The SafeSheath MSP™ Introducer Sheath Kit with Integral Hemostasis Valve is for introduction of pacing leads or catheters during pacing lead or defibrillatory catheter placement procedures.

The introducer sets, Adelante®-S Series are intended for introduction of pacing leads or catheters into the body.

Device Description

The components of the SafeSheath MSP™ Introducer Kit consists of a sheath with sideport tubing, stopcock and heomostasis valve. The distal end of the sheath may be configured for a straight sheath or with a curve. The sheath length must be able to provide a conduit from the insertion site to the epicardial target sites.

A guiding dilator will accompany the straight or curved sheath, to assist with the guiding and steering of the sheath to the intended location.

A standard vessel dilator that will assist in insertion.

A .035" x 135 cm guidewire.

A standard 12cc syringe.

A 18 gauge XTW introducer needle.

A transvalvular insertion tube, which can be used to open the hemostasis valve during insertion of delicate leads or catheters, may also be packaged with the introducer kit,

A Pacing Lead Stabilizer (PLS) that can be used to facilitate the removal of the introducer sheath, may also be packaged with the introducer kit.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the SafeSheath MSP™ Introducer Kit and the Adelante-S Series Introducer Set.

It's important to note that the provided text contains information for two separate devices, both of which are Introducer Sets. The first part (up to page 1 of 3) refers to the SafeSheath MSP™ Introducer Kit (K934901 is its predicate device, not its own 510(k) number which is missing). The later part (starting from "AUG 2 9 2012") refers to the Adelante®-S Series (510(k) Number K122084).

Since the request is about "the device" in the singular, and the information is fragmented across two different submissions, I will provide the acceptance criteria and study information for both devices as presented, clarifying which device each section refers to.

Analysis for the SafeSheath MSP™ Introducer Kit (Thomas Medical Products, Inc.)

This submission primarily relies on substantial equivalence to a predicate device (K934901) and includes qualification testing for the new device. It is not a clinical study demonstrating performance against clinical acceptance criteria.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test)	Reported Device Performance
Functional Testing	All samples passed the protocol qualification testing requirements.
Visual Testing	All samples passed the protocol qualification testing requirements.
Leak Testing	All samples passed the protocol qualification testing requirements.
Valve Body to Stopcock Pull Test	All samples passed the protocol qualification testing requirements.
PVC Tubing to Valve Housing Peel Test	All samples passed the protocol qualification testing requirements.

Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated, described as "All samples."
- Data Provenance: Not specified, but implied to be in-house laboratory testing (retrospective in the context of submission).
Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This was engineering/qualification testing, not a clinical study requiring expert ground truth.
Adjudication Method
- Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This was not a comparative effectiveness study involving human readers or AI.
Standalone Performance Study (Algorithm Only)
- No. This is a physical medical device (introducer sheath), not an algorithm.
Type of Ground Truth Used
- Engineering specifications and testing protocols.
Sample Size for the Training Set
- Not applicable. There's no "training set" in the context of device qualification testing.
How Ground Truth for the Training Set Was Established
- Not applicable.

Analysis for the Adelante®-S Series Introducer Set (Oscor Inc.)

This document is an FDA 510(k) clearance letter for the Adelante®-S Series. It states that the device is substantially equivalent to legally marketed predicate devices, but it does not provide details about specific acceptance criteria or the study that proves the device meets those criteria. The clearance letter itself is a determination based on a submission from the manufacturer, which would have contained such details, but those details are not in the provided text.

Therefore, for the Adelante®-S Series, I can only state what is not present in the provided excerpt:

Table of Acceptance Criteria and Reported Device Performance
- Not provided in the given text. The document is the FDA's clearance letter, stating substantial equivalence, but it does not detail the specific performance criteria or the results from the manufacturer's testing.
Sample Size Used for the Test Set and Data Provenance
- Not provided in the given text.
Number of Experts Used to Establish Ground Truth and Qualifications
- Not provided in the given text. (Likely not applicable as it's a physical device validation, similar to the SafeSheath, rather than an expert-adjudicated clinical study).
Adjudication Method
- Not provided in the given text.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study is not typically required for an introducer sheath and is not mentioned.
Standalone Performance Study (Algorithm Only)
- No. This is a physical medical device, not an algorithm.
Type of Ground Truth Used
- Not provided in the given text. (Expected to be engineering specifications and testing protocols, similar to the SafeSheath).
Sample Size for the Training Set
- Not applicable / Not provided in the given text.
How Ground Truth for the Training Set Was Established
- Not applicable / Not provided in the given text.

