The BridgePoint Medical Mantaray™ Catheter is indicated for directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the peripheral vasculature.

Device Description

The Mantaray™ 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 peripheral vasculature through the central guidewire lumen or through one of two sideports (identified by radiopaque markers). The sideports 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.

AI/ML Overview

This document pertains to the 510(k) premarket notification for the BridgePoint Medical Mantaray™ Catheter, a medical device. The information provided is for a traditional medical device (catheter) and does not involve AI/ML technology, thus many of the requested fields are not applicable.

Here's an analysis of the provided text:

1. Table of acceptance criteria and the reported device performance:

Since this is a 510(k) for a conventional medical device, the "acceptance criteria" are typically demonstrating substantial equivalence to a predicate device through various performance and safety tests. The "reported device performance" indicates that the Mantaray™ Catheter met these established criteria, confirming it performs as intended and is substantially equivalent. Specific quantitative targets or ranges for each test are not explicitly detailed in this summary but are implied to have been met.

Acceptance Criteria (Type of Test)	Reported Device Performance
In vitro Bench Testing:
Tensile	Met established criteria
Burst	Met established criteria
Fatigue	Met established criteria
Inflation & Deflation Time	Met established criteria
Dimensional	Met established criteria
Guidewire Insert & Withdrawal	Met established criteria
Flexibility	Met established criteria
Trackability	Met established criteria
Guidewire Re-Direction	Met established criteria
Markerband Movement & Removal	Met established criteria
Markerband & Guidewire Interaction	Met established criteria
Kink Resistance	Met established criteria
Coating	Met established criteria
Torque	Met established criteria
Surface Defects	Met established criteria
Corrosion Resistance	Met established criteria
Luer and Hub Tests	Met established criteria
Balloon Protector Removal	Met established criteria
Radiopacity	Met established criteria
In vivo Testing (Animal Model):
Functional performance	No reported complications, no angiographic evidence of vessel injury or downstream embolism, no abnormal pathologic findings
Safety	All six animals survived the in-life period
Biocompatibility Testing:
Cytotoxicity L929 MEM ISO	Successfully completed previously, non-toxic
Kligman Sensitization (Maximization) ISO	Successfully completed previously, non-sensitizing
Irritation- Intracutaneous Injection ISO	Successfully completed previously
Acute Systemic Cytotoxicity ISO	Successfully completed previously
Pyrogen - ISO	Successfully completed previously
Hemocompatibility (Direct and Indirect) Hemolysis ASTM	Successfully completed previously
In Vitro Hemocompatibility Assay ISO	Successfully completed previously
Complement Activation (Direct) Assay ISO	Successfully completed previously
In Vivo Thrombogenicity Assay ISO	Successfully completed previously
Unactivated Partial Thromboplastin Time ISO	Successfully completed previously

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 (In vivo): Six animals (porcine model). Each animal had Mantaray™ Catheters inserted into four arteries.
Data Provenance: The in vivo testing was conducted using a porcine animal model. The country of origin for the data is not specified, but the applicant (BridgePoint Medical) is located in Plymouth, MN, USA. The study was prospective in nature for the in vivo portion. Bench testing data provenance is not specified.

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 for this type of device and study. "Ground truth" in the context of this 510(k) submission refers to objective measurements from bench testing and observations/pathology from the animal study, not expert consensus on medical images. The evaluation involved angiographic assessment, histology, pathology, hematology, serum chemistry, and gross necropsy. These would be performed by qualified veterinary pathologists, angiographers, and laboratory technicians, but their specific number and years of experience are not detailed.

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

Not applicable. The in vivo study involved objective biological and pathological assessments and did not require adjudication of human reader interpretations. Bench testing results are typically objective measurements.

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 is a conventional medical device (catheter) and does not involve AI/ML.

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

Not applicable. This is a conventional medical device (catheter) and does not involve an algorithm.

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

In vitro (Bench Testing): Objective physical and mechanical measurements according to established testing protocols and ISO standards.
In vivo (Animal Study): Angiographic evaluation, histology, pathology, hematology, serum chemistry, and gross necropsy. These are objective biological and pathological assessments.

