(29 days)
Not Found
Not Found
No
The summary describes a mechanical introducer kit and does not mention any software, algorithms, or AI/ML capabilities.
No
This device is an introducer kit used to introduce catheters and pacing leads into a vessel, not for treating a disease or condition itself.
No
The device is an introducer kit designed to facilitate the insertion of other catheters into a vessel. Its purpose is to physically introduce or provide access for other devices, not to diagnose a medical condition.
No
The device description explicitly lists multiple hardware components (Peel-Away Introducer, Obturator, Seal-Away™ detachable hemostasis valve, Guidewire, Syringe, and Needle).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "introduction of catheters into a vessel" and "introduction of pacing leads, angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel". This describes a device used in vivo (within the body) for medical procedures.
- Device Description: The description details components like a peel-away introducer, obturator, hemostasis valve, guidewire, syringe, and needle. These are all tools used for accessing and introducing devices into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. There's no mention of analyzing biological samples like blood, urine, or tissue.
Therefore, the Seal-Away CS™ Introducer Kit and Seal-Away™ Hemostasis Adapter are medical devices used for vascular access and introduction of other devices into the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Seal-Away CS™ Introducer Kit is a percutaneous catheter introducer kit with peelaway sheath that is indicated for the introduction of catheters into a vessel.
The Seal-Away™ Hemostasis Adapter is indicated for the introduction of pacing leads, angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing blood loss is essential.
Product codes
DYB
Device Description
The Seal-Away CST™ introducer kit includes a Peel-Away Introducer, Obturator, Seal-Away™ detachable hemostasis valve, Guidewire, Syringe and Needle. The introducer kits are provided sterile, and are intended for single-use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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Key Metrics
Not Found
Predicate Device(s)
Peel away Sheath Introducer and Obturator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
8.0 510(k) Summary
Special 510(k): Device Modification
| OCT - 9 2001 | 510(k) Summary |
|---|---|
| (As required by 21 CFR 807.92) |
Submitter Information A.
| Submitter's Name: | St. Jude Medical, Daig Division |
|---|---|
| Address: | 14901 DeVeau Place |
| Minnetonka, Minnesota 55345-2126 U.S.A. | |
| Telephone Number: | (952) 352-9769 |
| Contact Person: | Jim M. Taufen |
| Date Submission Prepared: | 07-Sep-2001 |
B. Device Information
| Trade Name: | Seal-Away CST™ Introducer Kit |
|---|---|
| Common or Usual Name: | Percutaneous Catheter Introducer |
| Classification Name: | Percutaneous Catheter Introducer (per 21 CFR Part |
| 870.1340) | |
| Device Classification: | Class II (per 21 CFR Part 870.1340) |
| Panel - Cardiovascular | |
| Predicate Device: | Peel away Sheath Introducer and Obturator |
| St. Jude Medical, Daig Division | |
| Device Description: | The Seal-Away CST™ introducer kit includes a Peel- |
| Away Introducer, Obturator, Seal-Away™ detachable | |
| hemostasis valve, Guidewire, Syringe and Needle. The | |
| introducer kits are provided sterile, and are intended for | |
| single-use only. | |
| Intended Use: | The Seal-Away CS Introducer kits are designed for the |
| introduction of catheters into a vessel. |
Comparison of Required Technological Characteristics C.
All technological characteristics of the Seal-Away™ CS introducer kit are substantially equivalent to the predicate device including product design, packaging, sterilization, and labeling.
Support of the Substantial Equivalence D.
St. Jude Medical, Daig Division considers the Seal-Away CS introducer kit to be substantially equivalent to the predicate device.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the light background of the emblem.
OCT - 92001
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jim M. Taufen St. Jude Medical Daig Division 14901 DeVeau Place Minnetonka, MN 55345
Re: K013029
Seal-Away CS™ Introducer Kit Regulation Number: 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 7, 2001 Received: September 10, 2001
Dear Mr. Taufen:
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, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with
2
Page 2 - Mr. Jim M. Taufen
all the Act's requirements, 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) Premarket notification. The FDA finding of substantial equivalence of your device to a legally premated noutineation one and 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
L
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page
KO13029 510(k) Number (if known): __
Device Name:
Seal-Away CS™ Introducer Kit
Indications for Use:
The Seal-Away CS™ Introducer Kit is a percutaneous catheter introducer kit with peelaway sheath that is indicated for the introduction of catheters into a vessel.
The Seal-Away™ Hemostasis Adapter is indicated for the introduction of pacing leads, angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing blood loss is essential.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division of Cardiovascular & Re
| 510(k) Number | K013024 |
|---|---|
| -------------------------------------------------- | --------- |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ------------------------------------------ | -------------------------------------------------- |
|---|