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 or the coronary vasculature.

Device Description

The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and an introducer sheath. 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 braided single-lumen tubing, fitted with a female luer hub at the proximal end 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, 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 sheath is supplied in 4F, 5F and 6F compatible sizes and lengths of 90cm, 70cm, 45cm, 25cm and 10 cm. A vessel dilator which is 0.035" guide wire compatible is provided with each sheath. The 4F and 5F 10cm sheaths will also be offered with a 0.018" guide wire compatible dilator. 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 this coating.

AI/ML Overview

The provided text is a 510(k) Summary for the Halo One Thin-Walled Guiding Sheath, a medical device. It describes the device, its intended use, and comparative testing to a predicate device to demonstrate substantial equivalence.

However, the questions you've asked about acceptance criteria and studies are typically related to Software as a Medical Device (SaMD) or AI/ML-driven devices. Such devices usually involve performance metrics like accuracy, sensitivity, and specificity, and their studies often involve expert readers, ground truth establishment, and statistical analysis like MRMC studies.

The Halo One Thin-Walled Guiding Sheath is a physical medical device (a catheter introducer). The "performance data" in this document refers to a series of in vitro (laboratory) tests to ensure the physical and material properties of the sheath meet design specifications and are safe for use. These are not clinical studies in the typical sense of evaluating diagnostic accuracy or reader improvement with an AI algorithm.

Therefore, many of your questions are not applicable to the information provided in this 510(k) summary for a physical medical device. I will address the applicable parts based on the document's content.

Analysis based on the provided document:

The document describes the Halo One Thin-Walled Guiding Sheath, a physical medical device, and its substantial equivalence to a predicate device. The performance data presented is for non-clinical in vitro testing and biocompatibility assessments, not a study evaluating human-in-the-loop performance or algorithmic accuracy.

A table of acceptance criteria and the reported device performance:

The document lists numerous in vitro tests conducted. However, it does not provide a specific table of quantitative acceptance criteria and corresponding performance values for each test. Instead, it states a general 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 protocols and/or customer inputs."

Here's a list of the types of tests mentioned, which imply associated acceptance criteria:

Test Type	Implied Acceptance Criteria (General)	Reported Device Performance (General)
Visual Inspection (Outer Surface)	No visible defects, proper finish	Met all predetermined acceptance criteria
Simulated Use	Proper function during simulated procedures (e.g., connection, flushing, guidewire compatibility)	Met all predetermined acceptance criteria
Dimensional Testing	Conformance to specified dimensions (ID, OD, length, marker position)	Met all predetermined acceptance criteria
Radiopacity	Sufficient visibility under fluoroscopy	Met all predetermined acceptance criteria
Penetration Force of Dilator/Sheath	Within specified range for ease of entry	Met all predetermined acceptance criteria
Trackability of Dilator and Sheath	Ability to navigate vasculature without unwanted resistance	Met all predetermined acceptance criteria
Visual Inspection (Tip Rollback)	No unacceptable tip rollback/buckling	Met all predetermined acceptance criteria
Bend Radius/Kink	Resistance to kinking within specified parameters	Met all predetermined acceptance criteria
Valve Leak	No leakage from the valve	Met all predetermined acceptance criteria
Sheath Leak	No leakage from the sheath	Met all predetermined acceptance criteria
Sheath and Dilator Tensile Forces	Ability to withstand specified tensile forces without breaking	Met all predetermined acceptance criteria
Hub Torque/Stress Cracking	Resistance to cracking under torque	Met all predetermined acceptance criteria
Hub Stress Cracking (48 Hour Test)	Resistance to cracking over time	Met all predetermined acceptance criteria
Packaging (Visual Inspection, Emission, Heat Seals, Seal Strength)	Intact packaging, sterile barrier integrity	Met all predetermined acceptance criteria
Particulate Characterization	Particulate count within acceptable limits	Met all predetermined acceptance criteria
Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Hemocompatibility, Material Mediated Pyrogenicity)	No adverse biological reactions, non-toxic, non-pyrogenic, compatible with blood	Met ISO 10993-1 requirements and passed tests

Sample sizes used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for each in vitro test. For physical device performance testing, sample sizes are typically determined by statistical rationale for verification/validation (e.g., lot sizes, AQLs) but are not explicitly stated here.
- Data Provenance: The tests were performed "in vitro" (i.e., laboratory testing, not on human subjects or patient data). The testing was conducted as part of the device manufacturing and submission process, managed by ClearStream Technologies Ltd. in Ireland. The document does not specify a country of origin for the data beyond the manufacturer's location. These are non-clinical, prospective tests specifically conducted for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable as the device is a physical medical device, not an AI/ML-driven diagnostic tool where "ground truth" is established by expert interpretation of medical images or data. The "ground truth" for this device would be its physical and material properties meeting engineering specifications and safety standards, confirmed through validated testing methods.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in medical image interpretation studies (e.g., radiology) to resolve discrepancies between readers' assessments. For in vitro physical device testing, results are typically objective measurements or pass/fail determinations based on established protocols.
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:

