(20 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical function of a balloon catheter, with no mention of AI or ML algorithms for image analysis, data processing, or decision support.
Yes
The device is used for temporary occlusion of the superior vena cava to control hemorrhage, which is a therapeutic intervention.
No
The device is described as an "Occlusion Balloon catheter" used for temporary vessel occlusion, hemorrhage control, and perioperative occlusion. Its function is interventional, not diagnostic.
No
The device description clearly details a physical catheter with a balloon, shaft, lumens, and radiopaque markers, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Bridge Occlusion Balloon catheter is a device that is inserted directly into the superior vena cava (SVC) within the body. Its purpose is to physically occlude the vessel for temporary control of hemorrhage or perioperative occlusion. It does not analyze any specimens taken from the body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples. It focuses on the physical structure and function of the catheter for internal use.
Therefore, the Bridge Occlusion Balloon catheter is an invasive medical device used for a therapeutic or procedural purpose within the body, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MJN
Device Description
The Bridge Occlusion Balloon catheter 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 polyurethane balloon mounted on a dual lumen polyurethane shaft.
The hub port, marked BALLOON, is connected to the balloon inflation lumen. The unmarked hub port is connected to the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire. A strain relief is mounted to the catheter shaft just distal of the proximal hub.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
superior vena cava (SVC)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The shelf-life extension and packaging changes are supported by test data demonstrating that the device and packaging adhere to the same acceptance criteria used in the predicate 510(k) after aging equivalent to 2 years.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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December 23, 2020
The Spectranetics Corporation Sondra Chandler Regulatory Affairs Specialist 9965 Federal Drive Colorado Springs, Colorado 80921
Re: K203540
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 2, 2020 Received: December 3, 2020
Dear Sondra Chandler:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Carmen Gacchina Johnson, PhD Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203540
Device Name Bridge Occlusion Balloon
Indications for Use (Describe)
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.
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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3
Image /page/3/Picture/1 description: The image shows the Spectranetics logo. The logo consists of a blue diamond shape with a white circle inside, followed by the word "Spectranetics" in blue, and the tagline "Always Reaching Farther" in a smaller font size below the word "Spectranetics". The logo is clean and modern, and the blue color gives it a professional look.
510(k) Summary
This 510(k) summary was prepared in accordance with 21 CFR 807.92 Prepared on 02 December 2020
| 510(k) Submitter / Holder: Spectranetics | 9965 Federal Drive
Colorado Springs, CO 80921-3617
Establishment Registration No: 3007284006 |
|---------------------------------------------|----------------------------------------------------------------------------------------------------|
| | |
Contact: Sondra Chandler Regulatory Specialist II Office: 719-482-5909 Fax: 719.447.2040 Email: Sondra.chandler@philips.com
Subject Device
Device Trade Name: Bridge Occlusion Balloon Device Common Name: Catheter, Intravascular Occluding, Temporary Device Class: II Classification Requlation: 21 CFR 870.4450 Requlation Description: Vascular Clamp Product Code: MJN 510(k) Type: Special Model Numbers: 590-001
Predicate Device
The subject device (Bridge Occlusion Balloon) was compared to the following legally marketed predicate device: 510(k) Number: K153530 Manufacturer: Spectranetics Trade Name: Bridge Occlusion Balloon Device Common Name: Catheter, Intravascular Occluding, Temporary Model Numbers: 590-001
Device Description
The Bridge Occlusion Balloon catheter 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 polyurethane balloon mounted on a dual lumen polyurethane shaft.
The hub port, marked BALLOON, is connected to the balloon inflation lumen. The unmarked hub port is connected to the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire. A strain relief is mounted to the catheter shaft just distal of the proximal hub.
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.
4
Intended and Indications for Use
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.
Comparison of Technological Characteristics with the Predicate Device
The Bridge Occlusion Balloon Catheter is deliverable to the target vasculature to perform occlusion procedures. The subject device is identical to the predicate device in terms of technological characteristics. There are labeling differences between the subject and predicate device. The subject device labeling includes a new warning regarding increased risk of thrombus with prolonged dwell times. The labeling also includes clarified workflows to reduce this risk.
The predicate device was cleared with a 6-month shelf-life which was subsequently extended to 2 years after clearance. The subject device shelf-life is identical to the current 2-year shelf-life of the predicate device.
The predicate device has undergone minor packaging changes after clearance. The tray and lid have minor dimensional changes. The header bag changed from Tyvek to Tyvek and Nylon. The predicate device now uses packaging wedges. The subject device packaging is identical to the current predicate device packaging.
Performance Data
The shelf-life extension and packaging changes are supported by test data demonstrating that the device and packaging adhere to the same acceptance criteria used in the predicate 510(k) after aging equivalent to 2 years.
Design Verification and Validation Testing
IFU Validation was performed.
Preclinical and Clinical Data
No preclinical or clinical data was needed to support this submission.
Substantial Equivalence
Based on the similarities in design between the subject and predicate devices, and the IFU validation, performed, the subject Bridge Occlusion Balloon is substantially equivalent to the previously cleared Bridge Occlusion Balloon (K153530).