The steerable guiding sheath, model Adelante® Destino, is designed to assist with the introduction of intravascular devices into the heart using a steerable feature to provide better maneuverability and easier access to hard-to-reach places in the heart. On the steerable handle there is a side port for aspiration and flushing. The guiding sheath comprises of: shaft, steerable handle and side port. The dilator is included with each sheath.

AI/ML Overview

The provided text describes a 510(k) submission for the Adelante® Destino steerable guiding sheath. This document focuses on demonstrating substantial equivalence to predicate devices through functional and performance testing, rather than a clinical study evaluating AI performance or human reader improvement. Therefore, many of the requested points, such as AI-specific sample sizes, expert qualifications for ground truth in AI, MRMC studies, or standalone algorithm performance, are not applicable to this submission.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:

Test Name/ Description	Acceptance Criteria	Reported Device Performance
Sheath visual and dimensional test	Visual and dimensional specifications and requirements for the Destino sheath must be met.	Pass
Pull test of sections test	Joints must withstand a pull force of 15 N or 3.37 lbf.	Pass
Sheath hub bond test	Sheath to hub joint must withstand a pull force of 15 N or 3.37 lbf.	Pass
Freedom from air leakage test	Sheath must not leak prior to and after the insertion of the dilator and a catheter/device.	Pass
Kink and roll test	The device should be free of any kinks and bends (before and after dilator removal). The sheath body sections must be smooth, properly bonded, and free from damages after the roll test.	Pass
Deflection and handle test	Assembled sheath should deflect 180 degrees in one direction and 90 degrees in the other direction. Sheath should move less than 20 degrees total after introducing test piece ten times. Lock should not break or the handle should not separate throughout the entire test.	Pass
Sheath thermal shock test	After testing, there shall be no discoloration, broken/frayed tubing, cracked split caps, or any other constructional defects or signs of degradation due to testing.	Pass
Dilator visual and dimensional test	Visual and dimensional specifications and requirements for the Destino dilator must be met	Pass
Sheath and dilator fit, functionality, and transition test	The hubs shall have a female 6% (Luer) taper conical fitting for syringes. The sheath must allow the insertion of a 8F (maximum) device. The dilator must be able to snap/lock into the sheath hub. There must be a smooth tapered transition between the sheath and dilator tips. The tips must have a radius free from sharp edges or damages. Any gap between the dilator and sheath must be less than 1 mm.	Pass
Device insertion and withdrawal test	The sheath/dilator tips, as well as the device, must be without damages after the Seldinger method.	Pass
Dilator thermal shock test	After testing, there shall be no discoloration, broken/frayed tubing, cracked split caps, or any other constructional defects or signs of degradation due to testing.	Pass
EtO residual levels testing	EtO residuals must be within limits	Pass
Bioburden testing	Bioburden levels must be within limits	Pass
Endotoxins testing	Endotoxins (LAL) levels must be within limits	Pass
Product sterility testing	Product must remain sterile	Pass

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample sizes used for each functional and performance test.
The data provenance is not specified beyond indicating "Functional and performance testing was conducted." This implies in-house laboratory testing, not human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The ground truth for these engineering performance tests would be established by the test procedures and objective metrics, not by expert consensus in a clinical context.

4. Adjudication method for the test set:

Not applicable. These are objective engineering tests with defined acceptance criteria.

5. 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:

Not applicable. This is a 510(k) submission for a medical device (steerable guiding sheath), not an AI-powered diagnostic or assistive technology.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

The ground truth for the functional and performance tests is derived from established engineering and manufacturing specifications and test standards. These are objective, measurable outcomes.

8. The sample size for the training set:

Not applicable. This is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI algorithm.

In summary: The submission for the Adelante® Destino describes a set of engineering and performance tests to demonstrate the safety and effectiveness of the device against predefined acceptance criteria. All tests passed, supporting the claim of substantial equivalence to predicate devices. The document does not involve AI, human reader studies, or clinical data.

Summary

{0}------------------------------------------------

JUN 2 9 2012

Submitted by: Oscor Inc. 3816 De Soto Blvd. Palm Harbor, FL. 34683

June 29, 2012

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 K120459.

1. Contact Person:

Ms. Mila Doskocil Vice President of Regulatory Affairs & Quality Assurance Oscor Inc. 3816 De Soto Blvd.

