(14 days)
Not Found
No
The summary describes a mechanical guidewire and does not mention any AI or ML components or functionalities.
No
The device is a guidewire used to facilitate catheter placement and exchange during diagnostic or interventional procedures, which are procedural aids, not therapeutic devices.
No
Explanation: The device description states its purpose is to "facilitate catheter placement and exchange during diagnostic or interventional procedures." While it assists in procedures, it does not itself perform a diagnostic function (i.e., it doesn't diagnose a condition or disease).
No
The device description explicitly states it is a "sterile, single-use wire" and mentions physical characteristics like length and radiopacity, indicating it is a physical medical device, not software only.
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 device "facilitates catheter placement and exchange during diagnostic or interventional 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 to diagnose a condition.
- Device Description: The description reinforces this by detailing the physical characteristics of a guidewire used for navigation within the body (sterile, single-use, lengths, radiopaque).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This guidewire does not fit that description.
N/A
Intended Use / Indications for Use
The Back-Up Meier Steerable Guidewire facilitates catheter placement and exchange during diagnostic or interventional procedures including AAA endovascular graft procedures.
Product codes
DQX
Device Description
The proposed Back-Up Meier Steerable Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures including AAA endovascular graft procedures. The Back-Up Meier Steerable Guidewires are sterile, single-use wirres and are available in different tip shapes with overall wire lengths of 185cm - 300cm. 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)
Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing regimen.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
KO20283
January 25, 2002
ATTACHMENT H
FEB 1 1 2002
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 chooses 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 Back-Up Meier Steerable Guidewire is as follows:
| Trade Name: | Back-Up Meier Steerable Guidewire |
|---|---|
| Manufacturer: | Boston Scientific Corporation |
| 8600 NW 41st Street | |
| Miami, Florida 33166-3355 | |
| Device Generic Name: | Guidewire |
| Classification: | According to Section 13 of the Federal Food, Drug and |
| Cosmetic Act, the device classification is Class II, | |
| Performance Standards. | |
| Predicate Devices: | The following device is referenced in this premarket |
| notification as the predicate device for the Back-Up Meier | |
| Steerable Guidewire: | |
| Boston Scientific Corporation -- Back-Up Meier Steerable | |
| Guidewire (K011906) | |
| The device mentioned above has been determined | |
| substantially equivalent by FDA. |
1
The proposed Back-Up Meier Steerable Guidewires are Device Description: intended to facilitate catheter placement and exchange during diagnostic or interventional procedures including AAA endovascular graft procedures. The Back-Up Meier Steerable Guidewires are sterile, single-use wirres and are available in different tip shapes with overall wire lengths of 185cm - 300cm. The distal segment of the wire is radiopaque to aid in visualization of the device under fluoroscopy. The Back-Up Meier Steerable Guidewire facilitates catheter Indications for Use: placement and exchange during diagnostic or interventional procedures including AAA endovascular graft procedures. Safety and Performance: Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing regimen. Based on the Indication for Use, technological Conclusion: characteristics and safety and performance testing, the Back-Up Meier Steerable Guidewire has been shown to be safe and effective for its intended use.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2002
Ms. Jennifer Bolton, RAC Senior Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537
Re: K020283
Trade Name: Back-Up Meier Steerable Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Wire, Guide, Catheter Regulatory Class: Class II (two) Product Code: DQX Dated: January 25, 2002 Received: January 28, 2002
Dear Ms. Bolton:
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.
3
Page 2 - Ms. Jennifer Bolton, RAC
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I Dri 3 issualled or our device complies with other requirements of the Act that IDA has made a decormination administered by other Federal agencies. You must or ally it edelal statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Cr K Fatt 607), labeling (21 CFR Part 820); and if applicable, the electronic forum in the quality systems (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) I hils letter will anow you to ogen mailing of substantial equivalence of your device to a legally prematication. The PDF intembers 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 If you desire specific acrise for your avitro diagnostic devices), please contact the Office of additionally 21 CFN Fall 007.10 101 11:10 Till Times on the promotion and advertising of Compliance at (301) 594-610. Ticalationship, tions of (301) 594-4639. Also, please note the your device, prease connervanding by reference to premarket notification" (21CFR Part 807.97). Tegulation chitteed, "Wilsoranang of responsibilities under the Act may be obtained from the Outer general information on your respectional 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,
Kalle Mell
O. Bram D. Zuckerman, M.D.
Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| 510(k) Number (if known): | New Application |
|---|---|
| ---------------------------------- | ----------------- |
Device Name:
Back-Up Meier Steerable Guidewire
Indications for Use:
The Back-Up Meier Steerable Guidewire facilitates catheter placement and exchange The Buok Op Molor Stockentional procedures including AAA endovascular graft procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K020283
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)