(21 days)
Not Found
No
The summary describes a physical medical device (guidewire) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
A guidewire for percutaneous entry of peripheral vessels is an access device, not a therapeutic device. It facilitates a medical procedure but does not directly treat a disease or condition.
No
The device is a guidewire used for percutaneous entry into peripheral vessels, not for diagnosing medical conditions. Its function is to facilitate the placement of other devices.
No
The device description explicitly states the guidewires are constructed of stainless steel and nickel titanium alloy, indicating a physical hardware component.
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's body.
- Device Description: The description details a physical guidewire used for navigating within blood vessels. This is a surgical/interventional device, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 and 0.018 inches and in lengths ranging from 45 to 145 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vessels, not indicated for use in the coronary or cerebral 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 (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 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
VascuPuncture™ PICC Guidewire with Hydro-Silk Coating NeoMetrics, Inc.
APR 1 9 2004
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: | March XX, 2004 |
| Trade Name: | VascuPuncture™ PICC Guidewire with Hydro-Silk Coating |
| 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, dated September 30, 2003. |
| 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
and 0.018 inches and in lengths ranging from 45 to 145 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
biocompatibility testing. |
| Conclusion: | VascuPuncture™ PICC Guidewire with Hydro-Silk Coating
is substantially equivalent to the VascuPuncture™ PICC
Guidewire. This conclusion is based upon the fact that this
device is substantially equivalent to the predicate device in
terms of functional design, indications for use, principles of
operation and performance characteristics. |
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 2004
NeoMetrics, Inc. c/o Mr. Gene Champeau President 14800 28th Ave. N., Suite 150 Plymouth, MN 55447
Re: K040786
VascuPuncture™ PICC Guidewire with Hydro-Silk Coating Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: March 24, 2004 Received: March 29, 2004
Dear Mr. Champeau:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becare in ad the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in to May 28, 1976, the enactment cate of the Medical Device Amendments, or to conimer of the to 112) 2012-12-12 in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Cosmetter rece (10c) that the device, subject to the general controls provisions of the Act. The I va may, are every maxes 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.
2
Page 2 -- Mr. Gene Champeau
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 (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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Omer R. Vachner
( 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):_K040786
Vascu Puncture PICC Guidewire with Hydro-Silk Coating Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessies using the Seldinger technique. VascuPuncture Guidewires are not indicated for use in the coronary or cerebral vasculature.
Prescription Use X (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)
ina R. Lochner
(Division Sign-Off) Division of Cardiovascular Devices
· ~ ~ Number_ K640 786
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