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 consists of a thin-walled (Up to 1F reduction in outer diameter compared to standard sheaths of equivalent French size) sheath made from single-lumen tubing, fitted with a female luer hub at the proximal end and a formed atraumatic distal tip. The thin-wall design reduces the thickness of the sheath wall to help facilitate intravascular access from access sites including but not limited to radial, femoral, popliteal, tibial and pedal. A detachable hemostasis valve, employing a crosscut silicone membrane and incorporating a side arm terminating in a 3-way stopcock, is 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 Halo One Thin-Walled Guiding sheath is supplied in 4F, 5F and 6F compatible sizes and lengths of 90cm. 70cm. 45cm. 25cm and 10 cm. The Halo One Thin-Walled Guiding Sheath 4F, 5F and 6F 25cm and 10cm sheaths will be offered with a 0.018" and 0.035" guide wire compatible dilator option. The Halo One Thin-Walled Guiding Sheath is also offered as an access kit in 4F,5F and 6F 10cm and 25cm lengths incorporating access needle (21G x 4cm or 19G x 7cm option available) and access guidewire in both 0.018" (0.018" x 80cm or 0.018" x 50cm option available) and 0.035" (0.035" x 80cm or 0.035" x 50cm option available) configurations to the existing predicate device product range. All sheath configurations (lengths) are provided with a hydrophilic coating over the distal portion of the sheath to provide a lubricious surface to ease insertion. The shorter sheath configurations (25cm and 10cm) are also provided without the coating.

AI/ML Overview

This document is a 510(k) Summary for a medical device called the "Halo One Thin-Walled Guiding Sheath." It is a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

The information provided does not describe an AI/ML powered device, nor does it detail a study that proves the device meets specific acceptance criteria related to AI/ML performance. Instead, it describes a conventional medical device (a catheter introducer) and outlines non-clinical performance testing for its physical and functional characteristics.

Therefore, many of the requested categories for AI/ML device studies cannot be answered from this document.

Here's an attempt to answer the relevant parts based on the provided text, and identify where the information is not applicable (N/A) for an AI/ML context:

1. A table of acceptance criteria and the reported device performance

The document provides a general list of performance criteria that were evaluated for the subject device to demonstrate substantial equivalence to the predicate device. However, it does not present a specific table with detailed quantitative acceptance criteria and their corresponding reported device performance values. It only states that the device "met all predetermined acceptance criteria" and that tests "demonstrate that the technical characteristics and performance criteria... is substantially equivalent to the predicate."

Here's a summary of the characteristics and performance criteria evaluated:

Acceptance Criteria Category	Reported Device Performance (as stated in document)
Visual Inspection of sheath, access guidewire and access needle	Met predetermined acceptance criteria; findings demonstrate substantial equivalence.
Simulated use of sheath, access guidewire and access needle	Met predetermined acceptance criteria; findings demonstrate substantial equivalence.
Dimensional Testing of Dilator / Sheath	Met predetermined acceptance criteria; findings demonstrate substantial equivalence.
Compatibility Testing of sheath, access guidewire and access needle	Met predetermined acceptance criteria; findings demonstrate substantial equivalence.
Penetration Force of Dilator / Sheath	Met predetermined acceptance criteria; findings demonstrate substantial equivalence.
Trackability of Dilator and Sheath	Met predetermined acceptance criteria; findings demonstrate substantial equivalence.
Trackability of device in sheath	Met predetermined acceptance criteria; findings demonstrate substantial equivalence.
Visual Inspection (Tip-Rollback)	Met predetermined acceptance criteria; findings demonstrate substantial equivalence.
Bend Radius / Kink	Met predetermined acceptance criteria; findings demonstrate substantial equivalence.
Leak Testing	Met predetermined acceptance criteria; findings demonstrate substantial equivalence.
Needle Ultrasound visibility	Met predetermined acceptance criteria; findings demonstrate substantial equivalence.
Packaging Testing (Visual Inspection, Bubble Emission of Pouches, Visual Inspection of Sterile Barrier Packaging Heat Seal, Seal Strength Tensile Method)	Met predetermined acceptance criteria; findings demonstrate substantial equivalence.
Biocompatibility (ISO 10993-1)	Met predetermined acceptance criteria; findings demonstrate substantial equivalence.

