(63 days)
Not Found
No
The device description and intended use describe a purely mechanical introducer kit with no mention of software, algorithms, or any features that would suggest AI/ML capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is an introducer kit designed to facilitate the insertion and removal of various leads and catheters into the vascular system. It does not provide any therapeutic effect itself.
No
The device is described as an introducer kit used for the insertion of leads and catheters, not for diagnosing medical conditions. Its function is to facilitate the placement of other medical devices.
No
The device description clearly outlines physical components like a splittable sheath introducer, vessel dilator, hemostasis valve, needle, guidewire, and syringe, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the introduction of pacing/defibrillator leads and catheters into the vascular system. This is a procedural device used in vivo (within the body) for accessing blood vessels.
- Device Description: The description details a physical device (sheath introducer, dilator, etc.) used for a surgical/interventional procedure. It doesn't mention any components or functions related to analyzing biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or any other elements typically associated with IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a tool for accessing the vascular system during a medical procedure, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
The Large bore splittable introducer kit is intended to provide percutaneous access to the vascular system for the purpose of delivering various types of catheters, pacing leads, and defibrillator leads.
For the introduction of various types of pacing or defibrillator leads and catheters.
For the introduction of various types of catheters.
Product codes
DYB
Device Description
The Thomas Medical Products Inc. Large bore splittable introducer kit(s) consists of a splittable sheath introducer and appropriately sized vessel dilator. A hemostasis valve is incorporated at the proximal end of the sheath. The valve reduces blood loss through the sheath during the catheter / lead introduction. The 'splittable' function allows for removal of the sheath from the vascular system over the inserted catheter or lead and then removal the sheath from the lead by splitting the device along its' longitudinal axis.
The sheath is available packaged (1) sterile with an appropriately sized dilator, (2) sterile as a procedural convenience kit with an 18 gage XTW needle, guidewire, and 12 cc syringe, and (3) bulk non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
643438
FEB 1 5 2005
510(k) SUMMARY SECTION VI: [as required by section 807.92(c)]
Submitter's Information: A.
| Name: | Thomas Medical Products, Inc. |
|---|---|
| Address: | 65 Great Valley Parkway |
| Malvern, PA 19355 | |
| Telephone Number: | 610.296.3000 |
| Facsimile: | 610.296.4591 |
| Contact Person: | Tim Stoudt |
| Title: | Manager, QA Engineering / RA |
| Date Submission Prepared: | December 7, 2004 |
Device Information: B.
Trade name: Classification Name(s): Common or usual name(s): Not assigned at the time of submission Catheter Introducer (21 CFR §870.1340) Large bore splittable introducer kit, Hemostatic, peel-away, dialysis introducer
Legally marketed device to which equivalence is claimed: C.
Thomas Medical Products, Inc., Tear-away sheath introducer kit - K934901
Description of the device: D.
The Thomas Medical Products Inc. Large bore splittable introducer kit(s) consists of a splittable sheath introducer and appropriately sized vessel dilator. A hemostasis valve is incorporated at the proximal end of the sheath. The valve reduces blood loss through the sheath during the catheter / lead introduction. The 'splittable' function allows for removal of the sheath from the vascular system over the inserted catheter or lead and then removal the sheath from the lead by splitting the device along its' longitudinal axis.
The sheath is available packaged (1) sterile with an appropriately sized dilator, (2) sterile as a procedural convenience kit with an 18 gage XTW needle, guidewire, and 12 cc syringe, and (3) bulk non-sterile.
Intended use of the device: E.
The Large bore splittable introducer kit is intended to provide percutaneous access to the vascular system for the purpose of delivering various types of catheters, pacing leads, and defibrillator leads.
Summary of the technological characteristics of the device compared to the F. predicate device:
The technological characteristics of the device are the same as those of the predicate devices.
Substantial equivalence rationale: G.
The Thomas Medical Products Inc. Large bore splittable introducer kit has similar general intended use / indications for use and technological characteristics as other previously cleared devices. Therefore, based on these similarities, the Thomas Medical Products, Inc. Large bore splittable introducer kit is substantially equivalent to the legally marketed predicate devices.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three stylized lines or strokes. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 5 2005
Mr. Tim Stoudt Manager, QA Engineering/RA Thomas Medical Products, Inc. 65 Great Valley Parkway Malvern, PA 19355
Re: K043438
Trade/Device Name: Large Bore Splittable Introducer Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer Catheter Regulatory Class: II Product Code: DYB Dated: January 17, 2005 Received: January 18, 2005
Dear Mr. Stoudt:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your because is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce prox 201125 201125 2011 de necs that have been require approval of a premarket approval application (PMA). and Costictly (110) free ) 120) that the general controls provisions of the Act. The r ou may, merers, inisies of the Act include requirements for annual registration, listing of general oonly is free wing 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 11 your de for 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 r lease be actived had i termination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I with 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
2
Page 2 - Mr. Tim Stoudt
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
s (2005) (2005) (2005) (2005) (2005) (21) (2) 63) -542-642-481): 21 CFR 1000 forth in the quality systems (QS) regulation (2 ~21 cm 6 oee ,) ; 21 CFR 1000-1050.
product radiation control provisions (Sections 53 =542 of the Action 5 product radiation control provisions >> > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > This letter will allow you to begin marketing your advice of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of yo premarket notification. The PDA imaling of substantial equive 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
rs of the many of the many of 10, 276, 0100 - Also, massa note the regulati If you desire specific advice for your uc vice on our lassing segments the regulation entitled,
contact the Office of Compliance at (240) 276-0120. Also, please note You contact the Office of Compilatics at (240) 270 - 1210 FR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21) - 1 the Division of Small "Misbranding by reference to premarks. Louitieursn' (et Act from the Division of Small
other general information on your responsibilities under the tall from pumber (800) 638 other general information on your responsion its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its today himl. Manufacturers, International and Consumer Assistance as to to to and industry/support/index.html.
Sincerely yours,
Duna D. Vochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
For the introduction of various types of catheters.
Prescription Use __ × (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)
to be dner
Division Sir -Off) (Division of Cardiovascular Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number Ko 4343