Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No.
The device is described as a guide catheter used to introduce other interventional devices and provide a conduit, rather than directly treat a medical condition itself.

Diagnostic

No

The device is a guide catheter used to introduce other interventional devices into the vasculature and reinforce them. It does not gather information for diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical catheter with various material components (stainless steel, nitinol, PTFE, platinum/iridium), dimensions, and physical properties. It also includes a dilator accessory. This is a hardware medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Rist™ 071 Radial Access Guide Catheter is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is for the introduction of interventional devices into the vasculature. This is a procedural device used in vivo (within the body) to facilitate medical procedures.
Device Description: The description details a physical catheter designed to be inserted into blood vessels. It does not describe a device used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide diagnostic information.
Lack of Diagnostic Function: The device's function is to provide access and support for other devices. It does not perform any tests or analyses on biological samples to diagnose a condition.

IVD devices are specifically designed to be used in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Rist™ 071 Radial Access Guide Catheter does not fit this definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Rist™ 071 Radial Access Guide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Product codes

DQY, QJP

Device Description

The Rist™ 071 Radial Access Guide Catheter is a single lumen, variable stiffness catheter with a stainless steel and nitinol reinforced shaft to provide support. The embedded stainless-steel flat wire cross coil is in the proximal section of the catheter, which transitions to a nitinol round wire single coil in the distal end. The catheter has a radiopaque platinum/iridium marker band on the distal end to aid in visualization. The distal 25 cm of the Rist™ 071 Radial Access Guide Catheter has a hydrophilic coating which reduces the insertion force and allows the catheter to traverse the vasculature more easily. The catheter has a nominal outer diameter of 0.084 inches and a nominal inner diameter of 0.071 inches. It is available in three working lengths: 95 cm, 100 cm, and 105 cm. The Rist™ 071 Radial Access Guide Catheter has a PTFE-lined lumen to reduce friction with other devices introduced through the lumen. It is intended to provide access to the target site via transradial access and, once in place, provides a reinforcing conduit for other intravascular devices. A radial access dilator is included as an accessory. The Rist™ 071 Radial Access Guide Catheter is supplied sterile, non-pyrogenic, and intended for single use only.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral, coronary, and neuro vasculature

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

Design verification and validation were performed to ensure that the Rist™ 071 Radial Access Guide Catheter meets its performance specifications and to support substantial equivalence to the predicate device. Based on the risk analysis, it was determined that certain tests conducted for the predicate device could apply to the subject device, and certain tests should be repeated.

The summary of tests performed on the subject Rist™ 071 Radial Access Guide Catheter (Table D.1) includes:

Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility (Complement Activation, ASTM Hemolysis, Platelet & Leukocyte Count, Partial Thromboplastin Time (PTT))) - All tests showed acceptable results.
Sterilization Validation (per ANSI/AAMI/ISO 11135:2014 and AAMI TIR 28:2016) - Product was sterile.
Packaging - All units met acceptance criteria.
Catheter and Dilator Tensile Strength (per ISO 10555-1:2013/Amd. 1:2017(E)) - All units met acceptance criteria.
Catheter PTFE Delamination - All units met acceptance criteria.
Torque - All units met acceptance criteria.
Catheter Burst Pressure (per ISO 10555-1:2013/Amd. 1:2017(E)) - All units met acceptance criteria.
Particulate Testing (per USP ) - All units met acceptance criteria.
Coating Integrity - All units met acceptance criteria.
Leak (Liquid & Air) (per ISO 10555-1:2013/Amd. 1:2017(E)) - All units met acceptance criteria.
Catheter Dimensional Inspection - All units met acceptance criteria.
Dilator Dimensional Inspection - All units met acceptance criteria.
Chemical Compatibility - All units met acceptance criteria.
Visual Inspection of Catheter and Dilator - All units met acceptance criteria.
Catheter Coating Length - All units met acceptance criteria.
Kink Resistance - All units met acceptance criteria.
In vitro Simulated Use Study - All acceptance criteria were met.

A summary of the prior tests deemed applicable to the subject device (Table D.2) from the Predicate RIST™ Cath Radial Access Long Sheath (K191551) includes:

Corrosion (per ISO 10555-1:2013/Amd. 1:2017(E)) - All units met acceptance criteria.
Hub Compatibility (per ISO 594-1:1986 and ISO 594-2:1998) - All units met acceptance criteria.
Radiopacity - All acceptance criteria were met.
Label Content - All units met acceptance criteria.
Label Legibility - All units met acceptance criteria.
Barcode - All units met acceptance criteria.
Dilator Working Length - All units met acceptance criteria.
Useability (as part of Design Validation) - All acceptance criteria were met.

Shelf-life testing (product and packaging) to support the labeled shelf life of 6 months was performed and all acceptance criteria were met.

