(93 days)
Not Found
No
The summary describes a mechanical delivery sheath and its components, with no mention of AI, ML, image processing, or data-driven algorithms. The performance studies focus on physical properties and functionality.
No
Explanation: The device is intended for the introduction of diagnostic and therapeutic devices, not as a therapeutic device itself.
No
Explanation: The device is described as "intended for the introduction of diagnostic and therapeutic devices into the human vasculature." This indicates it is a tool for delivering other devices, not a diagnostic device itself.
No
The device description clearly outlines physical components like a braided sheath, side port, stopcock, hemostatic valve, and dilator, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "introduction of diagnostic and therapeutic devices into the human vasculature." This describes a tool used during a medical procedure to facilitate the use of other devices, not a device that performs a diagnostic test on a sample in vitro (outside the body).
- Device Description: The description details a physical device (sheath, dilator, stopcock, valve) designed for insertion into the body. It does not mention any components or functions related to analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties and functionality of the device for insertion and use within the body (tensile strength, leakage, compatibility, kink resistance, torque, radio-detectability). They do not involve testing or analyzing biological samples.
IVD devices are specifically designed to perform tests on samples like blood, urine, or tissue to diagnose diseases or conditions. This device is a delivery system for other devices used within the body.
N/A
Intended Use / Indications for Use
The Breezeway II products are intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements.
Do not use this device for neural placements.
Product codes
DYB
Device Description
The Breezeway II-Delivery Sheath consists of a braided sheath with a side port with a three-way stopcock, hemostatic valve, and dilator. The Breezeway II Plus models include these same components plus a loader accessory. The distal tip of the sheath is radiopaque and contains side flush portholes. The dilator can be locked on to the hub of the sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human vasculature, including but not limited to intracardiac, renal or other peripheral placements.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended User: Cardiologist, Electrophysiologist Surgeon, Neurovascular Surgeons
Environmental Use: Hospital
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
Non-Clinical Performance Data: A summary of the bench performance testing for design verification of Breezeway II Delivery Sheath products has demonstrated that the product, as designed, meets Oscor Inc. design input requirements and conforms to ISO 11070:2014, sterile single-use intravascular introducers, dilator and guidewire. Performance testing is presented in summary detailing the well-established testing protocols, acceptance criteria, details of deviations, expected results and actual results. The basis for a determination of substantial equivalence of the device is demonstrated by the following:
- Tensile Force: All tested devices met the test acceptance criteria, minimum 15N between critical joints (Sheath Section, Sheath Shaft to Sheath Hub, Dilator Hub, Accessory Tool Hub, Side Port Arm Tube to Sheath Hub and Stopcock Valve, and Sideport Arm Tube to Loader Proximal Hub and Stopcock), per ISO 11070:2014.
- Liquid Leakage: All tested devices met the test acceptance criteria, no fluid leakage from critical joints (Hemostasis Valve, or under pressure), per ISO 11070:2014.
- Device Compatibility: All tested device met the test acceptance criteria, compatible dimensions (Introducer Sheaths with Dilators, Dilator with Transseptal Needle, Dilator and Guidewire, and Accessory Tool with Sheath Introducer), per Oscor Inc. design requirement.
- Device Functionality and Transition: All tested devices met the test acceptance criteria, no gap or damage following insertion (Sheath with Dilator, and Accessory Tool with Sheath Introducer), per Oscor design requirement.
- Flushing and Aspiration: All tested devices met the test acceptance criteria, capable of aspiration without obstruction or ingress of air through susceptible areas (Sheath Introducer, and Accessory Tool), per ISO 11070:2014.
- Introducer Sheath Kink Resistance: All tested devices met the test acceptance criteria, capable of bending 180°, per Oscor design requirement.
- Sheath Introducer Torque: All test devices met the test acceptance criteria, free of exposed braid at 180° and 360° rotation, per Oscor design requirement.
- Radio-detectability: All test devices (Sheath and Dilator) met the test acceptance criteria of visibility and identification under fluoroscopy, per Oscor design requirement.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 3, 2021
Oscor, Inc. Doug Myers VP of QA and RA 3816 DeSoto Boulevard Palm Harbor, Florida 34683
Re: K210627
Trade/Device Name: Breezeway II Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: May 4, 2021 Received: May 5, 2021
Dear Doug Myers:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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,
Finn Donaldson Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210627
Device Name Breezeway II
Indications for Use (Describe)
The Breezeway II products are intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements.
Do not use this device for neural placements.
| 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
1. Submission Sponsor
Oscor Inc.
Address: 3816 DeSoto Boulevard
Palm Harbor, Florida 34683
USA
727-937-2511 Phone:
Fax: 737-934-9835
Doug Myers, VP or QA and RA Contact:
2. Date Prepared
April 19, 2021
3. Device Identification
| Trade/Proprietary Name: | Breezeway II |
|---|---|
| Common/Usual Name: | Delivery Sheath |
| Classification Name: | Catheter Introducer |
| Classification Regulation: | 870.1340 |
| Product Code: | DYB |
| Device Class | Class II |
| Classification Panel: | Cardiovascular |
Legally Marketed Predicate Device 4.
