The Heraeus TMW Guidewire is intended to facilitate the introduction and placement of catheters and interventional devices during Percutaneous Transluminal Angioplasty (PTA) and/or Percutaneous Transluminal Coronary Angioplasty (PTCA).

Device Description

Heraeus TMW Guidewire is a steerable guidewire constructed of a bi-metal core wire. The distal core is made of Triton™ Nitinol alloy and has a coiled wire feature at the distal end. The proximal core is comprised of PTFE coated Stainless Steel material. The wire is available in .014" diameter and lengths ranging from 180 to 300 cm. The distal segment is coated with hydrophilic coating and is shapeable with a 3 cm radiopaque distal tip.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Heraeus TMW Guidewire, demonstrating its substantial equivalence to a predicate device. This document focuses on the physical and technological characteristics and performance testing of a medical device (guidewire), not an AI/ML-based medical device. Therefore, many of the requested criteria for an AI/ML device, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (algorithm only without human-in-the-loop performance)," "training set sample size," or "ground truth establishment for training set," are not applicable or do not exist in this context.

However, I can extract information related to acceptance criteria, testing, and ground truth as it pertains to this physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that: "The Heraeus TMW Guidewire System met all predetermined acceptance criteria and compared favorably with the predicate device." However, a specific table detailing the exact numerical acceptance criteria and the corresponding reported performance values is not provided in this summary. It lists the types of tests conducted and implies that the results met the criteria and compared favorably to the predicate.

Acceptance Criteria Category	Specific Test/Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
Biocompatibility	Cytotoxicity	Compliance with ISO 10993-1:2009 & G95-1	Met
Biocompatibility	Sensitization	Compliance with ISO 10993-1:2009 & G95-1	Met
Biocompatibility	Intracutaneous Reactivity	Compliance with ISO 10993-1:2009 & G95-1	Met
Biocompatibility	Acute Systemic Toxicity	Compliance with ISO 10993-1:2009 & G95-1	Met
Biocompatibility	Pyrogen Testing	Compliance with ISO 10993-1:2009 & G95-1	Met
Biocompatibility	Hemolysis	Compliance with ISO 10993-1:2009 & G95-1	Met
Biocompatibility	Complement Activation	Compliance with ISO 10993-1:2009 & G95-1	Met
Biocompatibility	In-Vivo Thrombogenicity	Compliance with ISO 10993-1:2009 & G95-1	Met
Shelf Life	Not specified (implied)	Met	Met
Functional Specifications	Particulate testing	Not specified (implied)	Met
Functional Specifications	Corrosion resistance	Not specified (implied)	Met
Functional Specifications	Dimensional inspection	Not specified (implied)	Met
Functional Specifications	Sterilization	Not specified (implied)	Met
Functional Specifications	Sterile package integrity testing	Not specified (implied)	Met
Functional Specifications	Tensile strength	Not specified (implied)	Met
Functional Specifications	Tip stiffness	Equivalent to predicate device	Compared favorably
Functional Specifications	Torque response	Equivalent to predicate device	Compared favorably
Functional Specifications	Radiopacity	Not specified (implied)	Met
EO Sterilization Residuals	Compliance with ISO 10993-7	Met	Met

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

Sample Size: The document does not specify the exact sample sizes (number of units tested) for each in vitro bench test. It generically states "bench tests were utilized."
Data Provenance: The tests were "in vitro bench tests," meaning they were conducted in a laboratory setting, not on patient data. There is no information on country of origin of data, or whether it was retrospective or prospective, as these are concepts typically relevant to human subject studies.

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

This information is not applicable. The "ground truth" for a physical medical device like a guidewire is established through objective engineering and materials science principles and standards (e.g., ISO, ASTM). It does not involve human expert interpretation of images or clinical data in the same way an AI/ML diagnostic device would.

4. Adjudication method for the test set:

This is not applicable. The performance of a physical device against engineering specifications does not typically involve an adjudication method by multiple human experts.

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, an MRMC comparative effectiveness study was not done. This device is a guidewire, not an AI/ML diagnostic or assistive tool for human readers.

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

No, this is not an AI/ML algorithm. Its performance is inherent in its physical and mechanical properties.

7. The type of ground truth used:

The "ground truth" for this device is based on established engineering specifications, material properties, and biocompatibility standards (e.g., ISO 10993-1, ISO 10993-7, "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995"). The device's performance is measured against these objective standards and compared to the predicate device's known characteristics.

8. The sample size for the training set:

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

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

Not applicable, as there is no training set for a physical device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

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

October 20, 2017

Heraeus Medical Components, LLC Margaret Batchelder Principal Regulatory Specialist 2605 Fernbrook Lane North, Suite J Plymouth, Minnesota 55447

Re: K173052

Trade/Device Name: Heraeus TMW Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: September 27, 2017 Received: September 28, 2017

Dear Margaret Batchelder:

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 devicerelated 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.

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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/ResourcesforYou/Industry/default.htm. 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

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,

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

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Indications for Use

510(k) Number (if known) K173052

Device Name Heraeus TMW Guidewire

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Research Use (Part 21 CFR 601 Subpart D)	Compassionate Use (21 CFR 601 Subpart E)
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Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary -- K173052 6

