The ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire is a steerable wire intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of equipment such as atherectomy and compatible stent devices during other diagnostic and therapeutic intravascular procedures.

Device Description

The ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire is a steerable guide wire intended to facilitate placement of balloon dilatation catheters during Percutaneous Transluminal Coronary Angioplasty (PTCA) and Percutaneous Transluminal Angioplasty (PTA). The wire is also intended to facilitate the placement of equipment, such as atherectomy and compatible stent devices, during other diagnostic and therapeutic intravascular procedures. It is not intended for use in the cerebral vasculature.

The proximal and distal portions of the guide wire are constructed from a core assembly. A series of tapers and flats, which reduce the diameter of the core wire distally, yields the desired tip flexibility. The ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire is coated with Microglide® from 40cm to 3cm back from the distal tip, while the remaining portion is coated with polytetrafluoroethylene (PTFE). Both coatings are intended to reduce friction for improved movement of the wire within the catheter.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (guide wire) submitted in 1997. It describes the device, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence. However, it does not contain the specific acceptance criteria, study details, and performance metrics typically found in recent AI/ML device submissions.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions related to sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone performance, as this information is not present in the given text.

The document focuses on demonstrating substantial equivalence based on materials, design, functional properties, and packaging compared to previously approved guide wires, as well as bench and animal testing results that show "adequate" or "performs as well as or better than" the predicate devices.

Here's a breakdown of what is available based on your request, and what is absent:

1. Table of acceptance criteria and the reported device performance:

Absent. The document describes testing performed (tensile strength, torsional strength, rotational accuracy, tip flexibility) and states the device "has adequate" or "acceptable" performance, but it does not provide specific numerical acceptance criteria or quantitative performance results in a table format.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Absent. The "In vivo Testing" section mentions "An animal study was completed," but does not specify the number of animals (sample size), species, or any other details about the study design or data provenance beyond it being an animal study.

3. 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 / Absent. This type of ground truth establishment by human experts is typically relevant for interpretative devices (e.g., AI for image analysis). For a guide wire, performance is typically assessed through physical and functional tests, not by expert interpretation of data.

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

Not applicable / Absent. See point 3.

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:

Not applicable. This is a physical medical device, not an AI/ML-based diagnostic or interpretative device that would involve human readers.

6. 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.

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

For the bench testing, the "ground truth" would be the engineering specifications and established test methodologies for guide wires.
For the in vivo animal study, the "ground truth" was a comparison of its performance against a predicate guide wire in specific procedures, implicitly using direct observation of physical function as the basis of comparison ("performs as well as or better than the ACS Hi-Torque Floppy Xtra Support® Guide Wire").

8. The sample size for the training set:

Not applicable / Absent. This device is a physical product and does not involve AI/ML models that require a "training set."

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

Not applicable / Absent. See point 8.

Summary of available information regarding studies and acceptance criteria (from the text):

Study Types Performed:

Bench Testing:
- Tensile strengths (distal tip and hypotube junction) - demonstrated "adequate tensile strength."
- Torsional strength (distal tip and hypotube junction) - showed "adequate torsional tip strength."
- Rotational accuracy - showed "adequate torque response."
- Tip flexibility - demonstrated "acceptable tip flexibility."
In vivo Testing (Animal Study):
- Purpose: To evaluate and compare the performance of the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire to a predicate device (ACS Hi-Torque Floppy Xtra Support® Guide Wire, K913353).
- Context: Used in combination with specific devices (Johnson and Johnson (JJIS) Stent Delivery System, DVI AtheroCath-GTO Atherectomy Catheter, and CVIS UltraCrossIntravascular ultrasound catheter).
- Results: "performs as well as or better than the ACS Hi-Torque Floppy Xtra Support® Guide Wire in the majority of the performance parameters."
Biocompatibility:
- Relied on data from the predicate 0.014" HI-TORQUE BALANCE® Guide Wire due to identical materials, demonstrating biocompatibility for short-term use.

Data Provenance (limited):

Bench testing is typically conducted in a lab setting.
In vivo testing was an "animal study." No country of origin is specified.
Biocompatibility data was from a predicate device.

Acceptance Criteria (as implied by outcomes):
The acceptance criteria are not explicitly stated with quantitative thresholds, but are indicated by qualitative statements of performance:

"adequate tensile strength"
"adequate torsional tip strength"
"adequate torque response"
"acceptable tip flexibility"
"performs as well as or better than" the predicate device in the animal study.
Biocompatibility "demonstrate[d]" for short-term use.

This document serves as a substantial equivalence submission, which typically relies on comparisons to already approved devices and demonstrating that the new device does not raise new questions of safety or effectiveness. The level of detail on specific performance metrics and study designs is less compared to what might be expected from a pre-market approval application (PMA) or a submission for a novel device, especially one incorporating AI/ML.

Summary

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971815

APPENDIX V

SUMMARY OF SAFETY AND EFFECTIVENESS

JUL - 9 1997

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This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990.

