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

Device Description

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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the Stingray™ Orienting Balloon Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the document does not contain information about acceptance criteria, a standalone study to prove device performance against those criteria, or details related to human reader performance with/without AI assistance. The evaluations described are primarily engineering/bench tests demonstrating that changes to the device (balloon material, manifold adhesive, wire lumen) do not alter its performance from the predicate device.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document in the format of specific acceptance criteria values and reported performance values. The submission instead lists a series of design evaluations that were conducted to demonstrate substantial equivalence to the predicate device. These are engineering/bench tests, not clinical performance metrics. The document states "has demonstrated substantially equivalent performance characteristics as compared to the predicate Stingray™ Orienting Balloon," implying the device met internal specifications for these tests, but the specific numerical acceptance criteria and outcomes are not detailed for public consumption in this summary.

Evaluation Category	Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance (Summary)
Mechanical/Physical Tests
Tensile	Implied: Met internal specs	Demonstrated substantially equivalent performance.
Torque	Implied: Met internal specs	Demonstrated substantially equivalent performance.
Hub Leak	Implied: Met internal specs	Demonstrated substantially equivalent performance.
Kink Resistance	Implied: Met internal specs	Demonstrated substantially equivalent performance.
Guidewire Insertion/Withdrawal	Implied: Met internal specs	Demonstrated substantially equivalent performance.
Distal Flexibility	Implied: Met internal specs	Demonstrated substantially equivalent performance.
Distal Trackability	Implied: Met internal specs	Demonstrated substantially equivalent performance.
Crossing Profile	Implied: Met internal specs	Demonstrated substantially equivalent performance.
Guidewire Redirection	Implied: Met internal specs	Demonstrated substantially equivalent performance.
Markerband Movement	Implied: Met internal specs	Demonstrated substantially equivalent performance.
Markerband Removal	Implied: Met internal specs	Demonstrated substantially equivalent performance.
Coating Coverage and Delamination	Implied: Met internal specs	Demonstrated substantially equivalent performance.
Particulate	Implied: Met internal specs	Demonstrated substantially equivalent performance.
Surface Defects	Implied: Met internal specs	Demonstrated substantially equivalent performance.
Wire Insertion Through Hub	Implied: Met internal specs	Demonstrated substantially equivalent performance.
Hemostasis Valve	Implied: Met internal specs	Demonstrated substantially equivalent performance.
Balloon Protector Removal	Implied: Met internal specs	Demonstrated substantially equivalent performance.
Guidewire/Markerband Interaction	Implied: Met internal specs	Demonstrated substantially equivalent performance.
Hub Aspiration	Implied: Met internal specs	Demonstrated substantially equivalent performance.
Balloon Performance Tests
Balloon Burst	Implied: Met internal specs	Demonstrated substantially equivalent performance.
Balloon Fragmentation	Implied: Met internal specs	Demonstrated substantially equivalent performance.
Balloon Fatigue	Implied: Met internal specs	Demonstrated substantially equivalent performance.
Balloon Inflation/Deflation	Implied: Met internal specs	Demonstrated substantially equivalent performance.
Balloon Dimensions	Implied: Met internal specs	Demonstrated substantially equivalent performance.
Biocompatibility Tests	Implied: Met required specifications	Device is biocompatible and met required specifications.
Cytotoxicity	Implied: Met required specifications	Device is biocompatible and met required specifications.
Sensitization	Implied: Met required specifications	Device is biocompatible and met required specifications.
Intracutaneous Injection	Implied: Met required specifications	Device is biocompatible and met required specifications.
Acute Systemic Toxicity	Implied: Met required specifications	Device is biocompatible and met required specifications.
Pyrogenicity	Implied: Met required specifications	Device is biocompatible and met required specifications.
Hemolysis	Implied: Met required specifications	Device is biocompatible and met required specifications.
Unactivated Partial Thromboplastin Time	Implied: Met required specifications	Device is biocompatible and met required specifications.
In vivo Thrombogenicity	Implied: Met required specifications	Device is biocompatible and met required specifications.
Complement Activation	Implied: Met required specifications	Device is biocompatible and met required specifications.
In vitro Hemocompatibility	Implied: Met required specifications	Device is biocompatible and met required specifications.
Physiochemical Evaluates	Implied: Met required specifications	Device is biocompatible and met required specifications.

