Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No.
The device is a guiding catheter, designed to facilitate the introduction of other diagnostic and interventional devices, rather than directly treating a condition itself.

Diagnostic

No

The device description clearly states it is designed "for the introduction of interventional and diagnostic devices" and performs "as a guiding catheter." This indicates it is a tool for delivering other devices, not a diagnostic device itself.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (guiding catheter, inner guide) made of materials like stainless steel mesh, polyamide elastomer, polytetrafluoroethyelene, and polyester elastomer. It also mentions sterilization and physical performance testing, indicating a hardware device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
Device Function: The R2P SlenGuide is a guiding catheter designed to be introduced into the peripheral vasculature of the lower extremities to facilitate the delivery of other interventional and diagnostic devices. It is used within the body during a medical procedure.
Lack of Diagnostic Testing: The description does not mention any function related to analyzing samples or performing diagnostic tests on bodily fluids or tissues. Its purpose is purely procedural – guiding other devices.

Therefore, based on the provided information, the R2P SlenGuide is a surgical/interventional device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The R2P (radial to peripheral) SlenGuide is designed for the introduction of interventional and diagnostic devices into the peripheral vasculature of the lower extremities.

Product codes

DQY

Device Description

The R2P SlenGuide is a single use, ethylene oxide sterilized device that is designed to perform as a guiding catheter for interventional procedures in the peripheral vasculature. It is packaged with a guiding catheter and an inner guide.

Guiding Catheter: features a three-layer construction, which consists of a stainless steel mesh sandwiched between an outer layer of polyamide elastomer and an inner layer of polytetrafluoroethyelene. The distal end has a hydrophilic coating and contains a "soft-tip," which is visible under fluoroscopy.

Inner Guide: is an accessory device for the guiding catheter. Its purpose is to help direct the guiding catheter to the lesion, and once achieved, the inner guide is removed, in order to proceed with the interventional procedure. It is comprised of polyester elastomer, and the distal portion is a flexible polyester elastomer, containing tungsten, which is visible under fluoroscopy.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral vasculature of the lower extremities

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 was conducted to ensure that the R2P SlenGuide met the applicable design and performance requirements throughout its shelf life, verify conformity to the applicable external and internal standards, and demonstrate substantial equivalence to the predicate device. With the exception of the Radiodetectability] and Cleanliness tests2, the following performance tests were performed on non-aged and accelerated aged samples.

Performance testing met the predetermined acceptance criteria and results support a determination of substantial equivalence.

Summary of Performance Testing - Guiding Catheter:

Radio-detectability: Test samples using X-ray equipment, that are tested according to ASTM F640-12
Surface quality: Check external surfaces of samples with a magnifier (x 2.5 times or more)
Peak tensile force: Using an autograph, measure peak tensile strength of samples
Freedom from leakage: Using a syringe filled with water, apply and maintain pressure to the catheter, and then inspect for liquid and air leakage
Hub performance: Test hubs for gauging, liquid leakage, air leakage, separation force, unscrewing torque, ease of assembly, resistance to overriding, and stress cracking
Distal tip appearance: Check physical appearance of distal tip with a microscope (x 10 times or more)
Particulate evaluation: Slide samples into an apparatus filled with purified water, and measure/evaluate residual particles
Torque Strength: Confirm R2P Slenguide has appropriate torque strength by measuring the rotation of the catheter, when twisting off
Coating lubricity: After the particulate evaluation test, visually evaluate coating under magnification. Then, after pushing and pulling samples in an apparatus, confirm coating lubricity by measuring sliding forces
Evaluation of flexibility and kink resistance: Wind samples around mandrels, until the samples have kinked, and record mandrel size that caused samples to kink
Distal tip flexibility: Measure tip force when samples are pushed by an apparatus
Kink condition: Kink the samples, and visually inspect with a magnifying glass
Flexural rigidity: Samples are set on an apparatus, and maximum force is applied, in order to measure shaft strength
Distal tip strength: Samples are clamped and pulled to measure tensile strength
Cleanliness: Water is injected into the samples and is visually inspected for foreign matter
Product dimensions: Measure by inner and outer diameter, effective length, and extended length