Key Metrics

Not Found

Predicate Device(s)

RIST™ Cath Radial Access Long Sheath (K191551)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

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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 and 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, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.

July 27, 2021

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular % Marianne Grunwaldt Senior Director of Quality Assurance and Regulatory Affairs InNeuroCo. Inc. 19700 Sterling Road. Suite 1 Pembroke Pines, Florida 33332

Re: K211990

Trade/Device Name: Rist 071 Radial Access Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, QJP Dated: June 25, 2021 Received: June 28, 2021

Dear Marianne Grunwaldt:

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

1

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 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 (OS) 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 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,

Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211990

Device Name Rist™ 071 Radial Access Guide Catheter

Indications for Use (Describe)

The Rist™ 071 Radial Access Guide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

510(k) Number	K211990
Date Summary Prepared	June 25, 2021
Sponsor	Micro Therapeutics, Inc.
	d/b/a ev3 Neurovascular
	9775 Toledo Way
	Irvine, CA 92618
	Establishment Registration: 2029214
Sponsor Contact	Amnon Talmor
	E-mail Address: amnon.talmor@medtronic.com
Prepared By	Marianne Grunwaldt
	E-mail Address: marianne@inneuroco.com
Trade Name:	Rist™ 071 Radial Access Guide Catheter
Regulation Number:	21 CFR 870.1250
Device Common or
Classification Name:	Percutaneous Catheter
Product Class:	Class II
Product Panel:	Cardiovascular, Neurovascular
Product Code:	DQY, QJP
Predicate Devices:	RIST™ Cath Radial Access Long Sheath (K191551)

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A) Device Description

The Rist™ 071 Radial Access Guide Catheter is a single lumen, variable stiffness catheter with a stainless steel and nitinol reinforced shaft to provide support. The embedded stainless-steel flat wire cross coil is in the proximal section of the catheter, which transitions to a nitinol round wire single coil in the distal end. The catheter has a radiopaque platinum/iridium marker band on the distal end to aid in visualization. The distal 25 cm of the Rist™ 071 Radial Access Guide Catheter has a hydrophilic coating which reduces the insertion force and allows the catheter to traverse the vasculature more easily. The catheter has a nominal outer diameter of 0.084 inches and a nominal inner diameter of 0.071 inches. It is available in three working lengths: 95 cm, 100 cm, and 105 cm. The Rist™ 071 Radial Access Guide Catheter has a PTFE-lined lumen to reduce friction with other devices introduced through the lumen. It is intended to provide access to the target site via transradial access and, once in place, provides a reinforcing conduit for other intravascular devices. A radial access dilator is included as an accessory. The Rist™ 071 Radial Access Guide Catheter is supplied sterile, non-pyrogenic, and intended for single use only.

B) Indications for Use

The Rist™ 071 Radial Access Guide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

C) Technological Characteristics and Basis for Substantial Equivalence

The Rist™ 071 Radial Access Guide Catheter, is substantially equivalent in its intended use/indications for use, technology and principle of operation, materials, sterilization method and performance to the predicate device, the RIST™ Cath Radial Access Long Sheath 510(k) #K191551. A comparison of the technological characteristics of the subject device and the predicate device, is summarized in Table C.1 below.

| Parameter | Predicate Device
RIST™ Cath Radial Access
Long Sheath | Subject Device
Rist™ 071 Radial Access Guide
Catheter |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K191551 | K211990 |
| Classification | Class II | Same |
| Product Code | DQY | DQY, QJP |
| Review Panel | Cardiology | Cardiology, Neurology |
| Indications for
Use | The RIST™ Cath Radial Access Long
Sheath is indicated for the introduction
of interventional devices into the
peripheral, coronary, and neuro
vasculature. | The Rist™ 071 Radial Access Guide
Catheter is indicated for the
introduction of interventional devices
into the peripheral, coronary, and neuro
vasculature. |