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

This information is not present in the document. The document describes engineering and biocompatibility evaluations, not a clinical test set with human or observational data.

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 present in the document. The evaluations described are bench tests and biocompatibility tests, not studies requiring expert ground truth establishment in a clinical context.

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

This information is not present in the document. Adjudication methods are typically relevant for clinical studies or studies using human interpretation, which is not the type of evaluation 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

This information is not present in the document. MRMC studies and AI assistance are not relevant to this device or its 510(k) submission, which predates widespread AI in medical devices (2010). The device is a physical catheter, not an AI diagnostic tool.

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

This information is not present in the document. This concept is not applicable to a physical medical device like a catheter.

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

This information is not present in the document. The evaluations described are primarily laboratory/bench tests and biocompatibility assessments, where "ground truth" would relate to meeting predefined engineering specifications and international standards for material safety, rather than clinical outcomes or expert consensus on medical images/diagnoses.

8. The sample size for the training set

This information is not present in the document. This concept is entirely irrelevant to the type of device and submission (physical catheter, 510(k)).

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

This information is not present in the document. This concept is entirely irrelevant to the type of device and submission.

Summary

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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:	K101591
----------------	---------

Applicant Information:

Date Prepared:	June 28, 2010
Name:	BridgePoint Medical
Address:	2800 Campus Drive, #50Plymouth, 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:	Stingray™ Orienting Balloon Catheter
Common Name:	Percutaneous Catheter
Classification Name:	Percutaneous Catheter

Predicate Devices:

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

K080987 - Stingray™ Orienting Balloon Catheter

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Device Description:

Intended Use:

The BridgePoint Medical Stingray™ Orienting Balloon Catheter is indicated for directing, steering, controlling, and supporting a guide wire in order to access discrete regions of the coronary and peripheral vasculature.

Comparison to Predicate Device(s):

The design of the BridgePoint Medical Stingray™ Orienting Balloon Catheter is similar to the original cleared Stingray™ Orienting Balloon Catheter (K080987) with the exception of the balloon material durometer, manifold adhesive, and wire lumen dimension and material. The modified Stingray™ Orienting Balloon underwent the following evaluations and has demonstrated substantially equivalent performance characteristics as compared to the predicate Stingray™ Orienting Balloon:

Tensile .
Torque .
. Hub Leak
Kink Resistance .
Guidewire Insertion/Withdrawal .
Distal Flexibility .
. Distal Trackability
Balloon Burst .
. Balloon Fragmentation
. Balloon Fatigue
Balloon Inflation/Deflation .
. Balloon Dimensions
Crossing Profile .
Guidewire Redirection .
. Markerband Movement
. Markerband Removal
. Coating Coverage and Delamination
Particulate .
Surface Defects .
. Wire Insertion Through Hub
Hemostasis Valve .
. Balloon Protector Removal
Guidewire/Markerband . Interaction
Hub Aspiration .

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The following design evaluations were not performed on the modified device as the device and performance characteristics of the modified device have not changed from the predicate Stingray™ Orienting Balloon Catheter:

Radiopacity .
Corrosion Resistance .
. Packaging

As well, the modified Stingray™ Orienting Balloon Catheter has undergone the following biocompatibility evaluations and has met the required specifications demonstrating the device is biocompatible:

Cytotoxicity .
. Sensitization
. Intracutaneous Injection
Acute Systemic Toxicity .
. Pyrogenicity
. Hemolysis
Unactivated Partial Thromboplastin Time .
. In vivo Thrombogenicity
Complement Activation .
In vitro Hemocompatibility .
. Physiochemical Evaluates

Summary:

Based upon the intended use and descriptive information provided in this pre-market notification, the BridgePoint Stingray™ Orienting Balloon Catheter has 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 consists of a stylized eagle or bird-like figure with three wing-like shapes, representing human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

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

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

AUG Ó 6 2010

Re: K101591

Trade/Device Name: BridgePoint Medical Stingray™ Orienting Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Dated: July 16, 2010 Received: July 19, 2010

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Jill Munsinger

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

suma R. h. hmer

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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Indications for Use

AUG 0 6 2018

510(k) Number (if known): K101591

Device Name: BridgePoint Medical Stingray™ Orienting Balloon Catheter

Indications For Use:

Prescription Use X____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

umar. Jo. Jiliner

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number KIO 159 (

Page 1 of 1

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).