Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter, with no mention of AI or ML.

Therapeutic

No
The device is a large bore catheter used to facilitate the insertion and guidance of interventional devices, and as a conduit for retrieval devices, meaning it assists in procedures but does not directly treat a disease or condition itself.

Diagnostic

No

Explanation: The device is described as a catheter used for facilitating the insertion and guidance of other interventional devices and as a conduit for retrieval devices. Its function is to provide access and support for therapeutic or interventional procedures, not to diagnose medical conditions by acquiring or processing information about the patient's health status.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical catheter with various material components, a lumen, a hub, and accessories, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for facilitating the insertion and guidance of interventional devices into blood vessels and for use as a conduit for retrieval devices. This is an in vivo application, meaning it is used within the living body.
Device Description: The description details a physical catheter designed for insertion into the neurovascular system.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.

IVD devices are used to perform tests on samples taken from the body, not to directly interact with the body's internal structures in the way this catheter does.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The CERENOVUS Large Bore Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The CERENOVUS Large Bore Catheter is also indicated for use as a conduit for retrieval devices.

Product codes (comma separated list FDA assigned to the subject device)

DQY

Device Description

The CERENOVUS Large Bore Catheter is a variable stiffness, single lumen catheter designed to be introduced over a steerable guide wire or microcatheter into the neuro vasculature. The catheter shaft is composed of a stainless steel variable pitch braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with polymer materials, which encapsulate the stainless steel braid construction. The catheter has a stiff proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The distal end of the catheter has a radiopague marker band to facilitate fluoroscopic visualization and has a hydrophilic coating to provide lubricity for navigation of vessels. The proximal end of the catheter has a luer fitting located on the end of the catheter hub. An ID band is placed at the distal end of the hub over a strain relief. The catheter is packaged with a hemostasis valve with a side port and two peel-away introducers as accessories. The hemostasis valve with side port is used for flushing and insertion of catheters. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the hemostasis valve.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

neurovascular system

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)

Performance Testing - Bench: Bench testing was conducted to demonstrate substantial equivalence. Tests included: Visual Inspection, Catheter ID, Introducer ID, Catheter OD, Introducer OD, Catheter Working Length, Introducer Working Length, Distal Tip Length, Hub Luer Taper, Air Leak testing, System Liquid Leakage, Delamination of PTFE Liner, Kink (Distal & Proximal), Tip Movement, Tip Linear Stiffness, Coating Lubricity & Durability, Coating Length, Catheter Tensile Strength, Introducer Separation Force, Particle Count, Burst Pressure (static), In-vitro Usability Studies, Packaging Visual Inspection, and Packaging Dye Leak. All samples met the established acceptance criteria for all tests.
Performance Testing - Animal: No animal testing was required.
Performance Testing - Clinical: No clinical studies were required.
Sterilization: Validated 100% Ethylene Oxide sterilization process to ensure sterility assurance level (SAL) of 10-6 in accordance with ISO 11135-1.
Shelf-Life Testing: One year shelf life based on successful stability testing.
Biocompatibility Testing: Assessed in accordance with ISO 10993-1 and FDA Guidance. Tests included: Cytotoxicity (MEM Elution), Sensitization (Maximization Study), Irritation (Intracutaneous Reactivity), Acute Systemic Toxicity, Pyrogenicity (Material Mediated), In Vitro Hemolysis, Complement Activation, In Vivo Thromboresistance Study - Jugular Vein, and ISO 10993-18 Chemical Characterization (Exaggerated Extraction). All tests passed, concluding the test article is non-cytotoxic, non-sensitizer, non-irritant, non-toxic, nonpyrogenic, non-hemolytic, not a potential activator of the complement system, thromboresistant, and extractable compounds do not present a toxicological risk.

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.

K183463

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.

Not Found

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

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).

Summary

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 acronym followed by the words "U.S. Food & Drug Administration" on the right. The FDA part of the logo is in blue, while the Department of Health & Human Services logo is in black.

November 8, 2019

Codman & Shurtleff, Inc. Kirsten Franco, MS, RAC Regulatory Affairs Manager 325 Paramount Drive Raynham, Massachusetts 02767

Re: K191237

Device Name: CERENOVUS Large Bore Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: October 7, 2019 Received: October 9, 2019

Dear Kirsten Franco:

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,

Xiaolin Zheng, Ph.D. Director (Acting) DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K191237

Device Name CERENOVUS Large Bore Catheter

Indications for Use (Describe)

The CERENOVUS Large Bore Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The CERENOVUS Large Bore Catheter is also indicated for use as a conduit for retrieval devices.

