(141 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a delivery sheath, with no mention of AI or ML.
No
Explanation: The device description states its purpose is to "facilitate the introduction of catheters to any r from heart chambers," and its intended use is to "facilitate the intracardiac placement of diagnostic and therapeutic devices." This indicates it is a delivery system for other devices, not a therapeutic device itself.
No
The device is a delivery sheath intended to facilitate the placement of other diagnostic and therapeutic devices, not to perform diagnosis itself.
No
The device description clearly outlines physical components such as a sheath, dilator, stopcock, and valve, and the performance studies focus on physical properties and functionality of these components. There is no mention of software as a component or function of the device.
No, 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 Function: The Adelante Breezeway Delivery Sheath is a tool used to physically introduce other diagnostic and therapeutic devices into the heart. It facilitates the placement of these devices within the body.
- Lack of Specimen Analysis: The device itself does not analyze any biological specimens. It's a delivery system, not a diagnostic test.
The description clearly states its purpose is to "facilitate the intracardiac placement of diagnostic and therapeutic devices." This is an in vivo (within the living body) function, not an in vitro (in glass, or outside the body) diagnostic function.
N/A
Intended Use / Indications for Use
The Adelante® Breezeway Delivery Sheath is intended to facilitate the intracardiac placement of diagnostic and therapeutic devices.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The Adelante® Breezeway Delivery Sheath is designed to facilitate the introduction of catheters to any r from heart chambers, including the left atrium via a transseptal puncture. This introducer delivery sheath of the nearl chambere, moldarity the ide port with a three-way stopcock, hemostatic valve, and a dilator.
The distal tip of the sheath has side flush portholes. The dilator can be locked on to the sheath. The sheath is supplied in 10 F and two overall lengths, 63 cm and 81 cm, and dilator is supplied in two r rie sheath is oupplied in 10 r and the dilator profile curves are 55, 70, 90, 120 degrees. There are no accessories supplied with this device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart chambers, including the left atrium
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)
Functional and performance testing was conducted to assess the safety and effectiveness of the Adelante® Breezeway.
Key results from tests listed:
- Sheath visual and dimensional tests (includes curve verification): Pass (Specific visual and dimensional specifications)
- Dilator visual and dimensional tests (includes curve verification): Pass (Specific visual and dimensional specifications)
- Dilator to TS needle and Guidewire visual and dimensional tests: Pass (Free and smooth insertions and other insertion/transition requirements)
- Sheath joints bonding tests: Pass (All joints must withstand a designated pull force)
- Dilator body to hub bond test: Pass (Hub bond to dilator tube must withstand a designated pull force)
- Sheath and Dilator fit, functionality, and transition tests: Pass (Compatibility with Luer fitting, compatibility with 10 F device, dilator to sheath fit must be within specifications)
- Air leakage testing: Pass (The sheath must not leak prior to and after the insertion of a dilator and a catheter/device)
- Sheath side port holes flush test: Pass (The sheath must be capable of aspiration/flushing with and without inserted dilator/device.)
- Torque response test: Pass (Minimum 1:1 torqueability, Pre-determined torque force)
- Insertion and withdrawal of dilator into sheath hemostatic valve test: Pass (Insertion and withdrawal force must be within specifications)
- Device insertion and withdrawal test: Pass (No damage when using the Seldinger method)
- Kink and Roll tests: Pass (Free of kinks and bends)
- Radio-detectability test: Pass (Device must be radio-detectable and visible under fluoroscopy)
- Exposure to Ethylene Oxide sterilization and Thermal shock: Pass (Device must be physically and functionally unaffected by EtO and thermal shock exposure)
- Testing of EtO residual levels: Pass (EtO residuals must be within limits)
- Product sterility testing: Pass (Product must remain sterile)
- Bioburden testing: Pass (Bioburden levels must be within limits)
- Endotoxins testing: Pass (Endotoxins (LAL) levels must be within limits)
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.
K090114, K072719, K081341, K001139, K061015
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
§ 870.1340 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
510(k) Summary
Submitted by: Oscor Inc. 3816 De Soto Blvd. Palm Harbor, FL. 34683
OCT 2 0 2010
October 12, 2010
This 510(k) Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of 21 CFR, Part 807.92.
The assigned 510(k) number is K101497.
1. Contact Person:
Ms. Mila Doskocil Vice President of Regulatory Affairs & Quality Assurance Oscor Inc. 3816 De Soto Blvd. Palm Harbor, Fl. 34683 Phone: (727) 937-2511 Fax: (727) 934-9835
2. Device Name and Classification
- Trade Name: Adelante® Breezeway .
- Common/Usual Name: Delivery Sheath .
- Classification Name: Introducer, Catheter .
- Device Class : Class II .
- Regulation Number: 21 CFR 870.1340 ●
- Classification Panel : Cardiovascular .
