The BridgePoint Medical Stingray™ Guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Stingray™ Guidewires are not to be used in the cerebral blood vessels.

When used as part of the BridgePoint Medical System (consisting of the CrossBoss™ Catheter, Stingray™ Catheter, and Stingray™ Guidewire), the Stingray™ Guidewire is indicated for use to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention.

Device Description

The modified Stingray™ Guidewires are conventionally constructed, single use. disposable guidewires that consist of a full-length stainless steel shaft with proximal PTFE coating where the distal portion of the stainless steel core is taper ground to provide distal flexibility. The distal portion also includes a coaxially positioned coil constructed of platinum/tungsten material for visibility under fluoroscopy. The coil is fixed to the stainless steel core wire via silver alloy solder and is hydrophilic coated. The distal tip of the guidewire is supplied with an angled geometry which transitions to a conventional rounded tip. A short extension with an approximate diameter of 0.0035" (which is a monolithic extension of the core wire) extends approximately 0.007" distal of the rounded tip.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the BridgePoint Medical Stingray™ Guidewire, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific quantitative performance metrics against predefined acceptance criteria for a new, distinct function. Instead, the "acceptance criteria" are implied by the performance of the predicate device and the design requirements for the modified guidewires. The study aimed to show that the modifications did not negatively impact the performance of the original design.

Therefore, the table below reflects this approach:

Acceptance Criteria (Implied)	Reported Device Performance
Maintain physical attributes (flexibility, radiopacity, lubricity, tensile, torque, etc.) comparable to predicate devices.	The modified Stingray™ Guidewires were evaluated using in vitro bench testing for: Tensile, Dimensional, Guidewire Insert & Withdrawal, Flexibility, Fatigue, Coating, Torque, Surface Defects, and Tip Memory, and Corrosion. All results demonstrated that the modified guidewires met the original design requirements of the currently marketed Stingray™ Guidewires.
Biocompatibility of new materials (core wire, PTFE colorant) comparable to existing standards.	Biocompatibility tests included: Cytotoxicity, Kligman Sensitization, Irritation, Acute Systemic Cytotoxicity, Pryogen, Hemocompatibility (In Vitro & Complement Activation Assay), In Vivo Thrombogenicity, and Unactivated Partial Thromboplastin Time. All results demonstrated the materials, manufacturing processes, and design met established performance criteria and will perform as intended.
Performance as intended for facilitating placement of balloon dilatation catheters or other intravascular devices during PTCA and PTA.	The modifications (core wire material change from 304 to 302 stainless steel, PTFE colorant change, and platinum tungsten coil diameter change from 0.0025" to 0.0020" for specific models) were demonstrated to meet the original design requirements through bench testing. In vivo testing on the modified device was not deemed necessary as animal studies were successfully completed with the currently marketed Stingray™ Guidewires (the predicate).

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

Sample Size for Test Set: Not explicitly stated. The document refers to "in vitro bench testing" and "biocompatibility tests" but does not specify the number of test articles or samples used for each test.
Data Provenance: The studies were in vitro bench tests and biocompatibility tests. The document does not specify the country of origin for the data, but the submission is to the U.S. FDA, implying adherence to relevant US standards. The nature of these tests means they are not retrospective or prospective patient data, but rather controlled laboratory experiments.

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

This section is not applicable for this type of submission. The "ground truth" for this device's performance evaluation is based on engineering specifications, material science, and established biocompatibility standards. It does not involve human interpretation or consensus from clinical experts for the primary performance evaluation. The success is determined by meeting predefined engineering and biological criteria.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., medical imaging reads) to resolve discrepancies. Given that this study relied on objective bench testing and biocompatibility assessments, no human adjudication was required.

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 section is not applicable. This is a submission for a modified medical guidewire, not an AI software device. Therefore, no MRMC study or AI-related comparative effectiveness analysis was performed or is relevant.

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

This section is not applicable. This device is a physical medical guidewire, not an algorithm or AI software. There is no "standalone performance" in the context of an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

Engineering Specifications and Design Requirements: The performance criteria used for the bench tests (tensile, flexibility, torque, etc.) are derived from the original design requirements for the Stingray™ Guidewires, which are established engineering standards for medical guidewires.
Biocompatibility Standards: The biocompatibility tests are assessed against recognized international standards for biological evaluation of medical devices (e.g., ISO 10993 series).
Predicate Device Performance: The primary ground truth is the established performance and safety profile of the legally marketed predicate Stingray™ Guidewires (K081187 and K083727), to which the modified device is compared for substantial equivalence.

8. The Sample Size for the Training Set

This section is not applicable. This is not an AI or machine learning device, so there is no concept of a "training set."

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

This section is not applicable for the same reason as point 8.