Submitter:	Heraeus Medical Components, LLC1805 Fernbrook Lane North, Suite JPlymouth, MN 55447
Contact Person:	Margaret Batchelder, Principal Regulatory Specialist1805 Fernbrook Lane North, Suite JPlymouth, MN 55447763-225-6675 (voice)763-559-7676 (fax)
Summary PreparationDate	September 27, 2017
Device Name	Heraeus TMW Guidewire
DeviceClassification:	Common Name: GuidewireClassification Name: Catheter, Guidewire Device Classification: Class II, 21 CFR §870.1330Product Code: DQX
Intended Use:	The Heraeus TMW Guidewire is intended to facilitate the introductionand placement of catheters and interventional devices duringPercutaneous Transluminal Angioplasty (PTA) and/or PercutaneousTransluminal Coronary Angioplasty (PTCA).
Contraindications:	The guidewire is not intended for use in the cerebral vasculature.
Device Description	Heraeus TMW Guidewire is a steerable guidewire constructed of a bi-metal core wire.The distal core is made of Triton™ Nitinol alloy and has a coiled wirefeature at the distal end. The proximal core is comprised of PTFEcoated Stainless Steel material.The wire is available in .014" diameter and lengths ranging from 180to 300 cm. The distal segment is coated with hydrophilic coating andis shapeable with a 3 cm radiopaque distal tip.
Predicate Device:	The subject device is substantially equivalent to the Hi-TorqueBalance Middleweight Guidewire (K152709, 10/21/2015)manufactured by Abbott Vascular.
Principle ofOperation:	The Heraeus TMW Guidewire is operated by a manual process.
Comparison ofTechnologicalCharacteristics	The key technological and performance similarities examined betweenthe approved devices and the proposed Heraeus TMW Guidewiredevice are as follows:
	Indications for use - The Indications for use for the proposed device isa subset of indications for use of the predicate device as proposeddevice,
	Fundamental scientific technology, including design are equivalent tothe predicate devices
	Operating principle - equivalent to the predicate devices
	Packaging materials - equivalent to the predicate device
	Sterility assurance level and method of sterilization - equivalent tothe predicate devices
	The length and diameter of the device are equivalent to thedimensions of the predicate devices.
	The proposed device and that of the predicate device are identical inthat they are constructed with equivalent materials to provideequivalent tip stiffness, torque responses, and coating properties.
	The proposed device has equivalent tip stiffness characteristics to thatthe predicate device
SubstantialEquivalence	The Heraeus TMW Guidewire System is substantially equivalent tothe substantially equivalent to the Hi-Torque Balance MiddleweightGuidewire (K152709). Substantial equivalence, which is summarizedin the following table, is based on indications for use, physical andtechnological characteristics, and comparative device testing.

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	TMW Guidewire(current submission)	Abbott VascularHi-Torque BalanceMiddleweight Universal IIGuidewire (K152709)	Abbott VascularHi-Torque BalanceMiddleweight EliteGuidewire (K152709)
DeviceCommon/UsualName	Catheter Guide Wire	Catheter Guide Wire	Catheter Guide Wire
Device Class	Class II	Class II	Class II
Product Code /Regulation	DQX / 21 CFR 870.1330	DQX / 21 CFR 870.1330	DQX / 21 CFR 870.1330
RegulationName	Catheter Guide Wire	Catheter Guide Wire	Catheter Guide Wire
Prescription Use	Rx Only	Rx Only	Rx Only
Indications forUse	The Heraeus TMWGuidewire is intended tofacilitate the introduction andplacement of catheters andinterventional devices duringPercutaneous TransluminalAngioplasty (PTA) and/orPercutaneous TransluminalCoronary Angioplasty(PTCA).	To facilitate the placement ofballoon dilatation cathetersduring percutaneoustransluminal coronaryangioplasty (PTCA) andpercutaneous transluminalangioplasty (PTA). This guidewire may also be used withcompatible stent devicesduring therapeutic procedures.	To facilitate the placement ofballoon dilatation cathetersduring percutaneoustransluminal coronaryangioplasty (PTCA) andpercutaneous transluminalangioplasty (PTA). Thisguide wire may also be usedwith compatible stent devicesduring therapeuticprocedures.
Guidewire OD	0.014"	0.014"	0.014"
GuidewireLength	180 & 300 cm	190 & 300 cm	190 & 300 cm
GuidewireMaterials	Nitinol Cobalt, StainlessSteel, Pebax, PlatinumTungsten, Solder, andAdhesive	Nitinol, Stainless Steel,Radiopaque Coil, Solder,Polymer Jacket, Adhesive	Nitinol, Stainless Steel,Radiopaque Coil, Solder,Adhesive
GuidewireCoating	PTFE, Hydrophilic coating	PTFE, Hydrophilic coating	PTFE, Hydrophilic coating
Tip Shape	Straight Tip	Straight, J-Tip	Straight, J-Tip
Sterile Device?	Yes	Yes	Yes
SterilizationType	Ethylene Oxide	Irradiation	Irradiation
EO SterilizationResiduals	Per ISO 10993-7	N/A	N/A
Disposable /Reusable	Disposable	Disposable	Disposable

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Performance Testing: In vitro bench tests were utilized to demonstrate equivalence with reference to the FDAs guidance document "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995".
The performance testing assessment supports that the biocompatibility, shelf life, and functional specifications of the proposed Guidewire device were met.

The Heraeus TMW Guidewire device test data supports the claims of substantial equivalence to the predicate devices. Biological Safety of the predicate device has been established through biocompatibility testing carried out in compliance with ISO10993-1:2009 and G95-1, FDA General Program Memorandum: Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.

The following bench tests were conducted or evaluated to support the proposed device:

. biocompatibility testing (including: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen Testing, Hemolysis, Complement Activation, In-Vivo Thrombogenicity)
particulate testing ●
corrosion resistance
dimensional inspection ●
sterilization ●
sterile package integrity testing
tensile strength ●
tip stiffness ●
torque response ●
corrosion resistance ●
. radiopacity
. tip stiffness

The Heraeus TMW Guidewire System met all predetermined acceptance criteria and compared favorably with the predicate device.

Conclusion: Heraeus considers the Heraeus TMW Guidewire to be equivalent to the predicate device. This conclusion is based upon the fact that 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.