(179 days)
Intended for use in facilitating the percutaneous introduction of catheters, interventional devices, and temporary pacing leads into the vasculature (including the radial artery).
The Emcee™ Introducer Set is comprised of a percutaneous introducer sheath and dilator. The set may also contain a guidewire and/or an obturator. The Emcee™ Introducer Sheath is comprised of an insert molded hemostatic sheath hub and cap design which encapsulates a hemostatic gasket system. The hub also incorporates a sideport extension line with an attached stopcock. The tubing portion of the sheath is percutaneously introduced into the patient's vasculature. The sideport extension is used for purposes of blood access maintenance and fluid administration. Subsequent to the physician gaining access to the patient's vasculature, a guidewire is inserted into the blood vessel. The Sheath/Dilator combination may be backloaded over the Guidewire to direct the device into the lumen of the vessel. Once the Sheath/Dilator assembly is in place, the dilator and Mini Guidewire (if used) are removed. The Emcee™ Dilator is a tapered plastic tube with an integral luer hub which is inserted into the Emcee™ Introducer Sheath. The Dilator is longer than the Sheath and with its tapered distal tip, serves to facilitate and support the entry of the Sheath into the patient's vasculature. Once the Emcee™ Introducer Sheath is in place, the Dilator is removed. The Emcee™ Introducer Set will be offered with dilators to accommodate the following guidewire diameters: .018", .025", .032", .035", and .038". Other sizes of dilators will also be provided to address physician preferences. The Emcee™ Obturator is a plastic tube with an integral luer hub which is inserted into the Emcee™ Introducer Sheath. The Obturator is approximately the same length as the Sheath and is intended to support the tubing portion of the Sheath while the device remains In Vivo. Components of the Emcee™ Introducer Set have a lubricious coating for a smooth entrance and removal from the vasculature.
The provided document is a 510(k) summary for the Emcee™ Introducer Set, a medical device. It describes the device, its intended use, and states that performance testing was done, but it does not provide specific acceptance criteria or the detailed results of a study that proves the device meets those criteria.
Instead, it states: "The new Emcee™ Introducer Set has been subjected to non-clinical performance testing to provide data supporting its safety and effectiveness for its intended uses." It also mentions "Biocompatibility testing having its basis in International Standards Organization (ISO) 10993-1 (1992)E..." and concludes the device "is considered to be biocompatible."
Therefore, based only on the provided text, I cannot fill in most of the requested information. The document focuses on regulatory approval (510(k) process) based on substantial equivalence to predicate devices, rather than detailed performance study results against predefined acceptance criteria.
However, I can extract the following:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. | The document states the device "has been subjected to non-clinical performance testing to provide data supporting its safety and effectiveness for its intended uses." This implies performance was deemed acceptable for regulatory purposes, but no specific metrics or thresholds are provided. |
| Biocompatibility conforming to ISO 10993-1 (1992)E | "The Emcee™ Introducer Set is considered to be biocompatible." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified.
- Data provenance: Not specified (implied to be from non-clinical testing, likely in a lab setting).
- Retrospective or prospective: Not specified.
3. 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/Not specified. This information would typically be relevant for studies involving subjective human assessment (e.g., image interpretation), which is not the nature of the described "non-clinical performance testing" for an introducer set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified, for the same reasons as point 3.
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
- No. This is a physical medical device (catheter introducer), not an AI/imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For biocompatibility, the ground truth was "International Standards Organization (ISO) 10993-1 (1992)E "Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests"."
- For other "non-clinical performance testing," the specific ground truth is not detailed but would likely involve established engineering standards, material science properties, and functional benchmarks relevant to introducer sheaths (e.g., insertion force, hemostasis, flow rates, structural integrity).
8. The sample size for the training set
- Not applicable. As a physical device undergoing non-clinical testing, there isn't a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
- Not applicable.
