The 110cm V-18 Control Wire is intended for general intravascular usc including the placement of PTA balloon catheters requiring an 0.018" guide wire in hemodialysis AV access procedures. The wire can be torqued to facilitate placement of diagnostic or therapeutic catheters. This device is intended for peripheral vascular use only. A torque device is included with cach wire to facilitate directional manipulation of the guide wire.

Device Description

The 110 cm V-18 Control Wire wire is for use in the percutaneous introduction of catheters including Hemodialysis Access Management procedures. The 110 cm V-18 Control Guide Wire is a sterile, single-use wire that is available in a 110cm nominal wire length, a nominal of 0.018" diameter, a nominal 8 cm taper length, and a shapeable tip. The core is a tapered stainless steel wire which provides the pushability, flexibility, torquability and steerability needed to maneuver into tortuous vessels. The most distal portion of the wire is shapeable. The distal end of the core is covered with a heat-flow polyurethane compounded with tungsten. The tungsten provides the radiopacity necded for visualization. The heatflow is coated with a hydrophillic polymer for ease of use and enhances appearance. A torque device, also cleared in the V-18 Strike 510(k) (K934359) is included in the package and is intended for use at the proximal end of the guide wire to allow manipulation of the wire during the percutaneous procedure.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Boston Scientific V-18 Control Wire and does not contain the specific details required to fully address all aspects of your request regarding acceptance criteria and a definitive study proving the device meets those criteria.

However, based on the principle of substantial equivalence for 510(k) submissions, we can infer the "acceptance criteria" and the "study" by understanding how these types of devices are approved.

Here's an attempt to answer your questions based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria in a table. Instead, it relies on the concept of substantial equivalence to a predicate device. The primary "acceptance criterion" is that the new device (110cm V-18 Control Wire) performs equivalently or better than the predicate device (V-18 Strike Control Guide Wire, K934359) for its intended use, particularly for the new length and additional indication (hemodialysis AV access management).

The "reported device performance" is essentially that the new device met the performance characteristics of the predicate device.

Acceptance Criterion (Inferred)	Reported Device Performance (Inferred)
Technological Characteristics: Equivalent design, manufacturing, sterilization, and fundamental technology to the predicate V-18 Strike Control Guide Wire (except for length).	The 110 cm V-18 Control Wire incorporates equivalent packaging, fundamental technology, manufacturing, and sterilization as the V-18 Strike Control Guide Wire. Its design is identical to the V-18 Strike Control Wire except for the 110cm length. This implies it meets the same performance benchmarks as the predicate in terms of materials, construction, and basic function.
Device Compatibility: Met minimum requirements for intended use.	Device compatibility testing was performed, and the results met minimum requirements and are adequate for its intended use. This suggests that the device interacts as expected with other components (e.g., catheters) and within the physiological environment.
Biocompatibility: Met minimum requirements for intended use.	Biocompatibility testing was performed, and the results met minimum requirements and are adequate for its intended use. This indicates the device is safe for contact with biological tissues and fluids, and does not pose unacceptable risks of toxicity or adverse reactions.
No new safety or performance issues raised.	No new safety or performance issues were raised during the testing regimen. This is a critical acceptance point, as any new issues would necessitate further investigation or design changes.
Performance characteristics of distal wire segments (e.g., Distal Tip Torsion, Combined Load Failure, Torque Response, Tip Flexibility, Polyurethane/PTFE Coating Adherence Test, Torque Slip Force, Pull Tensile Test, Collett Release Test, Deformation Test) are equivalent to the predicate.	Since the distal wire segments are identical to the V-18 Strike Control Wire, the previous test data for these characteristics are considered representative and applicable to the 110cm V-18 Control Wire. This implies the new device performs identically to the predicate in these crucial aspects. The Conclusion states it has been "shown to be adequate for its intended use and is considered to be substantially equivalent."

