(55 days)
The Back-Up Meier Guidewire is intended to facilitate 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.
This document is a 510(k) summary for the Back-Up Meier Guidewire. It does not describe an AI medical device or a study that employs acceptance criteria in the typical sense for algorithm performance. Instead, it demonstrates substantial equivalence to predicate devices for a physical medical device. Therefore, most of the requested information regarding AI device acceptance criteria and study particulars is not applicable.
Here's an analysis based on the provided text, focusing on the available information and noting the inapplicable sections:
1. Table of Acceptance Criteria and Reported Device Performance
For this medical guidewire, "acceptance criteria" are related to its physical properties, intended use, and biocompatibility, as demonstrated through comparison with predicate devices. Specific quantitative performance metrics in terms of clinical accuracy (like sensitivity, specificity) for a diagnostic AI device are not applicable here.
| Acceptance Criterion (from document) | Stated Performance / Outcome |
|---|---|
| Intended Use | Facilitates placement of a catheter during diagnostic or interventional intravascular procedures. |
| Biocompatibility | Tested per ISO 10993. All data demonstrate this device is biocompatible for its intended use. |
| Substantial Equivalence | Compared to predicate devices (Platinum Plus Guidewire, Amplatz Super Stiff Guidewire). All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised. |
| Sterility | Sterile. |
| Single-use | Single-use. |
| Tip Shapes | Available in different tip shapes. |
| Overall Wire Lengths | Available in 185 cm - 300 cm. |
| Radiopacity | Distal segment is radiopaque to aid in visualization under fluoroscopy. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. This document pertains to a physical medical device (a guidewire) and its substantial equivalence to existing predicate devices. It does not involve a "test set" of data for algorithm performance evaluation. Testing for such devices typically involves bench testing, material testing, and potentially animal or limited human clinical trials (though not detailed here for this 510(k) summary) rather than data-driven algorithm evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. As above, there is no "test set" requiring expert-established ground truth for an AI algorithm. The evaluation of this device is based on its physical characteristics, materials, and comparison to legally marketed predicate devices, assessed by regulatory bodies and engineers/scientists, not clinical experts establishing ground truth for diagnostic accuracy.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No "test set" or adjudication method for AI algorithm performance is mentioned. The review process for a 510(k) submission involves FDA reviewers assessing the provided documentation and testing results to determine substantial equivalence.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This document is for a physical medical device, not an AI device. Therefore, no MRMC study, human reader improvement with AI assistance, or effect size is relevant or reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical guidewire, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. For a physical guidewire, "ground truth" doesn't apply in the context of diagnostic accuracy. Its performance is evaluated through engineering tests, biocompatibility testing (ISO 10993 standards), and comparisons of its design and materials to predicate devices to ensure safety and effectiveness for its intended mechanical function within the body.
8. The sample size for the training set
- Not applicable. This document is for a physical medical guidewire, not an AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This document is for a physical medical guidewire, not an AI device that requires a training set and associated ground truth establishment.
{0}------------------------------------------------
ਰਾਸੀ।
0040
Summary of Safety and Effectiveness
| GeneralProvisions | Trade Name: Back-Up Meier GuidewireClassification Name: Wire, Guide |
|---|---|
| Name ofPredicateDevices | Platinum Plus GuidewireAmplatz Super Stiff Guidewire |
| Classification | Class II |
| PerformanceStandards | Performance Standards have not been established by FDA under Section 514of the Food, Drug and Cosmetic Act |
| Intended Useand DeviceDescription | The Back-Up Meier Guidewires are intended to facilitates placement of acatheter during diagnostic or interventional intravascular procedures TheBack-Up Meier Guidewires are sterile, single-use wires and are available indifferent tip shapes with overall wire lengths of 185 cm - 300 cm. The distalsegment of the wire is radiopaque to aid in visualization of the device underfluoroscopy. |
| Biocompatibility | The Back-Up Meier Guidewires have been tested for biocompatibility perISO 10993. All data demonstrate this device is biocompatible for its intendeduse. |
| Summary ofSubstantialEquivalence | The Back-Up Meier Guidewires have been tested and compared to thepredicate devices. All data gathered demonstrate this device as substantiallyequivalent. 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
§ 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.