(90 days)
The ACS HI-TORQUE RULER™ Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA), or percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of equipment, such as compatible stent devices, during other diagnostic and therapeutic intravascular procedures. It should not be used with atherectomy devices. It is not intended for use in the cerebral vasculature.
The ACS HI-TORQUE RULER™ 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), and other diagnostic and therapeutic intravascular procedures. It is not intended for use in the cerebral vasculature or for use with atherectomy devices.
The proximal and distal portions of the guide wire are constructed from a core assembly. A series of tapers, which reduce the diameter of the core wire distally, yields the desired tip flexibility. The distal 30 centimeters proximal to the tip of the ACS HI-TOROUE RULER™ 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.
This document describes the safety and effectiveness of the ACS HI-TORQUE RULER™ Guide Wire. The device is found substantially equivalent to predicate devices. The submission focuses on bench testing, biocompatibility testing, and animal testing to demonstrate performance.
Here's an analysis of the provided information, framed by your requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for a medical device (guide wire) and not an AI/software device, the "acceptance criteria" are not framed in terms of precision, recall, or other machine learning metrics. Instead, they are related to physical and biological performance attributes of the guide wire. The "reported device performance" are the results of the specific tests conducted.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Non-cytotoxic | Non-cytotoxic |
| Biocompatibility: Non-hemolytic | Non-hemolytic |
| Biocompatibility: Pass systemic injection test | Pass |
| Biocompatibility: Pass intracutaneous test | Pass |
| Biocompatibility: Pass intramuscular implant | Pass |
| Biocompatibility: Pass sensitization test | Pass |
| Biocompatibility: Non-pyrogenic | Non-pyrogenic |
| Bench Testing: Acceptable polyimide adhesion | Acceptable strength of polyimide adhesive (by pull test) |
| Bench Testing: Acceptable laser weld strength | Acceptable strength of laser weld on platinum bands (by pull test) |
| Bench Testing: Adequate tensile strength | Adequate tensile strength of distal tip (by pull test) |
| Bench Testing: Adequate torsional tip strength | Adequate torsional tip strength (by turns-to-failure test) |
| Bench Testing: Acceptable tip flexibility | Equivalent tip flexibility to predicate and acceptable |
| Bench Testing: 1:1 torque response | 1:1 torque response (by rotational accuracy test) |
| Animal Testing: Acceptable clinical performance | Acceptable clinical performance in compatible balloon dilatation catheters and stent delivery devices (after Microglide® application improvement) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size (for Bench and Biocompatibility): Not specified in terms of number of units tested for each individual test. The document generally states "These tests demonstrated..." without providing specific counts.
- Test Set Sample Size (for Animal Testing): "two subsequent animal studies" were performed. The number of animals or procedures within those studies is not specified.
- Data Provenance: The tests are likely performed by the manufacturer (Guidant Corporation / Advanced Cardiovascular Systems) in a laboratory setting. The country of origin for the data is not explicitly stated, but given the company's location (Santa Clara, California) and submission to the FDA, it's highly probable the data was generated in the United States. The testing is prospective for the specific device being submitted, as it was conducted specifically to gather data for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to a physical device submission like this.
- For Biocompatibility: Expert interpretation of test results would be performed by toxicologists, biologists, or lab personnel following established standards (e.g., ISO 10993). The number and qualifications of these experts are not provided.
- For Bench Testing: Engineers and material scientists would interpret the results against pre-defined engineering specifications. The number and qualifications are not provided.
- For Animal Testing: Veterinarians and possibly interventional cardiologists/radiologists (or equivalent in animal models) would assess clinical performance. The number and qualifications are not provided.
4. Adjudication Method for the Test Set
This is not applicable in the context of device performance testing as described. Adjudication methods (like 2+1) are typically used for establishing ground truth in medical image analysis or clinical endpoint assessment with multiple human readers. Here, the "ground truth" is defined by objective physical/chemical measurements or observed biological reactions.
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
This section is not applicable. This submission is for a physical medical device (guide wire), not an AI/software device, and therefore no MRMC studies or AI assistance are part of its evaluation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
- For Biocompatibility: The "ground truth" is established by adherence to recognized biocompatibility standards and test methodologies (e.g., ISO 10993 series), which define what constitutes "non-cytotoxic," "non-hemolytic," "pass," etc. These are objective measures against established biological thresholds.
- For Bench Testing: The "ground truth" is established by engineering specifications and industry standards. For example, a pull test result is compared against a minimum tensile strength requirement, or a torque response is objectively measured.
- For Animal Testing: The "ground truth" is established through direct observation of the device's function and biological response in vivo, assessed by veterinary and medical professionals, following pre-defined endpoints for "acceptable clinical performance." This likely involves qualitative and quantitative assessments during the animal procedures.
8. The Sample Size for the Training Set
This section is not applicable as this is a physical device submission, not an AI/machine learning model submission. There is no "training set" in this context.
9. How the Ground Truth for the Training Set was Established
This section is not applicable as there is no training set.
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SEP | 7 |997
APPENDIX VI
SUMMARY OF SAFETY AND EFFECTIVENESS
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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.
- ACS HI-TORQUE RULER™ Guide Wire Trade Name: 1. Guide Wire Common Name:
-
- Device Classification: Vascular guide wire
Performance Standards: 3.
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 RULER™ Guide Wire
The ACS HI-TORQUE RULER™ 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), and other diagnostic and therapeutic intravascular procedures. It is not intended for use in the cerebral vasculature or for use with atherectomy devices.
