The Bridge Occlusion Balloon catheter is indicated for use for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage.

Any use for procedures other than those indicated in the instructions is not recommended.

Device Description

The Bridge Occlusion Balloon is designed to be delivered percutaneously to the superior vena cava (SVC) for the purpose of providing occlusion of the SVC and providing emergency control of hemorrhage and perioperative occlusion in the event of an SVC tear or perforation during a lead extraction procedure

The Bridge Occlusion Balloon catheter is constructed of a compliant balloon mounted on a dual lumen shaft. This guidewire lumen is used to pass the catheter over a guidewire.

Three platinum-iridium radiopaque markers are placed within the balloon segment of the catheter to provide visual reference points for balloon positioning within the SVC prior to inflation.

AI/ML Overview

This document describes the Bridge Occlusion Balloon, a device intended for temporary vessel occlusion of the superior vena cava (SVC). The purpose of the document is to demonstrate its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally focused on device specifications and performance attributes, rather than specific quantitative metrics with thresholds. This is typical for equivalence claims where the device aims to match the performance of a legally marketed predicate and where the performance itself is described in functional terms.

Performance Characteristic	Acceptance Criteria (Implied by testing)	Reported Device Performance
Design Verification & Validation Tests
Crossing Profile	Acceptable for intended use	Met specifications
Balloon Working Length	Within specified range	Met specifications
Guidewire Compatibility	Compatible with specified guidewire	Met specifications
Catheter Effective Length	Within specified range	Met specifications
Surface Appearance	Free from defects	Met specifications
Distal Tip Configuration	Conforms to design	Met specifications
Luer Compatibility	Compatible with Luer fittings	Met specifications
Performance Tests
Deployment & Retraction	Smooth and reliable operation	Met specifications
Inflation & Deflation Time	Within specified time limits	Met specifications
Balloon Bond Strength	Adequate for intended use	Met specifications
Inflated Balloon Size Stability	Stable at intended pressure	Met specifications
Tip Bond Strength	Adequate for intended use	Met specifications
Hub Bond Strength	Adequate for intended use	Met specifications
Flexibility & Kink	Sufficient flexibility, kink-resistant	Met specifications
Leak Testing	No leaks detected	Met specifications
Balloon Burst Volume	Capable of sustained inflation	Met specifications
Device Fatique	Resists fatigue under intended use	Met specifications
Sterilization	Sterile per ISO 11135	Validated (Half Cycle)
Biocompatibility	Biocompatible for intended contact	Met specifications
Cytotoxicity	Non-cytotoxic	Met specifications
Sensitization	Non-sensitizing	Met specifications
Intracutaneous Reactivity	Non-reactive	Met specifications
Acute Systemic Toxicity	Non-toxic	Met specifications
C3a Complement Activation	Acceptable levels	Met specifications
SC5b-9 Complement Activation	Acceptable levels	Met specifications
Direct Hemolysis	Non-hemolytic	Met specifications
Indirect Hemolysis	Non-hemolytic	Met specifications
Partial Thromboplastin Time	Acceptable levels	Met specifications
Material Mediated Pyrogenicity	Non-pyrogenic	Met specifications
Preclinical (Animal Study)	Achieves SVC occlusion	Demonstrated SVC occlusion

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

The document does not explicitly state the numerical sample sizes for each specific test (e.g., how many balloons were tested for burst volume, how many animals were used in the preclinical study). However, it lists various "Design Verification and Validation Testing" categories, along with "Performance Testing," "Sterilization," and "Biocompatibility" tests.

Preclinical Testing: Mentioned as "preclinical GLP testing." The specific number of animals is not provided.
Data Provenance: The preclinical study was a prospective study conducted to demonstrate the device's intended use in SVC occlusion. The location of these studies is not specified, but they were conducted by the device manufacturer for regulatory submission in the USA.

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

This information is not applicable in the context of this device and study. The studies described are engineering, materials, and animal studies, not studies involving human interpretation or subjective assessment by experts to establish a "ground truth" as it would be for AI/imaging devices. The "ground truth" for these tests are the objective measurement results and observations of physical performance and biological response.

4. Adjudication Method for the Test Set

Not applicable. As described above, the tests are primarily objective measurements and observations, not requiring expert adjudication in the manner medical imaging studies might.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The device is a physical medical device (balloon catheter), not an AI algorithm for diagnostic interpretation that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the various tests:

Engineering and Performance Tests: Ground truth is based on the design specifications and measurable physical/chemical properties (e.g., dimensions, material properties, inflation/deflation times, bond strengths, leak detection).
Biocompatibility Tests: Ground truth is established by standardized biological assays and observation of biological reactions (e.g., cell viability for cytotoxicity, skin reaction for sensitization, blood component analysis for hemolysis).
Preclinical Animal Study: The ground truth for this segment relates to the objective demonstration of SVC occlusion within the animal model, observed through physiological measurements or imaging.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The term "training set" is not relevant to the described studies for this physical medical device.

