(89 days)
Not Found
Not Found
No
The summary describes a physical guidewire and its mechanical properties, with no mention of software, algorithms, or AI/ML capabilities.
No
The device, a guidewire, is intended to facilitate the placement of diagnostic or therapeutic catheters, but it is not described as performing a therapeutic function itself.
No
The device is a guidewire used to facilitate the placement of other catheters, not to diagnose a condition. Its function is to provide access for diagnostic or therapeutic catheters.
No
The device description explicitly states it is a guidewire with accessories (torque device, introducer) and describes physical testing (tensile, flexibility, torque strength, etc.), indicating it is a physical medical device, not software-only.
Based on the provided information, the Transend EX Platinum Guidewire is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "general intravascular use, including the neuro and peripheral vasculature" to facilitate the placement of catheters. This is an in vivo (within the living body) application, not an in vitro (outside the living body) diagnostic test.
- Device Description: The description focuses on the physical properties and performance of the guidewire itself for navigation within blood vessels.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide diagnostic information based on such analysis.
- Anatomical Site: The anatomical site is "intravascular," which is within the body.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Transend EX Platinum Guidewire is a medical device used for procedural guidance within the body.
N/A
Intended Use / Indications for Use
Transend EX Platinum Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The wire can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries. A torque device (pin vise) is included with the wire to facilitate directional manipulation of the guidewire. A guidewire introducer is included with each wire to facilitate the introduction of the guidewire into catheter hubs or hemostatic valves.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The BSC Transend EX Platinum Guidewire with hydrophilic coating and accessories are intended for general intravascular use including the peripheral and neurovasculature. The devices will be provided sterile, and are intended for one procedure use only. Testing and evaluation included tip tensile, tip flexibility, torque strength, torque response, coating adherance, coating extraction, lubricity testing, biocompatibility and in vivo testing.
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)
Testing and evaluation included tip tensile, tip flexibility, torque strength, torque response, coating adherance, coating extraction, lubricity testing, biocompatibility and in vivo testing.
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.
BSC Transend EX Steerable Guidewire, BSC Preceder Guidewire, Terumo Corporation's Glidewire Gold Guidewire
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
510(k) Premarket Notification
BSC Transend EX Platinum Guidewire
·
ﻪﺳﺴ
April 2, 1997
JUL ** | 1997
ATTACHMENT K
SUMMARY OF SAFETY AND EFFECTIVENESS
1
ATTACHMENT K
SUMMARY OF SAFETY AND EFFECTIVENESS
Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification either an "... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation choose to submit a summary of information respecting safety and effectiveness. According to §513(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects ... "
The summary regarding the adverse health effects of the proposed Transend EX Platinum Guidewire is as follows:
| Trade Name: | Transend EX Platinum Guidewire |
|---|---|
| Manufacturer: | BSC/SciMed Life Systems, Inc. |
| 2010 E. Center Circle | |
| Maplegrove, MN 55441 | |
| Device Generic Name: | Guidewire |
| Classification: | According to Section 513 of the Federal Food, Drug and |
| Cosmetic Act, the device classification is Class II, | |
| Performance Standards (CFR 870.1330). | |
| Predicate Devices: | BSC Transend EX Steerable Guidewire |
| BSC Preceder Guidewire | |
| Terumo Corporation's Glidewire Gold Guidewire |
Product Desription:
The BSC Transend EX Platinum Guidewire with hydrophilic coating and accessories are intended for general intravascular use including the peripheral and neurovasculature. The devices will be provided sterile, and are intended for one procedure use only. Testing and evaluation included tip tensile, tip flexibility, torque strength, torque response, coating adherance, coating extraction, lubricity testing, biocompatibility and in vivo testing.
Conclusion:
Based on the Indication for Use, technological characteristics and safety and performance testing, the Transend EX Platinum Guidewire has been shown to be safe and effective for its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle's head with three profiles layered on top of each other. The eagle's head is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle's head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mary P. LeGraw Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537
Re : K971254 Transend EX Platinum Guidewire Requlatory Class: II (two) Product Code: DQX Dated: April 2, 1997 Received: April 3, 1997
Dear Ms. LeGraw:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page -
New Application 510(k) Number (il known):
Ocvice Name: Transend EX Platinum Guidewire
Indications I-or Use:
Transend EX Platinum Guidewire is intended for general intravascular use, The including the neuro and peripheral vasculature. The wire can be torqued to .. facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries. A torque device (pin vise) is included with the wire to facilitate directional manipulation of the guidewire. A guidewire introducer is included with each wire to facilitate the introduction of the guidewire into catheter hubs or hemostatic valves.
(Division Sign Circ (Division Sign - Charavascurat, Respiratory, Division
in the arological sological and News
510(k) Number -
(PLEASE OO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CORH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K971254 |
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
| OR | |
|---|---|
| -- | ---- |
| Over-The-Counter Use | |
|---|---|
| -- | ---------------------- |
(Optional Format 1-2-96)