Transend EX Platinum Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The wire can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries. A torque device (pin vise) is included with the wire to facilitate directional manipulation of the guidewire. A guidewire introducer is included with each wire to facilitate the introduction of the guidewire into catheter hubs or hemostatic valves.

Device Description

The BSC Transend EX Platinum Guidewire with hydrophilic coating and accessories are intended for general intravascular use including the peripheral and neurovasculature. The devices will be provided sterile, and are intended for one procedure use only. Testing and evaluation included tip tensile, tip flexibility, torque strength, torque response, coating adherance, coating extraction, lubricity testing, biocompatibility and in vivo testing.

AI/ML Overview

The provided text describes the 510(k) Premarket Notification for the BSC Transend EX Platinum Guidewire. This document details the regulatory approval process for a medical device and typically does not include detailed clinical study reports with acceptance criteria, performance metrics, and information on training/test sets as would be found in a study for an AI/ML device.

However, based on the information provided, I can infer some aspects and highlight what is not present given the nature of a 1997 510(k) for a guidewire, which predates the common rigorous study designs for AI/ML devices.

Here's an analysis based on the provided text, structured according to your requested information, with explicit notes about what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Performance Metric	Reported Device Performance/Conclusion
Mechanical Properties	Tip Tensile Strength	Not explicitly quantified in this summary, but included in "Testing and evaluation" and considered safe and effective.
	Tip Flexibility	Not explicitly quantified in this summary, but included in "Testing and evaluation" and considered safe and effective.
	Torque Strength	Not explicitly quantified in this summary, but included in "Testing and evaluation" and considered safe and effective. "The wire can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters."
	Torque Response	Not explicitly quantified in this summary, but included in "Testing and evaluation" and considered safe and effective.
Coating Properties	Coating Adherence	Not explicitly quantified in this summary, but included in "Testing and evaluation" and considered safe and effective.
	Coating Extraction	Not explicitly quantified in this summary, but included in "Testing and evaluation" and considered safe and effective.
	Lubricity	Not explicitly quantified in this summary, but included in "Testing and evaluation" and considered safe and effective.
Biocompatibility	Biocompatibility Testing	Not explicitly quantified, but included in "Testing and evaluation" and considered safe and effective, implying it met relevant standards.
In Vivo Performance	In Vivo Testing (for general intravascular use, peripheral/neurovasculature)	Not explicitly quantified, but included in "Testing and evaluation" and ultimately concluded as "safe and effective for its intended use" based on "technological characteristics and safety and performance testing." This implies acceptable performance in animal or limited human use, consistent with 510(k) requirements for similar devices.
Overall Conclusion	Safety and Effectiveness for intended use	"The Transend EX Platinum Guidewire has been shown to be safe and effective for its intended use."

Missing Information: For a 1997 510(k) submission for a non-AI/ML device, the acceptance criteria are generally qualitative or involve meeting established mechanical and biological standards (e.g., ISO or ASTM for guidewires) rather than numerical performance metrics like sensitivity/specificity for an AI algorithm. The document states "Testing and evaluation included..." a list of tests, implying that the device met the acceptance criteria for each of these tests, which are typically defined by internal company standards or recognized consensus standards. Specific numerical targets for tensile strength, flexibility, etc., are not disclosed in this summary but would have been part of the full submission.

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

Sample Size: Not specified. For mechanical and biocompatibility testing of a guidewire, the "test set" would refer to the number of guidewire units subjected to each specific test (e.g., how many wires for tensile strength, how many samples for biocompatibility). This information is not in the provided summary.
Data Provenance: Not applicable in the context of clinical data for an AI/ML device. For a physical device like a guidewire, testing is typically done in a laboratory setting (in vitro) and potentially animal studies (in vivo). The summary mentions "in vivo testing," but doesn't specify the exact nature (animal vs. human), location, or retrospective/prospective nature.

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

This concept is not applicable for the approval of this physical guidewire device. "Ground truth" established by experts is primarily relevant for diagnostic devices, especially those involving image interpretation where expert consensus is used to label data.
For a guidewire, safety and effectiveness are established through engineering tests (mechanical, material science) and biological tests (biocompatibility, in-vivo performance) against pre-defined specifications and regulatory standards, not expert annotation of a test set.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert labeling of data, which is common in AI/ML performance studies for diagnostic tasks. This does not apply to the testing of a mechanical guidewire.

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

No, an MRMC study was not done. MRMC studies are used to assess the comparative performance of human readers, often with and without AI assistance, on diagnostic tasks involving case-based data. This guidewire is a therapeutic/interventional device, not a diagnostic one.

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

Not applicable. There is no algorithm for this device. The "performance" being evaluated is the physical guidewire itself, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation would be defined by engineering specifications, material science standards, and biocompatibility standards. For example, a guidewire's tensile strength would be measured against a pre-defined engineering specification. Biocompatibility would be assessed against ISO standards. In-vivo performance would likely be assessed against functional outcomes (e.g., successful navigation, lack of adverse events) in an animal model or limited human use. There is no concept of "expert consensus," "pathology," or "outcomes data" in the sense of labeling a dataset for an AI model.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. There is no training set or associated ground truth for this device.

In summary, the provided document is a 510(k) summary for a medical device cleared in 1997. It describes a physical product (a guidewire) and its regulatory pathway. The concepts of "acceptance criteria" and "study" in this context refer to engineering, biocompatibility, and functional testing to demonstrate substantial equivalence to predicate devices, rather than the rigorous statistical and clinical study methodologies typically associated with modern AI/ML device performance evaluation against specific performance metrics on labeled datasets.

Summary

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K971254

510(k) Premarket Notification
BSC Transend EX Platinum Guidewire

ﻪ‌ﺳﺴ

April 2, 1997

JUL ** | 1997

ATTACHMENT K

SUMMARY OF SAFETY AND EFFECTIVENESS

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ATTACHMENT K

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 choose 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 Transend EX Platinum Guidewire is as follows:

Trade Name:	Transend EX Platinum Guidewire
Manufacturer:	BSC/SciMed Life Systems, Inc.2010 E. Center CircleMaplegrove, MN 55441
Device Generic Name:	Guidewire
Classification:	According to Section 513 of the Federal Food, Drug andCosmetic Act, the device classification is Class II,Performance Standards (CFR 870.1330).
Predicate Devices:	BSC Transend EX Steerable GuidewireBSC Preceder GuidewireTerumo Corporation's Glidewire Gold Guidewire

Product Desription:

Conclusion:

Based on the Indication for Use, technological characteristics and safety and performance testing, the Transend EX Platinum Guidewire has been shown to be safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle's head with three profiles layered on top of each other. The eagle's head is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle's head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Mary P. LeGraw Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537

Re : K971254 Transend EX Platinum Guidewire Requlatory Class: II (two) Product Code: DQX Dated: April 2, 1997 Received: April 3, 1997

Dear Ms. LeGraw:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other qeneral 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/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page -

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

Ocvice Name: Transend EX Platinum Guidewire

Indications I-or Use:

Transend EX Platinum Guidewire is intended for general intravascular use, The including the neuro and peripheral vasculature. The wire can be torqued to .. facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries. A torque device (pin vise) is included with the wire to facilitate directional manipulation of the guidewire. A guidewire introducer is included with each wire to facilitate the introduction of the guidewire into catheter hubs or hemostatic valves.

(Division Sign Circ (Division Sign - Charavascurat, Respiratory, Division
in the arological sological and News

510(k) Number -

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

Concurrence of CORH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	K971254

Prescription Use
(Per 21 CFR 801.109)

	OR
--	----

	Over-The-Counter Use
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(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.