The SonoStik Guide Wire Introducer is used to facilitate the introduction of a guide wire and catheter through the skin into a vein or artery of the peripheral vasculature. The SonoStik Guide Wire Introducer is not intended for use in the coronary arteries or neurovasculature.

Device Description

The SonoStik Guide Wire Introducer is intended to facilitate the introduction of a guide wire and catheter through the skin into a vein or artery of the peripheral vasculature. The device consists of a plastic housing containing an Introducer Wheel, Advancing Wheels, and a guide wire. The mechanism of action of the SonoStik Guide Wire Introducer is accomplished by the Introducer Wheel and the two Advancing Wheels inside the plastic housing. The SonoStik Guide Wire Introducer housing has a "male end" connector capable of mating with the back end of a compatible needle introducer and accurately positions the guide wire through the plastic housing and into the back end of the needle. Once mated, the Introducer and cannula/needle are used to insert the needle into the tissue or vessel. The Introducer Wheel is turned, advancing the guide wire into the vessel lumen. The device has a transparent tube at the proximal end of the device which enables the user to visualize guide wire advancement as they engage the introducer wheel.

The SonoStik Guide Wire Introducer is compatible with and intended to be used with the MedSource Labs VeroTrue Conventional IV Catheter (K193278 catheter and needle set in 18-, 20-, and 22-gauge sizes.

AI/ML Overview

The provided text is a 510(k) summary for the SonoStik Guide Wire Introducer. It describes a medical device, its intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device.

However, the questions you asked are largely related to software as a medical device (SaMD) or AI/ML-enabled medical devices, specifically in the context of diagnostic performance evaluation using methodologies like MRMC studies, ground truth establishment by experts, and analysis of metrics like sensitivity, specificity, or AUC.

The SonoStik Guide Wire Introducer is a physical medical device, not software or AI. Therefore, the information typically requested for AI/ML device acceptance criteria and performance studies (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, effect size of human reader improvement with AI assistance, standalone algorithm performance, type of ground truth like pathology or outcomes data) is not relevant and not present in this document.

The document focuses on the physical and functional aspects of the device.

Here's what can be extracted from the document regarding the device's evaluation, though it won't directly answer most of your detailed questions about AI/ML device performance:

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

The document broadly states: "Testing found the SonoStik Guide Wire Introducer met all applicable acceptance criteria associated with the introduction of a guide wire and catheter through the skin into a vein or artery of the peripheral vasculature."

The specific acceptance criteria are not detailed in a table, but the types of tests performed indicate the areas of evaluation:

Acceptance Criterion (Inferred from tests)	Reported Device Performance
Biocompatibility	Met applicable acceptance criteria. (Implies no adverse biological reactions)
Bacterial Endotoxin	Met applicable acceptance criteria. (Implies acceptable levels of endotoxins, indicating sterility or appropriate manufacturing)
Packaging Performance	Met applicable acceptance criteria. (Ensures product integrity, sterility, and protection during transport and storage, specifically noting "pouch seal were lengthened")
Product Performance (Functionality)	Met applicable acceptance criteria associated with the introduction of a guide wire and catheter through the skin into a vein or artery of the peripheral vasculature. (Implies successful guide wire advancement, compatibility with specified needles/catheters, and proper mechanical function after worst-case sterilization simulation, environmental conditioning, and 1-year accelerated aging). "Design control testing demonstrated that these changes do not negatively impact the performance of the proposed device when compared to the predicate."
Material Safety	Implicitly met through biocompatibility and endotoxin testing, and by the nature of non-clinical testing for equivalence. Nitinol guidewire (new material) tested.
Sterilization Effectiveness	Implicitly met by bacterial endotoxin testing and performance after "worst-case sterilization simulation"
Shelf-life/Aging	Met acceptance criteria after "1-year accelerated aging".

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The document only mentions "worst-case non-clinical testing." For physical device performance, this usually means testing a sufficient number of units to demonstrate statistical confidence or to meet engineering specification requirements, but exact numbers are not provided.
Data Provenance: Not applicable in the context of clinical data for AI/ML devices. The testing was laboratory-based non-clinical performance and safety testing.

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

Not applicable. This is for a physical device, not an AI/ML diagnostic algorithm that requires expert interpretation for ground truth. Performance was assessed mechanically and through established laboratory methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This concept is relevant for establishing a reference standard from multiple expert opinions in diagnostic studies, not for the physical performance testing of a medical device.

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:

No. This is a physical device, not an AI or imaging device where MRMC studies are performed to evaluate diagnostic accuracy and reader performance.

