(98 days)
No
The summary describes a mechanical guide wire and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a guide wire that facilitates the placement of other therapeutic devices (balloon dilatation catheters, stent devices) but does not directly deliver therapy itself.
No
The device is described as a guide wire intended to facilitate the placement of other catheters and devices during therapeutic procedures, not for diagnosis.
No
The device description clearly describes a physical guide wire made of stainless steel, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during a medical procedure (PTCA and PTA) to facilitate the placement of other devices (balloon catheters and stents). This is an interventional device, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics and function of a guide wire used within the body.
- Lack of IVD Indicators: There is no mention of analyzing samples from the human body (blood, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to diagnose diseases or conditions in vitro (outside the body).
Therefore, this device is a medical device used for therapeutic and interventional purposes, not an IVD.
N/A
Intended Use / Indications for Use
The HI-TORQUE PROGRESS Guide Wire Family 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
DOX
Device Description
The HI-TORQUE PROGRESS Guide Wire Family is a new family of guide wires. designed to provide improved torque response and crossing while maintaining tactile feedback in stenotic vessels. The subject wire is a core to tip design, where the core material runs through the entire length of the wire. This family of guide wires have a maximum diameter of 0.0140" with a stainless steel core and are provided in 190cm extendable and 300cm exchange lengths. The distal core segment of the PROGRESS is offered in 5 configurations: PROGRESS 40, PROGRESS 80, PROGRESS 120, PROGRESS 140T and PROGRESS 200T. Each configuration is identical in design except for those design features that impact tip stiffness.
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
In vitro bench testing performance evaluations demonstrated that the HI-TORQUE PROGRESS Guide Wire Family met the acceptance criteria and performed comparable to the matching predicate devices. No new safety or effectiveness issues were raised during the testing program and therefore, the HI-TORQUE PROGRESS Guide Wire Family may be considered substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
HI-TORQUE PILOT Guide Wire (K030549), HI-TORQUE ADVANCE Guide Wire (K060449), HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire, (K072460)
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
510(k) Summary
SEP 2 5 2009
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.
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- Submitter's Name
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- Submitter's Address
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- Telephone
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- Fax
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Contact Person
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Date Prepared
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- Device Trade Name
Device Common Name 8.
- Device Trade Name
Device Classification Name 9.
- Predicate Device Name
Abbott Vascular 26531 Ynez Road, Temecula, CA 92591 (951) 914-3246 (951) 914-0339 Michele Walz June 15, 2009 HI-TORQUE PROGRESS Guide Wire Family Guide Wire Catheter Guide Wire (DOX)
HI-TORQUE PILOT Guide Wire (K030549, cleared May 14, 2003), HI-TORQUE ADVANCE Guide Wire (K060449, cleared May30, 2006), HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire, (K072460, cleared April 11, 2008) and Asahi guide wire families.
11. Device Description
The HI-TORQUE PROGRESS Guide Wire Family is a new family of guide wires. designed to provide improved torque response and crossing while maintaining tactile feedback in stenotic vessels. The subject wire is a core to tip design, where the core material runs through the entire length of the wire. This family of guide wires have a maximum diameter of 0.0140" with a stainless steel core and are provided in 190cm extendable and 300cm exchange lengths. The distal core segment of the PROGRESS is offered in 5 configurations: PROGRESS 40, PROGRESS 80, PROGRESS 120, PROGRESS 140T and PROGRESS 200T. Each configuration is identical in design except for those design features that impact tip stiffness.
- Indication for Use
The HI-TORQUE PROGRESS Guide Wire Family 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
1
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.
14. Performance Data
In vitro bench testing performance evaluations demonstrated that the HI-TORQUE PROGRESS Guide Wire Family met the acceptance criteria and performed comparable to the matching predicate devices. No new safety or effectiveness issues were raised during the testing program and therefore, the HI-TORQUE PROGRESS Guide Wire · Family may be considered substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Abbott Vascular c/o Ms. Michele Walz Senior Regulatory Affairs Associate 26531 Ynez Road Temecula, CA 92591-4628
SEP 2 5 2009
Re: K091825
Trade/Device Name: HI-TORQUE PROGRESS Guide Wire Common Name: Guide wire Regulation Number: 21 CFR 870.1330 Regulatory Class: II Product Code: DOX Dated: September 14, 2009 Received: September 15, 2009
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 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); medical device reporting (reporting of medical
3
Page 2 -- Ms. Michele Walz
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.fda.gov/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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
R. bohner
Image /page/3/Picture/7 description: The image shows a handwritten symbol or signature next to the words "Bra" and "Dir". The symbol appears to be a stylized letter or a unique mark. The text is printed in a simple, sans-serif font and is positioned to the right of the symbol.
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
510(k) Number (if known): K091825
Device Names:
HI-TORQUE PROGRESS Guide Wire Family
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)
Dummer R. Vochner
(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K0 91825
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