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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3

510(k) Summary - K191237

Pursuant to the requirements of 21 CFR Section 807.92(c), this 510(k) summary is provided as part of this Premarket Notification containing sufficient details to understand the basis for a determination of substantial equivalence.

| Submitter | Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham, MA 02767 |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Kirsten Franco
Phone: (484) 868-7991
Email: kfranco5@its.jnj.com |
| Date Prepared | June 19, 2019 |
| Device Trade
or Proprietary
Name | CERENOVUS Large Bore Catheter |
| Device
Classification | Regulatory Classification: II
Common or Usual Name: Catheter, Percutaneous
Classification Name: Percutaneous Catheter
Regulation Number: 21 CFR 870.1250
Product Code: DQY
Classification Panel: Cardiovascular |

| Predicate
Device | 510(k)
Number | Date Cleared | Device Name | Manufacturer |
|---------------------|------------------|----------------|----------------------------------------|-----------------------|
| | K183463 | March 13, 2019 | AXS Catalyst Distal Access
Catheter | Stryker Neurovascular |

Continued on next page

4

Device The CERENOVUS Large Bore Catheter is a variable stiffness, single lumen catheter Description designed to be introduced over a steerable guide wire or microcatheter into the neuro vasculature. The catheter shaft is composed of a stainless steel variable pitch braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with polymer materials, which encapsulate the stainless steel braid construction. The catheter has a stiff proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The distal end of the catheter has a radiopague marker band to facilitate fluoroscopic visualization and has a hydrophilic coating to provide lubricity for navigation of vessels. The proximal end of the catheter has a luer fitting located on the end of the catheter hub. An ID band is placed at the distal end of the hub over a strain relief. The catheter is packaged with a hemostasis valve with a side port and two peel-away introducers as accessories. The hemostasis valve with side port is used for flushing and insertion of catheters. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the hemostasis valve. Indications for The CERENOVUS Large Bore Catheter is indicated for use in facilitating the insertion Use and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The CERENOVUS Large Bore Catheter is also indicated for use as a conduit for retrieval devices. Predicate A comparison of the similarities and differences of product features between the Comparison CERENOVUS Large Bore Catheter and the predicate device is presented in Table 1.

| Description | Subject Device:
CERENOVUS Large Bore Catheter
(K191237) | Predicate Device:
AXS Catalyst Distal Access Catheter
(K183463) |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | DQY | Same |
| Regulatory Name | Catheter, Percutaneous | Same |
| Classification | Class II - 21 CFR 870.1250 | Same |
| Basic Design | Variable stiffness single lumen catheter | Same |
| Indications For Use | The CERENOVUS Large Bore Catheter is indicated for use in
facilitating the insertion and guidance of appropriately sized
interventional devices into a selected blood vessel in the
neurovascular system. The CERENOVUS Large Bore
Catheter is also indicated for use as a conduit for retrieval
devices. | The AXS Catalyst Distal Access Catheter is
indicated for use in facilitating the insertion and
guidance of appropriately sized interventional
devices into a selected blood vessel in the
peripheral and neurovascular systems. The AXS
Catalyst Distal Access Catheter is also indicated
for use as a conduit for retrieval devices. |
| Dimensions: | | |
| Length | 125 - 135 cm | 115 - 132 cm |
| ID | 0.071" | 0.068" |
| Distal OD | 0.081" | 0.082" |
| Proximal OD | 0.0825" | 0.0825" |
| Catheter Coating | Hydrophilic | Hydrophilic |
| Coating Length | 30 cm | Same |
| Materials: | | |
| Marker Band | Metal Platinum (90%) / Iridium (10%) | Same |
| Braid | Stainless Steel | Nitinol wire and polymer fiber |
| Liner | PTFE Liner | Same |
| Hub | Polyamide | Nylon |
| Strain Relief | | Thermoplastic rubber (Polyolefin) |

