Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and mechanical performance of a guide wire, with no mention of AI or ML technologies.

Therapeutic

No
The device is a guide wire used to facilitate the placement of other medical equipment, not to directly treat a condition. While it aids in "therapeutic intravascular procedures," it is an accessory tool rather than a therapeutic device itself.

Diagnostic

No

The device is a guide wire used to facilitate the placement of other medical equipment for both diagnostic and therapeutic intravascular procedures, but it does not perform diagnostic functions itself.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical guide wire constructed from stainless steel and other materials, with a hydrophilic coating. This is a hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes the device as being used in vivo (within the body) to facilitate the placement of other medical devices during procedures like PTCA and PTA. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
Device Description: The description details a physical guide wire designed to be inserted into blood vessels. This is consistent with an in vivo medical device, not an in vitro diagnostic test.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.

Therefore, this device is a medical device used in vivo for interventional procedures, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The HI-TORQUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating have the following intended uses:

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, IVUS and compatible stent devices during other diagnostic and therapeutic intravascular procedures.
The ACS HI-FORQUE BALANCE MIDDLEWEIGHTM Could Vire is a seeeeeble wite intended to facilitate the placement of balloon dilatation catheres during percurancous. intended to facilitate the placement of onliness on transitionin' angioplasy (PTA).
transluminal coronary angloplasy (PTCA) and perculances attensioning as atterectomy. IVUS transluminal coronary angloplash (r r Ca) and percedent such as atherectony, IVUS and
The wire is also intended to facilitate the passioned intravacular procedures, The wire is also intended to facinate die pracement of organism intravascular procedures.

Product codes

DQX

Device Description

The HI-TOROUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating are steerable guide wires with a nominal diameters of 0.014" and two lengths: a 190 cm extendable length and a 300 cm exchange length. The proximal end of the 190 cm models are tapered to fit into the hypotube portion of the ACS DOC Guide Wire Extension (K902755, approved September 4, 1990).

The wires are constructed from a stainless steel proximal shaft and a distal superelastic ELASTINITE Shaft for flexibility and performance. The distal end of this guide wires have radiopaque tips that are available either as a straight, shapeable configuration or as a preshaped J configuration. The guide wires have proximal markers at 90 and 100 cm from the distal tip. The hydrophilic coating is applied to the distal portion of the wire guide wire. The proximal shaft of the guide wire is coated with polytetrafluoroethylene.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Bench testing was performed to demonstrate that the HI-TORQUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similar to the predicate HI-TORQUE BALANCE® Guide Wire. The following tests were performed:

Accelerated Aging .
Distal Tip Pull Test ●
Distal Tip Turns-to-Failure Test ●
Rotational Accuracy Test .
Tip Flexibility Test
Hypotube Junction Pull Test ●
Hypotube Junction Maximum Torque test ●
Coating Adherence/Integrity ●

In vivo animal testing in a canine model with healthy coronary arteries was performed to demonstrate performance properties of the HI-TORQUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHTTM Guide Wire with HYDROCOAT™ Hydrophilic Coating in comparison to the predicate guide wire. The results showed that the new wires performed in an equivalent manner to the predicate devices. The results from the bench tests plus the animal testing showed that the new HI-TORQUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating met acceptance criteria and performed in a manner equivalent the predicate HI-TORQUE BALANCE® Guide Wire and the HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire. No new safety or effectiveness issues were raised during the testing program.

Key Metrics

Not Found

Predicate Device(s)

K925381, K971815, K950216

Reference Device(s)

K902755

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

K-173494

510(k) SUMMARY

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

| 1. | Submitter's Name: | Guidant Corporation
Advanced Cardiovascular Systems, Inc. DEC 12 1997 |
|----|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Submitter's Address: | 3200 Lakeside Drive
Santa Clara, CA 95052 |
| | Telephone: | 408-235-3995 |
| | Fax: | 408-235-3743 |
| | Contact Person: | Margaret Anderson |
| | Date Prepared: | September 13, 1997 |
| 2. | Device Trade Name: | HI-TORQUE BALANCE™ Guide Wire with
HYDROCOAT™ Hydrophilic Coating

ACS HI-TORQUE BALANCE MIDDLEWEIGHT™
Guide Wire (K971815, approved July 9, 1997)

The HI-TOROUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating are steerable guide wires with a nominal diameters of 0.014" and two lengths: a 190 cm extendable length and a 300 cm exchange length. The proximal end of the 190 cm models are tapered to fit into the hypotube portion of the ACS DOC Guide Wire Extension (K902755, approved September 4, 1990).

