(87 days)
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.
No.
The device is a guide wire, which is a tool used to facilitate the placement of other therapeutic devices (like balloon dilatation catheters and stent devices) and diagnostic equipment. It does not perform a direct therapeutic action itself.
No.
The device is a steerable guide wire intended to facilitate the placement of other medical equipment during intravascular procedures, including diagnostic procedures, but it does not perform diagnostic functions itself.
No
The device description clearly details a physical guide wire with specific dimensions, materials (hydrophilic coating, PTFE), and physical characteristics (radiopaque tip, straight or J tip). There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a guide wire used to facilitate the placement of other devices (balloon catheters, atherectomy devices, stent devices) during intravascular procedures. This is a surgical or interventional device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the physical characteristics of a guide wire used within the body.
- Performance Studies: The performance studies involve bench testing and in vivo animal testing, focusing on the physical and functional performance of the guide wire within a biological system, not on the analysis of biological samples.
IVD devices are used to perform tests on samples like blood, urine, tissue, etc., outside of the body to diagnose or monitor conditions. This guide wire is used inside the body during a medical procedure.
N/A
Intended Use / Indications for Use
The a ACS HI-TORQUE® SUPER S'PORT™ 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 and compatible stent devices during other diagnostic and therapeutic intravascular procedures.
Product codes (comma separated list FDA assigned to the subject device)
74DQX, DQX
Device Description
The ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is a steerable guide wire 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, September 4, 1990).
The ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating has a radiopaque tip and is are available with either a straight tip configuration, which allows the physician to shape the guide wire tip in a preferred shape, or a pre-shaped "J" tip configuration, which allows the physician the convenience using a guide wire with the tip pre-shaped.
The hydrophilic coating is intended to facilitate wire movement within 0.014" diameter devices. The proximal shaft of the ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is coated with polytetrafluoroethylene (PTFE).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed to demonstrate that the ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similar to the predicate ACS HI-TORQUE® IRON MAN™ 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
- Coating Adherence/Integrity .
In vivo animal testing in a canine model with healthy coronary arteries was performed to demonstrate performance properties of the the ACS HI-TORQUE® SUPER S'PORT™ 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 ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating met acceptance criteria and performed in a manner equivalent the ACS HI-TORQUE® IRON MAN™ Guide Wire. No new safety or effectiveness issues were raised during the testing program.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
APR 2 4 1998
4980294
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. | |||
| Submitter's Address: | 3200 Lakeside Drive | ||
| Santa Clara, CA 95052 | |||
| Telephone: | 408-235-3480 | ||
| Fax: | 408-235-3743 | ||
| Contact Person: | David Kolesar | ||
| Date Prepared: | January 26, 1998 | ||
| 2. | Device Trade Name: | ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with | |
| HYDROCOAT™ Hydrophilic Coating ACS HI-TORQUE® | |||
| Device Common Name: | Guide Wire | ||
| Device Classification Name: | Catheter Guide Wire (74DQX) | ||
| 3. | Predicate Device: | ACS HI-TORQUE® IRON MAN™ Guide Wire (K963702) | |
| ACS HI-TORQUE®BALANCE™ Guide Wire with | |||
| HYDROCOAT™ Hydrophilic Coating (K973494) |
4. Device Description:
The ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is a steerable guide wire 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, September 4, 1990).
The ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating has a radiopaque tip and is are available with either a straight tip configuration, which allows the physician to shape the guide wire tip in a preferred shape, or a pre-shaped "J" tip configuration, which allows the physician the convenience using a guide wire with the tip pre-shaped.
The hydrophilic coating is intended to facilitate wire movement within 0.014" diameter devices. The proximal shaft of the ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is coated with polytetrafluoroethylene (PTFE).
131
1
-
న. Intended Use:
The the ACS HI-TORQUE® SUPER S'PORT™ 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 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
-
- Performance Data:
Bench testing was performed to demonstrate that the ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similar to the predicate ACS HI-TORQUE® IRON MAN™ Guide Wire. The following tests were performed:
- Performance Data:
-
Accelerated Aging .
-
. Distal Tip Pull Test
-
. Distal Tip Turns-to-Failure Test
-
. Rotational Accuracy Test
-
. Tip Flexibility 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 the ACS HI-TORQUE® SUPER S'PORT™ 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 ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating met acceptance criteria and performed in a manner equivalent the ACS HI-TORQUE® IRON MAN™ 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 the ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating may be considered substantially equivalent to the ACS HI-TORQUE® IRON MAN™ Guide Wire.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines representing hair or movement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 4 1998
Mr. David Kolesar Senior Regulatory Affairs Coordinator Guidant Corporation 3200 Lakeside Drive Santa Clara, CA 95052
Re: K980294 ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with Trade Name: Hydrocoat™ Hydrophilic Coating Requlatory Class: II Product Code: DQX January 26, 1998 Dated: Received: January 27, 1998
Dear Mr. Kolesar:
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 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). 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 reqistration, 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 Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with 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 regulatory action. In addition, FDA may publish further announcements
4
Page 2 - Mr. Melinyshyn
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.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callaman, Ph.D. Director Division of Cardiovascular, Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATION FOR USE STATEMENT
DEVICE NAME:
ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with Hydrocoat™ Hydrophilic Coating
INDICATIONS FOR USE:
The ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with Hydrocoat™ Hydrophilic Coating is steerable wire intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
The ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with Hydrocoat™ Hydrophilic Coating is also intended to facilitate the placement of equipment, such as atherectomy and stent devices, during other diagnostic and therapeutic intravascular procedures.
CONTRAINDICATIONS:
The ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with Hydrocoat™ Hydrophilic Coating is not intended for use in the cerebral vasculature.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Div. of Cardiovascular, Respiratory, | |
| and Neurological Devices | |
| 510(k) Number | K980294 |
| Prescription Use
(Per 21 CFR 801.109 | OR | Over-The-Counter
(Optional Format 1-1-96) |
|----------------------------------------------------------------------------------|----|----------------------------------------------|
| | | |