- . Product Code: DYB
3. Substantial Equivalence
The Adelante® Breezeway is substantially equivalent to the following predicate devices:
-
- Oscor Inc., Adelante® Sigma, Sigma AT and Targa, K090114
-
- Boston Scientific, Convoy Advanced Delivery Sheath Kit, K072719
-
- Thomas Medical, Reinforced Catheter Introducer system, K081341
- Biosense Webster Inc., Preface Guiding Sheath, K001139 4)
- St. Jude Medical, Fast-Cath Hemostasis and Transseptal Introducer, K061015 5)
4. Device Description
The Adelante® Breezeway Delivery Sheath is designed to facilitate the introduction of catheters to any r from heart chambers, including the left atrium via a transseptal puncture. This introducer delivery sheath of the nearl chambere, moldarity the ide port with a three-way stopcock, hemostatic valve, and a dilator.
The distal tip of the sheath has side flush portholes. The dilator can be locked on to the sheath. The sheath is supplied in 10 F and two overall lengths, 63 cm and 81 cm, and dilator is supplied in two r rie sheath is oupplied in 10 r and the dilator profile curves are 55, 70, 90, 120 degrees. There are no accessories supplied with this device.
5. Intended Use of the Device
The Adelante® Breezeway Delivery Sheath is intended to facilitate the intracardiac placement of diagnostic and therapeutic devices.
1
- Summary of Technological Characteristics of the Device Compared to the Predicate Devices The Adelante® Breezeway Delivery Sheath has similar technological characteristics as the predicate devices. They are similar in materials, function, and intended use.
7. Tests and Conclusions
Functional and performance testing was conducted to assess the safety and effectiveness of the Adelante® Breezeway. See table below.
| Test Name/ Description | Acceptance Criteria | Pass /Fail |
|---|---|---|
| Sheath visual and dimensional tests | ||
| (includes curve verification) | Specific visual and dimensional specifications | Pass |
| Dilator visual and dimensional tests | ||
| (includes curve verification) | Specific visual and dimensional specifications | Pass |
| Dilator to TS needle and Guidewire visual | ||
| and dimensional tests | Free and smooth insertions and other insertion/transition | |
| requirements | Pass | |
| Sheath joints bonding tests | All joints must withstand a designated pull force | Pass |
| Dilator body to hub bond test | Hub bond to dilator tube must withstand a designated pull | |
| force | Pass | |
| Sheath and Dilator fit, functionality, and | ||
| transition tests | Compatibility with Luer fitting, compatibility with 10 F | |
| device, dilator to sheath fit must be within specifications | Pass | |
| Air leakage testing | The sheath must not leak prior to and after the insertion of | |
| a dilator and a catheter/device | Pass | |
| Sheath side port holes flush test | The sheath must be capable of aspiration/flushing with and | |
| without inserted dilator/device. | Pass | |
| Torque response test | Minimum 1:1 torqueability | |
| Pre-determined torque force | Pass | |
| Insertion and withdrawal of dilator into | ||
| sheath hemostatic valve test | Insertion and withdrawal force must be within | |
| specifications | Pass | |
| Device insertion and withdrawal test | No damage when using the Seldinger method | Pass |
| Kink and Roll tests | Free of kinks and bends | Pass |
| Radio-detectability test | Device must be radio-detectable and visible under | |
| fluoroscopy | Pass | |
| Exposure to Ethylene Oxide sterilization | ||
| and Thermal shock | Device must be physically and functionally unaffected by | |
| EtO and thermal shock exposure | Pass | |
| Testing of EtO residual levels | EtO residuals must be within limits | Pass |
| Product sterility testing | Product must remain sterile | Pass |
| Bioburden testing | Bioburden levels must be within limits | Pass |
| Endotoxins testing | Endotoxins (LAL) levels must be within limits | Pass |
As required by the risk analysis performed for the Adelante® Breezeway, the designated individual(s) As required by the risk andivities and the results of the results of the activities demonstrated that the penomed all vermoditori and valiation actimation and in conformance with the design control requirements as specified in 21 CFR, Part 820.30.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the edge. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Oscor Inc. Mila Doskocil Director of Regulatory Affairs/Compliance 3816 De Soto Boulevard Palm Harbor, FL 34683
OCT 2 0 2010
Re: K101497
Trade/Device Name: Adelante Breezeway Delivery Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: October 1, 2010 Received: October 4, 2010
Dear Ms. Doskocil:
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.
3
Page 2 - Ms. Mila Doskocil
Enclosure
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
Bram D. Zuckerman, M.D.
am D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
OCT 2 0 2010
510(k) Number (if known): K101497
Device Name: Adelante Breezeway Delivery Sheath
Indications For Use: The Adelante Breezeway Delivery Sheath is intended to facilitate the intracardiac placement of diagnostic and therapeutic devices.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K161452
101
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