The Biotronik Streamer polymer guide wire is a disposable medical device designed for single use only. It consists of a PTFE coated 195cm 0.014" diameter stainless steel core wire, one end of which is reduced in diameter over a 38cm segment in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness and is varied to produce 3 unique levels of support, standard support, extra support (ES) and extra distal support (XT). There are a total of 8 versions of the guidewire, 2 standard support versions (straight & J), 4 extra support versions (straight and ), Bulach and Berlin) and 2 extra distal support versions (straight & J}. The distal part of the reduced section is covered with a platinum tungsten spring coil of equivalent diameter to the main core body. This provides greater visibility on x-ray equipment. A 30cm length of blue heat shrink polymer tubing is applied over the tapered distal end of the wire and ground to form a constant outer diameter, OD. The polymer jacket over distal coils provides for smoother lead-guidewire interaction.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Streamer Polymer Guidewire" and focuses on demonstrating its substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria and performance against them.

Therefore, the requested information for acceptance criteria and specific study details (like sample sizes for test/training, ground truth methods, expert qualifications, MRMC studies, or standalone performance) is not present in the provided document. The document describes a "Summary of Testing" but does not provide granular details on acceptance criteria or the specific methodologies for each test.

Based on the information provided, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the successful tests "demonstrated the Streamer Polymer Guidewires consistently performed within their design parameters, are safe and effective and perform as well as the predicate devices." However, specific quantitative acceptance criteria or detailed performance metrics are not provided.

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

Sample Size for Test Set: Not provided.
Data Provenance: The testing was conducted by Brivant Limited, an Irish company. No information on the country of origin of the data or whether it was retrospective or prospective is given.

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

Not applicable/Not provided. This type of information is typically relevant for studies involving human interpretation (e.g., imaging diagnostics), not for hardware performance testing of a guidewire. The ground truth for guidewire performance is typically based on engineering specifications and physical measurements.

4. Adjudication method for the test set:

Not applicable/Not provided. This is not relevant for the type of bench testing described for a guidewire.

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:

No. This is not applicable as the device is a medical guidewire, not an AI-powered diagnostic tool involving human readers.

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

Yes, a standalone performance assessment was done in the sense that the guidewire's physical characteristics were tested independently. However, the details of "algorithm only" performance are not applicable since it's a physical device, not a software algorithm. The "Summary of Testing" lists various physical and mechanical tests:
- Tensile strength
- Torque strength
- Torque response
- Coating performance
- Radiopacity
- Tip flexibility
- Catheter compatibility testing
- Accelerated aging
- Transportation testing
- Sterilisation validation adoption
- Biocompatibility testing (in compliance with ISO 10993-1 and ISO 10993-4)

7. The type of ground truth used:

For the physical tests, the "ground truth" would be the established engineering specifications, material standards, and benchmark performance of predicate devices. The document states that the successful tests "demonstrated the Streamer Polymer Guidewires consistently performed within their design parameters" and "perform as well as the predicate devices."

8. The sample size for the training set:

Not provided. This is generally not applicable for non-AI medical devices undergoing physical performance testing.

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

Not applicable/Not provided as there is no specific "training set" in the context of physical product testing for a guidewire in the way it is understood for AI/ML models.

Summary

{0}------------------------------------------------

K083094/

Image /page/0/Picture/1 description: The image shows the logo for Brivant Medical Engineering. The word "BRIVANT" is in large, bold, sans-serif font, with a line underneath it. Below the line, the words "MEDICAL ENGINEERING" are printed in a smaller, sans-serif font. The logo is simple and professional, suggesting a company that is focused on medical technology.

