Intended for use in facilitating the percutaneous introduction of catheters, interventional devices, and temporary pacing leads into the vasculature. The device also will deliver therapeutic solutions administered through the stopcock sidearm to the vasculature wall surrounding the sheath.

Device Description

The Emcee Infusion Introducer Sheath Set is comprised of a percutaneous introducer sheath and a dilator. The Emcee Infusion Introducer Sheath Set may also contain a guidewire. Design features have been added to the Emcee Introducer Set (K980504) to enhance the facilitating the percutaneous introduction of catheters, interventional devices, and temporary pacing leads into the vasculature. These design features include the addition of the dilator (from a point slightly distal to the dilator hub to a point proximal to the sheath tip). These design features permit a fluid ulfator nub to a point proximal to the space between the outer dilator wall and the inner sheath wall, and exiting into the vasculature lumen via the sheath sideholes.

AI/ML Overview

The provided text describes a 510(k) summary for the Emcee™ Infusion Introducer Sheath Set. It focuses on demonstrating substantial equivalence to predicate devices and includes information about non-clinical performance testing, specifically biocompatibility. However, it does not contain information related to acceptance criteria, a study proving the device meets acceptance criteria, or any of the detailed questions about sample sizes, ground truth, expert involvement, or multi-reader multi-case studies typically associated with AI/algorithm performance evaluations.

Therefore, I cannot populate the table or answer most of the specific questions as the provided document pertains to a medical device's 510(k) submission, not an AI/algorithm study.

Here's what can be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance

The document mentions "non-clinical performance testing to provide data supporting its safety and effectiveness for its intended uses." Specifically, it states:

Acceptance Criteria Category	Reported Device Performance	Study to Prove Performance
Biocompatibility	The Emcee Infusion Introducer Sheath Set is considered to be biocompatible.	Testing having its basis in International Standards Organization (ISO) 10993-1 (1992)E "Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests"
Functional Equivalence	Functions equivalently to the Emcee Introducer Set for vasculature access.	Implied through comparison to predicate device without specific test details provided.
Drug Delivery	Will deliver therapeutic solutions administered through the stopcock sidearm to the vasculature wall surrounding the sheath.	Implied through description of design features and intended use. No specific performance metrics or studies are detailed.

Missing Information:

The document does not provide details for the following:

Sample sized used for the test set and the data provenance: Not applicable as this is a physical medical device, not an AI/algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of available information:

The 510(k) summary primarily focuses on demonstrating the substantial equivalence of the Emcee Infusion Introducer Sheath Set to existing predicate devices (Emcee™ Introducer Set and LocalMed™ InfusaSleeve™ II). The performance testing mentioned is non-clinical, with biocompatibility being the only specifically detailed test, based on ISO 10993-1. The document does not describe any studies involving algorithms, human readers, or performance metrics typically associated with AI device evaluations.

Summary

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VII. 510(K) SUMMARY

Manufacturer:	SCHNEIDER/NAMICGlens Falls, New York 12801
Contact Person:	Karin L. SmithRegulatory Affairs Specialist
	Telephone Number: (518) 798-0067Facsimile Number: (518) 742-4463
Date Prepared:	August 28, 1998
Trade Name:	Emcee™ Infusion Introducer Sheath Set
Common Name:	Catheter Introducer
Classification Name:	Introducer, Catheter
Predicate Devices:	Emcee™ Introducer Set (K980504)LocalMed™ InfusaSleeve™ II (K952317)

Intended Use:

The Emcee Infusion Introducer Sheath Set is intended for use in facilitating the The Emcee Infusion introduction of cathers, interventional devices and temporary pacing leads
percutaneous introduction of catheters, interventional devices administered perculaneous introduction of canied. Fills and will deliver therapeutics shooth through the stopcock sidearm to the vasculature wall surrounding the sheath.

Product Description:

The Emcee Infusion Introducer Sheath Set is comprised of a percutaneous introducer The Encee Infusion maroducor Biso contain a guidewire. The Emcee Infusion Introducer Sheath Set may also be a part of a kit.

Design Fcatures have been added to the Emcee Introducer Set (K980504) to enhance the Design Natures nave been sacilitating the percutaneous introduction of catheres, interventional devices, and temporary pacing leads into the vasculature. These design interventional devices, and temporary parting of the sheath shaft in conjunction with a Icatures include the uddition of the dilator (from a point slightly distal to the dilator hub to a point proximal to the sheath tip). These design features permit a fluid ulfator nub to a point proximal to the space between the outer dilator wall and the inner sheath wall, and exiting into the vasculature lumen via the sheath sideholes.

983039

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VII. 510(K) Summary (Cont.)

The Emcee Infusion Introducer Sheath Set functions equivalently to the Emcee Into Lucer Set for vasculature access. The dilator/sheath assembly is advanced into the vasculature over a guidewire. The dilator is then removed with the guidewire, leaving the sheath in the vasculature. Devices can now be inserted through the sheath.

When desired by the physician, the sheath-dilator system can be used to deliver therapeutic solutions. Prior to infusing therapeutic solutions, the modified dilator is reintroduced. The therapeutic solution can then be administered via the stopcock on the sheath sidearm, and will be delivered into the vasculature lumen via the sheath sideholes.

Components of the Emcee Infusion Introducer Sheath Set have a lubricious coating for a smooth entrance and removal from the vasculature.

Comparison to Predicate Device:

The Emcee Infusion Introducer Sheath Set indications and design are substantially equivalent to the predicate devices.

Performance Testing:

The Emcee Infusion Introducer Sheath Set has been subjected to non-clinical performance testing to provide data supporting its safety and effectiveness for its intended uses.

Biocompatibility:

The materials used in the Emcee Infusion Introducer Sheath Set have been subjected to biocompatibility testing having its basis in International Standards Organization (ISO) 10993-1 (1992)E "Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests". The Emcee Infusion Introducer Sheath Set is considered to be biocompatible.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three arms or lines extending from it.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 1999 MAY

Ms. Karin L. Smith Regulatory Affairs Specialist Boston Scientific Corporation NAMIC Technology Center 18 Pruyn's Island Glens Falls, NY 12801-4400

Re : кавзозя Trade Name: Emcee™ Infusion Introducer Sheath Sct Regulatory Class: II Product Code: DYB February 4, 1999 Dated: Received: February 9, 1999

Dear Ms. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895.

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Page 2 - Ms. Karin L. Smith

with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act obrigation you might matectronic Product Radiation Control provisions, or other Federal Laws or Regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, " Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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II. Premarket Notification Required Information (Cont.)

INDICATIONS FOR USE

Page 1 of 1

510(k) Number__

Device Name: Emcee™ Infusion Introducer Sheath Set

Indications For Use:

(PLEASE DO NOT WRITE BEI.OW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluations (ODE)

ormatizing

Labels	Values
Division Sign-Off	L. Gabriel Ja Naser
Date	5/7/99
510(k) Number	K983039

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

Emcee™ Infusion Introducer Sheath Set

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).