(112 days)
No
The device description and intended use focus on mechanical components and their function in introducing catheters. There is no mention of AI, ML, image processing, or any data-driven analysis or decision-making capabilities.
No.
The device is used for introducing other catheters or biopsy devices, but it does not directly provide therapy. It is an introducer, which is an accessory to therapeutic or diagnostic devices.
No
This device is an introducer for various cardiovascular catheters or biopsy devices. Its function is to facilitate the introduction of other devices, not to diagnose conditions itself.
No
The device description clearly outlines physical components such as sheaths, valves, sideports, dilators, and guidewires, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Fast-Cath hemostasis and transseptal introducers are used to introduce catheters into the heart. They are tools used during a medical procedure performed directly on the patient's body.
- Lack of Specimen Analysis: The device description does not mention any analysis of biological specimens. While the sideport allows for blood sampling, the device itself is not performing the diagnostic test on that sample. The diagnostic test would be performed separately in a laboratory setting using other IVD devices.
Therefore, based on the provided information, the Fast-Cath introducers are invasive medical devices used for procedural access, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
DYB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart, interatrial septum
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)
Testing has demonstrated that the new devices are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K982187, K973840, K052644, K964518
Reference Device(s)
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
510(k) SUMMARY
| AUG 0 3 2006 | |
|---|---|
| Submitter's Name: | St. Jude Medical |
| Address: | 14901 DeVeau Place |
| Minnetonka, 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 Introducer |
| Fast-Cath Transseptal Introducer | |
| Device Classification Name: | 21 CFR 870.1340 |
| Classification: Class II | |
| Product Code: DYB | |
| Predicate Devices: | Fast-Cath Intracardiac Introducer |
| K982187, K973840 | |
| Fast-Cath Transseptal Introducer | |
| K052644 | |
| Fast-Cath Transseptal Catheter Introducer | |
| K964518 |
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.
1
[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.
2
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.
3
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
4
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_________________________________________________________________________________________________________________________________________________________________
5
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