(25 days)
Not Found
Not Found
No
The summary describes a standard medical device (introducer) with no mention of AI/ML features, image processing, or performance studies related to algorithmic analysis.
No
The device is an introducer designed to facilitate entry of other medical devices into a vessel, not to directly treat a medical condition.
No
The device is described as an introducer designed for the insertion of various catheters and electrodes into a vessel. Its function is to facilitate access and minimize blood loss, not to diagnose a condition or disease.
No
The device description clearly outlines physical components (sheath, hub, hemostasis valve, sideport, dilator) and is intended for physical introduction into a vessel, indicating it is a hardware medical device.
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 and electrodes into a vessel. This is an invasive procedure performed on a living patient.
- Device Description: The description details components like a sheath, hub, valve, and dilator, all designed for accessing and managing a blood vessel.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with the body's internal structures like blood vessels.
N/A
Intended Use / Indications for Use
The Ultraflex™ EV Hemostasis Introducer is designed for the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing blood loss is essential.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The Ultraflex™ EV (9-12F) Hemostasis Introducers are introducers designed to provide easy access to the vascular system while providing convenient temporary closure of a standard indwelling introducer access site. The introducers include a sheath, hub, hemostasis valve, sideport for 3-way stopcock, and dilator. The introducers 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
vessel
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Ultraflex™ Hemostasis Introducer
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
B.
012922
SEP 2 5 2001
510(k) Summary (As required by 21 CFR 807.92)
A. Submitter Information
| Submitter's Name: | St. Jude Medical, Daig Division |
|---|---|
| Address: | 14901 DeVeau Place |
| Minnetonka, Minnesota 55345-2126 U.S.A. | |
| Telephone Number: | 952-933-4465 |
| Contact Person: | Kirk Honour |
| Date Submission Prepared: | August 24, 2001 |
| Device Information | |
| Common or Usual Name: | Ultraflex™ EV Hemostasis Introducer |
| Classification Name: | Catheter Introducer |
| Predicate Device: | Ultaflex™ Hemostasis Introducer |
| St. Jude Medical, Daig Division | |
| Device Description: | The Ultraflex™ EV (9-12F) Hemostasis Introducers are |
| introducers designed to provide easy access to the | |
| vascular system while providing convenient temporary | |
| closure of a standard indwelling introducer access site. | |
| The introducers include a sheath, hub, hemostasis valve, | |
| sideport for 3-way stopcock, and dilator. The | |
| introducers are provided sterile, and are intended for | |
| single-use only. | |
| Intended Use: | The Ultraflex™ EV Hemostasis Introducers are designed |
| for the introduction of angiographic catheters, closed end | |
| catheters, balloon catheters and electrodes into a vessel | |
| where minimizing blood loss is essential. |
C. Comparison of Required Technological Characteristics
All technological characteristics of the Ultraflex™ EV Hemostasis Introducers are substantially equivalent to the predicate device including product design, sterilization, and labeling.
D. Support of the Substantial Equivalence
St. Jude Medical, Daig Division considers the Ultraflex™ EV Hemostasis Introducers to be substantially equivalent to the predicate device, Ultraflex™ Hemostasis Introducers.
1
Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 5 2001
Mr. Kirk Honour Regulatory Affairs St. Jude Medical Daig Division 14901 Deveau Place Minnetonka, MN 55345
Re: K012922
Trade Name: Ultraflex™ EV Hemostasis Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer. Regulatory Class: II Product Code: DYB Dated: August 31, 2001 Received: August 31, 2001
Dear Mr. Honour:
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 all the Act's requirements, including, but not limited to: registration and listing (21
2
Page 2 - Mr. Kirk Honour
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 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 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,
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of of 1
510(k) Number (if known):
Ultraflex™ EV Hemostasis Introducer Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Ultraflex™ EV Hemostasis Introducer is designed for the introduction of 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 & Respiratory Devices
| 510(k) Number | 12012922 |
|---|---|
| --------------- | ---------- |
| Prescription Use
| (Per 21 CFR 801.109) | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------------------------------ | -------------- | ---- | ---------------------- |
(Optional Format 1-2-96)