(143 days)
No
The summary describes a physical guide wire with mechanical properties and coatings, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device aids in the placement of leads but does not directly treat a disease or condition itself.
No
The device is a guide wire intended to aid in the placement of leads, which is a therapeutic or interventional function, not a diagnostic one.
No
The device description explicitly states it is a "single use guide wire" consisting of a "core wire with springs, and coatings," which are physical components, 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 "aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature." This describes a device used within the body during a medical procedure, not a device used to examine specimens outside the body to diagnose or monitor a condition.
- Device Description: The description details a physical guide wire with a core wire, springs, and coatings, designed for insertion into the coronary vasculature. This is consistent with an invasive medical device, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
Therefore, the Attain Hybrid Guide Wire is an invasive medical device used in a surgical or interventional procedure, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.
Product codes
DQX
Device Description
The Attain Hybrid Guide Wire is a single use guide wire designed to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature. The guide wires consist of a core wire with springs, and coatings. Near the distal end of the device, the core wire consists of tapers to allow differing support or stiffness levels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary vasculature
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
Device verification testing was performed to demonstrate the Attain Hybrid Guide Wires meet established performance criteria and to support equivalency to the referenced predicate devices. Visual, performance and compatibility testing was completed. All design and compatibility requirements were met. Biocompatibility testing consistent with ISO 10993-1: 2003: "Biological Evaluation of Medical devices – Part 1: Evaluation and Testing" was also conducted. The Attain Hybrid Guide Wire will be sterilized using a validated EtO sterilization process.
Key Metrics
Not Found
Predicate Device(s)
Guidant HI-TORQUE WHISPER Guide Wires with Hydrocoat Hydrophilic Coating (Models 6726, 6737, 6738, 4482, 4483, 4581, 4586, 4583, and 4588) - K030019, Medtronic Stylet Kit Models 6254, 6282 and 6293 K010906, Medtronic GT-1 Guide Wires (Floppy, Hi-Per Flex and Light Support) K983927, Medtronic Silk Guide Wires K903923
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
Attain Hybrid Guide Wires K
510(K) SUMMARY
K06 32/0
MAR 1 5 2007
| Date Prepared: | October 20, 2006 |
|---|---|
| Submitter: | Medtronic, Inc. |
| Cardiac Rhythm Disease Management | |
| 7000 Central Avenue NE | |
| Minneapolis, MN 55432 | |
| Contact: | Michelle Nivala |
| Regulatory Affairs Specialist | |
| Telephone: | (763) 505-7863 |
| Fax: | (763) 505-7877 |
| E-Mail: | michelle.d.nivala@medtronic.com |
| Proprietary Name: | Attain Hybrid Guide Wire |
| Common Name: | Catheter guide wire |
| Device Classification: | Class II, 21 CFR 870.1330 |
| Product Code: | DQX |
Summary of Substantial Equivalence
The intended use, design, materials and performance of the Attain Hybrid Guide Wires are substantially equivalent to the following predicate devices:
- · Guidant HI-TORQUE WHISPER Guide Wires with Hydrocoat Hydrophilic Coating (Models 6726, 6737, 6738, 4482, 4483, 4581, 4586, 4583, and 4588) - K030019 cleared January 24, 2003.
- · Medtronic Stylet Kit Models 6254, 6282 and 6293 K010906 cleared April 5, 2001
- · Medtronic GT-1 Guide Wires (Floppy, Hi-Per Flex and Light Support) K983927 cleared March 11, 1999
- · Medtronic Silk Guide Wires K903923 cleared November 21, 1990
Image /page/0/Picture/12 description: The image shows the Medtronic logo with the word "Confidential" to the right of it. The Medtronic logo consists of a stylized human figure inside of a circle. The word "Medtronic" is written in a bold, sans-serif font.
1
Traditional 510(k) 510(k) Summary
Attain Hybrid Guide Wires K
Device Description
The Attain Hybrid Guide Wire is a single use guide wire designed to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature. The guide wires consist of a core wire with springs, and coatings. Near the distal end of the device, the core wire consists of tapers to allow differing support or stiffness levels.
Indications for Use
The Attain Hybrid Guide Wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.
Technoloqical Characteristics
Intended use, design, materials, performance and packaging materials are substantially equivalent to the predicate devices referenced.
Summary of Testing
Device verification testing was performed to demonstrate the Attain Hybrid Guide Wires meet established performance criteria and to support equivalency to the referenced predicate devices. Visual, performance and compatibility testing was completed. All design and compatibility requirements were met.
Biocompatibility testing consistent with ISO 10993-1: 2003: "Biological Evaluation of Medical devices – Part 1: Evaluation and Testing" was also conducted.
The Attain Hybrid Guide Wire will be sterilized using a validated EtO sterilization process.
Conclusion
Medtronic considers the Attain Hybrid Guide Wires to be substantially equivalent to legally marketed predicate devices through the data and information presented. No safety or effectiveness issues were identified.
Image /page/1/Picture/14 description: The image shows the Medtronic logo with the word "Confidential" to the right of it. The Medtronic logo consists of a circular emblem with abstract figures inside, followed by the word "Medtronic" in a bold, sans-serif font. The word "Confidential" is written in a smaller, regular font, indicating the sensitive nature of the document or information associated with the logo. The logo and text are in black against a white background.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes extending from its back, representing the department's commitment to health and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle symbol. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic, Inc. c/o Ms. Michelle Nivala Regulatory Affairs Specialist 1015 Gramsie Road Shoreview, MN 55126-3082
MAR 1 5 2007
Re: K063210
Trade/Device Name: Attain Hybrid Guide Wires Models GWR419378, GWR419388 Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: March 5, 2007 Received: March 8, 2007
Dear Ms. Nivala:
We have reviewed your Section 510(k) promarket 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 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.
3
Page 2 - Ms. Michelle Nivala
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 (240) 276-0120. 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 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,
R. bochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Traditional 510(k) Indications for Use Attain Hybrid Guide Wires K
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Attain Hybrid Guide Wire
Indications for Use:
The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.
Prescription Use
· AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Duna R. Sochner
(Division Sign-Off) On ision of Cardiovascular Devices
510(K) Number KO G 3210
Image /page/4/Picture/17 description: The image shows the Medtronic logo with the word "Medtronic" in bold black letters. To the left of the word is a circular graphic with a figure inside. To the right of the word "Medtronic" is the word "Confidential" in a smaller, non-bold font.