(35 days)
Not Found
No
The description focuses on the physical construction and mechanical properties of a guide wire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a guide wire intended to facilitate the delivery of other catheter-based interventional devices or stent devices during therapeutic procedures. It is an accessory device, not a therapeutic device itself.
No
The device is primarily intended to facilitate the delivery of other interventional devices and create pathways within vessels. While it can "distinguish the vasculature," this function is supportive of interventional procedures rather than a standalone diagnostic purpose.
No
The device description clearly describes a physical guide wire constructed from stainless steel with a PTFE shrink tube, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) to facilitate interventional procedures like PTCA and PTA. It's used to guide catheters and stents within the vasculature.
- Device Description: The description details a physical guide wire designed for insertion into 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 for procedural guidance.
N/A
Intended Use / Indications for Use
This HI-TORQUE guide wire is intended to facilitate the delivery of catheter-based interventional devices 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.
The guide wire may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.
Product codes
DQX
Device Description
The HI-TORQUE POWERTURN Guide Wire Family has a diameter of 0.014" with a 190 cm extendable length and a 300 cm exchange length. The POWERTURN Guide Wire Family is available in three tip support models and is constructed from a 304V stainless steel core. Over the proximal coined section of the 190 cm model is a Wire Identifier consisting of a black PTFE shrink tube which is removable and is used to help physicians distinguish between two Abbott Vascular wires while being used simultaneously. The distal tip of the guide wire is available as a straight tip that is shapeable or as a pre-shaped "J". The straight shape allows the physician to shape the tip according to his/her preference and the pre-shaped tip provides the physician the convenience of a "J" shape without manual shaping.
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, including tip tensile strength, torque strength, torqueability, coating adherence and integrity (particulate testing), and friction testing were conducted on the new device. The in vitro bench tests demonstrated that the HI-TORQUE POWERTURN Guide Wire met all acceptance criteria and performed similarly to the predicate devices. It was not necessary to repeat biocompatibility testing as testing performed on the predicate device is applicable to the HI-TORQUE POWERTURN. No new safety or effectiveness issues were raised during the testing program and therefore, the HI-TORQUE POWERTURN Guide-Wire Family 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
K112957 p11/2
NOV - 8 2011
510(k) Summary
The 510(k) Summary is submitted in accordance with 21 CFR §807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.
| 1. Submitter's Name | Abbott Vascular |
|---|---|
| 2. Submitter's Address | P.O. Box 9018 |
| 26531 Ynez Road, Temecula, CA 92591 | |
| 3. Telephone | (951) 914-3242 |
| 4. Fax | (951) 914-0339 |
| 5. Contact Person | Kay Setzer |
| 6. Date Prepared | September 28, 2011 |
| 7. Device Trade Name | HI-TORQUE® POWERTURN Guide Wire Family |
| 8. Device Common Name | Guide Wire |
| 9. Device Classification Name | Catheter Guide Wire (DQX) |
| 10. Predicate Device Name | HI-TORQUE ADVANCE and ADVANCE LITE |
| (K060449, cleared May 30, 2006), HI-TORQUE | |
| BALANCE MIDDLEWEIGHT ELITE (K103101, | |
| cleared Feb. 10, 2011), and Medtronic Vascular | |
| GTX Guide Wire, K091582, cleared Dec. 4, 2009) |
11. Device Description
The HI-TORQUE POWERTURN Guide Wire Family has a diameter of 0.014" with a 190 cm extendable length and a 300 cm exchange length. The POWERTURN Guide Wire Family is available in three tip support models and is constructed from a 304V stainless steel core. Over the proximal coined section of the 190 cm model is a Wire Identifier consisting of a black PTFE shrink tube which is removable and is used to help physicians distinguish between two Abbott Vascular wires while being used simultaneously. The distal tip of the guide wire is available as a straight tip that is shapeable or as a pre-shaped "J". The straight shape allows the physician to shape the tip according to his/her preference and the pre-shaped tip provides the physician the convenience of a "J" shape without manual shaping.
1
12. Indication for Use
This HI-TORQUE guide wire is intended to facilitate the delivery of catheter-based interventional devices 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.
The guide wire may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.
13. Technological Characteristics
Comparison of the new device and predicate device(s) demonstrate that the technological characteristics such as product performance, design and indications for use are substantially equivalent to the current marketed predicate devices.
14. Performance Data
In vitro bench testing, including tip tensile strength, torque strength, torqueability, coating adherence and integrity (particulate testing), and friction testing were conducted on the new device. The in vitro bench tests demonstrated that the HI-TORQUE POWERTURN Guide Wire met all acceptance criteria and performed similarly to the predicate devices. It was not necessary to repeat biocompatibility testing as testing performed on the predicate device is applicable to the HI-TORQUE POWERTURN. No new safety or effectiveness issues were raised during the testing program and therefore, the
HI-TORQUE POWERTURN Guide-Wire Family may be considered substantially equivalent to the predicate devices.
15. Conclusions
Test results from the in vitro bench testing conducted on the subject device demonstrate that the HI-TORQUE POWERTURN Guide Wire Family met all acceptance criteria and performed similarly to the predicate devices and that no new safety or effectiveness issues were raised during the testing program. Therefore, the HI-TORQUE POWERTURN Guide Wire Family may be considered substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle-like symbol with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
NOV - 8 2011
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Abbott Vascular c/o Ms. Kay Setzer Senior Regulatory Affairs Associate 26531 Ynez Road Building G Temecula, CA 92590
Re: K112957
Trade/Device Name: HI-TORQUE® POWERTURN Guide Wire Family Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: September 29, 2011 Received: October 4, 2011
Dear Ms. Setzer:
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 includions 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, insting of devices, good manufacturing practice, labeling, and prohibitions against misbaanding and adulteration. ·
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device cr n 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
3
Page 2 - Ms. Kay Setzer
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fdaggov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
μL:
Bram D. Zuckerman, M.D. Director
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATION FOR USE
| 510(k) Number (if known): | K112957 |
|---|---|
| --------------------------- | --------- |
HI-TORQUE POWERTURN Guide Wire Family Device Names:
This HI-TORQUE guide wire is intended to facilitate the delivery of Indications catheter-based interventional devices during percutaneous transluminal for Use: coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.
The guide wire may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.
Prescription Use_ X (Per 21 CFR 801.109)
Over-The-Counter (Optional Format 1-1-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K112957 |
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