Summary of Performance Testing – Inner Guide:

Radio-detectability: Test samples using X-ray equipment, when tested according to ASTM F640-12
Surface quality: Check external surfaces of samples with a magnifier (x 2.5 times or more)
Peak tensile force: Using an autograph, measure peak tensile strength of samples
Freedom from leakage: Using a syringe filled with water, apply and maintain pressure to the catheter, and then inspect for liquid and air leakage
Distal tip appearance: Check physical appearance of distal tip with a microscope (x 10 times or more)
Flexural rigidity: Samples are set on an apparatus, and maximum force is applied, in order to measure shaft strength
Cleanliness: Water is injected into the samples and is visually inspected for foreign matter
Product dimensions: Measure by inner and outer diameter, effective length, and extended length

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K972978

Reference Device(s)

K142819, K090040

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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 14, 2016

Terumo Medical Corporation Ms. Monika McDole-Russell Senior Regulatory Affairs Specialist 265 Davidson Avenue, Suite 320 Somerset. NJ 08873

Re: K161546

Trade/Device Name: R2P SlenGuide Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 13, 2016 Received: September 14, 2016

Dear Ms. McDole-Russell:

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/1/Picture/7 description: The image shows the name "Brian D. Pullin -S" in a large, bold font. The text is black and is set against a light blue background. The letters are clear and easy to read.

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161546

Device Name R2PTM SlenGuide™

Indications for Use (Describe)

The R2P (radial to peripheral) SlenGuide is designed for the introduction of interventional and diagnostic devices into the peripheral vasculature of the lower extremities.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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3

510(K) SUMMARY

A. SUBMITTER INFORMATION (807.92(a)(1))

| Prepared by: | Monika McDole-Russell, MSRA, RAC
Manager, Regulatory Affairs
Terumo Medical Corporation
Tel. (732) 302-4900 ext.4273
Fax (732) 302-4905 |

--------------	-----------------------------------------------------------------------------------------------------------------------------------------------------

Prepared for:	Owner/Operator
	Terumo Corporation
	44-1, 2-Chome, Hatagaya
	Shibuya-Ku, Tokyo
	Japan 151-0072
	Owner/Operator Number: 801 002 6

Manufacturer and Sterilization Facility (Applicant)

Ashitaka Factory of Terumo Corporation 150 Maimaigi-cho Fujinomiya, Shizuoka 418-0015, Japan Registration Number: 968 183 4

Contact Person:	Monika McDole-Russell, MSRA, RAC
	Manager, Regulatory Affairs
	Terumo Medical Corporation
	265 Davidson Avenue, Suite 320
	Somerset, NJ 08873
Tel.	(732) 302-4900 ext.4273
Fax	(732) 302-4905
E-mail:	monika.mcdolerussell@terumomedical.com

Date prepared: October 7, 2016

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B. DEVICE NAME (807.92(a)(2))

Proprietary Name:	R2PTM SlenGuideTM
Common Name:	Guiding Catheter
Classification Name:	Percutaneous Catheter
Classification Panel:	Cardiovascular
Regulation:	21 CFR 870.1250
Product Code:	DQY
Classification:	Class II

C. PREDICATE DEVICES (807.92(a)(3))

The legally marketed device(s) to which substantial equivalence is claimed are:

Predicate Device: K972978 Vista Brite Tip Guiding Catheters, manufactured by . Cordis Corporation.
Reference Device 1: K142819 Shuttle-SL Flexor Tuohy-Borst Side-Arm . Introducer Set, manufactured by Cook, Inc. (hereinafter referred to as "Flexor Introducer Set")*

*Flexor Introducer Set (K142819) is presented as a reference predicate for the Inner Guide.

Reference Device 2: K090040 Radifocus Glidecath/Glidecath XP, manufactured . by Terumo Corporation.

Radifocus Glidecath/Glidecath XP (K090040) is presented as a reference predicate for device length.

D. REASON FOR 510(k) SUBMISSION

This premarket notification (510(k)) is being submitted for the R2P SlenGuide, manufactured by Ashitaka Factory of Terumo Corporation, for the purposes of establishing substantial equivalence to a legally marketed predicate device.