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

Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

February 24, 2016

Spectranetics. Inc. Mr. Christopher McLellan Regulatory Affairs Manager 9965 Federal Drive Colorado Springs, Colorado 80921

Re: K153530

Trade/Device Name: Bridge Occlusion Balloon Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: December 8, 2015 Received: December 9, 2015

Dear Mr. McLellan:

This letter corrects our substantially equivalent letter of February 5, 2016.

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 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

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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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Brian D. Pullin -S

for 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

510(k) Number (if known) K153530

Device Name Bridge Occlusion Balloon

Indications for Use (Describe)

Any use for procedures other than those indicated in the instructions is not recommended.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) summary was prepared in accordance with 21 CFR 807.92(c) Prepared on December 8, 2015.

510(k) Submitter / Holder:	Spectranetics9965 Federal DriveColorado Springs, CO 80921.3617Establishment Registration No: 3007284006
Contact:	Christopher McLellanRegulatory Affairs ManagerOffice: 719.447.2475Mobile: 719.314.8561Fax: 719.447.2040Email: christopher.mclellan@spnc.com

Subject Device

Device Trade Name:	Bridge Occlusion Balloon
Device Common Name:	Catheter, Intravascular Occluding, Temporary
Device Class:	II
Classification Regulation:	21 CFR 870.4450
Regulation Description:	Vascular Clamp
Product Code:	MJN
510(k) Type:	Traditional
Model Number:	590-001

Predicate Device

The Bridge Occlusion Balloon was compared to the following legally marketed predicate device:

510(k) Number:	K140273
Manufacturer:	Boston Scientific
Trade Name:	Equalizer Occlusion Balloon Catheter
Device Common Name:	Catheter, Intravascular Occluding, Temporary

Device Description

The Bridge Occlusion Balloon catheter is constructed of a compliant balloon mounted on a dual lumen shaft. This guidewire lumen is used to pass the catheter over a guidewire.

Three platinum-iridium radiopaque markers are placed within the balloon segment of the catheter to provide visual reference points for balloon positioning within the SVC prior to inflation.

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Image /page/4/Picture/2 description: The image shows the Spectranetics logo. The logo consists of a blue diamond shape with a white outline on the left, followed by the word "Spectranetics" in blue, and the tagline "Always Reaching Farther" in black below the word "Spectranetics". The logo is clean and modern, and the colors are bright and eye-catching.

Intended and Indications for Use

The Bridge Occlusion Balloon catheter is indicated for use for temporary vessel occlusion in applications including perioperative occlusion and emergency control of hemorrhage.

Any use for procedures other than those indicated in the instructions is not recommended.

Technological Characteristics

The Bridge Occlusion Balloon is similar in design characteristics and performance to the predicate device. Similar to the predicate, the Bridge Occlusion Balloon is deliverable to the target vasculature and is appropriately sized to perform vascular occlusion procedures. The subject device includes vessel specificity (SVC) in its proposed indication, which differs from the predicate. Performance testing data, including preclinical animal studies have demonstrated that the Bridge Occlusion Balloon is substantially equivalent to the predicate device.

Performance Data

The following testing was conducted to validate and verify that the subject device met all specifications and was substantially equivalent to the predicate device:

Design Verification and Validation Testing

Dimensional and Visual Tests ●
- o Crossing Profile, Balloon Working Length, Guidewire Compatibility, Catheter Effective Length, Surface Appearance, Distal Tip Configuration, Luer Compatibility
. Performance Testing
- Deployment and Retraction, Inflation and Deflation Time, Balloon Bond o Strength, Inflated Balloon Size Stability, Tip Bond Strength, Hub Bond Strength, Flexibility and Kink, Leak Testing, Balloon Burst Volume, Device Fatique

Sterilization

Half Cycle Validation per ISO 11135 .
Biocompatibility:
- Cytotoxicity ●
- Sensitization ●
- Intracutaneous Reactivity ●
- . Acute Systemic Toxicity
- . C3a Complement Activation
- . SC5b-9 Complement Activation
- Direct Hemolvsis
- Indirect Hemolysis ●
- Partial Thromboplastin Time
- Material Mediated Pyrogenicity

Preclinical and Clinical Data:

Preclinical data were gathered to demonstrate substantial equivalence of the Bridge Occlusion Balloon when used as intended. The preclinical GLP testing demonstrated

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Image /page/5/Picture/2 description: The image shows the Spectranetics logo. The logo consists of a blue geometric shape on the left, followed by the word "Spectranetics" in a bold, blue font. Below the word "Spectranetics" is the tagline "Always Reaching Farther" in a smaller, lighter font. The logo is clean and modern, and the blue color gives it a sense of trust and reliability.

that the Bridge Occlusion Balloon meets its intended use of SVC occlusion. No clinical testing was required for the Bridge Occlusion Balloon.

Substantial Equivalence

Based on the similarities in design between the subject and predicate devices, and the performance data, the Bridge Occlusion Balloon is substantially equivalent to the legally marketed Equalizer Occlusion Balloon Catheter.

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).