(224 days)
Not Found
No
The 510(k) summary describes a physical medical device (a guide wire) and its intended use and performance testing. There is no mention of software, algorithms, image processing, AI, ML, or any related concepts. The focus is on the physical properties and performance of the guide wire itself.
No
The device is a guide wire intended to facilitate the placement of other therapeutic devices (balloon dilatation catheters and stent devices), not to directly provide a therapeutic effect itself.
No
The device is a guide wire intended to facilitate the placement of other medical devices (balloon dilatation catheters, stent devices) during therapeutic procedures, not to diagnose a condition.
No
The device description clearly describes a physical guide wire, which is a hardware component, not software.
Based on the provided information, 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 catheters and stent devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). These are in vivo procedures performed directly on a patient.
- Device Description: The description details a physical guide wire used within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. This guide wire is used inside the body during a medical procedure.
N/A
Intended Use / Indications for Use
The HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.
Product codes
DQX
Device Description
The HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire is a steerable guide wire available in a diameter of 0.0140" and in lengths of 190 cm DOC extendable length and a 300 cm exchange length. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The distal segment of the guide wire is coated with a new lubricious coating to improve guide wire movement in the catheter. The proximal end of the guide wire utilizes SMOOTHGLIDE coating technology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Coronary, refers to percutaneous transluminal coronary angioplasty (PTCA).
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
In vitro bench testing performance evaluations demonstrated that the HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire met the acceptance criteria and performed comparable to the predicate device. No new safety or effectiveness issues were raised during the testing program and therefore, the HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire may be considered substantially equivalent to the predicate device.
Key Metrics
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.
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510(k) Summary
APR 1 1 2008
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 | Abbott Vascular, Cardiac Therapies |
|---|---|---|
| 2. | Submitter's Address | 26531 Ynez Road, Temecula, CA 92591 |
| 3. | Telephone | (951) 914-4544 |
| 4. | Fax | (951) 914-0339 |
| 5. | Contact Person | Michele Walz |
| 6. | Date Prepared | August 30, 2007 |
| 7. | Device Trade Name | HI-TORQUE BALANCE MIDDLEWEIGHT |
| UNIVERSAL II Guide Wire | ||
| 8. | Device Common Name | Guide Wire |
| 9. | Device Classification Name | Catheter Guide Wire (DQX) |
| 10. | Predicate Device Name | HI-TORQUE BALANCE MIDDLEWEIGHT |
| UNIVERSAL Guide Wire (K013833, cleared Jan 16 |
- |
11. Device Description
The HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire is a steerable guide wire available in a diameter of 0.0140" and in lengths of 190 cm DOC extendable length and a 300 cm exchange length. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The distal segment of the guide wire is coated with a new lubricious coating to improve guide wire movement in the catheter. The proximal end of the guide wire utilizes SMOOTHGLIDE coating technology.
- Indication for Use
The HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.
13. 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 device.
- Performance Data
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In vitro bench testing performance evaluations demonstrated that the HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire met the acceptance criteria and performed comparable to the predicate device. No new safety or effectiveness issues were raised during the testing program and therefore, the HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire may be considered substantially equivalent to the predicate device.
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Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized bird or a series of interconnected human profiles. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Abbott Vascular clo Ms. Michele Walz Regulatory Affairs Associate 26531 Ynez Road Temecula, CA 92590
APR 1 1 2008
Re: K072460
Trade Name: Hi-Torque Balance Middleweight Universal II Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: March 24, 2008 Received: March 25, 2008
Dear Ms. Walz:
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.
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
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forth in the quality systems (QS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Duna R. bohner
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE
长072460 510(k) Number (if known):
Device Names:
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire
Indications for Use:
This HI-TORQUE Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter (Optional Format 1-1-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
hum R. vi Ames
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K672460
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