Streamer Polymer Guidewire 510(k)

510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

(1) Submitter's Name / Contact Person:

Contact Person:

Brivant Limited, Parkmore West Business Park Galway. Ireland

JUL - 7 2009

Tomas Furey, Vice President Regulatory Affairs Tel: +353 91 385037 Fax: +353 91 766598

(2) Summary Preparation Date:

May 14, 2009

(3) Device Name and Classification: Trade Name: Common Name: . Classification Name: Device Classification:

Biotronik Streamer Polymer Guidewire Guidewire Catheter, Guidewire Class II, 21 CFR §870.1330

(4) Summary of Substantial Equivalence

Predicate devices: Brivant Guidewire (K060551) and Whisper EDS Guidewire (K030019)

The Streamer Polymer Guidewires have minor design differences from the predicate Brivant guidewire and Whisper EDS Guidewire.

The Streamer Polymer guide wires are intended for use in the coronary and peripheral vasculature to facilitate the selective placement of interventional catheters with compatible guidewire lumen and Biotronik coronary venous leads. The intended use is similar to that of the Whisper EDS and the Brivant guidewire with features of the Streamer intended use incorporated into both predicates.

The techological characteristics of the Streamer Guidewire and the predicate guidewires are closely similar. Where there are differences these differences are minor such that they do not affect safety or effectiveness. Brivant have conducted testing which compares the techical similarities between the Streamer Guidewire and predicate devices and this data demonstrates that the minor technical differences have not diminished safety or effectiveness

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the text "BRIVANT" in large, bold letters, with a line underneath. Below that, in smaller letters, is the text "MEDICAL ENGINEERING". The text is black and the background is white.

As a result the Streamer Polymer Guidewire is substantially equivalent to the Brivant Guidewire predicate.

(5) Description of the Device:

The distal part of the reduced section is covered with a platinum tungsten spring coil of equivalent diameter to the main core body. This provides greater visibility on x-ray equipment. A 30cm length of blue heat shrink polymer tubing is applied over the tapered distal end of the wire and ground to form a constant outer diameter, OD. The polymer jacket over distal coils provides for smoother lead-guidewire interaction.

{6) Statement of Intended Use:

(7) Technological Characteristics.

Comparisons of the proposed and predicate devices show that the technological characteristics such as materials, performance characteristics, sterilization and packaging are substantially equivalent to the currently marketed devices.

(8) Summary of Testing:

Performance testing involving the following testing has been completed; tensile strength, torque strength, torque response, coating performance, radiopacity, tip flexibility, catheter compatibility testing, accelerated aging, transportation testing, sterilisation validation adoption, and biocompatibility testing in compliance with ISO 10993-1 and ISO10993-4 has been successfully completed.

The successful tests demonstrated the Streamer Polymer Guidewires consistently performed within their design parameters, are safe and effective and perform as well as the predicate devices.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird-like figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Brivant, Limited % Mr. Tomas Furey Vice President Regulatory Affairs Parkmore West Business Park Galway IRELAND

JUL - 7 2009

Re: K083094

Trade/Device Name: Streamer Polymer Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: II Product Code: DQX Dated: May 29, 2009 Received: June 2, 2009

Dear Mr. Furey:

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 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.

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

{3}------------------------------------------------

Page 2-Mr. Tomas Furey

and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050:

If you desire specific advice for your device on-our-labeling-regulation (21-CFR-Part-801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

yna R. bohner

Image /page/3/Picture/8 description: The image shows a black and white drawing of a cursive letter 'S' with a horizontal line underneath it. The 'S' is stylized with a loop at the top and a curved body. The horizontal line is straight and positioned directly below the base of the 'S'.

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

Enclosure

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the text "BRIVANT" in a large, bold font, with a line underneath it. Below the line, the words "MEDICAL ENGINEERING" are written in a smaller font. The text is black and the background is white.

Streamer Polymer Guidewire Special 510(k)

Indications for Use

K083094 510(k) Number (if known):

Device Name: Streamer Polymer Guidewire

Indications for Use:

Prescription Use × (Per 21 CFR 801 Subpart D) AND/OR

Over the Counter Use_ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

uriel P. Palmer

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number

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.