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 modified 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

The provided text describes a 510(k) summary for the BridgePoint Medical Mantaray™ Catheter. It outlines the device, its intended use, and a comparison to a predicate device, focusing on modifications made. The document details performance data derived from in vitro bench testing.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly state acceptance criteria with specific numerical limits. Instead, it lists a series of performance characteristics that were evaluated to confirm the device meets original design requirements and is substantially equivalent to the predicate. The performance is reported as meeting these requirements through bench testing.

Acceptance Criteria (Implied)	Reported Device Performance
Tensile strength	Met (confirmed via in-vitro bench testing)
Burst strength	Met (confirmed via in-vitro bench testing)
Fatigue	Met (confirmed via in-vitro bench testing)
Inflation & Deflation Time	Met (confirmed via in-vitro bench testing)
Dimensional accuracy	Met (confirmed via in-vitro bench testing)
Hydration	Met (confirmed via in-vitro bench testing)
Guidewire Insert & Withdrawal	Met (confirmed via in-vitro bench testing)
Flexibility	Met (confirmed via in-vitro bench testing)
Trackability	Met (confirmed via in-vitro bench testing)
Guidewire Re-Direction	Met (confirmed via in-vitro bench testing)
Markerband Movement & Removal	Met (confirmed via in-vitro bench testing)
Markerband & Guidewire Interaction	Met (confirmed via in-vitro bench testing)
Kink Resistance	Met (confirmed via in-vitro bench testing)
Coating performance	Met (confirmed via in-vitro bench testing - specifically regarding its removal)
Torque	Met (confirmed via in-vitro bench testing)
Surface Defects	Met (confirmed via in-vitro bench testing)
Balloon Protector Removal	Met (confirmed via in-vitro bench testing)
Overall Goal: Substanti al equivalence to predicate device in performance.	Achieved: "results in a device that meets the original design requirements of the currently marketed Mantaray™ Catheter as demonstrated in the bench tests above."

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

The document does not specify exact sample sizes for each bench test. It states that "in vitro bench testing" was used. The data provenance is not explicitly mentioned (e.g., country of origin), and the tests are described as in vitro bench testing, implying a controlled, laboratory setting rather than a clinical study. It is not retrospective or prospective in the clinical sense.

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)

This information is not provided. The evaluation was based on in vitro bench testing, which typically relies on engineers and technicians demonstrating adherence to specifications, rather than clinical experts establishing ground truth in the way medical imaging or diagnosis studies would.

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

This information is not provided. Given the nature of in vitro bench testing for a mechanical device, a formal adjudication method like those used for expert consensus in clinical studies is not applicable or described.

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

No, an MRMC comparative effectiveness study was not done. This device is a catheter, not an AI-assisted diagnostic tool.

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

This question is not applicable. The device is a physical medical catheter, not an algorithm. Performance was evaluated based on its physical characteristics and functionality in a standalone manner (in vitro).

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

The "ground truth" for this device's performance is adherence to established engineering specifications and functional requirements for a percutaneous catheter, as assessed through various in vitro bench tests. The predicate device's performance served as a benchmark for substantial equivalence.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.

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

This information is not applicable. As stated above, there is no "training set." The "ground truth" for the device's design and manufacturing would have been established through engineering design specifications and quality control procedures, informed by the predicate device's characteristics and clinical needs.

Summary

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FEB - 3 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:	K120129
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Applicant Information:

Date Prepared:	January 13, 2012
Name:	BridgePoint Medical
Address:	13355 10th Ave. N., Ste. #110Plymouth, MN 55441Phone: 763-225-8500Fax: 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 modified BridgePoint Medical Mantaray™ Catheter is substantially equivalent in intended use, method of operation and technical aspects to the following predicate device:

K111963 - Mantaray™ 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 modified Mantaray™ Catheters are substantially equivalent to the current Mantaray™ Catheters, K111963 in that they are both designed to direct, steer, control and support a guidewire in accessing discrete regions of the peripheral vasculature.

The modified Mantaray™ Catheter is constructed of the same materials as the current Mantaray™ Catheter. Modifications were made to remove the coating on the balloon segment, which alleviates the need to soak the device for 10 minutes prior to use. The modified and current Mantaray™ Catheters are manufactured using similar 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 modified 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 .
. Hydration
. Guidewire Insert & Withdrawal
. Flexibility
. Trackability
. Guidewire Re-Direction
Markerband Movement & Removal ●
Markerband & Guidewire Interaction ◆
Kink Resistance .
Coating .
. Torque
. Surface Defects
. Balloon Protector Removal, and

In vivo testing was not deemed necessary based on the significance of the proposed modification to the baseline device. Removal of the coating from the distal 6 cm of the catheter results in a device that meets the original design requirements of the currently

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marketed Mantaray™ Catheter as demonstrated in the bench tests above. Animal studies were successfully completed with the currently marketed Mantaray™.

Likewise, the removal of coating from the distal 6 cm of the device did not warrant additional biocompatibility testing as all materials are included in the currently marketed Mantaray™ Catheter.

Summary:

Based upon the intended use and descriptive information provided in this pre-market notification, the modified BridgePoint Mantaray™ Catheters 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 & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure. The image is black and white.

Public Health Service

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

FEB - 3 2012

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

Re: K120129

Trade/Device Name: Mantaray™ Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: January 13, 2012 Received: January 17, 2012

Dear Ms. Munsinger:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave to viewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered pror to May 2014 sified in accordance with the provisions of the Federal Food. Drug, devices mut have been roomsomed require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelore, mains 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 adultier. Trease noter CDFL wire, 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 If your device is classified (boo as or a) Existing major regulations affecting your device can be may be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may round in wrther 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

M.J. Hillebrand

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 I of 1

M.A.Kildenne

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K120129

Page 19 of 82

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).