E. DEVICE DESCRIPTION (807.92(a)(4))

Principle of Operation Technology

The R2P SlenGuide is operated by manual process.

Design/Construction

The R2P SlenGuide is a single use, ethylene oxide sterilized device that is designed to perform as a guiding catheter for interventional procedures in the peripheral vasculature. It is packaged with a guiding catheter and an inner guide; a description of

5

each component is provided below.

Guiding Catheter: features a three-layer construction, which consists of a stainless steel mesh sandwiched between an outer layer of polyamide elastomer and an inner layer of polytetrafluoroethyelene. The distal end has a hydrophilic coating and contains a "soft-tip," which is visible under fluoroscopy.

Inner Guide: is an accessory device for the guiding catheter. Its purpose is to help direct the guiding catheter to the lesion, and once achieved, the inner guide is removed, in order to proceed with the interventional procedure. It is comprised of polyester elastomer, and the distal portion is a flexible polyester elastomer, containing tungsten, which is visible under fluoroscopy.

Materials

The materials for the R2P SlenGuide are provided in the table below.

Name of Component	Raw Material
Guiding
Catheter	Shaft	Polyamide elastomer
Pigment
	Outer layer*	Distal
part	Polyamide elastomer
Pigment
		Soft-tip	Polyamide elastomer
Tungsten
	Inner layer*	Polytetrafluoroethylene
	Braid†	Stainless steel
	Hub*	Polyamide 12
Pigment
	Hydrophilic polymer coating*	Dimethyl acrylic amide -
glycidyl methacrylate
copolymer
	Anti-kink protector	Polyester elastomer
Pigment
Inner
Guide	Shaft*	Distal part	Polyester elastomer
Tungsten
		Proximal part	Polyester elastomer
	Hub*	Polyamide
	Lock adaptor	Polycarbonate
Adhesive		Cyanoacrylate

Table 5.1: List of Materials

*Blood contacting material.

*Soft-tip is not braided.

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Specifications

The specifications for the R2P SlenGuide are provided in the table below.

Part	Specification
Catheter Size	7Fr.
Catheter ID/OD	2.20 mm/2.37 mm
Catheter Effective Lengths*	120 and 150 cm
Inner Guide ID/OD	1.15 mm/2.10 mm
Inner Guide Extended Length†	30 mm
Accepts Guide Wire Diameter	0.035"

Table 5.2: R2P SlenGuide Specifications

*The length from the proximal anti-kink protector to the guiding catheter distal tip. *The length that the inner guide extends past the guiding catheter's tip.

F. INDICATIONS FOR USE (807.92(a)(5))

The R2P (radial to peripheral) SlenGuide is designed for the introduction of interventional and diagnostic devices into the peripheral vasculature of the lower extremities.

G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))

The R2P SlenGuide, subject of this Traditional 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to:

Predicate Device: K972978 Vista Brite Tip Guiding Catheters, manufactured by . Cordis Corporation.
Reference Device 1: K142819 Flexor Introducer Set*, manufactured by Cook, . Inc.

*Flexor Introducer Set (K142819) is presented as a reference predicate for the Inner Guide.

Reference Device 2: K090040 Radifocus Glidecath/Glidecath XP*, manufactured . by Terumo Corporation.

Radifocus Glidecath/Glidecath XP (K090040) is presented as a reference predicate for device length.

A comparison of the technological characteristics is summarized in the table below.

