The BridgePoint Medical Peripheral System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices.

Device Description

The additional models and modified Mantaray™ 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 coated with hydrophilic coating. 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"-0.0065" (which is a monolithic extension of the core wire) extends approximately 0.007" distal of the rounded tip.

AI/ML Overview

This document describes the BridgePoint Medical Peripheral System: Mantaray™ Guidewires, a Class II Percutaneous Guidewire, and its special 510(k) submission (K121745) for modified models. The submission focuses on demonstrating substantial equivalence to previously cleared Mantaray™ Guidewires (K120881, K120533).

Based on the provided text, the device is a medical guidewire, and the "acceptance criteria" and "device performance" refer to the results of in vitro bench testing and biocompatibility testing used to demonstrate substantial equivalence to a predicate device.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the modified guidewires were to meet the "original design requirements of the currently marketed Mantaray™ Guidewires" as demonstrated through bench tests and to demonstrate biocompatibility.

Acceptance Criteria Category	Specific Tests Performed	Reported Device Performance
Mechanical/Physical Performance	Tensile	Met established performance criteria
	Dimensional	Met established performance criteria
	Guidewire Insert & Withdrawal	Met established performance criteria
	Flexibility	Met established performance criteria
	Fatigue	Met established performance criteria
	Torque	Met established performance criteria
	Surface Defects	Met established performance criteria
	Coating	Met established performance criteria
	Corrosion	Met established performance criteria
	Tip Memory	Met established performance criteria
	Radiopacity	Met established performance criteria
Biocompatibility	Cytotoxicity	Met established performance criteria
	Irritation	Met established performance criteria
	Kligman Sensitization	Met established performance criteria
	Acute Systemic Cytotoxicity	Met established performance criteria
	Hemocompatibility (Direct & Indirect)	Met established performance criteria
	In Vitro Hemocompatibility	Met established performance criteria
	Complement Activation Assay (Indirect)	Met established performance criteria
	In Vivo Thrombogenicity	Met established performance criteria
	Pyrogen	Met established performance criteria
	Unactivated Partial Thromboplastin Time	Met established performance criteria

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

The document does not specify the exact sample sizes for each in vitro bench test or biocompatibility test. It generally states that the "additional models and modified Mantaray™ Guidewires have been evaluated using the following in vitro bench testing." Given that this is a 510(k) submission for a modification to an existing device, the testing would have been conducted internally by BridgePoint Medical. The data provenance is prospective in the sense that the tests were performed specifically for this submission, using new samples of the modified devices. These are not clinical studies, so country of origin of patient data is not applicable.

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

This information is not applicable (N/A) because the device is a guidewire, and the "ground truth" for its performance is established through in vitro bench testing and biocompatibility assessments against predefined engineering specifications and ISO standards, not through expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable (N/A) for the same reasons as #3. Adjudication methods are typically used in clinical studies or studies involving human judgment (e.g., radiologist reads) to resolve discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study assesses the impact of a device (often AI-based) on human reader performance in interpreting medical data. The Mantaray™ Guidewires are physical medical devices, and their performance is evaluated through bench testing, not through human interpretation of cases.

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

This is not applicable (N/A). The Mantaray™ Guidewire is a physical medical device, not an algorithm or software. Its performance is inherent to its physical properties and design, not an independent algorithm.

7. The type of ground truth used

The "ground truth" for the performance of the Mantaray™ Guidewires is based on:

Engineering specifications and standards: The device's physical and mechanical properties (tensile strength, flexibility, radiopacity, etc.) were tested against established design requirements and likely relevant industry standards.
Biocompatibility standards: The materials used were tested against accepted biocompatibility standards to ensure they are safe for human contact.
Predicate device comparison: The ultimate "ground truth" for this 510(k) is the demonstration of substantial equivalence to the previously cleared Mantaray™ Guidewires, meaning the modified device performs comparably to a device already deemed safe and effective.

8. The Sample Size for the Training Set

This is not applicable (N/A). There is no "training set" as this is not a machine learning or AI-driven device. The guidewires are manufactured physical products.