The wires are constructed from a stainless steel proximal shaft and a distal superelastic ELASTINITE Shaft for flexibility and performance. The distal end of this guide wires have radiopaque tips that are available either as a straight, shapeable configuration or as a preshaped J configuration. The guide wires have proximal markers at 90 and 100 cm

1

from the distal tip. The hydrophilic coating is applied to the distal portion of the wire guide wire. The proximal shaft of the guide wire is coated with polytetrafluoroethylene.

Intended Use: ર્જ
The HI-TORQUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating have the following intended uses:
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, IVUS and compatible stent devices during other diagnostic and therapeutic intravascular procedures.
Technological Characteristics: 6.

Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties (see below), sterilization, and packaging are identical or substantially equivalent to the currently marketed predicate device. The design feature that distinguish the new guide wire from that of the predicate wire is the new hydrophilic coating.

Performance Data: 7.
Bench testing was performed to demonstrate that the HI-TORQUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similar to the predicate HI-TORQUE BALANCE® Guide Wire. The following tests were performed:
Accelerated Aging .
Distal Tip Pull Test ●
Distal Tip Turns-to-Failure Test ●
Rotational Accuracy Test .
Tip Flexibility Test
Hypotube Junction Pull Test ●
Hypotube Junction Maximum Torque test ●
Coating Adherence/Integrity ●

2

In vivo animal testing in a canine model with healthy coronary arteries was performed to demonstrate performance properties of the HI-TORQUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHTTM Guide Wire with HYDROCOAT™ Hydrophilic Coating in comparison to the predicate guide wire. The results showed that the new wires performed in an equivalent manner to the predicate devices.

The results from the bench tests plus the animal testing showed that the new HI-TORQUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating met acceptance criteria and performed in a manner equivalent the predicate HI-TORQUE BALANCE® Guide Wire and the HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire. No new safety or effectiveness issues were raised during the testing program.

8. Conclusions:

Since the new guide wires have the same intended use, similar design and technological characteristics, equivalent performance properties, identical sterilization and packaging, and no new safety or effectiveness issues, the HI-TORQUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating may be considered substantially equivalent to the predicate HI-TORQUE BALANCE® Guide Wire and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire respectively.

3

Rockville MD 20867

DEC 1 2 1997

Ms. Margaret Anderson Requlatory Affairs Guidant Corporation 3200 Lakeside Drive, P.O. Box 58167 Santa Clara, California 95052-8167

K973494 Re : HI-TORQUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating II (two) Requlatory Class: Product Code: DQX Dated: September 13, 1997 Received: September 15, 1997

Dear Ms. Anderson:

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 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, 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 requlatory 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 obliqation you might have under sections 531 through 542 of the Act for devices under the

4

Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general 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

5

ા રત

Indications for Use Statement

510(k) Number (if known):

.

Device Name:

HI-TORQUE BALANCE™ Guide Wire with HYDROCOAT™ Hydrophilic Coating

ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating ...

Indications for Use:

The ACS HI-FORQUE BALANCE MIDDLEWEIGHTM Could Vire is a seeeeeble wite intended to facilitate the placement of balloon dilatation catheres during percurancous. intended to facilitate the placement of onliness on transitionin' angioplasy (PTA).
transluminal coronary angloplasy (PTCA) and perculances attensioning as atterectomy. IVUS transluminal coronary angloplash (r r Ca) and percedent such as atherectony, IVUS and
The wire is also intended to facilitate the passioned intravacular procedures, The wire is also intended to facinate die pracement of organism intravascular procedures.

(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) | OR | Over-The-Counter
(Optional Format 1-1-96) |

------------------------------------------	------------------------------------------	----------------------------------------------

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices	K973494
510(k) Number

510(k) Number