(102 days)
No
The description focuses on the physical characteristics and materials of a guidewire, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is a guidewire, which is used to direct other catheters, not to treat a condition itself.
No
Explanation: The TFX Medical Guidewire is described as a tool for directing catheters through blood vessels, which is an interventional or procedural purpose, not a diagnostic one. There is no mention of it being used to identify or analyze a condition.
No
The device description clearly outlines physical components made of stainless steel, including a core wire, ribbon wire, spring wire, welds, coating, and tips. This indicates a hardware device, not a software-only device.
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 guidewires are for directing a catheter through a blood vessel or other natural channel. This is an in vivo application, meaning it is used within the living body.
- Device Description: The description details the physical components and materials of the guidewire, which are designed for mechanical manipulation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body, not to be inserted into the body for therapeutic or diagnostic procedures like guiding catheters.
N/A
Intended Use / Indications for Use
TFX Medical Guidewires are intended to fit inside a percutaneous catheter for the purpose of directing it through a blood vessel or other natural channel excluding use in coronary arteries and in the neurovasculature.
Product codes
74 DQX
Device Description
TFX Medical will supply a standard range of guidewires as sterile, packed finished products, and will also supply in bulk to other manufacturer to their specific size requirements (for example: for inclusion in a kit).
The kev features of the TFX Medical Guidewire are:
- O Core Wire
- O Ribbon Wire (where fitted)
- O Spring Wire
- O Welds
- Coating (p.t.f.e. coating or uncoated stainless steel)
- Tips (available straight and "J" forms, one or two tips)
Guidewires will be manufactured of grade 302/304 stainless steel and be available:
- . with and without a ribbon wire
- ♥ in fixed and moveable core designs
- . uncoated and p.t.f.e. coated
- with straight and "J" formed end(s)
- with and without a length marking
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessel or other natural channel excluding use in coronary arteries and in the neurovasculature.
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)
Test data in the premarket notification demonstrates TFX Medical Guidewires meeting the requirements of the appropriate parts of British Standard BS 7174: 1990: Part 4.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K914531, K924607, K924438, K841926, K871297, K901899, K920824, K920891, K902152/3, K770977, K864058, K871882, K901224, K914138, K921200, K935170, K935198, K941229
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
Image /page/0/Picture/1 description: The image shows the logo for TFX Medical Incorporated. The logo is black and white and features the letters "TFX" in a bold, sans-serif font. The word "Medical" is written to the right of the letters "TFX", and the word "Incorporated" is written above the "cal" in "Medical". The logo is simple and modern, and it is likely used to represent the company's brand.
DEC - 3 1996
510(k) SUMMARY
[As required by 21 CFR 807.92]
Submitter and Contact Person 1.
Neil R. Armstrong Group Regulatory Affairs Manager TFX Medical Group Tall Pines Park Jaffrev NH 03452 Tel: (603) 532 7706 (603) 532 8211 Fax:
Device Name 2.
Trade Name TFX Medical Guidewire
Common Name Guidewire
Classification Name
Wire, Guide, Catheter 74 DQX; 21 CFR 870.1330; Class II medical device
Comparison Devices 3.
| Teleflex Guidewire - | K850677/B |
|---|---|
| Teleflex Teflon® Coated Guidewire - | K860258/A |
| Teleflex Steerable Guidewire - | K871850 |
Arrow International Inc. -K914531, K924607, K924438 Argon Medical Corporation -K841926, K871297 Cook Incorporated -K901899, K920824, K920891 Guidewire Technologies -K902152/3 Lake Region Manufacturing -K770977. K864058. K871882. K901224, K914138, K921200,
Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108
A. Definition of the Derivative
1
Description of Device 4.
TFX Medical will supply a standard range of guidewires as sterile, packed finished products, and will also supply in bulk to other manufacturer to their specific size requirements (for example: for inclusion in a kit).
The kev features of the TFX Medical Guidewire are:
- O Core Wire
- O Ribbon Wire (where fitted)
- O Spring Wire
- O Welds
- Coating (p.t.f.e. coating or uncoated stainless steel)
- Tips (available straight and "J" forms, one or two tips)
Guidewires will be manufactured of grade 302/304 stainless steel and be available:
- . with and without a ribbon wire
- ♥ in fixed and moveable core designs
- . uncoated and p.t.f.e. coated
- with straight and "J" formed end(s)
- with and without a length marking
క్. Intended Use
TFX Medical Guidewires are intended to fit inside a percutaneous catheter for the purpose of directing it through a blood vessel or other natural channel excluding use in coronary arteries and in the neurovasculature.
6. Summary of Technological Characteristics
TFX Medical Guidewire will be made of stainless steel, with fixed or moveable cores, with or without a ribbon wire, with one or two straight or "J" form tips and will be available uncoated and p.t.f.e. coated. All these technical characteristics are the same as the predicate Teleflex Guidewires.
7. Summary of Performance Data
Test data in the premarket notification demonstrates TFX Medical Guidewires meeting the requirements of the appropriate parts of British Standard BS 7174: 1990: Part 4.