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

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 steell 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) extrands approximately 0.007" distal of the rounded tip.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the BridgePoint Medical Mantaray™ Guidewire, focusing on modifications to an already cleared device. This submission does not include a study that proves the device meets acceptance criteria in the sense of a clinical trial or a performance study using human or image data.

Instead, this 510(k) is for a modified version of an existing guidewire, and the acceptance criteria and supporting "study" are based on comparative bench testing and biocompatibility testing to demonstrate substantial equivalence to the predicate device. The core idea is that if the modified device performs similarly to the predicate device in key functional and safety aspects, and the changes are minor, then it is considered substantially equivalent.

Here's an analysis of the provided information based on your requested points, recognizing that the "device" here is a guidewire, not a diagnostic or AI-driven system, so some of your points are not directly applicable.

1. A table of acceptance criteria and the reported device performance

The document lists performance characteristics that were evaluated for the modified Mantaray™ Guidewire and states that the device "met the established performance criteria." However, it does not provide specific numerical acceptance criteria or quantitative performance results in a table. It only lists the types of tests performed and a general statement of successful completion.

Acceptance Criteria (General)	Reported Device Performance
Mechanical Performance:
Tensile Strength	Met established criteria
Dimensional Accuracy	Met established criteria
Guidewire Insert & Withdrawal	Met established criteria
Flexibility	Met established criteria
Fatigue Resistance	Met established criteria
Coating Integrity	Met established criteria
Torque Response	Met established criteria
Surface Defect Absence	Met established criteria
Tip Memory Retention	Met established criteria
Radiopacity	Met established criteria
Biocompatibility:
Cytotoxicity	Met established criteria
Kligman Sensitization	Met established criteria
Irritation	Met established criteria
Prothrombin Time Assay	Met established criteria
Complement Activation Assay	Met established criteria
In Vivo Thrombogenicity	Met established criteria
In Vitro Hemocompatibility	Met established criteria
Unactivated Partial Thromboplastin Time	Met established criteria
Pyrogenicity	Met established criteria
Acute Systemic Cytotoxicity	Met established criteria

The "established performance criteria" are defined by the predicate device's performance and the general requirements for guidewires of this type. The study demonstrates that the modified device performs comparably to the predicate and meets these safety and performance benchmarks.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated in terms of number of guidewires tested for each category. For bench testing, typical "sample sizes" would refer to the number of units tested per configuration/material, which is not provided.
Data Provenance: The testing was "in vitro bench testing" and "biocompatibility tests," implying laboratory settings. There is no mention of country of origin for data.
Retrospective or Prospective: Not applicable for bench and biocompatibility testing. These are controlled laboratory tests performed to demonstrate device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This is a physical medical device (guidewire), not a diagnostic algorithm or imaging system requiring expert interpretation for "ground truth." The performance criteria are objective, physical measurements and biological responses.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No expert adjudication was required for the bench and biocompatibility test results.

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

Not applicable. This device is a guidewire, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a guidewire, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is based on established engineering specifications, material science principles, and biological safety standards. Bench tests (e.g., tensile strength, flexibility, radiopacity) have objective, measurable outcomes compared against predetermined ranges or relative to the predicate device's performance. Biocompatibility tests compare material interactions against known safe biological responses.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set."

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

Not applicable. No training set was used.

Summary

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BridgePoint Medical Mantarav™ Guidewire Special 510(k)

1. 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: K120881

Applicant Information:

Date Prepared:	April 18, 2012
----------------	----------------

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, Catheter Guide Wire, 870.1330
Trade Name:	Mantaray™ Guidewire
Common Name:	Catheter Guide Wire
Classification Name:	Catheter Guide Wire

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:

K111488 - Mantaray™ Guidewires

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Device Description:

Intended Use:

The BridgePoint Medical Mantaray™ Guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous rannelur on angiography (PTA). The Mantaray™ Guidewires are not to be used in cerebbel hanside vessels.

Comparison to Predicate Device(s):

The additional models and modified Mantaray™ Guidewires are substantially equivalent to the previously cleared Mantaray™ Guidewires, K111488, in that they are all designed to facilitate placement of balloon dilatation catheters or other intravascular devices during PTA.

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™ Guidenives are manufactured using the same 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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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
Coating .
Torque .
Surface Defects .
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 MantarayTM Guidewires.

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

. Cytotoxicity
Kligman Sensitization .
Irritation .
Prothrombin Time Assay (Indirect) Complement Activation Assay (Indirect) .
- . In Vivo Thrombogenicity, and

In Vitro Hemocompatibility

Unactivated Partial Thromboplastin Time. .
. Pyrogen
Hemocompatibility (Indirect) .

Acute Systemic Cytotoxicity

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 Mantaray™ Guidewires have been shown to be substantially equivalent to the currently marketed predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

APR 1 8 2012

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

Re: K120881

Trade/Device Name: Mantaray™ Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: March 22, 2012 Received: March 23, 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, 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.

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Page 2 – Ms. Jill Munsinger

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hilleber

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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8. INDICATIONS FOR USE STATEMENT

510(k) Number: (TBA)

BridgePoint Medical Mantaray™ Guidewires Device Name:

Indications For Use:

X 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

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

K120881 510(k) Number_

Page 18 of 111

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.