1.	Trade Name:	ACS HI-TORQUE BALANCE MIDDLEWEIGHT™Guide Wire
	Common Name:	Guide Wire
2.	Device Classification:	Vascular Guide Wire

3. Performance Standards:

Performance standards have not been established under Section 514 of the Federal Food, Drug, and Cosmetic Act for vascular guide wires.

Device Description: 4.

5. Summary of Substantial Equivalence:

A comparison of the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire to the predicate ACS HI-TORQUE BALANCE® Guide Wire (K925381, approved February 12, 1993), indicates that the new guide wire is substantially equivalent to the predicate guide wire with regard to its materials, design, and functional properties, and packaging.

The ACS BALANCE MIDDLEWEIGHT™ Guide Wire is a steerable guide wire intended to facilitate placement of balloon dilatation catheters during Percutaneous Transluminal Coronary Angioplasty (PTCA) and Percutaneous

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Transluminal Angioplasty (PTA). The wire is also intended to facilitate the placement of equipment, such as atherectomy and compatible stent devices, during other diagnostic and therapeutic intravascular procedures. It is not intended for use in the cerebral vasculature. The ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire is substantially equivalent to the ACS Hi-Torque Floppy Xtra Support® Guide Wire (K913353, approved October 23, 1991) with regard to its intended use.

The design of the new ACS BALANCE MIDDLEWEIGHT" Guide Wire is constructed from a stainless steel core wire. Like the predicate 0.014" HI-TORQUE BALANCE® guide wire, the new guide wire design includes a series of tapers and flats which reduce the diameter of the core wire distally, yielding the desired tip flexibility. Unlike the 0.014" HI-TORQUE BALANCE® Guide Wire, the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ wire diameters and tapers along the length of the distal portion of the guide wire have been modified to yield the desired support over the distal 30 centimeters of the wire. This modification involves no new materials or processes in comparison to the predicate wire, and has no effect on the distal tip of the guide wire. Therefore, the tapers and diameters positioned at different locations proximal to the tip cannot significantly impact the safety or effectiveness of the guide wire.

ર્. Testing Data:

Bench Testing:

The tensile strengths of the guide wire distal tip and hypotube junction were determined by pull tests. These tests demonstrated that the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire has adequate tensile strength.

The torsional strength of the distal tip and hypotube junction were determined by turns-to-failure tests. This test showed that the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire has adequate torsional tip strength.

The correlation between rotation of the proximal end and the corresponding rotation of the distal end of the guide wire was determined by the rotational accuracy test. This test showed that the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire has an adequate torque response.

The tip flexibility testing demonstrated that tip flexibility of the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire has acceptable tip flexibility.

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In vivo Testing:

An animal study was completed to evaluate and compare the performance of the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire to that of the ACS Hi-Torque Floppy Xtra Support® Guide Wire (K913353, October 23, 1991) when used in combination with the Johnson and Johnson (JJIS) Stent Delivery System, the DVI AtheroCath-GTO Atherectomy Catheter, and with the CVIS UltraCrossIntravascular ultrasound catheter.

The results of these studies show that the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire performs as well as or better than the ACS Hi-Torque Floppy Xtra Support® Guide Wire in the majority of the performance parameters when used to facilitate the placement of equipment, such as atherectomy and compatible stent devices, and during other diagnostic and therapeutic intravascular procedures.

Biocompatibility:

Since the materials for the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire are identical to those of the predicate 0.014" HI-TORQUE BALANCE® Guide Wire, the biocompatibility data from the predicate device were used to demonstrate that the materials and processes utilized in the new guide wire are biocompatible for short term use within the vascular system.

7. Sterilization:

The ACS BALANCE MIDDLEWEIGHT™ Guide Wire is sterilized by the same methods and following the same parameters as those used for the predicate 0.014" HI-TORQUE Balance@ Guide Wire (K925381, approved February 12, 1993),

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1. Conclusion:
  The ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire is substantially equivalent to the predicate devices, the 0.014" HI-TORQUE BALANCE® Guide Wire (K925381, approved February 12, 1993), and the Hi-Torque Floppy Xtra Support® Guide Wire (K913353, approved October 23, 1991).

Signed:

Mora Miraji

Mona Mirapuri

Regulatory Affairs Coordinator

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Mona Mirapuri Regulatory Affairs Coordinator Guidant Corporation ----- JUL -- 9 1997 Advanced Cardiovascular Systems 3200 Lakeside Drive P.O. Box 58167 -----------------------------------------------------------------------------------Santa Clara, California 95052-8167

Re: K971815 ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire Requlatory Class: II (two) Product Code: DQX Dated: May 16, 1997 Received: May 17, 1997

Dear Ms. Mirapuri:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 additionally 809:10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known):

Device Name: ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use(Per 21 CFR 801.109)	✓

Over-The-Counter(Optional Format 1-1-96)
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	Tana A. Ar (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
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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.