The Transend™ 300 ES Guidewire and Transend™ 300 Floppy Guidewire are intended for general intravascular use, including the neuro and peripheral vasculature. The guidewires can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. These devices are not intended for use in coronary arteries. A torque device (pin vise) is included to facilitate directional manipulation of the guidewires.

Device Description

The Transend™300 ES Guidewire and Transend™ 300 Floppy Guidewire are intended for general intravascular use, including the neuro and peripheral vasculature. The 300cm length allows exchange of therapeutic devices without the use of other exchange devices, i.e. extension wires. The Transend™300 ES Guidewire and Transend™ 300 Floppy Guidewire have a nominal diameter of 0.014".

All device materials, manufacturing processes and product dimensions are identical to the Boston Scientific Scimed ChoICE™ ES 300cm exchange guidewire and the ChoICE™ 300cm Floppy exchange guidewire.

AI/ML Overview

The provided document describes the safety and effectiveness of the Transend™ 300 ES Guidewire and Transend™ 300 Floppy Guidewire, primarily through a comparison to predicate devices and in vitro performance testing. It does not detail an AI-driven device, a multi-reader multi-case (MRMC) comparative effectiveness study, or a standalone algorithm-only performance study. Therefore, sections pertaining to these aspects, ground truth, and expert evaluation are not applicable based on the provided text.

Here's an analysis of the available information:

Acceptance Criteria and Device Performance

The acceptance criteria for the Transend™ 300 ES Guidewire and Transend™ 300 Floppy Guidewire are implicitly defined by their "substantial equivalence" to predicate devices and successful in vitro and biocompatibility testing, indicating that the devices perform according to their intended use and are safe. The document directly compares features and explicitly states the outcomes of testing.

Acceptance Criteria / Feature	Reported Device Performance (Transend™ 300 ES Guidewire and Transend™ 300 Floppy Guidewire)
Functionality	Substantially equivalent to predicate devices.
Intended Use	Substantially equivalent to predicate devices (general intravascular use, neuro and peripheral vasculature, not for coronary arteries).
Design	Substantially equivalent to predicate devices.
Materials	Substantially equivalent to predicate devices (predominately stainless steel, platinum, PTFE, polyurethane, lubricious coating).
Method of Operation	Substantially equivalent to predicate devices.
Size (Diameter)	0.014" minimum; substantially equivalent to predicate devices.
Length	300cm; substantially equivalent to predicate devices (specifically ChoICE™).
Sterilization Methods	Substantially equivalent to predicate devices.
Packaging	Substantially equivalent to predicate devices.
Biocompatibility	Confirmed according to ISO-10993; substantially equivalent to predicate devices.
Labeling	Substantially equivalent to predicate devices.
Particle Analysis	Testing included; results indicate proper performance and safety.
Friction Testing	Testing included; results indicate proper performance and safety.
Angular Rotation	Testing included; results indicate proper performance and safety.
Tip Buckling	Testing included; results indicate proper performance and safety.
Tip Stiffness	Testing included; results indicate proper performance and safety.

Study Details

2. Sample size used for the test set and the data provenance

The document explicitly states "In vitro performance testing" for the guidewires, including particle analysis, friction testing, angular rotation, tip buckling, and tip stiffness. However, no specific sample sizes for these tests are provided in the document. The data provenance is implied to be laboratory-based (in vitro) testing conducted by Boston Scientific Target. There is no mention of human subject data, retrospective or prospective studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The studies described are in vitro performance and biocompatibility tests for medical devices, not diagnostic or AI-based assessments requiring expert ground truth for interpretation of images or patient data.

4. Adjudication method for the test set

This information is not applicable, as the tests described are objective, physical, and chemical performance evaluations rather than subjective interpretations requiring adjudication.

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

This information is not applicable as the document describes a guidewire device, not an AI-assisted diagnostic tool or system that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the document describes a physical medical device (guidewire) and its in vitro performance, not an algorithm or AI system.

7. The type of ground truth used

For the in vitro performance tests (particle analysis, friction, angular rotation, tip buckling, tip stiffness), the "ground truth" would be established by objective, predetermined engineering and material science specifications or industry standards for guidewire performance.
For biocompatibility testing, the ground truth was established by adherence to ISO-10993, which provides a framework for biological evaluation of medical devices.

8. The sample size for the training set

This information is not applicable as the document describes a guidewire device, not an AI or machine learning model that would require a training set.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as above.

Summary

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SECTION 2 – 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

July 17, 2002 a. Date Prepared:

b. Contact Person

George J. Prendergast Regulatory Affairs Specialist II Boston Scientific Target 47900 Bayside Parkway Fremont, CA 94538

c. Trade Name

Transend™ 300 ES Guidewire Transend™ 300 Floppy Guidewire

d. Common Name

Catheter Guidewire

e. Classification Name

Catheter Guidewire (21 CFR Section 870.1330)

f. Identification of Predicate Devices

Number	Description	Clearance Date
K950069	DasherTM - 14 Guidewire	12 April 1995
K950113	ChoICETM Extra SupportGuidewireChoICETM Floppy Guidewire	31 March 1995

Transend™ 300 ES Guidewire, Transend™ 300 Floppy Guidewire 510(k) Submission

OCT 1 6 2002

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g. Device Description

h. Intended Use

The Transend™300 ES Guidewire and Transend™ 300 Floppy Guidewire Indications For Use are as follows:

The Transend 300 ES Guidewire and Transend 300 Floppy Guidewire are intended for general intravascular use, including the neuro and peripheral vasculature. The guidewires can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. These devices are not intended for use in coronary arteries. A torque device (pin vise) is included with the guidewires to facilitate directional manipulation of the guidewires.