K122958 Delivery Sheath, Model Adelante Breezeway
5. Device Description
The Breezeway II-Delivery Sheath consists of a braided sheath with a side port with a three-way stopcock, hemostatic valve, and dilator. The Breezeway II Plus models include these same components plus a loader accessory. The distal tip of the sheath is radiopaque and contains side flush portholes. The dilator can be locked on to the hub of the sheath.
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The Adelante Breezeway Delivery Sheath (K122958) is modified with the following changes, to be marketed as the Breezeway II and Breezeway II Plus Delivery Sheath:
- Addition of French sizes (9F, 11F, 12F, and 14F).
- . Extending the usable length to 110 cm (for 6F to 10F sizes).
- . Sheath Hub for new French sizes (9F to 14 F) designed to incorporate larger French sizes.
- . Dilator hub design features a screw on design for the 6F, 7F, and 8F sizes, and an oval shaped hub with lock for 9F to 14 F sizes.
- Dilator material for 14F size is LDPE for the body, and HDLE for the hub, no material changes to other sizes.
- Addition of a loader accessory component as an added option to facilitate the insertion of devices through the sheath's hemostatic valve (Breezeway II Plus only)
6. Indications for Use Statement
The Breezeway II products are intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements.
Do not use this device for neural placements.
7. Substantial Equivalence Discussion
The following table compares Breezeway II products to the predicate device with respect to intended use, technological characteristics and principles of operations, providing more detailed information regarding the bases for the determination of substantial equivalence.
| Comparator | New Device | Predicate Device |
|---|---|---|
| Device Name | Breezeway II Delivery Sheath and | |
| OEM Branding (ODS III) | Adelante Breezeway Delivery | |
| Sheath | ||
| Regulatory Decision | This submission | K122958 |
| Product Code | DYB | Same as Breezeway II |
| Regulation Number | 870.1340 | Same as Breezeway II |
| Regulation Name | Introducer, Catheter | Same as Breezeway II |
| Intended Use | To facilitate the intracardiac | |
| placement of diagnostic and | ||
| therapeutic devices | Same as Breezeway II | |
| Device Placement/ | ||
| Introduction | Intracardiac, renal, or other | |
| placements, not for neural placement | Same as Breezeway II | |
| Environmental Use | Hospital | Same as Breezeway II |
| Intended User | Cardiologist, Electrophysiologist | |
| Surgeon, Neurovascular Surgeons | Same as Breezeway II | |
| Single Use | Yes | Same as Breezeway II |
| Tissue Contact | Yes | Same as Breezeway II |
| Labeling | Sterile, Single Use, Prescription | Same as Breezeway II |
| Table 7A. Comparison of the technological characteristics of Breezeway II to predicate device. | ||||
|---|---|---|---|---|
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| Comparator | New Device | Predicate Device |
|---|---|---|
| French Size | 6F to 14 F | 6F to 10F |
| Usable Length | 79 cm (6F to 14 F) | |
| 110 cm (6F to 10F) | 68 to 86 cm | |
| Distal Tip Fixed Curve | 45°, 180° | 55°, 70°, 90°, 120° |
| Sheath Hub Design | Breezeway II small hub | |
| (6F to 8F) | ||
| Breezeway II large hub | ||
| (9F to 14F) | Breezeway Sigma Hub | |
| Sheath Hub Cap | Small cap, a screw-in feature (6F to | |
| 8F) | ||
| Large cap (9F to 14F) | Sigma Cap | |
| Sheath Hub Cap Material | Polycarbonate | Same as Breezeway II |
| Hemostatic Valve Material | Silicone | Same as Breezeway II |
| Sheath side port with 3-Way | ||
| Stopcock | Yes | Same as Breezeway II |
| Shaft Construction | Multilayer Braided Shaft | Same as Breezeway II |
| Sheath Materials (Inner and | ||
| Outer Diameter) | Liner (Inner): PA12 | |
| Distal Tip (Outer): Pebax 45D | ||
| Proximal Shaft (Outer): Pebax 63D | Same as Breezeway II | |
| Sheath Coating | Hydrophobic | Same as Breezeway II |
| Sheath Flush Side Hole | Yes | Same as Breezeway II |
| Marker Band | Gold | Same as Breezeway II |
| Dilator Hub Design | Screw-in (6F to 8F) | |
| Oval Shape with Hub Lock (9F to 14F) | Oval Shape | |
| Dilator Material | 6F to 12F: HDPE (Body and Hub) | |
| 14F: LDPE (Body), HDPE (Hub) | HDPE (Body and Hub) | |
| Dilator Length | 85 cm to 115 cm | 68 cm and 86 cm |
| Max. Compatible Guidewire | 0.038" | Same as Breezeway II |
| Loader | Included for Breezeway II Plus | |
| Delivery Sheath and ODS III models | None | |
| Packaging Materials | Solid Bleached Sulfate (SBS) | |
| cardboard, Single Chevron pouch and | ||
| SBS cardboard product box | Same as Breezeway II | |
| Sterilization | Ethylene Oxide | Same as Breezeway II |
| Shelf Life | 3 years | Same as Breezeway II |
| Kit Components | Breezeway II Delivery Sheath: Sheath, | |
| Dilator, IFU | ||
| Breezeway II Plus Delivery Sheath: | ||
| Sheath Dilator, Loader, IFU | Sheath, Dilator, IFU |
Biocompatibility Data 8.
