(112 days)
The Fast-Cath hemostasis introducer is indicated for the introduction of various cardiovascular catheters or biopsy devices into the heart.
The Fast-Cath Transseptal Introducer is indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
Both the Fast-Cath hemostasis and transseptal introducers are used for introducing various catheters into the heart. The inner diameter measures 10F. The distal tips of the introducers are available in a variety of curve configurations to meet physician preferences for accessing different parts of the cardiac anatomy. Each introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and exchange over a guidewire. A sideport with a three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The sheaths contain radiopaque materials for visualization under fluoroscopy. A plastic dilator and stainless steel guidewire are packaged with the introducers and are designed to facilitate the introduction and passage of the introducer through the vasculature.
This 510(k) summary (K061015) describes the Fast-Cath Hemostasis Introducer and Fast-Cath Transseptal Introducer, which are catheter introducers used for introducing various catheters into the heart. The submission asserts substantial equivalence to previously cleared predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided K061015 summary, explicit acceptance criteria and corresponding reported device performance metrics are not detailed. The summary states:
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bench/Performance | Not explicitly stated in quantitative terms. | "Testing has demonstrated that the new devices are substantially equivalent to the predicate devices." |
| Design/Material | "similar design, materials, and technical requirements as the predicate devices." | "The catheters have similar design, materials, and technical requirements as the predicate devices." |
| Intended Use | Match or be substantially equivalent to predicate. | "The proposed modification is equivalent to the predicate with respect to intended use..." |
| Safety/Functionality | Implied to be equivalent to predicate. | "The proposed modification is equivalent to the predicate with respect to...performance specifications." |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide any specific information about the sample size used for any test set or the provenance of data (e.g., country of origin, retrospective or prospective). The summary merely states "Summary of Testing" and "Testing has demonstrated...", without elaborating on the nature or scope of this testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
There is no mention of experts or ground truth establishment in the context of clinical or performance data for either the test set or training set. Since the submission relies on substantial equivalence to predicate devices and likely refers to bench testing, expert review to establish ground truth as one might see in diagnostic AI studies is not applicable or detailed here.
4. Adjudication Method for the Test Set
As no specific test set involving human interpretation or performance evaluation is described, adjudication methods are not applicable or mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed or described. This type of study is typically relevant for diagnostic devices involving human interpretation of data, often comparing AI-assisted vs. unassisted human performance. This submission is for a medical device (catheter introducer), not a diagnostic algorithm.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone study, in the context of an algorithm's performance without human intervention, was not applicable and not performed or described. The device is a physical medical instrument, not a software algorithm.
7. Type of Ground Truth Used
Given the nature of the device (catheter introducer) and the type of submission (510(k) for substantial equivalence to predicate devices), the "ground truth" used for testing would most likely relate to engineering specifications, material properties, mechanical performance, and biocompatibility standards. It would not be clinical outcomes data, pathology, or expert consensus in the same way as for diagnostic devices. These would be assessed through bench testing and possibly animal studies (though not detailed here) comparing the device's physical and functional characteristics to established standards and predicate devices.
8. Sample Size for the Training Set
There is no mention of a "training set" in this 510(k) summary. The concept of a training set is relevant for machine learning algorithms, which are not described as part of this device. The testing described would be focused on verifying physical and functional equivalence, not training a model.
9. How the Ground Truth for the Training Set Was Established
Since no training set is discussed, the method for establishing its ground truth is not applicable or mentioned.
In summary, the provided 510(k) summary for K061015 is a standard submission for a physical medical device (catheter introducer) seeking substantial equivalence to predicate devices. It relies on a comparison of design, materials, intended use, and general performance specifications to existing, legally marketed devices. It does not provide the detailed information (such as explicit acceptance criteria, sample sizes for test/training sets, expert involvement, or adjudication methods) that would typically be associated with performance studies for diagnostic algorithms or devices where clinical efficacy and human interpretation are key endpoints. The "study" mentioned is general "testing" to demonstrate substantial equivalence, rather than a detailed clinical trial or AI performance study.
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510(k) SUMMARY
| AUG 0 3 2006 | |
|---|---|
| Submitter's Name: | St. Jude Medical |
| Address: | 14901 DeVeau PlaceMinnetonka, MN 55345 |
| Tel: | 952-933-4700 |
| Fax: | 952-930-9481 |
| Contact Person: | Glenn Jacques |
| Date of Summary Preparation: | April 12, 2006 |
| Device Common Name: | Introducer, Catheter |
| Device Trade Name: | Fast-Cath Hemostasis IntroducerFast-Cath Transseptal Introducer |
| Device Classification Name: | 21 CFR 870.1340Classification: Class IIProduct Code: DYB |
| Predicate Devices: | Fast-Cath Intracardiac IntroducerK982187, K973840Fast-Cath Transseptal IntroducerK052644Fast-Cath Transseptal Catheter IntroducerK964518 |
Device Description
Both the Fast-Cath hemostasis and transseptal introducers are used for introducing various catheters into the heart. The inner diameter measures 10F. The distal tips of the introducers are available in a variety of curve configurations to meet physician preferences for accessing different parts of the cardiac anatomy. Each introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and exchange over a guidewire. A sideport with a three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The sheaths contain radiopaque materials for visualization under fluoroscopy. A plastic dilator and stainless steel guidewire are packaged with the introducers and are designed to facilitate the introduction and passage of the introducer through the vasculature.
Indications for Use
The Fast-Cath hemostasis introducer is indicated for the introduction of various cardiovascular catheters or biopsy devices into the heart.
The Fast-Cath Transseptal Introducer is indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
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[510(k) Summary continued]
Comparison to Predicate Device
The catheters have similar design, materials, and technical requirements as the predicate devices.
Summary of Testing
Testing has demonstrated that the new devices are substantially equivalent to the predicate devices.
Conclusion
The proposed modification is equivalent to the predicate with respect to intended use, technological characteristics, and performance specifications.
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Image /page/2/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.
AUG 0 3 2006
St. Jude Medical c/o Mr. Glenn Jacques Regulatory Affairs Manager 14901 DeVeau Place Minnetonka, MN 55345
Re: K061015
Fast-Cath Hemostasis Introducer & Transseptal Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II (two) Product Code: DYB Dated: June 30, 2006 Received: July 3, 2006
Dear Mr. Jacques:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 to 898. In addition. TDA max publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Glenn Jacques
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r loase of acrised that I that your device complies with other requirements of the Act that I Drines Intacted and regulations administered by other Federal agencies. You must or any I outdi states and securements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product rainill allow you to begin marketing your device as described in your Section 510(k) rms let notification. The FDA finding of substantial equivalence of your device to a legally premated 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), please in you atten office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
simon R. V. Levin
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number:
Device Name:
Fast-Cath Transseptal Introducer
Indications for Use: The Fast-Cath Transseptal Introducer is indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nivin R. W. Lund
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
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INDICATIONS FOR USE
510(k) Number:
Device Name:
Fast-Cath Hemostasis Introducer
Indications for Use: The Fast-Cath hemostasis introducer is indicated for the introduction of various cardiovascular catheters or biopsy devices into the heart.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Deane P. Manig
Division Sign-Off) Division Olgh Sin
510(k) Number K061015
§ 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).