To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) and compatible stent devices during therapeutic intravascular procedures.

Device Description

The HI-TORQUE WHISPER™ LS and MS Guide Wires with Hydrocoat Hydrophilic Coating are guide wires with a 0.014" diameter and available in 175 cm and 190 cm extendable lengths and a 300 cm exchange length. The proximal end of the 175 cm and 190 cm models are tapered to fit into the hypotube portion of the ACS DOC® Guide Wire Extension. This enables the physician to extend the working length of this guide wire to facilitate catheter exchanges. The wires are constructed with a stainless steel core wire. The proximal section of the core wire has a constant diameter and the distal core segment tapers in diameter to the tip. Attached to the distal core is a tip coil that provides radiopacity. The distal 30 cm of the core wire is jacketed with a polyurethane coating that is coated with a hydrophilic coating. The proximal section of the wire is coated with polytetrafluoroethylene (PTFE). The distal tips of the guide wires are available either as a straight tip that is shapeable or as a pre shaped "J".

AI/ML Overview

The provided text describes the HI-TORQUE WHISPER™ LS and MS Guide Wires and asserts their substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or a detailed study report that would allow for a comprehensive answer to your request.

Medical device summaries often focus on performance data broadly, without detailing the precise acceptance criteria or the specifics of the studies unless they are novel or demonstrate significant changes in performance. This submission is for a device with a "new tungsten material" but asserts it performs equivalently to the predicate device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, or specific study types like MRMC, as this information is not present in the provided document.

Here's what can be extracted and inferred based on the available text:

Acceptance Criteria and Device Performance (Not explicitly stated in detail)

Acceptance Criteria Category	Specific Acceptance Criteria (Not detailed in text)	Reported Device Performance (as stated in text)
Performance	(Implicit: Must meet functional and safety standards equivalent to predicate)	"The results of the verification testing demonstrate that the HI-TORQE WHISPER™ LS and MS Guide Wires meet the established acceptance criteria and performs in a manner equivalent to the predicate device."
Material Characteristics	(Implicit: Properties of the new tungsten material, e.g., tensile strength, flexibility, biocompatibility)	"The HI-TORQUE WHISPER™ LS and MS Guide Wires with the new material has the same intended use, technological characteristics, performance properties, identical sterilization and substantially equivalent materials."
Sterilization	(Implicit: Must achieve sterility and maintain material integrity after sterilization)	"identical sterilization"
Packaging	(Implicit: Must protect the device and maintain sterility)	"substantially equivalent to the currently marketed predicate device."

Study Information (Inferred/Not Provided)

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document generally states "verification testing" was performed but does not detail the sample sizes or the nature (retrospective/prospective) of the data used. Data provenance (country of origin) is also not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not provided. For a guide wire, the "ground truth" and expert involvement in establishing it are typically not relevant in the same way they would be for an imaging AI device. Performance is usually assessed through physical and mechanical testing against engineering specifications.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. Adjudication methods are typically relevant for clinical studies where subjective interpretation or classification is involved, such as in diagnostic imaging. This is a physical device, and testing would involve objective measurements.
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 study is not relevant for this type of device. This is a physical guide wire, not a diagnostic AI tool, so there are no "human readers" or "AI assistance" in the context of an MRMC study.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated in these terms. For a medical device like a guide wire, "ground truth" would likely refer to established engineering and material science standards, industry benchmarks, and performance metrics (e.g., tensile strength, torque transmission, guidewire trackability, tip retention, coating integrity, biocompatibility, force to fracture, etc.) assessed through laboratory testing. The document states "established acceptance criteria," implying these pre-exist.
The sample size for the training set:
- Not applicable. There is no "training set" for a physical device like this. This terminology applies to machine learning algorithms.
How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.