Table 1. Subject and Predicate Device Comparison Summary

5

| Description | Subject Device:
CERENOVUS Large Bore Catheter
(K191237) | Predicate Device:
AXS Catalyst Distal Access Catheter
(K183463) |
|------------------------------------|---------------------------------------------------------------|-----------------------------------------------------------------------|
| Outer Jacket | Pebax, Urethane, Nylon | Pebax with Nylon, Tecoflex |
| Accessories Included: | | |
| Hemostasis valve | Hemostasis Valve with Side Port Extension Tubing | Rotating Hemostasis Valve; Tuohy Borst
Valve with Sideport |
| Introducer
Sheath | Peel-Away Sheath Introducer (2) | Same |
| Sterilization
Method | Ethylene Oxide | Same |
| Sterility Assurance
Level (SAL) | 10-6 | Same |
| Packaging | Polyethylene Hoop and Mounting Card, Pouch, Carton | Same |
| Shelf Life | 1 year | Same |

Non-Clinical Testing Summary

Performance Testing - Bench

Appropriate testing was identified based on design, risk analyses and the intended use of the CERENOVUS Large Bore Catheter to demonstrate that it is substantially equivalent to the legally marketed Predicate device. The following performance data are being provided in support of the substantial equivalence determination. All testing was conducted using sampling methods as required by Codman & Shurtleff, Inc. Design Control procedures. The bench testing included the following tests:

Test	Test Summary	Result
	Confirm that the CERENOVUS Large Bore	PASS:
Visual Inspection	Catheter meets the visual requirement described	Samples met the established
	in ISO 10555-1 Section 4.4	acceptance criteria
	Verify that the catheter internal diameters meet	PASS:
Catheter ID	the requirements	Samples met the established
		acceptance criteria
	Verify that the introducer internal diameters	PASS:
Introducer ID	meet the requirements	Samples met the established
		acceptance criteria
	Verify that the catheter outer diameters meet the	PASS:
Catheter OD	requirements	Samples met the established
		acceptance criteria
	Verify that the introducer outer diameters meet	PASS:
Introducer OD	the requirements	Samples met the established
		acceptance criteria
Catheter Working	Confirm the working length of a catheter as	PASS:
Length	defined in ISO10555-1 Section 3.6.	Samples met the established
		acceptance criteria
PASS:
Introducer	Confirm the working length of the introducer	Samples met the established
Working Length		acceptance criteria
	Verify the distal tip length of the catheter	PASS:
Distal Tip Length		Samples met the established
		acceptance criteria
	Verify that the catheter hub luer taper fit	PASS:
Hub Luer Taper	standard luer fittings using a taper device	Samples met the established
		acceptance criteria
Air Leak testing	Verify that there is no air leak into the hub	PASS:
	subassembly	Samples met the established
		acceptance criteria
	Verify that the catheter joint strength meets the
System Liquid
Leakage	freedom from leakage (liquid during	PASS:
	pressurization) requirements of ISO 10555-	Samples met the established
	1:2013. section 4.7	acceptance criteria

6

Test	Test Summary	Result
Delamination of
PTFE Liner	Verify that the PTFE has appropriately adhered
to the inner lumen of the catheter with braid
reinforcement	PASS:
Samples met the established
acceptance criteria
Kink (Distal &
Proximal)	Confirm that the CERENOVUS Large Bore
Catheter meets the requirement for the catheter
to remain stable and not kink during use	PASS:
Samples met the established
acceptance criteria
Tip Movement	Confirm that the CERENOVUS Large Bore
Catheter meets the tip column stiffness
requirement	PASS:
Samples met the established
acceptance criteria
Tip Linear
Stiffness	Test the tip flexibility of the CERENOVUS
Large Bore Catheter, relative to other devices of
similar design	PASS:
Samples met the established
acceptance criteria
Coating Lubricity
& Durability	Verify the lubriciousness and durability of the
catheter hydrophilic coating	PASS:
Samples met the established
acceptance criteria
Coating Length	Verify that the catheter hydrophilic coating
length meets the design requirements	PASS:
Samples met the established
acceptance criteria
Catheter Tensile
Strength	Verify that the catheter joint strength meets the
requirements of Section 4.5 of ISO 10555-1	PASS:
Samples met the established
acceptance criteria
Introducer
Separation Force	Confirm the force required to separate the peel-
away introducer accessory	PASS:
Samples met the established
acceptance criteria
Particle Count	Verify that the coating integrity of the catheter's
outer surface meets the requirements for content
of particulates.	PASS:
Samples met the established
acceptance criteria
Burst Pressure
(static)	Confirm the maximum hydrostatic pressure a
catheter can withstand using a Crescent
Hydraulic Burst-leak Tester	PASS:
Samples met the established
acceptance criteria
In-vitro Usability
Studies	Evaluate catheter usability parameters such as
trackability, tip stability and visibility under
fluoroscopy, durability, etc. Subject and
Predicate devices were tracked to the target site
to deliver a stent-retriever in the neurovascular
model that replicates the tortuosity, diameter
and location of the arteries in the
neurovasculature.	PASS:
Samples met the
established acceptance
criteria
Packaging Visual
Inspection	Confirm that the proposed packaging system has
no visible defects that would result in exposure
of the primary package or IFU	PASS:
Samples met the established
acceptance criteria
Packaging Dye
Leak	Evaluate sterile package integrity by detecting
and locating defects in package seals and
pinholes in the packaging materials	PASS:
Samples met the established
acceptance criteria

