(128 days)
No
The description focuses on the physical construction and material properties of a guide wire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a guide wire intended to facilitate the placement of other therapeutic devices (like balloon dilatation catheters, atherectomy, and stent devices) but does not directly perform a therapeutic action itself.
No
The device is a steerable guide wire intended to facilitate placement of other medical devices during diagnostic and therapeutic intravascular procedures, not to perform diagnostics itself.
No
The device description clearly details the physical construction of a guide wire, including materials, coatings, and a radiopaque tip. This indicates a hardware-based medical device, not a software-only one.
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, stents) within the patient's vascular system during procedures like PTCA and PTA.
- Device Description: The description details the physical construction of the guide wire, its coatings, and its radiopaque tip. These are all characteristics of a device used in vivo (within a living organism).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing on samples.
The device is an invasive medical device used for interventional procedures within the body.
N/A
Intended Use / Indications for Use
The HI-TORQUE IRON MAN™ 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.
Product codes
Not Found
Device Description
The HI-TORQUE IRON MAN™ 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, vields the desired tip flexibility. The distal 12 to 15 centimeters proximal to the tip of the ACS HI-TOROUE IRON MAN™ Guide Wire are coated with Microglide® 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. The platinum alloy coils provide the physicians with a radiopaque tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The cerebral vasculature (not intended for use in)
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)
In vivo Testing:
Two animal studies were completed to evaluate and compare the performance of the ACS HI-TORQUE IRON MAN™ Guide Wire to that of the ACS Hi-Torque Extra S'Port™ Guide Wire (K942066, July 18, 1994 and K950156, April 5, 1995) and the Boston Scientific Corporation .014" Platinum Plus Guide Wire (K935997, June 17, 1994), when used in combination with the JJIS Stent Delivery System, ACS TX 2000 Balloon Dilatation Catheter and the DVI AtheroCath-GTO Atherectomy Catheter. The results of these studies show that the ACS HI-TOROUE IRON MAN™ Guide Wire as well as or better than the S'Port and Platinum Plus wires in the majority of the performance parameters when used with the GTO catheter, TX 2000 catheter and the JJIS Stent Delivery System.
Bench Testing
The tensile strengths of the guide wire distal tip were determined by a pull test. These tests demonstrated that the HI-TORQUE IRON MAN™ Guide Wire has adequate tensile strength.
The torsional strength of the distal tip was determined by a turns-to-failure test. This test showed that the HI-TORQUE IRON MAN™ 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-TOROUE IRON MAN™ Guide Wire has an adequate torque response.
The tip flexibility testing demonstrated that tip flexibility of the ACS HI-TORQUE IRON MAN™ Guide Wire is equivalent to that of the predicate and is acceptable.
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.
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GUIDANT
JAN 2 2 1997
963702
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 IRON MAN TM 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.
ACS HI-TORQUE EXTRA IRON MANTM Guide Wire
The HI-TORQUE IRON MAN™ 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, vields the desired tip flexibility. The distal 12 to 15 centimeters proximal to the tip of the ACS HI-TOROUE IRON MAN™ Guide Wire are coated with Microglide® 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. The platinum alloy coils provide the physicians with a radiopaque tip.
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5. Summary of Substantial Equivalence:
A comparison of the ACS HI-TORQUE IRON MAN™ Guide Wire to the predicate ACS Hi-Torque Extra S'Port™ Guide Wire (K942066, July 18, 1994 and K950156. April 5. 1995). indicates that the new guide wire is substantially equivalent to the predicate guide wire with regard to the intended use, materials and design. In addition, the ACS HI-TOROUE IRON MAN™ is substantially equivalent to the Boston Scientific Corporation .014" Platinum Plus™ Guide Wire with regard to the functional dimensions of rotational accuracy and tip flexibility.
The HI-TORQUE IRON MAN™ 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 intended use of the HI-TOROUE IRON MAN™ Guide Wire is equivalent to the predicate guide wires noted above.
The materials used in the manufacture of the HI-TORQUE IRON MAN™ Guide Wire are identical to those in the predicate Hi-Torque Extra S'Port™ Guide Wire.
The design of the new ACS HI-TOROUE IRON MAN™ Guide Wire is constructed from a stainless steel core wire. Like the predicate ACS Hi-Torque Extra S'Port™ 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. Like the predicate ACS Hi-Torque Extra S'Port™ guide wire the intermediate coils are eliminated in the new design. Unlike the ACS Hi-Torque Extra S'Port™ Guide Wire, the ACS HI-TOROUE IRON MAN™ 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, the ACS Hi-Torque Extra S'Port™ Guide 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.
Testing Data: 6.
Biocompatibility
Since the materials for the HI-TORQUE IRON MAN™ Guide Wire are identical to those of the predicate Hi-Torque Extra S'Port™ Guide Wire, the biocompatibility data from the predicate device were used to demonstrate that the
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materials and processes utilized in the new guide wire are biocompatible for short term use within the vascular system.
In vivo Testing:
Two animal studies were completed to evaluate and compare the performance of the ACS HI-TORQUE IRON MAN™ Guide Wire to that of the ACS Hi-Torque Extra S'Port™ Guide Wire (K942066, July 18, 1994 and K950156, April 5, 1995) and the Boston Scientific Corporation .014" Platinum Plus Guide Wire (K935997, June 17, 1994), when used in combination with the JJIS Stent Delivery System, ACS TX 2000 Balloon Dilatation Catheter and the DVI AtheroCath-GTO Atherectomy Catheter. The results of these studies show that the ACS HI-TOROUE IRON MAN™ Guide Wire as well as or better than the S'Port and Platinum Plus wires in the majority of the performance parameters when used with the GTO catheter, TX 2000 catheter and the JJIS Stent Delivery System.
Bench Testing
The tensile strengths of the guide wire distal tip were determined by a pull test. These tests demonstrated that the HI-TORQUE IRON MAN™ Guide Wire has adequate tensile strength.
The torsional strength of the distal tip was determined by a turns-to-failure test. This test showed that the HI-TORQUE IRON MAN™ 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-TOROUE IRON MAN™ Guide Wire has an adequate torque response.
The tip flexibility testing demonstrated that tip flexibility of the ACS HI-TORQUE IRON MAN™ Guide Wire is equivalent to that of the predicate and is acceptable.
7. Sterilization:
The ACS HI-TORQUE IRON MAN™ Guide Wire is sterilized by the same methods and following the same parameters as those used for the predicate ACS Hi-Torque Extra S'Port™ Guide Wire (K942066, 7/18/94 and K950156, 4/5/95).
8. Conclusion:
The HI-TORQUE IRON MAN™ Guide Wire is substantially equivalent to the predicate ACS Hi-Torque Extra S'Port™ Guide Wire (K942066, 4/28/94 and
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K950156, 1/16/95) and the Boston Scientific Corporation .014" Platinum Plus™ Guide Wire (K935997, 6/17/94).
Signed:
Kevin Corrigan
Kevin Corrigan Manager, Regulatory Affairs
· .