(249 days)
Not Found
No
The description focuses on mechanical design features for facilitating device introduction and fluid delivery, with no mention of AI or ML.
Yes
The device is described as delivering "therapeutic solutions" to the vasculature wall, which indicates a therapeutic function beyond just introduction of other devices.
No
The device is described as an introducer sheath set intended for facilitating the percutaneous introduction of catheters, interventional devices, and temporary pacing leads into the vasculature, and delivering therapeutic solutions. Its purpose is interventional/therapeutic, not diagnostic.
No
The device description explicitly states it is comprised of a percutaneous introducer sheath and a dilator, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for facilitating the introduction of catheters and other devices into the vasculature and delivering therapeutic solutions. This is a direct intervention on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a physical device (sheath and dilator) used for accessing the vasculature. It does not describe a test or assay performed on a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely procedural and therapeutic delivery, not diagnostic testing.
N/A
Intended Use / Indications for 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.
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,
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
VII. 510(K) SUMMARY
| Manufacturer: | SCHNEIDER/NAMIC
Glens Falls, New York 12801 |
|----------------------|-------------------------------------------------------------------------|
| Contact Person: | Karin L. Smith
Regulatory Affairs Specialist |
| | Telephone Number: (518) 798-0067
Facsimile 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
1
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.
2
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.
3
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
4
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:
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,
(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)
OR
Over-The-Counter Use
Emcee™ Infusion Introducer Sheath Set