(80 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a guide wire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to facilitate the placement of other therapeutic devices (balloon dilatation catheters, stent devices) during therapeutic procedures (PTCA, PTA, other intravascular procedures), thereby playing a direct role in the therapeutic process.
No
The device is a guide wire used to facilitate the placement of other equipment during percutaneous transluminal coronary angioplasty (PTCA), percutaneous transluminal angioplasty (PTA), or other intravascular procedures, which are therapeutic interventions, not diagnostic ones. Although it mentions "other diagnostic or therapeutic intravascular procedures," the device itself is a tool for placement, not for diagnosis.
No
The device description clearly describes a physical guide wire with specific materials, dimensions, and coatings, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body to facilitate the placement of other medical devices during procedures like angioplasty. This is an in vivo application, not an in vitro (outside the body) diagnostic test.
- 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.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis. Its function is purely procedural – guiding other devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This guide wire does not fit that description.
N/A
Intended Use / Indications for Use
- To facilitate the placement of balloon dilatation catheters during . percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
- To facilitate the placement of equipment such as compatible stent . devices during other diagnostic or therapeutic intravascular procedures
Product codes
DOX
Device Description
The ACS HI-TORQUE ALL STAR™ 0.014" Guide Wire with Microglide® Coating is a steerable guide wire with a nominal diameter 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 is tapered to fit into the hypotube portion of the ACS DOC® Guide Wire Extension (K902755, cleared September 4, 1990). The proximal shaft of this guide wire is coated with polytetrafluoroethylene (PTFE) and the distal working end is coated with Microglide® Coating, a silicon based material. The distal end has a 3 cm, flexible, radiopaque tip that is provided either as a straight, shapeable configuration or as a preshaped J configuration. These guide wires have proximal markers at 90 and 100 cm from the distal tip.
Two features distinguish the new guide wire from the predicate guide wire: the addition of a segment of tetrafluoroethylene (TFE) shrink tubing around the distal portion of the guide wire proximal to the 3 cm tip and a more flexible 3 cm tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary vessels, cerebral vasculature (contraindicated)
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 ALL STAR™ 0.014" Guide Wire with Microglide Coating met acceptance criteria and performed similar to the predicate ACS HI-TORQUE EXTRA S'PORT™ 0.014" Guide Wire with Microglide "Coating. Four tests were performed as follows:
- . Distal Tip Pull Test
- . Distal Tip Turns-to-Failure Test
- . Rotational Accuracy Test
- Tip Flexibility Test .
In vivo animal testing in a canine model with healthy coronary arteries was performed to demonstrate performance properties of the ACS HI-TORQUE ALL STAR™ 0.014" Guide Wire in comparison to the predicate guide wire. The results showed that the ACS HI-TORQUE ALL STAR™ 0.014" Guide Wire performed in a manner equivalent to the ACS HI-TORQUE EXTRA S'PORT™ 0.014" Guide Wire.
The results from the four bench tests plus the animal testing showed that the new ACS HI-TORQUE ALL STAR™ Guide Wire met acceptance criteria and performed in a manner equivalent the predicate ACS HI-TORQUE EXTRA S'PORT™ 0.014″ 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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K 11011/2
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: | 26531 Ynez Road
Temecula, CA 92591-4628 | |
| | Telephone: | 909-914-2400 | AUG 25 1997 |
| | Fax: | 909-914-6690 | |
| | Contact Person: | Wayne R. Hohman | |
| | Date Prepared: | June 5, 1997 | |
| 2. | Device Trade Name: | ACS HI-TORQUE ALL STAR™ 0.014" Guide
Wire with Microglide® Coating | |
| | Device Common Name: | Guide Wire | |
| | Device Classification Name: | Catheter Guide Wire (74DQX) | |
| 3. | Predicate Device: | ACS HI-TORQUE EXTRA S'PORT™ 0.014"
Guide Wire with Microglide® Coating
(K950156, cleared April 5, 1995, and
K942066, cleared July 18, 1994) | |
Device Description: 4.
The ACS HI-TORQUE ALL STAR™ 0.014" Guide Wire with Microglide® Coating is a steerable guide wire with a nominal diameter 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 is tapered to fit into the hypotube portion of the ACS DOC® Guide Wire Extension (K902755, cleared September 4, 1990). The proximal shaft of this guide wire is coated with polytetrafluoroethylene (PTFE) and the distal working end is coated with Microglide® Coating, a silicon based material. The distal end has a 3 cm, flexible, radiopaque tip that is provided either as a straight, shapeable configuration or as a preshaped J configuration. These guide wires have proximal markers at 90 and 100 cm from the distal tip.
