(21 days)
No
The summary describes a physical guidewire made of nickel-titanium alloy and PTFE, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies are bench tests comparing physical characteristics.
No
The device is a guidewire intended to facilitate the placement of other devices, not to directly treat a condition or disease itself. Its function is primarily assistive in diagnostic and interventional procedures.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to facilitate the placement of devices for diagnostic and interventional procedures." This indicates its role in diagnostic processes, even if indirectly.
No
The device description explicitly states it is constructed of physical materials (nickel-titanium alloy, PTFE polymer jacket) and has physical dimensions (diameter, length), indicating it is a hardware device, not software-only.
Based on the provided information, the NeoMetrics Selectiva SB Guidewire is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the placement of devices for diagnostic and interventional procedures." This describes a tool used during a medical procedure, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details the physical construction of a guidewire, which is a medical device used to navigate within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The NeoMetrics Selectiva SB Guidewire's function is purely mechanical and procedural.
N/A
Intended Use / Indications for Use
The NeoMetrics Selectiva SB Guidewire is intended to facilitate the placement of devices for diagnostic and interventional procedures.
NOTE: These guidewires are not intended for PTCA use.
Product codes
DQX
Device Description
The Selectiva SB Guidewires are constructed of a nickel-titanium alloy with a PTFE polymer jacket. Devices are available in a diameter of 0.035 inches and in lengths ranging from 40 to 300 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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(s).
Key Metrics
Not Found
Predicate Device(s)
NeoMetrics Selectiva™ Guidewire (K013024), FlexMedics FlexFinder Guidewire (K943390)
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
NOV - 5 2003
Section 9 510(k) Summary
のお気になる。
| Submitter: | NeoMetrics, Inc.
14800 28th Avenue South, Suite 150
Plymouth, MN 55447
Telephone: 763-559-4440
Fax: 763-559-7676 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact
Person: | Mark Pederson
Product Development Engineer
Telephone: 763-559-4440
Fax: 763-559-7676
pedersonm@qwest.net |
| Date
Prepared: | October 14, 2003 |
| Trade Name: | Selectiva SB Guidewire |
| Classification
Name and
Number: | Wire, Guide, Catheter
870.1330 |
| Product Code: | DQX |
| Predicate
Device(s): | NeoMetrics Selectiva™ Guidewire (K013024)
FlexMedics FlexFinder Guidewire (K943390) |
| Device
Description: | The Selectiva SB Guidewires are constructed of a nickel-titanium
alloy with a PTFE polymer jacket. Devices are available in a
diameter of 0.035 inches and in lengths ranging from 40 to 300 cm. |
| Intended Use: | The NeoMetrics Selectiva SB Guidewire is intended to facilitate
the placement of devices for diagnostic and interventional
procedures.
NOTE: These guidewires are not intended for PTCA use. |
| Functional and
Safety Testing: | Representative samples of the device underwent bench testing to
demonstrate appropriate functional and performance characteristics
compared to the predicate device(s). |
| Conclusion: | The NeoMetrics Selectiva SB 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 of the modified device
compared to the originally, cleared device.
|
1
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and health. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV = 5 2003
NeoMetrics, Inc. c/o Mr. Mark Pederson Product Development Engineer 14800 28th Avenue South, Suite 150 Plymouth, MN 55447
Re: K033321 Selectiva SB Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: October 14, 2003 Received: October 21, 2003
Dear Mr. Pederson:
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. Mark Pederson
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 vours.
Elsie D. Harvey Jr
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section 3 Indications for Use
The NeoMetrics Selectiva SB Guidewire is intended to facilitate the placement of devices for diagnostic and interventional procedures.
NOTE: These guidewires are not intended for PTCA use.
Prescription Use
(Per 21 CFR 801.109)
Elyn Ots
Bran Zadema
11/4/03
Division of Cardiovascular & Respiratory Devices
510(k) Number K033321
Shaugh BD