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i. Product Feature Comparison

Feature	FasDasher™ – 14GuidewirePredicate device	Transend™ 300 ESGuidewireTransend™ 300 FloppyGuidewireSubject devices	ChoICETM PTCA ExchangeGuidewireChoICETM PTCA ExchangeGuidewirePredicate devices
Intended Use	FasDasher-14 Guidewire isintended to assist deliveryof catheters to selectedvascular sites (neuroperipheral and coronaryvasculature).	The Transend 300 ESGuidewire andTransend 300 FloppyGuidewire are intendedfor general intravascularuse, including the neuroand peripheralvasculature. These devicesare not intended for use incoronary arteries.	The ChoICE ES 300cmExchange GuidewireChoICE Floppy 300cmExchange Guidewire areintended to facilitate theplacement of balloondilatation catheters orother therapeutic devicesduring PTCA. The ChoICEguidewires are notintended for use in thecerebral vasculature.
Design:
Length	195cm	300cm	300cm
DistalOutsideDiameter	0.014" minimum	0.014" minimum	0.014" minimum
Materials	Predominately stainlesssteel, platinum,polytetrafluoroethylene,polyurethane, lubriciouscoating	Predominately stainlesssteel, platinum,polytetrafluoroethylene,polyurethane, lubriciouscoating	Predominately stainlesssteel, platinum,polytetrafluoroethylene,polyurethane, lubriciouscoating

Transend™ 300 ES Guidewire, Transend™ 300 Floppy Guidewire 510(k) Submission

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i. Comparison of Technological Characteristics

The Transend™300 ES Guidewire and Transend™ 300 Floppy Guidewire are substantially equivalent to the predicate devices in terms of functionality, intended use, design, materials, method of operation, size, length, sterilization methods, packaging, biocompatibility, and labeling.

k. Testing

In vitro performance testing of the Transend 300 ES Guidewire and the Transend 300 Floppy Guidewire included particle analysis, friction testing, angular rotation, tip buckling, and tip stiffness to gain clearance for a neurovascular and peripheral indications.

Biocompatibility testing was verified according to ISO-10993, Biological Evaluation of Medical Devices. Test results confirm biocompatibility of the Transend 300 ES Guidewire and the Transend 300 Floppy Guidewire.

All testing indicates that the devices are safe and perform according to their intended use.

1. Summary of Substantial Equivalence

Boston Scientific Target's determination of substantial equivalence to Boston Scientific Scimed's ChoICE™ Extra Support Guidewire and ChoICE™ Floppy Guidewire and Boston Scientific Target's FasDasher™- 14 Guidewire as predicate devices is based on the following.

The subject guidewires are substantially equivalent to the FasDasher-14 Guidewire with respect to the following:

size
intended use ●
labeling ●
. biocompatibility
packaging
functionality
method of operation

Transend™ 300 ES Guidewire, Transend™ 300 Floppy Guidewire 510(k) Submission

Boston Scientific Target

July 2002

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The subject guidewires are substantially equivalent to the Scimed's ChoICE™ Extra Support Guidewire and ChoICE™ Floppy Guidewire with respect to the following:

materials .
. size
. length
. labeling
packaging ●
sterilization methods .
. functionality
design
method of operation ●
biocompatibility ●

Based on the above information provided in this submission, Boston Scientific Target's Transend™ 300 ES Guidewire and Transend™ 300 Floppy Guidewire are substantially equivalent to Boston Scientific Target's FasDasher ™-14 Guidewire and Boston Scientific Scimed's ChoICE Extra Support Guidewire and ChoICE Floppy Guidewire.

Transend™ 300 ES Guidewire, Transend™ 300 Floppy Guidewire 510(k) Submission

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Image /page/5/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head and neck, with three distinct lines forming the head and neck. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 6 2002

Boston Scientific Target c/o Mr. George J. Prendergast 47900 Bayside Parkway Fremont, CA 94538

K022357 Re:

Transend™ 300 ES Guidewire and Transend™ 300 Floppy Guidewire Regulation Number: 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II (two) Product Code: DQX Dated: July 17, 2002 Received: July 19, 2002

Dear Mr. Prendergast:

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 - Mr. George J. Prendergast ·

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply 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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,

Dalatium

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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Image /page/7/Picture/0 description: The image shows the logo for Boston Scientific Target. The words "Boston Scientific" are stacked on top of the word "TARGET". The word "TARGET" is underlined. The font is a serif font.

INDICATIONS FOR USE STATEMENT

510(k) Number: _ K022.357

Device Name: Transend™ 300 ES Guidewire and Transend™ 300 Floppy Guidewire

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over The Counter Use

Division of Cardiovascular & Respiratory Devices
510(k) Number K022357

Transend™ 300 ES Guidewire, Transend™ 300 Floppy Guidewire 510(k) Submission

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.