Two features distinguish the new guide wire from the predicate guide wire: the addition of a segment of tetrafluoroethylene (TFE) shrink tubing around the distal portion of the guide wire proximal to the 3 cm tip and a more flexible 3 cm tip.
-
- Intended Use:
The ACS HI-TORQUE ALL STAR™ 0.014" Guide Wire with Microglide® Coating has the following intended uses:
- Intended Use:
1
- To facilitate the placement of balloon dilatation catheters during . percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
- To facilitate the placement of equipment such as compatible stent . devices during other diagnostic or therapeutic intravascular procedures
The ACS HI-TORQUE ALL STAR™ 0.014" Guide Wire with Microglide Coating has the following contraindications:
- Use in cerebral vasculature. .
- . Use with atherectomy devices.
NOTE: The predicate guide wire is indicated for use with atherectomy devices; the new guide wire is contraindicated for use with atherectomy devices.
-
Technological Characteristics: 6.
Comparison of the new and predicate devices shows 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. Two design features distinguish the new guide wire: an added segment of tetrafluoroethylene (TFE) shrink tubing around the distal portion of the guide wire just proximal to the 3 cm tip and a more flexible 3 cm tip. The TFE shrink tubing provides a continuous working diameter of 0.014″ in this distal portion of the guide wire. The decreased coefficient of friction of the TFE layer facilitates movement of the guide wire within 0.014" devices. The more flexible tip is designed to be more atraumatic in coronary vessels. -
- Performance Data:
Bench testing was performed to demonstrate that the ACS HI-TORQUE ALL STAR™ 0.014" Guide Wire with Microglide Coating met acceptance criteria and performed similar to the predicate ACS HI-TORQUE EXTRA S'PORT™ 0.014" Guide Wire with Microglide "Coating. Four tests were performed as follows:
- Performance Data:
-
. Distal Tip Pull Test
-
. Distal Tip Turns-to-Failure Test
-
. Rotational Accuracy Test
-
Tip Flexibility Test .
2
In vivo animal testing in a canine model with healthy coronary arteries was performed to demonstrate performance properties of the ACS HI-TORQUE ALL STAR™ 0.014" Guide Wire in comparison to the predicate guide wire. The results showed that the ACS HI-TORQUE ALL STAR™ 0.014" Guide Wire performed in a manner equivalent to the ACS HI-TORQUE EXTRA S'PORT™ 0.014" Guide Wire.
The results from the four bench tests plus the animal testing showed that the new ACS HI-TORQUE ALL STAR™ Guide Wire met acceptance criteria and performed in a manner equivalent the predicate ACS HI-TORQUE EXTRA S'PORT™ 0.014″ Guide Wire. No new safety or effectiveness issues were raised during the testing program.
-
- Conclusions:
Since the new guide wire has the same intended use (minus the atherectomy indication), similar design and technological characteristics, no new materials, equivalent performance properties, identical sterilization and packaging, and no new safety or effectiveness issues, the ACS HI-TORQUE ALL STAR™ Guide Wire with Microglide® Coating may be considered substantially equivalent to the predicate ACS HI-TORQUE EXTRA S'PORT™ Guide Wire with Microglide Coating.
- Conclusions:
3
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Wayne R. Hohman Senior Regulatory Affairs Coordinator Guidant Corporation Advanced Cardiovascular Systems 26531 Ynez Road, P.O. Box 9810 Temecula, California 92591-4628
AUG 25 1997
K972142 Re: ACS HI-TORQUE ALL STAR™ 0.014" Guide Wire with Microglide® Coating Requlatory Class: II (two) Product Code: DOX Dated: June 5, 1997 Received: June 6, 1997
Dear Mr. Hohman:
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 895. A substantially equivalent determination assumes compliance 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 requlations.
4
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 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. Callahon
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
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ACS HI-TORQUE ALL STAR™ 0.014" Guide Wire with Microglide Coating
Indications for Use:
- . To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
- To facilitate the placement of equipment such as compatible stent devices . during other diagnostic or therapeutic intravascular procedures.
Contraindications:
- Use in cerebral vasculature. .
- . Use with atherectomy devices.
(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 |
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
| 510(k) Number | K972142 |
|---|---|
| --------------- | --------- |
(Optional Format 1-1-96)
120