The materials, construction and intended use of Breezeway II Delivery Sheath devices are comparable to the predicate device. The biological safety of the catheter introducer was evaluated in accordance with ISO 10993-1:2009. Under these, for the stated indications for use the device was classified as (A) limited exposure external communicating device, contacting blood. The results for the biocompatible testing of the catheter introducer for, cytotoxicity, sensitization: intracutaneous toxicity, system toxicity (acute systemic injection and pyrogencity (material mediated pyrogen), and hemocompatibility
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(hemolysis, complement activation, in-vivo thrombogenicity) demonstrated no negative impacts from the materials that are used in Breezeway II. The catheter introducer materials in direct tissues contact include Pebax, Silicone, Polycarbonate, Pellethane, PA, and HDPE. Breezeway II Delivery Sheath products met the biological safety and compatibility requirements of ISO 10993-1: 2009.
9. Non-Clinical Performance Data
A summary of the bench performance testing for design verification of Breezeway II Delivery Sheath products has demonstrated that the product, as designed, meets Oscor Inc. design input requirements and conforms to ISO 11070:2014, sterile single-use intravascular introducers, dilator and guidewire. Performance testing is presented in summary detailing the well-established testing protocols, acceptance criteria, details of deviations, expected results and actual results. The basis for a determination of substantial equivalence of the device is demonstrated by the following:
- . Tensile Force: All tested devices met the test acceptance criteria, minimum 15N between critical joints (Sheath Section, Sheath Shaft to Sheath Hub, Dilator Hub, Accessory Tool Hub, Side Port Arm Tube to Sheath Hub and Stopcock Valve, and Sideport Arm Tube to Loader Proximal Hub and Stopcock), per ISO 11070:2014.
- Liquid Leakage: All tested devices met the test acceptance criteria, no fluid leakage from critical joints (Hemostasis Valve, or under pressure), per ISO 11070:2014.
- Device Compatibility: All tested device met the test acceptance criteria, compatible dimensions (Introducer Sheaths with Dilators, Dilator with Transseptal Needle, Dilator and Guidewire, and Accessory Tool with Sheath Introducer), per Oscor Inc. design requirement.
- . Device Functionality and Transition: All tested devices met the test acceptance criteria, no gap or damage following insertion (Sheath with Dilator, and Accessory Tool with Sheath Introducer), per Oscor design requirement.
- . Flushing and Aspiration: All tested devices met the test acceptance criteria, capable of aspiration without obstruction or ingress of air through susceptible areas (Sheath Introducer, and Accessory Tool), per ISO 11070:2014.
- . Introducer Sheath Kink Resistance: All tested devices met the test acceptance criteria, capable of bending 180°, per Oscor design requirement.
- . Sheath Introducer Torque: All test devices met the test acceptance criteria, free of exposed braid at 180° and 360° rotation, per Oscor design requirement.
- . Radio-detectability: All test devices (Sheath and Dilator) met the test acceptance criteria of visibility and identification under fluoroscopy, per Oscor design requirement.
Each test demonstrated that Breezeway II Delivery Sheaths meets the standard and the design requirement, making it substantially equivalent to the predicate device. As designed and tested, the differences between Breezeway II Delivery Sheaths and the predicate device do not raise new or different questions about safety or effectiveness that have not been mitigated as far as possible through design and verification testing.
10. Clinical Performance Data
There was no clinical testing required to support the medical device.
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Statement of Substantial Equivalence 11.
Breezeway II Delivery Sheath products have the same intended use as the legally marketed predicate device. Performance testing verified that Breezeway II Delivery Sheath products comply with all applicable voluntary standards such as ISO 10993-7, ISO 11737, ISO 11607, ISO 10993-1, ISO 10993-5, ISO10993-10, ISO 10993-11, ISO 10993-4 and ISO 14971. Breezeway II Delivery Sheath products also meets design requirements where no applicable standard could be used. This includes ISO 11070:2014. There was no recognized performance standards for this device.
lt has been shown in this Premarket Notification Submission that the differences between Breezeway II Delivery Sheath products and the legally marketed predicate device do not raise any questions regarding safety and effectiveness. Breezeway II Delivery Sheath products, as designed and manufactured, are determined to be substantially equivalent to the referenced legally marketed predicate device.