(88 days)
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 capabilities.
No
The device is a guide wire used to facilitate the placement of other therapeutic devices (balloon dilatation catheters and stents) during intravascular procedures, rather than providing therapy itself.
No
Explanation: The device, a guide wire, is used to facilitate the placement of other medical devices (balloon dilatation catheters, stent devices) during therapeutic procedures. Its function is primarily interventional/therapeutic, not to diagnose a condition.
No
The device description clearly describes a physical guide wire with specific dimensions, materials (hydrocoat, PTFE), and configurations (straight, "J" shape). It is a tangible medical device, not software.
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 catheters and stent devices during therapeutic intravascular procedures. This is a surgical or interventional procedure, not a diagnostic test performed on samples taken from the body (which is the definition of in vitro diagnostics).
- Device Description: The device is a guide wire, which is a tool used to navigate within blood vessels. This is a medical device used directly on or in the patient, not a reagent, instrument, or system intended for use in the examination of specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances in samples, or providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a medical device used for interventional procedures, not an in vitro diagnostic device.
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). The wire is also intended to facilitate the placement of compatible stent devices during therapeutic intravascular procedures.
Product codes
DQX
Device Description
The HI-TORQUE BALANCE UNIVERSALIM Guide Wire is a steerable guide wire available in a maximum diameter of 0.0137" and in lengths of 175 cm, 190 cm and 300 cm. The distal segment of the guide wire, up to the hypotube, is coated with hydrocoat to reduce friction for improved guide wire movement within the catheter. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The proximal core has a maximum diameter of 0.0137". The proximal end of the guide wire is coated with PTFE, which reduces friction of the wire within a catheter. The Balance Universal™ Guide Wire is DOC® extendable in the 175 cm and 190 cm lengths.
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 performance evaluations demonstrated that the HI-TORQUE BALANCE UNIVERSAL™ Guide Wire met the acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing program and therefore, the HI-TORQUE BALANCE UNIVERSAL™ Guide Wire may be considered substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
AUG 2 6 2003
510(k) SUMMARY
The 510(k) Summary is submitted in accordance with 21 CFR §807.92 and the requirements of the SMDA of 1990.
| 1. Submitter's Name: | Guidant Corporation |
|---|---|
| Vascular Intervention | |
| 2. Submitter's Address: | 26531 Ynez Road |
| 3. Telephone: | (909) 914-2676 |
| 4. Fax: | (909) 914-0339 |
| 5. Contact Person: | Bruce Cerwin |
| 6. Date Prepared: | May 28, 2003 |
| 7. Device Trade Name: | HI-TORQUE BALANCE UNIVERSAL™ Guide |
| Wires with Hydrocoat Hydrophilic Coating | |
| 8. Device Common Name: | Guide Wire |
| 9. Device Classification Name: | Catheter Guide Wire (74DQX) |
| 10. Predicate Device: | HI-TORQUE BALANCE MIDDLEWEIGHT (BMW) |
| UNIVERSAL™ Guide Wire with Hydrocoat | |
| Hydrophilic Coating (K013833) |
11. Device Description:
The HI-TORQUE BALANCE UNIVERSALIM Guide Wire is a steerable guide wire available in a maximum diameter of 0.0137" and in lengths of 175 cm, 190 cm and 300 cm. The distal segment of the guide wire, up to the hypotube, is coated with hydrocoat to reduce friction for improved guide wire movement within the catheter. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The proximal core has a maximum diameter of 0.0137". The proximal end of the guide wire is coated with PTFE, which reduces friction of the wire within a catheter. The Balance Universal™ Guide Wire is DOC® extendable in the 175 cm and 190 cm lengths.
- Intended Use:
To facilitate the 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 compatible stent devices during therapeutic intravascular procedures.
- Technological Characteristics:
Comparisons of the new and predicate devices show that the technological characteristics such as product performance, design and intended use are substantially equivalent to the current marketed predicate devices.
1
1031678
14. Performance Data:
In vitro bench testing performance evaluations demonstrated that the HI-TORQUE BALANCE UNIVERSAL™ Guide Wire met the acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing program and therefore, the HI-TORQUE BALANCE UNIVERSAL™ Guide Wire may be considered substantially equivalent to the predicate devices.
2
Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border 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
AUG 2 6 2003
Guidant Corporation c/o Mr. Bruce Cerwin Regulatory Affairs Associate 26531 Ynez Road Temecula, CA 92591-4628
Re: K031678
HI-TORQUE Balance Universal™ Guide Wire with Hydrocoat Hydrophilic Coating Regulation Number: 870.1330 Regulation Name: Catheter Guide Wire Introducer Regulatory Class: Class II Product Code: DQX Dated: July 1, 2003 Received: July 3, 2003
Dear Mr. Cerwin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 -- Mr. Bruce Cerwin
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
sincerrity, 8 ms,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
4
INDICATION FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
HI-TORQUE BALANCE UNIVERSAL™ Guide Wire with Device Names: Hydrocoat Hydrophilic Coating
To facilitate the placement of balloon dilatation catheters during Indications percutaneous transluminal coronary angioplasty (PTCA), for Use: percutaneous transluminal angioplasty (PTA) and compatible stent devices during therapeutic intravascular procedures.
(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 Devices
| 510(k) Number | K031675 |
|---|---|
| --------------- | --------- |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter
(Optional Format 1-1-96) |
| ------------------------------------------ | ------------------------------------------- | ---------------------------------------------- |
|---|