The BridgePoint Medical System (consisting of the CrossBoss™ Catheter, Stingray™ Orienting Balloon Catheter, and Stingray™ Guidewire) is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions) prior to PTCA or stent intervention.

Device Description

The CrossBoss Catheter is a single use over the wire disposable percutaneous catheter consisting of a full length coiled stainless steel shaft with polyester and polyurethane exterior. The coiled shaft provides torque and makes it possible to push the device, and also provides a guidewire lumen. The distal shaft transitions to an enlarged (1mm diameter) rounded distal tip. This stainless steel tip provides an atraumatic element that is intended to enhance the catheter's ability to move within the vasculature with reduced risk of arterial tissue engagement while providing radiopaque visibility. The distal portion of the CrossBoss Catheter is hydrophilic coated to enhance lubricity. The proximal portion includes an internal stainless steel hypotube stiffener that provides additional push. A torque device, coaxially positioned over the proximal portion of the CrossBoss Catheter, provides a comfortable user interface for device manipulation. The torque device (similar to a guidewire torque device) is positionable along the proximal portion of the catheter and includes a torsion release safety mechanism. This safety mechanism insures the torque input generated by the user remains within the torsional operating strength of the catheter shaft.

The Stingray Orienting Balloon Catheter is a single use, over-the-wire, disposable, dual lumen percutaneous catheter that facilitates the placement, support and steering of a guidewire into discrete regions of the coronary and peripheral vasculature through the central guidewire lumen or through one of two side-ports (identified by radiopaque markers). The side-ports connect with the central guidewire lumen and facilitate guidewire steering (at an angle to the central lumen) by allowing the guidewire to exit the catheter. The catheter contains a small non-compliant balloon segment used for fluoroscopic orientation on the distal tip of the flexible shaft.

The Stingray Guidewire is a conventionally constructed 0.014" diameter, single use, disposable guidewire that consists of a full-length stainless steel shaft with proximal PTFE coating where the distal portion of the shaft 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. The core wire (~0.0035" diameter) extends approximately 0.007" distal of the rounded tip.

AI/ML Overview

The provided document is a 510(k) summary for the BridgePoint Medical System. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. However, this document does not contain acceptance criteria for device performance or a study proving that the device meets specific performance criteria in the way typically associated with AI/ML-driven medical devices.

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices based on identical designs, prior bench testing, and biocompatibility tests. It briefly mentions a clinical study to support the system's function, but this study is not presented with acceptance criteria or detailed results in the context of device performance metrics.

Therefore, many of the requested items (e.g., specific acceptance criteria, sample size for test sets directly related to acceptance criteria, ground truth establishment, MRMC studies, standalone performance) are not present in this type of regulatory submission.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices, asserting that the prior bench testing and biocompatibility of the identical predicate devices are directly applicable. There are no explicit performance acceptance criteria (e.g., sensitivity, specificity, accuracy, or specific mechanical thresholds) outlined as part of this particular submission for the BridgePoint Medical System.

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

Test Set (Clinical Study):
- Sample Size: A "147 patient study" was conducted.
- Data Provenance: "in the United States."
- Retrospective or Prospective: Not explicitly stated, but clinical studies for regulatory submissions are typically prospective.

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

This information is not provided. The document states the clinical study "demonstrated the BridgePoint Medical System could successfully allow the placement of guidewires beyond chronic total occlusions with no significant increase in risk to the patient." It does not detail how the success or risk was formally adjudicated or who the experts were.

4. Adjudication Method for the Test Set:

This information is not provided.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

This information is not provided and is highly unlikely to be applicable to this type of device (catheters and guidewires), which are not typically "AI-assisted reader" devices. The device described is a physical medical instrument, not a diagnostic imaging AI algorithm.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This information is not applicable/provided. The device is a physical catheter system used by a human interventionalist, not an algorithm.

7. Type of Ground Truth Used:

For the 147-patient study: The "ground truth" or primary outcome likely relates to the successful intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions) and patient safety/risk assessment as determined by clinical observation and physician assessment during the procedure. The document states the study "demonstrated the BridgePoint Medical System could successfully allow the placement of guidewires beyond chronic total occlusions with no significant increase in risk to the patient." This implies clinical outcomes and expert judgment as the ground truth.

8. Sample Size for the Training Set:

This information is not provided and is not applicable in the context of this device. This is a physical medical device, not an AI/ML model that requires a "training set."

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

This information is not provided and is not applicable as there is no "training set" for this device.

