Intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal angioplasty (PTA), in peripheral arteries including but not limited to femoral, popliteal arteries. This guide wire may also be used with compatible interventional devices during therapeutic procedures. The guide wire may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.

Device Description

The Heraeus Peripheral Guidewire is a guidewire constructed using a steel core with an optional nitinol alloy tip encapsulated by polymer and lubricious outer layer. The distal polymer includes a radiopaque loading, and the distal polymer section has a hydrophilic coating.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Heraeus Peripheral Guidewire." This document focuses on demonstrating substantial equivalence to an already legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through clinical trials against pre-defined acceptance criteria for diagnostic performance (such as those associated with AI/ML-based devices).

Therefore, many of the specific questions about acceptance criteria for diagnostic performance, and detailed study methodologies (like sample sizes for test sets, expert adjudication, MRMC studies, standalone performance of an algorithm, and ground truth establishment for training sets) do not directly apply to this type of regulatory submission and the device described.

This document describes a guidewire, which is a physical medical instrument, not a diagnostic algorithm or AI system. The "performance testing" mentioned is bench testing to ensure physical and material properties meet established standards for similar devices.

However, I can extract and present the information that is relevant to the document's content:

Acceptance Criteria and Device Performance (Bench Testing for Physical Properties)

The document states that the Heraeus Peripheral Guidewire met all predetermined acceptance criteria through in vitro bench tests. While the specific numerical acceptance criteria values are not explicitly detailed in this summary, the types of performance characteristics evaluated are listed. The "reported device performance" is summarized by the statement: "The Heraeus Peripheral Guidewire met all predetermined acceptance criteria and compared favorably with the predicate."

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Acceptance Criteria Category (Type of Test)	Reported Device Performance
Biocompatibility Testing:	Met criteria per ISO 10993-1:2018 and 2016 FDA guidance.
- Cytotoxicity	Passed
- Sensitization	Passed
- Intracutaneous Reactivity	Passed
- Acute Systemic Toxicity	Passed
- Pyrogenicity Testing	Passed
- Hemolysis	Passed
- In-Vivo Thrombogenicity	Passed
- Coagulation	Passed
- Platelet Activation	Passed
- Haematology	Passed
- Complement Activation	Passed
Material/Physical Properties:	Met criteria.
- Corrosion resistance	Met criteria.
- Dimensional inspection	Met criteria.
- Sterile package integrity testing	Met criteria.
- Tensile strength	Met criteria.
- Tip flexibility	Met criteria.
- Torque strength	Met criteria.
- Torqueability	Met criteria.
- Kink/Fracture Resistance	Met criteria.
- Kink resistance	Met criteria.
- Radiopacity	Met criteria.
- Coating Integrity, Lubricity	Met criteria.
Functional/Simulated Use:	Met criteria.
- Track/Simulated Use	Met criteria.
- Particulate Evaluation	Met criteria.

Study Details (as applicable to a 510(k) for a physical device):

Sample sizes used for the test set and the data provenance:
- The document mentions "in vitro bench tests" and "test data," but does not specify the sample sizes (e.g., number of guidewires tested for each parameter).
- Data Provenance: The tests were conducted to demonstrate equivalence with reference to "FDA Guidance - Coronary and Cerebrovascular Guidewire Guidance - January 1995." The data would originate from Heraeus Medical Components, LLC's internal testing facilities. The provenance is implied to be laboratory-based (in-vitro bench tests). The document does not specify country of origin for the direct test data, but the company is in Plymouth, Minnesota, USA. It's retrospective in the sense that the tests were performed and compiled for the 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 "ground truth" here refers to pre-defined engineering and material specifications, not clinical diagnostic interpretations. The "experts" would be the engineers and quality assurance professionals performing and evaluating the bench tests.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to resolving discrepancies in expert interpretations of clinical data, which is not what was done for this device. The evaluation of bench tests typically relies on meeting pre-defined quantitative or qualitative engineering specifications.
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:
- Not applicable. This is a physical guidewire, not a diagnostic imaging/AI device. Therefore, no MRMC study looking at human reader improvement with AI assistance was conducted or would be relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, the "ground truth" for proving performance equivalence is based on established engineering specifications, material standards (e.g., ISO 10993-1), and comparative testing against the predicate device's known characteristics. It is not clinical "ground truth" like pathology or outcomes data.
The sample size for the training set:
- Not applicable. This concept relates to machine learning models. This device underwent bench testing, not a machine learning training process.
How the ground truth for the training set was established:
- Not applicable. As above, there was no machine learning training set for this device.