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

This is not applicable (N/A) for the same reason as #8.

Summary

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BridgePoint Medical Peripheral System special 510(k)

9. 510(K) SUMMARY

. JUL 1 3 2012

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

K121745 510(k) Number:

Applicant Information:

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

June 13, 2012

Device Information:

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

Predicate Devices:

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

K120881 -- Mantaray™ Guidewires K120533 - BridgePoint Medical Peripheral System

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Device Description:

Intended Use:

The BridgePoint Medical Mantaray™ Guidewires when used as part of the BridgePoint Medical Peripheral system are intended to facilitate placement of conventional guidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices.

Comparison to Predicate Device(s):

The additional models and modified Mantaray™ Guidewires are substantially equivalent to the previously cleared Mantaray™ Guidewires that are utilized in the BridgePoint Medical Peripheral System, K120533, in that they are all designed to facilitate placement of conventional guidewires beyond stenotic peripheral lesions prior to placement of other interventional devices.

The additional models of Mantaray™ Guidewires are a result of modifications to the overall guidewire length as compared to previously cleared models. The additional models of Mantaray™ Guidewires and previously cleared Mantaray™ Guidewires are manufactured using the same general processes and components and have the same 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 Mantaray™ Guidewires include a modification in the core wire material and colorant compound used in the proximal PTFE coating. 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 1308-38-9) 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.

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BridgePoint Medical Peripheral System special 510(k)

Performance Data:

The additional models and modified Mantaray™ 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 .
Torque Surface Defects .
Coating
Corrosion ●
Tip Memory, and
Radiopacity

In vivo testing was not deemed necessary based on the significance of the proposed modifications to the baseline device. The shorter length guidewires and modified proximal coating formulation results in a device that meets the original design requirements of the currently marketed Mantaray™ Guidewires as demonstrated in the bench tests above. Animal studies were successfully completed with the currently. marketed Mantaray™ Guidewires.

Biocompatibility tests were completed to ensure all materials utilized to construct the modified Mantaray™ Guidewires were biocompatible. Biocompatibility tests included:

Cytotoxicity
Irritation
Kligman Sensitization .
Acute Systemic Cytotoxicity
Hemocompatibility (Direct & Indirect) .
. In Vitro Hemocompatibility
Complement Activation Assay (Indirect) ●
In Vivo Thrombogenicity, and ●
Pyrogen -.
.
Unactivated Partial Thromboplastin Time.
All test results demonstrated the materials, manufacturing processes, and design of the modified Mantaray™ 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 additional models and modifications to the BridgePoint MantarayTM Guidewires have been shown to be substantially equivalent to the currently marketed predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUL 1 3 2012

BridgePoint Medical, Inc. c/o Jill Munsinger 13355 10th Ave N, Ste. 110 Plymouth, MN 55441

Re: K121745

Trade/Device Name: BridgePoint Medical Peripheral System: Mantaray™ Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DOX Dated: June 13, 2012 Received: June 14, 2012

Dear Ms. 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. Ilsting 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.

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Page 2 – Ms. Jill Munsinger

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 155aazes or wouldevice complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must or any I cutial statues and reguirements, including, but not limited to: registration and listing (21 Comply with an the Fee 816qurt Part 801); medical device reporting (reporting of medical CI K Fart 607), adoling (21 CFR 803); good manufacturing practice requirements as set device-related adverse ovents) (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 II you desire specific ad rios 10. Jour Venters Offices/CDRH/CDRHOffices/ucm115809.htm for go to happen with working and Radiological Health's (CDRH's) Office of Compliance. Also, please mote the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulations 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 rou may obtain outer generational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address (000) 050 x fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hilliker

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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BridgePoint Medical Peripheral System special 510(k)

8. INDICATIONS FOR USE STATEMENT

K121745 510(k) Number: (TBA) KASALS

Device Name: BridgePoint Medical Peripheral System

Indications For Use:

Prescription Use (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)

Page 1 of 1

CMGtkillebe

(Division Sian-Off) Division of Čardiovascular 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.