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.

AI/ML Overview

The provided text describes the acceptance criteria and the results of the functional and performance testing for the Adelante® Breezeway Delivery Sheath. However, it does not describe a study involving an AI/Machine Learning device or any human-in-the-loop performance. This document is a 510(k) premarket notification for a medical device (a catheter introducer), not an AI algorithm.

Therefore, many of the requested items related to AI/ML studies are not applicable or cannot be extracted from this text.

Here's a breakdown of the information that can be extracted, along with explanations for the missing AI-specific details:

Acceptance Criteria and Device Performance

Test Name/ Description	Acceptance Criteria	Reported Device Performance (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

Study Details (as applicable to a medical device, not an AI study)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify the sample sizes (number of devices tested) for the functional and performance tests. It mentions "Functional and performance testing was conducted" but provides no numerical details.
- Data provenance (country of origin, retrospective/prospective) is not applicable or provided, as these are lab/bench tests on manufactured devices, not clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the context of device performance, is established by adherence to engineering specifications and regulatory standards, not expert consensus on interpretations. The tests appear to be physical and chemical characterizations.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept is for clinical data interpretation, not for objective physical/chemical device testing.
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:
- No MRMC study was done. This device is a physical medical instrument (a delivery sheath), not an AI-powered diagnostic or assistive tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for this device's performance tests is based on engineering specifications, manufacturing standards, and regulatory requirements. For example, a bond must withstand a "designated pull force," and residual levels "must be within limits."
The sample size for the training set:
- Not applicable. This is not an AI/Machine Learning device, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable.

Summary regarding AI/ML aspects:
The provided document is a 510(k) summary for a traditional medical device (Adelante® Breezeway Delivery Sheath) and details its functional and performance testing against established acceptance criteria. It does not involve any AI or Machine Learning components, therefore, questions related to AI studies, training/test sets, expert adjudication, or reader studies are not applicable to the information presented. The "study" referenced is a series of benchtop and lab tests to ensure the device meets its design specifications and safety requirements.

Summary

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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:

1. Oscor Inc., Adelante® Sigma, Sigma AT and Targa, K090114
1. Boston Scientific, Convoy Advanced Delivery Sheath Kit, K072719
1. 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 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.

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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 visualand dimensional tests	Free and smooth insertions and other insertion/transitionrequirements	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 pullforce	Pass
Sheath and Dilator fit, functionality, andtransition tests	Compatibility with Luer fitting, compatibility with 10 Fdevice, dilator to sheath fit must be within specifications	Pass
Air leakage testing	The sheath must not leak prior to and after the insertion ofa dilator and a catheter/device	Pass
Sheath side port holes flush test	The sheath must be capable of aspiration/flushing with andwithout inserted dilator/device.	Pass
Torque response test	Minimum 1:1 torqueabilityPre-determined torque force	Pass
Insertion and withdrawal of dilator intosheath hemostatic valve test	Insertion and withdrawal force must be withinspecifications	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 underfluoroscopy	Pass
Exposure to Ethylene Oxide sterilizationand Thermal shock	Device must be physically and functionally unaffected byEtO 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.

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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.

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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

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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

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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).