Summary Limitations:

The provided text for both devices is primarily focused on the declaration of substantial equivalence for regulatory clearance. While it alludes to "Qualification Testing" for the SafeSheath, it only states that "All samples passed" without detailing the specific numeric thresholds of the acceptance criteria. For the Adelante-S Series, the provided text is solely the FDA's clearance letter, which does not contain the detailed study results or acceptance criteria themselves. Therefore, much of the requested information cannot be extracted directly from the given input.

Summary

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III.

510(k) SUMMARY (as required by 807.92(c))

SafeSheath MSPTM Introducer Kit

· 510(k) Notification

Page 1 of 3

510(k) SUMMARY

(As required by 21 C.F.R. 807.92)

AUG 29 2012

Submitter Information

Submitter's Name: Address:

Telephone Number: Facsimile: Contact Person: Title: Date Submission Prepared:

Device Information B.

Trade name:

Classification Names: Predicate Devices:

Device Description:

Thomas Medical Products, Inc. 65 Great Valley Parkway Malvern, PA 19355 (610) 296-3000 (610) 296-4591 Peter J. Rapp Director, Quality Assurance/Regulatory Affairs November 30, 2000

SafeSheath MSP™ Introducer Kit with Integral Hemostasis Valve Catheter Introducer

Tearaway Sheath Introducer Set with Integral Hemostatis Valve (K934901)

A guiding dilator will accompany the straight or curved sheath, to assist with the guiding and steering of the sheath to the intended location.

A standard vessel dilator that will assist in insertion.

A .035" x 135 cm guidewire.

A standard 12cc syringe.

A 18 gauge XTW introducer needle.

A transvalvular insertion tube, which can be used to open the hemostasis valve during insertion of delicate leads or catheters, may also be packaged with the introducer kit,

A Pacing Lead Stabilizer (PLS) that can be used to facilitate the removal of the introducer sheath, may also be packaged with the introducer kit.

The SafeSheath MSP™ Introducer Sheath Kit with Integral Hemostasis Valve is for introduction of pacing leads or catheters during pacing lead or defibrillatory catheter placement procedures.

Intended Use:

Thomas Medical Products

III- 1

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Comparison of Required Technological Characteristics C.

All technological characteristics of the SafeSheath MSP™ Introducer Sheath Kit with Integral All technological characteristics of the Sationall MB.
Hemostasis Valve are substantially equivalent to the predicate device (K934901) including product design, packaging, sterilization, and labeling.

Substantial Equivalence D.

Thomas Medical Products considers the SafeSheath MSP™ Introducer Sheath Kit with I homas Medical I roducts oblishers tantially equivalent to the following legally marketed meegral Ticmostasis Varve to be bath Introducer Set with Integral Hemostasis Valve (K934901).

Qualification Testing E.

Thomas Medical Products qualification testing of the SafeSheath MSP™ Introducer Sheath Thomas Mechour Products qualitional, visual, leak testing, Valve Body to Kit with thegial Tremostable moraboc ock pull test and PVC Tubing to Valve Housing Peel test. All samples passed the protocol qualification testing requirements.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

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

AUG 2 9 2012

Oscor Inc. c/o Ms. Mila Doskocil Vice President of Regulatory Affairs and Quality Assurance 3816 DeSoto Boulevard Palm Harbor, FL 34683

Re: K122084

Trade/Device Name: Introducer Set, Model Adelante-S Series Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: August 15, 2012 Received: August 17, 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, 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

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" (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) –

Device Name: Introducer Sets, Adelante®-S Series

The introducer sets, Adelante®-S Series are intended for introduction of pacing leads or catheters into the body.

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)

Division Slan-Off) Division of Cardiovascular Devices

510(k) Number K122084

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).