(55 days)
Not Found
Not Found
No
The summary describes a physical guidewire used for catheter placement and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a guidewire intended to facilitate catheter placement, which is an accessory to a procedure rather than a direct therapeutic intervention itself.
No
Explanation: The device is a guidewire used to facilitate catheter placement during procedures. It does not perform any diagnostic function itself, such as analyzing data or producing diagnostic information.
No
The device description clearly states it is a physical guidewire, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate placement of a catheter during diagnostic or interventional intravascular procedures." This describes a device used within the body to aid in a medical procedure, not a device used to test samples outside the body (in vitro).
- Device Description: The description details a physical wire used for navigation within blood vessels. This is consistent with an interventional or diagnostic medical device used in vivo.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the Back-Up Meier Guidewire is a medical device used for intravascular procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Back-Up Meier Guidewires are intended to facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The Back-Up Meier Guidewire is intended to facilitate placement of a catheter during diagnostic or interventional intravascular procedures.
Product codes (comma separated list FDA assigned to the subject device)
74 DQX
Device Description
The Back-Up Meier Guidewires are sterile, single-use wires and are available in different tip shapes with overall wire lengths of 185 cm - 300 cm. The distal segment of the wire is radiopaque to aid in visualization of the device under fluoroscopy.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Back-Up Meier Guidewires have been tested and compared to the predicate devices. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised.
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.
Platinum Plus Guidewire, Amplatz Super Stiff 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
ਰਾਸੀ।
0040
Summary of Safety and Effectiveness
| General
Provisions | Trade Name: Back-Up Meier Guidewire
Classification Name: Wire, Guide |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of
Predicate
Devices | Platinum Plus Guidewire
Amplatz Super Stiff Guidewire |
| Classification | Class II |
| Performance
Standards | Performance Standards have not been established by FDA under Section 514
of the Food, Drug and Cosmetic Act |
| Intended Use
and Device
Description | The Back-Up Meier Guidewires are intended to facilitates placement of a
catheter during diagnostic or interventional intravascular procedures The
Back-Up Meier Guidewires are sterile, single-use wires and are available in
different tip shapes with overall wire lengths of 185 cm - 300 cm. The distal
segment of the wire is radiopaque to aid in visualization of the device under
fluoroscopy. |
| Biocompatibility | The Back-Up Meier Guidewires have been tested for biocompatibility per
ISO 10993. All data demonstrate this device is biocompatible for its intended
use. |
| Summary of
Substantial
Equivalence | The Back-Up Meier Guidewires have been tested and compared to the
predicate devices. All data gathered demonstrate this device as substantially
equivalent. No new issues of safety or efficacy have been raised. |
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three wing-like shapes, symbolizing health, services, and human needs. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 3 2001
Ms. Jodi Lynn Greenizen Regulatory Affairs Project Manager Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537
Re: K011906 Back-Up Meier Steerable Guidewire Regulation Number: 870.1330 Regulatory Class: II (two) Product Code: 74 DQX Dated: June 18, 2001 Received: June 19, 2001
Dear Ms. Greenizen:
We have reviewed your Section 510(k) notification of intent to market the device referenced above we have reviewed your beedon Fre(is) hostantially equivalent (for the indications for use stated in and we nave decemmiou the aboved redicate devices marketed in interstate commerce prior to the enclosure) to regally marketed producato accass or to devices that have been May 26, 1970, the Chaomicit date of the Federal Food, Drug, and Cosmetic Act (Act). Teclassified in accordance market the device, subject to the general controls provisions of the Act. The Tourmay, therefore, market the Act include requirements for annual registration, listing of general controls profisions of actice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket n your do round the may be subject to such additional controls. Existing major regulations affecting your Apployal), it the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice equirements, 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 Drug 10gulation (FDA) will verify such assumptions. Failure to comply with the GMP regulation Administration (1 Dri) 111 vertir varily cadition, FDA may publish further announcements concerning may rount in regulater, as Register. Please note: this response to your premarket notification your dovioe in the Pouch any obligation you might have under sections 531 through 542 of the submission does not arroer any overgised your and and provisions, or other Federal laws or regulations.
2
Page 2 - Ms. Jodi Lynn Greenizen
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 diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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 807.97). Other general 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/dsma/dsmamain.html".
Sincerely yours,
J. E. Dillard, III
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
0337
Indications For Use
| 510(k) Number (if known) | Unknown |
|---|---|
| K011906 | |
| Device Name: | Back-Up Meier Guidewire |
| Indications for Use | The Back-Up Meier Guidewire is intended to facilitate placement of a catheter during diagnostic or interventional intravascular procedures. |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
11 - 11 - 11 -
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Regulatory Devices
510(k) Number
| Prescription Use (Per 21 CFR 801.109) | |
|---|---|
| --------------------------------------- | --------------- |
OR
| Over-The Counter Use (Optional Format 1-2-96) | |
|---|---|
| ----------------------------------------------- | --------------- |
ConfidentialConfidential
Boston Scientific Corporation