(27 days)
Not Found
No
The summary describes a physical medical device (guide wire) and its mechanical properties. There is no mention of software, algorithms, or any technology related to AI or ML.
No
This device is a guide wire used to facilitate the placement of other therapeutic devices (balloon dilatation catheters and stents) during angioplasty procedures, rather than directly performing a therapeutic function itself.
No
Explanation: The device is described as a guide wire intended to facilitate the placement of balloon dilatation catheters during angioplasty procedures. Its purpose is to aid in the delivery of therapeutic devices, not to diagnose a condition or provide diagnostic information.
No
The device description clearly describes a physical guide wire made of stainless steel with specific dimensions and configurations, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states that this guide wire is intended to facilitate the placement of other devices (balloon catheters and stents) within the body during procedures like PTCA and PTA. It is a tool used during a medical procedure, not a device that analyzes samples outside the body.
- Lack of Diagnostic Testing: There is no mention of this device being used to perform any kind of diagnostic test or analysis of biological samples.
Therefore, based on the provided information, this guide wire is a therapeutic medical device used in interventional procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This Hi-Torque Winn 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 (comma separated list FDA assigned to the subject device)
DQX
Device Description
The Hi-Torque Winn Guide Wire Family is a 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 190 cm extendable and 300 cm exchange lengths. The distal core segment of the Winn is offered in 5 configurations: Winn 40. Winn 80. Winn 120, Winn 140T and Winn 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
coronary, transluminal
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)
Performance testing was successfully completed on the predicate device, the HI-TORQUE PROGRESS Guide Wire Family. The following performance characteristics were leveraged for the proposed device:
- . Tensile Strength (Tip Pulls)
- Torque Strength (Turns to Separation) .
- Torqueability (Rotational Accuracy) .
- Tip Flexibility .
- Friction/Lubricity Test (Pig Aorta) .
- Coating Adhesion and Integrity Test (Particulate) .
- Biocompatibility .
- Cytotoxicity ISO Elution Test (MEM Extract)
- Hemolysis Test Direct Contact Method o
- Hemolysis Test Direct Contact Method I
- Hemolysis Test Extraction Method ■
- . Complement Activation (C3a & SC5b9)
- Coagulation (PT & PTT)
- Intracutaneous (Intradermal) Reactivity Test o
- USP Systemic Injection Test o
- Sensitization Maximization Test O
- Material Mediated Rabbit Pyrogen Test o
- Bacterial Endotoxins (LAL) for Medical Devices o
The Hi-Torque Winn is identical to the predicate device with respect to the materials, design, and manufacturing processes. Since no changes were made to the predicate device, no additional performance testing was conducted. The test results of the predicate device provide sufficient evidence to demonstrate the performance and safety of the device.
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
510(k) Summary
JUL - 8 2010
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 | 3200 Lakeside Drive, Santa Clara, CA 95054 |
| 3. Telephone | (408) 845-0688 |
| 4. Fax | (408) 845-3743 |
| 5. Contact Person | Laarni Ricafort |
| 6. Date Prepared | June 10, 2010 |
| 7. Device Trade Name | Hi-Torque Winn Guide Wire Family |
| 8. Device Common Name | Guide Wire |
| 9. Device Classification Name | Catheter Guide Wire (DQX) |
| 10. Predicate Device Name | HI-TORQUE PROGRESS Guide Wire (K091825, |
| cleared September 25, 2009) |
11. Device Description
The Hi-Torque Winn Guide Wire Family is a 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 190 cm extendable and 300 cm exchange lengths. The distal core segment of the Winn is offered in 5 configurations: Winn 40. Winn 80. Winn 120, Winn 140T and Winn 200T. Each configuration is identical in design except for those design features that impact tip stiffness.
- Indication for Use
This Hi-Torque Winn 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 device 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
1
Performance testing was successfully completed on the predicate device, the HI-TORQUE PROGRESS Guide Wire Family. The following performance characteristics were leveraged for the proposed device:
- . Tensile Strength (Tip Pulls)
- Torque Strength (Turns to Separation) .
- Torqueability (Rotational Accuracy) .
- Tip Flexibility .
- Friction/Lubricity Test (Pig Aorta) .
- Coating Adhesion and Integrity Test (Particulate) .
- Biocompatibility .
- Cytotoxicity ISO Elution Test (MEM Extract) ਼
- Hemolysis Test Direct Contact Method o
- Hemolysis Test Direct Contact Method I
- Hemolysis Test Extraction Method ■
- . Complement Activation (C3a & SC5b9)
- Coagulation (PT & PTT) 트
- Intracutaneous (Intradermal) Reactivity Test o
- USP Systemic Injection Test o
- Sensitization Maximization Test O
- Material Mediated Rabbit Pyrogen Test o
- Bacterial Endotoxins (LAL) for Medical Devices o
The Hi-Torque Winn is identical to the predicate device with respect to the materials, design, and manufacturing processes. Since no changes were made to the predicate device, no additional performance testing was conducted. The test results of the predicate device provide sufficient evidence to demonstrate the performance and safety of the device.
2
Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. 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 fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL - 8 2010
Abbott Vascular clo Ms. Laarni Ricafort Regulatory Affairs Associate 3200 Lakeside Drive Santa Clara, CA 95054
Re: K101648
Trade Name: Hi-Torque Winn Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: June 10, 2010 Received: June 10, 2010
Dear Ms. Ricafort:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
3
Page 2 - Ms. Laarni Ricafort
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 device-related adverse events) (21 CFR 803); 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.
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/CDRH0ffices/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.Vohmer
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):
Device Names: Hi-Torque Winn 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)
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)
ge to victims
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K101648
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