(122 days)
Not Found
Not Found
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
Therapeutic devices are those that treat a condition. This device is a guide wire used to facilitate the placement of other devices (balloon dilatation catheters), not to treat the condition itself. Therefore, it is not a therapeutic device.
No
Explanation: The device is described as a "steerable guide wire" used "to facilitate the placement of balloon dilatation catheters." Its function is entirely interventional, assisting in the delivery of other medical devices, not in diagnosing conditions.
No
The device description clearly outlines a physical guide wire constructed from stainless steel with various coatings and a radiopaque tip, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA)." This describes a procedure performed within the body (in vivo), not on samples taken from the body (in vitro).
- Device Description: The description details a physical guide wire designed to be inserted into the vasculature. This is consistent with an in-vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
IVD devices are specifically designed to be used in vitro 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 percutancous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The ACS HI-TORQUE CROSS-IT™ 400XT 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 tapcred 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. A hydrophilic coating is applied to the distal portion of the guide wire and the proximal section is coated with polytetrafluoroethylene.
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)
In vitro bench testing and in vivo performance evaluations were performed to demonstrate that the ACS HI-TORQUE CROSS-IT™ 400XT Guide Wires with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similar to the predicate devices. The following functional tests were performed: Tensile Strength, Torque Strength, Torqueability and Tip Flexibility Test.
The results from the tests demonstrated that the new ACS HI-TORQUE CROSS-IT™ 400XT Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent the predicate ACC HI-TORQUE CROSS-IT™ 300XT Guide Wire, the Wholey Hi-Torque Standard® 0.035" Guide Wire and the Commander, Standard, Steerable 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.
HI-TORQUE CROSS-IT™ 300XT Guide Wire with HYDROCOAT™ Hydrophilic Coating, Wholey Hi-Torque Standard® 0.035" Guide Wire, Commander, Standard, Steerable Guide Wire
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.
Not Found
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
1992169
OCT 28 1999
63
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 95054 |
| | Telephone: | 408-845-3995 |
| | Fax: | 408-845-3743 |
| | Contact Person: | Margaret Anderson |
| | Date Prepared: | July 20, 1999 |
| 2. | Device Trade Name: | HI-TORQUE CROSS-IT™ 400XT Guide Wire
with HYDROCOAT™ Hydrophilic Coating |
| | Device Common Name: | Guide Wire |
| | Device Classification Name: | Catheter Guide Wire (74DQX) |
| 3. | Predicate Device: | HI-TORQUE CROSS-IT™ 300XT Guide Wire
with HYDROCOAT™ Hydrophilic Coating |
| | | Wholey Hi-Torque Standard® 0.035" Guide Wire |
| | | Commander, Standard, Steerable Guide Wire |
4. Device Description:
The ACS HI-TORQUE CROSS-IT™ 400XT 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 tapcred 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. A hydrophilic coating is applied to the distal portion of the guide wire and the proximal section is coated with polytetrafluoroethylene.
- న్. Intended Use:
To facilitate the placement of balloon dilatation catheters during percutancous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
1
-
- Technological Characteristics:
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 modifications of the new guide wire compared to that of the predicate wire arc the coils and the dimensions of the core wire sections.
- Technological Characteristics:
-
- Performance Data:
In vitro bench testing and in vivo performance evaluations were performed to demonstrate that the ACS HI-TORQUE CROSS-IT™ 400XT Guide Wires with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similar to the predicate devices. The following functional tests were performed: Tensile Strength, Torque Strength, Torqueability and Tip Flexibility Test.
- Performance Data:
The results from the tests demonstrated that the new ACS HI-TORQUE CROSS-IT™ 400XT Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent the predicate ACC HI-TORQUE CROSS-IT™ 300XT Guide Wire, the Wholey Hi-Torque Standard® 0.035" Guide Wire and the Commander, Standard, Steerable 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, technological characteristics, performance properties, identical sterilization and packaging, and no new safety or effectiveness issues, the ACS HI-TORQUE CROSS-IT™ 400XT Guiler Guiler with HYDROCOAT™ Hydrophilic Coating may be considered substantially equivalent to the predicate ACS HI-TORQUE CROSS-IT™ 300XT Guide Wire with IIYDROCOAT™ Hydrophilic Coating, the Wholey Hi-Torque Standard® 0.035" Guide Wire and the Commander, Standard, Steerable Guide Wire.
- Conclusions:
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the three branches of government.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 28 1999
Ms. Margaret Anderson Regulatory Affairs Coordinator Guidant Corporation Vascular Intervention Group 3200 Lakeside Drive Santa Clara, CA 95054
K992169 Re :
R Frade Name: HI-TORQUE CROSS-IT™ 400XT Guide Wire with HYDROCOAT™ Hydrophilic Coating Requlatory Class: II Product Code: DQX Dated: September 13, 1999 Received: September 14, 1999
Dear Ms. 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 commerce prior of har ee that have been reclassified in accordance with rhe 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 A substantially equivalent determination assumes compliance with 895. 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 concerning your device in the
3
Page 2 - Ms. Margaret Anderson
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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" (21CFR 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,
Arthur A. Ciarlusli.
Jo, Wolf Sapirstein, M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
Device Name:
ACS HI-TORQUE CROSS-IT™ 400XT Guide Wire with HYDROCOAT™ Hydrophilic Coating
Indications for Use:
To facilitate the placement of balloon dilatation catheters during percutancous angin To facilitate the placement of banoon chalaton catherers and in all angloplasty
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)
*Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K992169
X Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter (Optional Format 1-1-96)