{0}------------------------------------------------
AUG - 7 1998
IX. 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: | May 22, 1998 |
| Trade Name: | Emcee Introducer Set |
| Common Name: | Catheter Introducer |
| Classification Name: | Introducer, Catheter |
| Predicate Devices: | MORSE® Hemostatic Catheter Introducer Set (K915078)Epic™ Introducer Sheath (K960310)Cook CHECK-FLO® Performer™ Introducer (K895044)Arrow Radial Artery Catheterization Set (K810675)Cordis Avanti™ Transradial Sheath Kit (K962746) |
Product Description:
The Emcee™ Introducer Set is comprised of a percutaneous introducer sheath and dilator. The set may also contain a guidewire and/or an obturator.
The Emcee™ Introducer Sheath is comprised of an insert molded hemostatic sheath hub and cap design which encapsulates a hemostatic gasket system. The hub also incorporates a sideport extension line with an attached stopcock. The tubing portion of the sheath is percutaneously introduced into the patient's vasculature. The sideport extension is used for purposes of blood access maintenance and fluid administration.
Subsequent to the physician gaining access to the patient's vasculature, a guidewire is inserted into the blood vessel. The Sheath/Dilator combination may be backloaded over the Guidewire to direct the device into the lumen of the vessel. Once the Sheath/Dilator assembly is in place, the dilator and Mini Guidewire (if used) are removed.
Emcee™ Introducer Set
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IX. 510(K) Summary (Continued)
The Emcee™ Dilator is a tapered plastic tube with an integral luer hub which is inserted into the Emcee™ Introducer Sheath. The Dilator is longer than the Sheath and with its tapered distal tip, serves to facilitate and support the entry of the Sheath into the patient's vasculature. Once the Emcee™ Introducer Sheath is in place, the Dilator is removed. The Emcee™ Introducer Set will be offered with dilators to accommodate the following guidewire diameters: .018", .025", .032", .035", and .038". Other sizes of dilators will also be provided to address physician preferences.
The Emcee™ Obturator is a plastic tube with an integral luer hub which is inserted into the Emcee™ Introducer Sheath. The Obturator is approximately the same length as the Sheath and is intended to support the tubing portion of the Sheath while the device remains In Vivo.
Components of the Emcee™ Introducer Set have a lubricious coating for a smooth entrance and removal from the vasculature.
Intended Use:
The Emcee™ Introducer Set is intended for use in facilitating the percutaneous introduction of catheters, interventional devices and temporary pacing leads into the vasculature. Included in this indication are procedures using the radial artery as an access site.
Comparison to Predicate Device:
The Emcee™ Introducer Set design and indications are substantially equivalent to the predicate devices. The manufacturing process, packaging, and sterilization for the Emcee™ Introducer Set mirrors that of SCHNEIDER/NAMIC's currently marketed device.
Performance Testing:
The new Emcee™ Introducer Set has been subjected to non-clinical performance testing to provide data supporting its safety and effectiveness for its intended uses.
Biocompatibility:
Emcee™ Introducer Sets were 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™ Introducer Set is considered to be biocompatible.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized representation of a human figure in profile, composed of three overlapping silhouettes. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 7 1998
Ms. Karin L. Smith Regulatory Affairs Specialist Schneider/Namic Pruyn's Island Glens Falls, NY 12801
Re: K980504 Emcee Introducer Set Trade Name: Requlatory Class: II Product Code: DYB May 22, 1998 Dated: Received: May 26, 1998
Ms. Smith: Dear
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/tray. 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
{3}------------------------------------------------
Page 2 - Ms. Karin L. Smith
A substantially equivalent determination assumes compliance to 895. 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 for devices under the Electronic 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) 594-4618. 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 requlation 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,
Tinas J. Callahan
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 (Continued)
INDICATIONS FOR USE
Page 1 of 1
510(k) Number K980504
Device Name: Emcee™ Introducer Set
Indications For Use:
17-2-242-2019-03-20
Intended for use in facilitating the percutaneous introduction of catheters, interventional devices, and temporary pacing leads into the vasculature (including the radial artery).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluations (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
Division of Cardiovas and Neurological Dev 510(k) Num
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
§ 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).