2. Sample sized used for the test set and the data provenance

The document does not specify sample sizes for any of the performance tests. It also does not discuss "data provenance" in terms of country of origin or retrospective/prospective, as these are typically relevant for clinical studies or AI/ML model training data, which is not the focus here. The testing appears to be non-clinical, in-vitro, or bench testing based on FDA guidance and internal risk assessments.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. This is a non-clinical device performance study, not an AI/ML study requiring expert ground truth for interpretation of medical images or data.

4. Adjudication method for the test set

N/A. Not applicable to non-clinical device performance testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This is not an AI/ML powered device, and no MRMC study is detailed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This is not an AI/ML powered device.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" would be established by physical measurements, standardized test methods, and pre-defined specifications derived from engineering requirements, applicable standards (e.g., ISO), and risk assessments. For biocompatibility, it's adherence to international standards like ISO 10993-1.

8. The sample size for the training set

N/A. This is not an AI/ML powered device.

9. How the ground truth for the training set was established

N/A. This is not an AI/ML powered device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below.

September 23, 2021

ClearStream Technologies Ltd. Annmarie Fitzgerald Senior Regulatory Affairs Specialist Moyne Upper Enniscorthy, Co. Wexford Ireland

Re: K212708

Trade/Device Name: Halo One Thin-Walled Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: August 25, 2021 Received: August 26, 2021

Dear Annmarie Fitzgerald:

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 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or

{1}------------------------------------------------

safety reporting (21) CFR CFR 4, Subpart B) for combination products postmarketing (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-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) 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 website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE assistance/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.

Finn Donaldson Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K212708

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 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)
✖ Prescription Use (Part 21 CFR 801 Subpart D)	❍ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

Halo One Thin-Walled Guiding Sheath

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:

ClearStream Technologies Ltd.

Moyne Upper,

Enniscorthy,

Co. Wexford, Ireland.

Phone: +353 53 9237111

Fax: +353 53 9237100

Contact Person: Annmarie Fitzgerald, Senior RA Specialist, Regulatory Affairs

Date of Submission: August 25, 2021

Subject Device:

Name of Device:	Halo One Thin-Walled Guiding Sheath
Common or Usual Name:	Catheter, Introducer
Classification:	Introducer, Catheter
Regulatory Class:	II (Product Code: DYB)
Regulation Number:	21 CFR 870.1340
Classification Panel:	Cardiovascular
Predicate Device:
510(k) Number:	K192313
Name of Device:	Halo One Thin-Walled Guiding Sheath
Common or Usual Name:	Catheter, Introducer
Classification:	Introducer, Catheter
Regulatory Class:	II (Product Code: DYB)
Regulation Number:	21 CFR 870.1340

TRADE SECRET / CONFIDENTIAL INFORMATION Notify CR Bard Before Releasing this Document.

clearStream
Technologies Ltd

{4}------------------------------------------------

Classification Panel: Cardiovascular

Device Description:

The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and an introducer sheath.

A detachable hemostasis valve, employing a crosscut silicone membrane and incorporating a side arm terminating in a 3-way stopcock, is 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 Halo One Thin-Walled Guiding sheath is supplied in 4F, 5F and 6F compatible sizes and lengths of 90cm. 70cm. 45cm. 25cm and 10 cm. The Halo One Thin-Walled Guiding Sheath 4F, 5F and 6F 25cm and 10cm sheaths will be offered with a 0.018" and 0.035" guide wire compatible dilator option.

