(90 days)
Not Found
Not Found
No
The device description is for a simple mechanical introducer and there are no mentions of AI, ML, or image processing.
No
The provided information lacks an "Intended Use / Indications for Use" section, which is crucial for determining if a device is therapeutic. The current description "PTFE Peel Away Microintroducer" suggests a tool for introducing other devices, not a device that directly treats a condition.
No
The provided text only describes the device as a "PTFE Peel Away Microintroducer" and lacks information about its intended use, indications for use, or any diagnostic capabilities.
No
The device description explicitly states "PTFE Peel Away Microintroducer," which is a physical medical device, not software.
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: This crucial section for identifying an IVD is "Not Found". IVDs are specifically intended for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Without an intended use related to analyzing biological samples, it's not an IVD.
- Device Description: The description "PTFE Peel Away Microintroducer" suggests a device used for accessing a body cavity or vessel, likely for introducing other medical devices. This is a common description for devices used in interventional procedures, not for analyzing biological samples.
- Lack of other IVD indicators: The absence of information about image processing, AI/ML, input imaging modality, anatomical site, patient age range, intended user/care setting, training/test sets, performance studies, key metrics, and predicate/reference devices further supports that this is not an IVD. These elements are often present in submissions for devices that involve analysis or interpretation of data, which is central to IVDs.
In summary, the description of the device and the lack of any information related to the analysis of biological samples strongly indicate that this is not an In Vitro Diagnostic device. It appears to be a device used for accessing the body during a medical procedure.
N/A
Intended Use / Indications for Use
Not Found
Product codes
DYB
Device Description
Not Found
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.
Not Found
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
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design.
NOV - 6 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Intromed c/o Mr. Robert Mosenkis President CITECH 5200 Butler Pike Plymouth Meeting, PA 19462-1298
Re: K072130 PTFE Peel Away Microintroducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: October 15, 2007 Received: October 16, 2007
Dear Mr. Mosenkis:
This letter corrects our substantially equivalent letter of October 31, 2007.
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 (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 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.
1
Page 2 - Mr. Robert Mosenkis
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 continue 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
B! Simmerman Jr
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures