(225 days)
The Fast-Cath™ Intra-Cardiac Introducer is indicated for use when Introducing various cardiovascular catheters or biopsy devices into the heart.
The Daig Intra-Cardiac Introducer includes a radiopaque sheath and dilator with specially curved distal portions to accommodate specific requirements. The introducer sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction / exchange. A side port with a three way stop cock is provided for air aspiration, fluid infusion, blood sampling, etc.
The provided text is a 510(k) summary for the Fast-Cath™ Intra-Cardiac Introducer. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies showcasing acceptance criteria. As such, the document does not contain a study that proves the device meets specific acceptance criteria in the manner typically seen for novel therapeutic or diagnostic devices.
The document states that the new indication for use is supported by demonstrating that "All technological characteristics of the Fast-Cath™ Intra-Cardiac Introducer with new indication for use are identical to the predicate device including product design, packaging, sterilization, and labeling (with the exception of the new indications)." and by referencing "Clinical literature has demonstrated that the use of an introducer to perform endomyocardial biopsy may reduce the complications associated with this procedure." and "Similar commercially available catheter introducers have been successfully used for introducing various cardiovascular catheters and biopsy devices into the heart."
Therefore, most of the requested information regarding acceptance criteria and a study to prove they are met cannot be extracted from this 510(k) summary.
However, I can provide what is available based on the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria or report device performance data. The basis of the submission is substantial equivalence to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in this document as part of a performance study. | Not reported in this document as part of a performance study. The device's performance is assumed to be equivalent to the predicate device due to identical technological characteristics. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No new performance study with a test set is described in this 510(k) summary. The submission relies on the substantial equivalence to a predicate device and existing clinical literature concerning introducers in general.
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. No ground truth establishment by experts for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set is described.
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
Not applicable. This is a medical device (catheter introducer), not an AI/software device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (catheter introducer), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. There is no new performance study described in this 510(k) summary to generate ground truth. The basis for safety and effectiveness is substantial equivalence to an existing predicate device and general clinical literature.
8. The sample size for the training set
Not applicable. This is a medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a medical device, not a machine learning model.
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MAI 2 1 1998
510(k) Summary
(As required by 21 CFR 807.92)
Submitter Information A. .
Submitter's Name:
Address:
Daig Corporation, a Division of St. Jude Medical, Inc.
14901 Deveau Place Minnetonka, MN 55345-2126
Telephone Number:
Contact Person:
Dean Bruhn-Ding
(612) 933-4700
Submission Prepared:
October 6 , 1997
Device Information B.
Common or Usual Name:
Intra-Cardiac Introducer Catheter Introducer
Classification Name:
Predicate Device:
Device Description:
Catheter Introducer
Catheter Introducer
Catheter Fast-Cath™ Transseptal Introducer
The Daig Intra-Cardiac Introducer includes a radiopaque sheath and dilator with specially curved distal portions to accommodate specific requirements. The introducer sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction / exchange. A side port with a three way stop cock is provided for air aspiration, fluid infusion, blood sampling, etc.
Section 8 - 510(k) Summary Fast-Cath™ Intra-Cardiac Introducer - Page 1 of 2
::
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Intended Use:
The Fast-Cath™ Intra-Cardiac Introducer is intend for use when introducing various cardiovascular catheters or biopsy devices into the heart
Comparison of Required Technological Characteristics C.
All technological characteristics of the Fast-Cath™ Intra-Cardiac Introducer with new indication for use are identical to the predicate device including product design, packaging, sterilization, and labeling (with the exception of the new indications).
D. Support of Substantial Equivalence
The Daig Corporation has received clearance to market the Fast-Cath™ Introducer for use in introducing cardiovascular catheters into the heart through the interatrial septum. The new indication for use included within the scope of this 510(k) also encompasses the use of Fast-Cath™ Introducers for Intra-Cardiac procedures that do not require penetration of the interatrial septum.
The clinical literature has demonstrated that the use of an introducer to perform endomyocardial biopsy may reduce the complications associated with this procedure. Similar commercially available catheter introducers have been successfully used for introducing various cardiovascular catheters and biopsy devices into the heart. At least one of these devices bears labeling that is substantially equivalent to the indication for use included within the scope of this 510(k).
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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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold line drawing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 | 1998
Mr. Dean Bruhn-Ding, RAC Director of Regulatory Affairs DAIG Corporation 14901 Deveau Place Minnetonka, MN 55345-2126
Re: K973840 Fast-Cath™ Intra-Cardiac Introducer Trade Name: Requlatory Class: II Product Code: DYB Dated: February 19, 1998 Received: February 20, 1998
Dear Mr. Bruhn-Ding:
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. 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.
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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical - General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, 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
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Page 2 - Mr. Dean Bruhn-Dinq
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 our 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1_______ of
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Fast-Cath™ Intra-Cardiac Introducer Device Name:
Indications for Use:
The Fast-Cath™ Intra-Cardiac Introducer is indicated for use when Introducing various cardiovascular catheters or biopsy devices into the heart.
DuAR
(Division Sign-Of Division of Car and Neurologica 19973891 510(k) Number_
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Av -
OR
Over-The-Counter Use (Optional Format 1-2-96)
§ 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).