Performance Testing - Animal

No animal testing was required as appropriate verification and validation of the subject device were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.

Performance Testing - Clinical

No clinical studies were required as appropriate verification and validation of the subject device were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.

7

Sterilization

The CERENOVUS Large Bore Catheter, as packaged with included accessories, is sterilized using a validated 100% Ethylene Oxide sterilization process to ensure sterility assurance level (SAL) of 10-6 in accordance with ISO 11135-1. The CERENOVUS Large Bore Catheter and all accessories meet EO residuals per EN ISO 10993-7 for a limited contact delivery system - externally communicating. The CERENOVUS Large Bore Catheter and all accessories are for single use only.

Shelf-Life Testing

The CERENOVUS Large Bore Catheter will have a shelf life of one year based on the successful completion of stability testing. Shelf life testing was performed using standard test methods and acceptance criteria. Prior to aging, all samples were exposed to standard transportation conditioning. Results of testing on the subject device all met established acceptance criteria.

Biocompatibility Testing

The CERENOVUS Large Bore Catheter was assessed for biocompatibility in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation of Testing within a Risk Management Process." and FDA Guidance for Industry and FDA Staff: Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (Issued June 16, 2016). The Subject device is considered an externally communicating medical device with circulating blood contact for less than 24 hours. The following Biocompatibility Testing was completed as part of this evaluation:

Summary of Catheter Biocompatibility Testing
Test	Summary of Results	Conclusion
Cytotoxicity
(MEM Elution)	The test article extract showed no evidence of causing cell
lysis or toxicity (grade = 0). The test article extract met the
requirements of the test since the grade was less than a grade
2 (mild reactivity).	The test article is considered
non-cytotoxic.
PASS
Sensitization
(Maximization
Study)	The test article exacts showed no evidence of causing
delayed dermal contact sensitization (all erythema scores
=0).	The test article was not
considered a sensitizer.
PASS
Irritation
(Intracutaneous
Reactivity)	The test article met the requirements of the test since the
difference between each test article extract overall mean
score and corresponding control overall mean score was 0.0
for both the saline and the sesame oil test article extracts.	The test article is considered
a non-irritant.
PASS
Acute Systemic
Toxicity	There was no mortality or evidence of systemic toxicity from
the extracts injected into the mice. Each test article extract
met the requirements of the study.	The test article does not
indicate signs of toxicity.
PASS
Pyrogenicity
(Material
Mediated)	No single animal showed a temperature rise of 0.5 °C or
more above its baseline temperature. The total rise of the
rabbits' temperature during 3 hours was 0.4 °C. The total
rise of rabbit temperatures during the 3 hour observation
period was within the acceptable USP limits.	The test article was judged
as nonpyrogenic.
PASS
In Vitro
Hemolysis	The hemolytic index for the test article in direct contact with
blood was 0.0%, and the hemolytic index for the test article
extract was 0.0%.	The test article is non-
hemolytic.
PASS

