(125 days)
Not Found
No
The 510(k) summary describes a simple mechanical guidewire and does not mention any AI or ML components, image processing, or data-driven performance metrics.
No
A therapeutic device is one that treats a disease or condition. This device is a guidewire, which is an accessory used in a procedure (percutaneous entry) but does not itself provide therapy. Its function is to facilitate the placement of other medical devices.
No.
The device is a guidewire used for percutaneous entry of peripheral vessels and does not perform any diagnostic function. Its description focuses on its physical characteristics and use in the Seldinger Technique, not on detecting or identifying diseases or conditions.
No
The device description explicitly states it is constructed of physical materials (stainless steel and nickel titanium alloy) and has physical dimensions (diameters and lengths), indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The VascuPuncture PICC Guidewire is a physical tool used within the body to facilitate the insertion of a catheter into a blood vessel. It is used for a procedural purpose, not for analyzing a sample outside the body.
- Intended Use: The intended use clearly states it's for "percutaneous entry of peripheral vessels using the Seldinger Technique," which is a surgical/interventional procedure.
The information provided describes a medical device used for a procedural purpose, not for in vitro analysis of biological samples.
N/A
Intended Use / Indications for Use
The VascuPuncture PICC Guidewire is intended for percutaneous entry of peripheral vessels using the Seldinger Technique. VascuPuncture Guidewires are 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 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
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
Representative samples of the device underwent bench testing to demonstrate appropriate functional and performance characteristics compared to the predicate device.
Key Metrics
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
Attachment 5 510(k) Summary
| Submitter: | NeoMetrics, Inc.
14800 28th Avenue South, Suite 150
Plymouth, MN 55447
Telephone: 763-559-4440
Fax: 763-559-7676 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gene Champeau
President
Telephone: 763-559-4440
Fax: 763-559-7676
gchampeau@qwest.net |
| Date Prepared: | May 21, 2003 |
| Trade Name: | VascuPuncture PICC Guidewire |
| Classification Name
and Number: | Wire, Guide, Catheter
870.1330 |
| Product Code: | DQX |
| Predicate Device(s): | VascuPuncture Access Wire, 510(k) number K012861, and Selectiva
Guidewire cleared via the 510(k) K013024. |
| 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 intended for percutaneous entry of
peripheral vessels using the Seldinger Technique. VascuPuncture
Guidewires are not intended for use in the coronary or cerebral vasculature. |
| Functional and Safety
Testing: | Representative samples of the device underwent bench testing to
demonstrate appropriate functional and performance characteristics
compared to the predicate device. |
| Conclusion: | The VascuPuncture PICC Guidewire modified as proposed in this
submission, is substantially equivalent to the predicate devices.
This conclusion is based upon the similarity in design, principles of
operation, materials, and performance and of the modified device
compared to the originally, cleared device. |
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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three parallel lines that curve and converge, resembling a stylized human figure or a bird in flight. The overall design is simple and recognizable, representing the department's mission and identity.
SEP 3 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Neo Metrics, Inc. C/O Gene Champeau 14800 28th Ave North Plymouth, MN 55447
Re: K031652
Trade/Device Name: VascuPuncture PICC Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Wire, Guide, Catheter Regulatory Class: Class II (two) Product Code: DQX Dated: September 2, 2003 Received: September 3, 2003
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
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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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 Page
510(k) Number (if known): K031652
VascuPuncture PICC Guidewire Device Name:
Indications for Use:
The VascuPuncture PICC Guidewire is intended for percutaneous entry of peripheral vessels using the Seldinger Technique. VascuPuncture Guidewires are not intended for use in the coronary or cerebral vasculature.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sig-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K091652 |
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Image /page/3/Picture/6 description: The image shows the text "Prescription Use" with a check mark above a line. Below this is the text "(Per 21 CFR 801.109)". The check mark indicates that the prescription use is being confirmed.
Over-the-Counter Use ___________
Or