K Number

Device Name

Halo One Thin-Walled Guiding Sheath

Manufacturer

C.R. BARD, INC

Date Cleared

2016-06-03

(37 days)

Product Code

DYB

Regulation Number

870.1340

Intended Use

The Halo One™ Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One™ Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature nor the coronary vasculature.

Device Description

The Halo One™ Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One™ Thin-Walled Guiding Sheath consists of a thin-walled (1F wall thickness) sheath made from braided single-lumen tubing, fitted with a female luer hub at the proximal end and has a formed atraumatic distal tip. A supplied hemostasis valve, employing a crosscut silicone membrane and incorporating a side arm terminating in a 3-way stopcock, may be connected to the sheath luer hub. The sheath is supplied with a compatible vessel dilator that snaps securely into the hemostasis valve hub. The sheath has a strain relief feature located at the luer hub and a radiopaque platinum-iridium marker located close to the distal tip. The vessel dilator is compatible with a 0.035" (0.89 mm) guidewire. The longer sheath configurations are provided with a hydrophilic coating over the distal portion of the sheath to provide a lubricious surface to ease insertion. The short sheath configuration is marketed with an appropriately sized guide wire for initial insertion of the device.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K984500

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 guiding sheath, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

No.
The device is a guiding sheath and introducer sheath used for the percutaneous introduction of intravascular devices in peripheral arterial and venous procedures, not for treating a condition itself.

Diagnostic

The device is described as a guiding and introducer sheath used for the percutaneous introduction of intravascular devices in peripheral arterial and venous procedures. Its purpose is to facilitate access for other devices, not to diagnose medical conditions or analyze patient data.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components made of materials like braided tubing, silicone, and platinum-iridium, and the performance studies focus on physical characteristics and biocompatibility, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Halo One™ Thin-Walled Guiding Sheath is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states it's for "peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices." This describes a device used within the body for procedural purposes, not for testing samples outside the body to diagnose conditions.
Device Description: The description details a physical device (sheath, dilator, valve) designed for insertion into blood vessels. This aligns with an interventional medical device, not an IVD.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.

Therefore, the Halo One™ Thin-Walled Guiding Sheath is an interventional medical device used in procedures, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

DYB

Device Description

A supplied hemostasis valve, employing a crosscut silicone membrane and incorporating a side arm terminating in a 3-way stopcock, may be connected to the sheath luer hub. The sheath is supplied with a compatible vessel dilator that snaps securely into the hemostasis valve hub. The sheath has a strain relief feature located at the luer hub and a radiopaque platinum-iridium marker located close to the distal tip.

The vessel dilator is compatible with a 0.035" (0.89 mm) guidewire. The longer sheath configurations are provided with a hydrophilic coating over the distal portion of the sheath to provide a lubricious surface to ease insertion. The short sheath configuration is marketed with an appropriately sized guide wire for initial insertion of the device.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Peripheral arterial and venous vasculature. NOT neurovasculature nor coronary 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

To demonstrate substantial equivalence of the subject device, the Halo One™ Thin-Walled Guiding Sheath to the predicate device, the technological characteristics and performance criterion were evaluated. Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures, the following in vitro tests were performed on the subject device:

Visual Inspection (Outer Surface)
- o Dilator Outer Surface
- Sheath Outer Surface o
Simulated Use
- Packaging Removal O
- Haemostasis Valve Connection o
- Sheath Inner Surface/Dilator Compatibility O
- Dilator Flushability o
- Valve Flushability O
- Sheath Flushability o
- Guidewire Compatibility o
- Dilator Disengagement by Hand o
- o Tape Adhesion
Dimensional Testing
- o Sheath ID
- Sheath Length O
- Marker Band to Tip Position o
- Sheath OD o
- Dilator OD o
- Dilator Extension Length
Radiopacity
Penetration Force of Dilator/Sheath
Trackability of Dilator and Sheath
Visual Inspection (Tip Rollback-Dilator & Sheath)
Bend Radius/ Kink
Valve Leak
Sheath Leak
Sheath and Dilator Tensile Forces
Hub Torque/Stress Cracking
Hub Stress Cracking (48 Hour Test)
Mini Guidewire Compatibility
Packaging
- o Visual Inspection
- Dye Penetration o
- Visual Inspection of Sterile Barrier Packaging Heat Seals o
- o Seal Strength Tensile Method
Cytotoxicity
Sensitization
Intracutaneous Reactivity
Acute Systemic Toxicity
Hemocompatibility
Material Mediated Pyrogenicity

The biocompatibility of the Halo One™ Thin-Walled Guiding Sheath was evaluated based on ISO 10993-1. The device is classified as an Externally Communicating Devices, Circulating Blood, Limited Contact (

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).