Table C.1 Technological Characteristics Comparison
	Predicate Device	Subject Device
Parameter	RIST TM Cath Radial Access
Long Sheath	RistTM 071 Radial Access Guide
Catheter
Catheter Shaft
Outer Jacket	Chronoflex AL 75A, Polyblend 55A
blend	Chronoflex AL 75A, Polyblend 55A
blend with revised Polyolefin
	Chronoflex C 85A	Chronoflex C 85A purchased from a new
vendor resulting in a polyurethane soft
block change
	Chronoflex C 45D	Same
	Pebax	Same
	Vestamid/72D Coextrusion	Same
Liner	Etched PTFE	Same
Catheter Shaft
Reinforcement	Stainless Steel Flat Wire
Nitinol Round Wire	Same
Marker Band	90% Platinum/10% Iridium	Same
Hub Material	Polycarbonate (Makrolon)	Same
Strain Relief	Polyolefin	Same
Coating	Hydrophilic Coating	Same
Catheter Working
Length	95, 100, 105* cm	95, 100, 105 cm
Catheter Inner
Diameter	0.079 inches	0.071 inches
Catheter Outer
Diameter	0.093 inches	0.084 inches
Dilator
Working Length	115 cm	Same
Dilator - ID	0.037 inches	0.040 inches
Dilator - OD	0.072 inches	0.068 inches
Dilator - Material	Pebax 72D with BaSO4 with
polycarbonate (Makrolon hub)	Same
Accessories	Dilator*	Same
Parameter	Predicate Device
RISTTM Cath Radial Access
Long Sheath	Subject Device
RistTM 071 Radial Access Guide
Catheter
Packaging	Tyvek/Nylon pouch	Tyvek/Nylon pouch with revised Anti-
blocking agent.
	Polyethylene support tube	Polyethylene support tube with revised
additive package antioxidant
	Packaging card	Same
	Solid Bleached Sulfate (SBS) carton	Same
Sterilization	Ethylene Oxide	Same
Number of Uses	Single Use	Same
* Since the clearance of the RISTTM Cath Radial Access Long Sheath two changes were made and documented
as per the FDA guidance document "Deciding When to Submit a 510(k) for a Change to an Existing Device."

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Table C.1 Technological Characteristics Comparison

6

Table C.1 Technological Characteristics Comparison

The two changes were the removal of the hemostasis valve originally included as an accessory, and the addition of a catheter with 105 cm working length.

D) Performance Data

Design verification and validation were performed to ensure that the Rist™ 071 Radial Access Guide Catheter meets its performance specifications and to support substantial equivalence to the predicate device. Based on the risk analysis, it was determined that certain tests conducted for the predicate device could apply to the subject device, and certain tests should be repeated. The summary of tests performed on the subject Rist™ 071 Radial Access Guide Catheter is included in Table D.1, and a summary of the prior tests deemed applicable to the subject device is included in Table D.2.

Test Performed	Test Method / Applicable Standard	Results
Biocompatibility	Cytotoxicity
(ISO MEM Elution)	The test article is considered
non-cytotoxic under the
conditions of this test. No
abnormal events such as pH
change or debris were noted.
	Sensitization
(ISO Magnusson-Kligman Method)	Under the conditions of this
protocol, the test article did not
elicit a sensitization response.
	Irritation
(ISO Intracutaneous Toxicity)	No significant dermal reactions
were observed at the injected test
and control sites in any of the
test subjects.
	Acute Systemic Toxicity
(ISO Systemic Injection)	None of the study subjects were
observed with abnormal clinical

