The Back-Up Meier Steerable Guidewire facilitates catheter placement and exchange during diagnostic or interventional procedures including AAA endovascular graft procedures.

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.

AI/ML Overview

The provided text describes a medical device, the "Back-Up Meier Steerable Guidewire," and its 510(k) premarket notification to the FDA. The document focuses on establishing substantial equivalence to a predicate device and does not involve a study with acceptance criteria and device performance as typically understood for AI/ML-based medical devices.

Therefore, many of the requested categories are not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a study. The "criteria" for this 510(k) submission are related to demonstrating substantial equivalence through bench testing and biocompatibility.
Reported Device Performance: The document states: "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."

This is a qualitative statement about the outcomes of the tests, not specific performance metrics (e.g., accuracy, sensitivity, specificity) against predefined numerical acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not applicable. The submission refers to "bench testing" and "biocompatibility testing," which typically involve a set number of devices or material samples for physical, mechanical, and biological evaluations, not a "test set" of patient data as implied by the question.
Data Provenance: Not applicable, as there is no patient data involved in this type of submission for this device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. There is no "ground truth" derived from expert consensus on patient data presented in this submission. The evaluation is based on engineering and biological test standards.

4. Adjudication Method for the Test Set:

Not applicable for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This type of study is not relevant for a guidewire device and its 510(k) submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No. This is not an AI/ML algorithm or software device.

7. The Type of Ground Truth Used:

Not applicable. The "ground truth" for the performance of a guidewire is compliance with established engineering and biocompatibility standards, not clinical outcomes data in the context of an AI/ML algorithm.

8. The Sample Size for the Training Set:

Not applicable. There is no AI/ML model being trained.

9. How the Ground Truth for the Training Set Was Established:

Not applicable for the reasons stated above.

Conclusion based on the provided text:

The submission for the Back-Up Meier Steerable Guidewire is a 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The "study" referenced refers to bench testing and biocompatibility testing to show the device meets requirements for its intended use. This is a much different type of evaluation than what is typically performed for AI/ML devices, and therefore, many of the requested details about acceptance criteria, data sets, and expert evaluations are not present in this document. The FDA's letter (K020283) confirms that the device was found substantially equivalent to the predicate device based on the information provided, which included these tests.

Summary

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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 Corporation8600 NW 41st StreetMiami, Florida 33166-3355
Device Generic Name:	Guidewire
Classification:	According to Section 13 of the Federal Food, Drug andCosmetic Act, the device classification is Class II,Performance Standards.
Predicate Devices:	The following device is referenced in this premarketnotification as the predicate device for the Back-Up MeierSteerable Guidewire:
	Boston Scientific Corporation -- Back-Up Meier SteerableGuidewire (K011906)
	The device mentioned above has been determinedsubstantially equivalent by FDA.

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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.

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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.

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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

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510(k) Number (if known):	New Application
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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)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.