The Halo One Thin-Walled Guiding Sheath is also offered as an access kit in 4F,5F and 6F 10cm and 25cm lengths incorporating access needle (21G x 4cm or 19G x 7cm option available) and access guidewire in both 0.018" (0.018" x 80cm or 0.018" x 50cm option available) and 0.035" (0.035" x 80cm or 0.035" x 50cm option available) configurations to the existing predicate device product range.

All sheath configurations (lengths) are provided with a hydrophilic coating over the distal portion of the sheath to provide a lubricious surface to ease insertion. The shorter sheath configurations (25cm and 10cm) are also provided without the coating.

clearStream
Technologies Ltd

{5}------------------------------------------------

Intended Use / Indications for Use:

Device Intended Use

The Halo One Thin-Walled Guiding Sheath is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

Indications for Use

Technological Comparison to Predicate Device:

The Halo One Thin-Walled Guiding Sheath has the following similarities to the Predicate Device Halo One Thin-Walled Guiding Sheath (K192313, cleared December 19, 2019):

· Same intended use.
. Same indications for use
Same target population/conditions of use .
. Same operating principle/mechanism of action
. Same fundamental scientific technology
. Similar packaging materials and configurations
Same sterility assurance level and method of sterilization .

The Halo One Thin-Walled Guiding Sheath (subject device) includes the following additions to the product range in comparison to the predicate device Halo One Thin-Walled Guiding Sheath (K192313, cleared December 2019):

1. The addition of 6F compatible size and lengths of 90cm, 70cm and 45cm to the range. A vessel dilator which is 0.035" guidewire compatible is provided with each sheath.
1. The 4F and 5F 25cm sheaths and 6F 10cm and 25cm sheaths will also be offered with a 0.018" quidewire compatible dilator.
1. The Halo One Thin-Walled Guiding Sheath will be further enhanced by the addition of access kits in 4F,5F and 6F 10cm and 25cm lengths incorporating access needle (21G x 4cm or 19G x 7cm option available) and access guidewire in both 0.018" (0.018" x 80cm or 0.018" x 50cm option available) and 0.035" (0.035" x 80cm or 0.035" x 50cm option available) configurations to the existing predicate device product range.

clearStream
Technologies Ltd

{6}------------------------------------------------

Performance Data:

To demonstrate substantial equivalence of the subject device to the predicate device, both technical characteristics and performance criteria were evaluated. Using FDA Guidance documents on non-clinical testing of medical devices and internal Risk Assessment procedures, testing for the following characteristics and performance criteria were evaluated for the subject device:

· Visual Inspection of sheath, access quidewire and access needle
. Simulated use of sheath, access guidewire and access needle
. Dimensional Testing of Dilator / Sheath
Compatibility Testing of sheath, access quidewire and access needle .
. Penetration Force of Dilator / Sheath
. Trackability of Dilator and Sheath
. Trackability of device in sheath
Visual Inspection (Tip-Rollback)
. Bend Radius / Kink
. Leak Testing
. Needle Ultrasound visibility
. Packaging Testing
- o Visual Inspection
- Bubble Emission of Pouches O
- Visual Inspection of Sterile Barrier Packaging Heat Seal O
- Seal Strength Tensile Method o

The biocompatibility of the Halo One Thin-Walled Guiding Sheath was evaluated based on ISO 10993-1. The device is classified as an externally communication device, circulating blood, limited contact (<24hrs). The results from these tests performed in accordance with standards and FDA guidance, demonstrate that the technical characteristics and performance criteria of the Halo One Thin-Walled Guiding Sheath is substantially equivalent to the predicate and that it can perform in a manner equivalent to devices currently on the market for the same intended use.

Conclusion:

The subject device, the Halo One Thin-Walled Guiding Sheath, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocol and / or customer inputs. The clinical and non-clinical tests demonstrate that the Halo One Thin-Walled Guiding Sheath is substantially equivalent to the predicate device, Halo One Thin-Walled Guiding Sheath.

clearStream
Technologies Ltd

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).