(81 days)
Not Found
No
The summary describes a physical guidewire and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a guidewire used for percutaneous entry into peripheral vessels, which is an accessory to a medical procedure rather than a therapeutic device itself. Its function is to facilitate the placement of other devices.
No
The device is a guidewire used for percutaneous entry into peripheral vessels, which is a procedural tool rather than a device designed to identify, assess, or monitor a medical condition.
No
The device description explicitly states it is constructed of stainless steel and nickel titanium alloy, indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "percutaneous entry of peripheral vessels using the Seldinger Technique." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The description details a physical guidewire used for navigating within blood vessels. This is a surgical/interventional tool, not a reagent or instrument used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a tool used in a medical procedure.
N/A
Intended Use / Indications for Use
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.
Product codes
DQX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vessels
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)
Functional and performance characteristics are demonstrated through equivalence with the predicate device and testing of representative device samples.
Biocompatibility is demonstrated through equivalence with legally marketed predicate devices and the result of ICPMS and prior biocompatibility testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
MAR 1 - 2005
K 043398
Appendix G
510(k) Summary
| Submitter: | NeoMetrics, Inc.
14800 28th Ave. N., Suite 150
Plymouth, MN 55447 |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gene Champeau
President
763-559-4440 (voice)
763-559-7676 (fax) |
| Date Prepared: | December 8th, 2004 |
| Trade Name: | VascuPuncture™ PICC Guidewire |
| Classification Name
and Number: | Wire, Guide, Catheter: 21 CFR 870.1330 |
| Product Code: | DQX |
| Predicate Device
Name and 510(k)
Number | VascuPuncture PICC Guidewire, K031652 and K040786 |
| Device Description: | DEVICE DESCRIPTION
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. |
| Intended Use: | 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. |
| Statement of
Technological
Comparison | Functional and performance characteristics are demonstrated
through equivalence with the predicate device and testing of
representative device samples.
Biocompatibility is demonstrated through equivalence with
legally marketed predicate devices and the result of ICPMS and
prior biocompatibility testing. |
| Conclusion: | VascuPuncture™ PICC Guidewire with a tungsten or gold
plated tungsten is substantially equivalent to the
VascuPuncture™ PICC Guidewire. This conclusion is based
upon the fact that this device is substantially equivalent to the
predicate devices in terms of functional design, indications for
use, principles of operation and performance characteristics |
1
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
2
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
3
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
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