(27 days)
Not Found
No
The description focuses on the physical construction and materials of a guide wire, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are bench and in vivo tests of mechanical properties.
No
The device is a guide wire used to facilitate the placement of balloon dilatation catheters, which are therapeutic devices. However, the guide wire itself is an accessory device used for placement, not for directly treating a medical condition.
No
Explanation: The device is described as a guide wire intended to facilitate the placement of balloon dilatation catheters. Its function is to aid in a medical procedure, not to diagnose a condition.
No
The device description clearly outlines a physical guide wire constructed from stainless steel with coatings and a radiopaque tip, 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 is to "facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA)." This describes a surgical/interventional procedure performed in vivo (within the body).
- Device Description: The description details a physical guide wire used to navigate within blood vessels. This is a medical device used for a procedural purpose, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a tool used directly within the body during a medical procedure.
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).
Product codes (comma separated list FDA assigned to the subject device)
DOX
Device Description
The ACS HI-TORQUE CROSS-IT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is a steerable guide wires with a maximum diameter of 0.014" 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, with varying core lengths and diameters for each design. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Notenc
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™ XT family of guide wires with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similar to the predicate devices. The following functional tests were performed: Distal Tip Pull Test, Distal Tip Turns-to-Failure Test, Rotational Accuracy Test and Tip Flexibility Test.
The results from the tests demonstrated that the new ACS HI-TORQUE CROSS-IT™ XT Guide Wires with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent the predicate ACS HI-TORQUE CROSS-IT™ 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.
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
3/25/99
32
ATTACHMENT 4
510(k) Summary
The 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. |
|-----------------------|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Submitter's
Address: | 3200 Lakeside Drive
Santa Clara, CA 95054 |
| | 3. Telephone: | 408-235-3995 |
| 4. | Fax: | 408-235-3743 |
| 5. | Contact Person: | Margaret Anderson |
| 6. | Date Prepared: | February 25, 1999 |
| 7. | Device Trade
Name: | • ACS HI-TORQUE CROSS-IT™ 100XT Guide Wire with
HYDROCOAT™ Hydrophilic Coating
• ACS HI-TORQUE CROSS-IT™ 200XT Guide Wire with
HYDROCOAT™ Hydrophilic Coating
• ACS HI-TORQUE CROSS-IT™ 300 XT Guide Wire with
HYDROCOAT™ Hydrophilic Coating |
| 8. | Device Common
Name: | Guide Wire |
| 9. | Device
Classification
Name: | Catheter Guide Wire (74DQX) |
| 10. Predicate Device: | | ACS HI-TORQUE CROSS-IT™ Guide Wire with
HYDROCOAT™ Hydrophilic Coating (K981381) |
| | | ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide
Wire with HYDROCOAT™ Hydrophilic Coating (K982083) |
| | | Commander, Standard, Steerable Guide Wire; C.R. Bard, Inc.
(K961271) |
1
-
- Device Description:
The ACS HI-TORQUE CROSS-IT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is a steerable guide wires with a maximum diameter of 0.014" 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, with varying core lengths and diameters for each design. 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.
- Device Description:
-
- Intended Use:
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
- Intended Use:
-
- 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 wires compared to that of the predicate wire are the lengths and diameters of the core wire sections. The 300XT design is manufactured with a gold solder.
- Technological Characteristics:
- Performance Data:
In vitro bench testing and in vivo performance evaluations were performed to demonstrate that the ACS HI-TORQUE CROSS-IT™ XT family of guide wires with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similar to the predicate devices. The following functional tests were performed: Distal Tip Pull Test, Distal Tip Turns-to-Failure Test, Rotational Accuracy Test and Tip Flexibility Test.
The results from the tests demonstrated that the new ACS HI-TORQUE CROSS-IT™ XT Guide Wires with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent the predicate ACS HI-TORQUE CROSS-IT™ and the Commander, Standard, Steerable Guide Wire. No new safety or effectiveness issues were raised during the testing program.
2
15. 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™ 100XT, 200XT and 300XT Guide Wires with HYDROCOAT™ Hydrophilic Coating may be considered substantially equivalent to the predicate ACS HI-TORQUE CROSS-IT™ Guide Wires with HYDROCOAT™ Hydrophilic Coating, the ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating and the Commander, Standard, Steerable Guide Wire.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 1999
Ms. Marqaret Anderson Requlatory Affairs Coordinator Guidant Corporation Vascular Intervention Group 3200 Lakeside Drive Santa Clara, CA 95054
Re: K990639
ACS HI-TORQUE CROSS-IT™ 100XT, 200XT and 300XT Guide Trade Name: Wires with HYDROCOAT™ Hydrophilic Coating Requlatory Class: II Product Code: DOX Dated: February 25, 1999 Received: February 26, 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 leqally 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 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 Requlation (QS) for Medical Devices: General requlation (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 requlatory action. In addition, FDA may publish further announcements concerning
4
Page 2 - Ms. Margaret Anderson
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.
This letter will allow you to begin marketing your device as described in vour 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,
Thomas J. Callahan
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
ATTACHMENT 2
Indications for Use Statement 510(k) Number (if known) ACS HI-TORQUE CROSS-IT™ 100XT Guide Wire with HYDROCOAT™ Device Name Hydrophilic Coating ACS HI-TORQUE CROSS-IT™ 200XT Guide Wire with HYDROCOAT™ Hydrophilic Coating ACS HI-TORQUE CROSS-IT™ 300XT Guide Wire with HYDROCOAT™ Hydrophilic Coating The ACS HI-TORQUE CROSS-IT™ 100XT, 200XT and 300XT Guide Wire Indications for with HYDROCOAT™ Hydrophilic Coating family of guide wires' intended Use use is: 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)
المل المستمبر المسلم المستمبر المسلمين والمسلمين المستقل المستقل المستوى المستوى المستوى المستوى المستقل المستقل المستقل المستوى المستوى المستوى المستقل المستقل المستقل المس Prescription Use __
Use (Per 21 CFR 801.109)
OR Over-The-Counter
(Division Sign-Off)
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K990639 510(k) Number_
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