The proximal and distal portions of the guide wire are constructed from a core assembly. A series of tapers, which reduce the diameter of the core wire distally, yields the desired tip flexibility. The distal 30 centimeters proximal to the tip of the ACS HI-TOROUE RULER™ 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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న. Summary of Substantial Equivalence:
A comparison of the ACS HI-TORQUE RULER™ Guide Wire to the predicate ACS Hi-Torque Extra S'Port™ (K942066 and K950156) indicates that the new guide wire is substantially equivalent to the predicate guide wire with regard to the intended use, materials and design.
The ACS HI-TOROUE RULER™ 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), and other diagnostic and therapeutic intravascular procedures. It is not intended for use in the cerebral vasculature or for use with atherectomy devices. The intended use of the ACS HI-TOROUE RULER™ Guide Wire is equivalent to the predicate guide wire noted above.
The materials used in the manufacture of the ACS HI-TORQUE RULER™ Guide Wire are similar to those in the predicate ACS Hi-Torque Extra S'Port™
The design of the new ACS HI-TORQUE RULER™ Guide Wire is constructed from a stainless steel core wire which extends into the distal-most solder of the guide wire. This feature is identical to that of the .014" ACS Hi-Torque Extra S'Port™ Guide 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-TORQUE RULER™ Guide Wire contains a series of Pt/Ir radiopaque bands attached onto the core wire using laser heat. Also, a polyimide tubing has been added to the intermediate portion of the core wire extending from the proximal end of the tip coil to the distal portion of the proximal taper. Additionally, proximal markers created by stripping and cleaning areas of Teflon are positioned at 90 cm and 100 cm from the distal tip of the guide wire. These proximal markers aid the physician in gauging wire position relative to a brachial or femoral guiding catheter tip when using a "bare wire" technique.
Testing Data: 6.
Biocompatibility
Materials for the ACS HI-TORQUE RULER™ Guide Wire are identical to those of the predicate ACS Hi-Torque Extra S'port™ Guide Wire, with the exception of the addition of Pt/Ir bands and polyimide tubing. Therefore,
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biocompatibility testing was completed on the ACS HI-TORQUE RULER™ Guide Wire. The results of this testing sre summarized below:
| Test Completed | Results |
|---|---|
| Cytotoxicity Test | Non-cytotoxic |
| Hemolysis | Non-hemolytic |
| Systemic Injection Test | Pass |
| Intracutaneous Test | Pass |
| Intramuscular Implant Test | Pass |
| Sensitization Test | Pass |
| LAL Pyrogen Test | Non-pyrogenic |
Bench Testing
The strength of the polyimide adhesion of the ACS HI-TORQUE RULER™ Guide Wire was determined by a pull test. These tests demonstrated that the strength of the polyimide adhesive of the ACS HI-TORQUE RULER™ Guide Wire is acceptable.
The strength of the laser weld of the platinum bands on the ACS HI-TORQUE RULERTM Guide Wire was determined by a pull test. These tests demonstrated that the strength of the laser weld on the platinum bands on the ACS HI-TORQUE RULER™ Guide Wire is acceptable.
The tensile strengths of the guide wire distal tip were determined by a pull test. These tests demonstrated that the ACS HI-TORQUE RULER™ 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 ACS HI-TORQUE RULER™ Guide Wire has adequate torsional tip strength.
The tip flexibility testing demonstrated that tip flexibility of the ACS HI-TORQUE RULER™ Guide Wire is equivalent to that of the predicate and is acceptable.
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 RULER™ Guide Wire has 1:1 torque response.
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Animal Testing
Initial animal testing identified an issue related to guide wire movement of the RULER™ wire within interventional devices. This problem was determined to be a result of inadequate Microglide® application to the polyimide sheath on the distal portion of the wire. An improved Microglide® application process was implemented and two subsequent animal studies confirmed that the RULER™ guide wire has acceptable clinical performance in compatible balloon dilatation catheters and stent delivery devices. However, using the RULER™ wire with atherectomy devices is not indicated since the polyimide sheath may become caught and/or impede the cutter of the device. Therefore, the ACS HI-TORQUE RULER™ Guide Wire is contraindicated for use with atherectomy devices.
Sterilization: 7.
The ACS HI-TORQUE RULER™ 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, 4/28/94 and K950156, 1/16/95).
Conclusion: 8.
The ACS HI-TORQUE RULER™ Guide Wire is substantially equivalent to the predicate ACS Hi-Torque Extra S'Port™ Guide Wire (K942066, 4/28/94 and K950156, 1/16/95).
Signed:
Duran Silveira
Susan Silavin, Ph.D. Regulatory Affairs Coordinator
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle symbol with three lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 1997
Susan Silavin, Ph.D. Guidant Corporation c/o Advanced Cardiovascular Systems 3200 Lakeside Drive P.O. Box 58167 Santa Clara, California 95052-8167
K972290 Re: ACS HI-TORQUE RULER™ Guide Wire Requlatory Class: II (two) Product Code: 74 DQX Dated: June 18, 1997 Received: June 19, 1997
Dear Dr. Silavin:
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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance 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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Page 2 - Susan Silavin, Ph.D.
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) 594-4639. 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. Callehan
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
K972290 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ACS HI-TORQUE RULER™ Guide Wire
Indications for Use:
The ACS HI-TORQUE RULER™ Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA), or percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of equipment, such as compatible stent devices, during other diagnostic and therapeutic intravascular procedures. It should not be used with atherectomy devices. It 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)
| 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
510(k) Number____K 972290
§ 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.