(81 days)
The VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessels using the Seldinger Technique. VascuPuncture Guidewires are not indicated for use in the coronary or cerebral vasculature.
The VascuPuncture™ PICC Guidewires are guidewires constructed of stainless steel and nickel titanium alloy with a lubricious coating. Devices are available in diameters of 0.014 to 0.018 inches and in lengths ranging from 45 to 135 cm.
The provided document is a 510(k) summary for the VascuPuncture™ PICC Guidewire, which is a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one would see for a novel AI/software medical device.
Therefore, much of the requested information cannot be extracted directly from this document. However, I will fill in what can be inferred or stated based on the nature of a 510(k) submission for a guidewire.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (guidewire), acceptance criteria and performance are typically related to physical and functional characteristics demonstrating equivalence to existing, legally marketed predicate devices. The document explicitly states:
"Functional and performance characteristics are demonstrated through equivalence with the predicate device and testing of representative device samples."
However, specific quantitative acceptance criteria (e.g., tensile strength > X, lubricity < Y) and their corresponding reported performance values are not provided in this 510(k) summary. The summary concludes that the device is "substantially equivalent to the predicate devices in terms of functional design, indications for use, principles of operation and performance characteristics."
Therefore, I cannot populate a table with numerical acceptance criteria and reported performance based on this document.
2. Sample size used for the test set and the data provenance
The document mentions "testing of representative device samples." However, it does not specify the sample size for any test set or the provenance of any data (e.g., country of origin, retrospective/prospective). This information would typically be found in detailed test reports, not in the 510(k) summary itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the type of device and submission described. For a guidewire, "ground truth" would not be established by experts interpreting data in the same way it would be for an AI diagnostic device (e.g., interpretation of medical images). Performance is assessed through engineering and biocompatibility testing.
4. Adjudication method for the test set
Not applicable for a physical medical device like a guidewire. Adjudication methods are relevant for subjective assessments, typically by experts, which are not detailed here.
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
Not applicable. This is not an AI/software device, and no human-in-the-loop studies are mentioned or expected for a guidewire.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software device.
7. The type of ground truth used
For a physical medical device like a guidewire, "ground truth" is established through:
- Engineering specifications and standards: Performance such as tensile strength, kink resistance, lubricity, torqueability, flexibility, etc., are measured against pre-defined engineering requirements and industry standards.
- Biocompatibility testing: Results of biological assessments (e.g., cytotoxicity, sensitization, irritation) are compared against established safety benchmarks.
- Comparison to predicate devices: The "ground truth" for substantial equivalence often involves demonstrating that the new device performs similarly or meets the same safety and effectiveness profiles as legally marketed predicate devices.
The document refers to "biocompatibility is demonstrated through equivalence with legally marketed predicate devices and the result of ICPMS and prior biocompatibility testing." This indicates the use of biocompatibility test results as a form of ground truth for that aspect.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/machine learning device. The document mentions "testing of representative device samples," which implies a test set for performance verification, but not a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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MAR 1 - 2005
K 043398
Appendix G
510(k) Summary
| Submitter: | NeoMetrics, Inc.14800 28th Ave. N., Suite 150Plymouth, MN 55447 |
|---|---|
| Contact Person: | Gene ChampeauPresident763-559-4440 (voice)763-559-7676 (fax) |
| Date Prepared: | December 8th, 2004 |
| Trade Name: | VascuPuncture™ PICC Guidewire |
| Classification Nameand Number: | Wire, Guide, Catheter: 21 CFR 870.1330 |
| Product Code: | DQX |
| Predicate DeviceName and 510(k)Number | VascuPuncture PICC Guidewire, K031652 and K040786 |
| Device Description: | DEVICE DESCRIPTIONThe VascuPuncture™ PICC Guidewires are guidewiresconstructed of stainless steel and nickel titanium alloy with alubricious coating. Devices are available in diameters of 0.014to 0.018 inches and in lengths ranging from 45 to 135 cm. |
| Intended Use: | The VascuPuncture PICC Guidewire is indicated forpercutaneous entry of peripheral vessels using the SeldingerTechnique. VascuPuncture Guidewires are not indicated for usein the coronary or cerebral vasculature. |
| Statement ofTechnologicalComparison | Functional and performance characteristics are demonstratedthrough equivalence with the predicate device and testing ofrepresentative device samples.Biocompatibility is demonstrated through equivalence withlegally marketed predicate devices and the result of ICPMS andprior biocompatibility testing. |
| Conclusion: | VascuPuncture™ PICC Guidewire with a tungsten or goldplated tungsten is substantially equivalent to theVascuPuncture™ PICC Guidewire. This conclusion is basedupon the fact that this device is substantially equivalent to thepredicate devices in terms of functional design, indications foruse, principles of operation and performance characteristics |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized design that resembles a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 - 2005
Mr. Gene Champeau President NeoMetrics, Inc. 14800 28th Ave. N., Suite 150 Plymouth, MN 55447
K043398 Re:
Trade/Device Name: VascuPuncture PICC Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: December 8, 2004 Received: December 10 ,2004
Dear Mr. Champeau:
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.
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
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Page 2 – Mr. Gene Champeau
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 (301) 594-4648. 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 (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
R. Wachner
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):
Device Name:
VascuPuncture™ PICC Guidewire
Indications For Use:
The VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessels using the Seldinger Technique
Prescription Use XXX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
DURING P. Le Lane 1
Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_k643398
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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.