(90 days)
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
The ACS HI-TORQUE CROSS-IT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is a steerable guide wires with a nominal diameter of 014" and available in: 175 cm and 190 cm extendable lengths 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. The wire is constructed from a stainless steel core wire. The distal end of the guide wire has a radiopaque tip that are available either as a straight or as a preshaped J. The hydrophilic coating is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with polytetrafluoroethylene.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ACS HI-TORQUE CROSS-IT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating:
Device: ACS HI-TORQUE CROSS-IT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Distal Tip Pull Test | Not explicitly stated, implied to be comparable to the predicate device. | "met the acceptance criteria and performed similar to the predicate HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating." "performed in a manner equivalent the predicate ACS HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating." |
| Distal Tip Turns-to-Failure Test | Not explicitly stated, implied to be comparable to the predicate device. | "met the acceptance criteria and performed similar to the predicate HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating." "performed in a manner equivalent the predicate ACS HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating." |
| Rotational Accuracy Test | Not explicitly stated, implied to be comparable to the predicate device. | "met the acceptance criteria and performed similar to the predicate HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating." "performed in a manner equivalent the predicate ACS HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating." |
| Tip Flexibility Test | Not explicitly stated, implied to be comparable to the predicate device. | "met the acceptance criteria and performed similar to the predicate HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating." "performed in a manner equivalent the predicate ACS HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating." |
Note on Acceptance Criteria: The document implies that the acceptance criteria for the new device were to perform similarly or equivalently to the predicate device (HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating) in these specific bench tests. The exact quantitative thresholds for "acceptance" are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified. The document only states "Bench testing was performed."
- Data Provenance: The origin of the data (e.g., country) is not specified. The testing described is "bench testing," which implies laboratory-based, non-clinical data. It is therefore prospective in nature, as the tests were conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. This device is a guide wire, and the testing described is bench testing of its physical and mechanical properties against a predicate device. There is no "ground truth" in the clinical sense established by human experts for this type of test. The ground truth essentially rests on the established performance characteristics of the predicate device.
4. Adjudication Method for the Test Set:
Not applicable. As described above, this was bench testing of physical properties, not a clinical study requiring adjudication of expert opinions.
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:
Not applicable. This document describes the clearance of a medical device (guide wire), not an AI-powered diagnostic tool. Therefore, an MRMC study and AI assistance metrics are not relevant.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI device. The "performance" being discussed is the physical performance of a guide wire.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context is the established performance characteristics and safety profile of the predicate device, the HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating. The new device was tested to demonstrate equivalent performance to this predicate.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. (See #8)
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APPENDIX V
510(k) SUMMARY
·
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510(k) SUMMARY
This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.
| 1. | Submitter's Name: | Guidant CorporationAdvanced Cardiovascular Systems, Inc. |
|---|---|---|
| Submitter's Address: | 3200 Lakeside DriveSanta Clara, CA 95054 | |
| Telephone: | 408-235-3995 | |
| Fax: | 408-235-3743 | |
| Contact Person: | Margaret Anderson | |
| Date Prepared: | April 15, 1998 | |
| 2. | Device Trade Name: | HI-TORQUE CROSS-IT™ Guide Wire withHYDROCOAT™ Hydrophilic Coating |
| Device Common Name: | Guide Wire | |
| Device Classification Name: | Catheter Guide Wire (74DQX) | |
| 3. | Predicate Device: | HI-TORQUE TRAVERSE® Guide Wire withHYDROCOAT™Hydrophilic Coating |
-
- Device Description:
The ACS HI-TORQUE CROSS-IT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is a steerable guide wires with a nominal diameter of 014" and available in:
- Device Description:
175 cm and 190 cm extendable lengths 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. The wire is constructed from a stainless steel core wire. The distal end of the guide wire has a radiopaque tip that are available either as a straight or as a preshaped J. The hydrophilic coating is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with polytetrafluoroethylene.
- న. Intended Use:
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
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Technological Characteristics: 6.
Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties, sterilization, and packaging are identical or substantially equivalent to the currently marketed predicate devices. The design feature that distinguishes the new guide wires from that of the predicate wires is the tapered distal coil. -
- Performance Data:
Bench testing was performed to demonstrate that the ACS HI-TORQUE CROSS-ITTM Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similar to the predicate HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating. The following tests were performed: Distal Tip Pull Test, Distal Tip Turns-to-Failure Test, Rotational Accuracy Test and Tip Flexibility Test.
- Performance Data:
The results from the bench tests showed that the new ACS HI-TORQUE CROSS-ITTM Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent the predicate ACS HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating. No new safety or effectiveness issues were raised during the testing program.
-
- Conclusions:
Since the new guide wires have the same intended use, technological characteristics, performance properties, identical sterilization and packaging, and no new safety or effectiveness issues, the ACS HI-TORQUE CROSS-IT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating may be considered substantially equivalent to the predicate ACS HI-TORQUE TRAVERSE® Guide Wires with HYDROCOAT™ Hydrophilic Coating.
- Conclusions:
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Image /page/3/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 5 1998
Ms. Margaret Anderson Guidant Corporation 3200 Lakeside Drive P.O. Box 58167 Santa Clara, CA 95052-8167
K981381 Re: ACS HI-TORQUE CROSS-IT™ Guide Wire with HYDROCOAT™ Coating Requlatory Class: II (two) Product Code: 74 DQX Dated: April 15, 1998 Received: April 16, 1998
Dear Mr. 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 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 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 requlations 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 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 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 - Ms. Margaret Anderson
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 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. C allahan, 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
510(k) Number (if known):
Device Name:
ACS HI-TORQUE CROSS-IT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating
Indications for Use:
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tien A Re
(Division Sign-Off) (Division Sign Off, Only)
Division of Cardiovascular, Respiratory, and Neurological Devices 19981.58 510(k) Number _
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter (Optional Format 1-1-96)
§ 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.