Summary

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BridgePoint Medical Stingray™ Guidewire Special 510(k)

ge 1 of 3

NOV 8 2012

9. 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: K122795

Applicant Information:

September 11, 2012 Date Prepared:

Name: Address:

BridgePoint Medical 13355 10th Ave. N., #110 Plymouth, MN 55441 Phone: 763-225-8500 Fax: 763-225-8718

Contact Person:	Jill Munsinger
Phone Number:	office: 763-225-8510 / cell: 651-270-0572
E-mail:	jmunsinger@bridgepointmedical.com

Device Information:

Classification:	Class II Percutaneous Guidewire
Trade Name:	Stingray™ Guidewire
Common Name:	Percutaneous Guidewire
Classification Name:	Percutaneous Guidewire

Predicate Devices:

The modified BridgePoint Medical Stingray™ Guidewires are substantially equivalent in intended use, method of operation and technical aspects to the following predicate device:

K081187 and K083727 - Stingray™ Guidewires K 102725 - BridgePoint Medical System consisting of the CrossBoss™ Catheter, Stingray™ Catheter and Stingray™ Guidewire

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BridgePoint Medical Stingray™ Guidewire Special 510(k)

K122795 Page 2

Device Description:

Intended Use:

The BridgePoint Medical Stingray™ Guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angiography (PTCA) and percutaneous transluminal angiography (PTA). The Stingray™ Guidewires are not to be used in cerebral blood vessels.

Comparison to Predicate Device(s):

The modified Stingray™ Guidewires are substantially equivalent to the previously cleared Stingray™ Guidewires. K081187 and K083727. in that they are all designed to facilitate placement of balloon dilatation catheters or other intravascular devices during PTCA and PTA procedures.

The Stingray™ Guidewires and previously cleared Stingray™ Guidewires are manufactured using the same processes and components and have similar physical attributes (flexibility, radiopacity, lubricity, tensile, torque, etc.). The distal tips of each device are radiopaque and can be seen with fluoroscopy for precise placement. All devices are highly lubricious for smooth delivery of multiple devices.

The modifications made to the originally cleared Stingray™ Guidewires include changes in the core wire material, colorant compound used in the proximal PTFE coating, and platinum tungsten coil diameter of the hydrophilic guidewires only (models M-3004 and M-3012). The core wire material is being modified from 304 stainless steel to 302 stainless steel. The PTFE colorant is being modified from chromium oxide green (CAS i 308-38-9) to cobalt titanate green (CAS 68186-85-6). Both of the new materials (core wire and proximal coating colorant) are currently used on other legally marketed devices within the same classification regulation for the same intended use. The distal platinum tungsten coil diameter is being modified from 0.0025" to 0.0020".

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BridgePoint Medical Stingray™ Guidewire Special 510(k)

K122795 Page 3 of 3

Performance Data:

The modified Stingray™ Guidewires have been evaluated using the following in vitro bench testing to confirm the performance characteristics as compared to the predicate device:

Tensile .
Dimensional .
Guidewire Insert & Withdrawal
Flexibility .
Fatigue .
Coating
Torque
Surface Defects
Tip Memory, and
Corrosion

In vivo testing was not deemed necessary based on the significance of the proposed modifications to the baseline device. The modified proximal coating formulation, core wire material, and distal coil dimensions result in a device that meets the original design requirements of the currently marketed Stingray™ Guidewires as demonstrated in the bench tests above. Animal studies were successfully completed with the currently marketed Stingray™ Guidewires.

Biocompatibility tests were completed to ensure all materials utilized to construct the modified Stingray™ Guidewires were biocompatibility tests included:

Cytotoxicity .
. Kligman Sensitization
Irritation .
Acute Systemic Cytotoxicity .
Pryogen .
Hemocompatibility
In Vitro Hemocompatibility t
. Complement Activation Assay (Direct)
In Vivo Thrombogenicity, and .
Unactivated Partial Thromboplastin Time.

All results demonstrated the materials, manufacturing processes, and design of the modified Stingray™ Guidewires met the established performance criteria and will perform as intended.

Summary:

Based upon the intended use and descriptive information provided in this pre-market notification, the modifications to the BridgePoint Stingray™ Guidewires have been shown to be substantially equivalent to the currently marketed predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

BridgePoint Medical Ms. Jill Munsinger 13355 10th Ave N, Suite #110 Plymouth, MN 55441 US

8 2012 NOV

Re: K122795

Trade/Device Name: Stingray Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Percutaneous Guidewire Regulatory Class: Class II Product Code: DQX Dated: October 10, 2012 Received: October 11, 2012

Dear Jill Munsinger:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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

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Page 2 - Ms. Munsinger

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/ucm115809.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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

M.S. Killebrew

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

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8. INDICATIONS FOR USE STATEMENT

510(k) Number: (TBA) K | ZZ795

BridgePoint Medical Stingray™ Guidewires Device Name:

Indications For Use:

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)

Cugs hellelie

Page 1 of 1

(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices

510(k) Number K122771

Page 18 of 71

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.