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

The document states that previous test data for the V-18 Strike Control Wire was not repeated for the 110cm V-18 Control Wire because the distal wire segments are identical. Therefore, the "test set" for the key performance characteristics (like distal tip torsion, torque response, etc.) would be the sample size used in the original V-18 Strike Control Wire testing (K934359).

Sample Size: Not specified in this document. It would be detailed in the original K934359 submission.
Data Provenance: Not specified in this document for the original predicate device data. The studies would have been retrospective in relation to this new 510(k) submission, as they were conducted on the predicate device.

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

This type of submission (for a guide wire) typically relies on in-vitro engineering testing rather than human expert interpretation of images or clinical outcomes to establish "ground truth." Therefore, the concept of "experts establishing ground truth" in the way it might apply to AI/imaging devices is not directly relevant here. The "ground truth" is established by the engineering specifications and validated testing methods measuring physical properties.

4. Adjudication Method for the Test Set

Again, for in-vitro engineering tests, adjudication methods like 2+1 or 3+1 are not typically used. The results are objective measurements against defined specifications (e.g., force, flexibility, adherence). Any discrepancies would be handled through repeat testing or investigation of the testing methodology.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving human interpretation of medical images where AI assistance might improve reader performance. The V-18 Control Wire is a therapeutic/interventional device (catheter guide wire).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone algorithm performance study was not done. This device does not involve an algorithm or AI that operates independently. Its performance is evaluated based on its physical properties and interaction with the human body and other medical instruments.

7. Type of Ground Truth Used

The ground truth used for this type of device, as per the description, would be based on:

In-vitro Engineering Test Data: Objective measurements of physical properties (e.g., tensile strength, torque response, flexibility, coating adherence) against established specifications.
Biocompatibility Standards: Compliance with recognized international standards for biological evaluation of medical devices.
Device Compatibility Data: Verification that the guide wire functions correctly with associated devices (e.g., catheters).

8. Sample Size for the Training Set

There is no explicit "training set" mentioned because this is not an AI/machine learning device. The "data" being referenced for substantial equivalence is the physical test data from the predicate device.

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

As there is no training set in the context of an AI/ML model, this question is not applicable. The "ground truth" for the predicate device's performance was established through rigorous engineering testing and adherence to established medical device standards and regulations at the time of its original 510(k) clearance (K934359).

Summary

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JAN 1 2 2004

Section 4 Summary of Safety and Effectiveness

(Pursuant To Section 12 per 21 CFR 807.92 of the SAFE MEDICAL DEVICES ACT of 1990)

General Provisions

1. Submitter's Name and Address	Boston Scientific CorporationOne Scimed PlaceMaple Grove, Minnesota 55311
2. Contact Person	Deborah ThomasRegulatory Affairs Specialist763-494-2078 (phone)763-494-2981 (fax)thomasd@bsci.com
3. Date Prepared	November 26, 2003
4. Proprietary Name	Boston Scientific Corporation V-18Control Wire
5. Common or Usual Name	Catheter Guide Wire
6. Product Code	74DQX
7. Classification of Device	Class II, 21 CFR Part 870.1330

Predicate Devices

Boston Scientific Strike™ (V-18) Control Guide Wire (K934359; cleared October 7, 1993)

Device Description

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Section 4

The 110 cm V-18 Control Wire is identical to Boston Scientific's currently marketed V-18 Strike Control Wire with the exception of the length and indication. The length of the 110 cmV-18 Control Wire is 110cm, while the lengths of the V-18 Strike Control Wire includes 150cm, 200cm, and 300cm offerings. With the exception of the length, the guide wire design is identical to the V-18 Strike Control Wirc (K934359, cleared October 7, 1993). The V-18 Strike Control Wire guide wire is for use in the percutaneous introduction of catheters. The 110cm V-18 Control Wire includes this indication and also includes hemodialysis AV access management interventions.

The core is a tapered stainless steel wire which provides the pushability, flexibility, torquability and steerability needed to maneuver into tortuous vessels. The most distal portion of the wire is shapeable. The distal end of the core is covered with a heat-flow polyurethane compounded with tungsten. The tungsten provides the radiopacity necded for visualization. The heatflow is coated with a hydrophillic polymer for ease of use and enhances appearance.