This question is not applicable. An MRMC study is designed to evaluate the impact of a diagnostic tool (often AI) on human reader performance. This document pertains to a physical medical device, not a diagnostic AI tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This question is not applicable. This device is a physical medical instrument, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For a physical medical device like this, the "ground truth" is typically defined by:
- Engineering Specifications: The design parameters the device must meet (e.g., diameter, length, tensile strength).
- Industry Standards: Compliance with relevant ISO standards (e.g., ISO 10993-1 for biocompatibility).
- Regulatory Guidance: Conformance to FDA guidance documents for medical devices.
- Risk Assessment: Demonstration that the device mitigates identified risks.
The biocompatibility "ground truth" was established based on ISO 10993-1, classifying the device and requiring specific biological tests (cytotoxicity, sensitization, etc.).
The sample size for the training set:

This question is not applicable. There is no "training set" in the context of a physical medical device submission like this. Training sets are relevant for AI/ML algorithms that learn from data.
How the ground truth for the training set was established:

This question is not applicable for the same reason as #8.

Summary

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December 19, 2019

C.R. Bard, Incorporated Elizabeth Delahunty Regulatory Affairs Manager Moyne Upper Enniscorthy, Ireland

Re: K192313

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 23, 2019 Received: August 26, 2019

Dear Elizabeth Delahunty:

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

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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 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,

For

Misti Malone 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K192313

Device Name Halo One Thin-Walled Guiding Sheath

Indications for Use (Describe)

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

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510(k) Summary

K192313

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: Elizabeth Delahunty, RA Manager

Date of Submission: August 23, 2019

Subject Device:

Name of Device: Halo One Thin-Walled Guiding Sheath Common or Usual Name: Catheter Introducer Classification Name: Introducer, Catheter Regulatory Class: II (Product Code DYB) Requlation Number: 21 CFR 870.1340

Predicate Device:

510(k) Number: K161183 Name of Device: Halo One Thin-Walled Guiding Sheath Common or Usual Name: Catheter Introducer Classification Name: Introducer, Catheter Requlatory Class: II (Product Code DYB) Regulation Number: 21 CFR 870.1340

Device Description:

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

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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 braided single-lumen tubing, fitted with a female luer hub at the proximal end 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, 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 sheath is supplied in 4F, 5F and 6F compatible sizes and lengths of 90cm, 70cm, 45cm, 25cm and 10 cm.

A vessel dilator which is 0.035" guide wire compatible is provided with each sheath. The 4F and 5F 10cm sheaths will also be offered with a 0.018" guide wire compatible dilator.

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 this coating.

Indications for Use of Device:

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 or the coronary vasculature.

Technological Comparison to Predicate Devices:

The Halo One Thin-Walled Guiding Sheath (subject device) has the following similarities to the predicate device, the Halo One Thin-Walled Guiding Sheath (clearance to market via K161183 on June 03, 2016):

. 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

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The Halo One Thin-Walled Guiding Sheath (subject device), incorporates the following differences:

. Design Differences:
- 1. Changed sheath shaft the manufacturing process.
- 1. Changed braiding design.
- 1. Changed sheath tip design.
- 1. Changed dilator tip design rollback (buckling) while providing a transition to the guidewire.
Material Differences: •
- 1. Changed material composition in the introducer shaft construction to address the failure mode which the predicate material caused.
- 1. Changed durometer of material to provide improved flexibility and kink resistance.

Performance Data:

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)
- Dilator Outer Surface o
- 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
- Tape Adhesion O
Dimensional Testing
- Sheath ID O
- Sheath Length O
- Marker Band to Tip Position O

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Sheath OD O
Dilator OD o
Dilator Extension Length o
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)
. Packaging
- o Visual Inspection
- Bubble Emission of Pouches o
- Visual Inspection of Sterile Barrier Packaging Heat Seals o
- Seal Strength Tensile Method о
. Particulate Characterization
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 (<24 hrs). The results from these tests demonstrate that the technological characteristics and performance criteria of the Halo One Thin-Walled Guiding Sheath are substantially equivalent to the predicate device, and that it can perform in a manner equivalent to devices currently on the market for the same intended use.

Conclusions:

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 protocols and/or customer inputs. The clinical and non-clinical tests

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demonstrate that the Halo One Thin-Walled Guiding Sheath is substantially equivalent to the predicate device, Halo One Thin-Walled Guiding Sheath.

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).