Summary

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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 & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 26, 2019

Heraeus Medical Components, LLC Chelsea Pioske Regulatory Affairs Manager 2605 Fernbrook Lane North, Suite J Plymouth, Minnesota 55447

Re: K191502

Trade/Device Name: Heraeus Peripheral Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: October 25, 2019 Received: October 28, 2019

Dear Chelsea Pioske:

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

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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 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 (OS) 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 Lydia Glaw 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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Indications for Use

510(k) Number (if known) K191502

Device Name Heraeus Peripheral Guidewire

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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Submitter:	Heraeus Medical Components, LLC1805 Fernbrook Lane North, Suite JPlymouth, MN 55447 USA
Contact Person:	Chelsea Becker, Regulatory Manager1805 Fernbrook Lane North, Suite JPlymouth, MN 55447 USA763-225-6500 (voice)763-559-7676 (fax)
Date Prepared:	November 25th, 2019
Trade Name:	Heraeus Peripheral Guidewire
Common Name:	Guidewire
Classification:	Class IIRegulation Number: 21 CFR 870.1330Catheter guide wire
Product Code:	DQX
Predicate Device:	The subject device is substantially equivalent to K122573;Abbott Hi-Torque Command guidewire.
Device Description:	The Heraeus Peripheral Guidewire is a guidewire constructedusing a steel core with an optional nitinol alloy tipencapsulated by polymer and lubricious outer layer. Thedistal polymer includes a radiopaque loading, and the distalpolymer section has a hydrophilic coating.
Indication for Use:	The peripheral guidewire is intended to facilitate theplacement of balloon dilatation catheters during percutaneoustransluminal angioplasty (PTA), in peripheral arteriesincluding but not limited to femoral, popliteal and infra-popliteal arteries. This guide wire may also be used withcompatible interventional devices during therapeuticprocedures. The guide wire may also be used to reach andcross a target lesion, provide a pathway within the vesselstructure, facilitate the substitution of one diagnostic orinterventional device for another, and to distinguish thevasculature.
Contraindications:	Not intended for use in the coronary or cerebral vasculature.
Principle ofOperation:	The Heraeus Peripheral Guidewire is manually inserted intovasculature through a compatible guiding catheter andadvanced to the target region.
SubstantialEquivalenceComparison:	The Heraeus Peripheral Guidewire is substantially equivalentto the Abbott Hi-Torque Command guidewire (K122573).Substantial equivalence is based on indications for use,physical and technological characteristics, and comparativedevice testing.
	Indications for use:• The indications for use for the Heraeus PeripheralGuidewire are equivalent to the predicate.
	Fundamental scientific technology• Dimensional characteristics – the length and diameter of the device are similar to the dimensions of the predicate devices• Materials – the device is constructed of equivalent materials to provide equivalent performance characteristics and coating properties• Operating principle - equivalent to the predicate device• Packaging materials - equivalent to the predicate device• Sterility assurance level and method of sterilization - equivalent to the predicate devices
PerformanceTesting:	In vitro bench tests were utilized to demonstrate equivalencewith reference to FDA Guidance - Coronary andCerebrovascular Guidewire Guidance - January 1995.The performance testing assessment supports that thebiocompatibility, shelf life, and functional specifications ofthe proposed guidewire device were met.
	The Heraeus Peripheral Guidewire device test data supportsthe claims of substantial equivalence to the predicate devices.Biological Safety of the predicate device has been establishedthrough biocompatibility testing carried out in compliancewith ISO 10993-1:2018 and the 2016 FDA guidance, "Use ofInternational Standard ISO 10993-1, “Biological evaluation ofmedical devices – Part 1: Evaluation and testing within a riskmanagement process."
	The following bench tests were conducted or evaluated tosupport the proposed device:• Biocompatibility testing:

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Cytotoxicity o
Sensitization o
Intracutaneous Reactivity O
Acute Systemic Toxicity O
Pyrogenicity Testing O
Hemolysis O
In-Vivo Thrombogenicity O
Coagulation O
0 Platelet Activation
o Haematology
o Complement Activation
Corrosion resistance ●
Dimensional inspection
Sterile package integrity testing ●
Tensile strength
Tip flexibility ●
Torque strength
Torqueability
Kink/Fracture Resistance
Kink resistance
Radiopacity ●
Coating Integrity, Lubricity ●
Track/Simulated Use ●
Particulate Evaluation ●

Conclusion:

The Heraeus Peripheral Guidewire met all predetermined acceptance criteria and compared favorably with the predicate

Heraeus considers the Heraeus Peripheral Guidewire to be equivalent to the predicate device. This conclusion is based upon the fact that the device has an equivalent intended use, and there are no differences that raise new types of questions of safety and effectiveness.

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.