STINGRAY ORIENTING BALLOON CATHETER

• K Number: K101591
• Device Name: STINGRAY ORIENTING BALLOON CATHETER
• Manufacturer: BRIDGEPOINT MEDICAL
• Date Cleared: 2010-08-06 ( 60 days)
• Product Code: DQY
• Regulation Number: 870.1250
• Type: Special
• Panel: CV
• Reference & Predicate Devices: K080987

Intended Use

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:

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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.

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).