Palm Harbor, FI. 34683

Phone: (727) 937-2511
Fax: (727) 934-9835

2. Device Name and Classification

Trade Name: Adelante® Destino .
Common/Usual Name: Steerable Guiding 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® Destino is substantially equivalent to the following predicate devices:

1. Oscor Delivery Sheath, Model Adelante Breezeway 510k #K101497
St. Jude Medical Agilis NxT Steerable Introducer 510k #K081645 2)
Medtronic FlexCath Steerable Sheath 510k #K102176 3)

4. Device Description

5. Intended Use of the Device

The steerable guiding sheath, model Adelante® Destino, is intended to facilitate the intracardiac placement of diagnostic and therapeutic devices.

6. Summary of Technological Characteristics of the Device Compared to the Predicate Devices

The Adelante® Destino Steerable Guiding Sheath has similar technological characteristics as the predicate devices mentioned above. They are similar in materials, function, and intended use. The difference from predicate devices is in the incorporation of a steerable handle to deflect the distal end of the sheath and the reinforcement of the tip using multiple biocompatible materials.

{1}------------------------------------------------

7. Tests and Conclusions

Functional and performance testing was conducted to assess the safety and effectiveness of the Adelante® Destino. See table below

Test Name/ Description	Acceptance Criteria	Pass /Fail
Sheath visual and dimensional test	Visual and dimensional specifications and requirements for theDestino sheath must be met.	Pass
Pull test of sections test	Joints must withstand a pull force of15 N or 3.37 lbf.	Pass
Sheath hub bond test	Sheath to hub joint must withstand a pull force of 15 N or 3.37lbf.	Pass
Freedom from air leakage test	Sheath must not leak prior to and after the insertion of thedilator and a catheter/device.	Pass
Kink and roll test	The device should be free of any kinks and bends (before andafter dilator removal). The sheath body sections must besmooth, properly bonded, and free from damages after the rolltest.	Pass
Deflection and handle test	Assembled sheath should deflect 180 degrees in one directionand 90 degrees in the other direction.Sheath should move less than 20 degrees total afterintroducing test piece ten times.Lock should not break or the handle should not separatethroughout the entire test.	Pass
Sheath thermal shock test	After testing, there shall be no discoloration, broken/frayedtubing, cracked split caps, or any other constructional defectsor signs of degradation due to testing.	Pass
Dilator visual and dimensional test	Visual and dimensional specifications and requirements for theDestino dilator must be met	Pass
Sheath and dilator fit, functionality, andtransition test	The hubs shall have a female 6% (Luer) taper conical fitting forsyringes. The sheath must allow the insertion of a 8F(maximum) device. The dilator must be able to snap/lock intothe sheath hub. There must be a smooth tapered transitionbetween the sheath and dilator tips. The tips must have aradius free from sharp edges or damages. Any gap betweenthe dilator and sheath must be less than 1 mm.	Pass
Device insertion and withdrawal test	The sheath/dilator tips, as well as the device, must be withoutdamages after the Seldinger method.	Pass
Dilator thermal shock test	After testing, there shall be no discoloration, broken/frayedtubing, cracked split caps, or any other constructional defectsor signs of degradation due to testing.	Pass
EtO residual levels testing	EtO residuals must be within limits	Pass
Bioburden testing	Bioburden levels must be within limits	Pass
Endotoxins testing	Endotoxins (LAL) levels must be within limits	Pass
Product sterility testing	Product must remain sterile	Pass

The following tests were performed on the Oscor predicate device, Adelante Breezeway, and adopted to the Adelante Destino:

. Dilator to transseptal needle and guidewire visual and dimensional test
Dilator body to hub bond test t
◆ Sheath side port holes flush test
. Radio-detectability test

8. Conclusion:

The test data results support the determination of substantial equivalency to predicate devices and it can be concluded that the device is safe and effective for its Intended Use.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.

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

JUN 2 9 2012

Oscor, Inc. c/o Ms. Mila Doskocil Vice President of Regulatory Affairs and Quality Assurance/Compliance 3816 De Soto Blvd. Palm Harbor, FL 34683

Re: K120459

Trade Name: Adelante Destino Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II (two) Product Code: DYB Dated: June 18, 2012 Received: June 19, 2012

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. Iisting 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

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 (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 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" (21 CFR 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

M. G. Willhoite

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

{4}------------------------------------------------

Attachment 2

Indications for Use Statement

K120459 510k Number (if known) –

Device Name: Steerable Guiding Sheath, model Adelante Destino

The steerable guiding sheath, model Adelante Destino is intended to facilitate the intracardiac placement of diagnostic and therapeutic devices.

Prescription Use _X (Per 21 CFR 801.109) (Optional Format 1-2-96) OR

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.A. Wilhelmsen

(Division Sian-Off) Division of Cardiovascular Devices

1120459 510(k) Number

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).