Summary of what the document does state regarding the study:

Study Purpose: To demonstrate that the BridgePoint Medical System functions "to enhance medical practice in facilitating the placement of guidewires or other interventional devices beyond chronic total occlusions."
Study Outcome: The "147 patient study... demonstrated the BridgePoint Medical System could successfully allow the placement of guidewires beyond chronic total occlusions with no significant increase in risk to the patient."
Context: This study appears to be part of the justification for substantial equivalence, implying that the clinical performance observed was comparable or superior to predicate devices without introducing new safety concerns.

In conclusion, this 510(k) summary focuses on demonstrating substantial equivalence of a physical medical device to existing predicate devices based on design, prior bench testing, and biocompatibility, supported by a general statement about a clinical study's positive outcome. It does not provide the detailed performance acceptance criteria or granular study details typically requested for AI/ML device evaluations.

Summary

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MAY 1 0 2011

510(K) SUMMARY

؟ ﺗﺮﻳﺒﺎ

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: ______________________________________________________________________________________________________________________________________________________________

Applicant Information:

Date Prepared:	January 18, 2011
----------------	------------------

Name: BridgePoint Medical Address: 2800 Campus Drive, #50 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:

Trade Name		Common Name Classification Name	Class
CrossBoss™ Catheter	Percutaneous Catheter	Percutaneous Catheter	Class II
StingrayTM Orienting Balloon Catheter	Percutaneous Catheter	Percutaneous Catheter	Class II
Stingray™ Guidewire	Percutaneous Guidewire	Percutaneous Guidewire	Class II

Predicate Devices:

The BridgePoint Medical System (comprised of the CrossBoss™ Catheter, Stingray™ Orienting Balloon Catheter, and Stingray™ Guidewire) is substantially equivalent (and in some cases identical) in intended use and/or method of operation and technical aspects to the following predicate devices:

Device	Reference 510(k) Number
LuMend FrontrunnerTM CTO Catheter	K013284, K023223, K023114, K031005, and K033535
CrossBossTM Catheter	K081130 and K091841
StingrayTM Orienting Balloon Catheter	K080987 and K101591
StingrayTM Guidewire	K081187 and K083727

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Device Description:

Intended Use:

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Comparison to Predicate Device(s):

The designs of the devices comprising the BridgePoint Medical System are identical to their respective predicate devices. Bench testing was previously conducted using the CrossBoss Catheter, Stingray Orienting Balloon Catheter, and Stingray Guidewire predicate devices in tests designed to address a chronic total occlusion application. Therefore, all prior bench performance testing (tensile, torque, kink resistance, trackability, corrosion, coating durability, particulate, balloon performance, dimensional, etc.) are directly applicable to this application. As well, all previous biocompatibility tests conducted for the aforementioned predicate devices is directly applicable to the devices that comprise the BridgePoint Medical System as they are identical.

As demonstrated in both animal studies and human clinical evaluations, the devices used as a system functions to enhance medical practice in facilitating the placement of guidewires or other interventional devices beyond chronic total occlusions. A 147 patient study was conducted in the United States that demonstrated the BridgePoint Medical System could successfully allow the placement of guidewires beyond chronic total occlusions with no significant increase in risk to the patient.

Summary:

Based upon the intended use and descriptive information provided in this pre-market notification. the BridgePoint Medical System consisting of the CrossBoss™ Catheter, Stingray™ Orienting Balloon Catheter, and Stingray™ Guidewire has been shown to be substantially equivalent to the currently marketed predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three parallel lines forming its body and wings.

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

MAY 1 0 2011

BridgePoint Medical, Inc. c/o Ms. Jill Munsinger Regulatory Affairs 2800 Campus Drive, #50 Plymouth, MN 55441

Re: K102725/S003

Trade/Device Name: Crossboss™ Catheter Model M-2000, Stingray™ Orienting Balloon Catheter Model M-1000 & Stingray™ Guidewire Model M-3004 Regulation Number: 21 CFR 870.1250 & 870-1330 Regulation Name: Percutaneous Catheter & Catheter guide wire Regulatory Class: Class II Product Code: DQY & DQX Dated: April 8, 2011 Received: April 11, 2011

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 In microal in microsite devices that have been reclassified in accordance with the provisions of the Federal Food, Dr u 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 affection 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

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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7. INDICATIONS FOR USE STATEMENT

510(k) Number: (TBA)

Device Name: BridgePoint Medical System consisting of the CrossBoss™ Catheter, StingrayTM Orienting Balloon Catheter, and Stingray™ Guidewire

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)

Page 1 of 1

(Division Sign-Off)
Division of Cardiovascular Devices

K102-728

510(k) Number__

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).