(89 days)
Not Found
No
The 510(k) summary describes a physical guidewire and its mechanical properties and intended use. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML.
No.
The document states that the guidewires facilitate the "selective placement of diagnostic or therapeutic catheters," implying that the guidewires themselves are not therapeutic devices but rather tools used to position other devices that may be therapeutic.
No
The device is a guidewire primarily used for facilitating the placement of other catheters, which can be diagnostic or therapeutic, but the guidewire itself is not described as performing a diagnostic function.
No
The device description clearly indicates it is a physical guidewire, a hardware component, and includes performance studies related to physical properties and biocompatibility.
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 "general intravascular use, including the neuro and peripheral vasculature" to facilitate the placement of diagnostic or therapeutic catheters. This describes a device used within the body for procedural guidance, not for testing samples outside the body.
- Device Description: The description reinforces its use as a physical tool for navigating blood vessels.
- 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 designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a procedural tool used directly in the patient's vasculature.
N/A
Intended Use / Indications for Use
The TransendTM 300 ES Guidewire and TransendTM 300 Floppy Guidewire are intended for general intravascular use, including the neuro and peripheral vasculature. The guidewires can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. These devices are not intended for use in coronary arteries. A torque device (pin vise) is included with the guidewires to facilitate directional manipulation of the guidewires.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The Transend™300 ES Guidewire and Transend™ 300 Floppy Guidewire are intended for general intravascular use, including the neuro and peripheral vasculature. The 300cm length allows exchange of therapeutic devices without the use of other exchange devices, i.e. extension wires. The Transend™300 ES Guidewire and Transend™ 300 Floppy Guidewire have a nominal diameter of 0.014".
All device materials, manufacturing processes and product dimensions are identical to the Boston Scientific Scimed ChoICE™ ES 300cm exchange guidewire and the ChoICE™ 300cm Floppy exchange guidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neuro and peripheral 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)
In vitro performance testing of the Transend 300 ES Guidewire and the Transend 300 Floppy Guidewire included particle analysis, friction testing, angular rotation, tip buckling, and tip stiffness to gain clearance for a neurovascular and peripheral indications.
Biocompatibility testing was verified according to ISO-10993, Biological Evaluation of Medical Devices. Test results confirm biocompatibility of the Transend 300 ES Guidewire and the Transend 300 Floppy Guidewire.
All testing indicates that the devices are safe and perform according to their intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SECTION 2 – 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
July 17, 2002 a. Date Prepared:
b. Contact Person
George J. Prendergast Regulatory Affairs Specialist II Boston Scientific Target 47900 Bayside Parkway Fremont, CA 94538
c. Trade Name
Transend™ 300 ES Guidewire Transend™ 300 Floppy Guidewire
d. Common Name
Catheter Guidewire
e. Classification Name
Catheter Guidewire (21 CFR Section 870.1330)
f. Identification of Predicate Devices
| Number | Description | Clearance Date |
|---|---|---|
| K950069 | DasherTM - 14 Guidewire | 12 April 1995 |
| K950113 | ChoICETM Extra Support | |
| Guidewire | ||
| ChoICETM Floppy Guidewire | 31 March 1995 |
Transend™ 300 ES Guidewire, Transend™ 300 Floppy Guidewire 510(k) Submission
OCT 1 6 2002
1
g. Device Description
The Transend™300 ES Guidewire and Transend™ 300 Floppy Guidewire are intended for general intravascular use, including the neuro and peripheral vasculature. The 300cm length allows exchange of therapeutic devices without the use of other exchange devices, i.e. extension wires. The Transend™300 ES Guidewire and Transend™ 300 Floppy Guidewire have a nominal diameter of 0.014".
All device materials, manufacturing processes and product dimensions are identical to the Boston Scientific Scimed ChoICE™ ES 300cm exchange guidewire and the ChoICE™ 300cm Floppy exchange guidewire.
h. Intended Use
The Transend™300 ES Guidewire and Transend™ 300 Floppy Guidewire Indications For Use are as follows:
The Transend 300 ES Guidewire and Transend 300 Floppy Guidewire are intended for general intravascular use, including the neuro and peripheral vasculature. The guidewires can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. These devices are not intended for use in coronary arteries. A torque device (pin vise) is included with the guidewires to facilitate directional manipulation of the guidewires.