Summary of Device Performance Claim:

The study referenced in the 510(k) summary asserts that the HI-TORQUE WHISPER™ LS and MS Guide Wires, with their new tungsten material, met "established acceptance criteria" and perform "in a manner equivalent to the predicate device." The conclusion explicitly states "no new safety or effectiveness issues were raised." This suggests the "study" was primarily a set of verification and validation tests demonstrating the new device's conformity to pre-defined physical and functional specifications, ensuring it performs identically or comparably to its previously cleared predicate.

Summary

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MAR 1 2002

K02D340

510(k) SUMMARY

The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92

Submitter's Name:	Guidant CorporationVascular Intervention
Submitter's Address:	26531 Ynez RoadTemecula, CA 92591
Telephone:Fax:	(909) 914-4581(909) 914-0339
Contact Person:	Jennifer Pae Riggs
Date Prepared:	January 25, 2002
Device Trade Name:	HI-TORQUE WHISPER™ LS and MS
Device Common Name:	Guide Wire
Device Classification Name:	Guide Wire Catheter
Device Classification:	Class II

Summary of Substantial Equivalence:

The design, materials, method of delivery and intended use features of the HI-TORQUE WHISPER™ LS and MS Guide Wires are substantially equivalent with regard to these features in their predicate device, the HI-TORQUE WHISPER™ LS and MS Guide Wires (K002206, August 24, 2000 and K013092, December 13, 2001).

Device Description:

A3-2

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segment tapers in diameter to the tip. Attached to the distal core is a tip coil that provides radiopacity. The distal 30 cm of the core wire is jacketed with a polyurethane coating that is coated with a hydrophilic coating. The proximal section of the wire is coated with polytetrafluoroethylene (PTFE). The distal tips of the guide wires are available either as a straight tip that is shapeable or as a pre shaped "J".

Intended Use:

Technological Characteristics:

Comparisons of the proposed and predicate device show that the technological characteristics such as materials, performance characteristics, sterilization and packaging are identical or substantially equivalent to the currently marketed predicate device. The only change is the new tungsten material.

Performance Data:

The results of the verification testing demonstrate that the HI-TORQE WHISPER™ LS and MS Guide Wires meet the established acceptance criteria and performs in a manner equivalent to the predicate device. No new safety or effectiveness issues were raised during the testing program.

Conclusions:

The HI-TOROUE WHISPER™ LS and MS Guide Wires with the new material has the same intended use, technological characteristics, performance properties, identical sterilization and substantially equivalent materials. Therefore, there are no new safety or effectiveness issues. The HI-TORQUE WHISPER™ LS and MS Guide Wires with the new material are substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2002

Ms. Jennifer Pae Riggs Guidant Corporation 26531 Ynez Road Temecula, CA 92591-4628

Re: K020340

HI-TORQUE WHISPER™ LS and MS Guide Wires with Hydrophilic Coating Regulation Number: 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: II (two) Product Code: DQX Dated: January 31, 2002 Received: February 1, 2002

Dear Ms. Riggs:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

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Page 2 - Ms. Jennifer Pae Riggs

comply with all the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the Hot Crequirements (1); good manufacturing practice requirements as set CI N Far 607); adoling (21 CFR Part 820); and if applicable, the electronic forth in the quind) byovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter wification. The FDA finding of substantial equivalence of your device to a legally premated notificated wice results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you doelly 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -Compinatee at (301) 594-666 of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Ource goneral Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Lhe

Bram Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement 510(k) Number K020340 (if known) HI-TORQUE WHISPER™ LS and MS Guide Wires with Hydrophilic Device Name Coating To facilitate the placement of balloon dilatation catheters during percutaneous Indications for transluminal coronary angioplasty (PTCA) and percutaneous transluminal Use angioplasty (PTA) and compatible stent devices during therapeutic intravascular procedures.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Over-The-Counter Use_ Prescription Use OR (Per 21 CFR 801.109) Division of Cardiovascular & Respiratory Devices
510(k) Number _ 1/202 C C 340 510(k) Number

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.