The steerable guiding sheath, model Adelante Destino is 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.

Device Description

This is a modification to Indications for Use statement only. There was no change in the text of IFU and method of use.

There is no modification to the device itself. The Adelante Destino Steerable Guiding Sheath has been cleared in K120459 and will remain intact and no modification to product labels.

AI/ML Overview

This 510(k) summary describes a modification to the Indications for Use (IFU) statement for the Adelante Destino Steerable Guiding Sheath (K122960). The submission explicitly states that there was no change in the device itself or its method of use. Therefore, the information typically associated with acceptance criteria and a study proving a device meets these criteria (such as performance metrics, sample sizes, ground truth establishment, or clinical study designs) is not applicable in this context.

The summary focuses on demonstrating substantial equivalence to predicate devices for the expanded indications, rather than proving performance against specific acceptance criteria through a study.

Here's a breakdown of why many of your requested points are not present in this document:

No change in device design or performance: The core of this 510(k) is an administrative change to the IFU, not a hardware or software modification that would necessitate new performance testing.
Focus on substantial equivalence to predicates: The justification for the expanded indications relies on the similarity of the proposed uses to existing cleared predicate devices, implying that the device's inherent performance characteristics, established in its original clearance (K120459), are sufficient for the broader indications.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a study proving the device meets acceptance criteria, as this information is not part of this specific 510(k) submission.

Summary of available information based on your request:

A table of acceptance criteria and the reported device performance:
- Not applicable. This 510(k) is for an expanded Indications for Use statement for an existing, unmodified device. There are no specific new acceptance criteria or reported performance data presented for this submission, as the device's performance was presumably established during its original clearance (K120459). The rationale for the expanded IFU is based on comparison to predicate devices for similar indications.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. No new test set data or clinical studies were conducted for this IFU modification.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. No new ground truth establishment was performed, as no new clinical data was generated for this submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or clinical study was conducted.
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 device is a steerable guiding sheath, not an AI-powered diagnostic tool. MRMC studies are not relevant to this type of medical device or this type of submission.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a hardware device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No new ground truth was established for this submission.
The sample size for the training set:
- Not applicable. This is a hardware device, not a machine learning model, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable. As above, no training set for a machine learning model is relevant here.

In summary, this 510(k) submission is solely focused on expanding the labeled indications for use of an already cleared and unmodified device, based on substantial equivalence to predicate devices with similar, broader indications. It does not contain information about new performance studies or acceptance criteria.

Summary

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510(k) SUMMARY

DEC | 3 2012 |

K122960

Device Name	Device Trade name	Common/classification name
Address andRegistration #	Steerable Guiding Sheath, ModelAdelante Destino	Introducer, Catheter
	Manufacturer	Sterilization Site
	Oscor Inc.3816 De Soto BoulevardPalm Harbor, FL 34683	1. International SterilizationLaboratory Inc. (ISL)217 Sampey Road, Groveland, FL347362. Oscor DMB Sterilizer3816 De Soto Boulevard, PalmHarbor, FL 346833. Oscor Caribe, LLCAvenida Las Americas, Nave I-2Santo Domingo, Dom. Republic
Contact	Mila Doskocil	mdoskocil@oscor.com
	V.P. of Regulatory Affairs & QualityAssurance	727-937-2511
	FDA Registration #1035166	FDA Registration #1061927 (ISL)10351663004785273
Device Class	Introducers, catheters, are classified as Class II, Reg No. 870.1340, codeDYB
Type of 510k	Traditional
Reason for 510k	Addition of indications into the Indications for Use statement.
Predicate DeviceInformation	Boston Scientific, Z flex 270 Steerable Sheath, K112541
	Enpath Medical, Steerable Sheath, K061119
	CryoCath Technologies, FlexCath Steerable Sheath, K081049

18193

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Intended Use

Proposed IFU only with modified Indications for Use statement is attached.

Previously cleared Indications for Use

The Adelante Destino Steerable Guiding Sheath is intended to facilitate the intracardiac placement of diagnostic and therapeutic devices.

Proposed Indications for Use:

The Adelante Destino Steerable Guiding Sheath is 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.

The Indications for Use statement is attached.

Device Description, Modification and Comparison to Predicate devices

This is a modification to Indications for Use statement only. There was no change in the text of IFU and method of use.

There is no modification to the device itself. The Adelante Destino Steerable Guiding Sheath has been cleared in K120459 and will remain intact and no modification to product labels.

Modification of Indications for Use statement was in the addition of indications for placement into vasculature and renal arteries. but restricted to peripheral placements only and excluding neural placements. The reason for modification is explained in the Rationale and Evaluation document attached.

The use of Destino guiding sheath has been compared to the predicate devices and found comparable to:

Boston Scientific: Z flex 270 Steerable Sheath is indicated for use to facilitate transvenous introduction of diagnostic/therapeutic catheters into the vasculature and into the chambers of the heart.

Enpath Medical Steerable Sheath is intended to be used to facilitate the placement of interventional devices into the peripheral and coronary systems.

CryoCath Technologies: The FlexCath Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.

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K122960	pg 3 of 3
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· · ·

Modification	This labeling modification has not altered the fundamental technology and
Statement	the intended use methods from the predicate devices.
SubstantialEquivalence	The additional indications for Adelante Destino Steerable Guiding Sheathdescribed in this submission are, in our opinion, substantially equivalent tothe predicate devices and other similar introducer/guiding sheaths incommercial distribution.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

and the comments of the comments of the comments of

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

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

Mila Doskocil Vice President of Regulatory Affairs & Quality Assurance Oscor Inc. 3816 De Soto Boulevard Palm Harbor, FL 34683

Re: K122960

Trade/Device Name: Adelante Destino Steerable Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 21, 2012 Received: September 25, 2012

Dear Mila 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.

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

DEC 1 3 2012

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Page 2 - Mila Doskocil

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

Sincerely yours,

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

Enclosure

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Indications for Use Statement

510k Number (if known) K122960

Device Name: Steerable Guiding Sheath, model Adelante Destino

Do not use this device for neural placements.

· ·

OR Over-The-Counter Use Prescription Use X (Per 21 CFR 801.109) (Optional Format 1-2-96)

(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 K122960

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).