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| Device Characteristic | | New Device:
Guiding Catheter of R2P
SlenGuide | Predicate Device:
Vista Brite Tip
Guiding Catheters
(K972978)* | Reference Device 1:
Flexor Introducer Set
(K142819)* | Reference Device 2:
Radifocus Glidecath
or Glidecath XP
(K090040) |
|---------------------------------------|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | | Terumo Corporation | Cordis Corporation | Cook, Inc. | Terumo Corporation |
| Intended
Use/Indication for
Use | | The R2P (radial to
peripheral) SlenGuide is
designed for the
introduction of
interventional and
diagnostic devices into the
peripheral vasculature of
the lower extremities | The guiding catheter is
intended for use for
intravascular
introduction of
interventional /
diagnostic devices into
the coronary or
peripheral vascular
systems | Flexor Introducers and
Guiding Sheaths are
intended to introduce
therapeutic or
diagnostic devices into
the vasculature,
excluding coronary and
neuro vasculature | The Radifocus Glidecath
(or Radifocus Glidecath
XP) is intended for use in
angiographic procedures.
It delivers radiopaque
media and therapeutic
agents to selected sites in
the vascular system. It is
also used to lead a guide
wire or catheter into the
target site. |
| Operation Principle | | Manual | same | same | same |
| Design/
Construction | Guiding
Catheter | Single lumen catheter,
stainless steel braid wire,
catheter, radiopaque tip,
and hub | same | N/A | Single lumen catheter,
stainless steel braid
wire, catheter
containing radiopaque
material(tungsten or
barium sulfate) and
hub |
| | Inner Guide | Made by plastic materials,
featuring a distal taper that
allows for smooth
transition with the
appropriately sized guide
wire | N/A | same | N/A |
| Device Characteristic | | New Device:
Guiding Catheter of R2P
SlenGuide | Predicate Device:
Vista Brite Tip
Guiding Catheters
(K972978)* | Reference Device 1:
Flexor Introducer Set
(K142819)* | Reference Device 2:
Radifocus Glidecath
or Glidecath XP
(K090040) |
| Materials | Guiding Catheter | • Outer layer:
Polyamide elastomer
(Nylon)
• Braid: Stainless steel
• Inner layer:
Polytetrafluoroethylen
e | same | N/A | |
| | Inner
Guide | • Shaft: Polyester
elastomer | N/A | • Shaft: Polyamide
elastomer (Nylon)
or Polyethylene | N/A |
| Package | | • Individual package on
which the product label
and the
peel-off labels are
attached
• 1 unit per package | same | same | same |
| Specifications | Guiding Catheter | • Effective lengths: 120
cm, 150 cm
• French size: 7Fr
• O.D.: 2.37 mm
• I.D.: 2.20 mm (0.087") | • Effective lengths:
55 cm, 90 cm, 95
cm
• French size: 7Fr
• O.D.: Soft tip:
2.30 mm
• I.D.: 2.0 mm
(0.078") | N/A | • Effective
lengths: 30 - 150cm
• French size:
5Fr, 4Fr
• O.D.:
5Fr 1.70 mm
4Fr 1.40mm
• I.D.:
5Fr 122mm(Double
braided)
1.12 mm(Single
braided)
4Fr 1.05 mm |
| Device Characteristic | | New Device:
Guiding Catheter of R2P
SlenGuide | Predicate Device:
Vista Brite Tip
Guiding Catheters
(K972978)* | Reference Device 1:
Flexor Introducer Set
(K142819)* | Reference Device 2:
Radifocus Glidecath
or Glidecath XP
(K090040) |
| | ุการ อนเล | Accepts guide wire
●
diameter: 0.035" | N/A | Accepts guide wire
●
diameter: 0.018",
0.035", and 0.038" | N/A |
| Sterilization | | Ethylene oxide | same | same | same |

Table 5.3: Summary of Comparative Information

8

9

*Based on publicly available information on the devices.

10

H. NON CLINICAL TESTS (807.92(b)(1))

Performance Testing

Performance testing was conducted to ensure that the R2P SlenGuide met the applicable design and performance requirements throughout its shelf life, verify conformity to the applicable external and internal standards, and demonstrate substantial equivalence to the predicate device. With the exception of the Radiodetectability] and Cleanliness tests2, the following performance tests were performed on non-aged and accelerated aged samples. The following tables provide a list of performance tests that were performed on the R2P SlenGuide.