2
i. Product Feature Comparison
| Feature | FasDasher™ – 14
Guidewire
Predicate device | Transend™ 300 ES
Guidewire
Transend™ 300 Floppy
Guidewire
Subject devices | ChoICETM PTCA Exchange
Guidewire
ChoICETM PTCA Exchange
Guidewire
Predicate devices |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | FasDasher-14 Guidewire is
intended to assist delivery
of catheters to selected
vascular sites (neuro
peripheral and coronary
vasculature). | The Transend 300 ES
Guidewire and
Transend 300 Floppy
Guidewire are intended
for general intravascular
use, including the neuro
and peripheral
vasculature. These devices
are not intended for use in
coronary arteries. | The ChoICE ES 300cm
Exchange Guidewire
ChoICE Floppy 300cm
Exchange Guidewire are
intended to facilitate the
placement of balloon
dilatation catheters or
other therapeutic devices
during PTCA. The ChoICE
guidewires are not
intended for use in the
cerebral vasculature. |
| Design: | | | |
| Length | 195cm | 300cm | 300cm |
| Distal
Outside
Diameter | 0.014" minimum | 0.014" minimum | 0.014" minimum |
| Materials | Predominately stainless
steel, platinum,
polytetrafluoroethylene,
polyurethane, lubricious
coating | Predominately stainless
steel, platinum,
polytetrafluoroethylene,
polyurethane, lubricious
coating | Predominately stainless
steel, platinum,
polytetrafluoroethylene,
polyurethane, lubricious
coating |
Transend™ 300 ES Guidewire, Transend™ 300 Floppy Guidewire 510(k) Submission
3
i. Comparison of Technological Characteristics
The Transend™300 ES Guidewire and Transend™ 300 Floppy Guidewire are substantially equivalent to the predicate devices in terms of functionality, intended use, design, materials, method of operation, size, length, sterilization methods, packaging, biocompatibility, and labeling.
k. Testing
In vitro performance testing of the Transend 300 ES Guidewire and the Transend 300 Floppy Guidewire included particle analysis, friction testing, angular rotation, tip buckling, and tip stiffness to gain clearance for a neurovascular and peripheral indications.
Biocompatibility testing was verified according to ISO-10993, Biological Evaluation of Medical Devices. Test results confirm biocompatibility of the Transend 300 ES Guidewire and the Transend 300 Floppy Guidewire.
All testing indicates that the devices are safe and perform according to their intended use.
1. Summary of Substantial Equivalence
Boston Scientific Target's determination of substantial equivalence to Boston Scientific Scimed's ChoICE™ Extra Support Guidewire and ChoICE™ Floppy Guidewire and Boston Scientific Target's FasDasher™- 14 Guidewire as predicate devices is based on the following.
The subject guidewires are substantially equivalent to the FasDasher-14 Guidewire with respect to the following:
- size
- intended use ●
- labeling ●
- . biocompatibility
- packaging
- functionality
- method of operation
Transend™ 300 ES Guidewire, Transend™ 300 Floppy Guidewire 510(k) Submission
Boston Scientific Target
July 2002
4
The subject guidewires are substantially equivalent to the Scimed's ChoICE™ Extra Support Guidewire and ChoICE™ Floppy Guidewire with respect to the following:
- materials .
- . size
- . length
- . labeling
- packaging ●
- sterilization methods .
- . functionality
- design
- method of operation ●
- biocompatibility ●
Based on the above information provided in this submission, Boston Scientific Target's Transend™ 300 ES Guidewire and Transend™ 300 Floppy Guidewire are substantially equivalent to Boston Scientific Target's FasDasher ™-14 Guidewire and Boston Scientific Scimed's ChoICE Extra Support Guidewire and ChoICE Floppy Guidewire.
Transend™ 300 ES Guidewire, Transend™ 300 Floppy Guidewire 510(k) Submission
5
Image /page/5/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head and neck, with three distinct lines forming the head and neck. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 2002
Boston Scientific Target c/o Mr. George J. Prendergast 47900 Bayside Parkway Fremont, CA 94538
K022357 Re:
Transend™ 300 ES Guidewire and Transend™ 300 Floppy Guidewire Regulation Number: 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II (two) Product Code: DQX Dated: July 17, 2002 Received: July 19, 2002
Dear Mr. Prendergast:
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.
6
Page 2 - Mr. George J. Prendergast ·
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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Dalatium
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Image /page/7/Picture/0 description: The image shows the logo for Boston Scientific Target. The words "Boston Scientific" are stacked on top of the word "TARGET". The word "TARGET" is underlined. The font is a serif font.
INDICATIONS FOR USE STATEMENT
510(k) Number: _ K022.357
Device Name: Transend™ 300 ES Guidewire and Transend™ 300 Floppy Guidewire
Indications for Use:
The Transend™ 300 ES Guidewire and Transend™ 300 Floppy Guidewire are intended for general intravascular use, including the neuro and peripheral vasculature. The guidewires can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. These devices are not intended for use in coronary arteries. A torque device (pin vise) is included to facilitate directional manipulation of the guidewires.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
(Per 21 CFR 801.109)
Over The Counter Use
Division of Cardiovascular & Respiratory Devices
510(k) Number K022357
Transend™ 300 ES Guidewire, Transend™ 300 Floppy Guidewire 510(k) Submission