(30 days)
Not Found
No
The description focuses on the physical construction and intended use of a guidewire, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a guidewire used for percutaneous entry into peripheral vessels, which is a procedural tool rather than a therapeutic device. It facilitates a medical procedure but does not directly treat a disease or condition itself.
No
The device description clearly states its purpose is for "percutaneous entry of peripheral vessels using the Seldinger Technique," indicating an interventional or procedural role rather than obtaining diagnostic information.
No
The device description explicitly states it is constructed of physical materials (stainless steel and nickel titanium alloy) and is a physical guidewire, not software.
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 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 blood vessels. This is a medical device used in a surgical or interventional procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVDs are devices used 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. The device is not intended 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 or without lubricious coatings. Devices are available in diameters of 0.014 to 0.018 inches and in lengths ranging from 40 to 145 cm. with a variety of coil material options available.
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 as part of Design Verification Testing.
Biocompatibility is demonstrated through successful completion of Biocompatibility Testing in accordance with ISO 10993.
Shelf Life is demonstrated through successful completion of accelerated aging studies and subsequent testing in accordance with ISO 11070.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
VascuPuncture PICC Guidewire, K031652, K040786, K043398
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 NeoMetrics, Inc.
..............................................................................................................................................................................
.
p. Loft Special 510(k)
4070150
Appendix J
FEB 1 5 2007
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: | January 12, 2007 |
| 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, K040786, K043398 |
| Device Description: | DEVICE DESCRIPTION
The VascuPuncture™ PICC Guidewires are guidewires
constructed of stainless steel and nickel titanium alloy with or
without lubricious coatings. Devices are available in diameters
of 0.014 to 0.018 inches and in lengths ranging from 40 to 145
cm. with a variety of coil material options available. |
| Intended Use: | The VascuPuncture PICC Guidewire is indicated for
percutaneous entry of peripheral vessels using the Seldinger
Technique. The device is not intended 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 as part of Design Verification
Testing. Comparison is summarized in Table 1 below:
Biocompatibility is demonstrated through successful
completion of Biocompatibility Testing in accordance with ISO
10993
Shelf Life is demonstrated through successful completion of
accelerated aging studies and subsequent testing in accordance
with ISO 11070 |
| Conclusion: | VascuPuncture™ PICC Guidewire with additional coatings and
coil material are safe and equivalent to the predicate product.
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,
risk analysis, and performance characteristics |
···
CONFIDENTIAL
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 6 7007
NeoMetrics, Inc. c/o Mr. Gene Champeau President 14800 28th Avenue, N. Suite 150 Plymouth, MN 55447
Re: K070150
VascuPuncture™ PICC Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (Two) Product Code: DQX Dated: January 12, 2007 Received: January 16, 2007
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.
2
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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
B.zimmerman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
VascuPuncture™ PICC Guidewire NeoMetrics, Inc.
Special 510(k)
Indications for Use
510(k) Number (if known): K070150
Device Name: VascuPuncture™ PICC Guidewire
Indications for Use:
The VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessels using the Seldinger Technique. The device is not intended 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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Bymmmn
Division Sign Off
Division of Cardiovascular Devices 510(k) Number
Page of of a
(Posted November 13, 2003)
02/08/2007
CONFIDENTIAL