A torque device, also cleared in the V-18 Strike 510(k) (K934359) is included in the package and is intended for use at the proximal end of the guide wire to allow manipulation of the wire during the percutaneous procedure.

Intended Use

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Section 4 Summary of Safety and Effectiveness

Technological Characteristics

The 110 cm V-18 Control Guide Wire will incorporate equivalent packaging, fundamental technology, manufacturing, and sterilization as those featured in the predicate Boston Scientific legally marketed guide wire, the V-18 Strike Control Guide Wire. The 110 cm V-18 Control Wire will incorporate an equivalent design as the V-18 Strike Control Guide Wire, except for the 110cm length. The currently marketed V-18 Strike Control Wire is offered in 150cm, 200cm, and 300cm lengths. The 110 cm V-18 Control Wire design is identical to the V-18 Strike Control Wire except for the length.

Non-Clinical Test Summary

Device compatibility testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests met minimum requirements and are adequate for it's intended use. No new safety or performance issues were raised during the testing regimen.

Since the 110cm V-18 guide wire design is identical to the currently marketed V-18 Strike Control Wire, except for the length, all data that was submitted for the V-18 Strike Control Wire is applicable to the 110cm V-18 Guide Wire. The following previous test data for V-18 Strike Control Wire was not repeated, but is representative of the 110cm V-18 Control Wire, since the distal wire segments are identical. These tests include: Distal Tip Torsion, Combined Load Failure, Torque Response, Tip Flexibility, Polyurethane/PTFE Coating Adherence Test, Torque Slip Force, Pull Tensile Test, Collett Release Test, and Deformation Test.

Conclusion

Based on the Indications for Use, technological characteristics, and results of the invitro testing and evaluation, the 110cm V-18 Control Wire has been shown to be adequate for its intended use and is considered to be substantially cquiva-lent to the V-18 Strike Guide Wire (K934359; cleared October 7, 1993).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 2004

Boston Scientific Corporation c/o Ms. Deborah Thomas Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311

K033742 Re:

Trade/Device Name: Boston Scientific V-18 Control Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: November 26, 2003 Received: November 28, 2003

Dear Ms. Thomas:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use black in the May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce prior to may 20, 2011 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Coometic Fore, market the device, subject to the general controls provisions of the Act. The r ou may, therefore, mains 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 may of subject to sater additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast be act now i be mination that your device complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 – Ms. Deborah Thomas

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
s (21 CFR) (2000) (2008) (2005) (2005-12-12) (2) CFR 1000-1050, forth in the quality systems (QS) regulation (2 -51 v as the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 53 -542 of the Action Section 5 product radiation control provisions (Sections 351-742 or uce received in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a le This letter will allow you to begin marketing your revies of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalevice of y premarket notification. The PDA finding of substantial equive 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), please
rs the regulation of the man 1961 - 1941 - also and the regulation entitled If you desire specific advice for your device in ca. Also, please contact the Office of Computation at (301) 57 - - - - - - - (21CFR Patt 807.97). You may obtain
"Misbranding by reference to premarket notification of Small "Misbranding by reference to premarket nonfication (es oct from the Division of Small)
other general information on your responsibilities under (800) 638-204 other general information on your responsibilities and consumer (800) 638-2041 or (301) 443-6597 or at its Internet address

(301) 443-0597 or at its intornet audioss
http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Ashley B. Brane

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: V-18 Control Guide Wire

Indications For Use:

The 110cm V-18 Control Wire is intended for general intravascular use including the The Troun' V To Control viatheters requiring an 0.018" guide wire in hemodialysis AV placemont of 1 17 . Balley can be torqued to facilitate placement of diagnostic or therapeutic catheters. This device is intended for peripheral vascular use only. A therupourily outherer is included with each wire to facilitate directional manipulation of the quide wire.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ashley B. Brown

SM. KJ

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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.