8. The sample size for the training set:

Not applicable. This is a conventional medical device without machine learning components. "Training set" is not relevant here. The manufacturing process and materials were based on the predicate device (Stingray™ Catheter).

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

Not applicable. There is no training set as this is not an AI/ML device.

Summary

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BridgePoint Medical Mantaray™ Catheter Special 510(k)

9. 510(K) SUMMARY

AUG 1 0 2011

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: July 8, 2011

Name: Address: BridgePoint Medical 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:

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

Predicate Devices:

The BridgePoint Medical Mantaray™ Catheter is substantially equivalent in intended use, method of operation and technical aspects to the following predicate device:

K080987 and K101591 - Stingray™ Catheter

Device Description:

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Intended Use:

The BridgePoint Medical Mantaray™ Catheter is indicated for directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the peripheral vasculature.

Comparison to Predicate Device(s):

The Mantaray™ Catheters are substantially equivalent to the Stingray™ Catheters, K080987 and K101591 in that they are both designed to direct, steer, control and support a guidewire in accessing discrete regions of the peripheral vasculature.

The Mantaray™ Catheter is constructed of the same materials as the Stingray Catheter. Modifications were made to the balloon size and proximal shaft stiffness. The Stingray™ Catheters and Mantaray™ Catheters are manufactured using the same processes and components and have similar physical attributes (balloon performance, trackability, tensile, radiopacity, and torque, etc.).

Both devices include radiopaque markers located within the balloon segment to indicate the location of the guidewire lumen ports.

Performance Data:

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

Tensile .
Burst .
Fatigue .
Inflation & Deflation Time .
Dimensional .
. Guidewire Insert & Withdrawal
Flexibility .
Trackability .
Guidewire Re-Direction ●
Markerband Movement & Removal .
Markerband & Guidewire Interaction .
Kink Resistance ●
Coating .
Torque .
Surface Defects ●
Corrosion Resistance .
Luer and Hub Tests .
Balloon Protector Removal, and ●
Radiopacity .

In vivo testing was also completed in accordance with 21 CFR Part 58, "Good Laboratory Practices for Nonclinical Laboratory Studies." The functional performance and safety of the Mantaray™ Catheters were evaluated in a porcine animal model. MantarayTM

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Catheters were inserted into four arteries in each of six animals used for the evaluation. The vessels were evaluated angiographically followed by histology and pathology. Hematology and serum chemistry along with gross necropsy were also used for evaluations. There were no reported complications during each treatment. All sixanimals survived the in-life period with no angiographic evidence of vessel injury or downstream embolism and no abnormal pathologic findings.

Biocompatibility testing on the Mantaray™ Catheters was not completed as all materials are included in the predicate device, Stingray™ Catheter. Biocompatibility testing was successfully completed previously and demonstrated the materials used in the design and manufacture of the device are non-toxic and non-sensitizing to biological tissues consistent with the intended use. The following Biocompatibility tests were previously completed:

Cytotoxicity L929 MEM ISO .
Kligman Sensitization (Maximization) ISO �
Irritation- Intracutaneous Injection ISO .
Acute Systemic Cytotoxicity ISO .
. Pyrogen - ISO
Hemocompatibility (Direct and Indirect) Hemolysis ASTM .
In Vitro Hemocompatibility Assay ISO .
Complement Activation (Direct) Assay ISO ●
In Vivo Thrombogenicity Assay ISO, and .
Unactivated Partial Thromboplastin Time ISO .

All test results demonstrated the materials, manufacturing processes, and design of the Mantaray™ Catheters 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 BridgePoint Mantaray™ Catheters have been shown to be substantially equivalent to the currently marketed predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing its wings and tail feathers. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the left side of the logo.

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

BridgePoint Medical, Inc. C/O Jill Munsinger 2800 Campus Drive, Ste. #50 Plymouth, MN 55441

Re: K111963

AUG 1 0 2011

Trade/Device Name: Mantaray™ Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: July 08, 2011 Received: July 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 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

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Page 2 – Ms. Jill Munsinger

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.

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™ Catheter Device Name:

Indications For Use:

The BridgePoint Medical Mantaray™ Catheter is indicated for directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the peripheral vasculature.

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

510(k) Number_

Page 19 of 80

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).