Summary

Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of a stylized human figure with three profiles facing right, representing the department's focus on people and health. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

June 3, 2016

ClearStream Technologies Ltd. c/o Mark Job Responsibility Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K161183

Trade/Device Name: Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: May 20, 2016 Received: May 24, 2016

Dear Mr. Job:

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 device-related 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.

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

Kenneth J. Cavanaugh -S

for

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

Enclosure

Indications for Use

510(k) Number (if known) K161183

Device Name Halo One Thin-Walled Guiding Sheath

Indications for Use (Describe)

The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature nor the coronary 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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Halo One™ Thin-Walled Guiding Sheath 510(k) Summary 21 CFR 807.92

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:

Submitter Information:

| Applicant: | ClearStream Technologies Ltd.
Moyne Upper,
Enniscorthy,
Co. Wexford, Ireland. |
|------------|----------------------------------------------------------------------------------------|
| Phone: | +353 53 9237111 |
| Fax: | + 353 53 9237100 |
| Contact: | Fiona Ní Mhulláin, Senior RA/QA Manager |
| Date | February 04, 2016 |

Subject Device Name:

Device Trade Name:	Halo One™ Thin-Walled Guiding Sheath
Common or Usual Name:	Catheter Introducer (21 CFR 870.1340,
Product Code DYB)
Classification:	Class II
Classification Panel:	Cardiovascular

Predicate Device:

. Cordis Brite Tip Catheter Sheath Introducer System: (K984500, cleared December 23, 1998)

Device Description:

Indications for Use of Device:

Comparison of Indications for Use to Predicate Device:

The indications for use statement for the Halo One™ Thin-Walled Guiding Sheath does not raise any new issues of safety and effectiveness based on the proposed indications for use statement as compared to the predicate device. Therefore, the subject device, the Halo One™ Thin-Walled Guiding Sheath, is substantially equivalent to the predicate device.

Technological Comparison to Predicate Devices:

The Halo One™ Thin-Walled Guiding Sheath has the following similarities to the predicate device, the Cordis Brite Tip Catheter Sheath Introducer System (clearance to market via K984500 on December 23, 1998):

. Same intended use
. Same indications for use

Same target population ●
. Same operating principle
. Same fundamental scientific technology
Same sterility assurance level and method of sterilization .

The Halo One™ Thin-Walled Guiding Sheath, incorporates the following differences:

Braided shaft
Thinner wall .
Marker band .
. Hydrophilic coating
Detachable haemostatic valve
. Component materials

Performance Data:

. Visual Inspection (Outer Surface)
- o Dilator Outer Surface
- Sheath Outer Surface o
Simulated Use .
- Packaging Removal O
- Haemostasis Valve Connection o
- Sheath Inner Surface/Dilator Compatibility O
- Dilator Flushability o
- Valve Flushability O
- Sheath Flushability o
- Guidewire Compatibility o
- Dilator Disengagement by Hand o
- o Tape Adhesion
. Dimensional Testing
- o Sheath ID

Sheath Length O
Marker Band to Tip Position o
Sheath OD o
Dilator OD o
Dilator Extension Length
Radiopacity ●
Penetration Force of Dilator/Sheath .
Trackability of Dilator and Sheath .
. Visual Inspection (Tip Rollback-Dilator & Sheath)
Bend Radius/ Kink .
Valve Leak .
Sheath Leak .
Sheath and Dilator Tensile Forces ●
Hub Torque/Stress Cracking .
. Hub Stress Cracking (48 Hour Test)
Mini Guidewire Compatibility ●
Packaging .
- o Visual Inspection
- Dye Penetration o
- Visual Inspection of Sterile Barrier Packaging Heat Seals o
- o Seal Strength Tensile Method
. Cytotoxicity
Sensitization ●
Intracutaneous Reactivity .
Acute Systemic Toxicity .
. Hemocompatibility
. Material Mediated Pyrogenicity