | OD: 18 mm |
| | | Length: 88 mm | | | Length: 88 mm |
5
K223613
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K223613
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7
K223613
PAGE 5 OF 6
Summary of substantial equivalence
Biocompatibility
The material changes proposed in this submission have no impact on the established biocompatibility of the device. Therefore, the previous passing results demonstrating that the InThrill Thrombectomy System (K220887) and accessories meet biological safety requirements per ISO 10993-1 are still applicable.
Sterilization
The subject device, including its accessories, 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. There have been no changes proposed that would affect device
8
sterilization; therefore, the previous sterilization process per K220887 remains applicable.
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 InThrill Thrombectomy System to the predicate devices. These tests included:
Performance Tests
- Graft Leak Testing (Pre-Simulated Use) ●
- In-Graft Simulated Use, InThrill Thrombectomy System ●
- . Graft Leak Testing (Post-Simulated Use)
- Graft Visual Inspection (Post-Simulated Use) ●
- Radial Force Testing
- Prescale Contact Paper Pressure Testing ●
- Graft Abrasion Testing
- Comparative Adherent Clot Removal Testing ●
- Visual Inspection of Vein-to-Graft Anastomosis (Pre-Simulated Use)
- Simulated Use, InThrill Catheter through Vein-to-Graft Anastomosis ●
- Visual Inspection of Vein-to-Graft Anastomosis (Post-Simulated ● Use)
Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications.
Pre-Clinical Study
A GLP Animal study was performed, which did not identify any new questions of safety or effectiveness for the InThrill Thrombectomy System in peripheral vessels within the indicated size range.
Clinical testing was not required for the determination of substantial equivalence.
Conclusion
The non-clinical tests demonstrate that the subject device does not raise new questions of safety or effectiveness and, therefore, is substantially equivalent to the predicate device.