8

Summary of Catheter Biocompatibility Testing (Continued)
Test	Summary of Results	Conclusion
Complement
Activation	The concentration of SC5b-9 in the Test Group 1 was
8,712.8 ± 427.3 ng/mL (mean ± S.D.) which was higher and
statistically different (p=0.0059) than the activated NHS
control, and was higher however not statistically different
(p=0.2048) than the negative control.	The test article was not
considered to be a potential
activator of the complement
system.
PASS
	The concentration of SC5b-9 in the Test Group 2 was higher
and statistically different than the activated NHS control, and
was not higher nor statistically different than the negative
control.
	The concentration of SC5b-9 in the Test Group 3 was higher
however not statistically different than the activated NHS
control, and was not higher nor statistically different than the
negative control.
In Vivo
Thromboresistan
ce Study -
Jugular Vein	Slight thrombus formation was noted with both the test and
control articles (Grade ≤ 2). Therefore, both test and control
articles were considered thromboresistant.	Both test and control articles
were considered
thromboresistant.
PASS
ISO 10993-18
Chemical
Characterization
(Exaggerated
Extraction)	FTIR: No bands of interest
GC/MS: No semi-volatile compounds greater than the
quantitation limit
ICP/MS: trace amounts of Mg, Zn, and Sb detected
UPLC/MS: No compounds greater than the quantitation limit
GC/MS HS: No volatile compounds greater than the
quantitation limit	Extractable compounds do
not present a toxicological
risk to patients
	FTIR: Most closely matches Pebax 4033 SN 00t
GC/MS: 3 peaks identified
UPLC/MS: Irganox 1010 standard analysis	Extractable compounds do
not present a toxicological
risk to patients
	FTIR: Most closely matches Nylon compound 600
GC/MS: No semi-volatile compounds greater than the
quantitation limit
UPLC/MS: Irganox 1010	Extractable compounds do
not present a toxicological
risk to patients

Summary of Introducer Biocompatibility Testing
Test	Summary of Results	Results
Cytotoxicity (MEM
Elution)	The test article extract showed no evidence of causing cell lysis or toxicity (grade = 0). The test article extract met the requirements of the test since the grade was less than a grade 2 (mild reactivity).	The test article is considered
non-cytotoxic.

PASS |
| Sensitization
(Maximization
Study) | The test article exacts showed no evidence of causing delayed dermal contact sensitization (all erythema scores =0). The test article was not considered a sensitizer. | The test article is not
considered a sensitizer.

PASS |
| Irritation
(Intracutaneous
Reactivity) | The test article met the requirements of the test since the difference between each test article extract overall mean score and corresponding control overall mean score was 0.0 for both the saline and the sesame oil test article extracts. | The test article is considered
a non-irritant.

PASS |
| Acute Systemic
Toxicity | There was no mortality or evidence of systemic toxicity from the extracts injected into the mice. Each test article extract met the requirements of the study. | The test article does not
indicate signs of toxicity.

PASS |
| Pyrogenicity
(Material
Mediated) | No single animal showed a temperature rise of 0.5°C or more above its baseline temperature. The total rise of the rabbits' temperature during 3 hours was 0.0°C. The total rise of rabbit temperatures during the 3 hour observation period was within the acceptable USP limits. The test article was judged as nonpyrogenic. | The test article was judged
as nonpyrogenic.

PASS |
| In Vitro
Hemolysis | The hemolytic index for the test article in direct contact with blood was 0.0%, and the hemolytic index for the test article extract was 0.0%. Both the test article in direct contact with blood and the test article extract were non-hemolytic. | The test article is non-
hemolytic.

PASS |

9

Summary of Introducer Biocompatibility Testing (Continued)
Test	Summary of Results	Results
Complement
Activation	The concentration of SC5b-9 in the test article sample was higher and statistically different than the activated NHS control, and was higher however not statistically different than the negative control.
The test article was not considered to be a potential activator of the complement system.	The test article was not considered to be a potential activator of the complement system.
PASS
Chemical
Characteriza-
tion	No peaks of significant interest, nor any residues in the extract found above the quantitation limits.	No presence of extractables

Conclusion

Based upon the intended use, design, materials, function, and side-by-side in-vitro testing, it is concluded that the subject device, CERENOVUS Large Bore Catheter is substantially equivalent to the predicate device, AXS Catalyst Distal Access Catheter (K183463, cleared 13 March 2019). The differences in verbiage in the Indications for Use statement, materials, and design, do not raise any questions regarding the safety and effectiveness of the device. The device, as designed, manufactured, packaged and sterilized, is substantially equivalent to the primary and referenced predicate device(s) currently marketed under the Federal Food, Drug and Cosmetic Act.