Component	Test	Standard
Guiding
Catheter	Radio-
detectability	ISO 10555-1:2013
Section 4.2,
ASTM F640-12	Test samples using X-ray equipment,
that are tested according to ASTM
F640-12
	Surface quality	ISO 10555-1:2013
Section 4.4	Check external surfaces of samples with
a magnifier (x 2.5 times or more)
	Peak tensile
force	ISO 10555-1:2013
Section 4.6
VIII.A.7 of FDA
Guidance3	Using an autograph, measure peak
tensile strength of samples
	Freedom from
leakage	ISO 10555-1:2013
Section 4.7	Using a syringe filled with water, apply
and maintain pressure to the catheter,
and then inspect for liquid and air
leakage
	Hub
performance	ISO 10555-1:2013
Section 4.8
ISO 594-2: 1998	Test hubs for gauging, liquid leakage,
air leakage, separation force,
unscrewing torque, ease of assembly,
resistance to overriding, and stress
cracking
	Distal tip
appearance	ISO 10555-1:2013
Section 4.12	Check physical appearance of distal tip
with a microscope (x 10 times or more)
	Particulate
evaluation	VIII.A.13 of FDA
Guidance3
USP
In-house Standard	Slide samples into an apparatus filled
with purified water, and
measure/evaluate residual particles

Table 5.4: Summary of Performance Testing - Guiding Catheter

1 Only non-aged sample was tested since the amount of contrast media contained in the product would not change over time.

2 Only non-aged sample was tested since the particulates inside the catheter lumen would not increase over time.

3 Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary

Angioplasty (PTCA) Catheters, September 8, 2010.

11

Component	Test	Standard	Test Method
	Torque Strength	VIII.A.10 of FDA
Guidance
In-house Standard3	Confirm R2P Slenguide has appropriate
torque strength by measuring the
rotation of the catheter, when twisting
off
	Coating
lubricity	VIII.A.12 of FDA
Guidance3
In-house Standard	After the particulate evaluation test,
visually evaluate coating under
magnification. Then, after pushing and
pulling samples in an apparatus,
confirm coating lubricity by measuring
sliding forces
	Evaluation of
flexibility and
kink resistance	VIII.A.9 of FDA
Guidance3
In-house Standard	Wind samples around mandrels, until
the samples have kinked, and record
mandrel size that caused samples to
kink
	Distal tip
flexibility	In-house Standard	Measure tip force when samples are
pushed by an apparatus
	Kink condition	In-house Standard	Kink the samples, and visually inspect
with a magnifying glass
	Flexural rigidity	In-house Standard	Samples are set on an apparatus, and
maximum force is applied, in order to
measure shaft strength
	Distal tip
strength	VIII.A.8 of FDA
Guidance3
In-house Standard	Samples are clamped and pulled to
measure tensile strength
	Cleanliness	In-house Standard	Water is injected into the samples and is
visually inspected for foreign matter
	Product
dimensions	In-house Standard	Measure by inner and outer diameter,
effective length, and extended length

Table 5.5: Summary of Performance Testing – Inner Guide

Component	Test	Standard
Inner Guide	Radio-detectability	ISO 10555-1:2013
Section 4.2
ASTM F640-12	Test samples using X-ray equipment, when tested according to ASTM F640-12
	Surface quality	ISO 10555-1:2013
Section 4.4	Check external surfaces of samples with a magnifier (x 2.5 times or more)
	Peak tensile force	ISO 10555-1:2013
Section 4.6
VIII.A.7 of FDA
Guidance3	Using an autograph, measure peak tensile strength of samples
	Freedom from
leakage	ISO 10555-1:2013
Section 4.7	Using a syringe filled with water, apply and maintain pressure to the catheter, and then inspect for liquid and air leakage
	Distal tip
appearance	ISO 10555-1:2013
Section 4.12	Check physical appearance of distal tip with a microscope (x 10 times or more)

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| | Flexural rigidity | In-house Standard | Samples are set on an apparatus, and
maximum force is applied, in order to
measure shaft strength |
|--|--------------------|-------------------|---------------------------------------------------------------------------------------------------------|
| | Cleanliness | In-house Standard | Water is injected into the samples and is
visually inspected for foreign matter |
| | Product dimensions | In-house Standard | Measure by inner and outer diameter,
effective length, and extended length |

Performance testing met the predetermined acceptance criteria and results support a determination of substantial equivalence.

Biocompatibility

In accordance with ISO 10993-1, the R2P SlenGuide is classified as: Externally Communicating Device, Circulating Blood, Limited Contact (