(163 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a guidewire, with no mention of AI or ML.
No
The device is a guidewire used for vessel entry to facilitate the introduction of another intravascular device, rather than performing a therapeutic function itself.
No
The device is a guidewire intended for percutaneous vessel entry to facilitate the introduction of other intravascular devices; it does not diagnose medical conditions.
No
The device description explicitly states it is comprised of physical components (stainless steel cable, coil, PTFE coating) and the performance studies involve physical testing (kink, torqueability, corrosion, etc.), 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 is for "percutaneous vessel entry typically using the Seldinger technique to facilitate subsequent introduction of an intravascular device." This describes a surgical or interventional procedure performed directly on a patient's body.
- Device Description: The device is a guidewire, a physical tool used to navigate within blood vessels.
- 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 screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a tool for a medical procedure.
N/A
Intended Use / Indications for Use
The AMPLATZER Noodlewire Guidewire is intended for percutaneous vessel entry typically using the Seldinger technique to facilitate subsequent introduction of an intravascular device.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The AMPLATZER Noodlewire Guidewire is a guidewire comprised of a stainless steel cable and coil. The cable wire component forms the inner body of the guidewire. The outer layer of the guidewire consists of a flat wire component coated with PTFE. The cable is placed within the coil. All components are secured together forming a single quidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessel
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)
A. Functional Testing
In-vitro testing was conducted in accordance with ISO 11070, Sterile single-use intravascular catheter introducers and FDA Coronary and Cerebrovascular Guidewire Guidance, January, 1995. The AMPLATZER Noodlewire samples were subjected to kink, torqueability, torque strength, corrosion, fracture, flexure, tip flexibility, lubricity, and pull testing.
In-vitro Simulated Life Testing to document performance of the AMPLATZER Noodlewire Guidewire under simulated, but accelerated, in-use conditions was performed.
Biocompatibility testing was completed per ISO 10993-1.
B. Clinical Studies
The AMPLATZER Noodlewire Guidewire was used as a part of a feasibility clinical trial conducted in the United States. Specific data to the Noodlewire Guidewire was collected as part of the clinical trial.
C. Conclusions Drawn from the Studies
The results of the testing indicated that the AMPLATZER Noodlewire Guidewire functions according to specifications and the materials used in the Noodlewire Guidewire are biocompatible. Therefore, the Noodlewire Guidewire is considered acceptable for human use.
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.
Not Found
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
Image /page/0/Picture/0 description: The image shows a sequence of handwritten alphanumeric characters. The sequence appears to be "K053181". The characters are written in a bold, slightly irregular style, giving them a hand-drawn appearance. The contrast between the characters and the background is high, making them easily readable.
510(k) Summary
APR 2 7 2006
| Application Date: | November 14, 2005 |
|---|---|
| Submission Type: | Traditional 510(k) |
| Applicant | |
| Manufacturing | |
| Address: | AGA Medical Corporation |
| 682 Mendelssohn Avenue | |
| Golden Valley, Minnesota 55427 | |
| Contact Person: | Patricia A. LaForte |
| Regulatory Affairs Associate | |
| Establishment | |
| Registration | |
| Number: | 2135147 |
| Device | |
| Classification Name: | Wire, Guide, Catheter |
| Device | |
| Common/Usual Name: | Guidewire |
| Device | |
| Proprietary Name: | AMPLATZER® Noodlewire Guidewire |
| Device | |
| Classification: | Class II, Reviewed by Cardiovascular |
| Device | |
| Product Code: | DQX |
| Reason for 510(k): | New Device Submission |
| Equivalence | |
| Device Comparison: | Lake Region Manufacturing Guidewire |
| Performance | |
| Standards: | Performance standards have not been promulgated to |
| date for these devices |
1
Device Description
The AMPLATZER Noodlewire Guidewire is a guidewire comprised of a stainless steel cable and coil. The cable wire component forms the inner body of the guidewire. The outer layer of the guidewire consists of a flat wire component coated with PTFE. The cable is placed within the coil. All components are secured together forming a single quidewire.
Intended Use
The AMPLATZER Noodlewire Guidewire is intended for percutaneous vessel entry typically using the Seldinger technique to facilitate subsequent introduction of an intravascular device.
Technological Characteristics as Compared to Predicate Device
The AMPLATZER Noodlewire Guidewire is constructed from the same biocompatible materials, coated with polytetrafluoroethylene (PTFE), packaged / sterilized utilizing the same materials / methods, and have the same principle of use as the predicate device.
Summary of Studies:
A. Functional Testing
In-vitro testing was conducted in accordance with ISO 11070, Sterile single-use intravascular catheter introducers and FDA Coronary and Cerebrovascular Guidewire Guidance, January, 1995. The AMPLATZER Noodlewire samples were subjected to kink, torqueability, torque strength, corrosion, fracture, flexure, tip flexibility, lubricity, and pull testing.
In-vitro Simulated Life Testing to document performance of the AMPLATZER Noodlewire Guidewire under simulated, but accelerated, in-use conditions was performed.
Biocompatibility testing was completed per ISO 10993-1.
B. Clinical Studies
The AMPLATZER Noodlewire Guidewire was used as a part of a feasibility clinical trial conducted in the United States. Specific data to the Noodlewire Guidewire was collected as part of the clinical trial.
C. Conclusions Drawn from the Studies
The results of the testing indicated that the AMPLATZER Noodlewire Guidewire functions according to specifications and the materials used in the Noodlewire Guidewire are biocompatible. Therefore, the Noodlewire Guidewire is considered acceptable for human use.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
127 7 7 2006
AGA Medical Corporation c/o Ms. Patricia A. LaForte Regulatory Affairs Associate 682 Mendelssohn Avenue Golden Valley, MN 55427
K053187 Re:
AMPLATZER® Noodlewire Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guidewire Regulatory Class: II Product Code: DQX Dated: March 24, 2006 Received: March 27, 2006
Dear Ms. LaForte:
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.
3
Page 2 – Ms. Patricia A. LaForte
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. 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 on ); pro "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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Duna R. Vichner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number:
Device Name: AMPLATZER® Noodlewire Guidewire
Indications for Use: The AMPLATZER Noodlewire Guidewire is intended for percutaneous vessel entry typically using the Seldinger technique to facilitate subsequent introduction of an intravascular device.
Prescription Use AND/OR × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Duna R. Lochnes
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number Kos
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