(1 days)
Not Found
No
The device description focuses on the physical components and mechanical features of a catheter introducer system, with no mention of software, algorithms, or data processing that would indicate AI/ML technology. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
Explanation: The device is described as an introducer system for percutaneous introduction of therapeutic or diagnostic devices, but it does not perform a therapeutic function itself.
No
The device is described as an introducer system for percutaneous introduction of intravascular devices, not for diagnosing conditions itself. It facilitates the use of other devices that may be diagnostic or therapeutic.
No
The device description explicitly details physical components like a sheath introducer, dilator, hemostasis valve, sideport extension, 3-way stopcock, and radiopaque tip, 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 it's for "percutaneous introduction of therapeutic or diagnostic intravascular devices" in arterial and venous procedures. This describes a device used in vivo (within the body) to facilitate other procedures, not a device used in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details a physical device (sheath introducer, dilator, valve, stopcock) designed for insertion into blood vessels. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
Therefore, the Reinforced Catheter Introducer System is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The RCIS is indicated for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The RCIS consists of a spiral reinforced sheath introducer and an appropriately sized dilator packaged in a tyvek/polymylar pouch.
Each reinforced introducer sheath features an integrated hemostasis valve system with a sideport extension and a 3-way stopcock. Fach introducer also has a radiopaque distal tip to aid the physician is correct placement of the device.
The RCIS dilator is lockable to the mating reinforced introducer sheath. The dilator has a straight curve configuration that extends approximately 2.5cm beyond the matching sheath when the dilator is locked to the sheath. The dilator is compatible with an up to 0.038" diameter guidewire.
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 (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.
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
510(k) SUMMARY SECTION 5: [as required by section 807.92(c)]
A. Submitter's Information:
| 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 / RA |
| Date Submission Prepared: | November 8, 2007 |
| MAY 14 2008 |
B. Device Information:
Trade name: Not assigned at the time of submission Classification Name(s): Catheter Introducer (21 CFR 8870.1340) Common or usual name(s): Reinforced Catheter Introducer System (RCIS)
C. Legally marketed device to which equivalence is claimed:
Arrow Transseptal Super Arrow-Flex Percutaneous Sheath (K970229) Terumo Medical Corporation Pinnacle Destination Peripheral Guiding Sheath (K051601)
D. Description of the device:
The RCIS consists of a spiral reinforced sheath introducer and an appropriately sized dilator packaged in a tyvek/polymylar pouch.
Each reinforced introducer sheath features an integrated hemostasis valve system with a sideport extension and a 3-way stopcock. Fach introducer also has a radiopaque distal tip to aid the physician is correct placement of the device.
The RCIS dilator is lockable to the mating reinforced introducer sheath. The dilator has a straight curve configuration that extends approximately 2.5cm beyond the matching sheath when the dilator is locked to the sheath. The dilator is compatible with an up to 0.038" diameter guidewire.
E. Intended use of the device:
The RCIS is indicated for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices.
KOB1341
p. Lot 2
1
F. Summary of the technological characteristics of the device compared to the predicate devices:
| Features | TMP
Reinforced
Sheath
[XD-
2809-00] | Super
Arrow
Flex
[CL-
07690] | Terumo
Pinnacle
Destination
[RSC05] |
|-----------------------------------------------|-------------------------------------------------|------------------------------------------|----------------------------------------------|
| Hemostasis valve provided | Yes | Yes | Yes |
| Compatible with .038" guide wire | Yes | Yes | Yes |
| Introducer available in 90cm length | Yes | Yes | Yes |
| Introducer set available in 6F | Yes | Yes | Yes |
| Introducer reinforced with a flat metal wire | Yes | Yes | Yes |
| Wire reinforcement completely
encapsulated | Yes | Yes | Yes |
| Radiopaque tip or marker | Yes | Yes | Yes |
| Sideport extension with 3-way stopcock | Yes | Yes | Yes |
| At least one matching dilator | Yes | Yes | Yes |
G. Substantial equivalence rationalc:
Thomas Medical Products, Inc. considers the Reinforced Catheter Introducer System substantially equivalent to the currently marketed predicate devices. This assessment is based upon analysis of similar technological characteristics, and indications for use.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2008
Intertek Testing Services c/o Mr. Jay Y. Kogoma 2307 E. Aurora Road, Unit 87 Twinsburg, OH 44087
Re: K081341
Reinforced Catheter Introducer System Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer Catheter Regulatory Class: Class II (two) Product Code: DYB Dated: May 12, 2008 Received: May 13, 2008
Dear Mr. Kogoma:
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.
3
Page 2 - Mr. Jay Y. Kogoma
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 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Brand D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of __ 1 _ .
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Indications For Use:
The [Reinforced Catheter Introducer System]* is indicated for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices.
*[or tradename]
Prescription Use _X (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter-Use (Per 21 CFR 801 Subpart C)
(Optional Format 11-13-03)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | ko 81341 |
510(k) "Indications For Use" Form (Replica of FDA Form)