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

Not applicable. There is no algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable in the AI/ML sense. "Ground truth" for this device would be its ability to physically perform its intended function (e.g., smoothly advance a guidewire, maintain integrity) as measured by engineering specifications and industry standards, and demonstrating biocompatibility. This is determined by validated test methods and comparison to a legally marketed predicate device.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. No training set for an algorithm.

In summary: The provided document is a 510(k) summary for a physical catheter introducer device. It describes its components, intended use, and the non-clinical (laboratory) testing performed to demonstrate its substantial equivalence to a previously cleared device. The detailed questions you've posed are designed for evaluating AI/ML-enabled medical devices, which have very different performance validation requirements than the SonoStik Guide Wire Introducer.

Summary

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November 4, 2024

SonoStik, LLC % Robert Mclain Sr. Quality and Regulatory Affairs Consultant Keystone Regulatory Services, LLC 342 E. Main Street Suite 207 Leola, Pennsylvania 17540

Re: K243061

Trade/Device Name: SonoStik Guide Wire Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 27, 2024 Received: October 29, 2024

Dear Robert Mclain:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Digitally signed by Finn E. Finn E. Donaldson -S Donaldson -S Date: 2024.11.04 10:35:26 -05'00'

Finn Donaldson Assistant Director (Acting) 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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Indications for Use

Submission Number (if known)

K243061

Device Name

SonoStik Guide Wire Introducer

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)

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510(k) Summary

Contact Details

Applicant

SonoStik, LLC 20 Jade Circle Canfield, OH 44406 United States Contact: Mr. Gary Wakeford Phone: (330)776-1173 Email: gary.wakeford@sonostik.com

Submission Correspondent

Keystone Regulatory Services, LLC 342 E. Main Street, Suite 207 Leola, PA 17540 United States Contact: Robert McLain Phone: 7176569656 E-Mail: rob.mclain@keystoneregulatory.com

Device Name

Device Trade Name

SonoStik Guide Wire Introducer

Common Name

Catheter introducer

Classification Name

Introducer, Catheter

Regulation Number

870.1340

Product Code

DYB

Legally Marketed Predicate Device

The proposed SonoStik Guide Wire Introducer is substantially equivalent to the SonoStik, LLC SonoStik Guide Wire Introducer (Product Code DYB) cleared under K152177.

Device Description Summary

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Wheel and the two Advancing Wheels inside the plastic housing. The SonoStik Guide Wire Introducer housing has a "male end" connector capable of mating with the back end of a compatible needle introducer and accurately positions the guide wire through the plastic housing and into the back end of the needle. Once mated, the Introducer and cannula/needle are used to insert the needle into the tissue or vessel. The Introducer Wheel is turned, advancing the guide wire into the vessel lumen. The device has a transparent tube at the proximal end of the device which enables the user to visualize guide wire advancement as they engage the introducer wheel.

Intended Use/Indications for Use

Indications for Use Comparison

The proposed SonoStik Guide Wire Introducer shares identical indications for use with the predicate device (K152177 - SonoStik Guide Wire Introducer).

Technological Comparison

The proposed SonoStik Guide Wire Introducer shares the following identical technical characteristics with the predicate device (K152177 - SonoStik Guide Wire Introducer) classification regulation, product code, panel, indication for use, sterilization method, and materials of construction with the exception of the following.

The proposed product's guide wire is composed of nitinol, is 218 mm in length, and features a taper from a distal outer diameter of 0.09 mm to 0.24 mm after the first 47.5 mm of distal length whereas the predicate's (K152177 guide wire is stainless steel, is 195 mm in length, and has a uniform outer diameter of 0.36 mm inches. To accommodate the change in guide wire length, the polycarbonate device housing and sterile barrier packaging pouch seal were lengthened compared to the predicate. Additionally, a new brand of cannulated needle and catheter sets in 18-, 20-, and 22gauge sizes was qualified as compatible with the proposed product. Design control testing demonstrated that these changes do not negatively impact the performance of the proposed device when compared to the predicate.

Non-Clinical Tests Summary and Conclusions

SonoStik LLC performed worst-case non-clinical testing in which the proposed SonoStik Guide Wire Introducer was assessed for biocompatibility, bacterial endotoxin, and packaging performance and product performance following worst-case sterilization simulation, environmental conditioning, and 1-year accelerated aging. Testing found the SonoStik Guide Wire Introducer met all applicable acceptance criteria associated with the introduction of a guide wire and catheter through the skin into a vein or artery of the peripheral vasculature. The testing supported the substantial equivalence of the subject device to the predicate device.

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).