		Table D.1 List of Tests Conducted on the Rist™ 071 Radial Access Guide Catheter

Test Performed	Test Method / Applicable Standard	Results
		signs indicative of toxicity
during the test period.
	Pyrogenicity
(Material Mediated Pyrogenicity)	The test article extracts did not
cause a pyrogenic response and
all validity criteria were met
during the assay.
	Hemocompatibility
(Complement Activation, SC5b-9 Assay)	The test article results in the
Sc5b-9 assay were not
statistically significant (p>0.05)
when compared to the reference
material and comparison article.
	Hemocompatibility
(ASTM Hemolysis - Direct Contact and Indirect
Method)	For Direct Contact method and
Indirect method, the test article
returned a blank corrected
percent hemolysis above the
negative control of 0.0%.
	Hemocompatibility
(Platelet & Leukocyte Count)	Under the conditions of this
protocol, the platelet count was
within specification.
	Hemocompatibility
(Partial Thromboplastin Time (PTT)	The test article did not create
any more material mediated
coagulation abnormalities in the
intrinsic pathway when
compared to the predicate.
Sterilization
Validation	Testing was performed per ANSI/AAMI/ISO
11135:2014 and AAMI TIR 28:2016	Product was sterile.
Packaging	The packaging was tested to ensure the sterile barrier
was not compromised.	All units met all the packaging
acceptance criteria.
Catheter and
Dilator Tensile
Strength	Testing was completed per ISO 10555-1:2013/Amd.
1:2017(E). Using a force gauge, test samples were
pulled until failure.	All units met the tensile strength
acceptance criteria.
Catheter PTFE
Delamination	Samples of the proximal and distal sections of the
catheter were tested to evaluate the adhesion of the
etched PTFE layer to the catheter shaft.	All units met the catheter PTFE
delamination acceptance criteria.
Torque	The distal end of the unit was held rigid while the
proximal end was turned until failure.	All units met the torque
acceptance criteria.
Catheter Burst
Pressure	Testing was completed per ISO 10555-1:2013/Amd.
1:2017(E) by clamping the distal end and pressurizing
the assembly was pressurized and peak pressure was
recorded.	All units met the catheter burst
pressure acceptance criteria.
Particulate
Testing	Particulate testing was performed in a tortuous model
and particulate count was evaluated per USP .	All units met the particulate
testing acceptance criteria.
Coating Integrity	Catheter samples were inspected under magnification
before and after conditioning and being passed through
a tortuous path for surface irregularities.	All units met the coating
integrity acceptance criteria.
Leak (Liquid)	Testing was completed per ISO 10555-1:2013/Amd.
1:2017(E) by connecting the catheter to test equipment,
sealing the distal end of the catheter, pressurizing the	All units met the liquid leak test
acceptance criteria.
Test Performed	Test Method / Applicable Standard	Results
	catheter, holding the pressure, and ensuring there was
no leakage.
Leak (Air)	Testing was conducted per ISO 10555-1:2013/Amd.
1:2017(E) to ensure no air leaks into the product
assembly.	All units met the air leak test
acceptance criteria.
Catheter
Dimensional
Inspection	The ID, OD, and working length were measured to
ensure the acceptance criteria were met.	All units met the catheter
dimensional inspection
acceptance criteria.
Dilator
Dimensional
Inspection	The ID and OD of the dilator were measured to ensure
the acceptance criteria were met.	All units met the dilator
dimensional inspection
acceptance criteria.
Chemical
Compatibility	Samples of catheter and accessories were exposed to
saline, dextrose, heparin, and radiocontrast and then
inspected for any signs of degradation and ensure the
ID had no obstruction.	All units met the chemical
compatibility acceptance criteria.
Visual Inspection
of Catheter and
Dilator	The catheter and dilator were inspected to ensure
smooth tip transition points and no surface defects
were present.	All units met the visual
inspection acceptance criteria.
Catheter Coating
Length	Catheter samples were inspected under magnification
after hydrating the coating, and the length of the
catheter covered with the hydrophilic coating was
measured to ensure specification was met.	All units met the catheter coating
length acceptance criteria.
Kink Resistance	Test units were wrapped around progressively smaller
diameter pegs and mandrels until a kink was
observed.	All units met the kink resistance
acceptance criteria.
In vitro
Simulated Use
Study	The Rist™ 071 Radial Access Guide Catheter was
prepared per the IFU. A simulated interventional
procedure was performed by physicians in order to
verify the product's performance.
Predicate devices were evaluated in order to establish a
baseline for trackability and support ratings.	All acceptance criteria were met.

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Table D.1 List of Tests Conducted on the Rist™ 071 Radial Access Guide Catheter

8

Table D.1 List of Tests Conducted on the Rist™ 071 Radial Access Guide Catheter

Table D.2 List of Tests Applied from the Predicate RIST™ Cath Radial Access Long Sheath (K191551)

Test Performed	Test Method / Applicable Standard	Results
Corrosion	Testing was conducted per ISO 10555-
1:2013/Amd. 1:2017(E)	All units met the corrosion
acceptance criteria.
Hub Compatibility	Catheter luers were tested per ISO 594-1:1986
and ISO 594-2:1998.	All units met the hub
compatibility acceptance
criteria.
Radiopacity	Physicians were shown fluoroscopic images
of the RIST Cath Radial Access Long Sheath
and asked to identify the location of the distal
tip, the shape of the catheter, and the location
of each curve along the shape of the catheter.	All acceptance criteria were met.
Label Content	Product label content is reviewed to ensure the
information included is accurate.	All units met the acceptance
criteria for label content.

9

Test Performed	Test Method / Applicable Standard	Results
Label Legibility	Labeling was inspected to ensure it remained
legible after transportation and environmental
conditioning.	All units met the acceptance
criteria for label legibility.
Barcode	Barcode was scanned on randomly selected
carton and pouch to ensure the scan matches
the appropriate information.	All units met the acceptance
criteria for barcode.
Dilator Working Length	The dilator length was measured to ensure it
met the dilator specification.	All units met the acceptance
criteria for dilator working length.
Useability (as part of
Design Validation)	Evaluators representative of the intended user
population evaluated the RIST™ Cath Radial
Access Long Sheath as per the Instructions
for Use.	All acceptance criteria were met.

Table D.2 List of Tests Applied from the Predicate RIST™ Cath Radial Access Long Sheath

E) Shelf-Life Testing

The labeled shelf life for the Rist™ 071 Radial Access Guide Catheter is 6 months. Shelf-life testing (product and packaging) to support the labeled shelf life was performed. All acceptance criteria were met.

F) Conclusion

Based on the verification and validation testing conducted for the subject device and the tests applied from the predicate, as well as the comparison of indications for use, operating principle and technological characteristics, Rist™ 071 Radial Access Guide Catheter is substantially equivalent to the predicate device RIST™ Cath Radial Access Long Sheath (K191551).