(20 days)
The Traxcess 0.014" Hydrophilic Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The wire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.
The Traxcess 0.014" Hydrophilic Guidewire consists of a 0.014" stainless steel shaft and a tapered nitinol tip contained within 0.012" platinum and stainless steel coils. The distal coil section contains a lubricious hydrophilic coating, and the proximal shaft section is coated with PTFE. The Guidewire is available in a variety of coil tip and overall lengths to suit the needs of the clinician.
The provided text describes a 510(k) premarket notification for the Traxcess 0.014" Hydrophilic Guidewire. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies to prove effectiveness or establish acceptance criteria based on new performance metrics.
Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth, etc.) is not typically part of a 510(k) submission for a guidewire device, as it is not an AI/ML driven device and does not involve diagnostic performance metrics.
Instead, the documentation focuses on:
- Nonclinical Testing: Physical tests to characterize tensile strength, torque strength, torqueability, tip flexibility, coatings, biocompatibility, and catheter compatibility.
- Animal Testing: Performed to confirm guidewire performance.
- Substantial Equivalence: The primary "proof" is that the device's technical and performance attributes are substantially equivalent to cited predicate guidewires (Runthrough NS, Transend EX Platinum Guidewire, Radifocus Glidewire GT with Gold Coil).
To directly answer your questions based only on the provided text, and acknowledging that these questions are more relevant to AI/ML or diagnostic devices:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (Summary from Nonclinical Testing) |
|---|---|
| Tensile Strength | Suitable for its intended use |
| Torque Strength | Suitable for its intended use |
| Torqueability | Suitable for its intended use |
| Tip Flexibility | Suitable for its intended use |
| Coatings (Hydrophilic/PTFE) | Suitable for its intended use (lubricity as described) |
| Biocompatibility | Suitable for its intended use |
| Catheter Compatibility | Suitable for its intended use |
| Guidewire Performance | Confirmed via animal testing to be suitable for its intended use |
Note: The document does not provide specific numerical acceptance criteria or performance values for these categories. It only states that the performance was "suitable for its intended use" and confirmed through testing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified for physical or animal testing.
- Data Provenance: Not specified, but generally, device manufacturers conduct such tests in-house or through contract labs, typically within the country of manufacture or relevant regulatory jurisdiction. These are prospective tests conducted specifically for the device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable. For physical and animal testing of a guidewire, "ground truth" is established through engineering and scientific measurements and observations, not expert consensus in the diagnostic sense. Animal studies involve veterinarians and other scientific personnel, but they are assessing physiological responses and device function, not diagnostic interpretations.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of diagnostic images or data. Physical and animal testing results are typically evaluated against pre-defined engineering specifications or observed physiological outcomes.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC study was not done. This device is a medical instrument (guidewire), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For nonclinical testing, the "ground truth" would be the direct physical measurements (e.g., force, length, torque values) and visual inspection against engineering specifications. For animal testing, it would be the observed physiological outcomes, successful navigation, and pathological assessment of tissues post-procedure, as observed and recorded by scientific personnel.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground truth for Training Set: Not applicable. This device is not an AI/ML algorithm.
In summary: The provided document is for a conventional guidewire device seeking 510(k) clearance based on substantial equivalence. The questions posed are primarily relevant to AI/ML or diagnostic devices that require clinical performance studies and ground truth establishment, which are not detailed or required in this specific 510(k) summary.
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510(k) Summary
| Trade Name: | Traxcess 0.014" Hydrophilic Guidewire | APR 17 20 |
|---|---|---|
| Generic Name: | Guidewire | |
| Classification: | Class II, 807.1330 | |
| Submitted By: | MicroVention, Inc.75 Columbia, Suite AAliso Viejo, CA 92656 | |
| Contact: | Kevin E. Daly | |
| Predicate Devices: | Runthrough NS (K063695)Transend EX Platinum Guidewire (K971254)Radifocus Glidewire GT with Gold Coil (K955801) |
Device Description:
The Traxcess 0.014" Hydrophilic Guidewire consists of a 0.014" stainless steel shaft and a tapered nitinol tip contained within 0.012" platinum and stainless steel coils. The distal coil section contains a lubricious hydrophilic coating, and the proximal shaft section is coated with PTFE. The Guidewire is available in a variety of coil tip and overall lengths to suit the needs of the clinician.
Indications for Use:
The Traxcess 0.014" Hydrophilic Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The wire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.
Nonclinical Testing:
Nonclinical testing was completed in accordance with the FDA guidance document entitled "Coronary and Cerebrovascular Guidewire Guidance, January 1995". In summary, physical tests were performed to characterize that the tensile strength, torque strength, torqueability, tip flexibility, coatings, biocompatibility, and catheter compatibility were suitable for its intended use. In addition, animal testing was performed to confirm guidewire performance.
Summary:
Based upon the technical and performance attributes of the Traxcess 0.014" Hydrophilic Guidewire, this device is substantially equivalent to the cited predicate devices.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 7 2008
Regulatory Technology Services LLC c/o Mr. Mark Job Responsible Third Party Official 1394 25th Street NW Buffalo, MN 55313
Re: K080863
Traxcess 0.014" Hydrophilic Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: March 27, 2008 Received: March 28, 2008
Dear Mr. Job:
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.
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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
er R. Vachner
A 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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Indications for Use
510(k) Number (if known): ¥090863
Device Name: Traxcess 0.014" Hydrophilic Guidewire
Indications for Use:
The Traxcess 0.014" Hydrophilic Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The wire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. de Anus
(Division Sign-Off) (Division Sign-off)
Division of Cardiovascular Devices
510(k) Number_ko كلك يكك تكلك بك كلك تك
§ 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.