(67 days)
TFX Medical I he introducer Assembly (1993191)
Not Found
No
The summary describes a mechanical introducer assembly and does not mention any AI/ML components or functionalities.
No.
The "Intended Use" states that the device is "intended to provide access to the venous system for device entry," not to treat a medical condition.
No
Explanation: The device is an Introducer Assembly with Rotator Lock, intended to provide access to the venous system for other devices. Its function is to facilitate entry, not to diagnose a condition or disease.
No
The device description clearly states it consists of a dilator and a split sheath introducer, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide access to the venous system for device entry". This describes a device used in vivo (within the body) to facilitate the insertion of other devices.
- Device Description: The description confirms it's a physical device (dilator and split sheath introducer) used for accessing the venous system.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, diagnosis, or treatment based on sample analysis.
- Reagents, calibrators, or controls typically associated with IVDs.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely procedural – creating access for other devices.
N/A
Intended Use / Indications for Use
The Introducer Assembly with Rotator Lock is intended to provide access to the venous system for device entry, when used in conjunction with additional percutaneous entry devices.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The Introducer Assembly with Rotator Lock consists of a dilator and a split sheath introducer that is used to provide access to the venous system for device entry, when used in conjunction with additional percutaneous critry devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous system
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)
All materials used in the fabrication of the Introducer Assembly with Rotator Lock were An matchals used in the faction safety tests as outlined in ISO 10993 Part 1 "Biological Evaluation of Medical Devices". Verification and Validation testing was performed Bloogical Evaluation of rivelion design and materials were found to be acceptable for the intended use
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.
TFX Medical I he introducer Assembly (1993191)
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
Image /page/0/Picture/0 description: The image shows the logo for Teleflex Medical. The logo is in black and white. The word "Teleflex" is in a bold, sans-serif font, and the word "MEDICAL" is in a smaller, sans-serif font below the word "Teleflex."
Teleflex Medical Group Headquarters 2345 Waukegan Road Bannockburn, IL 60015 USA 847-572-8002 Phone: 847-572-8001 Fax: www.teleflex.com
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Introducer Assembly with Rotator Lock
A. Name, Address, Phone and Fax Number of Applicant
Kobosil
Teleflex Medical Group Headquarters 2345 Waukegan Road, Suite 140 Bannockburn, IL 60015 USA Phone: 847-572-8002 847-572-8001 Fax:
-5 2006 MAY
B. Contact Person
Lori Hays Senior Manager, Regulatory Affairs
C. Date Prepared
February 24, 2006
D. Device Name
Trade Name: Introducer Assembly with Rotator Lock
Common Name: Catheter Introducer
Classification Name: Catheter Introducer
Product Code: DYB
Regulation Number: 870.1340
Class: II
E. Device Description
The Introducer Assembly with Rotator Lock consists of a dilator and a split sheath introducer that is used to provide access to the venous system for device entry, when used in conjunction with additional percutaneous critry devices.
Production of Children Children Children Children
1
F. Intended Use
The Introducer Assembly with Rotator Lock is intended to provide access to the venous system The Introduct I LSSeniory with conjunction with additional percutaneous entry devices.
G. Substantial Equivalence
The Introducer Assembly with Rotator Lock is substantially equivalent to the TFX Medical I he introducer Assembly (1993191) with respect to functionality, design, placement and use.
H. Summary of Testing
All materials used in the fabrication of the Introducer Assembly with Rotator Lock were An matchals used in the faction safety tests as outlined in ISO 10993 Part 1 "Biological Evaluation of Medical Devices". Verification and Validation testing was performed Bloogical Evaluation of rivelion design and materials were found to be acceptable for the intended use
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 5 2006
Teleflex Medical Group Headquarters c/o Ms. Lori Hays Senior Manager, Regulatory Affairs 2345 Waukegan Road, Suite 140 Bannockburn, IL 60015
Re: K060519
Introducer Assembly with Rotator Lock Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer -Regulatory Class: II Product Code: DYB Dated: April 6, 2006 Received: April 10, 2006
Dear Ms. Hays:
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 indivations for use stated in the enclosure) to legally marketed predicate devices marked 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, isting 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 may publish further announcements concerning your device in the Federal Register.
3
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast be devised and I Driv issualited your device complies with other requirements of the Act than Federal statutes and regulations administered by other Federal agencies. You must or any I odelui barees and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of N i at 807), its ensigned (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), please contact the 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,
Duna R. Wochner
\ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/1 description: The image shows the logo for Teleflex Medical. The word "Teleflex" is in a bold, sans-serif font, with the "T" stylized to look like a right angle. Below the word "Teleflex" is the word "MEDICAL" in a smaller, sans-serif font. The logo is black and white.
Teleflex Medical Group Headquarter 2345 Waukegan Koad Bannockburn, IL, 60015 USA 847-572-8002 Phone: Fax: 847-572-8001 www.teleflex.com
Indications for Use
Ko60519
510(k) Number (if known): K060519
Device Name: Introducer Assembly with Rotator Lock
Indications For Use:
The Introducer Assembly with Rotator Lock is intended to provide access to the venous system for device entry, when used in conjunction with additional percutaneous entry devices.
Prescription Use (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)
Duna R. Lunes
(Division Sign-Off)
Cardiovascular Devices
(A) Number_1 (06
Page 1 of 1