(86 days)
The Fast-Cath™ Intra-Cardiac Introducer is intended 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 sideport with a Three-way stopcock is provided for air aspiration, fluid infusion, blood sampling, etc.
Based on the provided 510(k) summary, there is no detailed study described that establishes specific acceptance criteria and demonstrates the device's performance against those criteria in a quantitative manner. This 510(k) relies on substantial equivalence to a predicate device rather than presenting new performance data from an independent study.
Here's a breakdown of why many of the requested points cannot be answered from the provided text:
- No specific acceptance criteria are stated. The submission focuses on asserting 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 contraindications and instructions for use)." This implies the acceptance criteria are met by virtue of being identical to a device already deemed safe and effective.
- No detailed study is mentioned. The submission references "clinical literature" and the successful use of "similar commercially available catheter introducers" and the predicate device (Daig's Fast-Cath™ Transseptal Catheter Introducers) as evidence of safety and effectiveness, but it does not describe a specific study conducted for this particular 510(k) submission with a test set, ground truth, or expert review.
However, based on the information provided, we can infer some aspects and explicitly state what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional equivalence to predicate device (product design, packaging, sterilization, labeling - excl. contraindications/IFU) | "All technological characteristics... are identical to the predicate device." |
| Safety and efficacy for introducing cardiovascular catheters or biopsy devices into the heart | Supported by "clinical literature" and successful historical use of similar devices and the predicate device. |
| Minimization of blood loss during catheter introduction/exchange (via hemostasis valve) | Device described as having a "hemostasis valve to minimize blood loss." |
| Capability for air aspiration, fluid infusion, blood sampling (via sideport with stopcock) | Device described as having a "sideport with a Three-way stopcock is provided for air aspiration, fluid infusion, blood sampling, etc." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. No dedicated test set described.
- Data Provenance: Not applicable. The "support" is based on existing clinical literature and historical use of predicate and similar devices, not a new dataset created for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth for a test set was established as part of this submission. The "ground truth" for the predicate device's safety and effectiveness would have been established through its own historical use and regulatory pathway, which is not detailed here.
4. Adjudication method for the test set
- Not applicable. No test set was 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
- No. This device is a medical introducer, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This device is a medical introducer, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this 510(k), the "ground truth" for demonstrating substantial equivalence relies on the established safety and effectiveness of the predicate device and the broader category of similar introducer devices as evidenced by "clinical literature" and successful market use. There is no new, explicitly defined ground truth established for this specific submission's performance claims.
8. The sample size for the training set
- Not applicable. No "training set" in the context of an algorithm or AI is described.
9. How the ground truth for the training set was established
- Not applicable. No "training set" or explicit ground truth for such a set is described.
In summary, this 510(k) submission primarily relies on the argument of substantial equivalence to an already legally marketed device rather than presenting a de novo study with explicit acceptance criteria and corresponding performance data. The support for substantial equivalence comes from:
- Identical technological characteristics to the predicate device.
- The general understanding and "clinical literature" demonstrating the safety and utility of similar introducer devices for cardiac procedures.
- The successful historical use of the predicate device (Fast-Cath™ Intra-Cardiac Catheter Introducer) and similar devices (Daig's Fast-Cath™ Transseptal Catheter Introducers).
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B
510(k) Summary
510(k) Summary
(as required by 21 CFR 807.92)
Submitter Information A.
| B. | |
|---|---|
| Submitter's Name | Daig Corporation, a St. Jude Medical Company |
| Address | 14901 DeVeau PlaceMinnetonka, Minnesota 55345-2126 U.S.A. |
| Telephone Number | (612) 933-4700 |
| Contact Person | Dean Bruhn-Ding |
| Submission Prepared | June 19, 1998 |
| Device Information | |
| Common or Usual Name | Intra-Cardiac Introducer, Catheter Introducer |
| Classification Name | Catheter Introducer |
| Predicate Device | Fast-Cath™ Intra-Cardiac Catheter Introducer |
| Device Description | The Daig Intra-Cardiac Introducer includes a radiopaquesheath and dilator with specially curved distal portions toaccommodate specific requirements. The introducer sheathis fitted with a hemostasis valve to minimize blood lossduring catheter introduction/exchange. A sideport with aThree-way stopcock is provided for air aspiration, fluidinfusion, blood sampling, etc. |
| Intended Use | The Fast-Cath™ Intra-Cardiac Introducer is intended for usewhen introducing various cardiovascular catheters or biopsydevices into the heart. |
C. Comparison of Required Technological Characteristics
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 contraindications and instructions for use).
D. Support of the Substantial Equivalence
The clinical literature has demonstrated that the use of an introducer to perform endomyocardial biopsy and cardiac catheterization may reduce the complications associated with this procedure. Literature supports the use of these products from both venous and arterial access Similar commercially available catheter introducers have been successfully used for sites. introducing various cardiovascular catheters and biopsy devices into the heart from both the arterial and venous access sites. In addition, Daig's Fast-Cath™ Transseptal Catheter Introducers (Reference Device) are routinely used on the septal side of the heart via transseptal access.
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Public Health Service
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SEP 1 6 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Dean Bruhn-Ding, RAC Director of Requlatory Affairs DAIG Corporation 14901 Deveau Pl. Minnetonka, MN 55345
Re : K982187 Fast-Cath™ Intra-Cardiac Introducer Trade Name: Regulatory Class: II Product Code: DYB Dated: June 19, 1998 Received: June 22, 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 Devices: 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 regulation 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 requlations.
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) 594-4586. 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" (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. Callahon
Thomas J. Callan Director Division of Cardiovascular, Respiratory ----and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _ 1 of
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Fast-Cath™ Intra-Cardiac Introducer
Indications for Use:
The Fast-Cath™ Intra-Cardiac Introducer is indicated for use when introducing various cardiovascular catheters or biopsy devices into the heart.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ta A. R
ision Sign-OM
on of Cardiovascular, Respiratory,
eurological Devices
Number. K982187
§ 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).